$4,750.00
Tissue engineering, or regenerative medicine, represents a promising therapeutic possibility for the treatment of aggressive and deadly diseases.
Tissue engineering, or regenerative medicine, represents a promising therapeutic possibility for the treatment of aggressive and deadly diseases. Biologics and cellular therapies for musculoskeletal injuries—including hard tissue (i.e., bone) and soft tissue (i.e., cartilage, ligaments, and tendons)—represent a billion dollar market that is showing the potential for continued growth. Unlike other disease indications which are still developing cellular therapies, the United States (U.S.) market for orthopedic biologic and cellular therapies has been growing since 1997 with the market introduction of autologous chrondocyte implantation. Over the forecast period covered in this report, the estimated value of the U.S. market for orthopedic biologic and tissue engineered products is expected to grow by approximately $984.4 million at a compound annual growth rate (CAGR) of 8.2%; of this holistic market, biologic and cellular therapies for hard musculoskeletal tissue are forecasted to grow at a CAGR of 7.2%, while soft musculoskeletal tissue products will grow at a CAGR of 10.6%.
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
Exhibit 2-2: Cartilage Repair and Regeneration Products, Market Forecast, 2014-2019
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