272 Pages | 75 Exhibits | 2013 Analysis | Forecasts Through 2017 Product Family: Market Reports

The market for tissue engineering and regenerative medicine products used in human therapeutics is one of the most rapidly growing sectors within the medical products market, and has reached only a small fraction of its long-term potential. The market is based on new biomaterials technologies, including synthetic materials, biologically derived materials, and genetically engineered materials, as well as stem cell technology, cell culture technology, and immunopassivation and immunomodulation. Advances in those technologies are enabling development of a new generation of medical devices based on cellular therapy, targeted cell stimulation, and engineered cell growth.

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.


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


1.1 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


2.1 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


3.1 Orthopaedic Disease Incidence and Existing Therapies
	3.1.1 Bone Fractures/Bone Repair and Replacement
	3.1.2 Cartilage Degeneration and Repair Osteochondral Allografts Osteochondral Autograft Transfer System and Mosaicplasty Autologous Chondrocyte Transplantation Matrix-induced Autologous Chondrocyte Implantation 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 Cartilage Autograft Implantation System 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


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


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


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


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


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


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



  1. 3H Biomedical AB
  2. Aastrom Biosciences
  3. AbioMed, Inc.
  4. Acell, Inc.
  5. AdiCyte
  6. Advanced Cell Technology, Inc.
  7. Aesculap/B Braun
  8. Agera Laboratories
  9. Aldagen
  10. AlloCure, Inc.
  11. Altrika Ltd
  12. American Medical Systems
  13. Amgen
  14. Amorcyte
  15. AMS Medical Solutions
  16. Angel Biotechnology
  17. AnGes MG
  18. Angioblast Systems, Inc.
  19. Anthrogenesis
  20. Applikon Biotechnology B.V.
  21. Arteriocyte
  22. Arthrokinetics plc
  23. Athersys, Inc.
  24. Atrium Medical
  25. Audax Medical
  26. BabyTooth Technologies, Inc.
  27. Bard Peripheral Vascular
  28. Baxter Healthcare
  29. Bayer Schering Pharma
  30. Berkeley Advanced Biomaterials
  31. Berlin Heart
  32. BIO2 Technologies, Inc.
  33. BioCancell Therapeutics
  34. Biocardia, Inc.
  35. BioEden
  36. Biofisica
  37. Biogen Idec
  38. Bioheart Inc.
  39. BioMimetic Therapeutics, Inc.
  40. Biorestorative Therapies
  41. BioSyntech
  42. Bioteck s.r.l.
  43. BioTransplant, Inc.
  44. Boston Scientific
  45. Brainstorm Cell Therapeutics, Inc.
  46. Bristol Myers Squibb
  47. California Stem Cell
  48. Calimmune, Inc.
  49. Carbon Medical Technologies, Inc.
  50. Capricor, Inc.
  51. Cardio3 BioSciences
  52. Cardium Therapeutics
  53. CBR Systems
  54. Cellerant Therapeutics
  55. Cellerix
  57. Cell Genesys
  58. Cellon SA
  59. Cells for Life Ltd. (Canada)
  60. Celltran Limited
  61. Cellulogix International
  62. Celprogen, Inc.
  63. Cerapedics, Inc.
  64. CJ CheilDejang
  65. CoAxia
  66. Co.don
  67. Cold Genesys, Inc.
  68. Coloplast
  69. Cook Group/Cook Biotech
  70. CorCell/Cord Blood America
  71. Cordis/Johnson & Johnson
  72. CORD:USE
  73. CordPartners (CorCell)
  74. Concentric Medical
  75. Cousin Biotech
  76. Covidien
  77. C.R. Bard
  78. Cryobanks International
  79. CryoCell International
  80. CryoCord (Malaysia)
  81. CryoLife
  82. Cryo-Save Group
  83. Curative Biosciences
  84. Curis
  85. Cyberkinetics Neurotechnology Systems
  86. Cyberonics
  87. Cytograft Tissue Engineering, Inc.
  88. Cytomedix, Inc.
  89. Cytori Therapeutics
  90. DePuy Orthopaedics/J&J
  91. DomaniCell (subsidiary of Progenitor Cell Therapy)
  92. Edwards Lifesciences
  93. Elan Pharmaceuticals
  94. Eli Lilly
  95. Eisai Pharmaceuticals
  96. ES Cell International
  97. Ethicon/J&J
  98. Fate Therapeutics, Inc.
  99. Fenwal
  100. Fibrocell Science
  101. Fidia Farmaceuticis S.p.A.
  102. Forest Pharmaceuticals (subsidiary of Forest Laboratories)
  103. Forticell Bioscience
  104. Fresenius Medical Care AG & Co. KGaA
  105. Future Health Technologies Ltd.
  106. Gambro AB
  107. Gamida Cell Ltd. Cell Therapy Technologies
  108. GeneGrafts LTD.
  109. Geistlich Pharma AG
  110. GenVec, Inc.
  111. Genzyme
  112. Geron Corporation
  113. GlaxoSmithKline
  114. Glen Mills
  115. Glycosan BioSystems, Inc.
  116. Harbor MedTech, Inc.
  117. Harvest Technologies
  118. Healthcord Cryogenics
  119. Haemonetics
  120. HemaCare
  121. Histogen
  122. Histogenics
  123. Hospira
  124. Humacyte, Inc.
  125. ICOS Therapeutics (subsidiary of Eli Lilly)
  126. Insception Biosciences
  127. Integra LifeSciences
  128. IntelliCell BioSciences
  129. International Stem Cell Corporation
  130. Islet Sciences
  131. Islet Sheet Medical
  132. Isolagen
  133. ISTO Technologies
  134. ITxM Cord Blood Services
  135. Jarvik Heart
  136. JCR Pharmaceuticals
  137. Jecoli Pty Ltd.
  138. J&J Gynecare
  139. Johnson & Johnson Mitek (DePuy Mitek)
  140. Johnson & Johnson Regenerative Therapeutics
  141. J.P. McCarthy Cord Stem Cell Bank
  142. Juventas Therapeutics, Inc.
  143. Kensey Nash
  144. Kinetic Concepts, Inc.
  145. LifebankUSA
  146. LifeCell
  147. LifeCord (LifeSouth Community Blood Centers)
  148. Lifeline Cord Blood Bank
  149. Living Cell Technologies
  150. LoneStar Heart
  151. Macropore Biosurgery, Inc.
  152. Matricel GmbH
  153. M.A.Z.E. Labs
  154. Medical Device Alliance/Arthrocare
  155. Medisorb Technologies
  156. Medistem Laboratories
  157. Medtronic
  158. Mercator MedSystems
  159. Mesoblast Ltd.
  160. MicroMed Cardiovascular
  161. Mirus Bio LLC
  162. Miltenyi Biotech
  163. Mosaic Biosciences
  164. MultiCell Technologies
  165. MultiGene Vascular Systems (MGVS) Ltd.
  166. Miromatrix Medical, Inc.
  167. Musculoskeletal Transplant Foundation
  168. Mylan Bertek Pharmaceuticals
  169. Neomedic
  170. NeoStem, Inc.
  171. New Brunswick Scientific
  172. NeuralStem
  173. NeuroMetrix
  174. Neuronyx, Inc.
  175. Neurotech Pharmaceuticals
  176. Newborn Blood Banking
  177. NMT Medical
  178. Novartis Corporation
  179. NovaThera/MedCell Bioscience
  180. NuVasive
  181. Olympus
  182. OrbusNeich
  183. Organogenesis
  184. Ormed GmbH & Co. KG
  185. Orthocell Pty Ltd
  186. Orthofix International NV
  187. Orthogen AG
  188. Ortho-McNeil
  189. Orthopeutics LLP
  190. Osiris Therapeutics, Inc.
  191. Osteopore International
  192. Osteotech
  193. OvaScience
  194. Pegasus Biologics
  195. Pervasis Therapeutics
  196. Pfizer
  197. Pioneer Surgical Technology
  198. Piramal Enterprises Limited
  199. Plureon Corporation
  200. Pluristem Therapeutics
  201. Progenitor Cell Therapy LLC
  202. Progentix Orthobiology BV
  203. Promedon
  204. Promethera Biosciences S.A./N.V.
  205. Prosurg
  206. Protein Polymer Technologies
  207. Q Therapeutics
  208. Regenerative Medical Services
  209. Regenerative Sciences
  210. Regenicin, Inc.
  211. ReGenLab SA
  212. RegenoCELL Therapeutics
  213. RenaMed Biologics
  214. ReNeuron Group plc
  215. Rhinocyte
  216. SaluMedica, LLC
  217. Saneron CCEL Therapeutics
  218. Sanofi Aventis
  219. Sartorius Corporation
  220. Shionogi Pharma (formerly Sciele Pharma)
  221. Scil Technology
  222. SecuraCell
  223. Sewon Cellontech
  224. Shire Regenerative Medicine
  225. Silimed Comercio de Produtos Medico-Hospitalares Ltda.
  226. Smith & Nephew
  227. Stem Cell Innovations
  228. StemCells Inc.
  229. StemCell Technologies
  230. StemCell Therapy International
  231. StemCor Systems
  232. StemCyte International
  233. Stemedica Cell Technologies
  234. Stem Sciences Cord Blood Bank
  235. StemTech International
  236. St. Jude Medical
  237. Stryker
  238. SurgaColl Technologies Ltd.
  239. Symetis AG
  240. SynCardia Systems
  241. SynerGene Therapeutics, Inc.
  242. SynGen, Inc.
  243. t2cure GmbH
  244. Tengion, Inc.
  245. Tepha Inc.
  246. TETEC Tissue Engineering Technologies AG
  247. Teva Pharmaceutical
  248. Theradigm
  249. Therics (subsidiary of Integra LifeSciences)
  250. Thoratec
  251. TiGenix NV
  252. Tissue Regenix Ltd.
  253. Tissue Repair Company (subsidiary of Cardium Therapeutics)
  254. Titan Pharmaceuticals
  255. Uromedica
  256. Uroplasty
  257. ViaCord
  258. Viacyte (formerly Novocell)
  259. ViCal
  260. W.L. Gore & Associates
  261. World Heart Corporation
  262. Wright Medical Group
  263. Wyeth
  264. XMEDICA S.R.L.
  265. Zellwerk GmbH
  266. Zen-bio
  267. Zimmer
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