Abstract
Opportunities in Stem Cell Research and Commercialization' is the latest
addition to the Drug Discovery Series which analyzes the key factors impacting
the commercial exploitation of adult, fetal and embryonic stem cells. This new
report provides pharmaceutical companies with a clear assessment of
opportunities and challenges presented to them by the stem cell market. It
also provides vital insights into stem cell technologies and therapies that
have already proven to be successful and analyzes those which have potential
future value. The regulatory climate and proprietary landscape are discussed
enabling you to formulate and optimize your stem cell strategies and position
yourself for growth in this emerging market. Use this latest report to
recognize areas poised for growth in the market for tissue repair and
regeneration, identify potential alliance partners and plan a long-term growth
strategy to secure your leading position in this market.
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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