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Genetics Bundle

TriMark Publications
May 1, 2011
1846 Pages - SKU: TRI6283538

Abstract Table of Contents Related Reports

The Genetics Reports Bundle includes the following TriMark Publications reports at a 15% discount off the individual reports being purchased separately:

Bioinformatics Markets.
DNA Sequencing and PCR Markets.
Gene Expression Reagents Markets.
Genomics World Markets.
Microarray Markets.
Personalized Medicine.
Pharmacogenomics for Clinical Use and in Drug Development.
Regenerative Medicine Markets.
RNA Interference Markets.
Stem Cell Markets.

Below are summaries of each report.

The life science informatics marketplace--known as bioinformatics--is set to expand as high-tech companies infiltrate this arena and biopharmaceutical companies incorporate key informatic solutions into their business strategies. TriMark Publications believes that many of the segments of bioinformatics described in this report offer an unusual opportunity for accelerated expansion within the coming years. This study is arranged to provide an overview of bioinformatics market segments and offer evidence that these segments are poised for significant future growth. Each segment is accompanied by analysis and forecasts by product type and application. This analysis surveys the bioinformatics market and the latest information regarding emerging new products and industry trends. The study will quantify and qualify the bioinformatics market segments as an area of research, product development and investment. Forecasts of the bioinformatics market and an analysis of products in the worldwide information-processing market will provide a basis for understanding the significance of past developments and future possibilities within this market category.

The focus of this TriMark Publications report is to describe the specific segment of the life sciences market called DNA sequencing. This analysis includes all of the generally-accepted DNA-oriented analytical activities that are currently used today, such as enabling technologies like polymerase chain reaction (PCR). It examines these measurement technology platforms and their reagents and supplies as utilized in biotechnology research, pharmacology and healthcare. Generally, diagnostic tests which are marketed primarily as over-the-counter products directly to patients are not included in this study, although there is inevitably some overlap. This examination will: 1) identify viable technology drivers through a comprehensive look at various platform technologies for molecular sequencing, including immunoassays electrophoretic methods, probe-based nucleic acid assays, microarrays and non-PCR sequencing; 2) obtain a complete understanding of the chief molecular sequencing tests for predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic applications; 3) discover feasible market opportunities via an identification of high-growth applications in different therapeutic areas, with a focus on the biggest and expanding markets-communicable diseases, cardiology and oncology; and 4) focus on global industry development through an in-depth analysis of the major world markets for molecular sequencing, including forecasts for growth.

The area of gene expression reagents is one of the newest and most important sectors of pharmaceutical and bioscience research and development. The term gene expression reagents refers to chemicals that are used in gene expression experiments that are performed to determine whether a particular gene is expressed--i.e., present--and in some cases at what levels, in a biological sample. The purpose of this TriMark Publications report is to describe the specific segments of the global gene expression reagents market. Within this area, the study covers those segments that are highly active in terms of innovation and growth. Specifically, this review examines the markets for gene expression reagents and small lab equipment all the way up to highly automated platforms. Emphasis is on those companies that are actively developing and marketing gene expression reagents for genomics research in the academic sector and the pharmaceutical, bioscience industry. This study concentrates on the laboratory reagent market segment and the companion gene expression reagents sector in the U.S. and around the world that use materials for genetic research. Particular attention is paid to those areas of the gene expression reagents sector that are showing the greatest growth or the most innovation.

Genomics is transforming the pharmaceutical industry. Companies are moving from drug discovery and development based on medicinal chemistry to the design of drugs based on information provided by genomics. Virtually all of the major pharmaceutical houses have either formed partnerships with genomics firms that began to emerge in the early 1990s or have created in house genomics divisions. The aim of this TriMark Publications study is to provide in depth information on the developing market for genomics products and services. The report will include detailed market analyses and discussions of industry trends in order to assess the impact of genomics on the current and emerging pharmaceutical and diagnostic markets. Forecasts and trends were developed from interviews with industry sources, as well as from an assessment of available and emerging technologies. The report focuses on how researchers are applying new genomic approaches to drug discovery and development, and on how these technologies can be used most effectively and in a high throughput capacity. Case studies analyzing particular applications of genomic technologies to specific disease related research are provided, and future trends and developments are forecasted. Information to prepare this study was derived from interviews with product managers, marketing strategists, research executives and others. These individuals are employed at leading genomics firms or in pharmaceutical and biotechnology companies that either contract with these firms or have developed in house genomics capabilities.

A microarray is an arrangement of miniaturized test sites or "spots" on a surface. Each spot is usually no more than 250 micrometers in diameter and contains biological molecules--usually DNA or protein--which act as probes for a test sample applied to the array. The surface may be a glass slide, a plastic plate with wells or a polymer bead. The microarray format allows many tests or experiments to be performed simultaneously, in parallel, leading to the generation of huge amounts of biological information for the application of only a tiny amount of sample. Microarrays are often also known as "biochips". The purpose of this TriMark Publications report is to describe the specific segment of the microarray market aimed at analysis of proteins and DNA. Protein microarray applications include: 1) expression profiling; 2) serum-based diagnostics; 3) protein-protein binding assays; 4 drug-target binding; and 5) receptor epitope binding. It examines the market for DNA and protein array testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including the research labs, hospital labs, and commercial laboratories. Additionally, the numbers of institutions using this type of testing and the factors that influence purchases are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the protein array market in the U.S. Each company is discussed in depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position.

Personalized medicine and pharmacogenomics are inextricably linked. Pharmacogenomics is the use of genetic variations (such as SNPs, gene expression variability, or other molecular signatures) to understand and correlate with differential response to pharmaceutical agents (drugs). Pharmacogenomics can be deployed clinically to stratify patients into responders and non-responders and this practice is termed personalized medicine. The purpose of this TriMark Publications report is to describe the specific market segment of the diagnostics market called personalized medicine. To frame the context of current approaches, pharmacogenomics seeks to identify and validate the signature(s) of molecular analytes and these are converted to assays using the tools of molecular diagnostics. The deployment of these molecular diagnostics assays on defining and targeting patient populations is the domain of personalized medicine. This study includes all of the generally-accepted imaging activities that are currently used in personalized medicine, including pharmacogenomics, genomics and theranostics. It examines associated clinical market segments in which personalized medicine has taken a prominent role including cancer treatment, cardiology and neurology markets.

Pharmacogenomics, the science of individualizing drug therapy based on the genetic makeup of individual patients, offers an unusual opportunity for future market growth. Applying pharmacogenomics would allow doctors to treat specific segments of the population based on their particular responses to a drug. The knowledge of the likely effectiveness of a drug in a patient makes the drug more reliable, and fewer drugs would have to be taken off the market due to adverse reactions in some, but not all, of the patients to whom they were administered. Additionally, reducing the occurrence of adverse effects to a drug effectually reduces the cost of patient care overall. This TriMark Publications study examines the market for diagnostic tests based on this science and the clinical measurement methods, the reagents and supplies being utilized in clinical medicine and the pharmaceutical industry. This report presents an overview of the latest information regarding emerging new products and industry trends and will not only quantify, but also, qualify the pharmacogenomic market segments as an area of research, product development and investment opportunity. Forecasts of the pharmacogenomic market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and the immense possibilities of the future.

Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands. Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine. This TriMark Publications report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures. The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.

Since its discovery, the naturally occurring RNA (ribonucleic acid) interference effect has been acclaimed as the most exciting technical breakthrough in biological research in the last decade. Some industry analysts predict that RNA interference (RNAi) may even surpass PCR as a top technology. RNAi allows scientists to silence the expression or effect of a gene under study. This is known as gene knockdown. This field has rapidly emerged as a fast-growing new market. The purpose of this TriMark Publications report is to review the market for RNAi testing equipment and supplies. RNAi is a mechanism in molecular biology where the presence of certain fragments of double-stranded RNA (dsRNA) interferes with the expression of a particular gene which shares a similar sequence with the dsRNA. This study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence market size and growth for RNAi testing. The main objectives of this study are to: 1) understand the different sectors of RNAi testing market and to look at a description of the instruments, reagents and supplies marketed by major companies in each segment; 2) obtain a complete understanding of the individual RNAi-testing platforms--from basic principles to clinical applications; 3) discover feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, with a focus on the biggest and expanding markets; 4) focus on global industry developments and trends through an in-depth analysis of the major world markets for RNAi measurement technology, including growth forecasts; and 5) present market figures related to the current value of RNAi testing, market projections, market share, key players and sector growth rates.

A stem cell is an extraordinary type of cell that has the ability to self-renew for long periods of time and to differentiate into specialized cells under appropriate physiological or experimental conditions. Traditionally, stem cells have been classified as either embryonic, adult (tissue-specific or cord blood) stem cells. Recent understanding of stem cell biology may provide new approaches for the treatment of a number of diseases as well as tissue/organ injuries, including cardiovascular disease, neurological disease, musculoskeletal disease, diabetes and hematopoietic disorders. Stem cell fate is determined by both intrinsic regulators and the extra-cellular environment (niche), and their expansion and differentiation ex vivo are generally controlled by growing them in a specific configuration (monolayer or three-dimensional culture). This process, which is vital to enable stem cells to be used for therapeutic purposes, is called differentiation. Differentiation is a process involving unspecialized cells progressing to become specialized cells with restricted developmental potential. The purpose of this TriMark Publications report is to describe the specific market segments of the medical research space using stem cells for research and development purposes. This study reviews all of the generally accepted analytical methods that are currently in use today for preparing and using stem cells. It examines the use of stem cells in developing new therapies for disease.

Bioinformatics Markets

1. Overview

1.1 Statement of Report

1.2 About this Report

1.3 Scope of this Report

1.4 Methodology

1.5 Executive Summary

2. Introduction

2.1 Global Bioinformatics Products Industry

2.2 Computers and Biology

2.3 Bioinformatics and the Internet

2.4 Company Evaluation Overview

2.5 Market Outlook

2.6 Competitive Structure

2.7 Applications of Bioinformatics

2.7.1 Medicine

2.7.2 Microbial Genomics

2.7.3 Agriculture

2.8 R&D

2.8.1 Allocation of R&D

2.8.2 Traditional Drug Discovery Process

2.8.3 Drug Discovery and Bioinformatics

2.8.4 Collaborative Agreements

2.9 The Human Genome Project (HGP)

2.9.1 Goals of the Human Genome Project

2.9.2 Benefits of the Human Genome Project

2.10 Barriers to Entry

2.11 Proteomics and Databases

2.11.1 Protein Database Standards

2.11.2 Future Trends

3. The U.S. Bioinformatics Market

3.1 Overview

3.2 Market Restraints and Drivers

3.2.1 Market Restraints

3.2.2 Market Drivers

4. Genomics

4.1 The Biotechnology Industry

4.2 The Development of a Genomics Market

4.2.1 Market Drivers

4.2.2 Market Restraints

4.2.3 Market Size and Growth Projections

4.2.4 The U.S. Genomics Market

4.3 Biochips and DNA Microarrays

4.3.1 Key Challenges

4.3.2 Freeware

4.3.3 New Tools

4.4 Bioinformatics

4.5 Disease Targets

4.6 Functional Genomics

4.7 Gene Sequencing

4.8 Gene Sequence Variation Detection

4.9 Comparative Genomics

4.10 Genome Database Arrays

4.11 High-throughput Genomics

4.11.1 High-throughput Technology

4.11.2 Lab on a Chip

4.12 Pharmacogenomics

4.13 Probe Arrays

4.13.1 Gene Expression Monitoring Arrays

4.13.2 DNA Analysis Arrays

4.14 Proteomics

4.15 Sequencing

4.16 Single Nucleotide Polymorphisms (SNPs)

4.17 Structural Genomics

4.18 Photolithography

4.19 Instrumentation

5. The Bioinformatics Industry

5.1 Definition and Role of Bioinformatics

5.1.1 Bioinformatics Sector Overview

5.1.2 The Future Status of Bioinformatics

5.1.3 Barriers to Growth

5.2 Types of Data and Bioinformatics Applications

5.2.1 Validated Core Modeling Technology

5.2.2 Broad Applicability

5.2.3 Data Management Compliant with Industry Standards

5.2.4 Open Architecture

5.2.5 Ease of Use

5.2.6 Increased Access

5.3 Functions of Bioinformatics Software

5.3.1 Data Management

5.3.2 Data Transformation

5.3.3 Data Collaboration

5.3.4 Interface for Online Data Sources

5.4 Target Markets for Informatics Software

5.5 Steps Involved in Bringing a Drug to Market

5.6 Costs Incurred in Developing a New Drug

5.7 Industry Drivers and Challenges

5.8 Industry Risks

5.9 Products of Bioinformatics

5.10 Bioinformatics Processes

5.11 Informatics Tools and Functionalities

5.11.1 Sequence to Structure

5.11.2 Lead Identification and Optimization

5.11.3 Development and Formulation

5.11.4 Improving Materials and Processes

5.11.5 Other Materials-Based Industries

5.12 Role of Bioinformatics in the Biotechnology Value Chain

5.13 Bioinformatics Market Segment

5.13.1 Databases

5.13.2 Hardware

5.13.3 Software

5.13.4 Bioinformatics Services

5.14 Bioinformatics Market Size

5.14.1 Sales and R&D

5.14.2 IT Budget

5.14.3 Projected Bioinformatics Market Size

5.15 Global Market Perspective

6. Bioinformatics Business

6.1 Bioinformatics Business Models

6.1.1 Changing Business Models

6.1.2 Competition for Pure Play Informatics Companies

6.1.3 Non-Profit Organizations

6.1.4 In-House Bioinformatics Solutions

6.1.5 Large IT Companies

6.2 Bioinformatics Target Disciplines

6.2.1 Comparative Genomics

6.2.2 Pharmacogenomics

6.2.3 Functional Genomics

6.2.4 Proteomics

6.2.5 Structural Genomics

6.2.6 Image Informatics

6.2.7 Clinical Trial Informatics

6.2.8 Cheminformatics

6.3 Bioinformatics Architecture

6.4 Bioinformatics Applications

6.4.1 Data Search Tools

6.4.2 Data Visualization Tools

6.4.3 Data Mining and Clustering

6.4.4 Enterprise Solutions

6.4.5 Data Warehousing

6.5 Evaluation of Bioinformatics Solutions

6.5.1 Requirements of Study

6.5.2 Shortlisting the Options

6.5.3 Scoring Patterns

6.5.4 Performance

6.5.5 Data Storage

6.5.6 Data Management in Drug Discovery

6.5.7 Key Issues in Bioinformatics Data Storage

6.6 Convergence of Industries

6.7 Proteins as a Driver

6.8 Current Bioinformatics Research

6.9 New Bioinformatics Modeling Algorithms

6.10 3D Modeling

6.11 Patenting Bioinformatics Algorithms

7. Recent Industry Activity

7.1 Collaborations and Acquisitions

7.2 Product Development and Launches

8. Corporate Profiles

8.1 Abbott Laboratories

8.2 Abgenix

8.3 Ablynx

8.4 Accelrys

8.5 Affimed Therapeutics

8.6 Affitech

8.7 Affymetrix

8.8 Agencourt Bioscience Corporation

8.9 Agensys

8.10 Agilent Technologies

8.11 Alexion Pharmaceuticals

8.12 AlgoNomics

8.13 ALLEZ Software

8.14 Amgen

8.15 Antisoma

8.16 Applied Biosystems

8.17 Arana Therapeutics

8.18 Ariadne Genomics

8.19 Array Genetics

8.20 Astellas Pharma

8.21 AstraZeneca

8.22 Automated Handling Systems

8.23 Avesthagen, Limited

8.24 Bioalma

8.25 BIOBASE Biological Databases

8.26 BioCarta

8.27 Biodatabases (AMITA Corporation)

8.28 BioDiscovery

8.29 Biogen Idec

8.30 BioInformatics

8.31 BioInformatics Services

8.32 BioInformatics Solutions

8.33 Biomax Informatics

8.34 BioServe Technologies

8.35 Biosiris

8.36 BioSoftSolutions

8.37 Biotique Systems

8.38 BioInvent International

8.39 Biosite Discovery

8.40 BioWa

8.41 BioWisdom

8.42 Bio-Xtal

8.43 Boehringer Ingelheim

8.44 Cambridge Antibody Technology Group

8.45 Capital Genomix

8.46 Celera Group

8.47 Cellectis

8.48 Cellomics

8.49 CeuticalSoft

8.50 Chemical Computing Group

8.51 Cimarron Software

8.52 CLONDIAG Chip Technologies

8.53 CodonCode Corporation

8.54 CompuDrug International

8.55 Compugen USA

8.56 Corimbia

8.57 Crucell

8.58 CSIRO Bioinformatics

8.59 CuraGen Corporation

8.60 CyberGene

8.61 Cytogen

8.62 Data Unlimited International

8.63 deCODE Genetics

8.64 Decodon

8.65 Deltagen

8.66 Digilab

8.67 DNA Software

8.68 DNAPrint Genomics

8.69 DNA Star

8.70 DxS

8.71 Dyax Corp.

8.72 Eisai

8.73 Elan Corporation

8.74 Electric Genetics Corporation

8.75 Elusys Therapeutics

8.76 Entagen

8.77 Entelos

8.78 Enzon Pharmaceuticals

8.79 Epigenomics

8.80 ePitope Informatics

8.81 EraGen Biosciences

8.82 European Bioinformatics Institute (EBI) Industry Programme

8.83 Evolutionary BioInformatics

8.84 Genamics

8.85 GeneData

8.86 Gene Logic

8.87 Genentech

8.88 Geneva Bioinformatics (GeneBio)

8.89 Genmab

8.90 GenOdyssee

8.91 Genolyze

8.92 Genomatica

8.93 GenomeQuest

8.94 Genomic Solutions

8.95 Genomining

8.96 Genovac

8.97 Genzyme

8.98 Geospiza

8.99 GlaxoSmithKline

8.100 Glycominds

8.101 Health Discovery Corporation

8.102 Hitachi Corporate Technology Group

8.103 IBM Life Sciences

8.104 ImClone Systems

8.105 ImmunoGen

8.106 Immunomedics

8.107 Improved Outcomes Software

8.108 INCOGEN

8.109 Incyte Corporation

8.110 Informagen

8.111 Ingenuity Systems

8.112 InNexus Biotechnology

8.113 Insilicos

8.114 Intrexon Corporation

8.115 Invitrogen Corporation

8.116 IO Informatics

8.117 Johnson & Johnson

8.118 LabVantage Solutions

8.119 Lexigen

8.120 Lifespan Biosciences

8.121 Lion Bioscience

8.122 MathEcology

8.123 Matrix Science

8.124 Medarex

8.125 Medicel

8.126 MedImmune

8.127 Merus

8.128 METabolic Explorer

8.129 Metahelix Life Sciences

8.130 Metalife

8.131 Micromet

8.132 Millennium Pharmaceuticals

8.133 Molecular Connections

8.134 Molecular Networks

8.135 Molecularware

8.136 MorphoSys

8.137 Nexus Genomics

8.138 Nonlinear Dynamics

8.139 Novartis

8.140 Ocimum Biosolutions

8.141 OmniViz

8.142 Partek

8.143 PDL BioPharma

8.144 Perlegen Sciences

8.145 Philogen

8.146 Philotec

8.147 Prokaria

8.148 Quantiom Bioinformatics

8.149 Relevant Software

8.150 Roche

8.151 Rosetta Inpharmatics

8.152 Sanofi-Aventis

8.153 SBI Science

8.154 Seascape Learning

8.155 Seattle Genetics

8.156 Scil Proteins

8.157 Simulations Plus

8.158 Spotfire

8.159 Strand Life Sciences

8.160 Sun Microsystems

8.161 Symphogen

8.162 Syngene

8.163 Tahoe Informatics

8.164 Tanox

8.165 3rd Millennium

8.166 ThromboGenics

8.167 Thomson Reuters

8.168 TIB MOLBIOL

8.169 Trion Pharma

8.170 Tripos

8.171 UBI Life Sciences

8.172 Viventia Biotech

8.173 VizX Labs

8.174 Wyeth

8.175 Xcellerex

8.176 Xencor

8.177 Xoma

8.178 Xpogen

DNA Sequencing and PCR Markets

1. Overview

1.1 Statement of Report

1.2 About This Report

1.3 Scope of the Report

1.4 Methodology

1.5 Executive Summary

2. Introduction to DNA Sequencing and Amplification and PCR Technology

2.1 Science Overview: Introduction to DNA

2.1.1 DNA Sequencing and PCR Applications Space

2.1.2 Proteomics

2.1.3 Products for the Genomics Market

2.2 The Impact of the Human Genome Project on Molecular Biology

2.3 Impact of DNA Sequencing Techniques on Biotechnology, Pharmaceutical and Healthcare Industries

2.4 Molecular Diagnostics in the Post-genomic Era-The Role of SNPs

2.5 Advances in Molecular Diagnostic Technologies

2.6 The Use of PCR Technology

2.7 Genetic Variability and Disease

3. Market Analysis of PCR and DNA Sequencing Product Market

3.1 Overview of the Sequencing and Amplification Market

3.1.1 Highlights of DNA Sequencing Market

3.1.2 Genomic Analysis Market Development

3.1.3 Leading U.S. and Canadian Companies Offering Sequencing Technology Platforms

3.1.4 Competition

3.1.5 Markets for DNA Sequencing

3.1.6 Market Opportunity

3.1.7 Market Dynamics

3.1.8 Overview of Current DNA Sequencing Technology Platforms and Players

3.1.9 Limitations of Current Sequencing Technologies

3.1.10 Overview of the Life Science Marketplace

3.1.11 Research Laboratories

3.1.11.1 Market Share

3.2 Paradigm Shift in Drug Discovery and Development

3.2.1 Systems Biology and the Need for More Effective Tools

3.2.2 Molecular Medicine and the New Therapeutics

3.2.3 Pharmacogenomics Using Genotyping and Phenotyping Clinical Biomarkers

3.2.4 The Market

3.3 Detection of Amplified DNA

3.3.1 Nucleic Acid Amplification Methods

3.3.2 Amplification of Refractory Mutation System (ARMS)

3.4 DNA Reagent Applications Market Share and Key Players

3.4.1 Product Description

3.4.1.1 Pricing

3.5 PCR/DNA Testing Market Analysis

3.5.1 Nucleic Acid-Amplification and Detection Systems: How Big a Market?

3.5.2 Market Size 2004-2010 and Growth Projections in DNA Amplification Instrumentation

3.5.2.1 U.S. Market

3.5.2.2 European Market

3.5.3 Market Share of Key Players in DNA Amplification

3.6 The Drivers of the Biotech Industry

3.6.1 Isolation of DNA for PCR Profiling

3.6.2 Analysis by PCR-Based DNA Typing

3.6.3 Rapid Isolation of DNA for RFLP and PCR

3.6.4 DNA for PCR-STR Typing

3.7 Biotechnology Instrumentation Outlook

3.7.1 Products for the Genomics Market

3.7.2 Genetic Analysis Products

4. Use of PCR and DNA Amplification Products

4.1 PCR Components

4.1.1 Primers for PCR

4.1.2 Equipment for PCR

4.2 Sources of DNA for PCR

4.3 PCR Primer Sequence

4.4 Thermostable DNA Polymerases

4.5 PCR Protocols

4.6 Microfluidic Automated DNA Analysis Using PCR

5. Technical Trends in PCR

5.1 Practical Applications of PCR

5.1.1 Overview

5.2 Quality Control Issues in PCR

5.3 Determining Length of cDNA Product

5.3.1 Direct Signal Amplification Using the Invader Assay

5.3.2 Biosensor Technologies

5.3.2.1 DNA Hybridization Biosensor Chips

5.3.2.2 PNA-Based Biosensors

5.4 Novel Nucleic Acid Amplification Techniques

5.5 Microplate Readers

5.6 Genotyping Methods

5.6.1 Use of DNA Sequencers

5.6.1.1 Capillary-Based Sequencers

5.6.1.2 Pyrosequencing

5.6.2 Use of Microarrays

5.7 RiboMaker Detection System

5.8 RNA Isolation Kits

5.9 Nucleic Acid Sample Prep Platforms

5.10 DNA Microarrays

5.10.1 The Technique

5.10.2 The Market

5.10.3 Gene Expression Monitoring Arrays

5.11 Emerging Markets of DNA Arrays

5.12 Alternatives to PCR Amplification

5.12.1 Locked Nucleic Acids (LNAs)

5.12.2 Multiplexed Nuclease-Protection Assay and ArrayPlate

6. Corporate Directory

6.1 Abbott Laboratories

6.2 Affymetrix

6.3 Agilent Technologies

6.4 AgriGen Biotech Pty

6.5 GE Healthcare

6.6 Applera Applied Biosystems

6.7 Avesthagen Gengraine Technologies, Pvt.

6.8 Bayer Corporation

6.9 BD Biosciences

6.10 Beckman Coulter

6.11 BGI Life Tech

6.12 bioMérieux

6.13 Bioneer

6.14 Bio-Rad Laboratories

6.15 BioTrove

6.16 Caliper LifeSciences

6.17 Cepheid

6.18 Cogenics (A subsidiary of Clinical Data)

6.19 CombiMatrix Corporation

6.20 Commonwealth Biotechnologies

6.21 Complete Genomics

6.22 CuraGen Corporation

6.23 Cytocell

6.24 Dako A/S

6.25 DiaDexus

6.26 DNA LandMarks

6.27 DNAVision

6.28 Enzo Biochem

6.29 Epicentre

6.30 Eppendorf AG

6.31 Eurofins Medigenomix

6.32 Exiqon

6.33 Febit Biomed

6.34 Geneart AG

6.35 GeneticTechnologies Limited

6.36 GeneWorks

6.37 Genisphere

6.38 Genizon BioSciences

6.39 Genovoxx

6.40 Gen-Probe

6.41 Genset

6.42 Genta

6.43 Genzyme

6.44 GVK BIO

6.45 Hamilton Thorne Biosciences

6.46 Helicos BioSciences Corporation

6.47 High Throughput Genomics

6.48 Hokkaido System Science

6.49 Hy Laboratories

6.50 Illumina

6.51 Incyte Corporation

6.52 Integrated DNA Technologies

6.53 Invitrogen

6.54 Inqaba Biotechnical Industries

6.55 Johnson & Johnson

6.56 Kreatech Holding BV

6.57 LI-COR

6.58 Sygnis Pharma AG

6.59 Lucigen

6.60 Luminex Corporation

6.61 Meridian Biosciences

6.62 Microchip Biotechnologies

6.63 Microsynth AG

6.64 MilleGen SA

6.65 Millennium Pharmaceuticals

6.66 MWG Biotech AG

6.67 Myriad Genetics

6.68 Nanogen

6.69 Nanosys

6.70 Nymox

6.71 Ocimum Biosolutions

6.72 Orchid Cellmark

6.73 Ostex

6.74 Pacific Biosciences

6.75 PamGene

6.76 Perlegen Sciences

6.77 PPD

6.78 PPGx

6.79 PrimmBiotech

6.80 Promega

6.81 Biotage

6.82 QIAGEN

6.83 Quidel

6.84 Research Biolabs Pte

6.85 Roche Diagnostics

6.86 Shanghai Sangon Biological Engineering Technology & Services Co.

6.87 Saturn Biotech

6.88 Sequenom

6.89 Sequetech

6.90 Shimadzu Biotech

6.91 Siemens AG

6.92 Tepnel Life Sciences

6.93 Third Wave Technologies

6.94 Visible Genetics

6.95 VisiGen Biotechnologies

6.96 Vysis

6.97 Wellcome Trust Sanger Institute

6.98 ZS Genetics

7. Market Trends and Forecasts

7.1 Market Dynamics

7.2 Future Considerations for Molecular Diagnostics

7.3 How Genomics is Transforming Pharmaceutical R&D

7.4 Cancer Markers

7.5 NAT and Personalized Medicine

7.6 Three Growth Areas of Molecular Diagnostics

7.7 RNA Detection

7.8 Ramification Amplification Method

7.9 Invader Assays/Third Wave Technologies

7.10 Molecular Beacons

8. Major Product Innovations/Launches in DNA Sequencing Industry

8.1 Major Product Innovations/Launches in DNA Sequencing Industry

8.2 Major Activities in DNA Sequencing Industry

Gene Expression Reagents Markets

1. Introduction

1.1 Statement of Report

1.2 Objectives and Goals of Study

1.3 Methodology

1.4 Executive Summary

1.4.1 Market Drivers

1.4.2 Market Restraints

1.4.3 Market Size and Growth Projections

1.5 What Is a Gene?

1.6 Gene Expression

1.7 Genetic Variability

1.8 The Human Genome Project (HGP)

1.9 Gene Databases

1.10 Sequencing and Resequencing

1.11 RNA Interference (RNAi)

1.12 DNA Tags

2. Genomics Technology and Industry

2.1 The Development of a Genomics Market

2.1.1 Market Size and Growth Projections

2.1.2 The U.S. Genomics Market

2.2 DNA Microarray Technology

2.2.1 Biochips

2.2.2 Photolithography

2.2.3 Instrumentation for DNA Microarray Analysis

2.2.4 Lab-on-a-Chip

2.2.5 DNA Microarrays

2.3 Applications of DNA Microarrays

2.3.1 DNA Sequence Analysis

2.3.2 Gene Expression Analysis

2.3.3 Effect of DNA Sequence and Gene Expression Monitoring on the Genomics Market

2.4 Bioinformatics

2.5 Functional Genomics

2.5.1 Gene Knockdown

2.5.2 Protein-Protein Interactions

2.5.3 Bioinformatics

2.5.4 Strategies of Functional Genomics Companies

2.5.5 Frontiers in Functional Genomics

2.6 Comparative Genomics

2.7 Pharmacogenomics

2.8 Proteomics

2.9 Structural Genomics

2.10 Disease Targets

2.10.1 Paradigm Shift in Drug Development: The Evolution of Targeted Therapies

2.10.2 Personalized Warfarin Therapy

3. How Genomics Is Revolutionizing Healthcare

3.1 Pharmaceutical Applications

3.2 Diagnostics

3.3 Toxicogenomics

3.4 The Market for DNA Microarrays

3.5 DNA Chip Technology Competition

3.6 Expression Profiling

3.7 Gene Sequencing—Advantages of Chip Array Technology

3.8 Applied Markets for Genomics

3.9 Genomics and the Pharmaceutical Companies

3.10 Cancer Markets

3.11 Agricultural Markets

3.11.1 Plant Genomics

3.11.2 Food Processing

3.11.3 Animal Husbandry

4. Proprietary Applications and Patents

4.1 What is Patentable?

4.2 Patents and Litigation

5. Business Analysis

5.1 Facilitation and Capitalization of the Convergence of Gene Expression Analysis and Proteomics

5.2 Competition

5.3 Market Opportunities for Functional Genomics

5.3.1 Metabolic Profiling

5.3.2 Anti-Fungal Targets

5.3.3 Nutrition

5.3.4 Crop Production

5.4 The Highly-Competitive Nature of the Genomics Industry

5.4.1 First-Generation Biotech

5.4.2 Second-Generation Genomics Companies

5.4.3 Next-Generation DNA Sequencing Companies

5.5 Strategic Alliances

6. Genomics Company Profiles

6.1 Affymetrix, Inc.

6.2 Agendia

6.3 Agilent Technologies, Inc.

6.4 Applied Biosystems Group

6.5 Bayer, AG

6.6 Biotage

6.7 Caliper Life Sciences

6.8 Celera Group

6.9 Cepheid

6.10 CLC bio

6.11 Clinical Data, Inc.

6.12 CuraGen Corporation

6.13 Cytocell Ltd.

6.14 diaDexus, Inc.

6.15 Enzo Biochem, Inc.

6.16 Exiqon A/S

6.17 GE Healthcare

6.18 Gene Link, Inc.

6.19 Gene Logic, Inc.

6.20 Genentech, Inc.

6.21 Genisphere, Inc.

6.22 Genomatix Software, Inc.

6.23 Genomic Solutions, Inc.

6.24 Gen-Probe, Inc.

6.25 Harvard Bioscience, Inc.

6.26 Helicos Biosciences Corporation

6.27 Human Genome Sciences, Inc.

6.28 Illumina, Inc.

6.29 Interleukin Genetics

6.30 LI-COR Biosciences

6.31 Luminex Corporation

6.32 Millennium Pharmaceuticals, Inc.

6.33 Monogram Biosciences, Inc.

6.34 Motorola, Inc.

6.35 MWG Biotech AG

6.36 Myriad Genetics, Inc.

6.37 Nanogen, Inc.

6.38 Nuvelo, Inc.

6.39 Orchid Cellmark

6.40 Pacific Biosciences, Inc.

6.41 QIAGEN, Inc.

6.42 Roche Diagnostics

6.43 Sequenom, Inc.

6.44 Third Wave Technologies, Inc.

6.45 Verenium Corporation

6.46 Visigen Technologies, Inc.

6.47 Brief Profiles of Companies Marketing Personalized Genomics Products

6.47.1 23andMe, Inc.

6.47.2 deCODE Genetics, Inc.

6.47.3 Navigenics, Inc.

6.48 Brief Profiles of Other Selected Genomics Firms

6.48.1 Aber Genomic Computing

6.48.2 Spotfire, Inc.

7. Genomics Challenges and Growth Factors

7.1 Market Drivers

7.1.1 Product Pipeline: Need for More Drug Candidates

7.1.2 Need for Increased Research and Development Productivity

7.2 A Genomics Market Bottleneck—Bioinformatics

7.3 Strategic Recommendations—Market Opportunities

7.3.1 More Comprehensive Tools Are Needed

7.3.2 Resolving Bottlenecks in Functional Genomics Market

7.4 Key Trends of Recent Mergers and Acquisition Deals

7.5 Chemogenomics

7.6 Pharmacogenomics

7.7 Biomarkers

7.8 Additional Genomics Market Opportunities

8. Bioinformatics

8.1 Types of Data and Bioinformatics Applications

8.1.1 Validated Core Modeling Technology

8.1.2 Broad Applicability

8.1.3 Data Management Compliant with Industry Standards

8.1.4 Open Architecture

8.1.5 Ease of Use

8.1.6 Increased Access

8.2 Functions of Informatics Software

8.2.1 Data Management

8.2.2 Transformation of Data into Knowledge

8.2.3 Collaboration Among Researchers

8.2.4 Interface for Online Data Sources

8.3 Target Markets for Informatics Software

8.3.1 Pharmaceutical Companies

8.3.2 Biotechnology Companies

8.3.3 Academic and Government Research Institutions

8.3.4 Agricultural, Environmental and Industrial Biotechnology Companies

8.4 Products of Bioinformatics

8.4.1 Sequences and Structure of Genes and Proteins

8.4.2 3-D Molecular Structures

8.4.3 Genome Structures and Functions

8.4.4 Bibliographic Data

8.5 Bioinformatics Processes

8.6 Informatics Tools and Functionalities

8.6.1 Sequence to Structure

8.6.2 Lead Identification and Optimization

8.6.3 Development and Formulation

8.6.4 Improving Materials and Processes in the Chemicals Industry

8.6.5 Other Materials-Based Industries

8.7 Role of Bioinformatics in the Value Chain

8.8 Bioinformatics Market Segments

8.8.1 Database

8.8.2 Hardware

8.8.3 Software

8.8.4 Bioinformatics Services

8.9 Bioinformatics Business Models

8.9.1 Changing Business Models

8.9.2 Selected Business Strategies

Glossary

Microarray Markets

1. Overview

1.1 Statement of Report

1.2 About This Report

1.3 Scope of the Report

1.4 Objectives

1.5 Methodology

1.6 Executive Summary

2. Overview of Microarrays

2.1 History of Microarrays

2.2 Genomics and Proteomics

2.2.1 Genetic Variability and Disease

2.3 General Theory of Microarrays

2.4 DNA Microarrays

2.5 Protein Microarrays

2.6 Tissue Microarrays

3. DNA Microarrays

3.1 Advantages and Drivers

3.2 Limitations and Barriers to Commercialization

3.3 DNA Microarray Technology Platforms

3.3.1 Reasons Why Researchers Utilize DNA Microarrays

3.3.2 Factors for Difficulties Applying DNA Microarrays Technology

3.4 Key Attributes of DNA Microarray Software

3.5 Applications

3.6 Future Directions for DNA Microarray Technology

3.6.1 High-Throughput Array Technology

3.6.2 Emerging Microarray Trends

3.6.3 Emerging Microarray Applications

3.6.4 Key Points for Developing Microarray Based Applications

3.7 Competitive Landscape for DNA Microarrays

4. Protein Microarrays

4.1 Critical Factors for Microarray Content

4.2 Key Findings on Use of Microarrays

4.3 Advantages and Drivers

4.4 Limitations and Barriers to Commercialization

4.5 Key Experimental Parameters of Protein Microarray Technology for Current and Future Users

4.6 Reasons Why Researchers Utilize Protein Microarrays

4.7 Factors for Adoption of Protein Microarrays Technology

4.8 Top Suppliers of Protein Microarray Slides and Products

4.9 Factors that Influence Sale Decisions

4.10 Future Innovations in Protein Microarray Technology

5. Current DNA Microarrays

5.1 Key Players

5.2.1 Microarray-Based Commercial Genotyping Activity

5.2.2 Location Analysis

5.3 Future Innovations in DNA Microarray Technology

6. Current Protein Microarrays

6.1 Protein Profiling Microarrays—Antibody Arrays

6.2 Protein Profiling Microarrays—Reverse Phase Microarrays

6.3 Multiplex Sandwich Microarrays—Planar

6.4 Multiplex Sandwich Immunoassays—Bead Based

6.5 Microarrays for Protein Function Studies

6.6 High Growth Applications

6.6.1 Cytokine Arrays

6.6.2 Whole Proteome Arrays

6.6.3 Microarray-Based Commercial Genotyping Activity

6.6.3.1 Microarray-Based Genotyping Applications

6.6.3.2 Microbial Applications

6.6.3.3 The Market for Microbial Genotyping Products

6.6.3.4 Comparative Genomic Hybridization (CGH)

6.6.4 ChIP-on-Chip Analysis

7. Technology

7.1 Production of Microarrays

7.2 2-D Versus 3-D Technology

7.3 Substrates and Surface Chemistries

7.4 Detection Methods

7.5 Instruments

7.6 Data Management and Informatics in Gene Expression

8. Applications

8.1 DNA Microarrays in Gene Expression

8.2 DNA Microarrays in SNP Analysis

8.3 DNA Microarrays in Cancer

8.4 Protein Expression

8.4.1 Cytokine Applications

8.4.2 Protein Function

8.4.3 Protein-Protein Interactions

8.5 Target /Biomarker Discovery

8.6 Drug Discovery and Development (Gene and Protein Microarrays)

8.7 Clinical Diagnostics (Gene and Protein Microarrays)

8.8 RNA Microarrays

8.9 Oligo Microarrays

8.10 Yeast Microarrays

8.11 Antibody Arrays

8.12 Arrays for Toxicogenomics

9. The Commercial Opportunity for Microarrays

9.1 Market Drivers for Microarrays

9.2 Market Restraints for Microarrays

9.3 Key Players

9.4 Market Size, Strategic Trends and Competitive Landscape for Protein Arrays

9.5 Marketing and Distribution

9.6 Protein Arrays Market Analysis

9.7 Genes Associated with Major Diseases

9.8 Software and Data Analysis

9.8.1 Supplier of DNA Microarray Analysis Software

9.8.2 Satisfaction with Software Features

9.8.3 Satisfaction with Software

9.8.4 Supplier Factors in Software Purchase Decision

9.8.5 Suppliers’ Role in Improving Data Sharing for DNA Microarrays

10. Company Profiles

10.1 Manufacturers

Personalized Medicine

1. Overview

1.1 Statement of Report

1.2 Scope of this Report

1.3 Methodology

1.4 Executive Summary

2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

2.1 Scope of this Section

2.2 Introduction to Pharmacogenomics/Personalized Medicine

2.3 The Compelling Case for Personalized Medicine

2.4 The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine

2.5 Examples of Personalized Medicine

2.5.1 Herceptin

2.5.2 Ziagen

2.5.3 Iressa

2.5.4 Erbitux

2.6 Personalized Medicine Product Pipeline

2.7 The Personalized Medicine Coalition

2.8 Regulatory Trends and Guidelines in the Personalized Medicine Space

2.9 FDA Approved Agendia’s MammaPrint® Diagnostic—The First IVDMIA to be Approved

2.10 A Changing Regulatory Landscape for Personalized Medicine

2.11 Patenting Personalized Medicine

2.11.1 U.S. Supreme Court Dismisses LabCorp Appeal

2.12 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used

2.12.1 EGFR Assay

2.12.2 Individualized Warfarin Therapy

2.12.3 UGT1A1 Molecular Assay for Camptosar

2.12.4 Response to Gleevec in Gastrointestinal Stromal Tumors

2.12.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases

2.12.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics

3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis

3.1 Scope of this Section

3.2 Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine

3.3 Snapshot of Diagnostics Industry Structure

3.4 The Case for Theranostics (Therapeutic/Companion Diagnostic)

3.5 Classification of Diagnostics by Risk

3.6 Personalized Medicine Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters

3.7 Segmentation of the Personalized Medicine Marketplace

3.8 Timeline for Impact of Various Segments in Personalized Medicine

3.9 Challenges for Personalized Therapeutics Development

3.10 Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine

3.11 Macro Trends in Personalized Medicine

3.12 Personalized Medicine: Industry SWOT Analysis

4. Company Profiles

4.1 Abbott Molecular, Inc./Vysis

4.2 Affymetrix, Inc.

4.3 Agendia

4.4 Celera Diagnostics

4.5 Cepheid

4.6 Clinical Data, Inc.

4.7 Dakocytomation

4.8 deCODE Genetics

4.9 DNA Direct, Inc.

4.10 DxS Ltd.

4.11 Exact Sciences Corp.

4.12 Exagen Diagnostics, Inc.

4.13 Gen-Probe

4.14 Genelex Corp.

4.15 Gene Logic, Inc.

4.16 Genentech, Inc.

4.17 Genomic Health, Inc.

4.18 Genzyme Genetics

4.19 Illumina

4.20 Luminex Corporation/Tm Biosciences

4.21 Monogram Biosciences

4.22 Myriad Genetics, Inc.

4.23 Nanogen

4.24 Osmetech plc

4.25 Perlegen Sciences, Inc.

4.26 PGxl Laboratories

4.27 Prometheus Laboratories, Inc.

4.28 Roche Diagnostics

4.29 Siemens Medical Solutions Diagnostics

4.30 Target Discovery, Inc.

4.31 Third Wave Technologies

4.32 Ventana Medical Systems

4.33 XDx, Inc.

Appendix 1: Qualitative Market Responses

Pharmacogenomics for Clinical Use and in Drug Development

1. Overview

1.1 Statement of Report

1.2 Objectives of this Report

1.3 Scope of the Study

1.4 Methodology

1.5 Executive Summary

2. Introduction

2.1 Pharmacogenomic Testing Overview

2.1.1 Clinical Applications

2.1.2 Technologies for Pharmacogenomic Diagnostic Tools

2.1.3 Drug and Diagnostic Combinations

2.1.4 Economic Impact of Healthcare Costs

2.2 Genetic Variation among Individuals

2.2.1 Population Genomics

2.2.2 SNPs and Haplotypes

2.2.3 HapMap

2.2.3.1 The International HapMap Project

2.2.3.2 HapMap Participants and Funding Sources

2.3 Drug Metabolism

2.3.1 Adverse Drug Reactions (ADRs)

2.3.2 Drug-Test Combinations

2.4 Impact of Pharmacogenomics

2.4.1 How Will Gene Variation Be Used in Predicting Drug Response?

2.4.2 How Will Drug Development and Testing Benefit from Pharmacogenomics?

2.4.3 Advantages of Pharmacogenomics

2.4.4 The Diagnostics-Therapeutics Fusion

2.4.5 Potential Challenges

2.4.6 Poor Metabolizer Phenotype Testing

2.4.7 Drug Repositioning

2.5 Pharmacogenomic Tests

2.5.1 CYP2D6

2.5.2 CYP2C19 and CYP2C9

2.5.3 CYP3A4 and CYP3A5 Genotyping

2.5.4 CYP1A2 and CYP2B6

2.5.5 NAT2, DPD, and UGT1A1

2.6 HercepTest

2.7 Drivers of Pharmacogenomic Testing

2.8 Pharmacogenomics and Drug Discovery

2.8.1 Business Implications of Pharmacogenomics in Drug Discovery

2.8.2 Impact of Pharmacogenomics on Drug Sales

2.8.3 Pressure to Optimize Drug Discovery Drives Use of Pharmacogenomics

3. Pharmacogenomic Testing Market: Size, Growth and Share

3.1 Global Pharmacogenomic Testing Markets by Technology Segments

3.1.1 Market Structure

3.1.2 Market Drivers in the Pharmacogenomic Diagnostics Testing Sector

3.1.3 Market Restraints in Pharmacogenomic Diagnostic Testing Segment

3.1.4 Principal Market Segments for Genomics Testing

3.1.4.1 Diagnostic Testing

3.1.4.2 Pharmacogenomic Testing

3.1.4.3 SNP Identification

3.1.5 Key Players in the Pharmacogenomic Diagnostics Testing Segment

3.1.6 Pharmacogenomic Testing Sector Analysis

3.2 U.S. Pharmacogenomic Testing Market

3.2.1 Market Overview

3.2.2 Diagnostic Testing Categories

3.3 European Pharmacogenomic Diagnostic Testing Market

3.4 Japanese Diagnostic Testing Market

4. Pharmacogenomic Disease Markers

4.1 SNPs

4.1.1 SNP Identification Market

4.1.2 Overview of SNP Identification

4.1.3 Strategies for SNP Identification

4.1.4 Candidate Gene Selection

4.1.5 Whole-Genome Linkage Disequilibrium Mapping

4.1.6 SNP Databases

4.1.7 Computational Tools for SNP Identification

4.1.8 SNPbrowser, Applied Biosystems

4.1.9 Progeny Suite, Progeny Software, LLC

4.1.10 Sentrix Array Matrix, Illumina

4.1.11 Third Wave Technologies (a Hologic Company)

4.2 Predictive Pharmacogenomics

4.2.1 Cancer Testing

4.2.2 Breast Cancer

4.2.3 Melanoma

4.2.4 Colon Cancer

4.2.5 Predictive Cancer Testing Market Size

4.2.6 Prostate Cancer

4.2.7 Lung Cancer

4.2.8 Acute Myelocytic Leukemia (AML)

4.2.9 Cystic Fibrosis

4.2.10 Genetic Test for Cardiac Ion Channel Mutations (Cardiac Channelopathies)

4.2.11 Cardiac Transplants

4.2.12 Thiopurine S-methyltransferase (TPMT) Genetic Test

4.2.13 CARING Study

4.2.14 Vilazodone

4.2.15 STRENGTH Trials (Statin Response Examined by Genetic HAP Markers)

4.2.16 HIV and AIDS

4.2.17 Herceptin and Tykerb

4.2.18 Asthma

4.2.19 Hepatitis C Viral Load

4.3 Examining the Impact of Pharmacogenomics in Specific Disease Application

4.3.1 The Impact of Pharmacogenomics in Bipolar and Other Psychiatric Disorders

4.3.2 Pharmacogenomics in Warfarin Treatment

4.3.3 Pharmacogenomics and Breast Cancer Treatment

4.3.4 Pharmacogenomics of Depression

4.3.4.1 Tricyclic Antidepressants

4.3.4.2 Serotonin Re-uptake Inhibitors

4.3.4.3 Mirtazapine and Venlafaxine

4.3.4.4 Nefazodone, Moclobemide, Reboxetine and Trazodone

4.3.5 Pharmacogenomics of Cardiovascular Disease

4.3.5.1 Beta-blockers

4.3.5.2 Angiotensin II Type 1 Receptor Antagonists and AT1 Receptor Antagonists (Sartans)

4.3.6 Pharmacogenomics of Thromboembolic Disorders

4.3.6.1 Warfarin

4.3.6.2 Acenocoumarol

4.3.6.3 Phenprocoumon

4.4 Gene Chips to Detect Cytochrome Variations

4.4.1 AmpliChip CYP450—Roche Diagnostics

4.4.2 GeneChip System—Affymetrix

4.4.3 NanoChip Molecular Biology Workstation—Nanogen, Inc.

5. Pharmacogenomic Testing: Development Issues

5.1 Adoption of Pharmacogenomic Testing

5.1.1 Pharmacogenomics Gatekeepers

5.1.1.1 Industry

5.1.1.1.1 Use of Pharmacogenomics in Drug Development

5.1.1.1.2 Co-development of Pharmacogenomics Diagnostics and Drugs

5.1.1.2 FDA as a Gatekeeper of Pharmacogenomics

5.2 Factors Influencing the Integration of Pharmacogenomics into Clinical Trials

5.3 Moderators of Growth

5.3.1 Classification of Extensive vs. Poor Metabolizer

5.3.2 Genetic Testing

5.3.3 Cost-Benefit of Pharmacogenomic Testing

5.3.4 Workforce Issues

5.3.5 Reimbursement

5.3.6 New CPT Test Codes and Payment Amounts

5.3.7 CMS and Other Third-party Payers

5.3.7.1 Reimbursement Challenges to Pharmacogenomic Testing

5.3.7.2 CMS Regulatory Responsibilities

5.3.7.3 Costs Associated with Pharmacogenomic Testing

5.4 Clinical Guidelines and Pharmacogenomic Testing

5.5 Good Laboratory Practice (GLP)

5.6 Quality Assurance Issues

5.6.1 Criteria Required to Establish a Genomic Test for Clinical Use

5.6.2 Microarrays in Clinical Diagnostic Use

5.7 Pre-therapeutic Pharmacogenomic Testing

5.8 Regulatory Requirements

5.9 Screening

5.10 Cost of Phenotyping vs. Genotyping

5.11 Pharmacogenomic Tests: New Product Development

5.12 Underutilization of Pharmacogenomic Tests

6. Business Trends in the Industry

6.1 Pharmacogenomic Initiatives within Pharmaceutical Companies

6.2 Pharmacogenomic Testing Growth Factors

6.3 Acquisition, License Agreements, Internal Development and Partnerships

6.4 Product Testing Depth in Pharmacogenomic Testing

6.5 Government Regulation

6.5.1 U.S. Regulations

6.5.2 U.K. Regulations

6.5.3 E.U. Regulations

6.5.4 Japanese Regulations

6.6 Increased Market Penetration in Pharmacogenomic Testing

6.7 Legal Issues

6.7.1 Federal Policy History

6.7.2 State Policy History

6.7.3 Federal Anti-Discrimination Laws and How They Apply to Genetics

6.7.3.1 The Genetic Information Nondiscrimination Act of 2008 (GINA)

6.7.4 Prescription Drug User Fee Act (PDUFA)

6.7.5 Liability Concerns for Pharmacogenomics Drug and Diagnostic Developers

6.8 Barriers to Growth

6.9 Drivers of Growth

6.10 Product Launches and Developments

6.11 Investment Parameters for Diagnostic Companies

6.12 Key Elements of the Pharmaceutical Value Chain

6.13 An Evaluation of Successful Pharmacogenomic Business Models

6.14 Ethical Considerations for Pharmacogenomic Applications

6.15 Drug Repositioning Services

6.16 Patent Protection of Pharmacogenomic Technology

6.17 FDA Product Submission and Review Process

6.18 FDA Pipeline for Pharmacogenomic Tests

6.19 Adaptive Clinical Trial Design

7. Important Technology Trends in Pharmacogenomics

7.1 Trends in Pharmacogenomic Testing

7.1.1 Toxicogenomics

7.2 Drug Metabolism

7.3 Personalized Medicine: the Genomic and Proteomic Approach

7.4 Biomarkers

7.4.1 Cancer

7.4.1.1 Leukemia: Gleevec and Dasatinib (BMS-354825)

7.4.1.2 Gefitinib (Iressa)

7.4.1.3 Colorectal Cancer

7.5 Cardiovascular Drugs

7.5.1 Arrhythmia

7.5.2 Hypertension

7.5.3 Hyperlipidemia

7.5.4 Myocardial Infarction

7.5.5 Heart Failure

7.6 Future Developments

7.6.1 GSK’s Pharmacogenomic Program

7.6.2 Roche’s Biomarker Strategy

7.6.3 Hypertension Markets

7.6.4 Expression Data to Integrate Pharmacology and Chemistry Data

7.6.5 Metabolomics

7.6.6 Theranostics

8. Overview and Conclusions

8.1 The Unrealized Promise of Pharmacogenomics

8.2 The New Drug Pipeline

8.3 Pharmacogenomics and Regulation

8.4 Pharmacogenomics and Reimbursement

8.5 Key Considerations for Realizing the Promise of Pharmacogenomics

8.6 Development of Easy to Use Point of Care Pharmacogenomic Tests

8.7 Development of Pharmacogenomic Tests during Drug Development

8.8 Pharmacogenomics’ Impact on Commercial Strategies

8.9 Pharmacogenomics’ Impact on the Blockbuster Model of Drug Development

8.10 Pharmacogenomics’ Impact on Clinical Trials

8.11 Pharmacogenomic Business Models

8.12 Structure of Pharmacogenomic Deals and Alliances

8.13 Challenges to Pharmacogenomics

9. Company Profiles

9.1 Abbott Laboratories

9.2 Affymetrix

9.3 Agilent Technologies, Inc.

9.4 Ambry Genetics

9.5 ARCA Biopharma, Inc.

9.6 Asper Biotech

9.7 AstraZeneca

9.8 Bayer

9.9 BioTrove, Inc.

9.10 Bristol-Myers Squibb

9.11 Celera Group

9.12 Clinical Data

9.13 CombinatoRx, Inc.

9.14 Complement Genomics Ltd.

9.15 Covance Inc.

9.16 CuraGen Corporation

9.17 Cypress Bioscience, Inc.

9.18 Dako (formerly DakoCytomation)

9.19 deCODE Genetics

9.20 DNAPrint Genomics

9.21 DxS

9.22 EraGen Biosciences

9.23 EXACT Sciences

9.24 Expression Analysis

9.25 FivePrime Therapeutics

9.26 GE Healthcare

9.27 Gene Express, Inc.

9.28 GeneGO Inc.

9.29 Genelex Corporation

9.30 Genentech

9.31 Genizon Biosciences Inc.

9.32 Genomic Health

9.33 Gentris

9.34 Genzyme

9.35 GlaxoSmithKline

9.36 g-Nostics Ltd.

9.37 Hologic

9.38 Human Genome Sciences

9.39 Illumina

9.40 Incyte, Inc.

9.41 InterGenetics Inc.

9.42 Interleukin Genetics

9.43 Iris BioTechnologies Inc.

9.44 Johnson & Johnson

9.45 Lab21

9.46 Life Technologies Corporation

9.47 Luminex Corp.

9.48 MediBIC Group

9.49 Melior Discovery Inc.

9.50 Merck & Co.

9.51 Merck Serano

9.52 Millennium Pharmaceuticals

9.53 Monogram Biosciences, Inc.

9.54 Myriad Genetics, Inc.

9.55 Nanogen

9.56 Nanosphere

9.57 Nitromed

9.58 Ocimum Biosolutions

9.59 Orchid Cellmark

9.60 Ore Pharmaceuticals

9.61 PharmaSeq

9.62 Prediction Sciences

9.63 Predictive Biosciences

9.64 Prometheus Laboratories

9.65 Progeny Software, LLC

9.66 Roche Diagnostics

9.67 Response Genetics, Inc.

9.68 Sequenom

9.69 SimuGen Ltd.

9.70 Sosei Group Corporation

9.71 Transgenomic, Inc.

9.72 TrimGen Corp.

9.73 Tripos International

9.74 Vertex Pharmaceuticals

9.75 VIA Pharmaceuticals, Inc.

9.76 Warnex

9.77 Wyeth

9.78 XDx, Inc.

Regenerative Medicine Markets

1. Overview

1.1 Statement of Report

1.2 Scope of this Report

1.3 Methodology

1.4 Executive Summary

2. Regenerative Medicine: An Overview of Segments

2.1 Tissue Engineering

2.1.1 Tissue-Engineered Skin

2.1.2 Tissue-Engineered Cartilage

2.1.3 Tissue-Engineered Bone

2.1.4 Tissue-Engineered Peripheral Nerves

2.1.5 Tissue-Engineered Cornea

2.1.6 Tissue-Engineered Blood Vessels

2.2 An Overview of Tissue Engineering and Regenerative Medicine (TERM)

2.2.1 Tissue-Engineered Products and Their Applications

2.2.1.1 Skin, Cartilage, Bone and Urological Applications

2.2.1.2 Cardiovascular Applications

2.2.1.3 Neurological Applications

2.2.1.4 Pancreas, Liver and Kidney Applications

2.2.1.5 Ophthalmic Applications

2.2.1.6 Dental Applications

2.2.1.7 Autologous and Allogeneic Products

2.2.2 Geographic Distribution of TERM Firms in the Five Focus Countries

2.3 Cell Therapy

2.3.1 Number of Patients Treated between 1988 and 2010 by Regenerative Medicine Therapies

2.3.2 Cell Culture Products

2.3.2.1 In Vitro Test Kits

2.3.2.2 Suppliers of Cells and Tissues

2.3.2.3 Suppliers of Culture Media and Reagents

2.3.2.4 Equipments for Stem Cell Research

2.3.2.5 Computer Software for Stem Cell Research

2.3.3 Overall Picture of Cell Therapy Industry

2.3.3.1 The Size of Cell Therapy Industry

2.3.3.2 The Age, Size and Location of Firms

2.3.3.3 Technology and Disease Focus

2.3.4 Cell Therapy Products and Companies

2.3.4.1 First Generation (Non-Stem Cell-based) Primary Products

2.3.4.2 Second Generation (Stem Cell-Based) Primary Products

2.3.4.3 Secondary Products

2.3.4.4 Products in Development

2.3.5 The Disease Focus of Clinical Trials

2.3.5.1 Stem Cell Industry Pipeline

2.3.6 Industry Collaboration in Stem Cell Space

2.3.6.1 Commercial Success in Stem Cell Industry

2.3.6.2 Major Shift to Stem Cells from Non-Stem Cell Technologies

2.3.6.3 Challenges to Commercial Development of Cell Therapies

2.3.6.4 Partnership of Stem Cell Companies with Large Pharmaceutical Companies

2.3.6.5 Strategic Approaches for Cell-Based Companies

2.3.6.6 The Need for Support from Large Pharmaceuticals

2.4 Scaffolding Biomaterials

2.4.1 Biomaterial Scaffolds in Regenerative Medicine

2.5 Growth Factors

3. Regenerative Medicine: The Next Evolution of Medical Treatments

3.1 Scope of this Chapter

3.2 Need for Regenerative Medicine

3.3 Current State of Regenerative Medicine

3.4 Future of Regenerative Medicine

3.5 Number of Products in Pipeline

3.6 Projected Timeline for Regenerative Medicine

3.7 Regenerative Medicine Products in the Market

3.7.1 Medtronic's Infuse Bone Graft and the LT-Cage Device

3.7.2 Genzyme's Carticel

3.7.3 Stryker's OP-1

3.7.4 Osyris/Nuvasive's Osteocel

3.7.5 RTI's Spinal Implants

3.7.6 Organogenesis' Apligraf

3.7.7 Advanced BioHealing's Dermagraft

3.7.8 Integra's Bilayer Matrix Wound Dressing

3.7.9 LifeCell's Alloderm

3.7.10 Cytori Therapeutics' Celution

3.8 Other Products of Importance in Regenerative Medicine

3.8.1 Tissue-Engineered Wound Healing Products

3.8.1.1 Oasis

3.8.1.2 Permacol

3.8.1.3 EZ-Derm

3.8.1.4 Matriderm

3.8.1.5 TransCyte

3.8.1.6 ICX-SKN

3.8.1.7 OrCel

3.8.1.8 Epicel

3.8.1.9 Myskin

3.8.1.10 VCT01

3.8.2 ICX-TRC-Hair Regeneration Therapy

3.8.3 Cartilage Regeneration

3.8.3.1 Novocart

3.8.3.2 BioSeed-C

3.8.3.3 BioSeed-Oral Bone

3.8.3.4 Chondrotissue

3.8.3.5 co.don Chondrotransplant

3.8.3.6 co.don Chondrotransplant DISC

3.8.3.7 co.don Chondrosphere

3.8.3.8 co.don Osteotransplant DENT

3.8.3.9 MACI Implant

3.8.3.10 Cartilink-3

3.8.3.11 Accell Evo3 Demineralized Bone Matrix

3.8.3.12 OsSatura BCP

3.8.4 Mozobil

4. Market Analysis of Regenerative Medicine Sector

4.1 Scope of this Chapter

4.1.1 Market for Regenerative Medicine Products

4.1.2 The Different Characteristics of Regenerative Medicine Industry in the Recent Past

4.1.3 Potential Market for Regenerative Medicine in the U.S.

4.2 Global Market for Stem Cells

4.3 Market for Cell Therapy in the U.S.

4.4 Global Market for Cord Blood Stem Cells

4.4.1 Public Cord Blood Banks

4.4.2 Private Cord Blood Banks

5. Business Models and Requirements for a Successful Regenerative Medicine Industry

5.1 Scope of this Chapter

5.1.1 The Limited Success Achieved by the Regenerative Medicine Products

5.1.2 Business Models in Regenerative Medicine

5.1.3 Current Model for Autologous Cell Therapies

5.1.4 Current Models for Allogeneic Cell Therapies

5.1.5 Key Factors for Successful Business Models for Cell Therapies

5.2 Commercial Manufacturing of Cell Therapy Products: Requirements

5.2.1 Elements of Commercial Manufacturing

5.2.1.1 Regulatory Requirements

5.2.1.2 Manufacturing Process Scale

5.2.1.3 In-House Manufacturing

5.2.1.4 Contract Manufacturing: Commercial and Academic

6. Diseases with Potential Applications for Regenerative Medicine

6.1 Regenerative Medicine and Diabetes

6.2 Regenerative Medicine for Cardiac Repair

6.3 Regenerative Medicine in Orthopedics

6.3.1 Orthobiologics in Orthopedics

6.3.2 Growth Factor Therapies in Orthopedics

6.3.3 Stem Cell Therapies in Orthopedics

6.4 Regenerative Medicine in Liver Diseases

6.4.1 Hepatocyte-Like Cells for Liver Disease

6.4.2 Cell Therapy for Liver Cirrhosis

6.4.3 CD 34+ Cells

6.5 Regenerative Medicine in Retinal Replacement Therapy

6.5.1 Retinal Transplantation

6.6 Regenerative Medicine in Central Nervous System (CNS) Disorders

6.6.1 Clinical Activity for Stem Cell Transplantation into the CNS

7. Current Stem Cell Research and Federal Funding in the U.S.

7.1 Scope of this Chapter

7.2 Stem Cell Policies in North America

7.3 Stem Cell Policies in South America

7.4 Stem Cell Policies in Europe

7.5 Stem Cell Policies in Asia/Oceania

7.6 Stem Cell Policies in Africa

7.7 Stem Cell Research and California Institute for Regenerative Medicine (CIRM)

7.7.1 CIRM Collaborative Funding

7.7.2 CIRM's funding for Clinical Applications

7.7.3 Early Translational Awards

7.7.4 CIRM's Disease Team Awards

7.8 Stem Cell Research Programs in Connecticut Department of Public Health

7.8.1 Seed Grant Awards from Connecticut Stem Cell Research Program in 2010

7.8.2 Established Investigator Awards from Connecticut Stem Cell Research Program in 2010

7.8.3 Group Project Awards from Connecticut Stem Cell Research Program in 2010

7.8.4 Core Facility Awards from Connecticut Stem Cell Research Program in 2010

7.8.5 Maryland Technology Development Corporation (TEDCO)

7.8.6 TEDCO's Fort Detrick Technology Transfer Initiative (FDTTI)

7.8.7 Johnson & Johnson Investment Fund

7.8.8 TEDCO's NAVAIR Technology Insertion (NAVTI) Program

7.8.9 TEDCO's TechStart Program

7.8.10 TEDCO's University Technology Development Fund (UTDF)

7.8.11 TEDCO's Working Capital Loan Fund

7.8.12 Maryland Technology Transfer and Commercialization Fund (MTTCF)

7.8.13 Maryland Stem Cell Research Fund

7.9 The New Jersey Commission on Science and Technology (NJCST)

7.9.1 Investigator Initiated Research Projects (IIRP) and Innovative, Developmental or Exploratory Activities (IDEA) in Stem Cell Research

7.9.2 Targeted Request for Applications for Investigation of iPS and Other Derivation Approaches

7.9.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell Research

7.9.4 Consortia Planning Awards

7.9.5 Institutional Development

7.10 Center for Stem Cell and Regenerative Medicine

7.11 Global Funding for Regenerative Medicine

7.12 Federal Funding of Stem Cell Research in the U.S.: Past and Present

7.12.1 The U.S. National Institute of Health (NIH) Guidelines to hESC Research

7.12.2 Types of Research Ineligible for NIH Funding

7.12.3 NIH's Leadership in Providing Funds for Stem Cell Research

7.12.4 NIH Guidelines Addressing the Projected Growth of Stem Cell-related Clinical Trials

7.12.5 Federal Agencies Providing Funds for Stem Cell Research

8. Company Profiles

8.1 Aastrom Biosciences, Inc.

8.1.1 Aastrom's Clinical Trial Programs

8.1.1.1 Dilated Cardiomyopathy

8.1.1.2 Critical Limb Ischemia

8.1.1.3 Osteonecrosis of the Femoral Head

8.1.1.4 Other Bone Disorders

8.1.2 Product Development

8.1.3 Aastrom's Cell Manufacturing

8.1.4 Aastrom's Business Performance

8.2 Advanced Cell Technology, Inc. (ACT)

8.2.1 ACT's Cellular Reprogramming

8.2.2 ACT's Stem Cell Differentiation

8.2.2.1 ACT's Retinal Pigment Epithelium (RPE) Program

8.2.2.2 ACT's Hemangioblast Program

8.2.2.3 ACT's Adult Stem Cell Program

8.2.3 ACT's Intellectual Property

8.2.4 ACT's Business Performance

8.2.5 ACT's Investment in Research and Development

8.3 Aldagen, Inc.

8.3.1 Aldagen's ALD-201

8.3.2 Aldagen's ALD-301

8.4 Altrika Ltd.

8.4.1 Myskin

8.4.2 Cryoskin

8.4.3 Altrika's Future Products

8.4.3.1 Lyphoderm

8.4.3.2 Corneal Bandage

8.4.3.3 Leukodepletion Filters

8.5 Alseres Pharmaceuticals, Inc.

8.5.1 Alseres' Product Pipeline

8.5.1.1 Celthrin-A Rho Inhibitor

8.5.1.2 Inosine

8.5.1.3 Oncomodulin and ALSE-100

8.5.1.4 Altropane-PD

8.5.2 Alseres' Science and Technology

8.5.2.1 Nerve Repair Pathways

8.5.2.2 The Pro-Regenerative Pathway

8.5.2.3 The Anti-Regenerative Pathway

8.5.2.4 Molecular Imaging

8.5.2.5 Dopamine Transporter

8.6 Amgen, Inc.

8.6.1 Amgen's Marketed Products

8.6.1.1 Aranesp (Darbepoetin Alfa)

8.6.1.2 Epogen (Epoetin Alfa)

8.6.1.3 Neulasta (Pegfilgrastim)/Neupogen (Filgrastim)

8.6.1.4 Enbrel (Etanercept)

8.6.1.5 Sensipar (Cinacalcet)

8.6.1.6 Vectibix (Panitumumab)

8.6.1.7 Nplate (Romiplostim)

8.6.2 Amgen's Marketing and Distribution

8.6.3 Amgen's Overall Business Performance

8.7 Amorcyte, Inc.

8.7.1 Amorcyte's Technology

8.7.1.1 AMR-001

8.8 AnGes MG, Inc.

8.8.1 AnGes' Genetic Medicine

8.8.2 HGF Genetic Medicine

8.8.3 Hemagglutinating Virus of Japan (HVJ) Envelope Vector

8.8.4 NF-kB Decoy Oligodeoxynucleotide

8.9 Angioblast Systems, Inc.

8.9.1 Angioblast's Technology and Applications

8.9.1.1 Allogenic Adult Stem Cells

8.9.1.2 Protein Therapeutics

8.9.1.3 Gene Slicing

8.10 Angion Biomedica, Corp.

8.10.1 HGF and c-Met Signaling in Tissue Repair and Organ Regeneration

8.10.2 PARP-1

8.10.3 TGFB1

8.11 Ars Arthro Biotechnology, Inc.

8.11.1 CaReS

8.11.2 Fibrocell

8.11.3 Fibroplus

8.12 Arteriocyte Medical Systems, Inc.

8.12.1 Blood Pharming

8.12.2 Cardiac Ischemia

8.12.3 Critical Limb Ischemia

8.12.4 Malaria Research

8.12.5 Orthopedic Regenerative Medicine

8.12.6 Proliferative Diabetic Retinopathy

8.12.7 Wound Healing

8.13 Athersys, Inc.

8.13.1 Athersys' Pipeline

8.13.2 MultiStem for Stem Cell Therapy

8.13.3 MultiStem for Bone Marrow (BM) Transport Support

8.13.4 MultiStem for Acute Myocardial Infarction

8.13.5 MultiStem for Stroke

8.13.6 Treatments for Obesity

8.13.7 Histamine H3 Receptor Antagonists

8.13.8 Athersys' Collaborations and Partnerships

8.13.8.1 Collaboration with Pfizer

8.13.8.2 Collaboration with Angiotech

8.13.8.3 Collaboration with Bristol-Myers Squibb

8.13.9 Athersys' Research and Development

8.13.10 Athersys' Business Performance

8.14 BeFutur Biotechnologies

8.14.1 BeFutur's Technologies

8.14.1.1 Cells and Tissue Engineering

8.14.1.2 Serum-Free Technology

8.15 BioE, Inc.

8.15.1 BioE's Products

8.16 Bioheart, Inc.

8.16.1 Bioheart's Product Candidates

8.16.1.1 MyoCell

8.16.1.2 MyoCell SDF-1

8.16.1.3 TGI 1200 Cell Isolation System

8.16.1.4 Bioheart 3370

8.16.2 Bioheart's Patents and Proprietary Rights

8.17 BioLine Rx

8.17.1 BioLine's Product Pipeline

8.17.1.1 BL-1020 Schizophrenia

8.17.1.2 BL-1040 for Acute Myocardial Infarction

8.17.1.3 BL-5010 for Skin Lesions

8.17.1.4 BL-1021 for Neuropathic Pain

8.17.1.5 BL-2030 for Inflammation

8.17.1.6 BL-1023 for Parkinson's Disease

8.17.1.7 BL-4010 for Cancer

8.17.1.8 BL-4040 for Acute Kidney Failure

8.17.1.9 BL-5030 for Thromboembolic Diseases

8.17.1.10 BL-5040 for Cachexia and Inflammatory Bowel Disease

8.18 BIOMET

8.18.1 BIOMET 3i

8.18.2 Clotalyst Autologous Serum Collection System

8.18.3 BioCUE Platelet Concentration System

8.19 BioMimetic Therapeutics, Inc.

8.19.1 BioMimetic's Product Candidates

8.19.2 BioMimetic's Research and Development

8.20 BioSafe Group SA

8.20.1 Sepax

8.20.2 Sepax System in Adult Stem Cell Banking

8.20.3 Coolmix

8.20.4 SepaxNet

8.21 BioTime, Inc.

8.21.1 BioTime's Stem Cell Products for Regenerative Medicine

8.21.2 BioTime's Embryome Database

8.21.3 BioTime's Progenitor and hES Cell Lines

8.21.4 BioTime's hES Cells Carrying Genetic Diseases

8.21.5 BioTime's ESpan Cell Growth Media

8.21.6 BioTime's ESpy Cell Lines

8.21.7 BioTime's Licensed Stem Cell Technology and Stem Cell Product Development Agreements

8.21.7.1 Wisconsin Alumni Research Foundation

8.21.7.2 ACTCellerate Technology

8.21.7.3 The iPS Technology

8.21.7.4 Lifeline

8.21.7.5 BioTime's Stem Cell Agreement with Reproductive Genetics Institute

8.21.8 BioTime's Plasma Volume Expanders and Related Products

8.21.8.1 Hextend

8.21.8.2 PentaLyte

8.22 Biovest International, Inc.

8.22.1 BiovaxID Cancer Vaccine

8.23 BrainStorm Cell Therapeutics, Inc.

8.23.1 BrainStorm's Technology

8.23.2 BrainStorm's Stem Cell Therapy

8.23.3 BrainStorm Technology-NurOwn

8.24 Cardio3 BioSciences

8.24.1 Cardio3's Product Pipeline

8.24.1.1 C-Cure

8.24.1.2 C-Cure2

8.24.1.3 Allo-Cure

8.24.1.4 G-Cure

8.24.1.5 C-Cath

8.24.2 Cardio3's Investors

8.25 CardioPolymers, Inc.

8.25.1 CardioPolymer's Products

8.25.1.1 Algisyl-LVR

8.25.1.2 Plexisyl-AF

8.25.2 CardioPolymer's Investors

8.26 CaridianBCT

8.26.1 Trima Accel Automated Blood Collection System

8.26.2 Spectra Optia Apheresis System

8.26.3 COBE Spectra Apheresis System

8.26.4 Elutra Cell Separation System

8.26.5 Atreus Whole Blood Processing System

8.26.6 OrbiSac System

8.26.7 COBE 2991 Cell Processor

8.27 Cardium Therapeutics, Inc.

8.27.1 Cardium Biologics

8.27.2 Cardium's Tissue Repair Company

8.27.3 Cardium's Gene Activated Matrix (GAM) Technology

8.27.4 Cardium's Biologics and Stem Cells for Regenerative Medicine

8.28 Cellartis AB

8.28.1 Cellartis' Products

8.28.1.1 The hES-CMC 2D: Cardiomyocyte Monolayers

8.28.1.2 The hES-CMC 002: Cardiomyocyte Clusters

8.28.1.3 The hES-HEO 002: Hepatocyte-like Cells

8.28.1.4 The hES-MP 002.5: Mesenchymal Progenitors

8.28.1.5 The hES Cell Lines

8.28.1.6 SCED 461: Human ES Cells

8.28.1.7 Monoclonal Antibodies

8.28.2 Cellartis' Licensing Activities

8.29 Cellerix

8.29.1 Ontaril

8.29.2 Cx501

8.30 Celgene Corporation

8.30.1 Celgene's Business Performance

8.30.2 Celgene's Commercial Stage Products

8.30.2.1 Revlimid (Lenalidomide)

8.30.2.2 Thalomid (Thalidomide)

8.30.2.3 Vidaza (Azacitidine for Injection)

8.30.2.4 Ritalin Family of Drugs

8.30.2.5 Alkeran (Melphalan)

8.30.2.6 IMiDs Compounds

8.30.2.7 Oral Anti-Inflammatory Agents

8.30.2.8 Kinase Inhibitors

8.30.2.9 Cellular Therapies

8.31 CellSeed, Inc.

8.31.1 CellSeed's Epithelial Cell Sheet for Corneal Regeneration

8.31.2 CellSeed's Regenerated Cardiac Patch

8.31.3 CellSeed's Epithelial Cell Sheet for Esophageal Regeneration

8.31.4 CellSeed's Cell Sheet for Periodontal Tissue Regeneration

8.31.5 CellSeed's Regenerated Cartilage Sheet

8.32 Cellular Dynamics International

8.32.1 The iCell Cardiomyocytes

8.32.2 Cellular Dynamics' Technology

8.33 Celltrix

8.33.1 Credurance

8.34 Cerco Medical

8.34.1 Cerco Medical's Concept

8.34.2 Bio-Artificial Endocrine Pancreas

8.35 Cook Biotech, Inc.

8.35.1 Cook's Technology

8.35.2 Biodesign Dural Graft

8.35.3 Dynamatrix Oral Graft

8.35.4 SiS Ophthalmic

8.35.5 Oasis Wound Matrix

8.35.6 Biodesign Staple Line Reinforcement

8.35.7 Biodesign Hiatal Hernia Graft

8.35.8 ECM for Pericardial Closure

8.35.9 ECM for Cardiac Tissue Repair

8.35.10 Biodesign 8-Layer Tissue Graft

8.35.11 Biodesign Abdominal Lock Graft

8.35.12 Biodesign Hernia Graft

8.35.13 Biodesign Inguinal Hernia Graft

8.35.14 Biodesign Umbilical Hernia Graft

8.35.15 Biodesign Anterior Pelvic Floor Graft

8.35.16 Biodesign Fistula Plug

8.35.17 Biodesign Posterior Pelvic Floor Graft

8.35.18 Surgisis Biodesign Peyronie's Repair Graft

8.35.19 Biodesign Tension-Free Urethral Sling

8.35.20 Biodesign Vaginal Erosion Repair Graft

8.35.21 AxoGuard Nerve Protector

8.35.22 AxoGuard Nerve Connector

8.35.23 FISH Femoral Introducer Sheath and Hemostasis Device

8.36 Cord Blood America (CBAI), Inc.

8.37 Cryo-Cell International, Inc.

8.37.1 Cryo Cell's License Agreements

8.37.1.l Cryo-Cell De Mexico

8.37.1.2 Asia Cryo-Cell Private Limited

8.37.1.3 Venezuela

8.37.1.4 China

8.37.1.5 Germany

8.37.1.6 Nicaragua

8.37.1.7 Pakistan

8.37.2 Uses of Cord Blood Stem Cells

8.38 Curis, Inc.

8.38.1 Curis' Business Performance

8.38.2 Curis' Research and Development

8.39 Cytori Therapeutics, Inc.

8.39.1 Cytori's Cosmetic and Reconstructive Surgery Market

8.39.2 Cytori StenSource Cell Banking Market

8.40 Develogen AG

8.40.1 Develogen's Pipeline

8.40.1.1 DG3173-Somatostatin Analog

8.40.1.2 Insulin Sensitizers

8.40.1.3 Beta Cell Regeneration Factor

8.41 Effector Cell Institute, Inc (ECI)

8.41.1 ECI's Cell-based Drug Discovery (CDD)

8.41.2 ECI's Regenerative Medicine

8.41.3 ECI's Cancer Therapeutic Agent Development Project (EC1301)

8.41.4 ECI's Anti-Inflammatory Drug Development Project (FROUNT)

8.41.5 ECI's High Throughput Screening by Automatic TAXIScan System

8.41.6 ECI's Products

8.41.6.1 TAXIScan System

8.41.6.2 Cytorecon

8.41.6.3 TAXIScan-FL

8.42 Epistem plc

8.42.1 Epistem's Cotract Research Services in Oncology

8.42.2 Epistem's Xenografting Models

8.42.3 Epistem's Cancer Cell Assays

8.42.4 Epistem's Angiogenesis Models

8.42.5 Epistem's Colon Cancer Models (Min/+)

8.42.6 Epistem's Histology, IHC, ISH and Gene Expression Profiling

8.42.7 Epistem's In Vitro Cytotoxicity Testing

8.42.8 Epistem's Plucked Hair Immunohistochemistry

8.42.9 Epistem's Emerging Protein Therapeutics

8.42.10 Epistem's Biomarker Technology

8.43 FivePrime Therapeutics, Inc.

8.43.1 FivePrime's Technology

8.43.2 FivePrime's Collaborations

8.44 Forticell Bioscience, Inc.

8.44.1 OrCell

8.45 Gamidia Cell Ltd.

8.45.1 Gamidia's Technology

8.46 GeneGrafts Ltd.

8.46.1 GeneGrafts's Technology

8.47 GenVec, Inc.

8.47.1 GenVec's Product Programs

8.47.1.1 TNFerade

8.47.1.2 Hearing and Balance

8.48 Genzyme Corporation

8.48.1 Genzyme's Business Performance

8.48.2 Genzyme's Genetic Diseases Segment

8.48.3 Genzyme's Hematology Oncology Segment

8.48.4 Genzyme's Cardiometabolic and Renal Segment

8.48.5 Genzyme's Biosurgery Segment

8.48.6 Genzyme's Genetics and Diagnostics Segment

8.48.7 Genzyme's Pipeline

8.49 Geron Corporation

8.49.1 Geron's Major Technology Platforms

8.49.1.1 Role of Telomere in Cancer and Aging

8.49.1.2 Human Embryonic Stem Cells: Source for the Manufacturing of Therapeutic Cells

8.49.2 Commercial Opportunities for Geron's Major Technology Platforms

8.49.2.1 Oncology

8.49.3 Geron's Human Embryonic Stem Cell Therapies

8.49.4 Geron's Patents and Proprietary Technology

8.49.5 Geron's Business Performance

8.49.6 Geron's Investment in Research and Development

8.50 Harvest Technologies Corporation

8.50.1 Harvest Technologies' Products

8.50.1.1 SmartPReP2 APC+

8.50.1.2 SmartPReP2 BMAC

8.51 HemaStem Therapeutics, Inc.

8.51.1 Cord Blood Program

8.52 HepaLife Technologies, Inc.

8.52.1 Liver Disease

8.52.1.1 HepaMate

8.53 Humacyte, Inc.

8.53.1 Humacyte's Products

8.54 Hydra Biosciences, Inc.

8.54.1 Hydra's Program

8.55 Intercytex Group plc

8.55.1 Vavelta-Skin Repair and Rejuvenation

8.55.2 SHEF-1-Stem Cell Line

8.55.3 CX-SKN-Skin Graft Replacement for Burns and Acute Wounds

8.55.4 ICX-TRC-Hair Regeneration

8.55.5 Cyzact-Chronic Wound Repair

8.56 Integra Lifesciences Holdings Corporation

8.56.1 Integra's Products

8.56.1.1 Integra's Orthopedic Product Portfolio

8.56.1.2 Dermal Regeneration and Engineered Wound Dressings

8.56.1.3 Nerve and Tendon

8.56.1.4 Bone Graft Substitutes for Extremity Reconstruction

8.56.1.5 Integra's OrthoBiologics

8.56.1.6 Duraplasty Products

8.56.2 Integra's Investment in Research and Development

8.56.3 Integra's Business Performance

8.57 International Stem Cell Corporation (ISCO)

8.57.1 Lifeline Cell Technology

8.57.2 Universal Stem Cell Bank

8.57.3 ISCO's Technology

8.58 Japan Tissue Engineering, Co., Ltd.

8.58.1 Autologous Cultured Epidermis

8.58.2 Autologous Cultured Cartilage

8.58.3 Autologous Cultured Corneal Epithelium

8.59 Karocell Tissue Engineering AB

8.59.1 Karocell's Autologous Cells

8.59.1.1 Keratinocytes

8.59.1.2 Melanocytes

8.59.1.3 Fibroblasts

8.59.1.4 Chondrocytes

8.59.1.5 Urothelial Cells

8.59.1.6 Karoskin

8.59.1.7 Karoderm

8.59.1.8 Cell Bank

8.59.2 Karocell's Research and Development

8.60 Kensey Nash Corporation

8.60.1 Biomaterials from Kensey

8.60.2 Kensey's Collagen Technology

8.60.3 Porous Tissue Matrix Technology

8.60.4 Kensey's Products

8.60.4.1 The Angio-Seal Vascular Closure Device

8.60.4.2 Vitoss Scaffold Foam

8.60.4.3 OsseoFit Porous Tissue Matrix

8.60.4.4 Epi-Guide Bioresorbable Barrier Matrix

8.61 Kiadis Pharma, BV

8.62 LifeCell

8.62.1 AlloDerm Regenerative Tissue Matrix

8.62.2 Strattice Reconstructive Tissue Matrix

8.62.3 Cymetra Micronized AlloDerm Tissue

8.63 MaxCyte, Inc.

8.63.1 Advantages of MaxCyte Platform System

8.63.2 MaxCyte's Collaborations

8.63.3 MaxCyte's Application in Immunotherapy

8.63.4 MaxCyte's Application in Regenerative Medicine

8.63.5 MaxCyte's Viral Vectors and Vaccines

8.63.6 MaxCyte XTS Scalable Transfection System

8.64 Mesoblast Ltd.

8.64.1 Mesoblast's Intervertebral Spinal Fusion

8.64.2 Lumbar Fusion

8.64.3 Cervical Fusion

8.64.4 Mesoblast's Intervertebral Disc Repair and Regeneration

8.64.5 Mesoblast's Product for Knee Osteoarthritis

8.64.6 Mesoblast's Investment in Angioblast Systems, Inc.

8.64.7 Angioblast's Product Candidate for Congestive Heart Failure

8.64.8 Angioblast's Product Candidate for Bone Marrow Transplantation

8.65 NanoCor Therapeutics, Inc.

8.65.1 NanoCor's Products

8.66 NeuralStem, Inc.

8.66.1 NeuralStem's Technology

8.66.2 NeuralStem's Research and Programs

8.66.3 NeuralStem's Intellectual Property

8.67 NeuroNova AB

8.67.1 NeroNova's Neurogenesis Qualifier-Technology

8.67.2 The sNN0029

8.67.3 The sNN0031

8.67.4 NeuroNova's Investors

8.68 Olympus Terumo Biomaterials Corporation

8.68.1 OSferion 60

8.68.2 Terudermis

8.68.3 Teruplug

8.68.4 Osferion

8.68.5 Boneceram P

8.69 Opexa Therapeutics, Inc.

8.69.1 Opexa's T-Cell Platform

8.69.2 Opexa's Stem Cell Platform

8.70 Organogenesis, Inc.

8.70.1 Products from Organogenesis

8.70.1.1 Apligraf

8.70.1.2 VCT01

8.70.1.3 CelTx for Oral Soft Tissue Regeneration

8.70.1.4 FortaGen

8.70.1.5 FortaPerm

8.70.1.6 BioSTAR

8.71 Orthovita, Inc.

8.71.1 Orthovita's Products

8.71.1.1 Vitoss

8.71.1.2 Vitoss and Bone Defect Grafting

8.71.1.3 Vitoss in Spinal Fusion and Grafting

8.71.1.4 Vitoss and Trauma

8.71.1.5 Vitomatrix and Dental, Periodontal, Oral and Craniomaxillofacial Defects

8.71.1.6 Cortoss Bone Augmentation Material

8.71.1.7 Cortoss and Vertebral Augmentation of Vertical Compression Fractures (VCFs)

8.71.1.8 Cortoss and Screw Augmentation

8.71.1.9 Orthovita's Aliquot Delivery System

8.71.2 Orthovita's Biosurgery Products

8.71.3 Partnership with Kensey for Vitoss Foam

8.71.4 Partnership with Angiotech for Vitagel and CellPaker

8.71.5 Partnership with Medafor for Vitasure

8.71.6 Orthovita's Business Performance

8.72 Osiris Therapeutics, Inc.

8.72.1 Osiris' Partnerships

8.72.2 Osiris' Technologies

8.72.3 Prochymal

8.72.4 Chondrogen

8.73 Osteotech, Inc.

8.73.1 Osteotech's Products

8.74 Pervasis Therapeutics, Inc.

8.74.1 Pervasis' Clinical Focus

8.74.2 Power of Endothelium

8.74.3 Therapeutic Applications of Pervasis' Products

8.74.3.1 Arteriovenous (AV) Access for Hemodialysis

8.74.3.2 Peripheral Arterial Disease

8.75 Pleuron

8.75.1 Pleuron's Technology

8.76 Pluristem Therapeutics, Inc.

8.76.1 Pluristem's PluriX 3D Bioreactor

8.76.2 Pluristem's PLacental eXpanded (PLX) Cells

8.76.3 PLX-PAD for Peripheral Artery Disease

8.76.4 PLX-IBD for Inflammatory Bowel Disease

8.76.5 PLX-MS for Multiple Sclerosis

8.76.6 PLX-STROKE for Ischemic Stroke

8.77 RegeneRx

8.78 ReNeuron Group plc

8.78.1 ReNeuron's Platform Technologies

8.78.2 ReNeuron's Cell Therapy Programs

8.78.3 ReNeuron's ReN001 for Stroke

8.78.4 ReNeuron's ReNcell Products

8.79 Revivicor, Inc.

8.79.1 Revivicor's Xenografting Technology

8.79.2 Revivicor's Islet Transplantation Technology

8.79.3 Revivicor's Infectious Disease Platform Technologies

8.80 Saneron CCEL Therapeutics, Inc.

8.80.1 Saneron's U-Cord-Cell Program

8.80.2 Saneron's Sert-Cell Program

8.81 Sangamo BioSciences, Inc.

8.81.1 Sangamo's ZFP Therapeutic Product Development Programs

8.81.2 ZFP Therapeutic Pre-Clinical Stage Programs

8.81.2.1 Neuropathic Pain (Cancer Pain)

8.81.2.2 Nerve Regeneration-Spinal Cord Injury (SCI) and Traumatic Brain Injury (TBI)

8.81.2.3 Parkinson's Disease (PD)

8.81.2.4 Stroke

8.81.2.5 ZFP Therapeutic Research Programs

8.81.3 Funding from Research Foundations

8.81.3.1 The Juvenile Diabetes Research Foundation International

8.81.3.2 The Michael J. Fox Foundation

8.81.3.3 The Bill and Melinda Gates Foundation

8.81.4 Sangamo's Research and Development Expenses

8.81.5 Sangamo's Business Performance

8.82 StemCells, Inc.

8.82.1 StemCell's Cellular Medicine Programs

8.82.2 StemCells' Enabling Technologies Program

8.82.3 StemCells' Patents, Proprietary Rights and Licenses

8.83 Stem Cell Authority Ltd.

8.83.1 The “Miracle" Mesenchymal Stem Cell-Mirachymal Stem Cells

8.84 Stem Cell Innovations (SCI)

8.84.1 SCI's Research and Development

8.84.2 SCI's Services

8.84.3 PluriCells and Derivatives

8.84.4 ACTIVTox

8.84.5 PredictivTox

8.84.6 Endogenous Protein Production

8.85 Stem Cell Sciences KK

8.85.1 SCS KK's Product/Service

8.85.1.1 CultiCell Medium for Embryonic Stem Cells

8.85.1.2 Contract/Sponsored Research on ES-derived Functional Cells

8.86 SyntheMed, Inc.

8.86.1 Repel-CVAdhesion Barrier

8.86.2 Resolve Adhesion Barrier Instillate

8.86.3 Repel Adhesion Barrier

8.86.4 SpineShield Adhesion Barrier Film

8.86.5 Relieve Adhesion Barrier Gel

8.86.6 SinusShield Adhesion Prevention Film

8.87 t2cure GmbH

8.87.1 BMCs in Regenerative Therapies

8.87.2 t2cure's Product Development Pipeline

8.88 Tengion

8.88.1 Tengion's Pipeline Overview

8.89 TiGenix

8.89.1 ChondroCelect

8.89.2 Chondromimetic

8.89.3 TGX002

8.89.4 TGX003

8.90 Thermogenesis Corp.

8.90.1 Products from Thermogenesis

8.90.1.1 AutoXpress Platform or AXP

8.90.1.2 MarrowXpress

8.90.1.3 BioArchive System

8.90.1.4 Res-Q

8.90.1.5 Thermoline

8.90.1.6 CryoSeal Fibrin Sealant (CryoSeal) System

8.90.2 Thermogenesis' Business Performance

RNA Interference Markets

1.Overview

1.1 Objectives

1.2 Scope

1.3 Methodology

1.4 Executive Summary

2 RNA Interference (RNAi)

2.1 Introduction

2.2 Overview of RNA Interference

2.2.1 Classes of Endogenous Small RNAs: siRNA, rasiRNA and miRNA

2.2.2 Mechanism of RNAi In Vivo

2.3 Glossary

2.4 What Areas of Research Does RNAi Impact?

2.4.1 RNAi Technology in Life Sciences Research, Drug Discovery and Development

2.4.2 RNAi Technology in Agriculture

3 Technology Trends in RNAi Space

3.1 Overview

3.2 End-User Segmentation

3.3 Technologies for Inducing RNAi

3.3.1 Methods for Detecting Gene Silencing

3.3.2 Comparison of Strategies for Target Validation

3.3.3 Libraries of siRNAs/shRNAs to Knock Down Genes En Masse

3.4 miRNA-Based RNAi: The Leading Edge of RNAi Space

3.4.1 Biological Function of miRNAs

3.4.2 Role of miRNAs in Disease

3.4.3 miRNA-based Diagnostics

3.4.4 miRNA-based Therapeutics

3.5 Market Shifts in RNAi Space: Where Is It Headed?

3.5.1 Intellectual Property and Patent Issues

3.5.2 Patents Covering the Molecular Characteristics of the RNAi Agent

3.5.3 Funding in RNAi Space: Grants, Venture Capital and IPOs

3.5.4 Partnerships, Alliances, Mergers and Acquisitions

3.6 SWOT Analysis of Technologies and Vendors in RNAi Space

4 RNAi Market Analysis

4.1 Overview

4.2 Market Data Collection and Respondent Pool

4.2.1 Respondent Pool Characteristics

4.3 RNAi Technologies / Products in Research Applications

4.4 RNAi Technologies/Products: Market Shares (Quantitative)

4.5 Quantitative Metrics of RNAi Usage: Market Opportunity and Growth

4.5.1 Growth of Various Segments in RNAi Space

4.5.2 Product Formats and Representation in RNAi Marketplace

4.6 RNAi Marketplace: Challenges, Unmet Needs and Drivers

4.6.1 Unmet Needs in RNAi Space

4.6.2 RNAi Market: Qualitative Growth Drivers

5 The RNAi Landscape

5.1 Overview

5.2 Market Segmentation of RNAi and Segment Characteristics

5.3 Quantitative Market Opportunities in RNAi Space

5.3.1 Opportunities in miRNA Space

5.3.2 Opportunities in siRNA/shRNA Space

5.4 RNAi Product Offerings and Associated Business Models

5.5 Challenges for RNAi Therapeutic Development

6 RNAi-Based Therapeutics: The Emerging Industry Landscape

6.1 Factors Contributing to the Success of RNAi Therapeutics

6.2 Advantages and Disadvantages of siRNA-based Drugs

6.3 Opportunities and Challenges with RNAi-based Therapeutics

6.4 The Gene Therapy Precedent

6.5 The Antisense Precedent

6.6 Interferon Response

6.7 Delivery of RNAi-based Therapeutics

6.8 Off-Target Effects

6.9 Overwhelming the Endogenous RNAi System—Affecting the microRNA Pathway

6.10 RNAi-based Therapeutics

6.10.1 Cancer

6.10.2 Cardiac Disease

6.10.3 Immunologic Disease

6.10.4 Infectious Disease

6.10.5 Inflammation

6.10.6 Lifestyle Therapeutics

6.10.7 Metabolic Disease

6.10.8 Neurologic Disease

6.10.9 Ophthalmic Disease

6.10.10 Renal Disease

6.10.11 Respiratory Disease

7 Company Profiles—U.S.

7.1 Alfacell Corporation

7.2 Allele Biotechnology and Pharmaceuticals, Inc.

7.3 Alnylam Pharmaceuticals

7.4 Ambion

7.5 Asuragen, Inc.

7.6 Avalon Pharmaceuticals, Inc.

7.7 B-Bridge International, Inc.

7.8 Bio-Rad Laboratories

7.9 Calando Pharmaceuticals, Inc.

7.10 Cepheid

7.11 Cequent

7.12 Clontech Laboratories, Inc.

7.13 CombiMatrix Corporation

7.14 Cyntellect, Inc.

7.15 CytRx Corp.

7.16 Dharmacon

7.17 Dicerna

7.18 Galenea Corporation

7.19 GeneCopoeia, Inc.

7.20 GeneThera, Inc.

7.21 Genlantis

7.22 GenoSensor

7.23 GRL, Inc.

7.24 IDT

7.25 Imgenex Corporation

7.26 Ingenuity Systems

7.27 Intradigm Corporation

7.28 Invitrogen

7.29 InvivoGen

7.30 Isis Pharmaceuticals, LLC

7.31 LC Sciences

7.32 Lentigen Corporation

7.33 MDRNA

7.34 Merck & Co., Inc.

7.35 Mirus Bio Corporation (Acquired by Roche)

7.36 Monsanto

7.37 Nastech Pharmaceutical Company, Inc.

7.38 New England BioLabs

7.39 Nucleonics, Inc.

7.40 Open Biosystems, Inc.

7.41 OPKO Health, Inc.

7.42 OriGene

7.43 Panomics, Inc.

7.44 PhaseRx

7.45 Promega Corp.

7.46 Quark Pharmaceuticals, Inc.

7.47 RXi Pharmaceuticals Corporation

7.48 Senetek PLC

7.49 Sigma-Aldrich

7.50 Sirna Therapeutics

7.51 Sirnaomics, Inc.

7.52 SomaGenics, Inc.

7.53 System Biosciences

7.54 Tacere Therapeutics

7.55 Targeted Genetics Corporation

7.56 Third Wave Technologies

7.57 Traversa

8 Company Profiles—Europe

8.1 Actigenics SA

8.2 Amaxa

8.3 AstraZeneca PLC

8.4 Cenix Bioscience GmbH

8.5 deVGen N.V.

8.6 DNAVision

8.7 Exiqon

8.8 Genovis

8.9 genOway

8.10 imaGenes GmbH

8.11 MWG Biotech AG

8.12 OZ Biosciences

8.13 Prosensa Holding

8.14 QIAGEN

8.15 RNAx GmbH (Germany)

8.16 Roche

8.17 Rosetta Genomics, Ltd.

8.18 Santaris Pharma A/S

8.19 Silence Therapeutics PLC

8.20 TaconicArtemis GmbH

8.21 TRANSAT

9 Company Profiles—Asia-Pacific

9.1 alphaGEN Co., Ltd.

9.2 Benitec, Ltd.

9.3 Bioneer

9.4 CytoPathfinder, Inc.

9.5 Genesis Research & Development Corp.

9.6 GeneDesign, Inc.

9.7 GNI Pharmaceutical Corporation

9.8 Koken Co., Ltd.

9.9 NanoCarrier Co., Ltd.

9.10 Oncolys Biopharma, Inc.

9.11 RealGene Bio-Technologies, Inc.

9.12 Samchully Pharmaceuticals

9.13 Samyang Corp.

9.14 Shanghai Biochip

9.15 Shanghai GenePharma Co.

9.16 Shanghai Genomics, Inc.

9.17 Transgene Biotek, Ltd.

10 Company Profiles—Rest of the World

10.1 Benitec, Ltd.

10.2 Tekmira

Stem Cell Markets

1. Overview

1.1 Statement of Report

1.2 Scope of the Report

1.3 Methodology

1.4 Executive Summary

1.4.1 Toxicity Screening for Drug Discovery and Development

1.4.2 Autologous Cell Therapy

1.4.2.1 Current Range of Applications for Autologous Cell Therapy (ACT)

1.4.2.2 Commercially Available Autologous Treatments

1.4.2.3 Autologous Treatment for Neurodegenerative Diseases

1.4.2.4 Autologous Cell Therapy and Wound Healing

1.4.2.5 Autologous Cell Therapy and Cosmetic Surgery

1.4.3 Allogeneic Cell Therapy

1.4.3.1 Allogeneic First Generation (Non-Stem Cell) Products

1.4.3.2 Second Generation (Stem Cell-Based) Products

1.4.3.3 Secondary Products

1.4.4 Three Basic Types of Allogeneic Stem Cell Products

1.4.4.1 Hematopoietic Stem Cells

1.4.4.2 Neural Stem Cells

1.4.4.3 Mesenchymal Stem Cells, Pancreatic Islet Stem Cells

1.5 Current State of Stem Cell Market

2. Biology of Stem Cells

2.1 Scope of this Chapter

2.2 Basic Properties of Stem Cells

2.3 Classification of Stem Cells, Stem Cell Lineages and their Derivation

2.3.1 Embryonic Stem Cells

2.3.1.1 Embryonic Germ Cells

2.3.1.1 Fetal Stem Cells

2.3.1.2 Umbilical Cord Stem Cells

2.3.2 Adult Stem Cells

2.3.2.1 Hematopoietic Stem Cells (Bone Marrow and Peripheral Blood)

2.3.2.2 Mesenchymal Stem Cells (Bone Marrow Stroma)

2.3.2.3 Gut Stem Cells

2.3.2.4 Liver Stem Cells

2.3.2.5 Bone and Cartilage Stem Cells

2.3.2.6 Epidermal Stem Cells (Skin and Hair)

2.3.2.7 Neuronal Stem Cells

2.3.2.8 Pancreatic Stem Cells

2.3.2.9 Eye Stem Cells

2.4 Stem Cell Lineage

2.5 Stem Cell Derivations

2.6 Sources of Stem Cells

2.7 Differentiation of Stem Cells

2.8 Self-Renewal of Stem Cells

2.9 Dedifferentiation of Cells

2.10 Nuclear Reprogramming of Stem Cells

3. Stem Cell Therapy

3.1 Scope of this Chapter

3.2 Diseases with Unmet Clinical Need: Primary Driver of Stem Cell Therapy

Market

3.3 Leading Healthcare Segments Offering Scope for Easy Entry into Stem Cell

Market

3.3.1 Stem Cell Therapy in Orthopedics

3.3.1.1 Stem Cells for the Repair of Tendons, Cartilages and Bone

3.3.2 Stem Cell Therapy for Cardiac Diseases

3.3.3 Stem Cell Therapy for Wound Healing

3.3.4 Stem Cell Therapy for Diabetes

3.3.5 Stem Cell Therapy for Neurodegenerative Diseases

3.3.5.1 Clinical Activity for Cell Therapy into CNS

3.3.6 Stem Cell Retinal Replacement Therapy

3.3.7 Stem Cell Therapy for Liver Diseases

3.3.7.1 Hepatocyte-like Cells for Liver Disease

3.3.7.2 Cell Therapy for Liver Cirrhosis

3.3.8 Cell Therapy for Peripheral Vascular Diseases

3.3.9 Cell Therapy for Blood Disorders

3.3.10 Biomaterials and Stem Cell Therapy

3.3.11 Stem Cell Application in Drug Discovery

3.4 Stem Cell Products in Development

3.5 Stem Cell and Related Products in the Global Market

3.5.1 Medtronic’s Infuse Bone Graft and the LT-Cage Device

3.5.2 GenZyme’s Carticel®

3.5.3 Stryker’s OP-1

3.5.4 Osyris/Nuvasive’s Osteocel®

3.5.5 RTI’s Spinal Implants

3.5.6 Organogenesis’ Apligraf®

3.5.7 Advanced Biohealing’s Dermagraft

3.5.8 Integra’s Bilayer Matrix Wound Dressing

3.5.9 LifeCell’s AlloDerm®

3.5.10 Gytori’s Celution®

3.6 Other Products of Importance in the Global Market

3.6.1 Tissue-Engineered Wound Healing Products

3.6.1.1 Oasis®

3.6.1.2 Permacol™

3.6.1.3 EZ-Derm®

3.6.1.4 Matriderm®

3.6.1.5 Alloderm®

3.6.1.6 TransCyte®

3.6.1.7 ICX-SKN®

3.6.1.8 OrCel®

3.6.1.9 Epicel®

3.6.1.10 Myskin™

3.6.1.11 EpiDex™

3.6.1.12 Genzyme’s MACI® Implant

3.6.1.13 Genzyme’s Epicel®

3.6.1.14 ICX-TRC—Hair Regeneration Therapy

3.6.1.15 VCT01™

3.6.2 Cartilage Regeneration

3.6.2.1 ChondroCelect/TGX001

3.6.2.2 TGX002

3.6.2.3 TGX003

3.6.2.4 NOVOCART™

3.6.3 BioTissue Technologies’ Products

3.6.3.1 BioSeed®-S

3.6.3.2 MelanoSeed

3.6.3.3 Oral Mucosa BioSeed®-M

3.6.3.4 BioSeed®-Oral Bone

3.6.3.5 BioSeed®-C

3.6.4 co.don®’s Autologous Cell Transplant Products

3.6.5 Fidia Advanced Biopolymers’ Regenerative Medicine Products

3.6.5.1 Hyalograft 3D™

3.6.5.2 Laserskin®

3.6.5.3 TISSUEtech autograft system™

3.6.5.4 Hyalograft™ C

3.6.6 Genzyme Biosurgery’s Tissue Engineering Products

3.6.6.1 Carticel®

3.6.6.2 Epicel®

3.6.7 Interface Biotech AS’ Tissue Engineered Products

3.6.7.1 Cartilink™-1

3.6.7.2 Cartilink™-2

3.6.8 Isotis S.A’s Tissue Engineered Products

3.6.8.1 OsSatura™

3.6.8.2 EpiDex

3.6.8.3 AcuDress

3.6.9 Karocell Tissue Engineering AB’s Tissue-Engineered Products

3.6.9.1 Skin Cells

3.6.9.2 Cartilage Cells

3.6.9.3 Melanocytes

3.6.9.4 Urothelial Tissue

3.6.10 Smith & Nephew’s Tissue Engineering Products

3.6.10.1 TransCyte

3.6.10.2 Dermagraft

3.6.11 Tetec Tissue Engineering Technologies AG’s Tissue Engineered Product

3.6.11.1 Novacart®

3.6.12 Verigen Transplantation Service International (VTSI)’s Tissue-Engineered Products

3.6.12.1 CACI

3.6.12.2 MACI®

3.6.12.3 MACI® (A)

3.6.13 XCELLentis’ Tissue-Engineered Products

3.6.13.1 Ceal Platform

3.6.13.2 LyphoDerm

4. Market Analysis of the Stem Cell Space

4.1 Scope of this Chapter

4.1.1 Various Market Segments in Stem Cell Space

4.1.2 Market for Cell Therapy in the U.S.

4.2 Market Segmentation by Source of Stem Cell Used

4.2.1 Human Embryonic Stem Cells (hESCs) in Cell Therapy

4.2.1.1 Investing Companies in hESCs

4.2.1.2 Engineered Cartilage using hESCs

4.2.1.3 Lung Tissue Differentiated from hESCs

4.2.1.4 Human Mesenchymal Stem Cells (MSCs)

4.2.2 Neural Stem Cells

4.2.3 Human Hematopoietic Stem Cells

4.2.4 Cord Blood Stem Cells

4.2.5 Cancer Stem Cells

4.3 Cord Blood Banking Market

4.3.1 Cord Blood Stem Cell Applications

4.3.1.1 Repairing Blood Vessels Using Cord Blood Stem Cells

4.3.1.2 Cardiomyocetes and Cord Blood Stem Cells

4.3.1.3 Congenital Heart Defects and Cord Blood Stem Cells

4.3.1.4 Peripheral Vascular Disease and Cord Blood Stem Cells

4.3.2 Growth of Public and Private Cord Blood Banks

4.3.2.1 Public Cord Blood (CB) Banks

4.3.2.2 Private Cord Blood Banks

4.3.2.3 The Collection Process of Cord Blood Cells

4.4 Cell Culture Products

4.4.1 In Vitro Test Kits

4.4.2 Suppliers of Cells and Tissues

4.4.3 Suppliers of Culture Media and Cell Reagents

4.4.4 Equipments for Stem Cell Research

4.4.5 Computer Software for Stem Cell Research

4.5 Cell Therapy Market

4.5.1 The Size of the Cell Therapy Industry

4.5.2 The Age, Size and Location of Firms

4.5.3 Firm Technology and Disease Focus

4.5.4 Cell Therapy Products and Companies

4.5.5 Products on the Market

4.5.5.1 First Generation (Non-Stem Cell Based) Primary Products

4.5.5.2 Second Generation (Stem Cell Based) Primary Products

4.5.5.3 Secondary Products

4.5.5.4 Products in Development

4.5.5.5 The Disease Targets of Trials

4.5.5.6 Stem Cell Industry Pipeline

4.6 Industry Collaboration in Stem Cell Space

4.7 Increasing Commercial Success in Stem Cell Industry

4.8 Transition from Tissue Engineering to Regenerative Medicine

4.9 Challenges to Commercial Development of Cell Therapies

4.9.1 Problems of Commercial Viability and Sustainability

4.9.2 Poor Sales and Limited Prospects for Some Forms of Cell Therapy

4.9.3 Lack of Investment from Large Companies

4.9.4 Lack of Clinical Demand and Uptake

4.10 Partnership of Stem Cell Companies with Large Pharmaceutical Companies

4.10.1 Strategic Approaches for Cell-based Companies

4.10.2 The Need for Support from Large Pharmaceuticals

5. Strategic Roadmap to Cell Therapy Industry

5.1 Scope of this Chapter

5.2 Options for the Commercial Manufacturing of Stem Cell Products

5.3 Regulatory Requirements for a Cell Therapy Industry

5.4 In-House Manufacturing of Cell Therapy Products

5.5 Contract Manufacturing

5.6 Effective Clinical Delivery Plan for Cell Therapies

5.7 Business Models in Stem Cell Therapy Sector

5.8 Current Models for Autologous Cell Therapies

5.9 Current Models for Allogeneic Cell Therapies

5.10 Value Chain Considerations and Developmental Path

5.11 Stem Cells: From the Laboratory to the Market

5.11.1 Value Analysis

5.11.2 Clinical Study Development

5.11.3 Product Commercialization

5.11.4 Importance of Specialty Society Support

5.11.5 Payor Coverage

6. Funding for Regenerative Medicine Research

6.1 Scope of this Chapter

6.2 The Intense Competitive Pressure for Funding

6.3 History of Stem Cell Research, Tissue-Engineering and Regenerative Medicine

6.4 The Story of Federal Funding of Stem Cell Research

6.4.1 Policy Changes

6.4.2 Types of Research Ineligible for NIH Funding

6.4.3 NIH Guidelines Addressing the Projected Growth of Stem Cell-Related Clinical Trials

6.4.4 CIRM Funding for Stem Cell Research and Regenerative Medicine

6.5 The Strong Financial Case for Stem Cell Research and Regenerative Medicine

6.5.1 Regenerative Medicine Cost vs. Existing Treatments

7. Current Stem Cell Research

7.1 Scope of this Chapter

7.2 Stem Cell Policies in North America

7.3 Stem Cell Policies in South America

7.4 Stem Cell Policies in Europe

7.5 Stem Cell Policies in Asia/Oceania

7.6 California Institute for Regenerative Medicine (CIRM)

7.6.1 CIRM Collaborative Funding

7.6.2 CIRM’s Funding for Clinical Applications

7.6.3 Early Translational Awards

7.6.4 Disease Team Awards

7.7 Stem Cell Research Programs in Connecticut Department of Public Health

7.7.1 Types of Awards by Connecticut Stem Cell Research Program, 2010

7.7.1.1 Seed Grant Awards

7.7.1.2 Established Investigator Awards

7.7.1.3 Group Project Awards

7.7.1.4 Core Facilities Awards

7.8 Maryland Technology Development Corporation (TEDCO)

7.8.1 TEDCO’s Programs: Funding Opportunities

7.8.1.1 Fort Detrick Technology Transfer Initiative (FDTTI)

7.8.1.2 J&J Investment Fund

7.8.1.3 NAVAIR Technology Insertion (NAVTI) Program

7.8.1.4 The TechStart Program

7.8.1.5 University Technology Development Fund (UTDF)

7.8.1.6 Working Capital Loan Fund

7.9 Maryland Technology Transfer and Commercialization Fund (MTTCF)

7.9.1 Maryland Stem Cell Research Fund

7.10 The New Jersey Commission on Science and Technology (NJCST)

7.10.1 Stem Cell Research in New Jersey

7.10.2 Stem Cell Research Grant Program

7.11 New York State Stem Cell Science (NYSTEM)

7.11.1 Investigator Initiated Research Projects and Innovative (IIRP),Developmental or Exploratory Activities (IDEA) in Stem Cell Research

7.11.2 Targeted RFA for Investigation of iPS and Other Derivation Approaches

7.11.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell

Research

7.11.4 Consortia Planning Awards

7.11.5 Institutional Development

7.11.6 Center for Stem Cell and Regenerative Medicine

7.11.7 Funding

8. Company Profiles

8.1 Aastrom Biosciences, Inc.

8.1.1 Aastrom’s TRC Technology

8.1.2 Aastrom’s Patents

8.1.3 Aastrom’s Clinical Development Programs

8.2 Advanced Cell Technology, Inc.

8.2.1 ACT’s Human ES Cell Technologies

8.2.2 ACT’s Cellular Reprogramming

8.2.3 ACT’s Stem Cell Differentiation

8.2.4 ACT’s Adult Stem Cell Program

8.2.5 ACT’s Intellectual Property

8.3 Aldagen, Inc.

8.4 Asterand plc

8.4.1 Asterand’s Models and Methods to Improve Drug Discovery

8.4.2 Asterand’s Product Offerings

8.4.2.1 Asterand’s Frozen and Fixed Tissues

8.4.2.2 Asterand Cell Lines

8.5 Alseres Pharmaceuticals, Inc.

8.5.1 Alseres’ Product Pipeline

8.5.1.1 Cethrin®, a Rho Inhibitor

8.5.1.2 Inosine

8.5.1.3 Oncomodulin and ALSE-100

8.5.1.4 Altropane® - PD

8.5.2 Alseres’ Science and Technology

8.5.2.1 Nerve Repair Pathways

8.5.2.2 The Pro-Regenerative Pathway

8.5.2.3 The Anti-Regenerative Pathway

8.5.2.4 Molecular Imaging

8.6 Amgen, Inc.

8.6.1 Amgen’s Clinical Developments

8.6.1.1 Amgen’s Clinical Developments in Osteoporosis

8.6.1.2 Amgen’s Clinical Developments in Oncology

8.6.2 Amgen’s Select Product Candidates

8.6.2.1 Amgen’s New Product Candidates

8.7 Amorcyte, Inc.

8.7.1 Amorcyte’s Technology

8.7.1.1 AMR-001: A Cell Therapy for Acute Myocardial Infarction

8.8 Angioblast Systems, Inc.

8.8.1 Angioblast’s Technology

8.8.1.1 Angioblast’s Allogenic Adult Stem Cells

8.8.1.2 Angioblast’s Protein Therapeutics

8.8.1.3 Angioblast’s Gene Silencing

8.9 Athersys, Inc.

8.9.1 Athersys’ Current Programs

8.9.2 Athersys’ Regenerative Medicine Programs

8.9.2.1 Multistem for Heart Attack

8.9.2.2 HSC Transplant Support in Hematologic Malignancy

8.9.2.3 Stroke

8.10 BeFutur Biotechnologies

8.10.1 BeFutur’s Serum Free Technology

8.10.2 BeFutur’s Stem Cells

8.11 BD Biosciences

8.12 BioE, Inc.

8.12.1 BioE’s Cell Technologies

8.12.1.1 Application of BioE's Multi-Lineage Progenitor Cell

8.12.1.2 Application of the MLPC in Regenerative Medicine

8.12.1.3 Application of PrepaCyte for Cord Blood

8.12.2 BioE’s Products

8.12.2.1 Multi-Lineage Progenitor Cell (MLPC®)

8.12.2.2 PrepaCyte®-CB

8.12.2.3 PrepaCyte®-WBC

8.12.2.4 ActiCyte®

8.12.2.5 VitaLyse®

8.13 Bioheart, Inc.

8.13.1 Bioheart’s Product Candidates

8.13.1.1 MyoCell®

8.13.1.2 MyoCell SDF-1

8.13.1.3 The TGI 1200 Cell Isolation system

8.13.1.4 Bioheart 3370®

8.13.1.5 MyoCath

8.14 BioMimetic Therapeutics, Inc.

8.14.1 BioMimetic’s Products

8.14.1.1 Augment™ Bone Graft

8.14.1.2 Augment™ Injectable Bone Graft

8.15 Biosafe Group SA

8.15.1 Biosafe’s Sepax System

8.15.2 Coolmix

8.15.3 SepaxNet

8.16 Brainstorm Cell Therapeutics, Inc.

8.16.1 BrainStorm Technology—NurOwn™

8.17 Cardio3 BioSciences

8.17.1 C-Cure™

8.17.2 Dopamine Transporter (DAT)

8.18 CaridianBCT

8.18.1 Caridian’s Products

8.18.1.1 Trima Accel® Collection System

8.18.1.2 Spectra Optia® Apheresis System

8.18.1.3 COBE® Spectra Apheresis System

8.18.1.4 Elutra® Cell Separation System

8.18.1.5 Atreus® Whole Blood Processing System

8.18.1.6 OrbiSac® System

8.18.1.7 COBE® 2991 Cell Processor

8.19 Cellartis AG

8.19.1 Cellartis’ Products

8.19.1.1 Cardiomyocyte Monolayers

8.19.1.2 Cardiomyocyte Clusters

8.19.1.3 Hepatocyte-like Cells

8.19.1.4 Mesenchymal Progenitors

8.19.1.5 The hES Cell Lines

8.19.1.6 Monoclonal Antibodies

8.19.1.7 VitroHES™

8.19.1.8 Stem Culture Tools

8.20 Cellerant Therapeutics, Inc.

8.20.1 Cellerant’s Pipeline

8.20.1.1 CLT-008

8.21 CellCyte Genetics Corporation

8.21.1 CellCyte’s Product Candidates

8.21.2 CellCyte’s Therapeutic Pipeline

8.21.2.1 Heart Repair

8.21.2.2 Cells for Use in the Liver

8.21.2.3 Delivery of Stem Cells to the Bone Marrow

8.21.2.4 Oncology-Adenocarcinoma Tumor Detection

8.21.3 CellCyte’s Device Division

8.21.3.1 Cell Expansion

8.21.3.2 Stem Cell Purification

8.22 Cellerix

8.22.1 Cellerix’s Products

8.22.1.1 Ontaril®

8.22.1.2 Cx501

8.23 CellSeed, Inc.

8.23.1 Regenerative Cornea Product from CellSeed

8.23.2 Regenerative Living Cardiac Patch

8.24 Cellular Dynamics International, Inc. (CDI)

8.24.1 Induced Pluripotent Stem (iPS) Cell Technology

8.24.2 Cardiomyocytes

8.24.3 Mastocytes

8.25 CellTran Ltd.

8.25.1 Myskin™

8.25.2 Lyphoderm

8.25.3 Products in Development

8.25.3.1 Vitiligo Treatment

8.25.3.2 Corneal Epithelial Treatment

8.25.3.3 Cell Migration Dressing

8.26 Cerco Medical

8.26.1 Cerco’s Concept

8.27 Cellular Engineering Technologies, Inc.

8.27.1 CET’s Human Amniotic Epithelial Stem Cells

8.27.2 CET’s Cryopreservation Media

8.27.3 CET’s Adipogenic Differentiation Media

8.27.4 CET’s Cardiomyocyte Differentiation Media

8.27.5 CET’s Chondrogenic Differentiation Media

8.27.6 CET’s Neural Differentiation Media

8.27.7 CET’s Osteogenic Differentiation Media

8.27.8 CET’s Amniotic Epithelial Stem Cell Expansion Media

8.27.9 CET’s Cord Blood Multipotent Unrestricted Somatic Stem Cell Expansion Media

8.27.10 CET’s Mesenchymal Stem Cell Expansion Media

8.27.11 CET’s Human Immunological Cells

8.27.12 CET’s Human Foreskin Fibroblast Cells

8.27.13 CET’s Human Umbilical Vein Endothelial Cell Expansion Media

8.27.14 CET’s Cryopreservation Media

8.27.15 CET’s Bioelectrode Cell-based Assays

8.27.16 CET’s Hepatic Drug Screening

8.27.17 CET’s Neural Drug Screening

8.27.18 CET’s Contract Research Services

8.28 Cord Blood America, Inc.

8.29 CorMatrix® Cardiovascular, Inc.

8.29.1 ECM Technology™

8.30 Cryo-Cell International, Inc.

8.31 Cytori Therapeutics, Inc.

8.31.1 Market for Clinical-Grade Cells

8.31.2 StemSource® and Cell Banking

8.31.3 Celution® System Pipeline

8.31.3.1 Cardiovascular Disease

8.32 CryoLife, Inc.

8.32.1 CryoLife’s Services and Products

8.32.1.1 Tissue Preservation Services

8.32.1.2 Human Cardiac Tissue

8.32.1.3 Human Vascular Tissue

8.32.1.4 Human Orthopedic Tissue

8.32.1.5 ProPatch Soft Tissue Repair Matrix

8.33 Epistem PLC

8.33.1 Xenografting

8.33.2 Cancer Stem Cell Assays

8.33.3 Angiogenesis Models

8.33.4 Colon Cancer Models

8.33.5 Oncology Biomarker Models

8.33.6 In Vitro Cytotoxicity Testing

8.33.7 Target Validation-Oncology

8.33.8 Inflammatory Bowel Disease

8.33.9 Dermatology

8.33.10 Histology and Molecular Services

8.33.11 Epistem’s Biomarkers

8.33.12 Epistem’s New Therapies

8.34 ES Cell International Pvt, Ltd.

8.34.1 ESI’s Technology

8.34.2 ESI’s Intellectual Property

8.35 Forticell Bioscience, Inc.

8.36 OrCel®

8.36.1 Technology

8.37 Gamida Cell

8.37.1 Gamida’s Technology

8.38 GenVec, Inc.

8.39 Geron Corporation

8.39.1 Geron and Human Embryonic Stem Cell Therapies

8.39.2 Geron’s Oligodendrocyte Progenitor Cells for Spinal Cord Injury (GRNOPC1)

8.39.3 Geron’s Cardiomyocytes for Heart Disease (GRNCM1)

8.39.4 Geron’s Islet Cells for Diabetes (GRNIC1)

8.39.5 Geron’s Osteoblasts for Osteoporosis and Non-Union Bone Fractures

8.39.6 Geron’s Chondrocytes for Osteoarthritis

8.39.7 Geron’s Dendritic Cells for Cancer Immunotherapy and to enable Therapeutic Graft Acceptance

8.39.8 Geron’s Immortalized Cells for Research

8.39.9 Geron’s hESC-derived Cells for Drug Screening and Toxicology

8.40 Glycosan Biosystems, Inc.

8.40.1 Extracel™ Hydrogel Kit

8.40.2 Extracel-X™ Hydrogel Kit

8.40.3 Extracel-HP™ Hydrogel Kit

8.40.4 Extracel-SS™ Hydrogel Kit

8.40.5 HyStem™ Hydrogel Kit

8.40.6 HyStem-C™ Hydrogel Kit

8.40.7 HyStem-HP™ Hydrogel Kit

8.40.8 HyStem-CSS™ Hydrogel Kit

8.40.9 PEGDA

8.40.10 PEGTA

8.40.11 PEGSSDA™ (PEGSSDA)

8.41 Humacyte, Inc.

8.41.1 Humacyte’s Technologies

8.41.1.1 Vascular Products

8.41.1.2 Injectable Products

8.41.1.3 Human Embryonic Stem Cell Therapies

8.42 Intercytex Group plc

8.42.1 Intercytex’s Pipeline

8.42.1.1 VAVELTA® - Skin Repair and Rejuvenation

8.42.1.2 SHEF-1 - Stem Cell Line

8.42.1.3 ICX-SKN—Skin Graft Replacement for Burns and Acute Wounds

8.42.1.4 ICX-TRC - Hair Regeneration

8.42.1.5 Cyzact®—Chronic Wound Repair

8.43 Integra LifeSciences Holding, Corp.

8.43.1 Integra’s Duraplasty Products

8.43.2 Integra’s Collagen for Spine

8.43.3 Integra’s Dermal Regeneration and Engineered Wound Dressings

8.43.4 Integra’s Nerve and Tendon Products

8.43.5 Human Cells, Tissues and Cellular and Tissue-Based Products from Integra

8.44 International Stem Cell Corporation

8.44.1 ISCO’s Technology

8.44.1.1 Somatic Cell Nuclear Transfer

8.44.1.2 Parthenogenesis

8.44.1.3 ISCO’s Therapeutic Focus

8.44.1.4 Retinal Degeneration

8.44.1.5 Diabetes Therapies

8.44.1.6 Liver Therapies

8.44.2 ISCO’s Products

8.45 Japan Tissue Engineering Co., Ltd.

8.45.1 Cultured Epidermis

8.45.2 Cultured Cartilage

8.45.3 Cultured Corneal Epithelium

8.46 LifebankUSA

8.46.1 Cord Blood Banking

8.47 Life Technologies Corporation

8.47.1 Life Technologies’ Customers

8.47.1.1 Life Science Researchers

8.47.1.2 Commercial Producers of Biopharmaceutical and Other High-Valued Proteins

8.47.1.3 Applied Markets

8.47.2 Life Technologies’ Products

8.48 Lonza

8.48.1 Lonza’s Products and Applications

8.49 MedCell Bioscience, Ltd.

8.49.1 MedCell’s MS-ten Technology

8.50 Medistem, Inc.

8.50.1 Method for Expansion of Stem Cells

8.50.2 Compositions of Placentally-derived Stem Cells for the Treatment of Cancer

8.50.3 Transcatheter Tumor Immunoembolization

8.50.4 Stem Cell Therapy for Cardiac Valvular Dysfunction

8.50.5 Treatment of Erectile Dysfunction by Stem Cell Therapy

8.50.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients

8.50.7 Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation

8.50.8 Cellular Therapy for Lower Back Pain

8.50.9 Compositions and Methods of Stem Cell Therapy for Autism

8.50.10 Stem Cell Therapy for Weight Loss

8.50.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof

8.50.12 Endometrial Derived Reparative/Regenerative Cells

8.50.13 Treatment of Insulin Resistance and Diabetes

8.50.14 Combination Treatment of Cardiovascular Disease

8.50.15 Stem Cell Therapy for Autism

8.50.16 Endometrial Regenerative Stem Cell Line

8.50.17 Medistem’s Angiostem Platform

8.51 Mesoblast Limited

8.51.1 Mesoblast’s Technologies

8.51.2 Mesoblast’s Applications in Bone Repair

8.51.2.1 Cartilage Regeneration

8.51.2.2 Disc Regrowth

8.51.3 Mesoblast’s Application in Heart Attack

8.51.3.1 Congestive Heart Failure

8.51.3.2 Peripheral Arterial Disease

8.51.4 Mesoblast’s Application in Wound Ulcers

8.51.5 Mesoblast’s Process and Product Development

8.51.5.1 GMP Process Development

8.51.5.2 Proof of Principle Models

8.52 Millipore Corporation

8.52.1 Millipore’s Drug Discovery and Development Services

8.52.2 Millipore’s Research and Development

8.53 Miltenyi Biotec

8.53.1 Miltenyi Biotec’s MACS® Technology

8.53.2 MACS® Cell Analysis

8.53.3 MACS® Cell Culture product line

8.54 Neostem, Inc.

8.54.1 NeoStem’s Services

8.55 NeuralStem, Inc.

8.55.1 NeuralStem’s Focus on Regenerative Medicine

8.55.2 The Potential of NeuralStem’s Tissue-Derived Stem Cell-based Therapy

8.55.3 Potential Markets

8.55.4 NeuralStem’s Technology

8.55.5 NeuralStem’s Research Programs

8.56 NeuroGeneration

8.56.1 NeuroGeneration’s Stem Cell Therapy

8.57 Novocell, Inc.

8.57.1 Novocell and Stem Cell Engineering

8.57.2 Novocell and Cell Encapsulation

8.57.3 Novocell’s Clinical Trials

8.58 Opexa Therapeutics, Inc.

8.58.1 Opexa’s Products

8.58.1.1 Tovaxin®

8.58.1.2 Current MS Treatments

8.59 Organogenesis, Inc.

8.59.1 Products from Organogenesis

8.59.1.1 Apligraf®

8.59.1.2 VCT01™

8.59.1.3 CelTx™ for Oral Soft Tissue Regeneration

8.59.2 Bio-surgery

8.59.2.1 FortaFlex®

8.59.3 Licensing Opportunities

8.59.3.1 FortaFlex® Collagen Biomaterial Technology

8.60 Orthovita, Inc.

8.60.1 Orthovita’s Products and Product Candidates

8.60.1.1 Orthovita’s Bone Defect Grafting Products

8.60.1.2 Orthovita’s Spinal Fusion and Grafting Products

8.60.1.3 Orthovita’s Trauma Products

8.60.1.4 Orthovita’s Dental, Periodontal, Oral and Cranio-Maxillofacial Products

8.61 Osiris Therapeutics, Inc.

8.62 Pervasis Therapeutics, Inc.

8.62.1 Vascugel®

8.62.2 PVS-10200 - Minimally Invasive

8.63 Pleuron Corp.

8.63.1 Plureon’s Technology

8.64 Pluristem Therapeutics, Inc.

8.64.1 Pluristem's PluriX™ 3D Bioreactor

8.64.2 Pluristem's PLacental eXpanded (PLX) Cells

8.64.3 PLX-PAD for Peripheral Artery Disease

8.64.4 PLX-IBD for Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)

8.64.5 PLX-MS for Multiple Sclerosis

8.64.6 PLX-STROKE for Ischemic Stroke

8.65 Reinnervate LLC

8.65.1 Reinnervate’s Technology

8.65.2 Reinnervate’s Culture Apparatus for Three Dimensional Cell Growth

8.65.3 Production of Synthetic Retinoids to Control Cell Differentiation

8.66 Regenocyte Therapeutic

8.66.1 Regenocyte’s Adult Stem Cell Therapy

8.67 ReNeuron Group Plc

8.67.1 ReNeuron’s Platform Technologies

8.67.2 ReNeuron’s Cell Therapy Programs

8.67.3 ReNcell® Products

8.68 Saneron Therapeutics, Inc.

8.68.1 Saneron’s U-CORD-CELL™ Program

8.68.2 Saneron’s SERT-CELL™ Program

8.69 Scikon Innovation, Inc.

8.69.1 Scikon’s Human Cell Products

8.70 Stem Cells, Inc.

8.70.1 StemCell’s Specialty Cell Culture Products

8.70.2 StemCell’s Patents

8.71 StemCell Technologies, Inc.

8.71.1 SCT’s Products

8.71.2 Hematopoietic Stem Cell Research

8.71.3 SCT’s Mesenchymal Stem Cell Products for Human Cells

8.71.4 SCT’s Products for Neural Stem Cells Research

8.71.5 Stem Cell Innovations (SCI)

8.71.6 SCI’s Research and Development

8.71.7 SCI’s Services

8.71.7.1 PluriCells™ and Derivatives

8.71.7.2 ACTIVTox®

8.71.7.3 PREDICTIVTox®

8.71.7.4 Endogenous Protein Production

8.72 Stem Cell Sciences KK

8.72.1 Cell-Based Therapy

8.72.2 SCS KK’s Product/Service

8.72.2.1 CultiCell Medium for Embryonic Stem Cells

8.72.3 Contract/Sponsored Research on ES-Derived Functional Cells

8.73 Stem Cell Therapy International, Inc.

8.73.1 Biological Preparations

8.73.2 Treatment of Patients with Diabetes

8.73.3 Treatment of Patients with Diabetic Retinopathy

8.73.4 Atherosclerosis Coronary Heart Disease and Cerebral Ischemia

8.73.5 Liver Cirrhosis

8.73.6 Non-Specific Ulcerative Colitis (Crohn’s Disease)

8.73.7 Immunomodulation before Capital Surgical Operations Wound Dystrophy

8.73.8 Acute Surgical Complications

8.73.9 Peritoneal Commissures of the Abdominal Cavity

8.73.10 Immunodeficient States in Children

8.73.11 Sickle-Cell Anemia Therapy

8.73.12 Complex Therapy of Down’s Disease

8.73.13 Complex Therapy of Cosmetic Problems

8.73.14 Diseases and Disorders of Nervous System

8.74 Stempeutics Research Private Limited

8.74.1 Research: Mesenchymal Stem Cells Derived from Wharton’s Jelly

8.74.2 Research: Mesenchymal Stem Cells Derived from Adipose Tissue

8.74.3 Research: Mesenchymal Stem Cells Derived from Dental Pulp

8.74.4 Research: Large Scale Upscaling of Mesenchymal Stem Cells

8.74.5 Research: Human Embryonic Stem Cells

8.74.6 Stempeutics’ Clinical Trials

8.74.6.1 Acute Myocardial Infarction (AMI)

8.74.6.2 Critical Limb Ischemia (CLI)

8.74.6.3 Chronic Obstructive Pulmonary Disease

8.74.6.4 Liver Cirrhosis

8.74.6.5 Osteoarthritis

8.74.6.6 Diabetes Mellitus - Type II

8.74.6.7 Cerebral Stroke (This Trial is being Conducted in Malaysia)

8.75 Tengion, Inc.

8.75.1 Tengion’s Technology

8.75.2 Tengion’s Pipeline

8.76 TheraVitae

8.76.1 TheraVitae’s Stem Cell Technology

8.76.2 TheraVitae’s Products

8.76.2.1 VesCell™ for Heart Disease

8.76.2.2 VesCell™ for Peripheral Artery Disease (PAD)

8.76.2.3 Future Products

8.77 VistaGen Therapeutics, Inc.

8.77.1 VistaGen’s Embryonic Stem Cell Technologies

8.77.2 Tools for Drug Discovery and Regenerative Medicine

8.77.3 New Generation Drug Screening Assays for Neurological Drugs

8.77.4 New Generation Drug Screening Assays for Metabolic Diseases

8.77.5 Toxicity Screening

8.78 ZenBio, Inc.

8.78.1 ZenBio’s Culture Media

Appendix 1: Clinical Trials in Stem Cell Space

Appendix 2: Stem Cell Glossary

Appendix 3: Consultants in Cell Therapy Sector

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