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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.

1. 1. Overview 3
2. 1.1 Statement of Report 3
3. 1.2 Scope of the Report 4
4. 1.3 Methodology 4
5. 1.4 Executive Summary 4
7. 2. Biology of Stem Cells 6
8. 2.1 Scope of this Chapter 6
9. 2.2 Basic Properties of Stem Cells and Their Classification 6
10. 2.3 Differentiation of Stem Cells 9
11. 2.3.1 Neural and Neuronal Differentiation 9
12. 2.3.2 Cardiomyogenic Differentiation of ESCs 9
13. 2.3.3 Differentiation of Mesenchymal Stem/Progenitor Cells 10
14. 2.4 Self Renewal of Stem Cells 10
15. 2.5 Dedifferentiation and Nuclear Reprogramming 11
16. 2.6 Functional Proliferation of Adult Mature Cells 12
17. 2.7 Nanog Promotes Transfer of Pluripotency after Cell Fusion 12
18. 2.8 MicroRNAs in Stem Cell Development 13
19. 2.9 Stem Cell Therapy 13
21. 3. Market Analysis of the Stem Cells Space 14
22. 3.1 Scope of this Chapter 14
23. 3.2 The Overall Market Opportunity and Segmentation of the Total Stem Cells Marketplace 14
24. 3.3 Potential Stem Cell Commercial Applications 17
25. 3.3.1 Cord Blood Stem Cells and Cord Blood Stem Cell Banking: Current Market Environment and Opportunity 17
26. 3.4 Results of Primary Market Survey to Characterize Qualitative and Quantitative Trends in the Stem Cells Space 19
27. 3.4.1 Characteristics of the Respondent Pool 20
28. 3.4.2 Utilization of the Different Classes of Stem Cells 22
29. 3.4.3 Quantitative Metrics of the Stem Cell Research Marketplace: Number of Experiments Performed, Research 23
30. 3.4.4 Evolution of Research Activities with the Different Types of Stem Cells: Current Usage Trends and Usage in 12 to 18 Months 27
31. 3.4.5 Types of Research Activities the End-User Community Performing with the Different Types of Stem Cells 29
32. 3.4.6 Challenges Facing Stem Cell Researchers 32
33. 3.4.7 Market Drivers and Research Questions Being Addressed in the Stem Cells Space 36
34. 3.4.8 Summary of Challenges and Opportunities in the Stem Cells Space Based on TriMark's Analysis 37
35. 3.4.9 Unmet Product Needs in the Stem Cells Research Space and Licensing/IP Constraints 38
36. 3.5 Competitive Landscape of the Stem Cells Marketplace 40
37. 3.5.1 SWOT Analysis of the Major Stem Cell Market Segments 46
38. 3.6 Market Size and Forecasts 49
40. 4. Worldwide Landscape of Stem Cell Research 53
41. 4.1 Scope of this Chapter 53
42. 4.2 Global Embryonic Stem Cell Research 53
43. 4.2.1 Top Research Institutions Worldwide in the Stem Cells Space and Global "Hot Spots" for Research and Therapeutics 54
44. 4.3 Stem Cell Research in the U.S. 56
45. 4.3.1 Proposition 71 in the State of California 57
46. 4.4 Intellectual Property (IP) Landscape Surrounding Stem Cells 58
47. 4.5 Who Will Finance Stem Cell Research? 60
48. 4.5.1 U.S. Government Policy on Stem Cell Research 61
49. 4.5.2 Current Federal Policy 63
50. 4.5.2.1 Moral Issues Affecting the Policy 64
51. 4.5.2.2 Significance and Requirement of Federal Funding 66
52. 4.5.2.3 Implementing the Current Policy 68
53. 4.5.3 International Law 70
54. 4.5.3.1 Australia 70
55. 4.5.3.2 U.K. 70
56. 4.5.3.3 Canada 70
57. 4.5.3.4 China 70
58. 4.5.3.5 Germany 71
59. 4.5.3.6 Switzerland 72
60. 4.5.3.7 Japan 72
61. 4.5.3.8 Israel 72
62. 4.5.3.9 Singapore 72
63. 4.5.4 Technological and Economical Disadvantage for U.S. 72
65. 5. Therapeutic Areas and Research Programs in the Stem Cells Space 74
66. 5.1 Scope of this Chapter 74
67. 5.2 Therapeutic and Other Markets Addressed by Stem Cells 74
68. 5.2.1 Hematopoietic Stem Cells (HSCs) 75
69. 5.2.2 Stem Cell Therapeutics for Cardiac and Ischemic Diseases 78
70. 5.2.3 Stem Cell Therapeutics for Type I Diabetes 80
71. 5.2.4 Stem Cell Therapeutics for Orthopedic Diseases 81
72. 5.2.5 Stem Cell Therapeutics for Neurological Disease 81
73. 5.3 Off-the-Shelf Stem Cells Being Developed 82
75. 6. Company Profiles 85
77. Appendix 1. Glossary of Terms in Stem Cell Biology 97
80. INDEX OF FIGURES
82. Figure 2.1: Derivation of Embryonic Stem Cells (ESCs) from the Inner Cell Mass of Blastocysts 7
83. Figure 2.2: Classification of Stem Cells: Embryonic Stem Cells versus Adult Stem Cells 8
84. Figure 2.3: Somatic Cell Nuclear Transfer (SCNT) 11
85. Figure 3.1: Segmentation of the Stem Cells Marketplace Based Upon Commercial Offerings-Products and Services 16
86. Figure 3.2: Geographical Breakout of Stem Cell End-User Survey Respondents 20
87. Figure 3.3: Affiliation (Pharma, Biotech, Academic/University) of Stem Cell End-user Survey Respondents 20
88. Figure 3.4: Most of the Survey Respondents are Studying Stem Cells or Using Stem Cells in their Research 21
89. Figure 3.5: Length of Time our Survey Respondent Pool has been Studying Stem Cells or Using Stem Cells in their Research Activities 21
90. Figure 3.6: Utilization/Research with Different Stem Cell types 22
91. Figure 3.7: Range of Number of Experiments Involving Stem Cells Conducted Per Week 23
92. Figure 3.8: Differences with Respect to Usage of Stem Cell Types 24
93. Figure 3.9: How Much Research Dollars are Spent Monthly on Research/Studies with Different Stem Cell Types 25
94. Figure 3.10: Growth of Research Spending in Various Segments of the Stem Cells Space (Defined by Stem Cell Type) 26
95. Figure 3.11: Growth in End-User Utilization of the Various Different Stem Cell Types 26
96. Figure 3.12: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 28
97. Figure 3.13: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 28
98. Figure 3.14: Broad Classification of Research Activities Being Performed with Stem Cells by Researchers 29
99. Figure 3.15: Current End-User Utilization Category of Adult Stem Cells (ASCs) 30
100. Figure 3.16: Current End-User Utilization Category of Human Embryonic Stem Cells (hESCs) 30
101. Figure 3.17: Current End-User Utilization Category of Human Cord Blood Stem Cells 30
102. Figure 3.18: Current End-User Utilization Category of Animal Stem Cells 31
103. Figure 3.19: Current End-User Utilization Category of Cancer Stem Cells 31
104. Figure 3.20: Challenges in the Study or Utilization of Adult Stem Cells (ASCs) 33
105. Figure 3.21: Challenges in the Study or Utilization of Human Embryonic Stem Cells (hESCs) 33
106. Figure 3.22: Challenges in the Study or Utilization of Human Cord Blood Stem Cells 34
107. Figure 3.23: Challenges in the Study or Utilization of Animal Stem Cells 34
108. Figure 3.24: Challenges in the Study or Utilization of Cancer Stem Cells 35
109. Figure 3.25: Top Unmet Needs in Commercial Products in the Stem Cells Research Space 38
110. Figure 3.26: Stem Cells Research Market, 2006-2011 51
111. Figure 4.1: Stem Cell Research Worldwide 55
114. INDEX OF TABLES
116. Table 2.1: The Different Types of Stem Cells and their Properties 8
117. Table 2.2: Adult Stem Cell (ASC) Differentiation Properties 9
118. Table 3.1: Characteristics of Different Stem Cell Types and Associated Market Opportunity 15
119. Table 3.2: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cell 16
120. Table 3.3: Selected Cord Blood Banks in the U.S. 18
121. Table 3.4: Selected Companies in the Cord Blood Stem Cell Technology and Therapeutics Development Space 19
122. Table 3.5: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 27
123. Table 3.6: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 27
124. Table 3.7: Market Shares of Companies/Institutions Offering Different Stem Cells to Researchers 41
125. Table 3.8: Market Shares of Companies/Institutions Offering Reagents for Stem Cell Research 42
126. Table 3.9: The Stem Cells Research Market Forecast, 2006-2011 50
127. Table 3.10: The World Market for Stem Cell Products and Services, 2005-2012 52
128. Table 4.1: Major Milestones in Stem Cell Research and Associated Timeline, 1981-2006 54
129. Table 4.2: Selected Stem Cell Hot Spots Worldwide Administering Non-FDA Approved Stem Cell Therapeutic Regimens 56
130. Table 4.3: NIH Funding of Stem Cell Research in the U.S., 2002-2006 57
131. Table 4.4: Snapshot of the Current Key Stem Cell Patents 59
132. Table 4.5: Stem Cell Derivations 68
133. Table 5.1: Estimate of Potential Market Opportunity for Stem Cell-based Therapeutics 74
134. Table 5.2: Autologous Versus Allogeneic Cell Therapy 75
135. Table 5.3: Diseases Treated with HSC Transplantation Today 76
136. Table 5.4: HSC Sources and their Properties 77
137. Table 5.5: Stem Cell Therapeutics for Hematological Diseases in Development 78
138. Table 5.6: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases in Development 79
139. Table 5.7: Stem Cell-based Therapeutics for Vascular Diseases in Development 80
140. Table 5.8: Stem Cell Therapeutics for Type I Diabetes in Development 80
141. Table 5.9: Stem Cell Therapeutics for Orthopedic Disease in Development 81
142. Table 5.10: Stem Cell Therapeutics for Neurological Disease in Development 82
143. Table 5.11: Segmentation of the Allogeneic Cell Therapy Market 84