The tissue engineering and regenerative medicine market first emerged in the mid-1990's and has since expanded substantially with sales projected to exceed $2 billion in 2013, growing 6.7% over 2012. Key players in the market include venture-funded start-ups as well as a number of major players in the pharmaceutical, biotechnology and medical device sectors. The existing market spans four segments, including wound care, orthopaedics, urological products, and neurology products. The market is projected to grow at a 9.1% compound annual rate from 2012 through 2017, approaching $3 billion by 2017.
EXECUTIVE SUMMARY Exhibit ES-1: Worldwide Market for Tissue Engineering and Regenerative Medicine Products, 2011-2017 Exhibit ES-2: Worldwide Market for Tissue Engineering and Regenerative Medicine Products by Region, 2011-2017 Exhibit ES-3: Target Procedures and Potential Markets by Segment Exhibit ES-4: Potential Procedure Volume by Region Exhibit ES-5: Potential Market Segment Size and Growth Comparison Exhibit ES-6: 2012 Tissue Engineering and Regenerative Medicine Suppliers' Sales and Market Share 1. TISSUE ENGINEERING AND REGENERATIVE MEDICINE TECHNOLOGIES 1.1 Biomaterials Technologies 1.1.1 Synthetic Materials 1.1.2 Biologically Derived Materials 1.1.3 Genetically Engineered Materials 1.2 Stem Cell Technologies 1.2.1 Stem Cell Sources 1.2.2 Stem Cell Extraction Techniques 1.2.3 Stem Cell Expansion 1.2.4 Stem Cell Delivery 1.2.5 Existing and Development-Stage Stem Cell Products 1.3 Cell Culture Technologies 1.4 Immunopassivation and Immunomodulation 1.4.1 Chimeric Immunopassivation 1.4.2 Immunomodulation 1.4.3 Cell Encapsulation Exhibit 1.1: Synthetic Materials Used in Tissue Engineering and Regenerative Medicine Exhibit 1.2: Biologically Derived Materials Used in Tissue Engineering and Regenerative Medicine Exhibit 1.3: Genetic Engineering Technologies for Tissue Engineering and Regenerative Medicine Exhibit 1.4: Stem Cell Sources Exhibit 1.5: Diseases Treated with Umbilical Cord Blood Stem Cell Transplants Exhibit 1.6: Materials Used in Stem Cell Culture Exhibit 1.7: Stem Cell Collection Products for Hematopoietic Stem Cell Transplantation Exhibit 1.8: Clinical Trials Involving Stem Cell Therapy 2. CARDIOVASCULAR APPLICATIONS OF TISSUE ENGINEERING AND REGENERATIVE MEDICINE 2.1 Cardiovascular Disease Incidence and Prevalence 2.2 Cardiovascular Applications and Market Potential 2.2.1 Heart Valve Repair and Replacement 2.2.2 Heart Failure and Myocardial Tissue Regeneration 2.2.3 Applications in Peripheral Vascular Disease 2.2.4 Applications in Coronary Artery Disease 2.3 Market Forecast for Cardiovascular Applications 2.4 Cardiovascular Market Drivers and Limiters 2.5 Leading Companies in Cardiovascular Tissue Engineering and Regenerative Medicine Exhibit 2.1: Worldwide Deaths by Cause Exhibit 2.2: Worldwide Incidence and Prevalence of Cardiovascular Disease by Region Exhibit 2.3: U.S. Trends in Congestive Heart Failure and Heart Valve Disorders Exhibit 2.4: Proportion of Patients with Heart Valve Disorders Treated with Existing Valve Repair and Replacement Devices in the U.S. Exhibit 2.5: Trends in Heart Transplants and Deaths from Heart Failure in the U.S. Exhibit 2.6: Worldwide Target Market for Cardiovascular Applications by Segment Exhibit 2.7: Worldwide Target Procedures for Cardiovascular Applications by Region and Segment, 2012 Exhibit 2.8: Worldwide Target Procedures for Tissue-Engineered Coronary Artery Bypass Grafts by Region, 2007-2017 Exhibit 2.9: Worldwide Target Procedures for Tissue-Engineered Heart Valves by Region, 2007-2017 Exhibit 2.10: Worldwide Target Procedures for Myocardial Tissue Regeneration in Heart Failure Therapy by Region, 2007-2017 Exhibit 2.11: Worldwide Target Procedures for Tissue-Engineered Peripheral Vascular Bypass Grafts/Critical Limb Ischemia Therapy by Region, 2007-2017 Exhibit 2.12: Worldwide Target Procedures for Tissue-Engineered Dialysis Access Shunts by Region, 2007-2017 Exhibit 2.13: Worldwide Target Procedures for Regenerative Medicine-Based Heart Angiogenesis/Refractory Angina Therapy by Region, 2007-2017 Exhibit 2.14: Worldwide Target Procedures for Cardiovascular Applications of Tissue Engineering and Regenerative Medicine by Region, 2007-2017 Exhibit 2.15: Leading Companies in Cardiovascular Tissue Engineering CHAPTER 3: ORTHOPAEDIC APPLICATIONS AND MARKETS 3.1 Orthopaedic Disease Incidence and Existing Therapies 3.1.1 Bone Fractures/Bone Repair and Replacement 3.1.2 Cartilage Degeneration and Repair 188.8.131.52 Osteochondral Allografts 184.108.40.206 Osteochondral Autograft Transfer System and Mosaicplasty 220.127.116.11 Autologous Chondrocyte Transplantation 18.104.22.168 Matrix-induced Autologous Chondrocyte Implantation 22.214.171.124 High Tibial Osteotomy 3.1.3 Meniscus Defects and Repair 3.1.4 Ligament and Tendon Injuries and Repair 3.1.5 Joint Degeneration and Destruction 3.1.6 Spinal Disc Degeneration and Repair 3.2 Emerging Tissue Engineering and Regenerative Medicine Technologies for Orthopaedic Applications and Markets 3.2.1 Bone Repair and Replacement 3.2.2 Cartilage Repair and Replacement 126.96.36.199 Cartilage Autograft Implantation System 188.8.131.52 Other Emerging Cartilage Repair and Replacement Technologies 3.2.3 Meniscus Repair and Replacement 3.2.4 Tendon and Ligament Repair and Replacement 3.2.5 Spinal Disc Repair and Replacement 3.2.6 Market Size, Market Potential and Forecast for Orthopaedic Applications 3.3 Market Drivers and Limiters 3.4 Leading Companies in Orthopaedic Tissue Engineering Exhibit 3.1: Patient Visits to Orthopaedic Surgeons, U.S., 1999-2009 Exhibit 3.2: Total Orthopaedic Surgery Procedures and Breakdown by Major Procedure, U.S., 2010 Exhibit 3.3: Worldwide Orthopaedic Surgery Procedures and Products Market, 2012 Exhibit 3.4: Ligament and Tendon Repair Procedures and Breakdown by Procedure, U.S. 2010 Exhibit 3.5: Tissue Engineering Bone and Cartilage Repair and Replacement Technologies Exhibit 3.6: Worldwide Orthobiologic Products Market, 2012 Exhibit 3.7: 2012 Sales and Market Share for Leading Suppliers in the Orthopaedic Tissue Engineering and Regenerative Medicine Market Exhibit 3.8: Worldwide Market for Tissue-Engineered Orthopaedic Products, 2011-2017 Exhibit 3.9: Worldwide Target Market for Orthopaedic Applications by Segment Exhibit 3.10: Worldwide Target Procedures for Orthopaedic Applications by Region and Segment, 2012 Exhibit 3.11: Worldwide Potential Markets for Orthopaedic Applications by Region and Segment, 2012 Exhibit 3.12: Leading Companies in Orthopaedic Tissue Engineering CHAPTER 4: APPLICATIONS AND MARKETS IN NEUROLOGY 4.1 Neurological Disease Prevalence and Incidence 4.2 Tissue Engineering and Regenerative Medicine Technologies for Neurological Applications and Market Potential 4.2.1 Tissue Engineering and Regenerative Medicine for Spinal Cord Injury and Amytrophic Lateral Sclerosis 4.2.2 Cell Implants for Parkinson's Disease 4.2.3 Cell Transplants for Epilepsy Treatment 4.2.4 Stem Cell Therapy for Multiple Sclerosis 4.2.5 Tissue Engineering for Peripheral Nerve Injury 4.2.6 Tissue Engineering Therapies for Stroke 4.2.7 Tissue Engineering Therapies for Alzheimer's Disease 4.2.8 Tissue Engineering and Cell Transplant Therapies for Central Nervous System Disorders 4.3 Market Forecast for Neurological Applications 4.4 Market Drivers and Limiters 4.5 Leading Companies in Neurological Tissue Engineering Exhibit 4.1: Worldwide Prevalence of Major Neurological Diseases by Region Exhibit 4.2: Worldwide Trends in Prevalence for Major Neurological Disorders, 2005-2030 Exhibit 4.3: Annual Incidence for Major Neurological Disorders Exhibit 4.4: Tissue Engineering Technologies for Treatment of Neurological Disorders Exhibit 4.5: Stroke Statistics for the U.S. Exhibit 4.6: Existing Therapies for Alzheimer's Disease Exhibit 4.7: Worldwide Target Market for Neurological Applications by Disease Segment Exhibit 4.8: Leading Companies in Neurological Tissue Engineering and Regenerative Medicine CHAPTER 5: APPLICATIONS AND MARKETS IN UROLOGY 5.1 Urological Disease Incidence and Prevalence 5.2 Tissue Engineering and Regenerative Medicine Technologies for Urological Applications and Market Potential 5.2.1 Treatment of Urinary Incontinence and Bladder Repair 5.2.2 Ureter Repair and Replacement 5.2.3 Urethral Repair 5.2.4 Penile Reconstruction 5.2.5 Tissue Engineering for Treatment of Vesicoureteral Reflux 5.2.6 Gene Therapy for Urological Dysfunction 5.3 Market Forecast for Urological Applications 5.4 Market Drivers and Limiters 5.5 Leading Companies in Urological Tissue Engineering Exhibit 5.1: Worldwide Incidence/Prevalence of Major Urological Diseases and Procedures by Region, 2012 Exhibit 5.2: Prevalence of Urinary Stress Incontinence by Degree of Severity and Region, 2012 Exhibit 5.3: Products for Treatment of Urinary Incontinence Exhibit 5.4: Penile Prosthesis Products Exhibit 5.5: Worldwide Urological Implant Device Market, 2011-2017 Exhibit 5.6: Worldwide Urological Tissue-Engineered Device Market versus Total Market, 2011-2017 Exhibit 5.7: Supplier Sales and Market Share in the Urological Implant Products Market, 2012 Exhibit 5.8: Worldwide Target Market for Urological Applications by Disease Segment CHAPTER 6: ORGAN REGENERATION TECHNOLOGIES AND MARKETS 6.1 Existing Products for Organ Supplementation 6.2 Organ Transplantation 6.3 Technologies for Organ Regeneration 6.3.1 Liver Regeneration 6.3.2 Pancreas and Islet Cell Regeneration 6.3.3 Kidney and Renal Tubule Regeneration 6.3.4 Small Intestine Regeneration 6.3.5 Bone Marrow Regeneration 6.3.6 Heart Regeneration 6.4 Emerging Markets for Organ Regeneration 6.5 Organ Regeneration Market Drivers and Limiters 6.6 Leading Companies in Organ Regeneration Exhibit 6.1: Worldwide Trends in Dialysis Patients by Region Exhibit 6.2: Ventricular Assist Devices and Artificial Hearts for Heart Supplementation and Replacement Exhibit 6.3: Worldwide Sales in the Heart Assist and Replacement Device Market Exhibit 6.4: U.S. Organ Transplant Procedures and Transplant Recipient Waiting List, 2006-2013 Exhibit 6.5: Organ Transplant Procedures and Registrations on Recipient Waiting List in Eurotransplant Countries, 2007-2011 Exhibit 6.6: U.S. Hospital Discharges with a Diagnosis of Liver Disease, 1995-2010 Exhibit 6.7: Worldwide Prevalence of Diabetes by Region, 2011 and 2030 Exhibit 6.8: Worldwide Target Market for Organ Regeneration Products Exhibit 6.9: Leading Companies in Organ Regeneration CHAPTER 7: TISSUE ENGINEERING AND REGENERATIVE MEDICINE FOR WOUND MANAGEMENT, SKIN REPAIR AND SKIN ULCER TREATMENT 7.1 Wound and Skin Disease Incidence and Prevalence 7.2 Tissue Engineering and Cell Transplantation Technologies for Wound Management, Skin Repair and Skin Ulcer Treatment and Market Potential 7.2.1 Wound Management 7.2.2 Burn Treatment 7.2.3 Skin Ulcer Treatment 7.2.4 Hernia and Soft Tissue Repair 7.3 Market Analysis and Forecast for Tissue Engineering and Regenerative Medicine Products for Wound Management, Skin Repair and Skin Ulcer Treatment 7.4 Market Drivers and Limiters 7.5 Competitor Analysis for Tissue Engineering and Regenerative Medicine Market for Wound Management, Skin Repair and Ulcer Treatment Exhibit 7.1: Wound and Skin Disease Incidence and Prevalence, 2011 Exhibit 7.2: Plastic and Reconstructive Surgery Procedures in the U.S., 2011 Exhibit 7.3: Tissue Engineering and Regenerative Medicine Products for Wound Management, Skin Repair, and Skin Ulcer Therapy Exhibit 7.4: Applications of Tissue-Engineered Wound and Skin Repair Products Exhibit 7.5: Worldwide Market for Tissue-Engineered Wound Management Products, 2011-2017 Exhibit 7.6: Tissue-Engineered Wound Management Product Supplier Sales and Market Share by Region, 2012 CHAPTER 8: COMPETITOR ASSESSMENT 8.1 Overview of Tissue Engineering and Regenerative Medicine Companies 8.2 Acquisitions, Mergers and Partnerships to Improve Competitive Position 8.3 Technology Portfolio Analysis for Leading Tissue Engineering and Regenerative Medicine Companies Exhibit 8.1: Overview of Leading Competitors in the Tissue Engineering and Regenerative Medicine Market Exhibit 8.2: Recent Acquisitions, Mergers and Partnerships in the Tissue Engineering and Regenerative Medicine Market Exhibit 8.3: Technology Portfolio Analysis for Key Companies in the Tissue Engineering and Regenerative Medicine Market CHAPTER 9: COMPANY PROFILES 9.1 Aastrom Biosciences 9.2 Advanced Cell Technology 9.3 Arteriocyte 9.4 Athersys 9.5 Bioheart 9.6 BioMimetic Therapeutics 9.7 BioTime 9.8 BioTissue Technologies 9.9 Cardium Therapeutics 9.10 CeraPedics 9.11 Cook Biotech 9.12 CryoLife 9.13 Cytograft Tissue Engineering 9.14 Cytomedix 9.15 Cytori Therapeutics 9.16 Gamida Cell Ltd. 9.17 GeneGrafts 9.18 Genzyme/Sanofi 9.19 Integra LifeSciences 9.20 International Stem Cell 9.21 LifeCell/Kinetic Concepts 9.22 Mesoblast 9.23 Neuralstem 9.24 NuVasive 9.25 Organogenesis 9.26 Orthopeutics 9.27 Osiris Therapeutics 9.28 Pluristem Therapeutics 9.29 ReNeuron 9.30 Shire Regenerative Medicine 9.31 StemCells Inc. 9.32 Tengion 9.33 TEI Biosciences 9.34 Viacyte APPENDIX - COMPANY LISTING