Table of Contents
Executive Summary 10
- Introduction to stem cells 10
- Regulatory and ethical issues 11
- Technologies and strategies 12
- Market analysis 13
- Adult stem cell programs 14
- Embryonic and fetal stem cell programs 15
- Patents in stem cell research 16
- Trends and opportunities 17
Chapter 1 Introduction to stem cells 20
- Summary 20
- Introduction 21
- Stem cell types 21
- Differentiated cell types 23
- Major milestones in stem cell research 24
- Characteristics of embryonic and adult stem cells 26
- Current uses of stem cells 29
- Potential uses of stem cells 30
Chapter 2 Regulatory and ethical issues 34
- Summary 34
- Introduction 35
- Regulation of cell and tissue therapies (USA) 35
- Ethical issues in embryonic stem cell research 38
- Global embryonic stem cell policies 40
- USA 41
- Europe 43
- Israel, Russian Federation and Asian nations 44
- Canada and Australia 45
Chapter 3 Technologies and strategies 48
- Summary 48
- Introduction 49
- Culture of adult stem cells 49
- Isolation and identification of stem cells 49
- Ex vivo expansion 51
- Prevention of differentiation in culture 51
- Preservation and scale-up 52
- Examples of adult stem cell cultures 52
- Hematopoietic stem cells 52
- Mesenchymal stem cells 55
- Neural stem cells 56
- Culture of mouse ESCs 57
- Culture of human ESCs 59
- Single cell cloning 62
- Challenges 62
- Tissue engineering 64
Chapter 4 Market analysis 68
- Summary 68
- Introduction 69
- The regulation of cellular therapy 69
- Human embryonic stem cells (hESCs) 69
- Human mesenchymal stem cells (MSCs) 70
- Human hematopoietic stem cells (HSCs) 70
- Stem cell mobilization 72
- Stem cell expansion 73
- Stem cell therapy and tissue engineering products 74
- Commercial applications 74
- Bone/cartilage regeneration 74
- Myocardial and vascular regeneration 75
- Pancreatic beta-cell regeneration 75
- Neuronal regeneration 76
- Skin replacement and wound healing 76
- Drug screening 76
- Embryonic and fetal stem cell programs 77
- Potential markets 77
- Overview of stem cell market forecasts 80
- The stem cell market, 2005-2010 81
- Preliminary observations 81
- Quantitative forecasts 82
- Stem cell competitive landscape 85
- Therapeutic stem cells and research/services 85
- Cord blood banks 88
- Cytokines 89
Chapter 5 Adult stem cell programs 92
- Summary 92
- Introduction 93
- Hematopoietic stem cell (HSC) transplantation 93
- Established clinical applications 94
- HSC mobilization products 96
- Emerging clinical applications 97
- Purification of HSCs for transplantation 98
- Harvesting of HSCs from cord blood 98
- HSC-based gene therapy 101
- Ex vivo expansion systems 102
- Mesenchymal stem cells for GvHD 104
- In vivo stem cell activation 104
- Stem cells for tissue repair/regeneration 106
- Tissue repair products 109
- Bone/cartilage regeneration 109
- Myocardial and vascular regeneration 111
- Beta-cell regeneration 116
- Neuronal regeneration 118
- Skin replacement and wound healing 120
- Other applications 121
- Novel approaches 122
- Stem cells for drug testing applications 124
Chapter 6 Embryonic and fetal stem cell programs 128
- Summary 128
- Introduction 129
- Human embryonic stem cell (hESC) lines 129
- hESC lines derived from blastocyst embryos 129
- Other approaches to derivation of hESC lines 131
- Somatic cell nuclear transfer 131
- Fusion technologies 132
- Single-cell embryo biopsy 133
- Other approaches 134
- Harnessing the power of ESCs 135
- Tissue repair/regeneration 135
- Initial challenges 136
- Directed differentiation of ESCs 137
- Nascent therapies 139
- Drug screening and discovery 141
- Miscellaneous applications 143
- Human fetal stem cell therapies 144
Chapter 7 Patents in stem cell research 148
- Summary 148
- Introduction 149
- Patent systems in Europe and the US 150
- Overview 150
- Post-issue challenges to patent validity 152
- Patent litigation 153
- Patenting of stem cells 154
- Survey of US stem cell patents 156
- Methodology 156
- Patent activity analysis 157
- Competitive analysis 159
- Most frequently cited patents 159
- Most prolific patent assignees 163
Chapter 8 Trends and opportunities 166
- Summary 166
- Slow beginnings, big promise 167
- Ensuring a strong proprietary position 168
- Exploiting accessible sources of adult stem cells 170
- Regenerative medicine takes shape 171
- Commercializing stem cells for drug screening 173
- Embracing embryonic stem cell research 174
Chapter 9 Appendix 178
- Specialist stem cell companies 178
- Companies with adult stem cell programs 180
- Companies with fetal and embryonic stem cell programs 184
- Cord blood banks around the world 187
- The top 30 stem cell patent citations 191
- Abbreviations 204
- Technical Terms 204
- Regulatory Terms 205
- Index 207
List of Figures
- Figure 1.1: History of stem cell research 25
- Figure 4.2: Commercial focus of 106 stem cell companies by type of stem
cell program 86
- Figure 4.3: Geographic location of 106 specialized stem cell companies 87
- Figure 4.4: Ownership status of 106 specialized stem cell companies 88
- Figure 4.5: Cord blood banks by region 89
- Figure 7.6: US stem cell patents, filed 1980-2005 157
- Figure 7.7: Patent activity analysis for types of Stem cells, filed
1980-2005 158
- Figure 7.8: Top 30 US stem cell patents: types of stem cell and technology
areas 161
- Figure 7.9: Top 30 US stem cell patents: therapy area 162
- Figure 7.10: Top 30 US stem cell patents by FCN, filed 1980-2005 162
List of Tables
- Table 4.1: Potential US patient populations for cell-based therapies, 2005
78
- Table 4.2: Annual direct expenditures in the US for selected diseases,
2005 78
- Table 4.3: Stem cell market forecasts by technology and product type,
2005-2010 84
- Table 4.4: Stem cell market forecasts by region, 2005-2010 85
- Table 7.5: Top 30 stem cell patents by forward citations (US filings),
1980-2005 160
- Table 7.6: Top 30 assignees for US stem cell patents (US filings
1980-2005) 164
- Table 8.7: Specialist companies with proprietary adult stem cells or
proprietary technogies 171
- Table 8.8: Specialist companies developing autologous and allogeneic
therapies for tissue regeneration/repair 172
- Table 9.9: 106 specialist stem cell companies 178
- Table 9.10: 106 specialist stem cell companies (cont.) 179
- Table 9.11: Commercial exploitation of adult stem cells for blood cancers
and other blood diseases 180
- Table 9.12: Commercial exploitation of adult stem cells for tissue
repair/regeneration 181
- Table 9.13: Commercial exploitation of adult stem cells for tissue
repair/regeneration (cont.) 182
- Table 9.14: Commercial exploitation of adult stem cells: miscellaneous
research/services 183
- Table 9.15: Programs utilizing human fetal stem cells 184
- Table 9.16: Programs utilizing human embryonic stem cells 185
- Table 9.17: Programs utilizing animal embryonic stem cells 186
- Table 9.18: Cord Blood Banks in the US and Canada 187
- Table 9.19: Cord Blood Banks in Mexico, Central and South America 188
- Table 9.20: Cord Blood Banks in the UK and rest of Europe 189
- Table 9.21: Cord Blood Banks in the Middle East, Asia, Africa, Australia
and New Zealand 190
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