CellTherapyNews — Stem Cell Markets

Stem Cell Markets
July 2008. 106 Pages, US$ 3,400 (electronic).

Published by TriMark Publications

Report Summary
Table of Contents
Sample PDF
TriMark Licensing Agreement

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 (R&D) 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.

Table of Contents

1. Overview 3
1.1 Statement of Report 3
1.2 Scope of the Report 4
1.3 Methodology 4
1.4 Executive Summary 5

2. Biology of Stem Cells 7
2.1 Scope of this Chapter 7
2.2 Basic Properties of Stem Cells and Their Classification 7
2.3 Differentiation of Stem Cells 10
2.3.1 Neural and Neuronal Differentiation 10
2.3.2 Cardiomyogenic Differentiation of ESCs 10
2.3.3 Differentiation of Mesenchymal Stem/Progenitor Cells 11
2.4 Self Renewal of Stem Cells 11
2.5 Dedifferentiation and Nuclear Reprogramming 12
2.6 Functional Proliferation of Adult Mature Cells 13
2.7 Nanog Promotes Transfer of Pluripotency After Cell Fusion 13
2.8 MicroRNAs in Stem Cell Development 14
2.9 Stem Cell Therapy 14

3. Market Analysis of the Stem Cell Space 15
3.1 Scope of this Chapter 15
3.2 The Overall Market Opportunity and Segmentation of the Total Stem Cell Marketplace 15
3.3 Potential Stem Cell Commercial Applications 18
3.3.1 Cord Blood Stem Cells and Cord Blood Stem Cell Banking: Current Market Environment and Opportunity 18
3.4 Results of Primary Market Survey to Characterize Qualitative and Quantitative Trends in the Stem Cells Space 21
3.4.1 Characteristics of the Respondent Pool 22
3.4.2 Utilization of the Different Classes of Stem Cells 24
3.4.3 Quantitative Metrics of the Stem Cell Research Marketplace: Number of Experiments Performed in Research 25
3.4.4 Evolution of Research Activities with the Different Types of Stem Cells: Current Usage Trends and Usage in 12 to 18 Months 29
3.4.5 Types of Research Activities the End-User Community Performs with the Different Types of Stem Cells 31
3.4.6 Challenges Facing Stem Cell Researchers 34
3.4.7 Market Drivers and Research Questions Being Addressed in the Stem Cell Space 38
3.4.8 Summary of Challenges and Opportunities in the Stem Cell Space Based on TriMark’s Analysis 39
3.4.9 Unmet Product Needs in the Stem Cell Research Space and Licensing/IP Constraints 40
3.5 Competitive Landscape of the Stem Cell Marketplace 42
3.5.1 SWOT Analysis of the Major Stem Cell Market Segments 49
3.6 Market Size and Forecasts 52

4. Worldwide Landscape of Stem Cell Research 56
4.1 Scope of this Chapter 56
4.2 Global Embryonic Stem Cell Research 56
4.2.1 Top Research Institutions Worldwide in the Stem Cells Space and Global “Hot Spots” for Research and Therapeutics 57
4.3 Stem Cell Research in the U.S. 59
4.3.1 Proposition 71 in the State of California 61
4.4 Intellectual Property (IP) Landscape Surrounding Stem Cells 62
4.5 Who Will Finance Stem Cell Research? 64
4.5.1 U.S. Government Policy on Stem Cell Research 64
4.5.2 Current Federal Policy 67
4.5.2.1 Moral Issues Affecting the Policy 68
4.5.2.2 Significance and Requirement of Federal Funding 70
4.5.2.3 Implementing the Current Policy 72
4.5.3 International Law 74
4.5.3.1 Australia 74
4.5.3.2 U.K. 74
4.5.3.3 Canada 74
4.5.3.4 China 75
4.5.3.5 Germany 76
4.5.3.6 Switzerland 76
4.5.3.7 Japan 76
4.5.3.8 Israel 76
4.5.3.9 Singapore 77
4.5.4 Technological and Economical Disadvantage for U.S. 77

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 Disease 86
5.3 Off-the-Shelf Stem Cells Being Developed 87
6. Company Profiles 90

Appendix 1. Glossary of Terms in Stem Cell Biology 104

INDEX OF FIGURES

Figure 2.1: Derivation of Embryonic Stem Cells (ESCs) from the Inner Cell Mass of Blastocysts 8
Figure 2.2: Classification of Stem Cells: Embryonic Stem Cells Versus Adult Stem Cells 9
Figure 2.3: Somatic Cell Nuclear Transfer (SCNT) 12
Figure 3.1: Segmentation of the Stem Cell Marketplace Based Upon Commercial Offerings—Products and Services 17
Figure 3.2: Geographical Breakout of Stem Cell End-User Survey Respondents 22
Figure 3.3: Affiliation (Pharma, Biotech, Academic/University) of Stem Cell End-User Survey Respondents 22
Figure 3.4: Survey Respondents Are Studying Stem Cells or Using Stem Cells in Their Research 23
Figure 3.5: Length of Time Survey Respondent Pool Has Been Studying Stem Cells or Using Stem Cells in Its Research Activities 23
Figure 3.6: Utilization/Research with Different Stem Cell Types 24
Figure 3.7: Range of Number of Experiments Involving Stem Cells Conducted Per Week 25
Figure 3.8: Differences with Respect to Usage of Stem Cell Types 26
Figure 3.9: Research Dollars Spent Monthly on Research/Studies with Different Stem Cell Types 27
Figure 3.10: Growth of Research Spending in Various Segments of the Stem Cells Space (Defined by Stem Cell Type) 28
Figure 3.11: Growth in End-User Utilization of the Various Different Stem Cell Types 28
Figure 3.12: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 30
Figure 3.13: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 30
Figure 3.14: Broad Classification of Research Activities Being Performed with Stem Cells by Researchers 31
Figure 3.15: Current End-User Utilization Category of Adult Stem Cells (ASCs) 32
Figure 3.16: Current End-User Utilization Category of Human Embryonic Stem Cells (hESCs) 32
Figure 3.17: Current End-User Utilization Category of Human Cord Blood Stem Cells 32
Figure 3.18: Current End-User Utilization Category of Animal Stem Cells 33
Figure 3.19: Current End-User Utilization Category of Cancer Stem Cells 33
Figure 3.20: Challenges in the Study or Utilization of Adult Stem Cells (ASCs) 35
Figure 3.21: Challenges in the Study or Utilization of Human Embryonic Stem Cells (hESCs) 35
Figure 3.22: Challenges in the Study or Utilization of Human Cord Blood Stem Cells 36
Figure 3.23: Challenges in the Study or Utilization of Animal Stem Cells 36
Figure 3.24: Challenges in the Study or Utilization of Cancer Stem Cells 37
Figure 3.25: Top Unmet Needs in Commercial Products in the Stem Cell Research Space 41
Figure 3.26: The U.S. Stem Cell Therapy Market Sales, 2005-2016 54
Figure 4.1: Stem Cell Research Worldwide 58

INDEX OF TABLES

Table 2.1: The Different Types of Stem Cells and Their Properties 9
Table 2.2: Adult Stem Cell (ASC) Differentiation Properties 10
Table 3.1: Characteristics of Different Stem Cell Types and Associated Market Opportunity 16
Table 3.2: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cells 17
Table 3.3: Selected Cord Blood Banks in the U.S. 20
Table 3.4: Selected Companies in the Cord Blood Stem Cell Technology and Therapeutics Development Space 21
Table 3.5: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 29
Table 3.6: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 29
Table 3.7: Market Share of Companies/Institutions Offering Different Stem Cells to Researchers 44
Table 3.8: Market Share of Companies/Institutions Offering Reagents for Stem Cell Research 45
Table 3.9: The U.S. Stem Cell Therapy Market Forecast, 2005-2016 53
Table 3.10: The World Market for Stem Cell Products and Services, 2005-2012 55
Table 4.1: Major Milestones in Stem Cell Research and Associated Timeline, 1981-2008 57
Table 4.2: Selected Stem Cell Hot Spots Worldwide Administering Non-FDA Approved Stem Cell Therapeutic Regimens 59
Table 4.3: NIH Funding of Stem Cell Research in the U.S., 2004-2009 60
Table 4.4: Snapshot of the Current Key Stem Cell Patents 63
Table 4.5: Stem Cell Derivations 72
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 85
Table 5.9: Stem Cell Therapeutics for Orthopedic Disease in Development 86
Table 5.10: Stem Cell Therapeutics for Neurological Disease in Development 87
Table 5.11: Segmentation of the Allogeneic Cell Therapy Market 89