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Regenerative Medicine Markets

5. Stem Cell Industry Highlights, 2012 1045.1 Business Development 1045.2 Clinical Trials 1045.3 Market Authorization 1045.4 Regulations 1055.5 Capital Market and Finances 1055.6 Investments in Xeno-Cell Therapy 1055.7 Collaborations in Stem Cell Science 1065.7.1 California Institute for Regenerative Medicine (CIRM) 1065.7.2 The International Translational Regenerative Medicine Center 111

6. Regenerative Medicines: A Brief Update from Selected Countries 1126.1 U.S. 1126.1.1 Key Institutions 1126.1.1.1 California Institute for Regenerative Medicine 1126.1.1.2 The New York Stem Cell Foundation 1126.1.1.3 NIH Center for Regenerative Medicine 1126.1.2 Innovative Company 1126.1.2.1 Aastrom Biosciences 1126.2 Canada 1136.2.1 Key Institutions 1136.2.1.1 Institute of Biomaterials & Biomedical Engineering, University of Toronto 1136.2.1.2 Terry Fox Research Institute 1136.2.1.3 Institute for Research in Immunology and Cancer, University of Montreal 1136.2.2 Innovative Companies 1136.2.2.1 Northern Therapeutics 1136.2.2.2 Octane Biotech 1136.3 U.K. 1136.3.1 Key Institutions 1146.3.1.1 Loughborough University 1146.3.1.2 U.K. Stem Cell Foundation 1146.3.1.3 University College, London 1146.3.2 Innovative Companies 1146.3.2.1 Intercytex 1146.3.2.2 Azellon Cell Therapeutics 1156.3.2.3 Cell Medica 1156.4 Sweden 1156.4.1 Key Institutions 1156.4.1.1 Karolinska Institutet 1156.4.1.2 The University of Lund 1156.4.2 Innovative Companies 1166.4.2.1 Vitrolife 1166.4.2.2 Cellartis 1166.4.2.3 Biolamina 1166.5 Brazil 1166.5.1 Key Institutions 1166.5.1.1 Universidade de SaoPaulo 1166.5.1.2 Fiocruz and Hospital Sao Rafael 1166.5.1.3 Universidade Federal do Rio de Janeiro 1176.5.1.4 Pontificia Universidade Catolica do Parana 1176.5.2 Innovative Company 1176.5.2.1 Excellion & CellPraxys 117

7. Market Analysis for Regenerative Medicine Sector 1187.1 Scope of this Chapter 1187.2 Opportunities for RM Products 1187.3 Commercial RM Products 1197.3.1 Leading Commercial Cell Therapy Products 1197.3.2 FDA Approved Cell-Based Products 1207.3.3 Growth Spurt by Regenerative Medicine (RM) 1217.4 Global Market for Tissue-Engineered Products 1227.4.1 Tissue Engineering and Stem Cell Industry 1247.5 Market for Stem Cell Therapy in Cardiology 1247.6 Market for RM Products in Orthopedics 1267.6.1 No Strong Alternatives for Medtronic's INFUSE 1277.6.2 Demineralized Bone Matrix (DBM) 1287.6.3 The Unproven Stem Cells in Orthopedics 1287.6.4 Future of Bone Replacement Market 1297.7 Global RM Market for Neurology Products 1307.8 Market for RM Dental Products 1317.9 Market for RM Cancer Products 132 7.10 RM Market for Urology Products 1337.11 Global Market for Skin Products 1347.12 Overall Global RM Market 1357.13 U.S. Market for Tissue-Engineered Skin 1367.14 U.S. RM Market for Orthopedic/Spine Products 1387.15 U.S. RM Market for Nerve Repair Products 1407.16 U.S. RM Market for Cardiovascular and Stroke Products 1417.17 U.S. Market for Anti-Inflammatory RM Products 1427.18 U.S. Market for RM Products in Diabetes 1427.19 Overall U.S. Regenerative Medicine Market 1437.19.1 U.S. RM Market by Segment 144

8. Stem Cell Industry 1468.1 Global Market for Stem cells 1478.2 Stem Cell Use in the U.S. 1488.2.1 Autologous Stem Cell Use in the U.S. 1488.2.2 U.S. Stem Cell Market Overview 1498.2.2.1 Potential U.S. Population for Cell-Based Therapies 1508.2.3 U.S. Market for Stem cells 1518.3 European Market for Stem Cells 1538.3.1 Autologous and Allogeneic Cell Therapy Companies in Europe 1548.4 Asia-Pacific Market for Stem Cells 1558.5 Autologous Cell Therapy 1568.5.1 Commercially Available Autologous Treatments 1568.5.1.1 Autologous Cell Therapy for Alzheimer's disease 1578.5.1.2 Autologous Cell Therapy for Multiple Sclerosis 1578.5.1.3 Autologous Cell Therapy for Wound Healing 1578.5.1.4 Autologous Therapy for Cosmetic Surgery 158

9. Business Models and Requirements for a Successful Regenerative Medicine Industry 1599.1 Scope of this Chapter 1599.2 Business Models in Regenerative Medicine 1599.2.1 Current Model for Autologous Cell Therapies 1609.2.2 Current Models for Allogeneic Cell Therapies 1619.3 Key Factors for Successful Business Models for Cell Therapies 1639.4 Requirements for Commercial Manufacturing of Cell Therapy Products 1639.4.1 Elements of Commercial Manufacturing 1639.4.1.1 Regulatory Requirements 1639.4.1.2 Manufacturing Process Scale 1649.4.1.3 In-House Manufacturing 1649.4.1.4 Contract Manufacturing: Commercial and Academic 165

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