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PharmaSphere: Emerging Biotechnologies - Stem Cell Therapy

  • November 2014
  • -
  • Global Data
  • -
  • 248 pages

PharmaSphere: Emerging Biotechnologies - Stem Cell Therapy

Summary

GlobalData’s report "PharmaSphere: Emerging Biotechnologies - Stem Cell Therapy", provides strategic analysis of the global stem cells industry. It discusses key development trends, regulatory requirements in various markets, recent deals activity and industry dynamic trends, as well as describes the operations strategy of these companies. Furthermore, it includes a geographical segmentation of various markets including the EU and US, as well as emerging markets such as China, India, SouthKorea, and Israel-providing in-depth analysis of these markets’ regulatory framework, key domestic players and their stem cell pipelines, and strategic outlook.

Throughout the report, GlobalData’s analysts provide you with expert insight, expanding on each strategy and factor discussed, with the aim of providing you with the tools needed for making informed business decisions.

Highlights

Key Questions Answered

- (Q.) What are the key market drivers of the global stem cell industry?
- (Q.) Who are the top players involved in the development of stem cell therapies in developed as well as developing countries?
- (Q.) What are the main regulatory measures affecting the stem cell industry in the US, Europe, Japan, India, South Korea, China and Israel?
- (Q.) What are the major trends in stem cell clinical trials and profiles of key investigators?
- (Q.) What specific strategies are companies utilizing to combat some of the challenges currently facing the development of therapies in the global stem cell industry?

Scope

- Stem Cell Market Dynamics: This report provides analysis of the key drivers and trends shaping the global Stem Cell therapy market, including manufacturing, emerging markets, and development pipeline.
- Financial Performance Insight: Report uses GlobalData’s proprietary data across 22 key financial metrics to provide insight over stem cell company performance.
- PipelineAnalysis: Detailed information on ten leading stem cell therapies; trend analysis of clinical trial studies and investigators covering over 1000 trials related to stem cell therapies.
- Deal strategies: Exhaustive discussion on the strategic implications and synergies of deals including, M&A, collaboration as well as capital raisings such as equity offerings, private equity and venture financing activities.
- Regulatory Implications: Guidelines for stem cell usage for developing therapies in seven major markets for stem cells including US, Europe, Japan, SouthKorea, Israel, China and India.
- Company Analysis: Company landscape covering 40 companies on full pipeline, financials and key overview information.

Reasons to buy

- Identify the key domestic players in various stem cell markets, including South Korea, Japan and emerging markets such as India and China.
- Understand the key drivers and trends in the global stem cell industry.
- Analyze and track the strategies that companies are using to enter and/or strengthen their position in the evolving stem cell industry, as well as efforts being made by innovator companies like Pfizer and Novartis to enter this market.
- Use this information as an independent source for your due diligence and transaction strategy.
- Understand the regulatory framework and be prepared to tackle challenges facing the stem cell based therapies.

Table Of Contents

PharmaSphere: Emerging Biotechnologies - Stem Cell Therapy
1 Table of Contents

2 Introduction 22
2.1 Report Scope 22
2.2 Upcoming Related Reports 24
2.3 Recently Published Reports 24
3 Stem Cell Overview 25
3.1 Definition 25
3.1.1 Renewal 25
3.1.2 Potency 25
3.2 Types of Stem Cell 26
3.2.1 Embryonic Stem Cells 27
3.2.2 Adult Stem Cells 27
3.2.3 Induced Pluripotent Stem Cells 28
3.2.4 Cord-Blood-Derived Stem Cells 28
3.2.5 Amniotic Stem Cells 28
3.2.6 Fetal Stem Cells 28
3.3 Stem Cell Research Timeline 29
3.4 Therapeutic Applications 30
3.4.1 Cardiovascular 30
3.4.2 Central Nervous System 30
3.4.3 Diabetes 30
3.4.4 Oncology 31
3.4.5 Ophthalmology 31
3.4.6 Musculoskeletal Disorders 32
3.5 Intellectual Property 32
3.5.1 United States 32
3.5.2 Europe 33
3.5.3 Japan 34
4 Stem Cell Pipeline 35
4.1 Development Stages 37
4.2 Therapy Areas 39
4.3 Indications 40
4.4 Platform Technology Transfers 42
4.4.1 Types of Stem Cell Platform Technologies 42
4.4.2 Partnerships Between Universities and Companies 43
4.5 Stem Cell Pipeline in Focus 44
4.5.1 Prochymal (Mesoblast) 44
4.5.2 Adult Autologous CD34+ Stem Cells (Baxter) 45
4.5.3 StemEx (Gamida Cell) 46
4.5.4 Allogeneic MPC for Bone Marrow Transplantation (Mesoblast) 47
4.5.5 Preob (Bone Therapeutics) 48
4.5.6 Cerecellgram (Pharmicell) 49
4.5.7 Revascor or CEP-41750 (Mesoblast) 50
4.5.8 Tumor Stem Cell Specific Dendritic Cell Therapy (Neostem Oncology) 51
4.5.9 GSK-2696273 (GlaxoSmithKline) 52
4.5.10 Lenti-D (Bluebird bio) 53
5 Stem Cell Clinical Trials 54
5.1 Clinical Trial Overview 54
5.2 Stages of Development 55
5.3 Trial Status 56
5.4 Therapy Area 57
5.5 Indication 58
5.6 Geography 59
5.7 Sponsors 60
5.8 Investigators 61
5.8.1 Specialty 61
5.8.2 Geography 62
5.8.3 Designation 63
5.8.4 Associated Organizations 64
6 Stem Cell Deals 66
6.1 Annual Trends 66
6.2 Deal Types 67
6.2.1 Average Deal Value 68
6.2.2 Deal Structure 68
6.3 Regions 69
6.4 Therapy Areas 70
6.5 Mergers and Acquisitions 71
6.5.1 MandA Deals by Region 72
6.6 Asset Transactions 73
6.7 Licensing Agreements 74
6.7.1 Licensing Agreements by Therapy Area 75
6.8 Partnerships 76
6.9 Capital Raisings 78
6.9.1 Equity Offerings 78
6.9.2 Private Equity 79
6.9.3 Venture Financing 79
6.10 Highlighted Deals 80
6.10.1 Mergers and Acquisitions 80
6.10.2 Licensing Agreements 83
6.10.3 Partnerships 85
6.10.4 Venture Financing 88
7 Stem Cell Regulation 89
7.1 Introduction 89
7.2 US 90
7.2.1 Overview 90
7.2.2 Regulatory Framework 90
7.2.3 Key Players 91
7.3 Europe 92
7.3.1 Overview 92
7.3.2 Regulatory Framework 92
7.3.3 Key Players 94
7.4 Japan 94
7.4.1 Overview 94
7.4.2 Regulatory Framework 94
7.4.3 Key Players 95
7.5 India 95
7.5.1 Overview 95
7.5.2 Regulatory Framework 95
7.5.3 Key Players 96
7.6 South Korea 97
7.6.1 Overview 97
7.6.2 Regulatory Framework 97
7.6.3 Key Players 99
7.7 China 99
7.7.1 Overview 99
7.7.2 Regulatory Framework 99
7.7.3 Key Players 100
7.8 Israel 100
7.8.1 Overview 100
7.8.2 Regulatory Framework 101
7.8.3 Key Players 102
8 Company Landscape 103
8.1 Organizational Split 103
8.2 Geographical Split 104
8.3 Company Analysis 105
8.3.1 Pharmicell 105
8.3.2 Mesoblast 109
8.3.3 Pluristem 114
8.3.4 NeoStem 118
8.3.5 Celgene 122
8.3.6 Cellerant Therapeutics 125
8.3.7 Cellular Biomedicine Group 127
8.3.8 K-Stemcell 130
8.3.9 Anterogen 133
8.3.10 Asterias Biotherapeutics 135
8.3.11 MediPost 138
8.3.12 Reliance Life Sciences 140
8.3.13 Stempeutics 142
8.3.14 Advanced Cell Technology 145
8.3.15 Athersys 147
8.3.16 Escape Therapeutics 150
8.3.17 Orbsen Therapeutics 153
8.3.18 Shenzhen Beike Biotechnology 155
8.3.19 StemCells 156
8.3.20 Bioheart 159
8.3.21 CHA Bio and Diostech 162
8.3.22 Cytomedix 165
8.3.23 Fate Therapeutics 168
8.3.24 Hygieia Innovation 171
8.3.25 Medistem 173
8.3.26 Neuralstem 175
8.3.27 Kasiak Research 178
8.3.28 ReNeuron 179
8.3.29 TiGenix NV 182
8.3.30 California Stem Cell 185
8.3.31 Capricor Therapeutics 188
8.3.32 Gamida Cell 190
8.3.33 Histocell 193
8.3.34 Bone Therapeutics 194
8.3.35 Cardio3 BioSciences 197
8.3.36 Promethera Biosciences 200
8.3.37 Stemedica 202
8.3.38 Tulane University 204
8.3.39 BrainStorm Cell Therapeutics 205
8.3.40 Cell Cure Neurosciences 207
8.4 Financial Analysis of Companies 209
8.4.1 Total Revenue 209
8.4.2 Cost of Revenue 210
8.4.3 Gross Profit 211
8.4.4 Selling, General, and Administrative Expenses 212
8.4.5 Research and Development 213
8.4.6 Total Operating Expense 214
8.4.7 Operating Income 215
8.4.8 Provision for Taxes 216
8.4.9 Net Income 217
8.4.10 Cash and Short-Term Investments 218
8.4.11 Net Property/Plants/Equipment 219
8.4.12 Long-Term Investments 220
8.4.13 Long-Term Debt 221
8.4.14 Total Debt 222
8.4.15 Debt-to-Equity Ratio 223
8.4.16 Cash Ratio 224
8.4.17 Market Capitalization 225
9 Strategic Outlook 227
9.1 Stem Cell Industry Challenges 227
9.1.1 Complicated Manufacturing Process 227
9.1.2 High Cost of Research, Production, and Commercialization 228
9.1.3 Untested Regulatory Pathways 229
9.1.4 Undercapitalized Sector 231
9.2 Stem Cell Market Opportunities 232
9.2.1 Discovery of Therapeutic Candidates 232
9.2.2 Promising Rise of Adult Stem Cells 232
9.2.3 Clinical Trial Outcomes Will Accelerate Deal-Making Opportunities 233
10 Appendix 235
10.1 Bibliography 235
10.2 Abbreviations 240
10.3 Methodology 244
10.3.1 Coverage 244
10.3.2 Secondary Research 244
10.3.3 Expert Panel Validation 245
10.4 About the Authors 245
10.4.1 Analyst 245
10.4.2 Director of Healthcare Industry Dynamics 246
10.4.3 Global Head of Healthcare 246
10.5 About the Industry Dynamics Team 247
10.6 About GlobalData 247
10.7 Disclaimer 247

1.1 List of Tables

Table 1: Milestones in Stem Cell Research 29
Table 2: Platform Technologies Adopted from Academic Institutions 43
Table 3: Prochymal 44
Table 4: Adult Autologous CD34+ Stem Cells 45
Table 5: StemEx 46
Table 6: Allogeneic MPC For Bone Marrow Transplantation 47
Table 7: Preob 48
Table 8: Cerecellgram 49
Table 9: Revascor 50
Table 10: Tumor Stem Cell Specific Dendritic Cell Therapy 51
Table 11: GSK-2696273 52
Table 12: Lenti-D (Bluebird bio) 53
Table 13: Highlighted MandA Deals, January 1, 2004-March 1, 2014 82
Table 14: Top 10 Stem Cell Licensing Agreement Deals, January 1 2004-March 1, 2014 84
Table 15: Top 10 Stem Cell Partnership Deals, January 1, 2004-March 1, 2014 86
Table 16: Top 10 Stem Cell Partnership Deals, 2004-2014 88
Table 17: Countries with Embyronic Stem Cell Policies 89
Table 18: Main Measures included in the HHS Guidelines on the use of hESCs and iPSCs. 91
Table 19: Main Measures included in the Ethical Guidelines for Biomedical Research on Human Participants 96
Table 20: Pharmicell Company Overview 106
Table 21: Pharmicell Stem Cell Product Pipeline 107
Table 22: Pharmicell Key Financials, 2011-2013 ($m) 109
Table 23: Mesoblast Company Overview 110
Table 24: Mesoblast Stem Cell Pipeline 111
Table 25: Mesoblast Key Financials, 2011-2013 ($m) 114
Table 26: Pluristem Company Overview 115
Table 27: Pluristem Therapeutics Inc. Stem Cell Pipeline 116
Table 28: Pluristem Key Financials, 2011-2013 ($m) 118
Table 29: NeoStem Company Overview 119
Table 30: NeoStem Stem Cell Pipeline 120
Table 31: NeoStem Inc. Key Financials, 2011-2013 ($m) 122
Table 32: Celgene Company Overview 123
Table 33: Celgene Stem Cell Pipeline 124
Table 34: Celgene Key Financials, 2011-2013 ($m) 125
Table 35: Cellerant Therapeutics Company Overview 126
Table 36: Cellerant Stem Cell Pipeline 127
Table 37: Cellular Biomedicine Group Company Overview 128
Table 38: Cellular Biomedicine Group Stem Cell Pipeline 129
Table 39: Cellular Biomedicine Group. Key Financials, 2011-2013 ($m) 130
Table 40: K-Stemcell Company Overview 131
Table 41: K-Stemcell Stem Cell Pipeline 132
Table 42: Anterogen Company Overview 133
Table 43: Anterogen Stem Cell Pipeline 134
Table 44: Asterias Biotherapeutics Company Overview 135
Table 45: Asterias Biotherapeutics Stem Cell Pipeline 137
Table 46: MediPost Company Overview 138
Table 47: MediPost Stem Cell Pipeline 139
Table 48: MediPost Key Financials, 2011-2013 ($m) 140
Table 49: Reliance Life Sciences Company Overview 141
Table 50: Reliance Life Sciences Stem Cell Pipeline 142
Table 51: Stempeutics Company Overview 143
Table 52: Stempeutics Stem Cell Pipeline 144
Table 53: Advanced Cell Technology Company Overview 145
Table 54: Advanced Cell Technology Stem Cell Pipeline 146
Table 55: Advanced Cell Technology Inc. Key Financials, 2011-2013 ($m) 147
Table 56: Athersys Company Overview 148
Table 57: Athersys Stem Cell Pipeline 149
Table 58: Athersys Key Financials, 2011-2013 ($m) 150
Table 59: Escape Therapeutics Company Overview 151
Table 60: Escape Therapeutics Stem Cell Pipeline 152
Table 61: Orbsen Therapeutics Company Overview 153
Table 62: Orbsen Therapeutics Stem Cell Pipeline 154
Table 63: Shenzhen Beike Biotechnology Company Overview 155
Table 64: Shenzhen Beike Biotechnology Stem Cell Pipeline 156
Table 65: StemCells Company Overview 157
Table 66: StemCells Stem Cell Pipeline 158
Table 67: Stempeutics Key Financials, 2011-2013 ($m) 159
Table 68: Bioheart Company Overview 160
Table 69: Bioheart Stem Cell Pipeline 161
Table 70: Bioheart Key Financials, 2011-2013 ($m) 162
Table 71: CHA Bio and Diostech Company Overview 163
Table 72: CHA Bio and Diostech Co., Ltd Stem Cell Pipeline 164
Table 73: CHA Bio and Diostech Key Financials, 2011-2013 ($m) 165
Table 74: Cytomedix Company Overview 166
Table 75: Cytomedix Stem Cell Pipeline 167
Table 76: CytomedixKey Financials, 2011-2013 ($m) 168
Table 77: Fate Therapeutics 169
Table 78: Fate Therapeutics Stem Cell Pipeline 170
Table 79: Fate Therapeutics Key Financials, 2011-2013 ($m) 171
Table 80: Hygieia Innovation Company Overview 172
Table 81: Hygieia Innovation Stem Cell Pipeline 173
Table 82: Medistem Company Overview 174
Table 83: MedistemStem Cell Pipeline 174
Table 84: Neuralstem Company Overview 175
Table 85: Neuralstem Stem Cell Pipeline 176
Table 86: Neuralstem Key Financials, 2011-2013 ($m) 177
Table 87: Kasiak Research Company Overview 178
Table 88: Kasiak Research Stem Cell Pipeline 179
Table 89: ReNeuron Company Overview 180
Table 90: ReNeuron Stem Cell Pipeline 181
Table 91: ReNeuron Group Key Financials, 2011-2013 ($m) 182
Table 92: TiGenix NV 183
Table 93: TiGenix Stem Cell Pipeline 184
Table 94: TiGenix NV Key Financials, 2011-2013 ($m) 185
Table 95: California Stem Cell Company Overview 186
Table 96: California Stem Cell Stem Cell Pipeline 187
Table 97: Capricor Therapeutics 188
Table 98: Capricor Stem Cell Pipeline 189
Table 99: Capricor Therapeutics Inc. Key Financials, 2011-2013 ($m) 190
Table 100: Gamida Cell Company Overview 191
Table 101: Gamida Cell Stem Cell Pipeline 192
Table 102: Histocell Company Overview 193
Table 103: Histocell Stem Cell Pipeline 194
Table 104: Bone Therapeutics 195
Table 105: Bone Therapeutics SA Stem Cell Pipeline 196
Table 106: Cardio3 BioSciences 197
Table 107: Cardio3 BioSciences Stem Cell Pipeline 198
Table 108: Cardio3 BioSciences Key Financials, 2011-2013 ($m) 199
Table 109: Promethra BioSciences 200
Table 110: Promethra BioSciences Stem Cell Pipeline 201
Table 111: Stemedica Company Overview 202
Table 112: Stemedica Stem Cell Pipeline 203
Table 113: Tulane University 204
Table 114: Tulane University Stem Cell Pipeline 205
Table 115: BrainStorm Cell Therapeutics 206
Table 116: BrainStorm Cell Therapeutics Stem Cell Pipeline 206
Table 117: Cellerant Therapeutics Key Financials, 2011-2013 ($m) 207
Table 118: Cell Cure Neurosciences Company Overview 208
Table 119: Cell Cure Neurosciences Stem Cell Pipeline 208
Table 120: Estimated Cost of manufacturing 2500 doses of autologous and allogeneic stem cell therapies 229

1.2 List of Figures

Figure 1: Number of Unique Stem Cell Therapies Per Company 36
Figure 2: Number of Stem Cell Therapy Indications Per Company (Top 27) 37
Figure 3: Stem Cell Therapy Programs by Stage of Development 38
Figure 4: Stem Cell Pipeline by Therapy Area 39
Figure 5: Stem Cell Pipeline By Indication (Top 31) 40
Figure 6: Stem Cell Pipeline by Number of Indications Under Investigation 41
Figure 7: Stem Cell Clinical Trials Annual Trend, 2004-2014 55
Figure 8: Stem Cell Clinical Trials by Phase of Development, 2004-March 1, 2014 56
Figure 9: Stem Cell Clinical Trials by Status, January 1, 2004-March 1, 2014 57
Figure 10: Stem Cell Clinical Trials by Therapy Area, January 1, 2004-March 1, 2014 58
Figure 11: Stem Cell Clinical Trials Top 20 Indications, January 1, 2004-March 1, 2014 59
Figure 12: Stem Cell Clinical Trials Top 15 Countries, January 1, 2004-March 1, 2014 60
Figure 13: Top Stem Cell Clinical Trial Sponsors, January 1, 2004-March 1, 2014 61
Figure 14: Stem Cell Investigator Specialties, January 1, 2004- March 1, 2014 62
Figure 15: Countries Ranked by Number of Stem Cell Trial Investigators, 2004-2014 63
Figure 16: Designations of Stem Cell Trial Investigators, January 1, 2004 - March 1, 2014 64
Figure 17: Leading Organizations Associated with Stem Cell Trial Investigators, January 1, 2004 - March 1, 2014 65
Figure 18: Stem Cell Deal Volume and Value Trends, 2004-2013 66
Figure 19: Stem Cell Deal Volume and Value by Type, January 1, 2004-March 1, 2014 67
Figure 20: Average Deal Value in the Stem Cell Sector, January 1, 2004-March 1, 2014 68
Figure 21: Stem Cell Partnership and Licensing Agreement Deal Structure, January 1, 2004-March 1, 2014 69
Figure 22: Stem Cell Deal Volume and Value by Region, January 1, 2004-March 1, 2014 70
Figure 23: Stem Cell Deal Volume and Value by Therapy Area, January 1, 2004-March 1, 2014 71
Figure 24: MandA Deal Volume and Value, January 1, 2004-March 1, 2014 72
Figure 25: Stem Cell MandA Deal Volume by Country, January 1, 2004-March 1, 2014 73
Figure 26: Stem Cell Asset Transaction Volume and Value, 2004-2013 74
Figure 27: Licensing Agreement Volume and Value, 2004-2013 75
Figure 28: Licensing Agreements by Therapy Area, January 1, 2004-March 1, 2014 76
Figure 29: Partnership Deal Volume and Value, 2004-2013 77
Figure 30: Equity Offering Volume and Value, 2004-2013 78
Figure 31: Venture Financing Deal Volume and Value, 2004-2013 80
Figure 32: Organizational Split Across the Stem Cell Industry 103
Figure 33: Regional Split of Stem Cell Company Headquarters 104
Figure 34: Distribution of Stem Cell Companies, by Country 105
Figure 35: Total Revenue of Public Stem Cell Companies (2013, $m) 210
Figure 36: Cost of Revenue of Public Stem Cell Companies (2013, $m) 211
Figure 37: Gross Profit of Public Stem Cell Companies (2013, $m) 212
Figure 38: SGA Expenses of Public Stem Cell Companies (2013, $m) 213
Figure 39: RandD Expenses of Public Stem Cell Companies (2013, $m) 214
Figure 40: Total Operating Expenses of Public Stem Cell Companies (2013, $m) 215
Figure 41: Operating Income of Public Stem Cell Companies (2013, $m) 216
Figure 42: Provision For Taxes of Public Stem Cell Companies (2013, $m) 217
Figure 43: Net Income of Public Stem Cell Companies (2013, $m) 218
Figure 44: Cash and Short-Term Investments of Public Stem Cell Companies (2013, $m) 219
Figure 45: Net Property/Plant/Equipment Spending of Public Stem Cell Companies (2013, $m) 220
Figure 46: Long Term Investments of Public Stem Cell Companies (2013, $m) 221
Figure 47: Long Term Debt of Public Stem Cell Companies (2013, $m) 222
Figure 48: Total Debt of Public Stem Cell Companies (2013, $m) 223
Figure 49: Debt-to-Equity Ratios of Public Stem Cell Companies (2013) 224
Figure 50: Cash Ratio of Public Stem Cell Companies (2013) 225
Figure 51: Market Capitalization of Public Stem Cell Companies (2013, $m) 226

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