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

Report S515

· 277 pages   · 45 Exhibits   · 176 Company Profiles   · Pub. Date April 2005   · Report #S515

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

Executive Summary

Major Clinical Areas

Cardiology

Neurology

Orthopedics

Urology

Skin

Dental

Organ Replacement and Regeneration

Development Challenges and Timescales

Corporate Participation

Technologies, Products and Markets

Section 1:        TISSUE/CELL DEVELOPMENT INDUSTRY BACKGROUND

1.1       Overview of Development in Stem Cell Therapy and Tissue Engineering

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 Cell Therapy and Tissue 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 Cell Therapy and Tissue Engineering

2.3.1          Introduction

2.3.2          Stroke

2.3.3          Parkinson’s Disease

2.3.4          Alzheimer’s 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 Cell Therapy and Tissue 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 Cell Therapy and Tissue 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/Integumentary Cell Therapy and Tissue 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 Tissue Engineering

2.7.1          Missing teeth

2.7.2          Periodontal disease

2.7.3          Drivers of Dental Tissue Engineering

2.8       Organ Transplantation, Tissue Engineering and Cell Therapies

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 of Tissue Engineering and Embryonic Stem Cell Therapy

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 Medical’s 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 Medical’s 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