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Global Regenerative Medicine Market Analysis & Forecast to 2022; Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries

Global Regenerative Medicine Market Analysis & Forecast to 2022; Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries

This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. Kelly Scientific analysis indicates that the global regenerative medicine market was worth $18.9 billion in 2016 and will grow to over $66 billion by 2022, with a CAGR of 23.3% between this time frame. Within this market, the stem cell industry will grow significantly at a CAGR of over x% and reach $x billion by 2022. Tissue engineering is forecast to grow at a CAGR of x% to 2022 and potentially reach $x billion. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 680 pages.

  • An overview of regenerative medicine that includes: stem cells, allogenic and autogenic cells, umbilical cord blood banking, tissue engineering and CAR T therapies.
  • Global regenerative medicine market, global breakdown, application breakdown and leading market players
  • Detailed account of the stem cell industry market by geography, indication and company profiles
  • Profiles, marketed/pipeline products, financial analysis and business strategy of the major companies in this space
  • Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for regenerative medicine
  • Insight into the challenges faced by stakeholders, particularly about the success vs. failure ratios in developing regenerative medicine drugs and therapies.
  • Insight into the biobanking industry globally and its impact on the overall market
  • Description and data for the prevalence of disease types that are addressed by regenerative medicine, stem cells, tissue engineering and CAR-T therapies
  • Financial market forecast through 2022 with CAGR values of all market segments outlined in the objective
  • SWOT analysis of the global market
  • Geographical analysis and challenges within key topographies including the USA, Japan, South Korea, China and Europe


1.0 Report Synopsis
1.1 Objectives of Report
1.2 Executive Summary
1.2 Key Questions Answered in this Report
1.3 Data Sources and Methodology
2.0 Introduction
2.1 Gurdon and Yamanaka Share the Nobel Prize
2.2 Stem Cell Clinical Trials: Initiated in 2010
2.3 Types of Stem Cells
2.4 Adult (Tissue) Stem Cells
2.5 Pluripotent Stem Cells
2.6 Somatic Cell Nuclear Transfer (SCNT)
2.7 Induced pluripotent Stem Cells (iPSC)
2.8 Mesenchymal Cells
2.8.1 MSCs in the Bone Marrow Stroma
2.8.2 Isolation, Marker Specificity and Functional Properties of MSCs
2.8.3 Oxygen Concentration and MSC Culture
2.8.4 Assays to Define MSCs
2.8.5 Differentiation Potential of MSCs
2.8.6 Therapeutic Potential of MSCs
2.8.7 Mesenchymal Stem Cells & Chronic Disease
2.8.8 MSCs and Amylotrophic Lateral Sclerosis
2.8.9 MSCs and Parkinson’s Disease
2.8.10 MSCs and Alzheimer Disease
2.8.11 MSCs and Rheumatoid Arthritis
2.8.12 MSCs and Type 1 Diabetes
2.8.13 MSCs and Cardiovascular Disease
2.9 Hematopoietic Stem and Progenitor Cells
2.9.1 In Vivo Assays for Hematopoietic Stem Cells
2.9.2 In Vitro Assays for Hematopoietic Stem and Progenitor Cells
2.9.3 Isolation of Hematopoietic Stem and Progenitor Cells
2.9.4 Culture of Hematopoietic Cells
2.9.5 Therapeutic uses of Hematopoietic Cells
2.10 Umbilical Cord Stem Cells
2.11 Heart Stem Cells
2.11.1 Cutting Edge Research in Heart Stem Cells
© Kelly Scientific 2018 www.kellysci.com
2.12 Mammary Stem Cells
2.12.1 Defining the Mammary Stem Cell
2.12.2 Influence of Model System on Stem Cell Identification
2.12.3 Breast Cancer Stem Cells
2.13 Neural Stem Cells
2.13.1 Identification of Neural Stem Cells
2.13.2 Function of Neural Stem Cells in Vivo
2.13.3 Neural Stem Cell Culture Systems
2.13.4 Isolation Strategies for Neural Stem Cells
2.13.5 Brain Tumour Stem Cells
2.13.6 Cutting Edge Research in Neural Stem Cells
2.14 Stem Cell Applications in Retinal Repair
2.14.1 Embryonic Stem Cells as Retina Therapeutics
2.14.2 Induced Pluripotent Stem Cells as Retina Therapeutics
2.14.3 Adipose Derived Mesenchymal Stem Cells as Retina Therapeutics
2.15 Liver Stem Cells
2.16 Gut Stem Cells
2.16 Pancreatic Stem Cells
2.17 Epidermal Stem Cells
3.0 Stem Cells and Clinical Trials
3.1 Introduction
3.2 Pluripotent Stem Cells
3.3 Limbal Stem Cells
3.4 Neural Stem Cells
3.5 Endothelial Stem or Progenitor Cells
3.6 Placental Stem Cells
3.7 Why Do Stem Cell Clinical Trials Fail?
3.8 What is the Future of Stem Cell Trials?
3.9 Cutting Edge Stem Cell Clinical Trials
3.10 Ocata Therapeutics Current Stem Cell Trials
3.11 CHA Biotech Current Stem Cell Trials
3.12 Pfizer Current Stem Cell Trials
3.13 GSK Current Stem Cell Trials
3.14 Bayer Current Stem Cell Trials
3.15 Mesoblast International Current Stem Cell Trials
3.16 Millennium Pharmaceutical Current Stem Cell Trial
3.17 AstraZeneca Current Stem Cell Trials
3.18 Merck Current Stem Cell Trials
3.19 Chimerix Current Stem Cell Trials
3.20 Eisai Current Stem Cell Trials
3.21 SanBio Current Stem Cell Trials
3.22 Celgene Current Stem Cell Trials
3.23 StemCells Current Stem Cell Trials
3.24 Genzyme (Sanofi) Current Stem Cell Trials
© Kelly Scientific 2018 www.kellysci.com
3.25 Teva Current Stem Cell Trials
3.26 MedImmune Current Stem Cell Trials
3.27 Janssen Current Stem Cell Trials
3.28 Seattle Genetics Current Stem Cell Trials
3.29 Baxter Healthcare Current Stem Cell Trials
3.30 InCyte Corp Current Stem Cell Trials
4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing
4.1 Introduction
4.2 Case Study: Genentech and Stem Cell Technology
4.3 3D Sphere Culture Systems
4.4 Stem Cells and High Throughput Screening
4.4.1 Embryonic Stem Cells
4.4.2 Adult Stem Cells
4.4.3 Opportunities & Challenges
4.5 Genetic Instability of Stem Cells
4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes
4.8 Coupling Precise Genome Editing (PGE) and iPSCs
4.9 Stem Cells & Toxicity Testing
4.9.1 Hepatotoxicity and iPSCs
4.9.2 Cardiotoxicity and iPSCs
4.9.3 Neurotoxicity and iPSCs
4.10 Stem Cell Disease Models
4.11 Defining Human Disease Specific Phenotypes
4.11.1 Molecular Phenotypes for Disease Modelling
4.11.2 Cellular Phenotypes for Disease Modelling
4.11.3 Physiological Phenotypes for Disease Modelling
4.11.4 Parkinson’s Disease
4.11.5 Alzheimer’s Disease
4.11.6 Amyotrophic Lateral Sclerosis
4.11.7 Huntington’s Disease
4.11.8 Spinal Muscular Atrophy
4.11.9 Down Syndrome
4.11.10 Cystic Fibrosis
4.11.11 Colorectal Cancer
4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening
5.0 Stem Cell Biomarkers
5.1 Pluripotent Stem Cell Biomarkers
5.2 Mesenchymal Stem Cell Biomarkers
5.3 Neural Stem Cell Biomarkers
5.4 Hematopoietic Stem Cell Biomarkers
6.0 Manufacturing Stem Cell Products
6.1 Manufacturing Strategies For Stem Cell Products
6.2 BioProcess Economics for Stem Cell Products
6.3 Capital Investment
6.4 Cost of Goods
6.5 Bioprocess Economic Drivers & Strategies
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6.6 hPSC Expansion & Differentiation using Planar Technology
6.7 hPSC Expansion using 3D Culture
6.8 Microcarrier Systems
6.9 Aggregate Suspension
6.10 Bioreactor Based Differentiation Strategy
6.11 Integrated hPSC Bioprocess Strategy
6.12 GMP Regulations and Stem Cell Products
7.0 Investment & Funding
7.1 What do Investors Want from Cell & Gene Therapy Companies?
7.2 What Makes a Good Investment?
7.3 What Types of Companies do Not Get Investment?
7.4 Global Funding
7.5 Cell & Gene Therapy Investment Going Forward
7.6 What Cell & Gene Companies are the Most Promising in 2018?
7.7 Insights into Investing in Cell and Gene Therapy Companies
8.0 Regenerative Medicine Market Analysis & Forecast to 2022
8.1 Market Overview
8.2 Global Frequency Analysis
8.3 Economics of Regenerative Medicine
8.4 Market Applications & Opportunities for Regenerative Therapies
8.4.1 Neurological Disease
8.4.2 Autoimmune Disorders
8.4.3 Cardiovascular Disease
8.4.4 Diabetes
8.4.5 Musculoskeletal Disorders
8.4.6 Ocular Disease
8.4.7 Orthopedic Disorders
8.4.8 Wound Healing
8.5 Global Financial Landscape
8.6 Regenerative Medicine Clinical Trial Statistics
8.7 Regenerative Medicine Market Forecast to 2021
8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021
8.9 Regenerative Medicine Geographical Location of Companies
8.10 Regenerative Medicine Technology Breakdown of Companies
8.11 Commercially Available Regenerative Medicine Products
8.12 Major Regenerative Medicine Milestones
9.0 Stem Cell Market Analysis & Forecast to 2022
9.1 Autologous & Allogenic Cell Market Analysis
9.2 Stem Cell Market by Geography
9.2.1 North America
9.2.2 Asia/Pacific
9.2.3 Europe
9.3 Stem Cell Market Forecast by Therapeutic Indication
9.3.1 Orthopedic/Musculoskeletal Stem Cell SubMarket
© Kelly Scientific 2018 www.kellysci.com
9.3.2 Cancer Stem Cell SubMarket
9.3.3 Cardiology/Vascular Stem Cell SubMarket Analysis
9.3.4 Wound Healing Stem Cell SubMarket Analysis
9.3.5 Skin Stem Cell SubMarket Analysis
9.3.6 Ocular Stem Cell SubMarket Forecast
9.4 Stem Cell Reagent Market Trends
10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2022
10.1 Geographical Analysis and Forecast to 2022
10.1.1 North America
10.1.2 Europe
10.1.3 Asia Pacific
10.2 Geographical Analysis by Company Share
10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2022
10.3.1 Orthopedic and Musculoskeletal
10.3.2 Oncology
10.3.3 Cardiology and Vascular
10.3.4 Dermatology
10.3.5 Oral and Dental
11.0 Biobanking Market Analysis
11.1 Increasing Number of Cord Blood Banks Globally
11.2 Global Biobanking Company Sector Analysis & Breakdown
11.3 Allogenic Versus Autologous Transplant Frequency
11.4 Biobanking Market Analysis & Forecast to 2022
11.5 Major Global Players
12.0 Global Access & Challenges of the Regenerative Medicine Market
12.1 Regenerative Medicine Market in the USA
12.2 Regenerative Medicine in Japan
12.2.1 Financial Investment
12.2.2 Unconventional Company Investment in Regenerative Medicine
12.3 Regenerative Medicine in China
12.4 Regenerative Medicine in South Korea
13.0 Cell and CAR T Therapy
13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy
13.1.1 Clinical Status of CD19 CAR-T Cells To Date
13.1.2 Clinical and Regulatory Challenges for Development of CAR T Cells
13.1.3 Key Regulatory Challenges Associated with CAR-T Development
13.1.4 Summary of Select CAR-T Products by Juno, Novartis and Kite
13.1.5 Clinical Benefit Versus Toxicity in CD19-Directed ALL Clinical Trials
13.1.6 How to Manage Toxicity of CAR-T Therapy
13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA
13.2.1 Center for Biologics Evaluation and Research (CBER)
13.2.2 Compliance and Surveillance
13.2.3 Extra Resources on Immunotherapeutics from the FDA
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13.2.4 Cellular, Tissue and Gene Therapies Advisory Committee
13.2.5 Consumer Affairs Branch (CBER) Contact in FDA
13.2.6 FDA Regulations Pertaining to Immunotherapies
13.2.7 Case Study Ovarian Cancer Immunotherapy Regulations
13.2.7.1 Efficacy
13.2.7.2 Adverse Effects
13.2.8 Trial Design Considerations for Immunotherapy
13.2.9 Development of Immune-Related Response Criteria (irRC) & Clinical Endpoints Specific to Immunotherapies
13.3 Regulations for Cell Therapy & Immunotherapy in Japan
13.3.1 PMDA and Cell Therapy & Immunotherapy
13.3.2 Increasing the Efficiency in Cell Therapy & Immunotherapy Regulatory Review
13.3.3 Forerunner Review Assignment System
13.3.4 Revised Guidelines for Clinical Evaluation of Anti‐Malignant Tumor Agents
13.3.5 Key Contacts Within the PMDA for Cell Therapy & Immunotherapeutics
13.4 European Regulation and Cell Therapy & Immunotherapeutics
13.4.1 Introduction
13.4.2 Challenges for Cell Therapy & Immunotherapy in EMEA
13.4.3 EMA Status on Potency Testing
13.4.3.1 In Vivo Potency Testing
13.4.3.2 In Vitro Potency Testing
13.4.3.3 Viable Cell Count
13.4.3.4 Autologous Cell Based Products
13.4.3.5 Reference Preparation
13.4.3.6 Adjuvant Containing Immunotherapy Products
13.4.4 EMA Status on Identifying hyper, Hypo or non-Responders
13.4.5 Challenges Relating to Biomarkers in Immunotherapy
13.4.6 Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy
13.4.7 Estimating Optimal Cut-Off Parameters
13.4.8 EU-Approved Immunotherapies in Melanoma
13.4.9 Key Contacts Within EMA for Cell Therapy & Immunotherapeutics
13.5 Manufacturing of Immunotherapies
13.5.1 Introduction
13.5.2 Generation of CAR-Modified T Cells
13.5.3 What Co-Stimulation and Activity Domain is Optimal to Use?
13.5.4 Optimizing Cell Culture Media
13.5.5 Manufacturing Lentiviral Vectors
13.5.6 Detection of Integrated CAR-Expressing Vectors
13.5.7 Donor Lymphocyte Infusion Procedure
13.5.8 Ex Vivo Costimulation & Expansion of Donor T Cells
13.5.9 Infusion to the Patient
13.5.10 Manufacturing Devices and Instruments Required for Immunotherapy Production
13.5.10.1 Leukapheresis
13.5.10.2 Cell Counters and Analyzer
13.5.10.3 Cell Seeding, Growth and Propagation
13.5.11 Good Manufacturing Procedure (GMP) for Immunotherapy
13.5.12 Case Study Production of Lentivirus Induced Dendritic Cells under GMP Conditions
13.5.13 Quality Control
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13.5.14 Regulatory Affairs
13.5.15 Key Challenges in Manufacturing
13.5.15.1 Electroporation of T-cells
13.5.15.2 Allogenic CAR T cells
13.5.15.3 Relapse Rates are Critical
13.5.15.4 Antigen Negative Relapse
13.5.15.5 Incorporating Suicide Genes
13.5.16 Automation in Cell Therapy Manufacturing
13.5.17 Autologous Cell Therapy Manufacture Scale Up
13.6 Supply Chain & Logistics
13.6.1 Introduction
13.6.2 Case Study: Juno Therapeutics
13.7 Pricing & Cost Analysis
13.7.1 Introduction
13.7.2 CAR T Therapy Market Evaluation
13.7.3 Current Deals Within the CAR T Market
14.0 Company Profiles
14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics)
14.1.1 Company Background
14.1.2 Products
14.1.3 Financials
14.1.4 Company Strategy
14.2 Athersys
14.2.1 Company Background
14.2.2 Products
14.2.3 Financial Analysis
14.2.4 Company Strategy
14.3 Baxter International (Baxalta, Shire)
14.3.1 Company Background
14.3.2 Financial Analysis
14.3.3 Company Strategy
14.4 Caladrius Biosciences (NeoStem)
14.4.1 Company Details
14.4.2 Products
14.4.2.1 CLBS20
14.4.2.2 CLBS03 Treg Cellular Therapy
14.4.2.3 CLBS12 CD34 Cell Therapy
14.4.3 Financial Analysis
14.4.4 Company Strategy
14.5 Cynata Therapeutics
14.5.1 Company Background
14.5.2 Product Details
14.5.3 Financial Data
14.5.4 Company Strategy
14.6 Cytori Therapeutics
14.6.1 Company Products
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14.6.2 Financial Analysis
14.6.3 Company Strategy
14.7 MEDIPOST
14.7.1 Company Details
14.7.2 Company Products
14.7.2.1 CellTree Umbilical Cord Blood Bank
14.7.2.2 CARTISTEM®
14.7.2.3 NEUROSTEM®
14.7.2.4 PNEUMOSTEM ®
14.7.3 Financial Analysis
14.8 Mesoblast
14.8.1 Company Details
14.8.1.1 Unique Features of Mesoblast and its Disruptive Technology
14.8.1.2 Allogeneic Mesenchymal Lineage Adult Stem Cells (MLCs)
14.8.1.3 Mechanism of Action of MLC Products
14.8.1.4 Manufacturing of Mesoblast MLC-Based Products
14.8.1.5 Mesoblast Patent Portfolio
14.8.2 Mesoblast Product Portfolio
14.8.2.1 MSC-100-IV/TEMCELL® for Acute Graft Versus Host Disease (aGVHD)
14.8.2.2 MPC-150-IM - Chronic Heart Failure (CHF)
14.8.2.3 MPC-25-IC for Acute Myocardial Infarction
14.8.2.4 MPC-06-ID - Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD)
14.8.2.5 MPC-300-IV for Biologic-Refractory Rheumatoid Arthritis
14.8.2.6 MPC-300-IV for Diabetic Nephropathy
14.8.2.7 MPC-100-IV for Crohn’s Disease
14.8.2.8 MPC-25-Osteo for Spinal Fusion
14.8.3 Mesoblast International Strategic Business Collaborations
14.8.4 Mesoblast Financial Analysis
14.9 NuVasive
14.9.1 Company Details
14.9.2 Biologic Products for the Spinal Surgery Market
14.9.2.1 Formagraft
14.9.2.2 AttraX
14.9.2.3 Propel DBM
14.9.2.4 Osteocel Plus and Pro
14.9.3 Financial Analysis
14.9.4 Company Business Strategy
14.10 Osiris Therapeutics
14.10.1 Company Profile
14.10.1.1 BioSmart Cryopreservation Technology
14.10.1.2 MSC Primer Technology
14.10.2 Products
14.10.2.1 Grafix
14.10.2.2 BIO 4
14.10.2.3 Cartiform
14.10.2.4 Stravix
14.10.3 Company Financial Analysis
14.10.4 Company Strategy
14.11 Plasticell
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14.11.1 Company Profile
14.12 Pluristem Therapeutics
14.12.1 Company Profile
14.12.2 Products
14.12.2.1 PLacental eXpanded (PLX) Cells
14.12.2.2 PLX-PAD
14.12.2.3 PLX-R18
14.12.3 Financial Analysis
14.12.4 Business Strategy
14.13 Pfizer
14.13.1 Company Profile
14.14 StemCells Inc
14.14.1 Company Profile
14.14.2 HuCNS-SC Platform Technology
14.14.3 Clinical Trial Analysis
14.14.4 Financial Analysis
14.15 STEMCELL Technologies
14.15.1 Company Details
14.15.2 Product Details
14.16 Takara Bio
14.16.1 Company Details
14.16.2 Product Portfolio
14.16.2.1 HF10 Anti-Cancer Therapy
14.16.2.2 TCR Gene Therapy
14.16.2.3 MazF Gene Therapy
14.16.3 Centre for Cell and Gene Processing
14.16.4 Company Financials
14.16.5 Company Strategy
14.17 Tigenix
14.17.1 Company Background
14.17.2 Products
14.17.3 Financial Data
14.17.4 Company Strategy
15.0 SWOT Industry Analysis
15.1 What has Strengthened the Industry Thus Far?
15.2 Allogenic and Autologous Stem Cell Industry SWOT Analysis
15.3 What are the Main Driving Forces of this Space?
15.4 Restraints of the Regenerative Medicine Industry as a Whole
15.5 Industry Opportunities Within this Sector
15.6 USA SWOT Analysis
15.6.1 Growth Opportunities
15.6.2 Drivers
15.6.3 Market Challenges
15.7 UK SWOT Analysis
15.7.1 Growth Opportunities
15.7.2 Drivers
15.7.3 Market Challenges
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15.8 South Korea SWOT Analysis
15.8.1 Growth Opportunities
15.8.2 Drivers
15.8.3 Market Challenges
15.9 China SWOT Analysis
15.9.1 Growth Opportunities
15.9.2 Drivers
15.9.3 Challenges
15.10 Japan SWOT Analysis
15.10.1 Opportunities
15.10.2 Market Drivers
15.10.3 Challenges
15.11 Singapore SWOT Analysis
15.11.1 Opportunities
15.11.2 Market Drivers
15.11.3 Challenges
List of Exhibits
Exhibit 2.1 Stem Cell Discovery and Development Timeline
Exhibit 2.2 Potential Therapeutic Uses of Stem Cells
Exhibit 2.3 Embryonic Stem Cell Differentiation
Exhibit 2.4 Pluripotent Stem Cells
Exhibit 2.5 Clinical Uses of Stem Cells
Exhibit 2.6 Illustration of Inner Cell Mass Generation for Stem Cell Culture
Exhibit 2.7 Drug Development Strategies for Patient Derived iPSCs
Exhibit 2.8 Mesenchymal Stem Cell Lineage Progression & Differentiation
Exhibit 2.9 Mesenchymal Stem Cell Differentiation
Exhibit 2.10 Potential Therapeutic Effects of MSCs
Exhibit 2.11 Hematopoietic Stem Cells & the Formation of Mature Blood Cells
Exhibit 2.12 Donor Types for HSC transplantation
Exhibit 2.13 Total Number of Stem Cell Donors 1989-Present
Exhibit 2.14 Cross Section of Umbilical Cord Sample for Stem Cell Extraction
Exhibit 2.15 Umbilical Cord Blood and Wharton’s Jelly; Sources of HSCs and MSCs
Exhibit 2.16 Comprehensive List of Conditions Treated by Cord Blood Transplants
Exhibit 2.17 Cardiac Progenator Cell Populations
Exhibit 2.18 Transplanted Cardiac Progenitor Cells: Potential Mechanism of Action in the Myocardium
Exhibit 2.19 Mammary Stem Cells in the Presence and Absence of Hormones
Exhibit 2.20 Mammary Stem Cell Tree Following Transplantation
Exhibit 2.21 Production of Neurons, Astrocytes and Oligodendrocytes from Neural Stem Cells
Exhibit 2.22 Physiology of the Eye
Exhibit 2.23 Physiological Functions of Each Eye Component
Exhibit 2.24 Healthy & Degenerated Retinal Pigment Epithelium
Exhibit 2.25 Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium
Exhibit 2.26 Using Stem Cells to Replace Dysfunctional Retinal Pigment Epithelial Cells
Exhibit 2.27 Using Stem Cells to Replace Retinal Nerve Cells
Exhibit 2.28 Stem Cells Located Around the Central Vein in the Liver
© Kelly Scientific 2018 www.kellysci.com
Exhibit 2.29 Gut Stem Cells are Located in the Crypts of Lieberhahn
Exhibit 2.30 Localization of Epidermal & Dermal Stem Cells
Exhibit 3.1 Current Therapeutic Areas and Disease States with Number of Stem Cell Clinical Trials, Globally
Exhibit 3.2 Current Geographical Location and Number of Stem Cell Clinical Trials, Globally
Exhibit 3.3 Current Geographical Location and Number of Stem Cell Clinical Trials, USA
Exhibit 3.4 Current Geographical Location and Number of Stem Cell Clinical Trials, Europe
Exhibit 3.5 Current Geographical Location and Number of Stem Cell Clinical Trials, East Asia
Exhibit 3.6 Select hESC and iPSC-Based Products in Clinical Trials by Disease, Stage and Trial Status
Exhibit 3.7 Selected Studies and Key Findings of PSC-Based Therapies in Development for AMD, Diabetes, Liver Disease, Parkinson’s and Thalassemia
Exhibit 3.8 Ocata Therapeutics Current Stem Cell Trials, Globally
Exhibit 3.9 CHA Biotech Current Stem Cell Trials, Globally
Exhibit 3.10 Pfizer Current Stem Cell Trials, Globally
Exhibit 3.11 GSK Current Stem Cell Trials, Globally
Exhibit 3.12 Bayer Current Stem Cell Trials, Globally
Exhbit 3.13 Mesoblast International Current Stem Cell Trials, Globally
Exhibit 3.14 Millennium Pharmaceutical Current Stem Cell Trials, Globally
Exhibit 3.15 AstraZeneca Current Stem Cell Trials, Globally
Exhibit 3.16 Merck Current Stem Cell Trials, Globally
Exhibit 3.17 Chimerix Current Stem Cell Trials, Globally
Exhibit 3.18 Eisai Current Stem Cell Trials, Globally
Exhibit 3.19 SanBio Current Stem Cell Trials, Globally
Exhibit 3.20 Celgene Current Stem Cell Trials, Globally
Exhibit 3.21 StemCells Current Stem Cell Trials, Globally
Exhibit 3.22 Genzyme (Sanofi) Current Stem Cell Trials, Globally
Exhibit 3.23 Teva Current Stem Cell Trials, Globally
Exhibit 3.24 MedImmune Current Stem Cell Trials, Globally
Exhibit 3.25 Janssen Current Stem Cell Trials, Globally
Exhibit 3.26 Seattle Genetics Current Stem Cell Trials, Globally
Exhibit 3.27 Baxter Healthcare Current Stem Cell Trials, Globally
Exhibit 3.28 InCyte Corp Current Stem Cell Trials, Globally
Exhibit 4.1 Disease Models Generated from iSPC using Genome Editing
Exhibit 4.2 Stem Cells Used for Drug Screening
Exhibit 4.3 Sucessful Human iPSC Mediate Therapy Cases
Exhibit 4.4 Number of US Patients That Could Benefit From Stem Cell Therapeutics
Exhibit 4.5 Genentechs Stem Cell Platform for Drug & Toxicity Screening
Exhibit 4.6 Key Challenges in Assessing Genetic Instability of Stem Cells
Exhibit 4.7 Comprehensive In Vitro Proarrhythmia Assay (CiPA) Components
Exhibit 4.8 Ex Vivo Gene Therapy and Stem Cell Technology
Exhibit 4.9 Genome Editing and iPSCs
Exhibit 4.10 Gene Edited iPSC/hES-Mediated Novel Therapy Development
Exhibit 4.11 Comparison of 3D and 2D Cultures of iPSC-Derived Hepatocytes Following Treatment with Toxins, Anti-Proliferative Agents and Other Drugs
Exhibit 4.12 Potential Applications of Human iPSCs for Liver Diseases
Exhibit 4.13 Myocardial Tissue: Cardiomyocytes, Endothelial Cells and Fibroblasts
© Kelly Scientific 2018 www.kellysci.com
Exhibit 4.14 Cardiovascular Disease-Specific Human Pluripotent Stem Cell Lines by Genetic Cause and Drug Testing
Exhibit 4.15 Culture of Human iPSC-Derived Dopaminergic Neurons over 14 Days
Exhibit 4.16 Strategies for Generating Disease Models Using Human Pluripotent Stem Cells (PSCs)
Exhibit 4.17 Criteria for Disease Modelling Using Pluripotent Stem Cells
Exhibit 4.18 Models of Monogenic Dominant Diseases
Exhibit 4.19 Models of Monogenic Recessive Diseases
Exhibit 4.20 Models of Monogenic X-linked Recessive Diseases
Exhibit 4.21 iPSCs in Neurological Disease Modeling, Drug Screening & Cell Therapy
Exhibit 4.22 Advantages and Uses of Intestinal Organoids
Exhibit 5.1: Main Biomarkers Associated with Pluripotent Stem Cells
Exhibit 5.2: Pluripotent Stem Cell Biomarkers
Exhibit 5.3 Main Biomarkers Associated with Mesenchymal Stem Cells
Exhibit 5.4 Mesenchymal Stem Cell Biomarkers
Exhibit 5.5 Main Biomarkers Associated with Neural Stem Cells
Exhibit 5.6 Neural Stem Cell Biomarkers
Exhibit 5.7 Main Biomarkers Associated with Hematopoietic Stem Cells
Exhibit 5.8 Hematopoietic Stem Cell Biomarkers
Exhibit 6.1 Bioprocess Development Considerations for hPSC-Derived Products
Exhibit 6.2 Technologies Used for Expansion & Differentiation of hPSC-Derived Cell Products
Exhibit 6.3 Comparison of Key Performance Characteristics of Cardiomyocytes, Hepatocytes, Neurons, Neural Progenitor Cells, Endoderm Progenitors and Hepatocytes in Planar & Bioreactor Based Differentiation Protocols
Exhibit 6.4 Integrated Expansion & Differentiation of hPSCs Studies by Cell, Process, Cell Density, Process Time and Target Cells Produced
Exhibit 6.5 hPSC Bioprocess Strategies, Planar, Segregated 3D & Integrated: Advantages & Disadvantages
Exhibit 6.6 Main Objectives of GMP Manufacturing
Exhibit 6.7 GMP Facilities Required for Stem Cell Product Manufacuring
Exhibit 6.8 Manufacturing Overview of hIPSCs under GMP Regulation
Exhibit 6.9 Key Steps in Manufacturing GMP Regulated iPSCs
Exhibit 6.10 Characterization and Release Assays for Human iPSCs Manufactured under GMP Conditions
Exhibit 6.11 MCB Viral Assays for use on Human iPSCs Bank
Exhibit 6.12 Differences Between Autologous & Allogeneic Cell Therapy Models
Exhibit 7.1 Selected Venrock Biotech and Healthcare Exits
Exhibit 7.2 Stem Cell Funding Bodies, Globally
Exhibit 7.3 Stem Cell Societies and Consortiums by Geography
Exhibit 7.4 Total Stem Cell NIH Funding 2014-2017
Exhibit 7.5 NIH Funded Stem Cell Related Projects 2014-2017
Exhibit 7.6 Tabular Data NIH Funded Stem Cell Related Projects 2014-2017
Exhibit 7.7 CIRM Investment Funding by Stem Cell Type
Exhibit 7.8 CIRM Stem Cell Project Investment Funding by Therapeutic Area
Exhibit 7.9 Promising Cell & Gene Companies
© Kelly Scientific 2018 www.kellysci.com
Exhibit 8.1 Global Frequency Indicator Trend of Terms Regenerative Medicine, Cell Therapy and Tissue Engineering, 2007-2017
Exhibit 8.2 GeoMap Frequency Indicator Trend of Terms Regenerative Medicine, Cell Therapy and Tissue Engineering, 2007-2017
Exhibit 8.3 Increased Proportion of People Over 65 Through 2050
Exhibit 8.4 Percentage of Global Population Aged 65 Plus 2015-2050
Exhibit 8.5 Global Alzheimer’s Disease Market Forecast 2016-2020
Exhibit 8.6 Global Cardiovascular Market Forecast 2016-2020
Exhibit 8.7 Global Diabetes Therapy and Device Market Forecast 2016-2020
Exhibit 8.8 Bone Graft Global Market Forecast 2016-2020
Exhibit 8.9 Bone Graft Global Market Forecast to 2020 by Geography
Exhibit 8.10 Total Global Financings of the Regenerative Medicine, Cell and Gene Therapy and Tissue Engineering Sector
Exhibit 8.11 Total Global Financing of Regenerative Medicine & Cellular/Gene Therapy by Type
Exhibit 8.12 Number of Global Clinical Trials by Phase of Regenerative Medicine, Cell and Gene Therapy Studies, 2015
Exhibit 8.13 Number of Global Clinical Trials by Indication of Regenerative Medicine, Cellular & Gene Therapeutics, 2015
Exhibit 8.14 Major Clinical Trial Events in Regenerative Medicine 2016
Exhibit 8.15 Global Regenerative Medicine Market Value Tabular Forecast 2016-2022
Exhibit 8.16 Global Regenerative Medicine Market Value Forecast 2016-2022
Exhibit 8.17 Regenerative Medicine Geographic Analysis and Forecast to 2022
Exhibit 8.18 Regenerative Medicine Geographic Forecast Table to 2022
Exhibit 8.19 Regenerative Medicine Market Share by Geography 2016
Exhibit 8.20 Regenerative Medicine Market Share Forecast by Geography 2022
Exhibit 8.21 North America Regenerative Medicine Forecast to 2022
Exhibit 8.22 European Regenerative Medicine Forecast to 2022
Exhibit 8.23 Asia Pacific Regenerative Medicine Forecast to 2022
Exhibit 8.24 RoW Regenerative Medicine Forecast to 2022
Exhibit 8.25 Geographical Location of Regenerative Medicine Companies
Exhibit 8.26 Regenerative Medicine Technology Breakdown of Companies
Exhibit 8.27 Number and Geographical Location of Regenerative Medicine, Cellular Therapy & Gene Therapy Companies, Globally
Exhibit 8.28 Select FDA-Approved Regenerative Medicine Products by Biologics. Cell Based and Biopharmaceuticals
Exhibit 8.29 Regulatory Approved & Commercialized Regenerative Medicine Products Currently on the Market
Exhibit 8.30 Major Regenerative Medicine Milestones in 2016
Exhibit 9.1 Global Stem Cell Therapy Market Forecast Table 2016-2022
Exhibit 9.2 Global Stem Cell Therapy Market Forecast 2016-2022
Exhibit 9.3 Stem Cell Market Share by Adult and Embryonic Stem Cells and Stem Cell Banking
Exhibit 9.4 Major Clinical Trial Events in Stem Cell Medicine 2016
Exhibit 9.5 Stem Cell Geographic Market Share Forecast 2016-2022
Exhibit 9.6 Global Stem Cell Market Share by Geographic Region 2016
Exhibit 9.7 Global Stem Cell Market Share by Geographic Region 2022
Exhibit 9.8 North American Stem Cell Market Forecast 2016-2022
Exhibit 9.9 Asia Pacific Stem Cell Market Forecast 2016-2022
Exhibit 9.10 European Stem Cell Market Forecast 2016-2022
© Kelly Scientific 2018 www.kellysci.com
Exhibit 9.11 Rest of the World Stem Cell Market Forecast 2016-2022
Exhibit 9.12 Market Share of Top Therapeutic Indications in Stem Cell Space, 2016
Exhibit 9.13 Market Share of Top Therapeutic Indications in Stem Cell Space, 2022 Forecast
Exhibit 9.14 Stem Cell Market Forecast by Therapeutic Indications 2016-2022
Exhibit 9.15 Orthopedic/Musculoskeletal Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.16 Cancer Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.17 Cardiology/Vascular Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.18 Wound Healing Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.19 Skin Stem Cell Products and Sources
Exhibit 9.20 Skin Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.21 Ocular Stem Cell SubMarket Forecast 2016-2022
Exhibit 9.22 Current Top Brands Being Used for Stem Cell R&D
Exhibit 9.23 Most Frequent Method of Obtaining Stem Cell Lines in R&D
Exhibit 9.24 Percentage of Stem Cell Characterization Analysis Kits Used in R&D
Exhibit 9.25 Percentage of Stem Cell Differentiation Kits Used in R&D
Exhibit 9.26 Most Common Types of Stem Cells Used in R&D by Mouse, Human & Rat Origin
Exhibit 10.1 Global Tissue Engineering Market Tabular Forecast to 2021
Exhibit 10.2 Global Tissue Engineering Market Forecast to 2021
Exhibit 10.3 Global Tissue Engineering Market Forecast by Geographic Region 2016-2022
Exhibit 10.4 North America Tissue Engineering Market Forecast 2016-2022
Exhibit 10.5 Europe Tissue Engineering Market Forecast 2016-2022
Exhibit 10.6 Asia Pacific Tissue Engineering Market Forecast 2016-2022
Exhibit 10.7 Geographical Breakdown of Tissue Engineering Companies Globally
Exhibit 10.8 Public and Privately Held Tissue Engineering Company Distribution, Globally
Exhibit 10.9 Main Players in the Tissue Engineering Market
Exhibit 10.10 Main Players in the CAR-T Market
Exhibit 10.11 Main Players in the TCR Market
Exhibit 10.12 Main Players in the NK Cell Market
Exhibit 10.13 Main Players in the TILs Market
Exhibit 10.14 Global Tissue Engineering Submarket Breakdown by Market Share 2016
Exhibit 10.15 Global Tissue Engineering Submarket Breakdown by Market Share Forecast 2022
Exhibit 10.16 Tissue Engineering Submarket Breakdown Forecast Table 2016-2022
Exhibit 10.17 Tissue Engineering Submarket Breakdown Forecast 2016-2022
Exhibit 10.18 Orthopedics/Musculoskeletal Tissue Engineering Market Forecast 2016-2022
Exhibit 10.19 Oncology Tissue Engineering Market Forecast 2016-2022
Exhibit 10.20 Cardiology and Vascular Tissue Engineering Market Forecast 2016-2022
Exhibit 10.21 Dermatology Tissue Engineering Market Forecast 2016-2022
Exhibit 10.22 Oral and Dental Tissue Engineering Market Forecast 2016-2022
Exhibit 11.1 Number of Stem Cell Donors by Geographical Location
Exhibit 11.2 Number and Geographical Location of Global Unrelated Cord Blood Units
Exhibit 11.3 Market Share of Companies in the BioBanking Industry
Exhibit 11.4 Market Share within Therapeutic Companies in the BioBanking Industry
Exhibit 11.5 Market Share within Cell & Tissue Banks in the BioBanking Industry
Exhibit 11.6 Percentage of Allogenic & Autologous Transplantations
Exhibit 11.7 Percentage Breakdown of Indications using Autologous Umbilical Cord Blood Transplants
Exhibit 11.8 Percentage Breakdown of Indications using Allogenic Umbilical Cord Blood Transplants
Exhibit 11.9 Global Cord Blood Banking Market Forecast 2016-2022
Exhibit 11.10 Stem Cell Biobanking Market Segments
Exhibit 11.11 Top Global Cord Blood and Tissue Companies
Exhibit 11.12 Important Players in the International Private Cord Bank Market
Exhibit 12.1 Key Challenges to the Regenerative Medicine & Cellular/Gene Therapy Market
Exhibit 12.2 Company and Indication that will Benefit from New 21st Century Cures Act, USA
Exhibit 12.3 Cell and Gene Based Therapy in Japan as Defined by the PMDA
Exhibit 12.4 Regulatory System in Japan for Regenerative Medicine and Cell and Gene Therapy Products
Exhibit 12.5 Main Stem Cell Research Institutes in China
Exhibit 13.1 Selected CD19-directed Product Candidates in Clinical Trials by Costimulatory & Binding Domains, Starting Cell Population, Vector and Ablation Technology
Exhibit 13.2 Select CD19-Directed ALL Clinical Trials
Exhibit 13.3 Select Anti-CD22 CAR-T Clinical Projects
Exhibit 13.4 CBER Compliance and Surveillance Activities
Exhibit 13.5 Contacts for the Cellular, Tissue and Gene Therapies Advisory Committee, FDA
Exhibit 13.6 Clinical Regulatory Pathway – Conventional Route
Exhibit 13.7 Clinical Regulatory Pathway – Option for Rapid Translation
Exhibit 13.8 PMDA Total Review Period of Standard Drugs
Exhibit 13.9 PMDA Total Review Period of Priority Drugs
Exhibit 13.10 Number of Approved Recombinant Protein Products by PMDA 1985-2013
Exhibit 13.11 Forerunner Review Assignment System Timeframe
Exhibit 13.12 Adaptive Licensing and Accelerated Approval in Japan‐US‐EU
Exhibit 13.13 Key Contacts Within PMDA, Japan
Exhibit 13.14 CheckMate 066 Clinical Trial
Exhibit 13.15 CheckMate 037 Clinical Trial
Exhibit 13.16 Contact Details for EMA Cell Therapy & Immunotherapy Experts
Exhibit 13.17 Method of Generating CAR-Modified T Cells
Exhibit 13.18 Clinical Activity, Cost Structure and Patient Convenience Flow Chart of CAR-T Therapy
Exhibit 13.19 General Technical and Personnel Requirements of a GMP, QC, QA, FDA Regulated Cell Therapy Manufacturing Facility
Exhibit 13.20 Technician/Scientific Requirements for CAR T Manufacturing
Exhibit 13.21 Selection of Apheresis Instruments Currently on the Market
Exhibit 13.22 Selection of Cell Counters and Analyzer Instruments Currently on the Market
Exhibit 13.23 Main Objectives of GMP Manufacturing Immunotherapeutics
Exhibit 13.24 Main Objectives of Quality Control While Manufacturing Immunotherapeutics
Exhibit 13.25 Main Objectives of Regulatory Affairs During Manufacturing Immunotherapeutics
Exhibit 13.26 CAR-T Studies Using mRNA Transfection Electroporation
Exhibit 13.27 Allogenic Versus Autologous Cell Manufacturing
Exhibit 13.28 Challenges for Autologous Cell Therapy Manufacture
Exhibit 13.29 Current Company/Institutions with Suicide Gene CAR T Projects
Exhibit 13.30 Advantages of Using Automated Cell Therapy Manufacturing
Exhibit 13.31 Main Drivers to Implement Automated Cell Therapy Manufacturing
Exhibit 13.32 Main Benefits of Automated Cell Therapy Manufacturing
Exhibit 13.33 Advantages & Disadvantages of Autologous Cell Therapy Manufacture Scale Up
Exhibit 13.34 Streptamer® -Based Magnetic Bead Cell Isolation Exhibit 13.35 Juno Therapeutics Manufacturing Facility Objectives
Exhibit 13.36 Annual Cost of Patented Cancer Therapeutics from 2000 to Today
Exhibit 13.37 Cost of Nivolumab, Pembrolizumab & Ipilimumab per mg
Exhibit 13.38 Current Juno Therapeutics Trials and CAR T Products
Exhibit 13.39 Current CAR T Business Deals
Exhibit 14.1 MultiStem Platform in Action
Exhibit 14.2 Key Advantages of MultiStem
Exhibit 14.3 Athersys Product and Clinical Pipeline
Exhibit 14.4 Athersys Key Business Strategies
Exhibit 14.5 Baxter International Product Revenue by Class
Exhibit 14.6 Baxter International Product Revenue by Geography
Exhibit 14.7 Baxter International Breakdown of Product Revenue
Exhibit 14.8 Caladrius Expertise in Cell Type and Therapeutic Application Portfolio
Exhibit 14.9 PCT Caladrius CLBS03 Treg Cellular Therapy Manufacturing Process
Exhibit 14.10 Caladrius Revenue 2014-2016
Exhibit 14.11 Caladrius Clinical Manufacturing Revenue 2014-2016
Exhibit 14.12 Caladrius Process Development Revenue 2014-2016
Exhibit 14.13 Cytori Cell Therapy Mechanism of Action in Angiogenesis, Inflammation and Wound Remodeling
Exhibit 14.14 Cytori Therapeutics Cell Therapy Clinical Pipeline
Exhibit 14.15 MediPost Product Pipeline by Indication and Clinical Study Phase
Exhibit 14.16 Medipost Sales Figures 2013-2016
Exhibit 14.17 CellTree Umbilical Cord Blood Bank Program Details and Pricing
Exhibit 14.18 Medipost Revenue Share by Product Category 2016
Exhibit 14.19 Medipost Sales Revenue by Product Category 2012 -2016
Exhibit 14.20 Medipost Umbilical Cord Blood Bank Revenue 2012-2016
Exhibit 14.21 Medipost Stem Cell Drug Sales Revenue 2012-2016
Exhibit 14.22 Medipost R&D Investment 2012-2016
Exhibit 14.23 Mesenchymal Lineage Adult Stem Cells (MLCs) Secrete a Variety of Immunomodulatory Molecules
Exhibit 14.24 Mesoblast Mesenchymal Lineage Adult Stem Cell (MLC) Functional Properties
Exhibit 14.25 Mesoblast Expanion and Immune Privilege of MLC Technology
Exhibit 14.26 Mesoblast Complementary Technology Platforms
Exhibit 14.27 Mechanism of Action of MPC-150-IM, MPC-06-ID, MPC-300-IV, TEMCELL(R)HS. Inj. and MSC-100-IV and MPC-25-OSTEO
Exhibit 14.28 Mesoblast MLC-Based Product Manufacturing and Distribution Process
Exhibit 14.29 Mesoblast Patent Portfolio with Expiration and Validity through 2035
Exhibit 14.30 Mesoblast Tier 1 and Tier 2 Product Candidates by Program and Clinical Stage
Exhibit 14.31 Mesoblast Lead Product MSC-100-IV/TEMCELL HS Inj
Exhibit 14.32 MSC-100-IV Treatment in Children with SR-aGVHD who Failed Other Modalities
Exhibit 14.33 MPC-300-IV for Treatment of Chronic Inflammatory Diseases
Exhibit 14.34 Mesoblast International Strategic Business Collaborations
Exhibit 14.35 Mesoblast FY2015 Share Price and Financial Analysis
Exhibit 14.36 Mesoblast Revenue Generated FY2014-FY2015
Exhibit 14.37 Mesoblast R&D Expenditure FY2014-FY2015
Exhibit 14.38 NuVasive Biologics Portfolio
Exhibit 14.39 NuVasive Global Revenue 2013-2015
Exhibit 14.40 NuVasive NON GAAP Operating Profit Margin 2013-2015
Exhibit 14.41 NuVasive Spinal Surgery Product and Biologic Revenue Breakdown 2013-2015
Exhibit 14.42 NuVasive USA and International Revenue Breakdown 2015
Exhibit 14.43 NuVasive Corporate Strategy Going Forward
Exhibit 14.44 Osiris Therapeutics Current Product Portfolio
Exhibit 14.45 Osiris Therapeutics Product Pipeline by Indication, Preclinical, Clinical and Market Stage
Exhibit 14.46 Exhibit Plasticel Partnerships and Collaborations with Industry and Academic Institutions
Exhibit 14.47 Pluristem Therapeutics Company Pipeline Portfolio by Product, Indication, Location & Phase
Exhibit 14.48 Pluristem Therapeutics Production of PLX-PAD & PLX-R18
Exhibit 14.49 Pluristem Therapeutics Revenue 2013-2015
Exhibit 14.50 Pluristem Therapeutics R&D Costs 2013-2015
Exhibit 14.51 Pfizer Stem Cell Policy
Exhibit 14.52 StemCell Inc Manufacturing Steps of Hu-CNS-SC Product
Exhibit 14.53 STEMCELL Technologies Product Portfolio
Exhibit 14.54 STEMCELL Technologies Brand Portfolio
Exhibit 14.55 Takara Bio Sales Revenue 2014-2019
Exhibit 14.56 Takara Bio Operating Sales 2014-2019
Exhibit 14.57 Takara BioIndustry Sales Revenue 2014-2018
Exhibit 14.58 Takara Bio Sales by Geographic Region FY2016
Exhibit 14.59 Tigenix Key Intellectual Property Patent Portfolio
Exhibit 14.60 Comprehensive List of Companies in the Stem Cell & Regenerative Medicine Industry
Exhibit 15.1 Advantages, Weaknesses, Opportunities & Threats of Allogenic & Autologous Stem Cells
Exhibit 15.2 Opportunistic Therapeutic Indications as Decided by Senior Key Opinion Leaders

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