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Stem Cell Markets

Stem cells have 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). The differentiation process is a key part of enabling stem cells to be used for therapeutic purposes.

The purpose of this report is to describe the specific market segments of the medical research space using stem cells for research and development purposes. This study addresses all of the generally accepted analytical methods that are currently in use today for preparing and using stem cells. The report then proceeds to examine the use of stem cells in developing new therapies for disease.

Table of Contents

TABLE OF CONTENTS

1. Overview 4

• 1.1 Statement of Report 4
• 1.2 Scope of the Report 5
• 1.3 Methodology 5
• 1.4 Executive Summary 6

2. Biology of Stem Cells 8

• 2.1 Scope of this Chapter 8
• 2.2 Basic Properties of Stem Cells and Their Classification 8
• 2.3 Differentiation of Stem Cells 11
  • 2.3.1 Neural and Neuronal Differentiation 11
  • 2.3.2 Cardiomyogenic Differentiation of ESCs 11
  • 2.3.3 Differentiation of Mesenchymal Stem/Progenitor Cells 12
• 2.4 Self-Renewal of Stem Cells 12
• 2.5 Dedifferentiation and Nuclear Reprogramming 13
• 2.6 Functional Proliferation of Adult Mature Cells 14
• 2.7 Nanog Promotes Transfer of Pluripotency After Cell Fusion 15
• 2.8 MicroRNAs in Stem Cell Development 15
• 2.9 Stem Cell Therapy 15

3. Market Analysis of the Stem Cell Space 17

• 3.1 Scope of this Chapter 17
• 3.2 Overall Market Opportunity and Segmentation of the Total Stem Cell Marketplace 17
• 3.3 Potential Stem Cell Commercial Applications 20
  • 3.3.1 Cord Blood Stem Cells and Cord Blood Stem Cell Banking: Current Market Environment and Opportunity 20
• 3.4 Results of Primary Market Survey to Characterize Qualitative and Quantitative Trends in the Stem Cells Space 23
  • 3.4.1 Characteristics of the Respondent Pool 24
  • 3.4.2 Utilization of the Different Classes of Stem Cells 26
  • 3.4.3 Quantitative Metrics of the Stem Cell Research Marketplace: Number of Experiments Performed in Research 27
  • 3.4.4 Evolution of Research Activities with Different Types of Stem Cells: Current Usage Trends and Usage in 12 to 18 Months 31
  • 3.4.5 Types of Stem Cell Research Activities Performed by the End-User Community 33
  • 3.4.6 Challenges Facing Stem Cell Researchers 36
  • 3.4.7 Market Drivers and Research Questions Being Addressed in the Stem Cell Space 40
  • 3.4.8 Summary of Challenges and Opportunities in the Stem Cell Space Based on TriMark’s Analysis 41
  • 3.4.9 Unmet Product Needs in the Stem Cell Research Space and Licensing/IP Constraints 42
• 3.5 Competitive Landscape of the Stem Cell Marketplace 44
  • 3.5.1 SWOT Analysis of the Major Stem Cell Market Segments 50
• 3.6 Market Size and Forecasts 54

4. Worldwide Landscape of Stem Cell Research 58

• 4.1 Scope of this Chapter 58
• 4.2 Global Embryonic Stem Cell Research 58
  • 4.2.1 Top Research Institutions Worldwide in the Stem Cells Space and Global “Hot Spots” for Research and Therapeutics 59
• 4.3 Stem Cell Research in the U.S. 62
  • 4.3.1 Proposition 71 in the State of California 64
• 4.4 Intellectual Property (IP) Landscape Surrounding Stem Cells 65
• 4.5 Who Will Finance Stem Cell Research? 67
  • 4.5.1 U.S. Government Policy on Stem Cell Research 67
  • 4.5.2 Current Federal Policy 70
    • 4.5.2.1 Moral Issues Affecting Pre-Obama Federal Policy 71
    • 4.5.2.2 Significance and Requirements for Federal Funding 73
    • 4.5.2.3 Draft Guidelines for the new NIH stem cell funding policy 75
  • 4.5.3 International Law 75
    • 4.5.3.1 Australia 75
    • 4.5.3.2 U.K. 75
    • 4.5.3.3 Canada 75
    • 4.5.3.4 China 75
    • 4.5.3.5 Germany 77
    • 4.5.3.6 Switzerland 77
    • 4.5.3.7 Japan 77
    • 4.5.3.8 Israel 77
    • 4.5.3.9 Singapore 77
  • 4.5.4 Technological and Economical Disadvantages for the U.S. 78

5. Therapeutic Areas and Research Programs in the Stem Cell Space 79

• 5.1 Scope of this Chapter 79
• 5.2 Therapeutic and Other Markets Addressed by Stem Cells 79
  • 5.2.1 Hematopoietic Stem Cells (HSCs) 80
  • 5.2.2 Stem Cell Therapeutics for Cardiac and Ischemic Diseases 83
  • 5.2.3 Stem Cell Therapeutics for Type I Diabetes 85
  • 5.2.4 Stem Cell Therapeutics for Orthopedic Diseases 86
  • 5.2.5 Stem Cell Therapeutics for Neurological Diseases 87
• 5.3 Off-the-Shelf Stem Cells Being Developed 89

6. Company Profiles 91

• 6.1 Aastrom Biosciences 91
• 6.2 Advanced Cell Technology 92
• 6.3 BioE 93
• 6.4 Bioheart 93
• 6.5 Cryo-Cell International 94
• 6.6 ES Cell International 95
• 6.7 Gamida Cell 95
• 6.8 GenVec 95
• 6.9 Geron 96
• 6.10 NeuroGeneration 97
• 6.11 Osiris Therapeutics 97
• 6.12 Pluristem Therapeutics 98
• 6.13 ReNeuron 99
• 6.14 StemCells, Inc. 99
• 6.15 Titan Pharmaceuticals 100
• 6.16 ViaCell (now PerkinElmer) 100

Appendix 1. Glossary of Terms in Stem Cell Biology 101


INDEX OF FIGURES

• Figure 2.1: Derivation of Embryonic Stem Cells (ESCs) from the Inner Cell Mass of Blastocysts 9
• Figure 2.2: Classification of Stem Cells: Embryonic Stem Cells Versus Adult Stem Cells 10
• Figure 2.3: Somatic Cell Nuclear Transfer (SCNT) 14
• Figure 3.1: Segmentation of the Stem Cell Marketplace Based Upon Commercial Offerings—Products and Services 19
• Figure 3.2: Geographical Breakout of Stem Cell End-User Survey Respondents 24
• Figure 3.3: Affiliation (Pharma, Biotech, Academic/University) of Stem Cell End-User Survey Respondents 24
• Figure 3.4: Survey Respondents That Are Studying Stem Cells or Using Stem Cells in Their Research 25
• Figure 3.5: Length of Time Survey Respondent Pool Has Been Studying Stem Cells or Using Stem Cells in Its Research Activities 25
• Figure 3.6: Utilization/Research with Different Stem Cell Types 26
• Figure 3.7: Number of Experiments Involving Stem Cells Conducted Per Week 27
• Figure 3.8: Differences with Respect to Usage of Stem Cell Types 28
• Figure 3.9: Research Dollars Spent Monthly on Research/Studies with Different Stem Cell Types 29
• Figure 3.10: Growth of Research Spending in Various Segments of the Stem Cells Space (Defined by Stem Cell Type) 30
• Figure 3.11: Growth in End-User Utilization of Various Stem Cell Types 30
• Figure 3.12: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 32
• Figure 3.13: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 32
• Figure 3.14: Broad Classification of Research Activities Being Performed with Stem Cells by Researchers 33
• Figure 3.15: Current End-User Utilization Category for Adult Stem Cells (ASCs) 34
• Figure 3.16: Current End-User Utilization Category for Human Embryonic Stem Cells (hESCs) 34
• Figure 3.17: Current End-User Utilization Category for Human Cord Blood Stem Cells 34
• Figure 3.18: Current End-User Utilization Category for Animal Stem Cells 35
• Figure 3.19: Current End-User Utilization Category for Cancer Stem Cells 35
• Figure 3.20: Challenges in the Study or Utilization of Adult Stem Cells (ASCs) 37
• Figure 3.21: Challenges in the Study or Utilization of Human Embryonic Stem Cells (hESCs) 37
• Figure 3.22: Challenges in the Study or Utilization of Human Cord Blood Stem Cells 38
• Figure 3.23: Challenges in the Study or Utilization of Animal Stem Cells 38
• Figure 3.24: Challenges in the Study or Utilization of Cancer Stem Cells 39
• Figure 3.25: Top Unmet Needs in Commercial Products in the Stem Cell Research Space 43
• Figure 3.26: U.S. Stem Cell Therapy Market Sales, 2005-2016 55
• Figure 4.1: Stem Cell Research Worldwide 61

INDEX OF TABLES

• Table 2.1: The Different Types of Stem Cells and Their Properties 10
• Table 2.2: Adult Stem Cell (ASC) Differentiation Properties 11
• Table 3.1: Characteristics of Different Stem Cell Types and Associated Market Opportunities 18
• Table 3.2: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cells 19
• Table 3.3: Selected Cord Blood Banks in the U.S. 22
• Table 3.4: Selected Companies in the Cord Blood Stem Cell Technology and Therapeutics Development Space 23
• Table 3.5: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 31
• Table 3.6: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 31
• Table 3.7: Market Share of Companies/Institutions Offering Different Stem Cells to Researchers 46
• Table 3.8: Market Share of Companies/Institutions Offering Reagents for Stem Cell Research 46
• Table 3.9: The U.S. Stem Cell Therapy Market Forecast, 2005-2016 55
• Table 4.1: Major Milestones in Stem Cell Research and Associated Timeline, 1981-2009 60
• Table 4.2: Selected Stem Cell Hot Spots Worldwide Administering Non-FDA Approved Stem Cell Therapeutic Regimens 62
• Table 4.3: NIH Funding of Stem Cell Research in the U.S., 2004-2009 63
• Table 4.4: Snapshot of the Current Key Stem Cell Patents 66
• Table 5.1: Estimate of Potential Market Opportunity for Stem Cell-based Therapeutics 79
• Table 5.2: Autologous Versus Allogeneic Cell Therapy 80
• Table 5.3: Diseases Treated with HSC Transplantation Today 81
• Table 5.4: HSC Sources and Their Properties 82
• Table 5.5: Stem Cell Therapeutics for Hematological Diseases in Development 83
• Table 5.6: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases in Development 84
• Table 5.7: Stem Cell-based Therapeutics for Vascular Diseases in Development 85
• Table 5.8: Stem Cell Therapeutics for Type I Diabetes in Development 86
• Table 5.9: Stem Cell Therapeutics for Orthopedic Disease in Development 86
• Table 5.10: Stem Cell Therapeutics for Neurological Disease in Development 88
• Table 5.11: Segmentation of the Allogeneic Cell Therapy Market 90

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