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Regenerative Medicine Markets
[May 22, 2013]

Regenerative Medicine Markets


NEW YORK, May 22, 2013 /PRNewswire via COMTEX/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Regenerative Medicine Marketshttp://www.reportlinker.com/p0236993/Regenerative-Medicine-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Supply,_Tissue_Banking_and_Transplantation 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 TriMark Publications 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 1. Overview 161.1 Statement of Report 161.2 Scope of this Report 181.3 Methodology 181.4 Executive Summary 19 2. Regenerative Medicines: An Overview of Segments 222.1 Tissue Engineering 222.1.1 Tissue-Engineered Skin 232.1.2 Tissue-Engineered Cartilage 232.1.3 Tissue-Engineered Bone 242.1.4 Tissue-Engineered Peripheral Nerves 252.1.5 Tissue-Engineered Cornea 262.1.6 Tissue-Engineered Blood Vessels 262.1.7 Progress and Promises for Tissue Engineering Industry 272.1.7.1 Key Positioning Strategies in Tissue Engineering Industry 272.1.7.2 Tissue Engineering Industry Participants 272.1.7.3 Tissue Engineering Firms by their Product Applications 282.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products 282.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products 292.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products 302.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney 302.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products 312.1.7.9 Tissue Engineering Firms Involved in Dental Products 312.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products 312.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets 312.2 Cell Therapy 322.2.1 Progress in Cell Therapy Product Research 342.2.2 Commercially Available Cell Therapy Products 352.2.3 Major Cell Therapy Companies 362.2.4 Locations of Cell Therapy Companies 382.2.5 Disease Focus by Cell Therapy 392.2.6 Cell Therapy Products and Companies 392.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc. 412.2.7 Potential Patients for Cell Therapy in the U.S. 412.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy 412.2.9 Cell Therapy Pipeline 422.2.10 Cell Therapy Clinical Trials by Indication 432.2.10.1 Major Cell Therapy Clinical Trials for Diabetes 432.2.10.2 Progress in Clinical Trials for Diabetes 442.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes 442.2.11 Major Four Targeted Disease Conditions for Clinical Trials 452.2.12 Commercial Success of Cell Therapies in Europe 462.2.13 Deals in Cell Therapy, 2007-2011 492.2.14 Commercial-Stage Cell Therapy Companies and Products 502.2.15 Cell Therapy Clinical Trials in the U.K. 512.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the U.K. 522.2.15.2 Cell Types Involved in the U.K. Clinical Trials 532.2.15.3 U.K. Cell Therapy Clinical Trials by Indication 532.3 Cell Culture Products 542.3.1 Market for Reagents Used in Cell Culture 552.3.2 Cell Culture Media 562.3.3 Market for Sera Used in Cell Culture 572.3.3.1 Suppliers of Culture Media and Reagents 582.3.3.2 In Vitro Test Kits 592.3.3.3 Suppliers of Cells and Tissues 592.3.3.4 Equipment for Stem Cell Research 602.3.3.5 Computer Software for Stem Cell Research 622.4 Scaffolding Biomaterials 632.5 Growth Factors 64 3. Regenerative Medicine: The Next Evolution of Medical Treatment 663.1 Scope of this Chapter 663.2 Need for Regenerative Medicine 663.3 Current State of Regenerative Medicines 663.4 Future of Regenerative Medicine 673.4.1 Number of Products in Pipeline 683.5 Projected Timeline for Regenerative Medicine 723.6 Selected Regenerative Medicine Products in the Market 723.6.1 Medtronic's Infuse Bone Graft and LT-Cage Device 733.6.2 Genzyme's Corticel 733.6.3 OP-1 from Stryker 753.6.4 Osteocel from Osyris/Nuvasive 753.6.5 Spinal Implants from RTI Biologics 763.6.6 Apligraf from Organogenesis 763.6.7 Dermograft from Advanced BioHealing 763.6.8 Integra's Bilayer Matrix for Wound Dressing 773.6.9 Alloderm from LifeCell 773.6.10 Celution from Cytori Therapeutics 783.6.11 Other Products of Importance in Regenerative Medicine 783.6.12 Tissue-Engineered Wound Healing Products 783.6.12.1 Oasis 793.6.12.2 Permacol 793.6.12.3 EZ-Derm 793.6.12.4 Matriderm 803.6.12.5 TransCyte 803.6.12.6 ICX-SKN 803.6.12.7 OrCel 813.6.12.8 Epicel 813.6.12.9 Myskin 823.6.12.10 VCT01 823.6.13 ICX-TRC--Hair Regeneration Therapy 823.6.14 Cartilage Regeneration 823.6.14.1 Novocart 823.6.14.2 BioSeed-C 833.6.14.3 BioSeed--Oral Bone 833.6.14.4 Chondrotissue 833.6.14.5 co.don Chondrotransplant 833.6.14.6 co.don Chondrotransplant DISC 833.6.14.7 co.don Chondrosphere 833.6.14.8 co.don Osteotransplant DENT 843.6.14.9 MACI Implant 843.6.14.10 Cartilink-3 843.6.14.11 Accell Evo3 Demineralized Bone Matrix 843.6.14.12 OsSatura BCP 843.6.15 Mozobil 843.7 Clinical Milestones in RM Sector, 2011-2012 843.7.1 GINTUIT (March 2012) 843.7.2 Ixmyelocel-T (February 2012) 843.7.3 Autologous CD34+ Stem Cells (February 2012) 853.7.4 HuCNS-SC (February 2012) 853.7.5 DeNovo ET (February 2012) 853.7.6 Retinal Pigment Epithelium Cells (January 2012) 853.7.7 AMR-001 (January 2012) 853.7.8 Avance Nerve Graft (January 2012) 853.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia (January 2012) 863.7.10 T-Cells Resistant to HIV (January 2012) 863.7.11 Tissue-Engineered Windpipe (November 2011) 863.7.12 Revascor (November 2011) 863.7.13 ReN001 Stem Cell Therapy (September 2011) 863.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers (August 2011) 863.7.15 ALD-301 for Critical Limb Ischemia (May 2011) 863.7.16 JVS-100 for Heart Failure (April 2011) 873.7.17 MultiStem for Ulcerative Colitis (March 2011) 873.7.18 HuCNS-SC Human Neural Stem Cells (March 2011) 873.8 Accelerated Pace of Deals in RM Sector 873.8.1 Acquisitions and Partnerships 873.8.1.1 Shire's Acquisition of Advanced BioHealing, Inc. (May 2011) 873.8.1.2 Terumo Americas Holding's Acquisition of Harvest Technologies (April 2011) 873.8.1.3 Sanofi's Acquisition of Genzyme Corporation (February 2011) 873.8.1.4 NeoStem's Acquisition of Progenitor Cell Therapy, LLC (January 2011) 873.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. (December 2011) 883.8.2 Notable Financings 883.8.2.1 Financing to AlloCure, Inc. (April 2012) 883.8.2.2 Financing to Promethera Biosciences (March 2012) 883.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. (February 2012) 883.8.2.4 Financing to Organovo (March 2012) 883.8.2.5 Financing to Cytomedix, Inc. (February 2012) 883.8.2.6 Financing to Fate Therapeutics, Inc. (May 2011) 883.8.2.7 Financing to Cellular Dynamics International, Inc. (April 2011) 893.8.2.8 Financing to Cytori Therapeutics (December 2010) 893.8.2.9 Overview of Capital Formation in RM Industry 89 4. Recent Advances in Regenerative Medicine and Stem Cell Research 904.1 Bioengineered Autologous Vein 904.2 Stem Cell Treatment for Spinal Cord Injury 904.3 Repairing Damaged Retina 904.4 A Possible Cure for Deafness 914.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc. 914.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem Cells 924.6.1 Recent Developments in Stem Cell Therapy in Cardiology 924.6.2 Recent Developments in Acute MI 924.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure 944.6.4 Stem Cells and Neurodegenerative Diseases 954.7 Disease Modeling: The Use of Inducible Cells 964.7.1 Modeling Disease with iPS Cells 964.7.2 Modeling Disease with Direct Neuronal Conversion 974.8 Stem Cell Transplants 974.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies 984.8.2 Stem Cell Types for Eye Disease Clinical Trials 984.8.2.1 Pluripotent Stem Cells 994.8.2.2 Neural Stem Cells 994.8.2.3 RPE Stem Cells 994.8.2.4 Limbal Stem Cells 994.8.2.5 Umbilical Cord Stem Cells 994.8.2.6 Bone Marrow Stem Cells 994.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration 994.8.2.8 Patch of hESC-Derived RPE Monolayer 1004.8.2.9 Patient-Derived RPE 1004.8.2.10 NSCs for AMD 1004.8.2.11 UCSCs for RP and AMD 1014.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases 1014.8.2.13 Corneal Repair 1014.8.2.14 Bioengineered Eye Tissues 1014.9 Regenerative Strategies in the Treatment of Diabetes 1014.9.1 Cell-Based Therapy for Diabetes 1024.9.2 Embryonic Stem Cells and Induced Pluripotent Cells 102 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 1327.10 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 10. Company Profiles 16710.1. Aastrom Biosciences, Inc. 16710.1.1 Aastrom's Cellular Therapy and Ixmyelocel-T 16710.1.1.1 Advantages of Patient's Bone Marrow and Ixmyelocel-T 16710.1.2 Aastrom's Clinical Trials 16810.1.2.1 REVIVE-CLI 16810.1.2.2 RESTORE-CLI 16810.2 Advanced Cell Technology, Inc. (ACT) 16810.2.1 ACT's Human ES Cell Programs 16910.2.2 ACT's Human Embryonic Stem Cell Technologies 16910.2.3 ACT's Cell Therapy Research Program 17010.2.3.1 Retinal Pigment Epithelium Program 17010.2.3.2 Hemangioblast Program 17010.2.3.3 Adult Stem Cell Program 17010.2.4 ACT's Intellectual Property 17110.3 AlloCure, Inc. 17210.3.1 AlloCure's Technology 17210.3.2 AlloCure's Clinical Trials 17310.3.2.1 Acute Kidney Injury 17310.3.2.2 Epidemiological Study of AKI 17310.3.2.3 Phase I Clinical Trial in AKI 17410.3.2.4 Phase II Clinical Trial in AKI 17410.4 Altrika Ltd. 17410.4.1 Myskin 17410.4.2 Cryoskin 17410.5 American Type Culture Collection, Inc. (ATCC) 17510.5.1 ATCC's Cell Lines and Hybridomas 17510.5.2 ATCC's Media, Sera and Reagents 17510.5.3 MTT Cell Proliferation Assay 17510.5.4 XTT Cell Proliferation Assay Kit 17510.5.5 Universal Mycoplasma Detection Kit 17610.5.6 DNA and RNA 17610.5.7 STR Profile Database 17610.5.8 hTERT Immortalized Cell Lines 17610.5.9 Embryonic Stem Cell Products 17710.5.10 Bacteria and Phages 17710.5.11 Fungi and Yeast 17710.5.12 Protozoa and Algae 17710.5.13 Viruses and Related Reagents 17710.5.14 Microbial DNA and RNA 17810.5.15 ATCC's Tissue Biology Products 17810.6 Avita Medical Limited 17810.6.1 ReCell 17810.7 Amorcyte, LLC 17810.7.1 AMR-001 17910.8 Ars Arthro AS 17910.8.1 CaReS 17910.8.2 Fibrocell 17910.8.3 Fibroplus 17910.9 Axiogenesis AG 17910.9.1 Human iPS Cell-Derived Cardiomyocytes 18010.9.2 Murine Cardiomyocytes ES 18010.9.3 Murine Cardiomyocytes iPS 18010.9.4 Murine Endothelial Cells 18010.9.5 Murine Smooth Muscle Cells 18110.10 AxoGen, Inc. 18110.10.1 Avance Nerve Graft 18110.10.2 AxoGuard Nerve Protector 18210.10.3 AxoGuard Nerve Connector 18210.11 Bellicum Pharmaceuticals, Inc. 18210.11.1 Bellicum's Technology 18310.11.2 Bellicum's Pipeline 18410.12 BetaStem Therapeutics, Inc. 18410.12.1 BetaStem's Technology 18510.13 Bioheart, Inc. 18510.13.1 MyoCell 18510.13.2 MyoCell SDF-1 18610.13.3 MyoCath 18610.13.4 LipiCell 18610.14 Biomet, Inc. 18710.14.1 Endobon Xenograft Granules 18710.14.2 RegenerOss Allograft 18810.14.3 Ground Cancellous Bone 18810.15 BioMimetic Therapeutics, Inc. 18910.15.1 Augment Bone Graft 19010.15.2 Augmatrix Biocomposite Bone Graft 19010.16 BioTissue Technologies AG 19110.16.1 BioSeed-C 19110.16.2 Chondrotissue 19110.16.3 BioSeed-Oral Bone 19210.17 Biovest International, Inc. 19210.17.1 Autovaxid 19210.17.2 Xcellerator 19310.17.3 Maximizer 19310.17.4 Minimax 19310.18 BrainStorm Cell Therapeutics, Inc. 19310.18.1 NurOwn 19410.19 California Stem Cell, Inc. 19410.19.1 Clinical Pipeline 19410.19.1.1 MotorGraft 19410.19.1.2 Cancer Stem Cell 19410.19.2 Cell Products 19510.19.2.1 MotorPlate and MotorVial 19510.19.2.2 NeuroPlate and NeuroVial 19510.19.2.3 OPCVial 19510.19.2.4 HepatoPlate 19610.19.3 Cell Culture Products 19610.19.3.1 StemBlast 19610.19.3.2 MotorBlast 19610.19.3.3 NeuroBlast 19710.19.3.4 OPC Media 19710.19.3.5 Cellular Transplant Solution 19710.20 Cardio3 Biosciences SA 19710.20.1 Products Pipeline 19810.20.1.1 C3BS-CQR-1 (C-Cure) 19810.20.1.2 Positive Phase II Results for C-Cure 19810.20.1.3 C3BS-CQR-1 (Protein) 19810.20.1.4 C-CATHez (Medical Device) 19810.21 Cellartis AB (Cellectis) 19910.21.1 iPS Engineering Hub 19910.21.2 Hepatocytes hiPS-HEP 19910.21.3 Cardiomyocyte Clusters hES-CMC 20010.21.4 Stem Cell Culture System DEF-CS 20010.22 CellSeed, Inc. 20010.22.1 Epithelial Cell Sheet for Corneal Regeneration 20010.22.2 Regenerated Cardiac Patch 20110.22.3 Epithelial Cell Sheet for Esophageal Regeneration 20110.22.4 Cell Sheet for Periodontal Regeneration 20110.22.5 Regenerated Cartilage Sheet 20110.23 Cellular Dynamics International, Inc. 20110.23.1 iCell Cardiomyocytes 20210.23.2 iCell Endometrial Cells 20210.23.3 iCell Hepatocytes 20210.23.4 iCell Neurons 20210.23.5 MyCell Products 20210.24 Chromocell Corporation 20310.24.1 Chromovert Technology 20310.24.2 Chromovert Applications 20310.24.2.1 Pain Relief 20310.24.2.2 Anxiety Treatments 20410.24.2.3 Respiratory Disorders 20410.25 Cognate Bioservices, Inc. 20410.25.1 Process Development 20410.25.2 Regulatory Services 20410.25.3 Assay Development 20510.25.4 Preclinical Services 20510.25.5 Stem Cell Services 20610.26 Cook Biotech, Inc. 20610.26.1 Cook's Technology 20610.26.2 Biodesign Dural Graft 20710.26.3 Dynamatrix Extracellular Membrane 20710.26.4 tarSys 20710.26.5 Oasis Wound Matrix 20710.26.6 Biodesign Staple Line Reinforcement 20810.26.7 Biodesign Hiatal Hernia Graft 20810.26.8 CorMatrix ECM 20810.26.9 ECM for Cardiac Tissue Repair 20910.26.10 Biodesign Incision Graft 20910.26.11 Biodesign Inguinal Hernia Graft 20910.26.12 Biodesign Parastomal Reinforcement Graft 21010.26.13 Biodesign Umbilical Hernia Graft 21010.26.14 Biodesign Anterior Pelvic Floor Graft 21010.26.15 Biodesign Fistula Plug 21110.26.16 LIFT with Biodesign 21110.26.17 Biodesign Posterior Pelvic Floor Graft 21110.26.18 Biodesign Peyronie's Repair Graft 21210.26.19 Biodesign Tension-Free Urethral Sling 21210.27 Cytomedix, Inc. 21210.27.1 Cytomedix's AutoloGel System 21310.27.1.1 The Working of AutoloGel System 21310.27.1.2 Balancing Effect of AutoloGel System 21310.27.1.3 Formulation of AutoloGel System 21410.27.2 Cytomedix's Angel PRP 21410.28 Cytonet, LLC 21510.28.1 Cytonet's Liver Cell Therapy 21510.28.2 SELICA III Clinical Trial 21510.29 Cytori Therapeutics, Inc. 21510.29.1 Cytori's Commercial Activities and Markets 21510.29.2 Cytori's Pipeline 21610.29.2.1 Celution System for Cardiovascular Disease 21610.29.2.2 Other Applications of Celution System 21710.29.2.3 PureGraft 21710.29.2.4 StemSource 21710.30 DanDrit Biotech A/S 21810.30.1 Dendritic Cell 21810.30.1.2 Colorectal Cancer Trial Phase II in Singapore 21910.30.1.3 Non-Small-Cell Lung Cancer, Phase II 21910.31 Fibrocell Science, Inc. 21910.31.1 Fibrocell's Technology 22010.31.2 Pipeline 22010.32 Forticell Bioscience, Inc. 22010.32.1 OrCel 22010.33 Gamida Cell Ltd. 22110.33.1 Gamida's Technology 22110.33.1.1 Copper Chelator Based Technology 22110.33.1.2 NAM Based Technology 22110.33.1.3 StemEx 22210.33.1.4 NiCord 22210.33.1.5 CordBridge 22310.33.1.6 NK Cell Product 22310.34 Harvest Technologies Corporation 22310.34.1 Smart PReP2 APC+ 22310.34.2 SmartPReP 2 BMAC 22410.35 Histogenics Corporation 22410.35.1 NeoCart 22410.35.2 VeriCart 22610.36 Humacyte, Inc. 22610.36.1 Humacyte Grafts 22610.37 Integra Lifesciences Holdings Corporation 22710.37.1 Integra's Products Overview 22710.37.2 Integra's Orthopedics Product Portfolio 22710.37.3 Integra's Extremity Reconstruction Product Portfolio 22710.37.3.1 Skin and Wound 22710.37.3.2 Bone and Joint Fixation Devices and Instruments 22810.37.3.3 Lower Extremity Products 22810.37.3.4 Upper Extremity Products 22810.37.3.5 Bone Graft Substitutes for Extremity Reconstruction 22810.37.3.6 Nerve and Tendon 22810.37.4 Integra's Spine Product Portfolio 22810.37.4.1 Integrated Interbody Fusion Devices 22910.37.4.2 Minimally Invasive Solutions 22910.37.4.3 Deformity Correction 22910.37.4.4 Orthobiologics 22910.37.4.5 Integra's Research and Development in Regenerative Medicine 22910.38 Intercytex Ltd. 22910.38.1 VAVELTA 23010.38.2 Epidermolysis Bullosa 23010.38.3 Scar Contractures 23110.38.4 Acne Scarring 23110.38.5 International Stem Cell Corporation 23110.38.6 Therapeutic Programs 23210.39 iPierian, Inc. 23210.39.1 Technology 23310.39.2 Product Development 23310.40 Japan Tissue Engineering Co., Ltd. 23310.40.1 Autologous Cultured Epidermis 23310.40.2 Autologous Cultured Cartilage 23410.40.3 Autologous Cultured Corneal Epithelium 23510.41 Kensey Nash Corporation 23510.41.1 Medeor Matrix 23610.41.2 Meso BioMatrix Scaffold 23610.41.3 Epi-Guide Bioresorbable Barrier Matrix 23610.41.4 OsseoFit Porous Tissue Matrix 23710.41.5 Vitoss Scaffold Foam Products 23710.42 Kiadis Pharma B.V. 23710.42.1 Kiadis' Pipeline 23810.42.1.1 ATIR 23810.42.1.2 Reviroc 23910.42.1.3 Rhitol 24010.43 Living Cell Technologies Limited (LCT) 24010.43.1 Diabecell 24010.43.2 Ntcell 24010.44 Life Cell Corporation 24110.44.1 AlloDerm 24110.44.2 Cymetra Micronized AlloDerm Tissue 24110.44.3 Strattice Reconstructive Tissue Matrix 24210.44.4 SPY Elite System 24210.45 MaxCyte, Inc. 24310.45.1 MaxCytes Technology Platform 24310.45.2 Drug Discovery Applications 24310.45.2.1 GPCRs 24310.45.2.2 Ion Channels 24310.45.3 Antibody Production 24410.45.4 General Protein Production 24410.45.5 Viral Vector and VLP Production 24410.45.6 Insect Cell Transfection 24410.45.7 Cell Therapy 24410.45.7.1 Dendritic Cell Vaccines 24410.45.7.2 Regenerative Medicine 24510.45.7.3 Chimeric Antigen Receptor (CAR) Immunotherapy 24510.46 MediStem, Inc. 24510.46.1 Intellectual Property 24610.46.1.1 Method for Expansion of Stem Cells 24610.46.1.2 Compositions of Placentally-Derived Stem Cells for the Treatment of Cancer 24610.46.1.3 Transcatheter Tumor Immunoembolization 24610.46.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction 24610.46.1.5 Treatment of Erectile Dysfunction by Stem Cell Therapy 24610.46.1.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients 24610.46.1.7 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation 24710.46.1.8 Cellular Therapy for Lower Back Pain 24710.46.1.9 Compositions and Methods of Stem Cell Therapy for Autism 24710.46.1.10 Stem Cell Therapy for Weight Loss 24710.46.1.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof 24710.46.1.12 Endometrial Derived Reparative/Regenerative Cells 24710.46.1.13 Treatment of Insulin Resistance and Diabetes 24810.46.1.14 Combination Treatment of Cardiovascular Disease 24810.46.1.15 Stem Cell Therapy for Autism 24810.46.2 Product Pipeline 24810.46.2.1 Endometrial Regenerative Cell Platform 24810.46.2.2 Angiostem Platform 24810.46.2.3 Tolerostem Platform 24810.47 Mesoblast Ltd. 24910.47.1 Revascor 24910.47.2 MPCs for Diabetics 24910.47.3 Bone Marrow Derived Allogeneic MPCs 24910.47.4 Macular Degeneration 25010.47.5 Diabetic Macular Edema 25010.47.6 Intervertebral Disc Repair Product 25010.47.7 Lumbar and Cervical Spinal Fusion Product 25110.47.8 Fracture Repair Product 25110.47.9 Arthritis Product 25110.48 MolMed S.p.A. 25210.48.1 MolMed's Technological Platforms 25310.49 NanoCor Therapeutics, Inc. 25310.49.1 Carfostin 25310.50 Neuralstem, Inc. 25310.50.1 Neuralstem's Technology Platforms: Stem Cells 25310.50.2 Pharmaceutical Compounds 25410.50.3 Neuralstem's Clinical Trials for Stem Cells 25510.50.4 Clinical Trials for Neuralstem's Pharmaceutical Compound 25510.51 NeuroNova AB 25510.51.1 Neurogenesis Qualifier 25510.51.2 NeuroNova's Projects 25610.52 Olympus Terumo Biomaterials Corp. 25610.52.1 OSferion60 25610.52.2 Terudermis 25610.52.3 OSferion 25810.52.4 Teruplug 25810.52.5 Bone Cream 25810.53 NewLink Genetics Corporation 25810.54 OncoMed Pharmaceuticals, Inc. 25910.54.1 OncoMed's Research on Cancer Stem Cells 25910.54.2 OncoMed's Platform 26010.54.3 OncoMed's Development Pipeline 26010.55 Opexa Therapeutics, Inc. 26110.55.1 T-Cell Platform 26110.56 Organogenesis, Inc. 26110.56.1 Apligraf 26110.56.2 Gintuit 26210.57 Orthovita, Inc. 26210.57.1 Vitoss 26310.58 Osiris Therapeutics, Inc. 26310.58.1 Osiris' Technologies 26410.58.1.1 Stem Cell Source 26410.58.1.2 Manufacturing Process 26410.59 Osteotech, Inc. 26510.59.1 MagniFuse 26510.59.2 Plexur P 26510.59.3 Plexur M 26610.59.4 FacetLinx Fusion Technology 26610.59.5 Grafton 26610.59.6 Xpanse Bone Inserts 26710.59.7 GraftCage TLX and GraftCage ACX 26710.60 Pervasis Therapeutics, Inc. 26710.61 Pluristem Therapeutics, Inc. 26810.62 Proneuron Biotechnologies, Inc. 26910.62.1 Spinal Cord Technology 26910.63 RegeneRx 27010.63.1 Tß4 Peptide Research 27010.64 ReNeuron Group PLC 27110.64.1 ReN001 27110.64.2 ReN009 27110.64.3 ReNcell VM and ReNcell CX 27210.65 Revivicor, Inc. 27210.65.1 Xenotransplantation Technology 27210.66 SanBio, Inc. 27310.66.1 SanBio's Product Pipeline 27310.66.1.1 SB623 27310.66.1.2 SB618 27310.66.1.3 SB308 27310.67 Saneron CCEL Therapeutics, Inc. 27410.67.1 U-Cord Cell Program 27410.67.2 Sert-Cell Program 27410.68 Sangamo Biosciences, Inc. 27410.68.1 SB-728 27410.68.2 SB-313 27510.68.3 Hemophilia 27510.69 Stem Cell Authority Ltd. 27510.69.1 MIRACHYMAL Stem Cells 27510.70 StemCells, Inc. 27510.70.1 StemCells' Research Collaborations 27610.70.1.1 Stanford University and Stanford School of Medicine 27610.70.1.2 UC Irvine 27610.70.1.3 OHSU Casey Eye Institute 27610.70.1.4 McLaughlin Research Institute 27610.70.2 StemCells' Therapeutic Programs 27610.70.3 Cells and Cell Lines 27710.70.4 Cell Culture Products 27710.70.5 Antibody Detection Reagents 27710.70.6 Purified Whole Stem Cell Lysates 27710.71 Stemline Therapeutics, Inc. 27810.71.1 Cancer Stem Cells 27910.71.2 Stemline Therapeutics' Platform 27910.72 Stratetech Corporation 27910.72.1 Stratatech's Core Technology 27910.73 Synthecon, Inc. 28010.73.1 Rotary Cell Culture Systems 28010.73.2 Biofelt (Bioabsorbable Scaffold) 28110.73.3 Biomerix 3D Scaffolds 28110.73.4 RollerCell 40 28110.74 Tengion, Inc. 28210.74.1 Tengion's Scientific Platform 28210.74.2 Tengion's Pipeline 28310.75 TiGenics NV 28310.75.1 ChondroCelect 28410.75.2 CX601 28410.75.3 Cx611 28510.75.4 Cx621 28510.76 Tissue Genesis, Inc. 28510.76.1 Clinical Therapies from Tissue Genesis 28510.76.1.1 Icellator 28610.76.1.2 Adipase 28610.77 Thermogenesis Corp. 28610.77.1 AXP System 28610.77.2 MXP System 28710.77.3 Manual Systems 28710.77.4 Res-Q 60 BMC System 28810.77.5 BioArchive System 28810.78 ViaCyte, Inc. 28810.78.1 Technology Overview 28910.79 Vistagen Therapeutics, Inc. 28910.79.1 Vistagen's Technology 28910.79.2 CardioSafe 3D 29010.79.3 LiverSafe 3D 29010.80 Zen-Bio, Inc. 290 Appendix 1: Allogeneic vs. Autologous Stem Cell Therapy 292Appendix 1.1: Manufacturing Process 292Appendix 1.2: Cost Differential 293Appendix 1.3: Donor Screening and Testing 294Appendix 1.4: Release Testing 294Appendix 1.5: Overall Analysis 294 INDEX OF FIGURES Figure 2.1: Geographic Distribution of Tissue Engineering Firms in Major Markets 32Figure 2.2: The Potential Uses of Embryonic Stem Cells 33Figure 2.3: Progress of Cell Therapy Product Research, 2012 34Figure 2.4: Commercially Available Cell Therapy Products, 2012 35Figure 2.5: Disease Focus by Regenerative Medicine 39Figure 2.6: Estimated Completion Dates for Stem Cell Based Clinical Trials Targeting Type 1 Diabetes, 2009-2015 45Figure 2.7: Number of Clinical Trials by Targeted Condition, 2005-2011 45Figure 2.8: Concentration of European Cell Therapy Firms, 2012 46Figure 2.9: European Stem Cell Platforms by Cell Source 47Figure 2.10: Autologous vs. Allogeneic Stem Cell Therapy Firms in Europe, 2012 48Figure 2.11: Autologous and Allogeneic Somatic Cell Therapy Firms in Europe, 2012 48Figure 2.12: Sponsors of Cell Therapy Clinical Trials in the U.K., 2012 52Figure 2.13: Clinical Trials Involving Allogeneic vs. Autologous Cell Therapy Products in the U.K., 2012 52Figure 2.14: Cell Types Involved in the U.K. Cell Therapy Clinical Trials, 2012 53Figure 2.15: U.K. Cell Therapy Clinical Trials by Indication, 2012 54Figure 2.16: Cell Culture Products Market by Segment, 2012 55Figure 2.17: Market for Reagents Used in Cell Culture, 2012-2019 56Figure 2.18: Market for Media Used in Cell Culture, 2012-2019 57Figure 2.19: Market for Serum Used in Cell Culture, 2012-2019 58Figure 5.1: CIRM's Grants for Disease Types by Funding Level, 2012 110Figure 7.1: Commercially Available Regenerative Products 119Figure 7.2: Global Market for Tissue Engineering Products, 2012-2019 123Figure 7.3: Global RM Market for Cardiology and Vascular Products, 2012-2019 126Figure 7.4: Alternatives for Medtronic's Infuse 128Figure 7.5: Global Market for RM Products in Orthopedics, Musculoskeletal and Spine, 2012-2019 130Figure 7.6: Global RM Market for Neurology Products, 2012-2019 131Figure 7.7: Global RM Market for Dental Products, 2012-2019 132Figure 7.8: Global Tissue Engineering and Cell Therapy Market for Cancer Products, 2012-2019 133Figure 7.9: Global Market for RM Products in Urology, 2012-2019 134Figure 7.10: Global Market for RM Products in Skin/Integument, 2012-2019 135Figure 7.11: Global Tissue Engineering and Cell Therapy Market, 2012-2019 136Figure 7.12: U.S. Market for Tissue Engineered Skin Replacement and Substitutes, 2012-2019 137Figure 7.13: U.S. Market for RM Products in Orthopedic/Spine, 2012-2020 139Figure 7.14: U.S. Market for RM Products in Nerve Repair, 2012-2020 140Figure 7.15: U.S. Market for RM Products in Cardiovascular Therapies, 2012-2020 141Figure 7.16: U.S. Market for RM Products in Anti-Inflammatory Therapies, 2012-2020 142Figure 7.17: U.S. Market for RM Products in Diabetes, 2012-2020 143Figure 7.18: U.S. Market for Regenerative Medicines, 2012-2020 144Figure 7.19: U.S. Regenerative Medicine Market by Segment, 2020 145Figure 8.1: Global Market for Stem Cell Products, 2012-2020 148Figure 8.2: U.S. Market for Stem Cell Products, 2012-2020 151Figure 8.3: Estimated U.S. Market for Stem Cell Therapy by Type, 2020 153Figure 8.4: European Market for Stem Cell Products, 2012-2020 153Figure 8.5: Number of Autologous and Allogeneic Cell Therapy Firms in Europe 154Figure 8.6: Asia-Pacific Market for Stem Cells, 2012-2019 155Figure 8.7: Global Autologous Cell Therapy Market, 2012-2019 156Figure 9.1: Cell-Based Business Models 159Figure 9.2: Current Autologous Business Models 161Figure 9.3: Current Allogeneic Business Models 162Figure 10.1: Aastrom's Cell Expansion Process 167 INDEX OF TABLES Table 2.1: Commercially Available Bioengineered Skin Products 23Table 2.2: A Partial List of Companies Offering Bioreactor Systems 25Table 2.3: Number of Tissue Engineering Companies in the Five Focus Countries 28Table 2.4: Number of Tissue Engineering Firms Developing Stem Cells Seeded to Scaffolds 28Table 2.5: Number of Tissue Engineering Firms Focusing on Skin, Cartilage, Bone and Urological Products 29Table 2.6: Number of Tissue Engineering Firms Focused on Cardiovascular Products 30Table 2.7: Number of Tissue Engineering Firms Focusing on Neurological Products 30Table 2.8: Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney 31Table 2.9: Number of TE Firms Focused on Autologous and Allogenic Products 31Table 2.10: Major Cell Therapy Companies 36Table 2.11: Geographical Distribution of Cell Therapy Companies 38Table 2.12: Cell Therapy Products on the Market 40Table 2.13: Cell Therapy Products on the Market by Type and Application 40Table 2.14: Potential Patients for Cell Therapy in the U.S. 41Table 2.15: Number of Patients Treated with Cell Therapy Between 1988 and 2010 42Table 2.16: Cell Therapy Pipeline, 2005-2011 42Table 2.17: Number of Stem Cell Clinical Trials by Indication, 2012 43Table 2.18: Major Cell Therapy Clinical Trials for Diabetes and Estimated Enrollment Targets, 2012 44Table 2.19: Progress in Clinical Trials for Diabetes, 2012 44Table 2.20: Cell Therapy Deals, 2007-2011 49Table 2.21: Select Cell Therapy Products with FDA/EMA Regulatory Approval, 1998-2010 50Table 2.22: Cell Therapy Companies and Products 50Table 2.23: Cell Therapy Products Approved in South Korea 51Table 2.24: Selected Suppliers of Culture Media and Reagents 58Table 2.25: Selected Suppliers of In Vitro Te To order this report:: Regenerative Medicine Markets Contact Clare: [email protected] US:(339) 368 6001 Intl:+1 339 368 6001 SOURCE Reportlinker http://rt.prnewswire.com/rt.gif NewsItemId=BR18985&Transmission_Id=201305221453PR_NEWS_USPR_____BR18985&DateId=20130522

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