US Market Report for Orthopedic Bone Graft Substitutes 2017 - MedCore

iData Research
589 Pages - IDR10401
$3,995.00

General Report Contents
• Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
• Market Drivers & Limiters for each chapter segment
• Competitive Analysis for each chapter segment
• Section on recent mergers & acquisitions
As of 2016, the synthetic bone grafts accounted for the largest portion of the market followed by the demineralized bone matrix (DBM) grafts. Market growth has been supported by the strong adoption of the BMP growth factor market, which is represented by Medtronic’s INFUSE® product. Furthermore, the fast growing cellular allograft market has benefited the bone graft substitute market by allowing greater osteogenic properties with the use of stem cells. The recent resurgence of growth in the cheaper allograft material market has pushed DBM prices lower in order to stay competitive.
The synthetic bone graft segment surpassed the DBM segment due to both a higher ASP and stronger unit sales growth in the U.S. market. Synthetic grafts are more commonly used in spinal surgeries rather than applications involving larger volumes, as with fracture repair. These large volume indications are the reason that cheaper options, such as allograft bone, play an important role in the market.

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TABLE OF CONTENTS I
LIST OF FIGURES XIX
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
3.2 REGULATORY ISSUES AND RECALLS 41
3.2.1 Bone Graft Substitutes 41
3.3 CLINICAL TRIALS 44
3.3.1 Bone Graft Substitutes 44
ORTHOPEDIC BONE GRAFT SUBSTITUTE MARKET 49
4.1 INTRODUCTION 49
4.1.1 Units per Procedure by Indication 50
4.2 MARKET OVERVIEW 51
4.2.1 Bone Graft Substitute Market by Material 51
4.2.2 Bone Graft Substitute Market by Indication 55
4.3 MARKET ANALYSIS AND FORECAST 59
4.3.1 Total Orthopedic Bone Graft Substitute Market 59
4.3.2 Bone Graft Substitute Market by Material 61
4.3.2.1 Total Allograft Bone Graft Substitute Market 61
4.3.2.2 Allograft Bone Graft Substitute Market by Indication 64
4.3.2.2.1 Spine 66
4.3.2.2.2 Trauma 72
4.3.2.2.3 Large Joint Reconstruction 78
4.3.2.2.4 Foot Reconstruction 84
4.3.2.2.5 Craniomaxillofacial 86
4.3.2.2.6 Oncology 88
4.3.2.3 Total Demineralized Bone Matrix Market 90
4.3.2.4 Demineralized Bone Matrix Market with and without Carriers 93
4.3.2.5 Demineralized Bone Matrix Market by Indication 94
4.3.2.5.1 Spine 96
4.3.2.5.2 Trauma 102
4.3.2.5.3 Large Joint Reconstruction 108
4.3.2.5.4 Foot Reconstruction 114
4.3.2.5.5 Craniomaxillofacial 116
4.3.2.5.6 Oncology 118
4.3.2.6 Total Synthetic Bone Graft Substitute Market 120
4.3.2.7 Synthetic Bone Graft Substitute Market by Indication 123
4.3.2.7.1 Spine 125
4.3.2.7.2 Trauma 131
4.3.2.7.3 Large Joint Reconstruction 137
4.3.2.7.4 Foot Reconstruction 143
4.3.2.7.5 Craniomaxillofacial 145
4.3.2.7.6 Oncology 147
4.3.3 Bone Graft Substitute Market by Indication 149
4.3.3.1 Spine 149
4.3.3.1.1 Cervical Spine 151
4.3.3.1.2 Thoracolumbar Spine 153
4.3.3.2 Trauma 155
4.3.3.2.1 Non-Union Trauma 157
4.3.3.2.2 Fresh Fracture Trauma 159
4.3.3.3 Large Joint Reconstruction 161
4.3.3.3.1 Hip Large Joint Reconstruction 163
4.3.3.3.2 Knee Large Joint Reconstruction 165
4.3.3.4 Foot Reconstruction 167
4.3.3.5 Craniomaxillofacial 170
4.3.3.6 Oncology 172
4.4 DRIVERS AND LIMITERS 174
4.4.1 Market Drivers 174
4.4.1.1 Allograft Bone Graft Substitute Market 174
4.4.1.2 Demineralized Bone Matrix Bone Graft Substitute Market 174
4.4.1.3 Synthetic Bone Graft Substitute Market 175
4.4.2 Market Limiters 177
4.4.2.1 Allograft Bone Graft Substitute Market 177
4.4.2.2 Demineralized Bone Matrix Bone Graft Substitute Market 177
4.4.2.3 Synthetic Bone Graft Substitute Market 178
4.5 COMPETITIVE MARKET SHARE ANALYSIS 180
ABBREVIATIONS 188
APPENDIX II: COMPANY PRESS RELEASES 190

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
Chart 4 1: Orthopedic Bone Graft Substitute Market by Material, U.S., 2013 – 2023 53
Chart 4 2: Orthopedic Bone Graft Substitute Market Breakdown by Material, U.S., 2016 54
Chart 4 3: Orthopedic Bone Graft Substitute Market Breakdown by Material, U.S., 2023 54
Chart 4 4: Orthopedic Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 57
Chart 4 5: Orthopedic Bone Graft Substitute Market Breakdown by Indication, U.S., 2016 58
Chart 4 6: Orthopedic Bone Graft Substitute Market Breakdown by Indication, U.S., 2023 58
Chart 4 7: Total Orthopedic Bone Graft Substitute Market, U.S., 2013 – 2023 60
Chart 4 8: Total Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 63
Chart 4 9: Allograft Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 65
Chart 4 10: Total Spine Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 67
Chart 4 11: Cervical Spine Bone Graft Substitute Market, U.S., 2013 – 2023 69
Chart 4 12: Thoracolumbar Spine Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 71
Chart 4 13: Total Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 73
Chart 4 14: Non-Union Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 75
Chart 4 15: Fresh Fracture Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 77
Chart 4 16: Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 79
Chart 4 17: Hip Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 81
Chart 4 18: Knee Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 83
Chart 4 19: Foot Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 85
Chart 4 20: Craniomaxillofacial Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 87
Chart 4 21: Oncology Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 89
Chart 4 22: Total Demineralized Bone Matrix Market, U.S., 2013 – 2023 92
Chart 4 23: Demineralized Bone Matrix Market by Indication, U.S., 2013 – 2023 95
Chart 4 24: Total Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 97
Chart 4 25: Cervical Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 99
Chart 4 26: Thoracolumbar Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 101
Chart 4 27: Total Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 103
Chart 4 28: Non-Union Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 105
Chart 4 29: Fresh Fracture Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 107
Chart 4 30: Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 109
Chart 4 31: Hip Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 111
Chart 4 32: Knee Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 113
Chart 4 33: Foot Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 115
Chart 4 34: Craniomaxillofacial Demineralized Bone Matrix Market, U.S., 2013 – 2023 117
Chart 4 35: Oncology Demineralized Bone Matrix Market, U.S., 2013 – 2023 119
Chart 4 36: Total Orthopedic Bone Graft Substitute Market, U.S., 2013 – 2023 122
Chart 4 37: Synthetic Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 124
Chart 4 38: Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 126
Chart 4 39: Cervical Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 128
Chart 4 40: Thoracolumbar Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 130
Chart 4 41: Total Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 132
Chart 4 42: Non-Union Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 134
Chart 4 43: Fresh Fracture Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 136
Chart 4 44: Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 138
Chart 4 45: Hip Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 140
Chart 4 46: Knee Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 142
Chart 4 47: Foot Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 144
Chart 4 48: Craniomaxillofacial Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 146
Chart 4 49: Oncology Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 148
Chart 4 50: Spine Bone Graft Substitute Market, U.S., 2013 – 2023 150
Chart 4 51: Cervical Spine Bone Graft Substitute Market, U.S., 2013 – 2023 152
Chart 4 52: Thoracolumbar Spine Bone Graft Substitute Market, U.S., 2013 – 2023 154
Chart 4 53: Total Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 156
Chart 4 54: Non-Union Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 158
Chart 4 55: Fresh Fracture Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 160
Chart 4 56: Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 162
Chart 4 57: Hip Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 164
Chart 4 58: Knee Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 166
Chart 4 59: Foot Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 169
Chart 4 60: Craniomaxillofacial Bone Graft Substitute Market, U.S., 2013 – 2023 171
Chart 4 61: Oncology Bone Graft Substitute Market, U.S., 2013 – 2023 173
Chart 4 62: Leading Competitors, Orthopedic Bone Graft Substitute Market, U.S., 2016 187

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: Class 2 Device Recall Endobon Xenograft Granules 41
Figure 3 5: Class 2 Device Recall Accell Evo3c Demineralized Bone Matrix Putty 41
Figure 3 6: Class 2 Device Recall AlloFuse DBM Putty 5cc 41
Figure 3 7: Class 2 Device Recall MicroFuse Bone Void Filler 42
Figure 3 8: Class 2 Device Recall Grafton 42
Figure 3 9: Class 2 Device Recall Optimum Expanse 42
Figure 3 10: Class 2 Device Recall Integra Mozaik 43
Figure 3 11: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix 44
Figure 3 12: Cerament Treatment of Fracture Defects (CERTiFy) 44
Figure 3 13: Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction 45
Figure 3 14: Assessment of nanOss Bioactive 3D in the Posterolateral Spine 45
Figure 3 15: AttraX® Putty vs. Autograft in XLIF® 45
Figure 3 16: Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System 46
Figure 3 17: Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion 46
Figure 3 18: Efficacy and Safety of SurgiFill™ on Spinal Fusion 46
Figure 3 19: Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease 47
Figure 3 20: Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine 47
Figure 3 21: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™ 48
Figure 4 1: Units per Procedure by Indication, Bone Graft Substitute Market, U.S., 2013 – 2023 50
Figure 4 2: Orthopedic Bone Graft Substitute Market by Material, U.S., 2013 – 2023 (US$M) 52
Figure 4 3: Orthopedic Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 (US$M) 56
Figure 4 4: Total Orthopedic Bone Graft Substitute Market, U.S., 2013 – 2023 59
Figure 4 5: Total Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 62
Figure 4 6: Allograft Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 64
Figure 4 7: Total Spine Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 66
Figure 4 8: Cervical Spine Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 68
Figure 4 9: Thoracolumbar Spine Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 70
Figure 4 10: Total Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 72
Figure 4 11: Non-Union Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 74
Figure 4 12: Fresh Fracture Trauma Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 76
Figure 4 13: Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 78
Figure 4 14: Hip Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 80
Figure 4 15: Knee Large Joint Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 82
Figure 4 16: Foot Reconstruction Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 84
Figure 4 17: Craniomaxillofacial Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 86
Figure 4 18: Oncology Allograft Bone Graft Substitute Market, U.S., 2013 – 2023 88
Figure 4 19: Total Demineralized Bone Matrix Market, U.S., 2013 – 2023 91
Figure 4 20: Demineralized Bone Matrix Market (with Carriers), U.S., 2013 – 2023 93
Figure 4 21: Demineralized Bone Matrix Market (without Carriers), U.S., 2013 – 2023 93
Figure 4 22: Demineralized Bone Matrix Market by Indication, U.S., 2013 – 2023 94
Figure 4 23: Total Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 96
Figure 4 24: Cervical Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 98
Figure 4 25: Thoracolumbar Spine Demineralized Bone Matrix Market, U.S., 2013 – 2023 100
Figure 4 26: Total Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 102
Figure 4 27: Non-Union Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 104
Figure 4 28: Fresh Fracture Trauma Demineralized Bone Matrix Market, U.S., 2013 – 2023 106
Figure 4 29: Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 108
Figure 4 30: Hip Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 110
Figure 4 31: Knee Large Joint Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 112
Figure 4 32: Foot Reconstruction Demineralized Bone Matrix Market, U.S., 2013 – 2023 114
Figure 4 33: Craniomaxillofacial Demineralized Bone Matrix Market, U.S., 2013 – 2023 116
Figure 4 34: Oncology Demineralized Bone Matrix Market, U.S., 2013 – 2023 118
Figure 4 35: Total Orthopedic Bone Graft Substitute Market, U.S., 2013 – 2023 121
Figure 4 36: Synthetic Bone Graft Substitute Market by Indication, U.S., 2013 – 2023 123
Figure 4 37: Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 125
Figure 4 38: Cervical Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 127
Figure 4 39: Thoracolumbar Spine Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 129
Figure 4 40: Total Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 131
Figure 4 41: Non-Union Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 133
Figure 4 42: Fresh Fracture Trauma Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 135
Figure 4 43: Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 137
Figure 4 44: Hip Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 139
Figure 4 45: Knee Large Joint Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 141
Figure 4 46: Foot Reconstruction Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 143
Figure 4 47: Craniomaxillofacial Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 145
Figure 4 48: Oncology Synthetic Bone Graft Substitute Market, U.S., 2013 – 2023 147
Figure 4 49: Spine Bone Graft Substitute Market, U.S., 2013 – 2023 149
Figure 4 50: Cervical Spine Bone Graft Substitute Market, U.S., 2013 – 2023 151
Figure 4 51: Thoracolumbar Spine Bone Graft Substitute Market, U.S., 2013 – 2023 153
Figure 4 52: Total Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 155
Figure 4 53: Non-Union Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 157
Figure 4 54: Fresh Fracture Trauma Bone Graft Substitute Market, U.S., 2013 – 2023 159
Figure 4 55: Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 161
Figure 4 56: Hip Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 163
Figure 4 57: Knee Large Joint Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 165
Figure 4 58: Foot Reconstruction Bone Graft Substitute Market, U.S., 2013 – 2023 168
Figure 4 59: Craniomaxillofacial Bone Graft Substitute Market, U.S., 2013 – 2023 170
Figure 4 60: Oncology Bone Graft Substitute Market, U.S., 2013 – 2023 172
Figure 4 61: Drivers and Limiters, Orthopedic Bone Graft Substitute Market, U.S., 2016 179
Figure 4 62: Leading Competitors, Orthopedic Bone Graft Substitute Market, U.S., 2016 186
Figure 6 1: Press Release Summary 190

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.

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