TABLE OF CONTENTS I
LIST OF FIGURES XVIII
LIST OF CHARTS XXIII
EXECUTIVE SUMMARY 1
U.S. ORTHOPEDIC BIOMATERIALS MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 6
MARKET DEVELOPMENTS 8
PROCEDURE NUMBERS 9
MARKETS INCLUDED 11
KEY REPORT UPDATES 13
VERSION HISTORY 13
RESEARCH METHODOLOGY 14
1.1 RESEARCH SCOPE 14
1.2 IDATA’S 9-STEP METHODOLOGY 14
Step 1: Project Initiation & Team Selection 14
Step 2: Prepare Data Systems and Perform Secondary Research 16
Step 3: Preparation for Interviews & Questionnaire Design 17
Step 4: Performing Primary Research 18
Step 5: Research Analysis: Establishing Baseline Estimates 20
Step 6: Market Forecast and Analysis 21
Step 7: Identify Strategic Opportunities 23
Step 8: Final Review and Market Release 24
Step 9: Customer Feedback and Market Monitoring 25
DISEASE OVERVIEW 26
2.1 BASIC ANATOMY 26
2.1.1 Osteology and Musculoskeletal System 26
2.2 DISEASE PATHOLOGY AND DISORDERS 28
2.2.1 General Diagnostic 28
2.2.2 Osteoporosis 29
2.2.3 Osteoarthritis 29
2.2.4 Indication for Bone Graft Procedure 30
2.2.5 Indication for Cartilage Repair 31
2.2.6 Degenerative Disc Disease 32
2.3 PATIENT DEMOGRAPHICS 34
2.3.1 General Statistics 34
PRODUCT ASSESSMENT 36
3.1 PRODUCT PORTFOLIOS 36
3.1.1 Bone Graft Substitutes 37
3.1.2 Growth Factors 41
3.1.2.1 Other products 44
3.1.3 Cellular Allografts 46
3.1.4 Cell Therapy 50
3.1.5 Hyaluronic Acid Viscosupplementation 54
3.1.6 Cartilage Repair 57
3.1.7 Spinal Machined Bone Allografts 59
3.2 REGULATORY ISSUES AND RECALLS 62
3.2.1 Bone Graft Substitutes 62
3.2.2 Growth Factors 65
3.2.3 Cell Therapy 66
3.2.4 Hyaluronic Acid Viscosupplementation 67
3.2.5 Cartilage Repair 68
3.2.6 Spinal Machined Bone Allografts 69
3.3 CLINICAL TRIALS 70
3.3.1 Bone Graft Substitutes 70
3.3.2 Growth Factors 75
3.3.3 Cellular Allografts 80
3.3.4 Cell Therapies 86
3.3.5 Hyaluronic Acid Viscosupplementation 88
3.3.6 Cartilage Repair 92
3.3.7 Spinal Machined Bone Allografts 97
ABBREVIATIONS 103
APPENDIX II: COMPANY PRESS RELEASES 105

Chart 1 1: Orthopedic Biomaterials Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Orthopedic Biomaterials Market Overview, U.S., 2016 & 2023 3

Figure 1 1: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (1 of 2) 4
Figure 1 2: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (2 of 2) 4
Figure 1 3: Companies Researched in this Report, U.S., 2016 5
Figure 1 4: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (1 of 2) 6
Figure 1 5: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (2 of 2) 7
Figure 1 6: Recent Events in the Orthopedic Biomaterials Market, U.S., 2013 – 2016 8
Figure 1 7: Orthopedic Biomaterials Markets Covered, U.S., 2016 (1 of 2) 9
Figure 1 8: Orthopedic Biomaterials Markets Covered, U.S., 2016 (2 of 2) 10
Figure 1 9: Orthopedic Biomaterials Markets Covered, U.S., 2016(1 of 3) 11
Figure 3 1: Bone Graft Substitutes Products by Company (1 of 3) 38
Figure 3 2: Bone Graft Substitutes Products by Company (2 of 3) 39
Figure 3 3: Bone Graft Substitutes Products by Company (3 of 3) 40
Figure 3 4: Growth Factors Products by Company 45
Figure 3 5: Estimates of Funding for Stem Cell Research 48
Figure 3 6: Cellular Allograft Products by Company 49
Figure 3 7: Cell Therapy Products by Company 53
Figure 3 8: Hyaluronic Acid Viscosupplementationby Products by Company 56
Figure 3 9: Cartilage Repair Products by Company 58
Figure 3 10: Spinal Machined Bone Allograft Products by Company 61
Figure 3 11: Class 2 Device Recall Endobon Xenograft Granules 62
Figure 3 12: Class 2 Device Recall Accell Evo3c Demineralized Bone Matrix Putty 62
Figure 3 13: Class 2 Device Recall AlloFuse DBM Putty 5cc 62
Figure 3 14: Class 2 Device Recall MicroFuse Bone Void Filler 63
Figure 3 15: Class 2 Device Recall Grafton 63
Figure 3 16: Class 2 Device Recall Optimum Expanse 63
Figure 3 17: Class 2 Device Recall Integra Mozaik 64
Figure 3 18: Class 2 Device Recall INFUSE(R) Bone Graft 65
Figure 3 19: Class 2 Device Recall Stryker Biotech 65
Figure 3 20: Class 2 Device Recall OnControl 66
Figure 3 21: Class 2 Device Recall Graft Delivery System 66
Figure 3 22: Class 3 Device Recall Euflexxa (1 sodium hyaluronate) 67
Figure 3 23: Class 2 Device Recall Smith & Nephew 68
Figure 3 24: Class 2 Device Recall Surgical Saw Blade Procedure Pack 68
Figure 3 25: Class 2 Device Recall Stryker Radius Spinal System 69
Figure 3 26: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix 70
Figure 3 27: Cerament Treatment of Fracture Defects (CERTiFy) 70
Figure 3 28: Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction 71
Figure 3 29: Assessment of nanOss Bioactive 3D in the Posterolateral Spine 71
Figure 3 30: AttraX® Putty vs. Autograft in XLIF® 71
Figure 3 31: Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System 72
Figure 3 32: Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion 72
Figure 3 33: Efficacy and Safety of SurgiFill™ on Spinal Fusion 72
Figure 3 34: Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease 73
Figure 3 35: Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine 73
Figure 3 36: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™ 74
Figure 3 37: A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 75
Figure 3 38: A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP® 75
Figure 3 39: The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation 76
Figure 3 40: Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation 76
Figure 3 41: RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion (AxA) 77
Figure 3 42: Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2 77
Figure 3 43: Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery (Intebody) 78
Figure 3 44: Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft 78
Figure 3 45: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport 79
Figure 3 46: Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery 79
Figure 3 47: Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury 80
Figure 3 48: Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury 80
Figure 3 49: rhBMP-2 in Cervical Arthrodesis 81
Figure 3 50: Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion 81
Figure 3 51: BMAC & Allograft vs BMP-2 82
Figure 3 52: Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine 82
Figure 3 53: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells (ARTHROSTEM) 83
Figure 3 54: Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study 83
Figure 3 55: Mesenchymal Stem Cells in Knee Cartilage Injuries 84
Figure 3 56: A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft 84
Figure 3 57: Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo) 85
Figure 3 58: Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation (BM-MSC) for Kienbock's Disease 86
Figure 3 59: The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction 86
Figure 3 60: Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid 87
Figure 3 61: Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects 87
Figure 3 62: Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection (GOTOX) 88
Figure 3 63: Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of HA (ViscOA) 88
Figure 3 64: Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis 89
Figure 3 65: Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid (PNHA1401) 89
Figure 3 66: To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection 90
Figure 3 67: Platelet-rich Plasma vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology (PRP) 90
Figure 3 68: Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy 91
Figure 3 69: Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee 91
Figure 3 70: DeNovo NT Longitudinal Data Collection (LDC) Knee Study 92
Figure 3 71: NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D) 92
Figure 3 72: Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair (REKREATE) 93
Figure 3 73: Confirmatory Study of NeoCart in Knee Cartilage Repair 93
Figure 3 74: the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle 94
Figure 3 75: Efficacy of BST-CarGel in Treating Chondral Lesions of the Hip 94
Figure 3 76: BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan 95
Figure 3 77: A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC 95
Figure 3 78: Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft (ODPHOENIX2) 96
Figure 3 79: Neocartilage Implant to Treat Cartilage Lesions of the Knee 96
Figure 3 80: Study of Nucel for One and Two Level Lumbar Interbody Fusion 97
Figure 3 81: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix 97
Figure 3 82: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation 98
Figure 3 83: Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion 98
Figure 3 84: Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine 99
Figure 3 85: Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC) 99
Figure 3 86: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn) (VCBM/ACDF) 100
Figure 3 87: Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC) 100
Figure 3 88: PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries (PEEK) 101
Figure 3 89: Restore CLINICAL TRIAL 101
Figure 3 90: A Prospective Study of NuCel® in Cervical Spine Fusion 102
Figure 3 91: Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy 102
Figure 5 1: Press Release Summary 105

Medtronic
Genzyme
DePuy Synthes
Anika Therapeutics
Ferring Pharmaceuticals
Stryker
NuVasive
Bioventus
Zimmer Biomet
Integra LifeSciences
RTI Surgical
Fidia Pharmaceuticals
MTF
Orthofix
Arthrex
AlloSource
Aastrom
Baxter
Harvest Technologies
Wright Medical
Bacterin International
Arteriocyte
Exactech
LifeNet Health
Biocomposites
Alphatec Spine
Celling Biosciences
Globus Medical
Nuo Therapeutics
K2M
*Not all companies are currently active in every segment or sub-report from this suite. For more details contact an iData Research Product Advisor.