代用骨移植片：グローバル市場分析と予測...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 20
2.1 Catalyst 21
2.2 Related Reports 21
3 Clinical Outcomes 23
3.1 Overview 23
3.2 Autograft Bone 24
3.3 Allograft Bone 25
3.4 Bone Graft Substitutes 27
3.4.1 BMPs/Growth Factors 27
3.4.2 DBMs 29
3.4.3 Synthetic Bone Substitutes 30
3.4.4 Cell-Based Matrices 32
4 Industry Overview 33
4.1 Procedural Trends 33
4.1.1 Overview 33
4.1.2 US 34
4.1.3 5EU 40
4.1.4 Asia-Pacific 45
4.1.5 South America 48
4.2 Market Access 52
4.2.1 US 52
4.2.2 5EU 58
4.2.3 Asia-Pacific 61
4.2.4 South America 65
4.3 Regulatory Issues/Recalls 68
4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical’s Augment Bone Graft (October 2013) 68
4.3.2 FDA Issued a Warning Letter over Globus Medical’s MicroFuse Bone Growth Putty (September 2013) 68
4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 69
4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 69
4.3.5 FDA Rejected Approval of Medtronic’s AMPLIFY rhBMP-2 Matrix (March 2011) 69
4.4 Mergers & Acquisitions/Key Partnerships 70
4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 70
4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 70
4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 71
4.4.4 Amedica Commenced Distribution of Dynamic Surgical’s Dynamic Bone Expandable Allograft (April 2012) 71
4.5 Economic Impacts 71
4.6 Market Drivers 72
4.6.1 Disadvantages of Autografts 72
4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 73
4.6.3 New Generation of Biological or Synthetic Materials 73
4.6.4 Cross-Selling 74
4.6.5 Improved Patient Awareness 75
4.7 Market Opportunities 76
4.7.1 Stem Cell Therapies 76
4.7.2 Foot and Ankle Market 77
4.7.3 Comprehensive Orthobiologics Platform 78
4.7.4 Antibiotics-Eluting Bone Graft Substitutes 79
4.7.5 Emerging Countries 80
4.8 Market Barriers 81
4.8.1 Variations in Regulations 81
4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 82
4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 83
4.8.4 Reimbursement and Pricing Pressure 83
4.8.5 Proving Clinical Efficacy 84
4.8.6 Medical Device Excise Tax 85
4.8.7 Substitutes 86
5 Competitive Assessment 88
5.1 Overview 88
5.2 Marketed Products 88
5.2.1 Advanced Biologics 88
5.2.2 AlloSource 89
5.2.3 Bacterin 91
5.2.4 Baxter 93
5.2.5 Biomet 94
5.2.6 DePuy Synthes 97
5.2.7 Exactech 99
5.2.8 Integra LifeSciences 101
5.2.9 Medtronic 103
5.2.10 Musculoskeletal Transplant Foundation (MTF) 106
5.2.11 NuVasive 107
5.2.12 Olympus Biotech 109
5.2.13 Orthofix 111
5.2.14 RTI Surgical 113
5.2.15 Stryker 116
5.2.16 Wright Medical 118
5.2.17 Zimmer 120
6 Unmet Needs 122
6.1 Clinical Data Transparency 122
6.2 Lack of Human Clinical Studies 123
6.3 Optimization of rhBMPs’ Dosage and Carrier 125
6.4 Standardization of DBM Products’ DBM Concentration across the Bone Banking Industry 126
6.5 Need for Products with Improved Osteoinductivity 127
6.6 Continued Research on Cell-Based Matrices 128
6.7 Need for Improved Medical Education on Bone Substitutes Products 129
6.8 Need for Cost Containment 131
7 Pipeline Products 132
7.1 Overview 132
7.2 Advanced Biologics’ OsteoMEM 132
7.3 Aursos’ Synthetic Bone Substitute 133
7.4 BioSET’s AMPLEX 133
7.5 CeraPedics’ i-FACTOR 133
7.6 NuVasive’s AttraX 133
7.7 Osiris Therapeutics’ OvationOS 134
7.8 Wright Medical’ Augment Bone Graft 134
8 Clinical Trials to Watch 135
8.1 Yale’s Review of Medtronic’s INFUSE Bone Graft 135
8.2 Wright Medical’s Augment Bone Graft 136
8.3 Orthofix’s Trinity Evolution 137
8.4 AlloSource’s AlloStem 138
8.5 NuVasive’s AttraX 138
8.6 CeraPedics’ i-FACTOR 139
8.7 BioSET’s AMPLEX 139
9 Current and Future Players 141
9.1 Trends in Corporate Strategy 141
9.2 Company Profiles 142
9.2.1 Alphatec Spine 142
9.2.2 AlloSource 144
9.2.3 Bacterin 146
9.2.4 Biomet 148
9.2.5 DePuy Synthes 150
9.2.6 Exactech 152
9.2.7 Globus Medical 153
9.2.8 Integra LifeSciences 155
9.2.9 Medtronic 157
9.2.10 NuVasive 160
9.2.11 Olympus Biotech 162
9.2.12 Orthofix 163
9.2.13 RTI Surgical 165
9.2.14 Stryker 167
9.2.15 Wright Medical 169
9.2.16 Zimmer Holdings 171
9.3 Other Players 174
10 Market Outlooks 177
10.1 Market Share Analysis 177
10.1.1 Global 177
10.1.2 US 178
10.1.3 5EU 181
10.2 By Geography 183
10.2.1 Overview 183
10.2.2 US 187
10.2.3 France 190
10.2.4 Germany 193
10.2.5 Italy 195
10.2.6 Spain 197
10.2.7 UK 199
10.2.8 Japan 201
10.2.9 Brazil 203
10.2.10 China 205
10.2.11 India 207
11 Appendix 210
11.1 Abbreviations 210
11.2 Bibliography 213
11.3 Report Methodology 222
11.3.1 Overview 222
11.3.2 Coverage 222
11.3.3 Secondary Research 222
11.3.4 Forecasting Methodology 223
11.3.5 Primary Research – Key Opinion Leader Interviews 224
11.3.6 Expert Panel Validation 225
11.4 Physicians and Specialists Included in this Study 226
11.5 About the Authors 229
11.5.1 Analysts 229
11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 230
11.6 About MediPoint 231
11.7 About GlobalData 231
11.8 Disclaimer 231