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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 4
2. 1.1 Statement of Report 4
3. 1.2 Scope of the Report 5
4. 1.3 Methodology 5
5. 1.4 Executive Summary 6
7. 2. Biology of Stem Cells 8
8. 2.1 Scope of this Chapter 8
9. 2.2 Basic Properties of Stem Cells and Their Classification 8
10. 2.3 Differentiation of Stem Cells 11
11. 2.3.1 Neural and Neuronal Differentiation 11
12. 2.3.2 Cardiomyogenic Differentiation of ESCs 11
13. 2.3.3 Differentiation of Mesenchymal Stem/Progenitor Cells 12
14. 2.4 Self-Renewal of Stem Cells 12
15. 2.5 Dedifferentiation and Nuclear Reprogramming 13
16. 2.6 Functional Proliferation of Adult Mature Cells 14
17. 2.7 Nanog Promotes Transfer of Pluripotency After Cell Fusion 15
18. 2.8 MicroRNAs in Stem Cell Development 15
19. 2.9 Stem Cell Therapy 15
21. 3. Market Analysis of the Stem Cell Space 17
22. 3.1 Scope of this Chapter 17
23. 3.2 Overall Market Opportunity and Segmentation of the Total Stem Cell Marketplace 17
24. 3.3 Potential Stem Cell Commercial Applications 20
25. 3.3.1 Cord Blood Stem Cells and Cord Blood Stem Cell Banking: Current Market Environment and Opportunity 20
26. 3.4 Results of Primary Market Survey to Characterize Qualitative and Quantitative Trends in the Stem Cells Space 23
27. 3.4.1 Characteristics of the Respondent Pool 24
28. 3.4.2 Utilization of the Different Classes of Stem Cells 26
29. 3.4.3 Quantitative Metrics of the Stem Cell Research Marketplace: Number of Experiments Performed in Research 27
30. 3.4.4 Evolution of Research Activities with Different Types of Stem Cells: Current Usage Trends and Usage in 12 to 18 Months 31
31. 3.4.5 Types of Stem Cell Research Activities Performed by the End-User Community 33
32. 3.4.6 Challenges Facing Stem Cell Researchers 36
33. 3.4.7 Market Drivers and Research Questions Being Addressed in the Stem Cell Space 40
34. 3.4.8 Summary of Challenges and Opportunities in the Stem Cell Space Based on TriMark's Analysis 41
35. 3.4.9 Unmet Product Needs in the Stem Cell Research Space and Licensing/IP Constraints 42
36. 3.5 Competitive Landscape of the Stem Cell Marketplace 44
37. 3.5.1 SWOT Analysis of the Major Stem Cell Market Segments 50
38. 3.6 Market Size and Forecasts 54
40. 4. Worldwide Landscape of Stem Cell Research 58
41. 4.1 Scope of this Chapter 58
42. 4.2 Global Embryonic Stem Cell Research 58
43. 4.2.1 Top Research Institutions Worldwide in the Stem Cells Space and Global "Hot Spots" for Research and Therapeutics 59
44. 4.3 Stem Cell Research in the U.S. 62
45. 4.3.1 Proposition 71 in the State of California 64
46. 4.4 Intellectual Property (IP) Landscape Surrounding Stem Cells 65
47. 4.5 Who Will Finance Stem Cell Research? 67
48. 4.5.1 U.S. Government Policy on Stem Cell Research 67
49. 4.5.2 Current Federal Policy 70
50. 4.5.2.1 Moral Issues Affecting Pre-Obama Federal Policy 71
51. 4.5.2.2 Significance and Requirements for Federal Funding 73
52. 4.5.2.3 Draft Guidelines for the new NIH stem cell funding policy 75
53. 4.5.3 International Law 75
54. 4.5.3.1 Australia 75
55. 4.5.3.2 U.K. 75
56. 4.5.3.3 Canada 75
57. 4.5.3.4 China 75
58. 4.5.3.5 Germany 77
59. 4.5.3.6 Switzerland 77
60. 4.5.3.7 Japan 77
61. 4.5.3.8 Israel 77
62. 4.5.3.9 Singapore 77
63. 4.5.4 Technological and Economical Disadvantages for the U.S. 78
65. 5. Therapeutic Areas and Research Programs in the Stem Cell Space 79
66. 5.1 Scope of this Chapter 79
67. 5.2 Therapeutic and Other Markets Addressed by Stem Cells 79
68. 5.2.1 Hematopoietic Stem Cells (HSCs) 80
69. 5.2.2 Stem Cell Therapeutics for Cardiac and Ischemic Diseases 83
70. 5.2.3 Stem Cell Therapeutics for Type I Diabetes 85
71. 5.2.4 Stem Cell Therapeutics for Orthopedic Diseases 86
72. 5.2.5 Stem Cell Therapeutics for Neurological Diseases 87
73. 5.3 Off-the-Shelf Stem Cells Being Developed 89
75. 6. Company Profiles 91
76. 6.1 Aastrom Biosciences 91
77. 6.2 Advanced Cell Technology 92
78. 6.3 BioE 93
79. 6.4 Bioheart 93
80. 6.5 Cryo-Cell International 94
81. 6.6 ES Cell International 95
82. 6.7 Gamida Cell 95
83. 6.8 GenVec 95
84. 6.9 Geron 96
85. 6.10 NeuroGeneration 97
86. 6.11 Osiris Therapeutics 97
87. 6.12 Pluristem Therapeutics 98
88. 6.13 ReNeuron 99
89. 6.14 StemCells, Inc. 99
90. 6.15 Titan Pharmaceuticals 100
91. 6.16 ViaCell (now PerkinElmer) 100
93. Appendix 1. Glossary of Terms in Stem Cell Biology 101
96. INDEX OF FIGURES
98. Figure 2.1: Derivation of Embryonic Stem Cells (ESCs) from the Inner Cell Mass of Blastocysts 9
99. Figure 2.2: Classification of Stem Cells: Embryonic Stem Cells Versus Adult Stem Cells 10
100. Figure 2.3: Somatic Cell Nuclear Transfer (SCNT) 14
101. Figure 3.1: Segmentation of the Stem Cell Marketplace Based Upon Commercial Offerings-Products and Services 19
102. Figure 3.2: Geographical Breakout of Stem Cell End-User Survey Respondents 24
103. Figure 3.3: Affiliation (Pharma, Biotech, Academic/University) of Stem Cell End-User Survey Respondents 24
104. Figure 3.4: Survey Respondents That Are Studying Stem Cells or Using Stem Cells in Their Research 25
105. Figure 3.5: Length of Time Survey Respondent Pool Has Been Studying Stem Cells or Using Stem Cells in Its Research Activities 25
106. Figure 3.6: Utilization/Research with Different Stem Cell Types 26
107. Figure 3.7: Number of Experiments Involving Stem Cells Conducted Per Week 27
108. Figure 3.8: Differences with Respect to Usage of Stem Cell Types 28
109. Figure 3.9: Research Dollars Spent Monthly on Research/Studies with Different Stem Cell Types 29
110. Figure 3.10: Growth of Research Spending in Various Segments of the Stem Cells Space (Defined by Stem Cell Type) 30
111. Figure 3.11: Growth in End-User Utilization of Various Stem Cell Types 30
112. Figure 3.12: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 32
113. Figure 3.13: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 32
114. Figure 3.14: Broad Classification of Research Activities Being Performed with Stem Cells by Researchers 33
115. Figure 3.15: Current End-User Utilization Category for Adult Stem Cells (ASCs) 34
116. Figure 3.16: Current End-User Utilization Category for Human Embryonic Stem Cells (hESCs) 34
117. Figure 3.17: Current End-User Utilization Category for Human Cord Blood Stem Cells 34
118. Figure 3.18: Current End-User Utilization Category for Animal Stem Cells 35
119. Figure 3.19: Current End-User Utilization Category for Cancer Stem Cells 35
120. Figure 3.20: Challenges in the Study or Utilization of Adult Stem Cells (ASCs) 37
121. Figure 3.21: Challenges in the Study or Utilization of Human Embryonic Stem Cells (hESCs) 37
122. Figure 3.22: Challenges in the Study or Utilization of Human Cord Blood Stem Cells 38
123. Figure 3.23: Challenges in the Study or Utilization of Animal Stem Cells 38
124. Figure 3.24: Challenges in the Study or Utilization of Cancer Stem Cells 39
125. Figure 3.25: Top Unmet Needs in Commercial Products in the Stem Cell Research Space 43
126. Figure 3.26: U.S. Stem Cell Therapy Market Sales, 2005-2016 55
127. Figure 4.1: Stem Cell Research Worldwide 61
130. INDEX OF TABLES
132. Table 2.1: The Different Types of Stem Cells and Their Properties 10
133. Table 2.2: Adult Stem Cell (ASC) Differentiation Properties 11
134. Table 3.1: Characteristics of Different Stem Cell Types and Associated Market Opportunities 18
135. Table 3.2: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cells 19
136. Table 3.3: Selected Cord Blood Banks in the U.S. 22
137. Table 3.4: Selected Companies in the Cord Blood Stem Cell Technology and Therapeutics Development Space 23
138. Table 3.5: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells 31
139. Table 3.6: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months 31
140. Table 3.7: Market Share of Companies/Institutions Offering Different Stem Cells to Researchers 46
141. Table 3.8: Market Share of Companies/Institutions Offering Reagents for Stem Cell Research 46
142. Table 3.9: The U.S. Stem Cell Therapy Market Forecast, 2005-2016 55
143. Table 4.1: Major Milestones in Stem Cell Research and Associated Timeline, 1981-2009 60
144. Table 4.2: Selected Stem Cell Hot Spots Worldwide Administering Non-FDA Approved Stem Cell Therapeutic Regimens 62
145. Table 4.3: NIH Funding of Stem Cell Research in the U.S., 2004-2009 63
146. Table 4.4: Snapshot of the Current Key Stem Cell Patents 66
147. Table 5.1: Estimate of Potential Market Opportunity for Stem Cell-based Therapeutics 79
148. Table 5.2: Autologous Versus Allogeneic Cell Therapy 80
149. Table 5.3: Diseases Treated with HSC Transplantation Today 81
150. Table 5.4: HSC Sources and Their Properties 82
151. Table 5.5: Stem Cell Therapeutics for Hematological Diseases in Development 83
152. Table 5.6: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases in Development 84
153. Table 5.7: Stem Cell-based Therapeutics for Vascular Diseases in Development 85
154. Table 5.8: Stem Cell Therapeutics for Type I Diabetes in Development 86
155. Table 5.9: Stem Cell Therapeutics for Orthopedic Disease in Development 86
156. Table 5.10: Stem Cell Therapeutics for Neurological Disease in Development 88
157. Table 5.11: Segmentation of the Allogeneic Cell Therapy Market 90