$3,750.00
The United States (U.S.) market for orthopedic biomaterials, as covered by the scope of this report, comprises bioresorbable fixation devices, visco supplementation products, cartilage repair and regeneration technologies.
The United States (U.S.) market for orthopedic biomaterials, as covered by the scope of this report, comprises bioresorbable fixation devices (pins, screws, tacks,and suture anchors), visco supplementation products (hyaluronic acid [HA]-basedtherapies), cartilage repair and regeneration technologies (cell-based approaches,cell-free scaffolds, and gene therapy), meniscal repair/regeneration/replacementtechnologies (allografts, bioresorbable fixation devices, and scaffolding and celltherapy technologies), and ligament and tendon repair/replacement/regenerationproducts (traditional sports medicine allografts and gene and cell-based therapies,platelet-rich plasma, scaffolds, and synthetic growth factors).
1. MUSCULOSKELETAL SYSTEM OVERVIEW …………………………………….. 1-1
1.1 Bone Structure and Function……………………………………………………. 1-1
1.1.1 Cellular Framework ………………………………………………….. 1-1
1.1.1.1 Osteoblasts ………………………………………………. 1-2
1.1.1.2 Osteocytes ……………………………………………….. 1-2
1.1.1.3 Osteoclasts ………………………………………………. 1-3
1.1.1.4 Osteogenesis ……………………………………………. 1-3
1.1.2 Bone Tissue ……………………………………………………………. 1-4
1.1.2.1 Cancellous and Cortical Bone Tissue……………. 1-4
1.1.2.2 Bone Marrow…………………………………………….. 1-6
1.1.3 Bone Anatomy…………………………………………………………. 1-6
1.1.3.1 Diaphysis and Epiphysis …………………………….. 1-6
1.1.3.2 Endosteum ……………………………………………….. 1-7
1.1.3.3 Periosteum ……………………………………………….. 1-7
1.1.4 Joint Components ……………………………………………………. 1-7
1.1.4.1 Cartilage…………………………………………………… 1-7
1.1.4.1.1 Elastic Cartilage……………………… 1-8
1.1.4.1.2 Fibrocartilage …………………………. 1-8
1.1.4.1.3 Hyaline Cartilage…………………….. 1-8
1.1.4.2 Bursae……………………………………………………. 1-10
1.1.4.3 Joint Cavity……………………………………………… 1-10
1.1.4.4 Menisci …………………………………………………… 1-10
1.1.4.5 Synovial Membrane and Fluid……………………. 1-10
1.1.4.6 Ligaments and Tendons……………………………. 1-11
1.1.4.7 Muscles ………………………………………………….. 1-11
1.1.5 Joint Structures ……………………………………………………… 1-12
1.1.5.1 Ankle ……………………………………………………… 1-13
1.1.5.2 Digits ……………………………………………………… 1-13
1.1.5.3 Elbow …………………………………………………….. 1-14
1.1.5.4 Hip…………………………………………………………. 1-14
1.1.5.5 Knee………………………………………………………. 1-14
1.1.5.6 Shoulder…………………………………………………. 1-14
1.1.5.7 Wrist ………………………………………………………. 1-15
1.1.6 Bone Formation and Remodeling……………………………… 1-15
1.1.6.1 In the Fetus …………………………………………….. 1-15
1.1.6.2 In Childhood ……………………………………………. 1-17
1.1.6.3 In Adulthood ……………………………………………. 1-17
1.1.6.4 In Old Age ………………………………………………. 1-17
1.1.6.5 Mechanical Stress and Wolff’s Law…………….. 1-18
1.1.7 Factors Affecting Bone Physiology……………………………. 1-18
1.1.7.1 Age………………………………………………………… 1-18
1.1.7.2 Gender …………………………………………………… 1-18
1.1.7.3 Genetic Disposition ………………………………….. 1-19
1.1.7.4 Hormonal Activity …………………………………….. 1-19
1.1.7.5 Physical Activity……………………………………….. 1-20
1.1.7.6 Cigarette Smoking……………………………………. 1-20
1.1.7.7 Alcohol and Caffeine Intake ………………………. 1-20
1.1.7.8 Nutritional Deficiencies……………………………… 1-21
1.2 Joint Structure and Function…………………………………………………… 1-22
1.2.1 Types of Joints ………………………………………………………. 1-22
1.2.1.1 Synarthroses …………………………………………… 1-22
1.2.1.2 Amphiarthroses ……………………………………….. 1-22
1.2.1.3 Diarthroses……………………………………………… 1-22
1.2.1.3.1 Ball-and-Socket…………………….. 1-23
1.2.1.3.2 Condyloid…………………………….. 1-23
1.2.1.3.3 Hinge ………………………………….. 1-23
1.2.1.3.4 Gliding…………………………………. 1-23
1.2.1.3.5 Pivot……………………………………. 1-23
1.2.2 Arthritis …………………………………………………………………. 1-23
1.2.2.1 Osteoarthritis…………………………………………… 1-24
1.2.2.2 Rheumatoid Arthritis…………………………………. 1-25
1.3 Management of Joint Disorders………………………………………………. 1-26
1.3.1 Joint Replacement………………………………………………….. 1-26
1.3.1.1 Dislocation………………………………………………. 1-27
1.3.1.2 Ligament and Tendon Injuries……………………. 1-27
1.3.1.3 Meniscal Injuries………………………………………. 1-28
Exhibit 1-1: Illustration of Bone Tissue ……………………………………………………….. 1-5
Exhibit 1-2: Types of Cartilage ………………………………………………………………….. 1-9
Exhibit 1-3: Stages of Bone Remodeling…………………………………………………… 1-16
2. BIORESORBABLE FIXATION DEVICES …………………………………………… 2-1
2.1 Materials……………………………………………………………………………….. 2-1
2.2 Products ……………………………………………………………………………….. 2-3
2.2.1 Bioresorbable Pins …………………………………………………… 2-3
2.2.2 Bioresorbable Screws, Nails, and Tacks ……………………… 2-8
2.2.3 Bioresorbable Interference Screws …………………………….. 2-8
2.2.4 Bioresorbable Suture Anchors……………………………………. 2-8
2.2.5 Bioresorbable Meniscal Repair Devices…………………….. 2-13
2.3 Market Analysis ……………………………………………………………………. 2-16
2.4 Competitive Analysis …………………………………………………………….. 2-19
Exhibit 2-1: Advantages of Bioresorbable Fixation Devices …………………………… 2-2
Exhibit 2-2: Factors Affecting the Properties of Bioresorbable Polymers …………. 2-4
Exhibit 2-3: Types of Bioresorbable Fixation Devices …………………………………… 2-5
Exhibit 2-4: 2013, Selected Bioresorbable Pins……………………………………………. 2-6
Exhibit 2-5: 2013, Selected Bioresorbable Nails, Screws, and Tacks ……………… 2-9
Exhibit 2-6: 2013, Selected Bioresorbable Interference Screws……………………. 2-11
Exhibit 2-7: 2013, Selected Bioresorbable Suture Anchors………………………….. 2-14
Exhibit 2-8: 2013, Selected Bioresorbable Meniscal Repair Devices …………….. 2-17
Exhibit 2-9: Bioresorbable Fixation Devices, Market Forecast, 2012-2017 ……. 2-18
Exhibit 2-10: 2012, Bioresorbable Fixation Devices Market, Share by Supplier… 2-21
3. VISCOSUPPLEMENTATION ……………………………………………………………. 3-1
3.1 Osteoarthritis Clinical Overview………………………………………………… 3-1
3.2 Viscosupplementation Therapy ………………………………………………… 3-1
3.3 Products ……………………………………………………………………………….. 3-4
3.3.1 Anika Therapeutics…………………………………………………… 3-6
3.3.2 Ferring Pharmaceuticals……………………………………………. 3-7
3.3.3 Fidia Pharma USA/Fidia Farmaceutici ………………………… 3-7
3.3.4 Genzyme/Sanofi………………………………………………………. 3-8
3.3.5 Seikagaku……………………………………………………………….. 3-8
3.3.6 Smith & Nephew………………………………………………………. 3-9
3.4 Emerging Products……………………………………………………………….. 3-13
3.5 Potential Viscosupplementation Patients………………………………….. 3-14
3.6 Product Reimbursement………………………………………………………… 3-18
3.7 Market Analysis ……………………………………………………………………. 3-18
3.8 Competitive Analysis …………………………………………………………….. 3-23
Exhibit 3-1: 2013, Administerers of Hyaluronic Acid Injection Therapy,
by Specialty …………………………………………………………………………… 3-3
Exhibit 3-2: 2013, Selected Viscosupplementation Products ……………………….. 3-10
Exhibit 3-3: 2013, Selected Emerging Viscosupplementation Therapies ……….. 3-15
Exhibit 3-4: 2012, Patients with Knee Osteoarthritis……………………………………. 3-17
Exhibit 3-5: Projected Incidence of Symptomatic Knee Osteoarthritis,
by 10-Year Age Group…………………………………………………………… 3-19
Exhibit 3-6: Historical and Future Annual Growth Rates
in the Elderly Population………………………………………………………… 3-22
Exhibit 3-7: Viscosupplementation Products, Market Forecast, 2012-2017 ……. 3-24
Exhibit 3-8: 2012, Viscosupplementation Products Market,
Share by Supplier…………………………………………………………………. 3-28
4. CARTILAGE REPAIR AND REGENERATION ……………………………………. 4-1
4.1 Clinical Overview……………………………………………………………………. 4-1
4.2 Products ……………………………………………………………………………….. 4-5
4.2.1 Cell-Based Approaches…………………………………………….. 4-7
4.2.1.1 Chondrocyte Transplantation ………………………. 4-7
4.2.1.1.1 Anika Therapeutics …………………. 4-7
4.2.1.1.2 BioTissue Technologies…………. 4-12
4.2.1.1.3 DePuy Mitek/
Johnson & Johnson ………………. 4-12
4.2.1.1.4 Geistlich Pharma…………………… 4-12
4.2.1.1.5 Genzyme/Sanofi …………………… 4-12
4.2.1.1.6 ProChon Biotech/Histogenics …. 4-13
4.2.1.1.7 Sanofi………………………………….. 4-14
4.2.1.1.8 TETEC/B. Braun Melsungen…… 4-14
4.2.1.1.9 TiGenix ……………………………….. 4-14
4.2.1.1.10 Allogeneic Juvenile
Chondrocytes……………………….. 4-14
4.2.1.2 Stem Cells………………………………………………. 4-15
4.2.1.2.1 Geron………………………………….. 4-16
4.2.1.2.2 Medipost ……………………………… 4-16
4.2.1.2.3 Mesoblast ……………………………. 4-17
4.2.1.2.4 Smith & Nephew …………………… 4-17
4.2.1.3 Growth Factor Technology ………………………… 4-17
4.2.1.3.1 BioMimetic Therapeutics/
Wright Medical Group ……………. 4-19
4.2.1.3.2 EMD Serono/Merck……………….. 4-19
4.2.1.3.3 Sanofi………………………………….. 4-19
4.2.1.3.4 TissueGene …………………………. 4-22
4.2.2 Cell-Free Composites and Scaffolds …………………………. 4-22
4.2.2.1 Anika Therapeutics…………………………………… 4-23
4.2.2.2 Arthro Kinetics…………………………………………. 4-27
4.2.2.3 Biomet ……………………………………………………. 4-27
4.2.2.4 BioTissue ……………………………………………….. 4-27
4.2.2.5 Cartiva……………………………………………………. 4-27
4.2.2.6 Cytex ……………………………………………………… 4-28
4.2.2.7 Histogenics……………………………………………… 4-28
4.2.2.8 Kensey Nash/Royal DSM………………………….. 4-28
4.2.2.9 Piramal Healthcare…………………………………… 4-29
4.2.2.10 Regentis Biomaterials ………………………………. 4-29
4.2.2.11 Smith & Nephew………………………………………. 4-29
4.3 Reimbursement ……………………………………………………………………. 4-30
4.4 Market Analysis ……………………………………………………………………. 4-31
4.5 Competitive Analysis …………………………………………………………….. 4-35
Exhibit 4-1: The Outerbridge Classification System for Chondral Defects………… 4-3
Exhibit 4-2: Arthroscopic Knee Surgery, Procedure Volumes Forecast,
2012-2017 …………………………………………………………………………….. 4-4
Exhibit 4-3: 2012, Cartilage Repair Procedures …………………………………………… 4-6
Exhibit 4-4: Genzyme’s Carticel Autologous Chondrocyte
Implantation Device………………………………………………………………… 4-8
Exhibit 4-5: 2013, Selected Chondrocyte Graft Products and Technologies …….. 4-9
Exhibit 4-6: 2013, Selected Emerging Stem Cell-Based Products for
Cartilage Repair …………………………………………………………………… 4-18
Exhibit 4-7: 2013, Selected Emerging Recombinant Human Growth
Factor Products ……………………………………………………………………. 4-20
Exhibit 4-8: 2013, Selected Cell-Free Scaffolds for Cartilage Repair
and Regeneration…………………………………………………………………. 4-24
Exhibit 4-9: Cartilage Repair and Regeneration Products,
Market Forecast, 2012-2017 ………………………………………………….. 4-32
Exhibit 4-10: Cartilage Regeneration, Potential Procedure
Volumes Forecast, 2012-2017 ……………………………………………….. 4-34
5. MENISCAL REPAIR, REGENERATION, AND REPLACEMENT …………… 5-1
5.1 Clinical Overview……………………………………………………………………. 5-1
5.1.1 Meniscal Injuries………………………………………………………. 5-2
5.1.1.1 Traumatic Tears ………………………………………… 5-2
5.1.1.2 Degenerative Tears……………………………………. 5-5
5.2 Current Treatment ………………………………………………………………….. 5-5
5.2.1 Nonoperative Treatment……………………………………………. 5-8
5.2.2 Surgical Treatment …………………………………………………… 5-8
5.2.2.1 Arthroscopic Suturing …………………………………. 5-8
5.2.2.2 Bioresorbable Fixation………………………………… 5-9
5.2.2.3 Meniscectomy …………………………………………… 5-9
5.3 Procedure Volumes………………………………………………………………. 5-10
5.4 Meniscal Repair and Regeneration …………………………………………. 5-10
5.4.1 Bioresorbable Fixation Products……………………………….. 5-10
5.4.2 Market Analysis ……………………………………………………… 5-12
5.4.3 Competitive Analysis ………………………………………………. 5-14
5.5 Meniscal Replacement ………………………………………………………….. 5-16
5.5.1 Meniscal Allografts …………………………………………………. 5-18
5.5.2 Market Analysis ……………………………………………………… 5-19
5.5.3 Competitive Analysis ………………………………………………. 5-21
5.6 Meniscal Repair, Regeneration, and Replacement Technologies
Under Development………………………………………………………………. 5-21
5.6.1 Scaffolding Technologies ………………………………………… 5-21
5.6.1.1 Collagen …………………………………………………. 5-24
5.6.1.2 Fibrin ……………………………………………………… 5-24
5.6.1.3 Polymers ………………………………………………… 5-25
5.6.2 Cell Therapy………………………………………………………….. 5-26
5.7 Combined Market Forecast ……………………………………………………. 5-30
Exhibit 5-1: Anatomy of the Knee Joint ………………………………………………………. 5-3
Exhibit 5-2: Common Types of Meniscal Tears……………………………………………. 5-4
Exhibit 5-3: Illustration of a Meniscal Tear…………………………………………………… 5-6
Exhibit 5-4: Comparison of Treatment Options for Meniscal Injuries……………….. 5-7
Exhibit 5-5: Meniscectomy and Meniscal Repair,
Procedure Volumes Forecast, 2012-2017………………………………… 5-11
Exhibit 5-6: 2013, Selected Bioresorbable Fixation Devices
for Meniscal Repair……………………………………………………………….. 5-13
Exhibit 5-7: Bioresorbable Fixation Devices for Meniscal Repair,
Market Forecast, 2012-2017 ………………………………………………….. 5-15
Exhibit 5-8: 2012, Market for Bioresorbable Fixation Devices for
Meniscal Repair, Share by Supplier ………………………………………… 5-17
Exhibit 5-9: 2013, Selected Meniscal Allografts………………………………………….. 5-20
Exhibit 5-10: Meniscal Allografts, Market Forecast, 2012-2017 ……………………… 5-22
Exhibit 5-11: 2012, Meniscal Allografts Products Market, Share by Supplier ……. 5-23
Exhibit 5-12: 2013, Selected Meniscal Scaffolding Products
Under Development………………………………………………………………. 5-27
Exhibit 5-13: Chondrogen Phase I/II Clinical Trial Results …………………………….. 5-29
Exhibit 5-14: Meniscal Repair, Regeneration, and Replacement Products,
Combined Market Forecast, 2012-2017 …………………………………… 5-31
6. LIGAMENT AND TENDON REPAIR, REGENERATION,
AND REPLACEMENT ……………………………………………………………………… 6-1
6.1 Clinical Overview……………………………………………………………………. 6-1
6.1.1 The Knee………………………………………………………………… 6-1
6.1.2 The Achilles Tendon…………………………………………………. 6-5
6.1.3 Hand Ligaments and Tendons …………………………………… 6-7
6.1.4 Shoulder Ligaments and Tendons………………………………. 6-8
6.2 Procedure Volumes………………………………………………………………. 6-10
6.3 Current Treatments ………………………………………………………………. 6-10
6.3.1 Anterior Cruciate Ligament Tears……………………………… 6-10
6.3.2 Rotator Cuff Tears………………………………………………….. 6-13
6.4 Allografts …………………………………………………………………………….. 6-14
6.5 Tissue Engineering……………………………………………………………….. 6-16
6.5.1 Biologic Scaffolds …………………………………………………… 6-16
6.5.2 Polymer-Based Scaffolds ………………………………………… 6-19
6.6 Growth Factors…………………………………………………………………….. 6-24
6.6.1 Platelet-Rich Plasma ………………………………………………. 6-24
6.6.2 Synthetic Growth Factors ………………………………………… 6-26
6.7 Cell and Gene Therapies……………………………………………………….. 6-27
6.7.1 Cell-Based Therapies Under Development ………………… 6-30
6.8 Market Analysis ……………………………………………………………………. 6-31
6.9 Competitive Analysis …………………………………………………………….. 6-36
6.10 Ligament and Tendon Replacement Market Status …………………… 6-36
6.11 Emerging Ligament and Tendon Regeneration Products Market…. 6-38
Exhibit 6-1: Anatomy of the Knee Joint ………………………………………………………. 6-3
Exhibit 6-2: Anterior Cruciate Ligament Injury ……………………………………………… 6-4
Exhibit 6-3: Achilles Tendon Rupture …………………………………………………………. 6-6
Exhibit 6-4: Ligaments of the Shoulder……………………………………………………….. 6-9
Exhibit 6-5: 2012, Ligament and Tendon Procedures, by Anatomic Location …. 6-11
Exhibit 6-6: 2013, Selected Allografts for Ligament and Tendon Replacement.. 6-15
Exhibit 6-7: 2013, Selected Tissue-Engineered Ligament and Tendon
Repair Products……………………………………………………………………. 6-21
Exhibit 6-8: 2013, Selected Collagen-Based Scaffolds Under Development
for Ligament and Tendon Repair…………………………………………….. 6-22
Exhibit 6-9: 2013, Selected Synthetic Scaffolds Under Development for
Ligament and Tendon Repair…………………………………………………. 6-23
Exhibit 6-10: Aperion Biologics’ Z-Lig Xenograft ………………………………………….. 6-25
Exhibit 6-11: 2013, Selected Growth Factor Products and Technologies
Under Development………………………………………………………………. 6-28
Exhibit 6-12: 2013, Selected Cell-Based Therapy Approaches Under
Development for Tendon Repair …………………………………………….. 6-32
Exhibit 6-13: Ligament and Tendon Allografts, Market Forecast, 2012-2017……. 6-33
Exhibit 6-14: 2012, Ligament and Tendon Allografts Market, Share by Supplier . 6-37
7. COMPANY PROFILES…………………………………………………………………….. 7-1
7.1 Arthrex, Inc. …………………………………………………………………………… 7-1
7.2 ConMed Linvatec/ConMed Corporation …………………………………….. 7-2
7.3 Fidia Pharma USA, Inc./Fidia Farmaceutici SpA …………………………. 7-4
7.4 Genzyme Corporation/Sanofi SA ……………………………………………… 7-4
7.5 Johnson & Johnson………………………………………………………………… 7-6
7.6 LifeNet Health, Inc………………………………………………………………….. 7-9
7.7 Medtronic, Inc………………………………………………………………………… 7-9
7.8 Musculoskeletal Transplant Foundation, Inc. ……………………………. 7-10
7.9 RTI Biologics, Inc………………………………………………………………….. 7-11
7.10 Smith & Nephew PLC……………………………………………………………. 7-12
APPENDIX: COMPANY LISTING……………………………………………………………… A-1
Figure: Viscosupplementation Products, Market Forecast, 2012-2017
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