Home > Testing Services Markets, SNP Analysis, DNA Sequencing, Retail Clinics, Companion Diagnostics (Table of Contents)

Testing Services Markets, SNP Analysis, DNA Sequencing, Retail Clinics, Companion Diagnostics

Kalorama Information
August 1, 2008
1000 Pages - SKU: KLI1836320

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DIAGNOSTIC TEST SERVICE COMMERCIALIZATION: A ROADMAP TO DIAGNOSTICS IN THE 21ST CENTURY

CHAPTER ONE: EXECUTIVE SUMMARY

Scope and Methodology
Market Trends
Clinical Chemistry
Coagulation tests
Flow Cytometry
Histology/Cytology
Infectious Diseases
Keys to Success

CHAPTER TWO: INTRODUCTION

Background
The U.S. Versus Europe
ASRs
Hospital Outreach and National Reference Lab Services
Lab Outreach Testing
Independent Laboratories
Status quo and Future
Tests in Development
Serendepity or Strategy?

CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS

Background
Market Analysis, revenue estimates 2007 - 2012
Testing Markets
ISC and ISH
Market and Growth
Market Share
Lab Launches and Acquisitions
Market Leaders
Evaluation of Lab Tests

Uniqueness
Need
Reimbursed
Incumbent
Recognized
Peer Reviewed

Competition from FDA Cleared Products
Cost
Competitive Technologies
Pathwork
BRCA analysis
Mammastatin
Limited Use of Molecular Testing for Colon Cancer.
TDT
Ovarian Cancer Testing
Future Leaders?
HIV Testing
Mental Illness
Test Services on the Horizon

CHAPTER FOUR: MARKET TRENDS/ DEMAND ANALYSIS

The Commercialization of Multiplexed and Complex Analyses
Opportunity Pricing and margins are attractive Demand for Esoteric Tests

CHAPTER FIVE: MARKET BARRIERS FOR TEST SERVICES

Regulatory affairs
Can the FDA Regulate New test Modalities?
IVDMIAs
Pending LDT Legislation
Reimbursement Imperative
Physician Uptake
Connectivity, a Force to Consider
The In Vivo - In Vitro Diagnostic Paradigm
Social media and Internet-Based Services

CHAPTER SIX: TESTS AND COMPANIES TO WATCH

23andMe, Inc.
Key Comment
Details
Affymetrix
Key Comment
Details
Agendia B.V.
Key Comment
Details
ARUP Laboratories
Key Comment
Athena Diagnostics, Inc.
Key Comment
Details
Atherotech
Key Comment
Details
AviaraDx (formerly Arcturus Biosciences
Key Comment
Details
Biomedical Diagnostics, LLC/Abviva, Inc.
Key Comment
Details
Biophysical Corporation
Key Comment
Details
Caris MPI
Key Comment
Clarient Inc. (formerly ChromaVision
Key Comment
Detail
Clinical Data, Inc
Key Comment
Details
CombiMatrix Molecular Diagnostics (CMDX
Key Comment
Details
Consumer Genetic
Key Comment
Details
Corgenix Medical Corporatio
Key Comment
Details
Correlogic Systems, Inc
deCode Genetics Inc.
Details
DiagnoCure
Key Comment
Details
DNA Direct, Inc.
Key Comment
Details
EXACT Sciences Corporation
Key Comment
Details
Exiqon A/S
Key Comment
Details
Focus Diagnostics, Inc.
Key Comment
Details
Genelex Corporation
Key Comment
Details
Genomic Health
Key Comment
Details
Genoptix, Inc.
Key Comment
Details
Genzyme Corporation
Details
InterGenetics, Inc.
Key Comment
Details
Knome, Inc.
Key Comment
Details
Lab21 Healthcare
Key Comment
Laboratory Corporation of America Holdings (LabCorp)
Key Comment
Details
LipoScience, Inc.
Key Comment
Details
Mayo Medical Laboratories
Key Comment
Details
Monogram Biosciences, Inc. (formerly ViroLogic)
Key Comment
Details
Myriad Genetics, Inc.
Key Comment
Details
NeuroMark
Key Comment
Details
Nuvera Biosciences
Key Comment
Details
Nymox Pharmaceuticals
Details
Oncolab, Inc.
Key Comment
Details
Panacea Pharmaceuticals, Inc.
Key Comment
Details
Pathway Diagnostics Corporation
Key Comment
Details
Pathwork Diagnostics (formerly Predicant Biosciences)
Key Comment
Details
Perceptronix Medical Inc.
Key Comment
Details
Power3 Medical Products, Inc.
Key Comment
Details
Precision Therapeutics, Inc.
Key Comment
Details
Prometheus Laboratories Inc.
Key Comment
Details
Psynomics Incorporated
Key Comment
Details
Quest Diagnostics Incorporated
Key Comment
Details
Rational Therapeutics
Key Comment
Details
Rosetta Genomics Ltd.
Key Comment
Details
Signature Genomic Laboratories, LLC
Key Comment
Details
Smart Genetics
Key Comment
Details
Specialty Laboratories
Key Comment
Details
SpectraCell Laboratories, Inc.
Key Comment
Details
Targeted Diagnostics & Therapeutics, Inc. (TDT)
Key Comment
Details
XDx Inc.
Key Comment
Details

CHAPTER SEVEN: CONCLUSION

Is There a Market for Test Services?
Strategies for Successful Market Entry

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Figure 1-1: Sales of 7 Key IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components, 2007
Figure 1-2: Growth Rate 7 IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components , 2007
Figure 1-3: Esoteric Test Service Revenues, Reference Labs and CLIA-registered Company Test Service Offerings, 2007 and 2012

CHAPTER TWO INTRODUCTION

Figure 2-1: Explosion of Test Capabilities 20th and 21st Century

CHAPTER THREE: MARKET OVERVIEW AND SUPPLY ANALYSIS

Table 3-1: Worldwide Esoteric Test Reagent Sales by Product Market, 2007
Figure 3-1: Esoteric Sales Across IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry), 2007
Table 3-2: Worldwide Test Servcies Market
Table 3-3: Esoteric and Genomic Service Test Sales, Selected Companies (Company, Location, Area, 2005-2008 sales, % of Change)
Table 3-4: Selected CLIA- Registered Company Lab Tests Evaluated Selected CLIA- mRegistered Company Lab Tests Evaluated (Uniqueness, Need, Reimbursement, Incumbent Presence, Recognizable Technology, Peer Reviewed)
Table 3-5: Selected CLIA-Registered Lab Test Services, 2007

CHAPTER FOUR: MARKET TRENDS AND DEMAND ANALYSIS

Table 4-1: Number of People Who Get Chronic Diseases Every Year

SNP GENOTYPING AND ANALYSIS MARKETS

CHAPTER ONE: EXECUTIVE SUMMARY

What is a SNP?
Applications
The Market
Competitive Analysis
Challenges
Scope and Methodology

CHAPTER TWO: INTRODUCTION

Background
SNP Analysis Methods

Amplification
Allele discrimination / assay reaction mechanism
Single Nucleotide Addition; Pyrosequencing
Assay Format
Detection Method

Scope and Methodology
Definitions

DNA Microarray
Genome-Wide Association
Linkage Analysis
Mass Spectrometry
Single-Nucleotide Polymorphism (SNP)

CHAPTER THREE: APPLICATIONS

Life Science Research
Pharmacogenetics / Pharmacogenomics

Case Study #1 -- SNPs in Gene for P-glycoprotein Affect Antidepressant Response
Case Study #2 - Celera Studying SNPs Associated With Heart Disease
Case Study #3 - Synonymous SNPs Alter mRNA Splicing with Obesity
Case Study #4 - University of Ottawa Heart Institute (UOHI) Coronary Artery
Disease Research

CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS

Industry Trends

Consolidation Occurring in Array and Life Science Markets
FDA Involvement Making Drug Industry More Comfortable
Acceptance of SNP Analysis, Pharmacogenetics Reached Tipping Point
Core Labs Becoming Established Paradigm

Technology Trends

Increased Multiplexing Expands Applications
End-Users Attracted to Larger-Scale SNP Platforms
Complexity of Biological Systems Requires Multiple Techniques
Miniaturization of Equipment and Instruments

Regulatory Trends

Introduction
Critical Path Initiative
March 2005 - “Guidance for Industry - Pharmacogenomic Data Submissions”
April 2005 - “Drug-Diagnostic Co-Development Concept Paper”
March 2006 - Critical Path Opportunities List
November 2006 - “Recommendations for the Generation and Submission of
Genomic Data”
August 2007 - “Pharmacogenomic Data Submissions — Companion Guidance”
August 2007 - FDA Updates Labeling of Warfarin (Coumadin)
December 2007 - EGAPP Reviews Use of CYP450 Genetic Testing For SSRIs

CHAPTER FIVE: PRODUCTS

Affymetrix

Overview of Affymetrix Products
Hardware

Applied Biosystems

Overview of Applied Biosystems Products
Assays and Reagent
Instruments

Beckman Coulter
CombiMatrix
febit
GE Healthcare
Illumina
Hardware
Microarrays
LI-COR Biosciences (Lincoln, NE)
Roche Applied Science
Sequenom
Services
Agencourt Biosciences
DNAPrint Genomics
Polymorphic DNA Technologies
Software
Applied Biosystems
Premier Biosoft
Public Tools

CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS

Consortia, Collaborative Projects
The Cancer Genome Atlas (TCGA) Pilot Project
Cancer Sequencing Project
Critical Path Institute
DNA Polymorphism Discovery Resource
Genetic Association Information Network (GAIN)
Genotype-To-Phenotype Database (GEN2PHEN)
International HapMap Project
Introduction & Background
Rationale for HapMap Approach
Process for Producing HapMap
Populations Included in HapMap
Measures Taken to Protect Donors’ Privacy
Laboratories and Technologies Involved in HapMap
Practical Use of the HapMap Data
MicroArray Quality Control (MAQC) Project
NIH Roadmap
NIH Roadmap for Medical Research
Pharmacogenetics Research Network (PGRN)
NIH Involvement, Funding for SNPs and Sequencing
Funding for Sequencing Projects Affecting SNP Market
Continued Rapid Growth in Sequence Production
Funding and Consortia for Sequencing
NHGRI Funds Large-Scale Sequencing Centers, 2006
Competitive Activity

CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS

Historical
Illumina as Bellwether for SNP Analysis Market
Applied Biosystems as Bellwether for RT-PCR Products
Forecast
Assumptions
SNP Revenues by Region
SNP Revenues by Product
Competitive Analysis

CHAPTER EIGHT: CORPORATE PROFILES

Affymetrix
Applied Biosystems
Illumina

CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS

Challenges
Cheaper Sequencing Creates Competition for SNP Analysis Platforms
Market Is Dominated by a Small Number of Suppliers
Issues Arise With Use of Public Databases
Data Management Requirements Limit Large-Scale Technologies
Diagnostic Market Holds Obstacles For New Innovations
Backlash Against Rush Into Genetic Testing, DTC Marketing
Standard Processes for SNP Experiments Still Not Established
Shortcomings in Sample Preparation and Handling Hinder Success
Privacy Concerns Pose Threat to Broad Technology Adoption
Strategic Recommendations

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Figure-1-1: SNP Analysis Market 2007-2013
Figure 1-2: Growth Rate in SNP Analysis Revenues 2008-2013

CHAPTER TWO: INTRODUCTION

Table 2-1 Adelle-Specific Invasive Cleavage
Table 2-2 Adelle-Specific Ligation
Table 2-1 Allele-Specific Primer Extension
Table 2-4 Single Base Primer Extension

CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS

Table 4-1: Critical Path Opportunities List

CHAPTER FIVE: PRODUCTS

Figure 5-1: Taq Man Assay
Figure 5-2: SOLID System Average Throughput Progress
Figure 5-3: SNPstream Method
Figure 5-4: Roche SimpleProbe System
Figure 5-5: Roche HybProbe System
Table 5-1 Products in the SNP Analysis Market
Table 5-2 Public SNP Tools and Resources (Tool, Website)

CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS

Figure 6-1: Domains of Genomes Sequenced by Year (Archaea, Bacteria, Eukaryota) Major Sequencing Centers, Jan 2008
Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008
Figure 6-4: Major Sequencing Centers and Percent of Sequencing Projects (WORLD, GENOSCOPE, BMC, Sanger, WashU, BROAD, JCVI, JGI), Jan 2008
Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008 ($M)
Figure 6-6: Human Genome Project Funding, DOE& NIH ’90-‘03
Figure 6-7: Areas Funding Genome Sequencing, Jan 2008 (Medical, Evolutionary, Agricultural, Environmental, Biotechnology)
Table 6-5: Large-Scale Sequencing Centers, NHGRI Funding, 2004-2006
Figure 6-8: Top Genome Sequencing Countries, Jan. 2008 (# projects)
Figure 6-9: SNP Analysis Related Deals (Companies, Date, Details of Deal)
Figure 6-10: SNP: NHGRI Funded Large-Scale Sequencing Ctrs, ‘07
Table 6-6: SNP Analysis-Related Deals (Companies, Date, Details of Deal)

CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS

Figure 7-1: Illumina Quarterly Revenues, 2001-2007 ($M)
Figure 7-2: Applied Biosystems Revenues in Real Time PCR/Applied Genomics
Table-7-1: Forecasted Revenues in the SNP Analysis Market
Figure-7-3: Forecasted Revenues in the SNP Analysis Market
Table 7-2: Growth Rate in SNP Analysis Tools Market, 2008-2013
Figure 7-4: Growth Rate in SNP Analysis Tools Market, 2008-2013
Figure 7-5: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
Table 7-3: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
Figure 7-6 SNP Market by Product Segment (Instruments, Consumables, Software & Services)
Table 7-4: SNP Market by Segment (Instruments, Consumables, Software & Services)
Table 7-5: Revenues Among the Top Companies in SNP Analysis (Illumina, Affymetrix, Applied Biosystems, Other)
Figure 7-7: SNP Analysis Market Share, 2007

CHAPTER EIGHT: CORPORATE PROFILES

Figure 8-1: Affymetrix’ Revenues by Product Type, 2004 - 2007
Figure 8-2: Illumina BeadStation Installed Base, 2004-2006

CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS

Figure 9-1: Estimated Decrease in Screening Price

COMPANION DIAGNOSTICS MARKETS (A REALISTIC ASSESSMENT OF THE OPPORTUNITIES, CHALLENGES, KEY PLAYERS AND IMPORTANT TRENDS IN PERSONALIZED MEDICINE)

CHAPTER ONE: EXECUTIVE SUMMARY

Background

Potential Benefits of Companion Diagnostics
Pitfalls of Personalized Medicine
Scope and Methodology
Market Factors and Estimates
Drivers For Companion Diagnostics
Assumptions
Important Trends
Possible Tactic: Royalty Model

CHAPTER TWO: OVERVIEW OF COMPANION DIAGNOSTICS

Personalized Medicine
Potential Benefits
Privacy and Public Perception
Biomarkers and Companion Diagnostics

Types of Biomarkers

CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS

Pharmacogenetics and Pharmacogenomics
Historical Basis
Current Techniques
Requirements
Cost-effectiveness
Applications

The Cytochrome System
Cancer
Amgen
UAMS Multiple Myeloma Project
DakoAssay for TOP2A
GE and Eli Lilly
Epigenomics and Abbott
Celera and Merk
bioMerieiux and Ipsen
Acute Lymphoblastic Leukemia

Regulatory Agencies
Applications of Genome More Challenging Than Expected
Cardiovascular Disease
RAS polymorphisms With Drug Effectiveness

Pgp
Thiazide diuretics
825T allele
HIT
Statins

Psychiatry and Pharmacogenetics/Pharmacogenomics
Is Herceptin a Paradigm?
A Balancing Act Between the Players

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS

Estimating Market Potential
Associated Testing
The Needs of Pharma and of Diagnostic Companies
Questions Determining Companion Diagnostics Growth
A Partial Change in Attitude
Intellectual Property
Cancer Market Potential Estimate
Ideal Market Potential - Cancer, Heart Disease, Psychiatric
Source: Kalorama Information
Challenges Unique to Companion Diagnostics
Privacy Concerns
Fear of Learning About Diseases
Use of Remnant Samples
Avoiding Pitfalls of Market Calculation
Companion Diagnostics Not Linked to Molecular Diagnostics
Demonic and SNP Analysis
Considering Time of Cooperative Development
Market Realities to Consider
Possible Tactic: Royalty Model

CHAPTER FIVE: COMPANY SUMMARIES

Overview
Abbott (Molecular) Diagnostics Subsidiary of Abbott Laboratories
Affymetrix, Inc.
Agilent Technologies, Inc
Althea Technologies, Inc.
Curidium Medica plc
Dako
Gen Probe
Genzyme Corporation
Ipsogen SAS
Lipomics Technologies, Inc.
Osmetech plc
Perlegen Sciences
Provista Life Sciences
Qiagen NV
Singulex, Inc.
Theranostics Health
Ventana Medical Systems

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

First Conclusion
Implications:
Second Conclusion
Implications:
Third Conclusion
Implications:
Fourth Conclusion
Implications:
Fifth Conclusion
Implications:
Sixth Conclusion
Implications:
Seventh Conclusion
Implications:
Eighth Conclusion
Implications:
Ninth Conclusion
Implications:
Tenth Conclusion
Implications:

APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018
Figure 1-1: Market Projection Trends for Companion Diagnostics in the United States: 2008 - 2018

CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS

Table 3-1 Companion Diagnostics Groups
Table 3-3: Frequency of Recessive Traits
Table 3-4: Existing Cancer Drugs Complimentary to Companion Diagnostics
Table 3-5: Recent Activities in Companion Diagnostics

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS

Table 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008
Figure 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008
Table 4-2: The Ideal Potential Companion Diagnostics Markets for Therapeutics Addressing the Top Four, High-Profile Cancers: 2008
Figure 4-2: The Ideal Potential Companion Diagnostics Markets forTherapeutics Addressing the Top Four, High-Profile Cancers: 2008
Figure 4-3: The Ideal Companion Diagnostics Market (Ideal vs. Likely to Benefit)
Figure 4-4 Subset of Ideal Market Likely to Benefit From Pharmaceutical Intervention (Likely to Benfit vs. Realistic Market)
Table 4-3: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018
Figure 4-1: Market Projection Trends for Companion Diagnostics* in the United States: 2008 - 2018

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

Table 6-1: Hypothetical Cancer Therapy Outcome Based on Associated Genes

RETAIL CLINICS, THE EMERGING MARKET FOR CONVENIENCE AND IN-STORE HEALTHCARE

CHAPTER ONE: Executive Summary: The Emergence of Retail Clinics; Service Providers; Suppliers; Issues And Trends; Scope and Methodology
CHAPTER TWO: Introduction: The U.S. Healthcare System Today; The Need For Alternatives; Establishing A Retail Clinic
CHAPTER THREE: Service Providers: The Industry; Convenience Clinic Sales Forecasts; The Market; Competitive Positions of Key Players
CHAPTER FOUR: OPPORTUNITIES FOR DIAGNOSTIC AND PHARMACEUTICAL COMPNIES: Point of Care Tests; Clinical Chemistry and Immunoassays; Vaccines
CHAPTER FIVE: Retail Outlets: Drug Stores; Food Stores; Mass Merchandisers; Other Outlets
CHAPTER SIX: Total Market: Growth of Retail Clinics; Opportunities for Suppliers; Increased Revenue for Retailers
CHAPTER SEVEN: Issues and Trends: Competition With Primary Care Providers; Regulation; Development of Standards; Expansion of Services; Labor Shortages
CHAPTER EIGHT: Company Profiles: Atlanticare; Aurora Quick Care; Checkups; Early Solutions Clinic; MedBasics; Minute Clinic; My Healthy Access; Quick Health; Now Medical Centers; Rediclinic; SmartCare Family Medical Centers; Solantic; Take Care Health Systems; Target Clinic Medical Associates; The Little Clinic
APPENDIX
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY: Figure 1-1: Estimated Number of U.S. Convenience Clinics, 2007 - 2011; Figure-1-2: Locations of Retail Clinics, 2007; Figure 1-3: Indirect Revenue to Drug Stores, Supermarkets, Mass Merchandising Outlets and Others with Retail Clinics
CHAPTER TWO: INTRODUCTION: Figure 2-1: National Health Expenditures (NHE) and NHE as a Percent of GDP, 1980 - 2011; Figure 2-2: Premium Increases vs. Increases in Workers Earnings and Prices, 1989 - 2005; Figure 2-3: Unnecessary Deaths Resulting From Variations in Health Care Quality; Figure 2-4: HEDIS Scores by Quality of Health Care Plan, 2006; Figure 2-5: Change in Out of Pocket Health Care Expenses for Medicaid Recipients, 1997 - 2002; Figure 2-6: Out of Pocket Health Care Expenses for Disabled and Non-Disabled Medicaid Recipients, 1997 vs. 2002; Figure 2-7: Proportion of Adults Under Age 65 With Chronic Conditions, 2003; Table 2-2: U.S. Health Care Coverage by State, 2007; Table 2-3: Cost Savings From Medical Tourism, 2007; Table 2-4: Estimated Number of U.S. Convenience Clinics, Expansion of U.S. Convenience Clinics by Major Chain (Aurora, QuickCare, Healthy Access, Minute Clinic, Quick Health, Solantis, Target Clinical, CheckUps, MedBasics, Now Medical Centers, RediClinic Others, Take Care Clinics, the Little Clinic) 2007 to 2011; Figure 2-8: Expansion of U.S. Convenience Clinics by Major Chain (Aurora QuickCare, Healthy Access, Minute Clinic, Quick Health, Solantis, Target Clinical, CheckUps, MedBasics, Now Medical Centers, RediClinic Others, Take Care Clinics, the Little Clinic) 2007 to 2011; Table 2-5: Characteristics of Retail Outlets, 2007 (Drug Stores, Food Stores, Mass Merchandizing Outlets); Table 2-6: Benefits and Drawbacks of Convenience Clinic Funding Approaches, 2007 92; Table 3-1: The U.S. Market for Retail Clinic Services, 2001-2011
CHAPTER THREE: SERVICE PROVIDERS: Figure 3-1: Growth of U.S. Retail Clinic Services, 2001-2011; Table 3-2, Leading Service Providers’ Revenues and Market Share; Figure 3-2: Market Shares of Leading Retail Clinic Service Provider, 2006
CHAPTER FOUR: OPPORTUNITIES FOR DIAGNOSTIC AND PHARMACEUTICAL COMPNIES: Table 4-1: Sales to Retail Clinics by Supplier Segment, 2001-2011 (POC Tests, Clinical Chemistry & Immuno-assays, Vaccines); Figure 4-1: Growth of Retail Clinic Supplier Sales by Type of Supplies, 2001-2011 (POC Tests, Clinical Chemistry & Immuno-assays, Vaccines); Table 4-2: U.S. Professional POC Test Sales, 2001-2011; Table 4-3: Leading POC Test Makers’ U.S. Revenues and Markert Share, 2006; Table 4-4: U.S. Professional POC Test Sales to Retail Clinics, 2001-2011; Table 4-5: U.S. Clinical Chemistry and Immunoassay Sales, 2001-2011; Table 4-6: Leading Clinical Chemistry and Immunoassay Suppliers’ Revenues and Market Share, 2006; Table 4-8: Diseases for which Vaccines are Available in the U.S., 2007; Table 4-9: U.S. Market for Preventative Vaccines, 2001-2011; Table 4-10: Leading Vaccine Manufacturers’ U.S. Revenues and Market Share, 2007; Table 4-11: U.S. Vaccine Sales to Convenience Clinics, 2001-2011
CHAPTER FIVE: RETAIL OUTLETS: Table 5-1: Number of Retail Clinics by Type of Retail Outlet (Drug Stores, Supermarkets, Mass Merchandising Outlets, Other), 2001-2011; Figure 5-2: Proportion of Rents Collected From Retail Clinics by Type of Retail Outlet, 2001-2011 (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others); Table 5-3: Indirect Income Generated by Retail Clinics by Type of Retail Outlet, 2001-2011, (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others); Figure 5-3: Proportion of Indirect Income Generated by Retail Clinics by Type of Retail Outlet, 2001-2011 (Drug Stores, Supermarkets, Mass Merchandising Outlets, Others); Table 5-4: Selected Retail Outlet Relationships with Convenience Clinics, 2007; Table 5-5: U.S. Drug Store Sales, 2001-2011; Table 5-6 Leading U.S. Drug Stores’ Revenues and Market Share, 2006; Table 5-7: U.S. Drug Store Direct Retail Clinic Revenues, 2001-2011 (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.); Table 5-8: U.S. Drug Store Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue); Figure 5-4: Direct vs. Indirect Revenues to Drug Stores From Retail Clinics, 2001-2011; Table 5-9: U.S. Food Store Sales, 2001-2011; Table 5-10: Leading Food Stores Revenues and Market Share, 2006; Table 5-11: U.S. Food Stores Direct Retail Clinic Revenues, 2001-2011 (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.); Table 5-12: U.S. Food Store Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue); Figure 5-5: Direct vs. Indirect Revenues to Food Stores from Retail Clinics, 2001-2011; Table 5-13: U.S. Mass Merchandiser Sales, 2001-2011; Table 5-14: Leading Mass Merchandisers Revenues and Market Share, 2006; Table 5-15: U.S. Mass Merchandiser Retail Clinic Revenues (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.); Table 5-16: U.S. Mass Merchandiser Indirect Retail Clinic Revenues, 2001-2011 (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue); Table 5-17: U.S. Other Retail Sales, 2001-2011; Table 5-18: Leading Other Outlets Revenues and Market Share, 2006; Table 5-19: US Other Outlets Direct Retail Clinics Revenues (No. of Stores, Sq. Ft Per Store, Cost Per Sq. Ft.); Table 5-20: U.S. Other Outlets Indirect Retail Clinic Revenues (Number of Clinics, Patients/Clinic/Day, Incremental Sales per Patient, Total Indirect Revenue)
CHAPTER SIX: MARKET SUMMARY: Table 6-1: Retail Clinic Service Revenues, 2001-2011; Table 6-2: Sales to Retail Clinics by Suppliers 2001-2011; Figure 6-1: Revenues from Retail Clinics (Direct Rents/Indirect Revenues)
CHAPTER SEVEN: ISSUES AND TRENDS: Table 7-1: Selected U.S. Federal and State Health Care Oversight Bodies, 2007

DNA SEQUENCING EQUIPMENT AND SERVICES MARKETS

CHAPTER ONE: EXECUTIVE SUMMARY: DNA Sequencing Applications; Types of Samples; Market Trends; Scope and Methodology
CHAPTER TWO: INTRODUCTION: Background; DNA Sequencing Applications; Types of Samples; DNA Sequencing Strategies; DNA Sequencing Chemistries and Techniques
CHAPTER THREE: SEQUENCER MARKET TRENDS AND FUNDING TRENDS: Market Trends; Microbes and Metagenomics Gaining Importance; Various Disruptive Technologies Rapidly Appearing On Market; Miniaturization of Sanger and CE Technology; Paired-End Techniques, Increasing Read-Lengths Expanding Applications; Funding Trends; Cancer Sequencing Project; NSF / USDA Microbial Genome Sequencing Program
CHAPTER FOUR: DNA SEQUENCER PRODUCTS: 454 Life Sciences (Branford, CT) / Roche; Applied Biosystems (Foster City, CA); Beckman Coulter; Illumina / Solexa; LI-COR Biosciences (Lincoln, NE)
CHAPTER FIVE: MARKET DATA: Revenues and Forecast
CHAPTER SIX: COMPETITIVE ANALYSIS: Features and Strengths of Next-Generation Sequencers
CHAPTER SEVEN: INTELLECTUAL PROPERTY AND LITIGATION: Affymetrix Wins Patent Infringement Case Against Illumina
CHAPTER EIGHT: DEALS
CHAPTER NINE: CORPORATE PROFILES: 454 Life Sciences (Branford, CT) / Roche; Applied Biosystems (Foster City, CA); Beckman Coulter (Fullerton, CA); GE Healthcare Life Sciences (Little Chalfont, UK); Helicos Biosciences (Cambridge, MA); Illumina / Solexa; Intelligent Bio-Systems (Waltham, MA); LI-COR Biosciences (Lincoln, NE); NABsys (Providence, RI)
CHAPTER TEN: TECHNOLOGIES UNDER DEVELOPMENT: NHGRI Funds Next Generation of Sequencing Technologies; 454 Life Sciences Corp; Agencourt Personal Genomics [Applied Biosystems]; Arizona State University, Tempe; Baylor College of Medicine, Human Genome Sequencing Ctr; Columbia University; Harvard University, Rowland Institute; moved to Boston Univ; LI-COR Inc; Microchip Biotechnologies Inc; Stanford University; Stanford Genome Technology Center; University of Gainesville, Florida; Second Group of Grants, $1000 Genome; Arizona State University, Tempe; Oak Ridge National Laboratory; Stanford University; University of British Columbia, Vancouver; University of Maine, Orono; University of North Carolina, Chapel Hill; Agencourt Personal Genomics [Applied Biosystems]; Network Biosystems; Columbia University; “Modulating Nucleotide Size in DNA for Detection by Nanopore”; Duke University; Harvard University; Nanofluidics; New York University; Oxford University and The Scripps Research Institute; University of California, San Diego; University of Illinois at Urbana-Champaign; VisiGen Biotechnologies; Boston University; Case Western Reserve University; General Electric Global Research; Helicos Biosciences; Lehigh University; University of California, San Diego; University of North Carolina, Chapel Hill; University of Washington, Seattle; Baylor College of Medicine, HGSC; Intelligent Bio-Systems
CHAPTER ELEVEN: CHALLENGES AND STRATEGIC RECOMMENDATIONS: Market Challenges; Strategic Recommendations
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY: Table 1-1: DNA Sequencer Equipment Revenues 1999-2006; Figure 1-1: Trending in the DNA Sequencer Equipment Market 2006-2012
CHAPTER THREE: SEQUENCER MARKET TRENDS AND FUNDING TRENDS: Figure 3-1: Distribution of Archaeal and Bacterial Genome Projects, Q1 2007 (JGI, TIGR, J Venter, World); Figure 3-2: Phylogenetic Distribution of Bacterial Genome Projects, Q1 '07; Figure 3-3: Number of Completely Sequenced Genomes (Published vs Unpublished) 1999 through Q1 2007; Figure 3-4: Distribution of Number of Projects Among Major Sequencing Centers Q1 2007; Figure 3-5: Funding by the Top Agencies in DNA Sequencing; Figure 3-6: U.S. Funding for the Human Genome Project DOE vs NIH 1990-2003; Figure 3-7: Distribution of the Number of Bacterial Sequencing Projects by Area of Focus (Agriculture/Food, Biomedical, Biotech, Environmental, Evolutionary); Table 3-1: FUGE Funding Recipients; Table 3-2 Large-Scale Sequencing Centers NHGRI Funding, 2007; Figure 3-8: NHGRI Funding of Large-Scale Sequencing Centers by Organization 2004-2006 (cumulative); Figure 3-9: NHGRI Funding of Large-Scale Sequencing Centers by Organization 2007; Figure 3-10: Broad Institute Organizational Structure; Table 3-3: NSF Plant Genome Research Project Recent Funding Awards (Title Start Date, Expiration Date, PI, Organizatino, Funding Amount); Table 3-4: NSF / USDA Microbial Genome Sequencing Program Recent Funding Awards (Title, Start Date, Expiration Date, PI, Organization, Funding Amount)
CHAPTER FOUR: DNA SEQUENCER PRODUCTS: Table 4-1: Key Products and Technologies Currently on the Market by Company (Company, Product/ Technology, Comments)
CHAPTER FIVE: MARKET DATA: Table 5-1: DNA Sequencer Equipment Revenues 1999-2006; Table 5-2: DNA Sequencer Equipment Revenues 2006-2012; Figure 5-1 DNA Sequencer Market, Market Share by Industry, 2006; Figure 5-2: Trending in the DNA Sequencer Equipment Market 1999-2006; Figure 5-3: ABI’s Quarterly Overall Sequencing Revenues 2001 to 2006; Figure 5-4: ABI’s Quarterly Overall Sequencing Revenues Q3 2005 to Q4 2006; Figure 5-5: Estimated Forecasted Price of Sequencing a Genome 1990-2030; Figure 5-6: Trending in the DNA Sequencer Equipment Market, 2006-2012
CHAPTER SIX: COMPETITIVE ANALYSIS: Table 6-1: Revenues and Market Shares of Leading DNA Sequencer System Suppliers, 2006 (Company, Market Share, Revenues, Trend); Figure 6-1: Market Shares, DNA Sequencer Systems, 2006; Table 6-2: Comparison of Next-Generation Sequencer System Features (Reads, Read Length, Number of Samples at Once, BP Output, Cost Comparison with Sanger/ CE, Consumable Cost per Run)
CHAPTER SEVEN: INTELLECTUAL PROPERTY AND LITIGATION: Table 7-1: Selected Sequencing-Related Patents Assigned or Licensed to Applied Biosystems (Assignee, Title, Patent #)
CHAPTER EIGHT: DEALS: Table 8-1: Notable Deals in Recent Years (Companies, Date, Details)
CHAPTER TEN: TECHNOLOGIES UNDER DEVELOPMENT: Table 10-1: First Set of NHGRI “$100,000 Genome” Grant Awardees October 2004 (Awardee, Title, Amount, Term); Table 10-2: First Set of NHGRI “$1,000 Genome” Grant Awardees October 2004 (Awardee, Title, Amount, Term); Table 10-3: Second Set of NHGRI “$100,000 Genome” Grant Awardees August 2005 (Awardee, Title, Amount, Term); Table 10-4: Second Set of NHGRI “$1,000 Genome” Grant Awardees August 2005 (Awardee, Title, Amount, Term); Table 10-5: Latest Set of NHGRI “$1,000 Genome” Grant Awardees October 2006 (Awardee, Title, Amount, Term); Table 10-6: Latest Set of NHGRI “$100,000 Genome” Grant Awardees October 2006 (Awardee, Title, Amount, Term); Table 10-7: Selected Group s Workingon Microfluidics for DNA Sequencing Applications (Number of Channels, Read Length, Time)

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