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TABLE OF CONTENTS
EXECUTIVE SUMMARY
i. Overview
ii. Tissue
Engineering and Organ Regeneration Technologies
iii. Tissue
Engineered Cardiovascular Products Market
iv. Tissue
Engineered Musculoskeletal Products Market
v. Tissue
Engineered Neurological Products Market
vi. Tissue
Engineered Urology Products Market
vii. Tissue
Engineered Organ Regeneration Products Market
viii. Tissue
Engineered Skin Repair and Replacement Products Market
ix. Combined
Potential Market Forecast
1. TISSUE
ENGINEERING
AND
ORGAN REGENERATION TECHNOLOGIES
1.1 Biomaterials
Technology
1.2 Synthetic
Materials
1.2.1 Scaffolds
1.2.1.1 Materials
1.2.1.2 Future Scaffold Technologies
1.2.2 Skin Repair and Replacement Materials
1.2.3 Bone Replacement Materials
1.2.4 Materials for Artificial Vascular Grafts
1.2.5 Hydrogel Technology
1.3 Biologically
Derived Materials
1.3.1 Collagen
1.3.1.1 Animal-Derived Collagen
1.3.1.2 Recombinant Collagen
1.3.2 New Materials and Applications
1.4 Genetically
Engineered Materials
1.4.1 Three-Dimensional Polymer Technology
1.4.2 Deoxyribonucleic Acid Transfection Vectors
1.4.3 Fibroblasts
1.4.4 Gene-Activated Matrices
1.4.5 Genetically Manipulated Cells
1.4.6 Genetically Modified Animal Organs
1.4.7 Mesenchymal Stem Cells
1.4.8 Neural Stem Cells
1.5 Cell Culture
Technologies
1.5.1 Bioreactors
1.5.1.1
Conventional Mammalian Cell Suspension Culture Systems
1.5.1.2 Flat Bed
Perfusion Systems
1.5.1.3 Hollow
Fiber Bioreactor Systems
1.5.2 Stem Cell Technology
1.5.2.1 Stem Cell
Extraction Methods and Devices
1.5.2.2 Stem Cell
Expansion Ex Vivo
1.5.2.3 Stem Cell
Expansion Culture Conditions
1.5.2.4
Biotechnology Aspects
1.5.2.5
Serum-Free Culture
1.5.2.6
Bioreactors
1.6
Immunoisolation Technologies
1.6.1 Chimeric Immunity
1.6.2 Antibody/Polymer Technology
1.6.3 Cell Encapsulation Technology
2. TISSUE
ENGINEERED CARDIOVASCULAR PRODUCTS MARKET
2.1 Disease
Incidence and Market Potential Estimates
2.1.1 Coronary Artery Disease
2.1.2 Acute Myocardial Infarction
2.1.3 Patients with End-Stage Disease
2.1.4 Dysfunctional Heart Valves
2.1.5 Transplantation
2.1.6 Peripheral Vascular Disease
2.1.7 Abdominal Aortic Aneurysms
2.2 Developmental
Issues
2.2.1 Bioreactors
2.3 Emerging
Technologies
2.3.1 Tissue Engineered Heart Valves
2.3.2 Biological Scaffolds
2.3.3 Antigen Removal
2.3.4 Synthetic Scaffolds
2.3.5 Early Calcification
2.3.6 Bioreactor Technology and Heart Valves
2.3.7 Bone Marrow Cells
2.3.8 Tissue Engineered Vascular Grafts
2.3.8.1 Synthetic Grafts and Scaffolds
2.3.8.1.1 Cell-Based Approaches
2.3.8.1.2 Polytetrafluoroethylene
2.3.8.1.3 Polyurethane
2.3.8.2 Smooth Muscle Cells
2.3.8.3 Biological Tissues
2.3.8.3.1 Allogenic Tissue
2.3.8.3.2 Decellularized Tissue
2.3.8.3.3 Xenogenic Tissue
2.3.8.4 Collagen/Polymer Composite Constructs
2.3.8.5 Chitosans
2.3.8.6 Collagen Matrix
2.3.8.7 Genetically Altered Tissue
2.3.8.8 Elastin Scaffold
2.3.9 Cell-Based
Approaches to Myocardial Tissue Regeneration
2.3.9.1 Muscle Cell Therapy
2.3.9.2 Stem Cell Therapy
2.3.9.2.1 Stem Cell Mobilization
2.3.9.2.2 Mesenchymal Stem Cells
2.3.9.2.3 Human
Embryonic Stem Cells
2.3.9.2.4 Myoblasts Versus Stem Cells
2.3.9.2.5 Stem Cell Mobilization Study
2.4 Gene Therapy
2.4.1 Therapeutic
Angiogenesis
2.4.1.1 Routes of Administration
2.4.1.1.1 Direct
Infusion
2.4.1.1.2
Intracoronary Injection
2.4.1.1.3
Adenoviral Vector Delivery
2.4.1.1.4 Lipid
Gene Delivery Systems
2.4.1.1.5 Naked
Deoxyribonucleic Acid
2.4.1.1.6
Transmyocardial Revascularization
2.4.1.1.7
Fibroblastic Growth Factor
2.4.1.1.8 Growth
Factors Under Development
2.4.1.1.9
Angiopoietins
2.4.1.1.10
Chrysalin
2.4.1.1.11 PR39
Peptide
2.4.2 Restenosis
Prevention
2.4.2.1 Drug-Eluting Coronary Stents
2.4.2.2 Bioengineered Surfaces
2.4.2.3 Catheter-Mediated Gene Transfer
2.4.3
Adenoviral-Based Gene Therapy
2.5 Market
Analysis
2.6 Market
Drivers and Limiters
2.7 Key Companies
and Competitor Market Shares
3. TISSUE
ENGINEERED MUSCULOSKELETAL PRODUCTS MARKET
3.1 Disease
Incidence and Existing Therapies
3.1.1 The Joint
Degeneration Process
3.1.2 Cartilage
Injuries
3.1.2.1 Current Treatments
3.1.2.1.1 Knee
Cartilage Removal Outcomes
3.1.2.1.2
Osteochondral Grafting
3.1.2.2 Viscosupplementation
3.1.3 Ligament
and Tendon Injuries
3.1.3.1 Anterior Cruciate Ligament Repair
3.1.3.1.1
Ligament Fixation
3.1.4 Soft-Tissue Shoulder Repair
3.1.4.1 Rotator Cuff Repair
3.1.4.1.1 Rotator Cuff Patch Materials
3.1.5 Meniscal Repair
3.1.5.1 Treatment
3.1.5.2 Transplantation
3.1.6 Bone Grafts
3.1.6.1 Orthopedic Indications
3.1.6.2 Treatment
3.1.6.2.1 Fracture Repair
3.1.6.2.2 Revision Total Joint Surgery
3.1.6.2.3 Bone Cysts and Tumors
3.1.6.2.4 Spinal Indications
3.1.6.3 Potential Bone Grafting Procedures
3.1.6.4 Bone Grafting Materials
3.1.6.4.1 Allogenic Bone Grafts
3.1.6.4.2 Synthetic Bone Grafts
3.1.6.5 Bone Grafting Market
3.2 Technologies
Under Development
3.2.1 Cartilage Repair and Replacement
3.2.1.1 Cell Transplantation
3.2.1.1.1
Autologous Chondrocyte Implantation
3.2.1.1.2
Mesenchymal Stem Cells
3.2.1.2 Genetically Altered Cells
3.2.1.3 Acellular Matrices
3.2.1.3.1 Polymer Matrices
3.2.1.3.2 Collagen Matrices
3.2.1.3.3 Growth
Factor-Impregnated Matrices
3.2.2 Ligament Repair and Replacement
3.2.2.1 Biologic Scaffolds
3.2.2.1.1 Small
Intestinal Submucosa
3.2.2.1.2
Collagen Scaffolds
3.2.2.1.3
Allogenic Scaffolds
3.2.2.1.4
Xenogenic Scaffolds
3.2.2.2 Mesenchymal Stem Cells
3.2.3 Meniscus
Repair and Replacement
3.2.3.1 Allogenic Meniscal Transplants
3.2.3.2 Xenographic Scaffolds
3.2.3.3 Collagen Scaffolds
3.2.3.4 Polymeric Templates
3.2.3.5 Mesenchymal Stem Cells
3.2.4 Bone Repair
and Replacement
3.2.4.1
Biomaterial Technologies for Bone Repair
3.2.4.2 Bone Growth Factors
3.2.4.2.1 Bone
Morphogenic Proteins
3.2.4.2.2
Fibroblast Products
3.2.4.2.3
Extracted Products
3.2.4.2.4
Bovine-Sourced Products
3.2.4.2.5 Cell
Separating Systems
3.2.4.3 Demineralized Bone Matrix
3.2.4.4 Cell Transplantation
3.2.4.4.1
Autologous Cells
3.2.4.4.2 Stem
Cells
3.2.4.5 Synthetic
Peptides
3.2.4.6
Polyethylene Oxide and Polybutylene Terephthalate Scaffold
3.2.4.7 Gene
Therapy
3.2.4.7.1 Gene
Therapy Versus Growth Factors
3.2.4.7.2
Systemic Gene Therapy
3.2.4.7.3
Regional Gene Therapy
3.2.4.7.4 Lim
Mineralization Protein Gene
3.3 Market
Analysis
3.3.1 Market
Drivers and Limiters
3.3.2 Key
Companies
4. TISSUE
ENGINEERED NEUROLOGICAL PRODUCTS MARKET
4.1 Existing
Treatments
4.1.1 Alzheimer’s Disease
4.1.2 Epilepsy
4.1.3 Multiple Sclerosis
4.1.4 Parkinson’s Disease
4.1.5 Peripheral Nerve Injury
4.1.6 Spinal Cord Injury
4.1.7 Stroke
4.2 Technologies
Under Development
4.2.1 Cell Transplantation
4.2.1.1 Embryonic
Stem Cells
4.2.1.2 Ependymal
Stem Cells
4.2.1.3 Fetal
Porcine Cells
4.2.1.4
Implantable Cell Systems
4.2.1.5 Retinal
Pigmented Epithelial Cell Transplants
4.2.1.6 Sonic
Hedgehog
4.2.1.7
Transgenic-Engineered Neurons
4.2.2 Gene Therapy
4.2.3 Nerve Regeneration
4.2.3.1
Decellularized Matrix
4.2.3.2
Peripheral Nerve Guide
4.2.4 Spinal Cord Regeneration
4.2.4.1 Dural
Graft Matrix
4.2.4.2 Embryonic
Stem Cells
4.2.4.3 Growth
Factors
4.2.4.4
Remyelinating Monoclonal Antibodies
4.2.4.5
Transgenically Engineered Porcine Cells
4.2.5 Stroke Treatments
4.2.5.1 Fetal
Porcine Cells
4.2.5.2 Growth
Factors
4.2.5.3
Neurological Self-Repair System
4.2.5.4
Oligopeptide EAK16
4.3 Market
Analysis
4.4 Market
Drivers and Limiters
4.4.1 Market Drivers
4.4.2 Market Limiters
4.5 Key Companies
5. TISSUE
ENGINEERED UROLOGY PRODUCTS MARKET
5.1 Disease
Incidence
5.1.1 Key Applications
5.2 Existing
Products and Therapies
5.2.1 Bladder, Ureter, and Urethra Repair
5.2.2 Penile Prostheses
5.2.3 Urinary Incontinence
5.2.4 Vesicoureteral Reflux
5.3 Technologies
Under Development
5.3.1 Biomaterials in Urological Tissue Engineering
5.3.2 Bladder Repair and Replacement
5.3.3 Cell-Based Gene Therapy
5.3.4 Genital Tissue Engineering
5.3.5 Reconstituted Structures
5.3.6 Ureter Repair and Replacement
5.3.7 Urethral Augmentation
5.4 Market
Analysis
5.4.1 Market Drivers and Limiters
5.4.1.1 Market
Drivers
5.4.1.2 Market
Limiters
5.4.2 Key Companies
6. TISSUE
ENGINEERED ORGAN REGENERATION PRODUCTS MARKET
6.1 Disease
Incidence
6.1.1 Liver Disease
6.1.2 Kidney Disease
6.1.3 Diabetes
6.1.4 Intestinal Disorders
6.1.4.1 Intestinal Pseudo-Obstruction
6.1.4.2 Microvillus Inclusion Disease
6.1.4.3 Short Bowel Syndrome
6.1.5 Bone Marrow Disease
6.1.5.1 Aplastic Anemia
6.1.5.2 Leukemia and Lymphoma
6.2 Existing
Treatments
6.2.1 Ex Vivo Systems
6.2.1.1 Kidney Dialysis
6.2.2 Organ Transplantation
6.2.2.1 Liver Transplantation
6.2.2.1.1 Split
Cadaveric Livers
6.2.2.1.2 Liver
Segments from Living Donors
6.2.2.2 Kidney Transplantation
6.2.2.3 Pancreas Transplantation
6.2.2.4 Intestinal Transplantation
6.2.2.5 Bone Marrow Transplantation
6.3 Emerging
Organ Supplementation Devices
6.3.1 Artificial Livers
6.3.2 Artificial Kidneys
6.4 Emerging
Markets for Organ Regeneration
6.4.1 Research Approaches to Organ Regeneration
6.4.1.1
Scaffolding
6.4.1.2 Stem Cell
Injection
6.4.1.3
Xenotransplantation
6.4.2 Bone Marrow Replacement
6.4.2.1 Products
and Technologies
6.4.2.1.1
Extraction Technology
6.4.2.1.2
Mesenchymal Stem Cells
6.4.2.1.3
Perfusion-Based Cell Expansion
6.4.2.1.4 Stem
Cell Expansion Culture Conditions
6.4.2.1.5 Stem
Cell Expansion Ex Vivo
6.4.2.1.6
Three-Dimensional Cell Growth Scaffolds
6.4.3 Intestine
6.4.3.1 Products
and Technologies
6.4.4 Kidney
6.4.4.1 Products
and Technologies
6.4.4.1.1 Growth
Factors
6.4.4.1.2 Stem
Cells
6.4.5 Liver
6.4.5.1 Products
and Technologies
6.4.5.1.1
Laboratory-Grown Liver Cells
6.4.5.1.2 Stem
Cells
6.4.6 Pancreas
6.4.6.1 Products
and Technologies
6.4.6.1.1
Artificial Pancreas
6.4.6.1.2
Encapsulated Cell Technology
6.4.6.1.3 Other
Technologies
6.5 Market
Analysis
6.5.1 Market Drivers and Limiters
6.5.1.1 Market
Drivers
6.5.1.1.1 Cost
6.5.1.1.2 Disease
Incidence Increases
6.5.1.1.3 Organ
Shortages
6.5.1.2 Market
Limiters
6.5.1.2.1
Advances in Alternative Therapies
6.5.1.2.2
Developmental Issues
6.5.1.2.3
Immunosuppression
6.5.1.2.4 Lack of
Research
6.5.1.2.5 Success
in Treatment
6.5.2 Key Companies
7. TISSUE
ENGINEERED SKIN REPAIR AND REPLACEMENT PRODUCTS MARKET
7.1 Disease
Incidence
7.1.1 Burns
7.1.2 Skin Ulcers
7.1.2.1 Diabetic
Foot Ulcers
7.1.2.2 Pressure
Ulcers
7.1.2.3 Venous
Stasis Ulcers
7.1.3 Plastic or Reconstructive Surgery
7.2 Current and
Emerging Products and Technologies
7.2.1 Artificial Skin
7.2.1.1 Allograft
Technology
7.2.1.2
Cell-Based Technology
7.2.1.3 Skin
Regeneration Products
7.2.1.4 Synthetic
Skin Substitutes
7.2.2 Ulcer Treatment
7.2.3 Wound Repair
7.3 Market
Analysis
7.3.1 Market Drivers
7.3.2 Market Limiters
7.4 Key Companies
8. COMPANY
PROFILES
8.1 Aastrom Biosciences, Inc.
8.2
Boston Scientific
Corporation
8.3 CellECT Bio, Inc.
8.4 Cook Group
8.5 CryoLife, Inc.
8.6 Curis, Inc.
8.7 Cytomatrix, Inc./CordLife, Inc.
8.8 GenVec, Inc.
8.9 Genzyme Corporation
8.10 Integra LifeSciences Holdings Corporation
8.11 IsoTis OrthoBiologics, Inc.
8.12 LifeCell Corporation
8.13 Osiris Therapeutics, Inc.
8.14 Osteotech, Inc.
8.15
Protein Polymer Technologies, Inc.
8.16
ReGen Biologics, Inc.
8.17 Regeneration Technologies, Inc.
8.18 Smith & Nephew, Inc./Smith & Nephew
PLC
8.19 StemCells, Inc.
8.20 TEI Biosciences, Inc.
8.21 Tepha, Inc.
8.22 Titan Pharmaceuticals, Inc.
8.23 Teraklin Medical Products, Inc./Teraklin AG
8.24 Valentis, Inc.
8.25 Wright Medical Technology, Inc.
APPENDIX:
COMPANY LISTING
LIST OF EXHIBITS
Exhibit ES-1:
Tissue Engineered Cardiovascular Products, United States and
Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit ES-2:
Tissue Engineered Musculoskeletal Products, United States and
Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit ES-3:
Tissue-Engineered Neurological Products, United States and Worldwide
Potential Market Forecasts, 2003 and 2013
Exhibit ES-4:
Tissue Engineered Urological Products, United States and Worldwide
Potential Market Forecasts, 2003 and 2013
Exhibit ES-5:
Tissue Engineered Organ Regeneration Products, United States and
Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit ES-6:
Tissue Engineered Skin Repair and Replacement Products, United
States and Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit ES-7:
Tissue Engineered Skin Repair and Replacement Products, Market
Forecast, 2003-2013
Exhibit ES-8:
Tissue Engineered Products, United States and Worldwide Combined
Potential Market Forecasts, 2003 and 2013
Exhibit 1-1:
2004, Selected Synthetic Biomaterials Used in Tissue Engineering and
Organ Replacement/Regeneration Applications
Exhibit 1-2:
2004, Selected Synthetic Materials Used in the Manufacture of Tissue
Engineered Products
Exhibit 1-3:
2004, Selected Bone Replacement Materials
Exhibit 1-4:
2004, Selected Biologically Derived Materials Used in Tissue
Engineering and Organ Replacement/Regeneration Applications
Exhibit 1-5:
2004, Selected Genetically Engineered Materials in Development
Exhibit 1-6:
Comparison of Cell Extraction Devices and Methods
Exhibit 2-1:
Potential Number of Patients for Cardiovascular Tissue Engineering
Exhibit 2-2:
2003, Heart Valve Replacement and Repair, Procedure Volumes
Exhibit 2-3:
Heart Transplantation, Historical Procedure Volumes, 1993-2003
Exhibit 2-4:
2003, Aortic and Peripheral Vascular Repair, Procedure Volumes
Exhibit 2-5:
2004, Selected Emerging Tissue Engineered Heart Valves
Exhibit 2-6:
2004, Selected Emerging Tissue Engineered Vascular Grafts
Exhibit 2-7:
2004, Selected Cell-Based Myocardial Regeneration Products
Exhibit 2-8:
2004, Selected Cell Infusion Catheters for Cardiac Use
Exhibit 2-9:
2004, Selected Emerging Products for Angiogenesis
Exhibit 2-10:
2004, Selected Emerging Products for Anti-Restenosis
Exhibit 2-11:
Tissue Engineered Cardiac and Vascular Products,
United States
and Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit 2-12:
Technologies Competing with Tissue-Engineering, 2003 and 2013
Exhibit 2-13:
2003, Tissue-Engineered Cardiovascular Products Market, Leading
Competitors, by Segment
Exhibit 2-14:
Tissue Engineered Cardiovascular Therapy Products, Product
Introduction Forecast, by Company, 2008 and 2013
Exhibit 3-1:
2003, Cartilage-Related Knee Arthroscopy Procedure Volumes, by Type
Exhibit 3-2:
2004, Selected Current and Emerging Viscosupplementation Products
Exhibit 3-3:
2003, Ligament and Tendon Repair/Replacement Procedures, by Site
Exhibit 3-4:
2004, Selected Rotator Cuff Patches
Exhibit 3-5:
Rotator Cuff Patches, Potential Market Forecast, 2004-2008
Exhibit 3-6:
2003, Meniscal Repair and Replacement, Procedure Volumes, by Type
Exhibit 3-7:
2003, Orthopedic and Spinal Bone Grafting, Potential Procedure
Volumes
Exhibit 3-8:
2003, Leading Tissue Processors
Exhibit 3-9:
2004, Applications for Allogenic Bone in Musculoskeletal Surgery
Exhibit 3-10:
2003, Allogenic and Synthetic Bone Replacement Products Market
Exhibit 3-11:
2004, Selected Companies Developing Tissue Engineering Technologies
for Orthopedic Applications
Exhibit 3-12:
2004, Selected Tissue Engineered Cartilage Repair and Replacement
Products
Exhibit 3-13:
2004, Cost Comparison of Knee Procedures, by Type
Exhibit 3-14:
2004, Selected Emerging Ligament Repair and Replacement Products
Exhibit 3-15:
2004, Selected Emerging Meniscal Repair and Replacement Products
Exhibit 3-16:
2004, Selected Tissue Engineered Bone Repair Products
Exhibit 3-17:
2003, Allogenic Demineralized Bone Matrix Products Market, End-User
Sales and Share by Product/Supplier
Exhibit 3-18:
Comparison of Growth Factors and Gene Therapy for Bone Repair
Exhibit 3-19:
Gene Therapy Delivery Methods for Bone Repair
Exhibit 3-20:
2003, Tissue Engineered Musculoskeletal Products Market, by Type
Exhibit 3-21:
United States and Worldwide, Tissue Engineered Musculoskeletal
Products, Potential Market Forecasts, 2003 and 2013
Exhibit 3-22:
End-User Revenues of Tissue Engineered Products in Musculoskeletal
Surgery
Exhibit 4-1:
2004, Parkinson’s Disease Drug Treatments, by Drug Category and
Mechanism
Exhibit 4-2:
2004, Selected Tissue Engineered Products for the Treatment of
Neurological Diseases
Exhibit 4-3:
Tissue-Engineered Neurological Products, United States and Worldwide
Potential Market Forecasts, 2003 and 2013
Exhibit 4-4:
Competing Technologies in Neurological Therapy, 2003 and 2013
Exhibit 4-5:
Tissue Engineered Neurological Therapy Products, Product
Introduction Forecast, by Company, 2008 and 2013
Exhibit 5-1:
2003, Potential Urological Applications for Tissue Engineering
Technology
Exhibit 5-2:
2003, Tissue Engineered Urological Products, Procedure Volumes
Exhibit 5-3:
Tissue Engineered Urological Products, United States and Worldwide
Potential Market Forecasts, 2003 and 2013
Exhibit 5-4:
Competitive Technologies in Urological Therapy, 2003 and 2013
Exhibit 5-5:
Tissue Engineered Urology Products, Product Introduction Forecast,
by Company, 2008 and 2013
Exhibit 6-1:
Selected Organ Diseases, Facts and Figures
Exhibit 6-2:
2003, Organ Transplantation, Procedure Volumes
Exhibit 6-3:
2004, Selected Emerging Organ Supplementation or Short-Term Support
Products
Exhibit 6-4:
2004, Selected Organ Regeneration Development Programs
Exhibit 6-5:
2004, Selected Emerging Tissue Engineered Products for Diabetes
Therapy
Exhibit 6-6:
Tissue Engineered Organ Regeneration Products, United States and
Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit 6-7:
Organ Replacement Technologies, 2003 and 2013
Exhibit 6-8:
2003, Tissue Engineered Organ Regeneration Products, Product
Introduction Forecast, by Company, 2003 and 2013
Exhibit 7-1:
2003, Tissue Engineered Burn and Ulcer Repair, Potential Procedure
Volumes
Exhibit 7-2:
2004, Selected Current and Emerging Tissue Engineered Skin Repair
and Replacement Products
Exhibit 7-3:
Tissue Engineered Skin Repair and Replacement Products, United
States and Worldwide Potential Market Forecasts, 2003 and 2013
Exhibit 7-4:
Tissue Engineered Skin Repair and Replacement Products, Market
Forecast, 2003-2013
Exhibit 7-5:
2003, Tissue Engineered Skin Repair and Replacement Products Market,
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