Table of Contents

EXECUTIVE SUMMARY…………………………………………………………………………. ES-1
i. Methodology……………………………………………………………………….. ES-2
Exhibit ES-1: 2014, U.S. Orthopedic Biologic and Tissue Engineered Products Market, Share by Products ……………………………………………………. ES-3
1. OVERVIEW OF MUSCULOSKELETAL DISEASES/DISORDERS…………. 1-1
1.1 Back Pain and Spine Surgery…………………………………………………… 1-1
1.2 Carpal Tunnel Syndrome…………………………………………………………. 1-5
1.3 Duchenne Muscular Dystrophy ………………………………………………… 1-6
1.4 Osteoarthritis …………………………………………………………………………. 1-7
1.5 Osteoporosis and Fractures …………………………………………………….. 1-8
1.6 Rheumatoid Arthritis……………………………………………………………….. 1-9
Exhibit 1-1: Musculoskeletal Surgery, Procedure Volumes Forecast, by Type, 2014-2019 ……………………………………………………………………. 1-2
2. U.S. MARKETS FOR BIOLOGIC MUSCULOSKELETAL SOFT TISSUE REGENERATION AND REPAIR PRODUCTS…………………………………….. 2-1
2.1 Cartilage Regeneration and Repair Technologies……………………….. 2-2
2.1.1 Currently Available Products ……………………………………… 2-2
2.1.1.1 Arthrex……………………………………………………… 2-2
2.1.1.2 Vericel ……………………………………………………… 2-3
2.1.1.3 Zimmer …………………………………………………….. 2-5
2.1.2 Products in Development ………………………………………….. 2-5
2.1.2.1 CellCoTec ………………………………………………… 2-6
2.1.2.2 Cytori Therapeutics ……………………………………. 2-6
2.1.2.3 Histogenics……………………………………………….. 2-7
2.1.2.4 ISTO Technologies…………………………………….. 2-7
2.1.2.5 Medipost…………………………………………………… 2-8
2.1.2.6 TETEC …………………………………………………….. 2-8
2.1.2.7 TiGenix…………………………………………………….. 2-9
2.1.2.8 TissueGene………………………………………………. 2-9
2.1.3 Market Forecast …………………………………………………….. 2-10
2.1.4 Competitive Analysis ………………………………………………. 2-11
2.2 Ligament and Tendon Repair Technologies……………………………… 2-15
2.2.1 Graft-Based Products Overview……………………………….. 2-17 2015 Medtech Insight i #A428
U.S. Markets for Orthopedic Biologic and Tissue Engineered Products Table of Contents
2.2.2 Tissue Engineering…………………………………………………. 2-17
2.2.2.1 Biologic Scaffolds…………………………………….. 2-19
2.2.2.2 Developmental Biologic Scaffolds ………………. 2-19
2.2.3 Market Forecast …………………………………………………….. 2-22
2.2.4 Competitive Analysis ………………………………………………. 2-23
2.3 Meniscus Repair and Regeneration Technologies …………………….. 2-27
2.3.1 Products Overview …………………………………………………. 2-29
2.3.2 Market Forecast …………………………………………………….. 2-30
2.3.3 Competitive Analysis ………………………………………………. 2-32
2.2.4 U.S. Markets for Biologic Soft Tissue Regeneration and Repair Products……………………………………………………… 2-35
Exhibit 2-1: 2014, Cartilage Repair Procedures …………………………………………. 2-12
Exhibit 2-2: Cartilage Repair and Regeneration Products, Market Forecast, 2014-2019 …………………………………………………………….. 2-13
Exhibit 2-3: 2014, Knee Cartilage Repair and Regeneration Products Market, Share by Supplier…………………………………………………………………. 2-16
Exhibit 2-4: 2015, Selected Allografts for Ligament and Tendon Replacement ……………………………………………………………. 2-18
Exhibit 2-5: 2015, Biologic Scaffolds and Matrices for Ligament and Tendon Repair……………………………………………………………………… 2-20
Exhibit 2-6: Ligament and Tendon Replacement and Regeneration Products, Market Forecast, 2014-2019 ………………………………………………….. 2-24
Exhibit 2-7: 2014, Ligament and Tendon Replacement and Regeneration Products Market, Share by Supplier………………………………………… 2-28
Exhibit 2-8: 2015, Selected Biologic Meniscal Repair Products ……………………. 2-31
Exhibit 2-9: Meniscal Replacement and Regeneration Products, Market Forecast, 2014-2019 …………………………………………………………….. 2-33
Exhibit 2-10: 2014, Meniscal Replacement and Regeneration Products Market, Share by Supplier…………………………………………………………………. 2-36
Exhibit 2-11: Musculoskeletal Soft Tissue Biologics Products, Market Forecast, 2014-2019 …………………………………………………………….. 2-38
3. U.S. MARKETS FOR BIOLOGIC MUSCULOSKELETAL HARD TISSUE REGENERATION AND REPAIR……………………………………………………….. 3-1
3.1 Bone Graft and Bone Substitute Products on the Market and Under Development …………………………………………………………………………. 3-2 2015 Medtech Insight ii #A428
U.S. Markets for Orthopedic Biologic and Tissue Engineered Products Table of Contents
3.1.1 Bone Autograft ………………………………………………………… 3-2
3.1.2 Bone Allografts and Machined Bone …………………………… 3-2
3.1.3 Demineralized Bone Matrix ……………………………………….. 3-3 3.1.4 Market Forecast …………………………………………………….. 3-11 3.1.5 Competitive Analysis ………………………………………………. 3-12
3.2 Growth Factor-Based Bone Grafts ………………………………………….. 3-17
3.2.1 Products Overview …………………………………………………. 3-20
3.2.1.1 Bioventus ……………………………………………….. 3-20
3.2.1.2 Medtronic ……………………………………………….. 3-20
3.2.1.3 Wright Medical Technology ……………………….. 3-21
3.2.2 Market Forecast …………………………………………………….. 3-22
3.2.3 Competitive Analysis ………………………………………………. 3-23
3.3 Other Biologics Currently Available or in Development ………………. 3-26
3.3.1 Cellular Bone Matrices ……………………………………………. 3-26
3.3.1.1 AlloSource………………………………………………. 3-28
3.3.1.2 Biomet ……………………………………………………. 3-28
3.3.1.3 NuVasive………………………………………………… 3-28
3.3.1.4 Orthofix…………………………………………………… 3-29
3.3.1.5 Osiris Therapeutics ………………………………….. 3-29
3.3.1.6 RTI Surgical…………………………………………….. 3-30
3.3.2 Cellular Regeneration Therapies in Development for Hard Bone Musculoskeletal Repair …………………………… 3-30
3.3.2.1 Cerapedics, Inc. ………………………………………. 3-30
3.3.2.2 Ferring Pharmaceuticals …………………………… 3-31
3.3.2.3 Mesoblast……………………………………………….. 3-31
3.3.3 Market Forecast …………………………………………………….. 3-32
3.3.4 Competitive Analysis ………………………………………………. 3-33
3.4 Emerging Areas of Cellular Therapy for Soft and Hard Tissue Repair and Regeneration ………………………………………………………. 3-39
3.4.1 Bone Marrow Aspirate Concentrate ………………………….. 3-39
3.4.2 Gene Therapy ……………………………………………………….. 3-40
3.4.2.1 Systemic Gene Therapy……………………………. 3-40
3.4.2.2 Regional Gene Therapy ……………………………. 3-40
3.4.3 Three-Dimensional Printing……………………………………… 3-40
3.5 U.S. Markets for Musculoskeletal Hard Tissue Regeneration and Repair Products……………………………………………………………… 3-41 2015 Medtech Insight iii #A428
U.S. Markets for Orthopedic Biologic and Tissue Engineered Products Table of Contents
3.6 Combined Market Summary for Hard and Soft Tissue Engineering and Cellular Therapy Products ……………………………………………….. 3-43
Exhibit 3-1: 2015, Description and Representative Pricing of Base Allografts Used in Spine Surgery…………………………………………………………………….. 3-4
Exhibit 3-2: 2015, Selected Bone Allograft and Machined Bone Products ……….. 3-5
Exhibit 3-3: 2015, Selected Demineralized Bone Matrix Products…………………… 3-8
Exhibit 3-4: Bone Allografts and Synthetic Bone Graft Substitutes, Market Forecast, 2014-2019 …………………………………………………………….. 3-13
Exhibit 3-5: 2014, Bone Allograft Products Market, Share by Supplier…………… 3-16
Exhibit 3-6: 2014, Demineralized Bone Matrix Products Market, Share by Supplier…………………………………………………………………. 3-18
Exhibit 3-7: Growth Factor-Based Products, Market Forecast, 2014-2019 …….. 3-24
Exhibit 3-8: 2014, Growth Factor-Based Products Market, Share by Supplier ………………………………………………………………………….. 3-27
Exhibit 3-9: Stem Cell Matrices and Other Osteobiologic Agents for Bone Healing and Enhancement of Spinal Fusion, Market Forecast, 2014-2019 …………………………………………………………….. 3-34
Exhibit 3-10: 2014, Market Shares of Stem Cell Applications for Bone Healing and Spinal Fusion by Application ……………………………………………. 3-36
Exhibit 3-11: 2014, Stem Cell Products and Other Orthobiologics for Bone Healing and Spinal Fusion, Share by Supplier ………………………….. 3-38
Exhibit 3-12: U.S. Biologic Products for Musculoskeletal Hard Tissue Repair and Regeneration, Combined Market Forecast, 2014-2019……….. 3-44
Exhibit 3-13: U.S. Hard and Soft Musculoskeletal Tissue Repair and Regeneration, Combined Procedure Volumes, 2014-2019………………………………. 3-47
Exhibit 3-14: U.S. Biologic Products for Musculoskeletal Hard and Soft Tissue Repair and Regeneration, Combined Market Forecast, 2014-2019 …………………………………………………………………………… 3-49
APPENDIX: COMPANY LISTING……………………………………………………………… A-1
BIBLIOGRAPHY ……………………………………………………………………………………… B-1