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TABLE OF CONTENTS
SECTION 1: EXECUTIVE
SUMMARY
1.1 Bioresorbable Fixation
Devices
1.2 Allogeneic and Synthetic
Bone Replacement
1.3 Orthobiologics
1.4 Synovial Fluid Replacement
1.5 Cartilage Repair and
Replacement
1.6 Meniscal Repair and
Replacement
1.7 Ligament and Tendon Repair
and Replacement
SECTION 2: BIORESORBABLE
FIXATION DEVICES
2.1 Synthetic Polymers
2.2 Cadaver Bone
2.3 Product Applications
2.3.1 Bioresorbable Pins
2.3.2 Bioresorbable Bone Screws,
Nails, Tacks
2.3.2.1 Competitive Analysis
2.3.3 Bioresorbable Interference
Screws
2.3.3.1 Competitive Analysis
2.3.4 Bioresorbable Suture
Anchors
2.3.4.1 Competitive Analysis
2.3.5 Bioresorbable Meniscal
Repair Devices
2.3.5.1 Competitive Analysis
2.4 Market Assessment
2.4.1 Meniscal Repair Market
2.4.2 Cruciate Ligament Fixation
Market
2.4.3 Shoulder Reconstruction
Market
2.4.4 Small Joint/Bone Fragment
Fixation Market
2.4.5 Potential Market for
Bioresorbable Fixation Devices
2.4.6 Competitive Shares
SECTION 3: ALLOGENEIC
AND SYNTHETIC BONE REPLACEMENT MATERIALS
3.1 Bone Biology
3.1.1 Bone Formation
3.1.2 Bone Remodeling
3.2 Bone Replacement Materials
3.2.1 Autograft
3.2.2 Allograft
3.2.2.1 Supply Constraints
3.2.2.2 Tissue Banking Industry
3.2.2.3 FDA Regulations
3.2.2.3.1 FDA vs. WRIGHT MEDICAL TECHNOLOGIES
3.2.2.3.2 FDA vs. REGENERATION TECHNOLOGIES
3.2.2.4 Base Tissues
3.2.2.5 Demineralized Bone
Matrix (DBM) Products
3.2.2.6 Machined Implants
3.2.2.7 Composite Implants
3.2.3 Synthetic Materials
3.2.3.1 Types of Synthetic
Materials
3.2.3.1.1 Hydroxyapatites
3.2.3.1.2 Calcium Phosphate, Calcium Sulfate Technologies
3.2.3.1.3 Polymethacrylate Cement
3.3 Indications for Bone Grafts
3.3.1 Major Orthopedic
Indications
3.3.1.1 Fracture Repair
3.3.1.2 Revision Total Joint
Surgery
3.3.1.3 Tumors/Bone Cysts
3.3.2 Spinal Indications
3.3.2.1 Spinal Fusion
3.3.2.1.1 Cervical Spinal Fusion
3.3.2.1.2 Lumbar Fusions
3.3.2.2 Vertebroplasty
3.4 Potential Number of Bone
Grafting Procedures
3.5 Competitors
3.5.1 Allogeneic Bone Suppliers
3.5.1.1 Competitive Market
Shares
3.5.1.1.1 DBM Products
3.5.1.1.2 Machined Implants
3.5.2 Synthetic Bone Replacement
Segment
3.5.2.1 Competitive Market
Shares
3.6 Market Assessment
SECTION 4: ORTHOBIOLOGICS
4.1 Bone Growth Factors
4.1.1 Transforming Growth
Factor-beta (TGF- ß)
4.1.1.1 Bone Morphogenetic
Proteins
4.1.1.1.1 Competitive Analysis
4.1.1.2 Recombinant BMP
Technologies
4.1.1.2.1 Competitive Analysis
4.1.1.3 BMP Regulation
4.1.1.4 Potential BMP
Reimbursement Issues
4.1.2 Fibroblast Growth Factors
(FGF)
4.1.3 Allogeneic-Derived Growth
Factors
4.1.4 Blood-Extracted Growth
Factors
4.1.4.1 Competitive Analysis
4.1.5 Recombinant
Platelet-Derived Growth Factor (rhPDGF)
4.2 Small Molecules
4.3 Stem Cell and Gene Therapy
4.3.1 Competitive Analysis
4.3.2 Other Companies
4.4 Strategic Partnerships and
Cross-Licensing of Orthobiologic Products
4.5 Market Assessment
SECTION 5: SYNOVIAL
FLUID REPLACEMENT
5.1 Treatments for
Osteoarthritis
5.1.1 Drug Therapy
5.1.2 Glucosamine and
Chondroitin Sulfate
5.1.3 Surgery
5.1.4 Synovial Fluid Replacement
5.1.4.1 Mechanism of Action
5.1.4.2 Prescribing Physicians
5.1.4.3 Hyaluronic Acid
5.1.4.3.1 Competitive Analysis
5.1.4.3.2 Other Synovial Fluid Replacement Products
5.1.4.4 Treatment Candidates
5.1.4.5 Market Assessment
SECTION 6: CARTILAGE
REPAIR AND REPLACEMENT
6.1 Cartilage Structure
6.2 Cartilage Injuries
6.2.1 Current Treatments for
Cartilage Injury
6.2.1.1 Corticosteroids
Injections
6.2.1.2 Arthroscopic Surgical
Treatments
6.3 Technologies Under
Development
6.3.1 Cell-Based Approaches
6.3.1.1 Chondrocyte
Transplantation
6.3.1.1.1 Competitive Analysis
6.3.1.1.2 Other Competitors
6.3.1.2 Stem Cell Technology
6.3.1.2.1 Competitive Analysis
6.3.1.3 Growth Factor Technology
6.3.1.3.1 Competitive Analysis
6.3.2 Scaffolds
6.3.2.1 Polymer-Based Scaffolds
6.3.2.1.1 Competitive Analysis
6.3.2.2 Collagen-Based Scaffolds
6.3.2.3 Other Scaffolds
6.3.3 Cartilage Resurfacing
6.4 Market Assessment
SECTION 7: MENISCAL
REPAIR AND REPLACEMENT
7.1 Meniscus
7.1.1 Meniscal Injuries
7.1.1.1 Traumatic Tears
7.1.1.2 Degenerative Tears
7.2 Current Treatments
7.2.1 Nonoperative Treatment
7.2.2 Partial and Complete
Meniscectomy
7.2.3 Arthroscopic Suturing
7.2.3.1 “Inside-Out”
Technique (Vertical)
7.2.3.2 “Outside-In”
Technique (Horizontal)
7.2.3.3 “All-Inside”
Technique
7.3 Meniscal Repair Technologies
7.3.1 Resorbable Devices
7.3.1.1 Competitive Analysis
7.3.2 Meniscal Repair Market
Assessment
7.3.2.1 Competitive Shares
7.4 Meniscal Replacement
7.4.1 Meniscal Allografts
7.4.1.1 Competitive Analysis
7.4.2 Scaffolding Technologies
7.4.3 Collagen Scaffolds
7.4.3.1 Competitive Analysis
7.4.4 Polymer Scaffolds
7.4.4.1 Competitive Analysis
7.4.5 Biological Scaffolds
7.4.5.1 Competitive Analysis
7.4.6 Gene and Cell Therapy
7.5 Meniscal Replacement and
Regeneration Market Assessment
SECTION 8: LIGAMENT AND
TENDON REPAIR AND REPLACEMENT
8.1 Ligament and Tendon Anatomy
8.2 Types of Ligaments and
Tendons
8.2.1 Knee Ligaments
8.2.1.1 Anterior Cruciate
Ligament
8.2.2 Achilles Tendon
8.2.3 Hand Ligaments and Tendons
8.2.4 Shoulder Ligaments and
Tendons
8.2.5 Rotator Cuff
8.3 Procedural Volumes
8.4 Current Treatments
8.4.1 ACL Tears
8.4.1.1 Autograft
8.4.1.1.1 Bone-Patella Tendon-Bone Graft
8.4.1.1.2 Hamstring Tendon Graft
8.4.1.1.3 Quadriceps Tendon Graft
8.4.1.2 Allograft
8.4.1.2.1 Allograft Transplants
8.4.2 Rotator Cuff Tears
8.4.2.1 Competitive Analysis
8.5 Emerging Technologies for
Ligament and Tendon Repair
8.5.1 Biologic Scaffolds
8.5.1.1 Collagen Scaffolds
8.5.1.1.1 Competitive Analysis
8.5.1.2 Acellular Tissue
Matrices
8.5.1.2.1 Competitive Analysis
8.5.1.3 Synthetic Scaffolds
8.5.1.3.1 Competitive Analysis
8.5.2 Growth Factors and Genes
8.5.2.1 Competitive Analysis
8.6 Market Assessment
8.6.1 Market Forecast
8.6.2 Market Share by Supplier
SECTION 9: COMPANY
PROFILES
9.1 AASTROM BIOSCIENCES, INC.
9.2 ADVANCED TISSUE SCIENCES,
INC.
9.3 ARTHREX, INC.
9.4 BIOMET, INC.
9.5 BIONX IMPLANTS, INC.
9.6 CONMED CORPORATION
9.7 CRYOLIFE, INC.
9.8 ETEX CORPORATION
9.9 EXACTECH, INC.
9.10 GENSCI REGENERATION
SCIENCES, INC.
9.11 GENZYME BIOSURGERY, INC.
9.12 INTEGRA LIFESCIENCES
HOLDINGS CORPORATION
9.13 INTERPORE CROSS
INTERNATIONAL, INC.
9.14 ISOTIS, N.V.
9.15 LIFECELL CORPORATION
9.16 MEDTRONIC, INC.
9.17 MITEK/ETHICON (A JOHNSON
& JOHNSON COMPANY)
9.18 MUSCULOSKELETAL TRANSPLANT
FOUNDATION
9.19 NEUCOLL, INC.
9.20 ORQUEST, INC.
9.21 ORTHOVITA, INC.
9.22 OSIRIS THERAPEUTICS
9.23 OSTEOTECH, INC.
9.24 REGEN BIOLOGICS, INC.
9.25 REGENERATION TECHNOLOGIES,
INC.
9.26 SMITH & NEPHEW, PLC
9.27 STRYKER BIOTECH
9.28 SYNTHES-STRATEC, INC.
9.29 TUTOGEN MEDICAL, INC.
9.30 WRIGHT MEDICAL TECHNOLOGY
APPENDIX A: COMPANY
LISTING
LIST OF EXHIBITS
Exhibit 1-1:
Projected Growth of the U.S. Orthopedic Biomaterials
Market, by Segment, 2001-2010E
Exhibit 1-2:
Examples of Resorbable Fixation Devices
Exhibit 1-3:
Advantages of Resorbable Fixation Devices
Exhibit 1-4:
Bioresorbable Fixation Devices, U.S. Market Forecast,
2001-2010E
Exhibit 1-5:
2001, Bioresorbable Fixation Devices, U.S. Share by
Supplier
Exhibit 1-6:
2001, Partnerships Between Allograft Suppliers/Processors
and Orthopedic/Spine Companies
Exhibit 1-7:
2001, Snapshot of the Tissue Banking Industry
Exhibit 1-8:
2001, U.S. Market for Bone Replacement Products, Share by
Tissue Type
Exhibit 1-9:
Selected Bone Morphogenetic Proteins for Orthopedic/Spinal
Applications under Research and Development
Exhibit 1-10: 2002,
Collaborative Efforts for the Development of Orthobiologic
Products
Exhibit 1-11: Bone
Morphogenetic Proteins for Orthopedic and Spinal Applications,
U.S. Market Forecast, 2001-2010E
Exhibit 1-12: Other
Orthobiologic Agents for Orthopedic and Spinal Applications, U.S.
Market Forecast, 2001-2010E
Exhibit 1-13: 2001,
U.S. Patients with Knee Osteoarthritis
Exhibit 1-14: Synovial
Fluid Replacement Therapy, U.S. Market Forecast, 2001-2010E
Exhibit 1-15: 2001,
Selected Participants in the Knee Osteoarthritis Synovial Fluid
Replacement Market
Exhibit 1-16: Causes
of Articular Cartilage Injury
Exhibit 1-17: Selected
Companies Developing Cartilage Repair and Replacement Products
Exhibit 1-18: Cartilage
Repair/Regeneration, U.S. Market Forecast, 2001-2010E
Exhibit 1-19: 2001,
Companies Offering Resorbable Polymer-Based Devices for Meniscal
Repair
Exhibit 1-20: Meniscal
Repair Products, U.S. Market Forecast, 2001-2010E
Exhibit 1-21: 2001,
U.S. Meniscal Repair Market, Share by Supplier
Exhibit 1-22: Meniscal
Replacement Scaffolding Products under Development in the U.S.
Exhibit 1-23: 2001,
Selected Collagen-Based Scaffolds Under Development for Ligament
and Tendon Replacement in the U.S.
Exhibit 1-24: 2001,
U.S. Ligament and Tendon Procedures, by Anatomical Location
Exhibit 1-25: 2001,
Tendon and Ligament Replacement, U.S. Share by Supplier
Exhibit 1-26: Tendon
and Ligament Replacement Products, U.S. Market Forecast,
2001-2010E
Exhibit 2-1:
Advantages of Resorbable Fixation Devices
Exhibit 2-2:
2001, Polymers Commercially Available or under Development
as Medical Implants
Exhibit 2-3:
Factors Affecting the Properties of Resorbable Polymeric
Materials
Exhibit 2-4:
Examples of Resorbable Fixation Devices
Exhibit 2-5:
2001, Selected Manufacturers of Commercially Available
Bioresorbable Pins
Exhibit 2-6:
2001, Selected Manufacturers of Commercially Available
Bioresorbable Bone Screws, Nails and Tacks
Exhibit 2-7:
2001, Selected Manufacturers of Commercially Available
Bioresorbable Interference Screws
Exhibit 2-8:
2001, Selected Manufacturers of Commercially Available
Bioresorbable Suture Anchors
Exhibit 2-9:
2001, Resorbable Polymer-Based Devices for Meniscal Repair
Exhibit 2-10: Bioresorbable
Fixation Devices, Potential U.S. Procedures, 2001-2010E
Exhibit 2-11: 2001,
U.S. Market for Bioresorbable Fixation Devices
Exhibit 2-12: Bioresorbable
Fixation Devices, U.S. Market Forecast, 2001-2010E
Exhibit 2-13: 2001,
Bioresorbable Fixation Devices, U.S. Share by Supplier
Exhibit 3-1:
Illustration of Bone Tissue
Exhibit 3-2:
Steps in the Bone Remodeling Process
Exhibit 3-3:
Types of Bone Grafts
Exhibit 3-4:
2001, Top Tissue Banks in the U.S.
Exhibit 3-5:
2001, Partnerships Between Allograft Suppliers/Processors
and Orthopedic/Spine Companies
Exhibit 3-6:
2001, Snapshot of the Tissue Banking Industry
Exhibit 3-7:
2001, Use of Base Tissue Bone Allografts in Orthopedic
Surgery
Exhibit 3-8:
2001, Use of Base Tissue Bone Allografts in Spine Surgery
Exhibit 3-9:
2001, Description and Representative Pricing of Base
Allografts in Spine Surgery
Exhibit 3-10: 2001,
OSTEOTECH’s Grafton Family of Products
Exhibit 3-11: 2001,
Demineralized Bone Matrix Products
Exhibit 3-12: 2001,
Companies Marketing Demineralized Bone Matrix-Type Products
Exhibit 3-13: 2001,
REGENERATION TECHNOLOGIES' Current and Future Allogeneic-Derived
Product Offerings
Exhibit 3-14: 2001,
Selected Machined Allografts by OSTEOTECH
Exhibit 3-15: 2001,
Machined Allograft Implant Products, by Supplier
Exhibit 3-16: 2001,
Representative Per Procedure Pricing of Machined Allograft
Implants
Exhibit 3-17: 2001,
Representative Per Procedure Pricing of Machined Allografts and
DBM Products
Exhibit 3-18: 2001, Materials Used in Commercially Available Synthetic
Bone Replacement Products
Exhibit 3-19: 2001,
Major Indications for Bone Grafts in Orthopedic and Spine Surgery
Exhibit 3-20: 2001,
Potential U.S. Open Reduction Fracture Procedures Employing Bone
Grafts
Exhibit 3-21: 2001,
Potential U.S. Revision Total Joint Procedures Employing Bone
Grafts
Exhibit 3-22: 2001,
Potential U.S. Tumor/Cyst Procedures Employing Bone Grafts
Exhibit 3-23: 2001,
Potential U.S. Bone Grafting Procedures in Spine Surgery
Exhibit 3-24: 2001,
Potential U.S. Bone Grafting Procedures in Orthopedic/Spine
Surgery
Exhibit 3-25: 2001,
Developers of Allogeneic Bone-Derived Products
Exhibit 3-26: 2001,
U.S. Retail Sales and Shares of DBM Products, by Brand
Exhibit 3-27: 2001
U.S. Retail Sales and Shares of DBM Products, by Distributor
Exhibit 3-28: 2001,
U.S. Market for Machined Allogeneic Implants, Share by Supplier
Exhibit 3-29: 2001,
Developers of Synthetic Bone Replacement Products
Exhibit 3-30: 2001,
U.S. Market for Synthetic Bone Replacement Products, Share by
Supplier
Exhibit 3-31: 2001,
U.S. Market for Bone Replacement Products, Share by Tissue Type
Exhibit 3-32: Allogeneic
and Synthetic Bone Replacement Products, U.S. Market Forecast,
2001-2010E
Exhibit 4-1:
The TGF-b Superfamily
Exhibit 4-2:
2002, Selected Bone Morphogenetic Proteins for Orthopedic
Applications under Research and Development
Exhibit 4-3:
MSD’s InFUSE vs. Control for Lumbar Fusion at 24-Month
Follow-Up
Exhibit 4-4:
2002, Selected Growth Factors for Orthopedic Applications
Available and under Research and Development
Exhibit 4-5:
Comparison of Growth Factors and Gene Therapy for Bone
Repair
Exhibit 4-6:
2001, Gene Therapy Delivery Methods for Bone Repair
Exhibit 4-7:
2002, Selective Orthopedic Stem Cell and Gene Therapy
Products under Research and Development
Exhibit 4-8:
2002, Collaborative Efforts for the Development of
Orthobiologic Products
Exhibit 4-9:
Open Reduction Fracture and Spinal Fusion Procedures,
Potential U.S. Procedures, 2001-2010E
Exhibit 4-10: Bone
Morphogenetic Proteins for Orthopedic and Spinal Applications,
Potential U.S. Market, 2001-2010E
Exhibit 4-11: Other
Orthobiologic Agents for Orthopedic and Spinal Applications,
Potential U.S. Market, 2001-2010E
Exhibit 4-12: Bone
Morphogenetic Proteins for Orthopedic and Spinal Applications,
U.S. Market Forecast, 2001-2010E
Exhibit 4-13: Other
Orthobiologic Agents for Orthopedic and Spinal Applications, U.S.
Market Forecast, 2001-2010E
Exhibit 5-1:
Nonpharmacologic Therapy for Patients with Osteoarthritis
of the Knee and Hip
Exhibit 5-2:
2001, Major Prescribers of Hyaluronic Acid-Injection
Therapy
Exhibit 5-3:
2001, Users of Hyaluronic Acid Injection Therapy, by
Specialty
Exhibit 5-4:
Effects of Hyaluronic Acid Therapy
Exhibit 5-5:
2001, Selected Participants in the Knee Osteoarthritis
Synovial Fluid Replacement Market
Exhibit 5-6:
2001, U.S. Patients with Knee Osteoarthritis
Exhibit 5-7:
U.S. Candidates for Synovial Fluid Replacement Therapy in
the Knee, 2001-2010E
Exhibit 5-8:
Synovial Fluid Replacement Products, U.S. Sales Forecast,
2001-2006E
Exhibit 5-9:
Synovial Fluid Replacement Therapy, U.S. Market Forecast,
2001-2010E
Exhibit 5-10: Synovial
Fluid Replacement Therapy, Potential U.S. Market, 2001-2010E
Exhibit 5-11: 2001,
U.S. Synovial Fluid Replacement Market, Share by Supplier
Exhibit 6-1:
Causes of Articular Cartilage Injury
Exhibit 6-2:
Classification of Chondral Damage—The Outerbridge
Classification System
Exhibit 6-3:
Prognostic Factors for Arthroscopic Debridement of the Knee
Exhibit 6-4:
2001E, U.S. Knee Procedures Performed for Cartilage-Related
Problems
Exhibit 6-5:
2001, Selected Companies Developing Cartilage Repair and
Replacement Products
Exhibit 6-6:
2001, Selected Companies Developing Chondrocyte
Transplantation Products
Exhibit 6-7:
2001, Selected Companies Developing Stem Cell-Based
Products for Cartilage Repair
Exhibit 6-8:
2001, Selected Companies with Polymer-Based Scaffolds for
Cartilage Repair under Development
Exhibit 6-9:
2001, Selected Companies with Collagen-Based Scaffolds for
Cartilage Repair under Development
Exhibit 6-10: 2001,
Selected Companies with Other Scaffold Materials for Cartilage
Repair under Development
Exhibit 6-11: 2001,
Selected Companies with Cartilage Resurfacing Products in
Development
Exhibit 6-12: U.S.
Knee Procedures Performed for Cartilage-Related Problems,
2001E-2010E
Exhibit 6-13: Cartilage
Repair/ Regeneration, U.S. Market Forecast, 2001-2010E
Exhibit 6-14: Cartilage
Repair/ Regeneration, Potential U.S. Market Forecast, 2001-2010E
Exhibit 7-1:
Illustration of a Healthy Knee
Exhibit 7-2:
Illustration of a Meniscus Tear
Exhibit 7-3:
Primary Care Diagnosis and Management of Suspected Meniscal
Tears
Exhibit 7-4:
Comparison of Treatment Options for Meniscal Injuries
Exhibit 7-5:
2001, Companies Offering Resorbable Polymer-Based Devices
for Meniscal Repair
Exhibit 7-6:
Meniscal Repair Products, U.S. Market Forecast, 2001-2010E
Exhibit 7-7:
Meniscal Repair Products, Potential U.S. Market Forecast,
2001-2010E
Exhibit 7-8:
2001, U.S. Meniscal Repair Market, Share by Supplier
Exhibit 7-9:
2001, Meniscal Replacement Products Available in the U.S.
Exhibit 7-10: 2001,
Meniscal Replacement Scaffolding Products under Development in the
U.S.
Exhibit 7-11: Meniscal
Replacement and Regeneration, U.S. Market Forecast, 2001-2010E
Exhibit 7-12: Meniscal
Replacement and Regeneration, Potential U.S. Market Forecast,
2001-2010E
Exhibit 7-13: 2001,
Acquisitions or Strategic Alliances in the Meniscal Replacement
Market
Exhibit 8-1:
Anatomy of the Knee Joint
Exhibit 8-2:
Achilles Tendon and Other Foot and Calf Structures
Exhibit 8-3:
Ligaments of the Hand
Exhibit 8-4:
Anatomy of the Shoulder
Exhibit 8-5:
2001, U.S. Ligament and Tendon Procedures, by Anatomical
Location
Exhibit 8-6:
Surgical Options for ACL Repair
Exhibit 8-7:
2001, Selected Companies Offering Ligament and Tendon
Allografts in the U.S.
Exhibit 8-8:
2001, Selected Collagen-Based Scaffolds under Development
for Ligament and Tendon Replacement in the U.S.
Exhibit 8-9:
2001, Selected Acellular Tissue Matrices under Development
for Ligament and Tendon Replacement in the U.S.
Exhibit 8-10: 2001,
Polymer-Based Scaffolds for Ligament and Tendon Replacement under
Development in the U.S.
Exhibit 8-11: 2001,
Selected Growth Factor Technologies under Development in the U.S.
Exhibit 8-12: Tendon
and Ligament Replacement Products, U.S. Market Forecast,
2001-2010E
Exhibit 8-13: 2001,
Tendon and Ligament Replacement Products, U.S. Share by Supplier
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