Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, 2004-2014

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
• 1.11 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