Regenerative Medicine Markets

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Publication Date: 2010-07-02

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Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made.

Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body\'s ability to repair itself (or not), or a surgeon\'s skilled hands. Now, the area of regenerative medicine promises to revolutionize humanity\'s ability to remediate countless physical maladies that have perpetually afflicted humans and other animals.

Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven\'t come close to nature\'s solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine.

This report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures. The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.

Table of Contents

 

  • INDEX OF FIGURES

  • Figure 2.1: Geographic Distribution of 73 TERM Firms in the Five Focus Countries, 2009 29
  • Figure 2.2: Geographic Distribution of the 15 TERM Firms in Germany, 2009 30
  • Figure 2.3: Geographic Distribution of the Five TERM Companies in the U.K., 2009 30
  • Figure 2.4: The Potential Uses of Embryonic Stem Cells 32
  • Figure 2.5: Cell Culture Products by Market Segment 34
  • Figure 2.6: Estimated Global Market for Cell and Tissue Analysis Products, 2008-2014 35
  • Figure 2.7: Growth in Size of Cell Therapy Industry, 2000-2008 40
  • Figure 2.8: Percent Break-up of Cell Therapy Companies by Product Type, 2008 41
  • Figure 2.9: Location of Primary Tissue Engineering Companies by Geography, 2008-2009 42
  • Figure 2.10: Breakdown of Primary Cell Therapy Products on Market by Geography, 2008-2009 44
  • Figure 2.11: The Geographical Distribution of Clinical Trials, 2008-2009 47
  • Figure 2.12: Implantation of a Hydrogel at the Site of an Injured Tissue 57
  • Figure 2.13: Implantation of CS-PEG Hydrogel 57
  • Figure 2.14: Implantation of CMP-PEG Scaffold 58
  • Figure 4.1: Global Market for Regenerative Medicine Products, 2008-2013 79
  • Figure 4.2: Estimated market for Regenerative Cell Therapy Products for Orthopedics, 2008-2012 80
  • Figure 4.3: Estimated U.S. Market for Regenerative Medicine Products, 2009-2014 80
  • Figure 4.4: Estimated U.S. Market for Bone Grafting/Bone Replacement, 2009-2014 81
  • Figure 4.5: Estimated U.S. Market for Bone Growth Stimulating Substances, 2009-2014 81
  • Figure 4.6: Estimated U.S. Market for Regenerative Products for Cartilage Repair, 2009-2014 82
  • Figure 4.7: Estimated Market for Stem cells, 2008-2012 84
  • Figure 4.8: Estimated Market for Cell Therapy Products in the U.S., 2009-2018 85
  • Figure 4.9: Estimated Global Market for Cord Blood Stem Cells, 2010-2015 86
  • Figure 4.10: Worldwide Growth of Public Cord Blood Banks, 2005-2009 86
  • Figure 4.11: Worldwide Growth of Private Cord Blood Banks, 2005-2009 87
  • Figure 5.1: Cell-based Business Models 89
  • Figure 5.2: Current Autologous Business Models 91
  • Figure 5.3: Current Allogeneic Business Models 92
  • Figure 7.1: CIRM\'s Grant Awards by Category, 2009 109
  • Figure 7.2: CIRM\'s Funding by Disease Application, 2009 110
  • Figure 7.3: CIRM\'s Funding by Disease Category 111
  • Figure 7.4: Estimated Increase in Worldwide Funding for RM Research, 2008-2018 117
  • Figure 8.1: Aastrom\'s Investment in Research and Development, 2007-2009 121
  • Figure 8.2: Aastrom\'s Business Performance, 2005-2009 122
  • Figure 8.3: ACT\'s Business Performance, 2008 and 2009 125
  • Figure 8.4: ACT\'s Investment in Research and Development, 2008 and 2009 125
  • Figure 8.5: Aranesp (Darbepoetin Alfa)\'s Sales in the U.S. and International Market, 2007-2009 136
  • Figure 8.6: U.S. Market for Epogen, 2007-2009 136
  • Figure 8.7: Global Market for Neulasta, 2007-2009 137
  • Figure 8.8: Global Market for Enbrel (Etanercept), 2007-2009 137
  • Figure 8.9: Global Market for Sensipar (Cinacalcet), 2007-2009 138
  • Figure 8.10: Global Market for Vectibix (Panitumumab), 2007-2009 139
  • Figure 8.11: Global Market for Nplate (Romiplostim), 2007-2009 139
  • Figure 8.12: Amgen\'s Three Large Wholesale Customers, 2007-2009 140
  • Figure 8.13: Amgen\'s Overall U.S. and International Market, 2007-2008 140
  • Figure 8.14: Athersys\' Investment and Development, 2007-2009 154
  • Figure 8.15: Athersys\' Business Performance, 2005-2009 154
  • Figure 8.16: Current Capitalization of Cardio3\'s Investors, 2009 170
  • Figure 8.17: Celgene\'s Business Performance, 2005-2009 181
  • Figure 8.18: Curis\' Business Performance, 2005-2009 198
  • Figure 8.19: Genzyme\'s Business Performance, 2005-2009 213
  • Figure 8.20: Genzyme\'s Percent of Revenue by Business Group, 2009 213
  • Figure 8.21: Geron\'s Business Performance, 2005-2009 220
  • Figure 8.22: Geron\'s Investment in Research and Development, 2005-2009 221
  • Figure 8.23: Integra\'s Investment in Research and Development, 2007-2009 229
  • Figure 8.24: Integra\'s Business Performance, 2005-2009 230
  • Figure 8.25: NeuroNova\'s Share Holders as of June, 2009 247
  • Figure 8.26: Orthovita\'s Business Performance, 2005-2009 255
  • Figure 8.27: Sangamo\'s Investment in Research and Development, 2007-2009 268
  • Figure 8.28: Sangamo\'s Business Performance, 2005-2009 268


  • INDEX OF TABLES

  • Table 2.1: Number of TERM Companies Identified in the Five Focus Countries, 2009 25
  • Table 2.2: Number of TERM Companies Developing Stem Cells Seeded to Scaffolds, 2009 25
  • Table 2.3: Number of Firms with Focus on Skin, Cartilage, Bone and Urological Applications, 2009 26
  • Table 2.4: Number of Firms Focusing on Cardiovascular Applications, 2009 27
  • Table 2.5: Number of Firms with a Focus on Neurological Applications, 2009 27
  • Table 2.6: Number of Firms Focused on Pancreas, Liver and Kidney Applications, 2009 28
  • Table 2.7: Number of Companies Focused on Autologous and Allogeneic Products, 2009 28
  • Table 2.8: Geographic Distribution of 37 U.S. TIRM Firms, 2009 29
  • Table 2.9: Geographic Location of 11 out of 13 TERM Firms in Japan, 2009 30
  • Table 2.10: Geographic Distribution of the Three TERM Firms in Sweden, 2009 31
  • Table 2.11: Number of Patients Treated with Cell Therapeutics, 1988-2010 33
  • Table 2.12: Some Selected Suppliers of In vitro Test Kits and Their Products 35
  • Table 2.13: Suppliers of Cells and Tissues 36
  • Table 2.14: Selected Suppliers of Media and Reagents 37
  • Table 2.15: Selected Providers of Equipments in Stem Cell Research 37
  • Table 2.16: Selected Providers of Computer Software for Stem Cell Research 39
  • Table 2.17: Geographical Distribution of Stem Cell-related Tissue Engineering Companies, 2008 41
  • Table 2.18: Breakdown of Cell Therapy Firms by Country, 2008-2009 43
  • Table 2.19: Cell Therapy Products on the Market by Type and Application Area, 2008-2009 44
  • Table 2.20: Data on Sales and Application for Skin and Cartilage Products, 2006-2008 45
  • Table 2.21: Reagent Sales by Selected Stem Cell Companies, 2008 46
  • Table 2.22: Sales of Secondary Products, 2007 46
  • Table 2.23: Disease Focus of Clinical Trials, 2008-2009 48
  • Table 2.24: Stem Cell Products in Phase II/III Trials, 2008-2009 49
  • Table 2.25: Licensing Activities in Pharmaceutical and Cell Therapy Industries 54
  • Table 2.26: Investment Activity in Cell Therapy Sector 54
  • Table 2.27: Novel Partnership by Large Pharmaceuticals with Universities 54
  • Table 2.28: Cell Therapy Companies with Greater than Ten Million by Market Cap, 2008 55
  • Table 3.1: Regenerative Medicine Product Development Status, 2008 62
  • Table 3.2: Top Ten Regenerative Medicine Products, 2008 66
  • Table 3.3: Wound Healing Products 72
  • Table 4.1: Worldwide Estimates of Key Industry Parameters, 2007 83
  • Table 4.2: Potential U.S. Populations for Cell-based Therapies 84
  • Table 5.1: The Required Elements of a Manufacturing Facility 94
  • Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate 95
  • Table 6.1: Diseases with Potential Applications for Regenerative Medicine 97
  • Table 7.1: Stem Cell Policies in North America 104
  • Table 7.2: Stem Cell Policies in South America 105
  • Table 7.3: Stem Cell Policies in Europe 106
  • Table 7.4: Stem Cell Policies in Asia/Oceania 107
  • Table 7.5: CIRM Funded Grants To-Date 108
  • Table 7.6: List of Upcoming Request for Applications (RFAs) Showing Commitments from Funding Partners 110
  • Table 7.7: Recipients of Funds from Connecticut Stem Cell Research Program, 2009 112
  • Table 7.8: Maryland Stem Cell Research Fund, 2008 114
  • Table 7.9: NJCST\'s Award of Grants for Stem Cell Research, 2008 114
  • Table 7.10: NYSTEM\'s IIRP Awards, 2008 115
  • Table 7.11: NIH Funding for Regenerative Medicine and Stem Cell Research, 2003-2009 119
  • Table 7.12: NIH Funding for Various Types of Stem Cell Research, 2004-2009 119
  • Table 8.1: Patents Owned by ACT 124
  • Table 8.2: Patents Owned by ACT\'s Subsidiary Mytogen, Inc. 124
  • Table 8.3: Patents Licensed to ACT by the University of Massachusetts 124
  • Table 8.4: Alseres\' Product Pipeline, 2009 129
  • Table 8.5: Amgen\'s Pipeline of Products 134
  • Table 8.6: Amgen\'s Approved Products 135
  • Table 8.7: AnGes\' Current Pipeline Status, 2010 144
  • Table 8.8: Angioblast\'s Product Development Overview 146
  • Table 8.9: Angion\'s Product Pipeline 146
  • Table 8.10: Angion\'s Product Pipeline 148
  • Table 8.11: Arteriocyte\'s Product Pipeline 150
  • Table 8.12: Developmental Status of Athersys\' Key Programs, 2010 151
  • Table 8.13: Biohearts Pipeline Product Candidates 157
  • Table 8.14: BioLines Product Pipeline, 2010 159
  • Table 8.15: BioMimetic\'s Current Product Candidates and Target Indications 160
  • Table 8.16: BioMimetic\'s Clinical Studies 161
  • Table 8.17: BioMimetic\'s Investment in Research and Development, 2005-2009 161
  • Table 8.18: BrainStorm\'s Intellectual Property 168
  • Table 8.19: Cardio3\'s Promising Product Pipeline 168
  • Table 8.20: Cellerix\'s Product Pipeline 180
  • Table 8.21: Celgene\'s Leading Product Candidates 183
  • Table 8.22: Private Cord Blood Banking vs. Public Donation 196
  • Table 8.23: Curis\' Current Research and Development Programs and Their Status 197
  • Table 8.24: Curis\' Revenues from Research and Development, 2008 and 2009 198
  • Table 8.25: Regulatory Status of Celution System 199
  • Table 8.26: Regulatory Status of PureGraft and CelBrush 200
  • Table 8.27: Develogen\'s Pipeline Overview 202
  • Table 8.28: Epistem\'s Emerging Pipeline of Protein Therapeutics 207
  • Table 8.29: FivePrime\'s Product Pipeline 209
  • Table 8.30: FivePrime\'s Collaborations 209
  • Table 8.31: Gamidia\'s Pipeline Products 211
  • Table 8.32: Genzyme\'s Pipeline of Products 217
  • Table 8.33: Cancer Therapeutics and Diagnostic Products being Developed by Geron 219
  • Table 8.34: The hESC-derived Product Candidates Developed by Geron and its Collaborators 219
  • Table 8.35: Geron\'s Patent Portfolio 220
  • Table 8.36: Hydra\'s Product Pipeline 225
  • Table 8.37: Intercytex\' Product Pipeline 225
  • Table 8.38: Kiadis\' Product Pipeline 239
  • Table 8.39: NeuralStem\'s Issued and Pending Patents 245
  • Table 8.40: NeuroNova\'s Product Pipeline 246
  • Table 8.41: Orthovita\'s Existing Orthobiologic and Biosurgery Products 252
  • Table 8.42: Orthovita\'s Biosurgery Products 254
  • Table 8.43: Osiris\' Therapeutic Product Pipeline 257
  • Table 8.44: Pervasis\' Product Pipeline 259
  • Table 8.45: RegeneRx\'s Product Development Pipeline 261
  • Table 8.46: Summary of Sangamo\'s Current Clinical Programs 266
  • Table 8.47: Current Status of StemCells\' Therapeutic Product Development Programs 269
  • Table 8.48: StemCells\' Cell Culture Products 270
  • Table 8.49: StemCells\' Patents Covering Stem and Progenitor Cells and Research Tools 271
  • Table 8.50: t2cure\'s Product Development Pipeline 276
  • Table 8.51: Tengion\'s Product Candidates Pipeline 277
  • Table 8.52: Thermogenisis\' Business Performance by Geographic Area, 2007-2009 279

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