Tissue Engineering and Cell Transplantation: Technologies, Opportunities, and Evolving Markets in the U.S.

Published by: Medtech Insight

Published: Jul. 1, 2007 - 355 Pages

Table of Contents

EXECUTIVE SUMMARY

i. Tissue Engineering and Cell Transplantation Technologies

ii. Tissue Engineered Cardiac and Vascular Products

iii. Tissue Engineered Musculoskeletal Products

iv. Tissue Engineered Neurologic Products

v. Tissue Engineered Urologic Products

vi. Tissue Engineered Organ Regeneration Products

vii. Tissue Engineered Skin Replacements and Substitutes

viii. Combined Market Forecast

Exhibit ES-1: Tissue Engineered Cardiac and Vascular Products, Potential Market Forecast, 2006 and 2016

Exhibit ES-2: Tissue Engineered Musculoskeletal Products, Potential Market Forecast, 2006 and 2016

Exhibit ES-3: Tissue Engineered Neurologic Products, Potential Market Forecast, 2006 and 2016

Exhibit ES-4: Tissue Engineered Urologic Products, Potential Market Forecast, 2006 and 2016

Exhibit ES-5: Tissue Engineered Organ Regeneration Products, Potential Market Forecast, 2006 and 2016

Exhibit ES-6: Tissue Engineered Skin Replacements and Substitutes, Potential Market Forecast, 2006 and 2016

Exhibit ES-7: Tissue Engineered Products, Combined Potential Market Forecast, 2006 and 2016

1. TISSUE ENGINEERING AND ORGAN REGENERATION TECHNOLOGIES

1.1 Biomaterials Technology

1.1.1 Synthetic Materials

1.1.1.1 Scaffold Materials

1.1.1.1.1 Types

1.1.1.1.2 Emerging Scaffold Technologies

1.1.1.2 Bone Replacement Materials

1.1.1.3 Artificial Vascular Graft Materials

1.1.1.4 Hydrogel Technology

1.1.2 Biologically Derived Materials

1.1.2.1 Collagen

1.1.2.1.1 Animal-Derived

1.1.2.1.2 Recombinant

1.1.2.2 Xenogenic Tissue

1.2 Genetically Engineered Materials

1.2.1 Deoxyribonucleic Acid Transfection Vectors

1.2.2 Genetically Manipulated Cells

1.2.3 Three-Dimensional Polymer Technology

1.2.4 Transgenics

1.2.5 Fibroblasts

1.2.6 Neural Stem Cells

1.2.7 Gene-Activated Matrices

1.3 Cell Culture Technology

1.3.1 Bioreactors

1.3.1.1 Flat-Bed Perfusion Systems

1.3.1.2 Hollow-Fiber Bioreactor Systems

1.3.1.3 Mammalian Cell Suspension Systems

1.4 Stem Cell Technology

1.4.1 Extraction Methods and Devices

1.4.2 Expansion Culture Conditions

1.4.3 Biotechnology Aspects

1.4.4 Serum-Free Culture

1.4.5 Bioreactors

1.4.6 Products

1.5 Immunoisolation Technology

1.5.1 Chimeric Immunity

1.5.2 Antibody/Polymer Technology

1.5.3 Cell Encapsulation Technology

Exhibit 1-1: 2007, Selected Synthetic Biomaterials Used in Tissue Engineering and Organ Regeneration Applications

Exhibit 1-2: 2007, Selected Synthetic Materials Used in the Manufacture of Tissue Engineered Products

Exhibit 1-3: 2007, Selected Bone Replacement Materials Used in Tissue Engineering and Organ Regeneration Applications

Exhibit 1-4: 2007, Selected Biologically Derived Materials Used in Tissue Engineering and Organ Regeneration Applications

Exhibit 1-5: 2007, Selected Emerging Genetically Engineered Materials Used in Tissue Engineering and Organ Regeneration Applications

Exhibit 1-6: Comparison of Cell Extraction Devices and Methods

2. TISSUE ENGINEERED CARDIAC AND VASCULAR PRODUCTS

2.1 Disease Incidence and Market Potential

2.1.1 Coronary Artery Disease

2.1.2 Heart Failure

2.1.3 Heart Valve Dysfunction

2.1.4 Myocardial Infarction

2.1.5 Peripheral Vascular Disease

2.1.5.1 Femoropopliteal Bypass

2.1.5.2 Abdominal Aortic Aneurysm

2.1.6 Heart Transplantation

2.1.6.1 Alternative to Transplant

2.1.7 Developmental Issues

2.2 Emerging Technologies

2.2.1 Tissue Engineered Heart Valves

2.2.1.1 Academic Research

2.2.1.2 Products

2.2.1.2.1 Biologic

2.2.1.2.2 Synthetic

2.2.2 Tissue Engineered Vascular Grafts

2.2.2.1 Bioreactors

2.2.2.2 Synthetic Grafts and Scaffolds

2.2.2.2.1 Polycarbonate Urethane

2.2.2.2.2 Polytetrafluoroethylene

2.2.2.3 Cell-Based Approaches

2.2.2.4 Collagen Matrix

2.2.2.5 Collagen/Polymer Composite Constructs

2.2.2.6 Elastin Scaffold

2.2.2.7 Sheet-Based

2.2.2.8 Xenogenic Tissue

2.2.2.9 Genetically Altered Tissue

2.2.3 Myocardial Tissue Regeneration

2.2.3.1 Scaffolding Patches

2.2.3.2 Cell-Based Approaches

2.2.3.2.1 Muscle Cell Transplantation

2.2.3.2.2 Embryonic Stem Cells

2.2.3.2.3 Peripheral Blood Stem Cells

2.2.3.2.4 Mesenchymal Stem Cells

2.2.3.2.5 Umbilical Cord Stem Cells

2.2.3.2.6 Myoblasts versus Embryonic Stem Cells

2.2.3.2.7 Gene Therapy

2.2.4 Therapeutic Angiogenesis

2.2.4.1 Cytokines

2.2.4.2 Routes of Administration

2.2.4.3 Recombinant Vascular Endothelial Growth Factor

2.2.4.4 Adenoviral Vector Delivery

2.2.4.5 Nitric Oxide Synthase Therapy

2.2.4.6 Recombinant Deoxyribonucleic Acid

2.2.4.7 Angiogen Delivery System

2.2.4.8 Polymer Delivery System

2.2.4.9 Fibroblast Growth Factor

2.2.4.10 Transmyocardial Revascularization

2.2.5 Restenosis Prevention

2.2.5.1 Drug-Eluting Coronary Stents

2.2.5.2 Bioengineered Surfaces

2.2.5.3 Adult Stem Cells

2.2.5.4 Catheter-Mediated Gene Transfer

2.2.5.5 Nitric Oxide Synthase Gene Transfer

2.2.5.6 Ex Vivo Delivery

2.2.5.7 Adenoviral-Based Gene Therapy

2.3 Market Analysis

2.3.1 Market Drivers

2.3.2 Market Limiters

2.3.3 Competitive Analysis

Exhibit 2-1: Heart Valve Replacement and Repair, Procedure Volumes Forecast, 2006-2011

Exhibit 2-2: Femoropopliteal Bypass, Procedure Volumes Forecast, 2006-2011

Exhibit 2-3: Abdominal Aortic Aneurysm Repair, Procedure Volumes Forecast, 2006-2011

Exhibit 2-4: Heart Transplantation, Historical Procedure Volumes, 1995-2005

Exhibit 2-5: 2007, Selected Emerging Tissue Engineered Heart Valves

Exhibit 2-6: 2007, Selected Emerging Tissue Engineered Vascular Grafts

Exhibit 2-7: 2007, Selected Emerging Tissue Engineered Myocardial Regeneration Products

Exhibit 2-8: 2007, Selected Emerging Tissue Engineered Angiogenesis Products

Exhibit 2-9: 2007, Selected Emerging Tissue Engineered Restenosis Prevention Products

Exhibit 2-10: Tissue Engineered Cardiac and Vascular Products, Potential Market Forecast, 2006 and 2016

Exhibit 2-11: Tissue Engineered Cardiac and Vascular Technologies, by Indication, 2006 and 2016

Exhibit 2-12: Tissue Engineered Cardiac and Vascular Products, Product Introduction Forecast, by Indication, 2012 and 2017

3. TISSUE ENGINEERED MUSCULOSKELETAL PRODUCTS

3.1 Disease Incidence and Existing Therapies

3.1.1 Joint Degeneration

3.1.2 Cartilage Injuries

3.1.2.1 Osteochondral Grafting

3.1.2.2 Viscosupplementation/Synovial Fluid Replacement Therapy

3.1.3 Ligament and Tendon Injuries

3.1.4 Shoulder Soft Tissue Tears

3.1.5 Meniscal Injuries

3.1.6 Bone Grafts

3.1.6.1 Fracture Repair

3.1.6.2 Revision Total Joint Surgery

3.1.6.3 Tumors/Bone Cysts

3.1.6.4 Spinal Indications

3.1.6.5 Vertebroplasty

3.1.7 Potential Bone Grafting Procedures

3.1.7.1 Bone Grafting Materials

3.1.7.1.1 Autogenous

3.1.7.1.2 Allogenic

3.1.7.1.3 Synthetic

3.1.7.2 Bone Grafting Market

3.2 Emerging Technologies

3.2.1 Cartilage Repair and Replacement

3.2.1.1 Cell Transplantation Techniques

3.2.1.1.1 Mesenchymal Stem Cells

3.2.1.1.2 Autologous Chondrocyte Implantation

3.2.1.1.3 Other Technologies

3.2.1.2 Genetically Altered Cells

3.2.1.3 Ultraviolet Light

3.2.1.4 Polymer Matrices

3.2.1.5 Collagen Matrices

3.2.1.6 Chrysalin

3.2.1.7 Cryopreservation

3.2.2 Ligament Repair and Replacement

3.2.2.1 Bioreactors

3.2.2.2 Biologic Scaffolds

3.2.2.2.1 Allogenic

3.2.2.2.2 Xenogenic

3.2.2.2.3 Collagen

3.2.2.2.4 Polymeric

3.2.2.3 Growth Factors

3.2.3 Meniscus Repair and Replacement

3.2.3.1 Allogenic

3.2.3.2 Xenogenic

3.2.3.3 Collagen

3.2.3.4 Polymeric

3.2.3.5 Mesenchymal Stem Cells

3.2.4 Bone Repair and Replacement

3.2.4.1 Biomaterials

3.2.4.2 Bone Growth Factors

3.2.4.3 Recombinant Growth Factors

3.2.4.3.1 Carrier Materials

3.2.4.3.2 Bone Morphogenic Proteins

3.2.4.4 Demineralized Bone Matrix

3.2.4.5 Cell Transplantation

3.2.4.5.1 Autologous Cells

3.2.4.5.2 Stem Cells

3.2.4.6 Synthetic Peptides

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

3.3 Market Analysis

3.3.1 Market Drivers

3.3.2 Market Limiters

3.3.3 Competitive Analysis

Exhibit 3-1: Arthroscopic Knee Surgery, Procedure Volumes Forecast, 2006-2011

Exhibit 3-2: 2006, Ligament and Tendon Repair and Replacement, Procedure Volumes

Exhibit 3-3: 2006, Meniscectomy and Meniscal Repair, Procedure Volumes

Exhibit 3-4: 2006, Bone Grafting in Orthopedic/Spinal Surgery, Potential Procedure Volumes

Exhibit 3-5: 2006, Bone Grafts and Bone Substitutes Market

Exhibit 3-6: 2007, Selected Tissue Engineered Orthopedic Products

Exhibit 3-7: 2007, Selected Tissue Engineered Cartilage Repair and Replacement Products

Exhibit 3-8: 2007, Selected Tissue Engineered Ligament Repair and Replacement Products

Exhibit 3-9: 2007, Selected Tissue Engineered Meniscal Repair and Replacement Products

Exhibit 3-10: 2007, Selected Tissue Engineered Bone Repair Products

Exhibit 3-11: Bone Morphogenetic Proteins, Market Forecast, 2006-2011

Exhibit 3-12: 2006, Allogenic Demineralized Bone Matrix Products, Share by Supplier

Exhibit 3-13: Comparison of Growth Factors and Gene Therapy for Bone Repair

Exhibit 3-14: Gene Therapy Delivery Methods for Bone Repair

Exhibit 3-15: Tissue Engineered Musculoskeletal Products, Potential Market Forecast, 2006 and 2016

Exhibit 3-16: Tissue Engineered Musculoskeletal Products, Product Introduction Forecast, by Indication, 2012 and 2017

4. TISSUE ENGINEERED NEUROLOGIC PRODUCTS

4.1 Existing Therapies

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 Technology Requirements

4.3 Emerging Technologies

4.3.1 Stem Cell Therapy

4.3.1.1 Embryonic Stem Cells and Spinal Cord Regeneration

4.3.1.2 Adult Stem Cells and Central Nervous System Disorders

4.3.1.3 Fetal Porcine Cells and Parkinson’s Disease

4.3.1.4 Retinal Pigment Epithelial Cell Transplants and Central Nervous System Disorders

4.3.2 Gene Therapy

4.3.2.1 Sonic Hedgehog

4.3.2.2 Growth Factors

4.3.2.3 Remyelinating Monoclonal Antibodies

4.3.3 Nerve Grafting

4.3.4 Peptide-Based Scaffolding

4.4 Market Analysis

4.4.1 Market Drivers

4.4.2 Market Limiters

4.4.3 Competitive Analysis

Exhibit 4-1: 2007, Selected Drugs Indicated for the Treatment of Parkinson’s Disease

Exhibit 4-2: 2007, Selected Current and Emerging Tissue Engineered Neurologic Products

Exhibit 4-3: Tissue Engineered Neurologic Products, Potential Market Forecast, 2006 and 2016

Exhibit 4-4: Tissue Engineered Neurologic Technologies, by Indication, 2006 and 2016

Exhibit 4-5: Tissue Engineered Neurologic Products, Product Introduction Forecast, 2012 and 2017

5. TISSUE ENGINEERED UROLOGIC PRODUCTS

5.1 Disease Incidence

5.1.1 Key Applications

5.2 Existing Therapies

5.2.1 Bladder, Ureteral, and Urethral Repair Surgery

5.2.2 Incontinence Treatment

5.2.3 Penile Prostheses

5.2.4 Vesicoureteral Reflux Treatment

5.3 Emerging Technologies

5.3.1 Biomaterials

5.3.2 Bladder Repair and Replacement Products

5.3.3 Cell-Based Gene Therapy Products

5.3.4 Genital Tissue Products

5.3.5 Reconstituted Structures

5.3.6 Ureter and Urethra Repair and Replacement Products

5.3.7 Urethral Augmentation Products

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 Competitive Analysis

Exhibit 5-1: 2006, Urologic Diseases/Disorders Potentially Treatable Using Tissue Engineering, Incidence and Prevalence

Exhibit 5-2: 2006, Urologic Treatments, Procedure Volumes

Exhibit 5-3: Tissue Engineered Urologic Products, Potential Market Forecast, 2006 and 2016

Exhibit 5-4: Tissue Engineered Urologic Technologies, by Indication, 2006 and 2016

Exhibit 5-5: Tissue Engineered Urologic Products, Product Introduction Forecast, 2012 and 2017

6. TISSUE ENGINEERED ORGAN REGENERATION PRODUCTS

6.1 Disease Incidence

6.1.1 Bone Marrow Disease

6.1.1.1 Aplastic Anemia

6.1.1.2 Leukemia and Lymphoma

6.1.2 Diabetes

6.1.3 Intestinal Disorders

6.1.3.1 Intestinal Pseudo-Obstruction

6.1.3.2 Microvillus Inclusion Disease

6.1.3.3 Short Bowel Syndrome

6.1.4 Kidney Disease

6.1.5 Liver Disease

6.2 Existing Therapies

6.2.1 Ex Vivo Systems

6.2.1.1 Kidney Dialysis Systems

6.2.2 Organ Transplantation

6.2.2.1 Bone Marrow Transplantation

6.2.2.2 Kidney Transplantation

6.2.2.3 Liver Transplantation

6.2.2.3.1 Split Cadaveric Livers

6.2.2.3.2 Liver Segments from Living Donors

6.2.2.4 Pancreas Transplantation

6.2.2.5 Small Bowel Transplantation

6.2.3 Artificial Organ Technologies

6.2.3.1 Artificial Kidney

6.2.3.2 Artificial Liver

6.2.3.3 Artificial Pancreas

6.3 Emerging Technologies

6.3.1 Genes

6.3.2 Scaffolds

6.3.3 Stem Cells

6.3.4 Xenotransplants

6.3.5 Emerging Technologies, by Organ Type

6.3.5.1 Bone Marrow

6.3.5.1.1 Products

6.3.5.2 Intestine

6.3.5.2.1 Products

6.3.5.3 Kidney

6.3.5.3.1 Products

6.3.5.4 Liver

6.3.5.4.1 Products

6.3.5.5 Pancreas

6.4.5.5.1 Products

6.4 Market Analysis

6.4.1 Market Drivers

6.4.2 Market Limiters

6.4.3 Competitive Analysis

Exhibit 6-1: Incidence and Prevalence of Major Organ Diseases

Exhibit 6-2: 2006, Organ Transplantation, Procedure Volumes

Exhibit 6-3: 2005, Average Cost of Transplantation, by Organ

Exhibit 6-4: 2007, Selected Emerging Artificial Organ Products

Exhibit 6-5: 2007, Selected Emerging Liver Failure Treatment Products

Exhibit 6-6: 2007, Selected Emerging Pancreatic Failure Treatment Products

Exhibit 6-7: Tissue Engineered Organ Regeneration Products, Potential Market Forecast, 2006 and 2016

Exhibit 6-8: Tissue Engineered Organ Regeneration Technologies, by Indication, 2006 and 2016

Exhibit 6-9: Tissue Engineered Organ Regeneration Products, Product Introduction Forecast, 2012 and 2017

7. TISSUE ENGINEERED SKIN REPLACEMENTS AND SUBSTITUTES

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 Surgery

7.1.4 Inguinal Herniorrhaphy

7.2 Technology Requirements

7.3 Current and Emerging Therapies

7.3.1 Tissue Engineered Skin Replacements/Substitutes

7.3.1.1 Tissue Engineered Skin

7.3.1.2 Dermal Equivalent Products

7.3.1.3 Epidermal Equivalent Products

7.3.1.4 Multilayer Equivalent Products

7.3.1.5 Other Products

7.4 Market Analysis

7.4.1 Market Drivers

7.4.2 Market Limiters

7.4.3 Competitive Analysis

7Exhibit 7-1: 2006, Potential Patient Population for Tissue Engineered Skin Replacements and Substitutes

Exhibit 7-2: Stages of Pressure Ulcers

Exhibit 7-3: Tissue Engineered Skin Replacements and Substitutes, Potential Market Forecast, 2006 and 2016

Exhibit 7-4: Tissue Engineered Skin Replacements and Substitutes, Market Forecast, 2006-2011

Exhibit 7-5: 2006, Tissue Engineered Skin Replacements and Substitutes Market, Share by Supplier

Exhibit 7-6: Tissue Engineered Skin Replacements and Substitutes, Product Introduction Forecast, 2012 and 2017

8. COMPANY PROFILES

8.1 Aastrom Biosciences, Inc.

8.2 CryoLife, Inc.

8.3 Curis, Inc.

8.4 GenVec, Inc.

8.5 Genzyme Corporation

8.6 Integra LifeSciences Holdings Corporation

8.7 LifeCell Corporation

8.8 Osiris Therapeutics, Inc.

8.9 Regeneration Technologies, Inc.

8.10 StemCells, Inc.

8.11 Tepha, Inc.

8.12 Titan Pharmaceuticals, Inc

APPENDIX: COMPANY LISTING

Abstract

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