Abstract
This report examines the status of technologies, applications and markets for tissue engineering, cell therapy and tissue/cell transplantation. The report reviews therapeutic tissue engineering, tissue reconstruction, cell therapies, tissue/organ transplantation and related technologies under various stages of development at over 150 companies. The report details the technology development, projected market introduction dates and/or current and forecast market size and competitor shares for products being developed to address major causes of death and disease spanning applications in cardiovascular, neurological, orthopaedic, urological, skin, organ and others. The report details the status of product development and assesses the current and forecast worldwide market for tissue engineering, cell therapy and transplantation
Table of Contents
Section 1: Introduction
- 1.1 Overview
- 1.2 Definitions
- 1.3 Growth of Key Procedures
- 1.4 Development Challenges
- 1.4.1 Material Based Tissue Replacements
- 1.4.2 Allograft Derived Tissue Replacements
- 1.4.3 Cell and Tissue Engineered Products
- 1.5 Market Expectations for Tissue Reconstruction and Engineering
- 1.6 Unmet Clinical Needs
- 1.7 Business Models Based Upon Tissue Engineering and Cell Therapy
- 1.8 Timescales
- 1.9 Sector Challenges
- 1.9.1 Reimbursement Issues
- 1.10 Regulatory, Cost Effectiveness and Clinical Issues
- 1.10.1 Regulatory
- 1.10.1.1 USFDA and the Regulation of Products Incorporating Human Tissues
- 1.10.1.2 The European Union and Tissue Engineering Directives
- 1.10.1.3 Tissue Engineering Directives in Other Regions
- 1.10.2 Cost Effectiveness
- 1.10.3 Clinical
- 1.10.1 Regulatory
- 1.11 Competition Intensity
- 1.11.1 Industry Focus
- 1.11.2 Investment Levels
- 1.11.3 Investor Returns
Section 2:Clinical Caseload
- 2.1 Overview
- 2.2 Cardiovascular Tissue Transplantation and Engineering
- 2.2.1 Introduction
- 2.2.2 Coronary Heart Disease
- 2.2.3 Myocardial Infarction
- 2.2.4 Congestive Heart Failure
- 2.2.5 Dysfunctional Heart Valves
- 2.2.6 Peripheral Vascular Disorders
- 2.2.7 Abdominal Aortic Aneurysms
- 2.2.8 Drivers of Cardiac Tissue Engineering
- 2.3 Neurological Tissue Transplantation and Engineering
- 2.3.1 Introduction
- 2.3.2 Stroke
- 2.3.3 Parkinsons Disease
- 2.3.4 Alzheimers Disease
- 2.3.5 Epilepsy
- 2.3.6 Traumatic Brain and Spinal Injury
- 2.3.7 Multiple Sclerosis
- 2.3.8 Drivers of Neurological Tissue Engineering
- 2.4 Orthopedic Tissue Transplantation and Engineering
- 2.4.1 Introduction
- 2.4.2 Non-union Fractures
- 2.4.3 Cartilage Damage and Repair
- 2.4.4 Ligament Damage
- 2.4.5 Vertebral Disc Damage
- 2.4.6 Bone Graft Materials
- 2.4.7 Drivers of Orthopedic Tissue Engineering
- 2.5 Urological Tissue Transplantation and Engineering
- 2.5.1 Introduction
- 2.5.2 Incontinence
- 2.5.3 Kidney Disease
- 2.5.4 Drivers of Urological Tissue Engineering
- 2.6 Skin Tissue Transplantation and Engineering
- 2.6.1 Introduction
- 2.6.2 Burns
- 2.6.3 Diabetic Ulcers
- 2.6.4 Venous Ulcers
- 2.6.5 Plastic Surgery
- 2.6.6 Drivers of Skin Tissue Engineering
- 2.7 Dental Transplantation and Engineering
- 2.7.1 Missing teeth
- 2.7.2 Periodontal disease
- 2.7.3 Drivers of Dental Tissue Engineering
- 2.8 Organ Transplantation and Engineering
- 2.8.1 Introduction
- 2.8.2 Liver
- 2.8.3 Heart
- 2.8.4 Cornea
- 2.8.5 Kidney
- 2.8.6 Pancreas
- 2.8.6.1 The Edmonton Protocol
- 2.8.7 Intestinal Tissue Engineering
- 2.8.8 Drivers of Organ Replacement Tissue Engineering
Section 3: Technologies, Products, and Markets
- 3.1 Overview
- 3.2 Cardiovascular
- 3.3 Neurology
- 3.4 Orthopedics
- 3.4.1 Bone
- 3.4.2 Cartilage
- 3.5 Urology
- 3.5.1 Kidney
- 3.5.2 Urinary Incontinence
- 3.6 Skin Cell Engineering
- 3.7 Dentistry
- 3.8 Hematopoietic Engineering
- 3.9 Organ Reconstruction and Replacement
- 3.9.1 Pancreas and Islet Cells
- 3.9.2 Liver
- 3.10 Potential for Tissue Engineering Reconstruction
Section 4: Company Profiles
- 4.1 3DM Inc.
- 4.2 Aastrom Bioscience Inc.
- 4.3 Acorda Therapeutics Inc.
- 4.4 Advanced Cell Technology, Inc.
- 4.5 Advanced Medical Solutions PLC
- 4.6 Aeolus Pharmaceuticals
- 4.7 Alexion Pharmaceuticals
- 4.8 AmCyte, Inc.
- 4.9 Angiotech Pharmaceuticals, Inc.
- 4.10 Anthrogenesis Inc. (Celgene Corp.)
- 4.11 Arbios Systems Inc.
- 4.12 Ariad Pharmaceuticals Inc.
- 4.13 Arthrex Inc.
- 4.14 Avax Technologies Inc.
- 4.15 Aventis
- 4.16 Baxter International Inc.
- 4.17 BD Biosciences
- 4.18 BeFutur Biotechnologies
- 4.19 Biocomposites
- 4.20 Biocoral Inc.
- 4.21 Bioheart Inc.
- 4.22 BioHybrid Technologies
- 4.23 BioLife Solutions Inc.
- 4.24 Biomet, Inc.
- 4.25 BioMimetic Pharmaceuticals
- 4.26 Bio Nova International
- 4.27 Bionx Implants, Inc. (CONMED Corporation)
- 4.28 BioSyntech
- 4.29 BioTissue Technologies GmbH
- 4.30 Bio-Vascular Inc.
- 4.31 Boston Scientific Corporation
- 4.32 BrainStorm Cell Therapeutics, Inc.
- 4.33 Breonics
- 4.34 BresaGen Inc.
- 4.35 Cambrex Bioproducts
- 4.36 CardioTech International Inc.
- 4.37 Celadon Science, LLC
- 4.38 Celdyne Corporation
- 4.39 Celgene Corporation
- 4.40 CellECT Bio Inc.
- 4.41 CellFactors Ltd
- 4.42 Cell Genesys Inc.
- 4.43 Cell-Lining GmbH
- 4.44 Cell Pathways, Inc.
- 4.45 Cell Science Therapeutics, Inc.
- 4.46 CellSeed, Inc.
- 4.47 CellTran Ltd
- 4.48 Celmed BioSciences, Inc. (Theratechnologies)
- 4.49 Cerco Medical
- 4.50 Chiron
- 4.51 Chromos Molecular Systems, Inc.
- 4.52 Chrysalis BioTechnology, Inc. (OrthoLogic)
- 4.53 Clinical Cell Culture (C3)
- 4.54 co.don AG
- 4.55 ColBar LifeSciences Ltd.
- 4.56 Cook Group
- 4.57 CorCell, Inc.
- 4.58 CRYO-CELL International, Inc.
- 4.59 CryoLife, Inc.
- 4.60 Curis Inc.
- 4.61 Cytograft Tissue Engineering
- 4.62 Cytomatrix LLC
- 4.63 Dentigenix, Inc.
- 4.64 Encelle Inc.
- 4.65 EnduraTEC Systems Group
- 4.66 E.S. Cell International Pte Ltd
- 4.67 Exactech, Inc.
- 4.68 Excorp Medical, Inc.
- 4.69 FibroGen, Inc.
- 4.70 Fidia Advanced Biopolymers
- 4.71 Gamida--Cell Ltd
- 4.72 Genta, Inc.
- 4.73 Genetix Ltd
- 4.74 Genetix Pharmaceuticals Inc.
- 4.75 GenVec, Inc.
- 4.76 Genzyme Corporation
- 4.77 Genzyme Biosurgery
- 4.78 Genzyme Oncology
- 4.79 Geron Corporation
- 4.80 HemoCleanse, Inc.
- 4.81 HepaLife Technologies, Inc.
- 4.82 Immerge Biotherapeutics
- 4.83 Inion Ltd
- 4.84 Innogenetics (XCELLentis)
- 4.85 InnovaCell Biotechnologie GmbH
- 4.86 Integra LifeSciences Inc.
- 4.87 Interface Biologics Inc.
- 4.88 Interpore Cross International Inc.
- 4.89 IsoTis OrthoBiologics
- 4.90 ISTO Technologies Inc.
- 4.91 Islet Sheet Medical
- 4.92 Islet Technology, Inc.
- 4.93 Ixion Biotechnology Inc.
- 4.94 Johnson & Johnson Inc. (Ethicon, DePuy)
- 4.95 Kaleidos Pharma, Inc.
- 4.96 Kensey Nash
- 4.97 Keratec
- 4.98 Kourion Therapeutics AG (ViaCell)
- 4.99 Lifebank Inc.
- 4.100 LifeCell Inc.
- 4.101 Life Medical Sciences Inc.
- 4.102 LifeStem Inc. (Calba Tech, Inc.)
- 4.103 Linvatec Corporation Inc. (ConMed)
- 4.104 MacroPore Biosurgery Inc.
- 4.105 MaxCyte
- 4.106 Medtronic
- 4.107 MG Biotherapeutics, LLC
- 4.108 MicroIslet Inc.
- 4.109 Millenium Biologix Inc.
- 4.110 Musculoskeletal Transplant Foundation
- 4.111 Natural Implant
- 4.112 Nephros Therapeutics Inc.
- 4.113 NeuroGeneration, Inc.
- 4.114 NeuroNova AB
- 4.115 Neuronyx Inc.
- 4.116 Neurotech SA and Neurotech U.S. Inc.
- 4.117 Novartis International AG
- 4.118 Novocell Inc.
- 4.119 Novo Nordisk A/B
- 4.120 Oligene GmbH
- 4.121 Organogenesis Inc.
- 4.122 Organ Recovery Systems
- 4.123 Ortec International Inc.
- 4.124 OrthoLogic Corporation
- 4.125 Orthovita
- 4.126 Osiris Therapeutics Inc.
- 4.127 OsteoBiologics
- 4.128 Osteotech
- 4.129 Polyganics Ltd
- 4.130 Poly-Med, Inc.
- 4.131 Protein Polymer Technologies Inc.
- 4.132 Progenitor Cell Therapy Inc.
- 4.133 ProNeuron Biotechnologies, Inc.
- 4.134 Protherics, PLC
- 4.135 ReGen Biologics Inc.
- 4.136 Regeneration Technologies Inc.
- 4.137 ReInnervate Ltd.
- 4.138 Renaissance Cell Technologies
- 4.139 ReNeuron Ltd
- 4.140 Revivicor, Inc.
- 4.141 Sanofi-Aventis
- 4.142 Sciperio Inc.
- 4.143 Selective Genetics
- 4.144 Sertoli Technologies Inc.
- 4.145 Smith & Nephew Ltd.
- 4.146 Spiration Inc.
- 4.147 Stem Cell Pharmaceuticals Inc.
- 4.148 StemCells Inc.
- 4.149 Stem Cell Sciences Ltd
- 4.150 StemCell Technologies Inc.
- 4.151 StemSource Inc.
- 4.152 Stryker Corporation
- 4.153 Surgical Dynamics Inc.
- 4.154 Synovis Life Technologies, Inc.
- 4.155 SyStemix, Inc.
- 4.156 Targeted Genetics Inc.
- 4.157 TEI Biosciences Inc.
- 4.158 Tepha Inc.
- 4.159 Theratechnologies Inc.
- 4.160 Therics Inc.
- 4.161 TiGenix N.V.
- 4.162 Tissue Transformation Technologies Inc.
- 4.163 TheraCyte Inc.
- 4.164 TissueMed Ltd
- 4.165 Titan Pharmaceuticals Inc.
- 4.166 TolerRx, Inc.
- 4.167 Transition Therapeutics Inc
- 4.168 Triage Medical Inc.
- 4.169 TriStem Corporation
- 4.170 Vesta Therapeutics
- 4.171 ViaCell, Inc.
- 4.172 Vital Therapies, Inc.
- 4.173 Vitrolife AB
- 4.174 VivoRx
- 4.175 Xcyte Therapies, Inc.
- 4.176 XCELLentis
Appendix: List of Companies
List of Exhibits
- ES 1: Diagram of Excorp Medicals Bioartificial Liver Support System (BLSS)
- ES 2: Developments in Cardiovascular Repair
- ES 3: Developments in Neurological Repair
- ES 4: Developments in Orthopedic Repair
- ES 5: Developments in Urology Repair
- ES 6: Developments in Skin Tissue Engineering
- ES 7: Developments in Dental Tissue Engineering
- ES 8: Developments in Hematopoietic Tissue Engineering
- ES 9: Developments in Organ Replacement Engineering
- Exhibit 1-1: Corporate Involvement in Tissue Transplantation and Engineering
- Exhibit 1-2: Worldwide Market for Tissue Engineered Products, 2005-2015
- Exhibit 2-1: Potential For Cardiovascular Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-2: Potential For Neurological Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-3: Examples of Bone Graft Materials
- Exhibit 2-4: Potential For Orthopedic Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-5: Suburethral Pubovaginal Sling Materials
- Exhibit 2-6: Potential For Urological Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-7: Potential For Skin Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-8: Potential For Dental Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 2-9: Potential For Organ Transplant Tissue Engineering -- Incidences of Applicable Surgical Procedures, 2005
- Exhibit 3-1: Cardiovascular Cell Engineering Companies--Timescales
- Exhibit 3-2: Key Developments for Cardiovascular Repair
- Exhibit 3-3: Neurological Cell Engineering Companies--Timescales
- Exhibit 3-4: Key Developments in Neurological Repair
- Exhibit 3-5: Orthopedic Cell Engineering Companies--Timescales
- Exhibit 3-6: Key Developments in Orthopedic Repair
- Exhibit 3-7: Urology Cell Engineering Companies--Timescales
- Exhibit 3-8: Key Developments in Urology Repair
- Exhibit 3-9: Skin Cell Engineering Companies--Timescales
- Exhibit 3-10: Key Developments in Skin Tissue Engineering
- Exhibit 3-11: Dental Tissue Engineering Companies--Timescales
- Exhibit 3-12: Key Developments in Dental Tissue Engineering
- Exhibit 3-13: Hematopoietic Cell Engineering Companies--Timescales
- Exhibit 3-14: Key Developments in Hematopoietic Tissue Engineering
- Exhibit 3-15: Organ Replacement Engineering Companies--Timescales
- Exhibit 3-16: Key Developments in Organ Replacement Engineering
- Exhibit 3-17: Worldwide Market for Tissue Engineered Products, 2005-2015
- Exhibit 4-1: Aastrom Biosciences Development Pipeline
- Exhibit 4-2: Acorda Therapeutics Product Pipeline
- Exhibit 4-3: Alexion Pharmaceuticals Product Development Pipeline
- Exhibit 4-4: Ariad Pharmaceuticals Clinical Programs
- Exhibit 4-5: Diagram of Excorp Medicals Bioartificial Liver Support System (BLSS)
- Exhibit 4-6: LifeCell Product Revenues, 2004
- Exhibit 4-7: OrthoLogic Product Development
- Exhibit 4-8: ViaCell Product Development Pipeline
