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MediPoint: Bone Grafts and Substitutes - APAC Analysis and Market Forecasts

Summary

Although autograft is still perceived as the gold-standard material in bone grafting, the wide array of alternatives available in the market has resulted in a gradual shift towards increased adoption of bone grafts and substitutes (BGS), especially in the US and European markets. In contrast to the general picture in developed countries, autograft bone still represents the most popular option during bone grafting in the Asia-Pacific (APAC) region and South America.

The global competitive landscape in each of the segments (including traditional allograft bone, machined allograft bone, BMPs, DBMs, synthetic bone substitutes, and cell-based matrices) is difficult to define as the regulatory conditions for BGS differ from country to country, and therefore the market leaders can vary significantly in each segment of the market.

Scope

- An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized APAC BGS market revenue and future forecasts from 2010 to 2012, forecast for 7 years to 2019.
- Investigation of current and future market competition for BGS.
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the BGS sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL).

Reasons to buy

- Understand the trends shaping and driving APAC BGS Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in APAC BGS market through 2019.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in APAC BGS market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Bone Grafts and Substitutes - APAC Analysis and Market Forecasts
1 Table of Contents

2 Introduction 18
2.1 Catalyst 19
2.2 Related Reports 20
3 Clinical Outcomes 21
3.1 Overview 21
3.2 Autograft Bone 22
3.3 Allograft Bone 23
3.4 Bone Graft Substitutes 25
3.4.1 BMPs/Growth Factors 25
3.4.2 DBMs 27
3.4.3 Synthetic Bone Substitutes 28
3.4.4 Cell-Based Matrices 30
4 Industry Overview 31
4.1 Procedural Trends 31
4.1.1 Overview 31
4.1.2 Asia-Pacific 32
4.2 Market Access 35
4.2.1 Asia-Pacific 35
4.3 Regulatory Issues/Recalls 39
4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013) 39
4.3.2 FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013) 40
4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 40
4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 40
4.3.5 FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011) 41
4.4 Mergers and Acquisitions/Key Partnerships 41
4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 41
4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 42
4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 42
4.4.4 Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012) 42
4.5 Economic Impacts 43
4.6 Market Drivers 44
4.6.1 Disadvantages of Autografts 44
4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 44
4.6.3 New Generation of Biological or Synthetic Materials 45
4.6.4 Cross-Selling 46
4.6.5 Improved Patient Awareness 46
4.7 Market Opportunities 47
4.7.1 Stem Cell Therapies 47
4.7.2 Foot and Ankle Market 49
4.7.3 Comprehensive Orthobiologics Platform 50
4.7.4 Antibiotics-Eluting Bone Graft Substitutes 50
4.7.5 Emerging Countries 51
4.8 Market Barriers 52
4.8.1 Variations in Regulations 52
4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 53
4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 54
4.8.4 Reimbursement and Pricing Pressure 55
4.8.5 Proving Clinical Efficacy 56
4.8.6 Medical Device Excise Tax 57
4.8.7 Substitutes 58
5 Competitive Assessment 60
5.1 Overview 60
5.2 Marketed Products 60
5.2.1 Advanced Biologics 60
5.2.2 AlloSource 61
5.2.3 Bacterin 63
5.2.4 Baxter 65
5.2.5 Biomet 66
5.2.6 DePuy Synthes 69
5.2.7 Exactech 71
5.2.8 Integra LifeSciences 73
5.2.9 Medtronic 75
5.2.10 Musculoskeletal Transplant Foundation (MTF) 78
5.2.11 NuVasive 79
5.2.12 Olympus Biotech 81
5.2.13 Orthofix 83
5.2.14 RTI Surgical 85
5.2.15 Stryker 88
5.2.16 Wright Medical 90
5.2.17 Zimmer 92
6 Unmet Needs 94
6.1 Clinical Data Transparency 94
6.2 Lack of Human Clinical Studies 95
6.3 Optimization of rhBMPs' Dosage and Carrier 97
6.4 Standardization of DBM Products' DBM Concentration across the Bone Banking Industry 98
6.5 Need for Products with Improved Osteoinductivity 99
6.6 Continued Research on Cell-Based Matrices 100
6.7 Need for Improved Medical Education on Bone Substitutes Products 101
6.8 Need for Cost Containment 102
7 Pipeline Products 104
7.1 Overview 104
7.2 Advanced Biologics' OsteoMEM 104
7.3 Aursos' Synthetic Bone Substitute 105
7.4 BioSET's AMPLEX 105
7.5 CeraPedics' i-FACTOR 105
7.6 NuVasive's AttraX 105
7.7 Osiris Therapeutics' OvationOS 106
7.8 Wright Medical' Augment Bone Graft 106
8 Clinical Trials to Watch 107
8.1 Yale's Review of Medtronic's INFUSE Bone Graft 107
8.2 Wright Medical's Augment Bone Graft 108
8.3 Orthofix's Trinity Evolution 108
8.4 AlloSource's AlloStem 109
8.5 NuVasive's AttraX 110
8.6 CeraPedics' i-FACTOR 110
8.7 BioSET's AMPLEX 111
9 Current and Future Players 112
9.1 Trends in Corporate Strategy 112
9.2 Company Profiles 113
9.2.1 Alphatec Spine 113
9.2.2 AlloSource 115
9.2.3 Bacterin 116
9.2.4 Biomet 118
9.2.5 DePuy Synthes 120
9.2.6 Exactech 122
9.2.7 Globus Medical 124
9.2.8 Integra LifeSciences 126
9.2.9 Medtronic 128
9.2.10 NuVasive 131
9.2.11 Olympus Biotech 133
9.2.12 Orthofix 134
9.2.13 RTI Surgical 136
9.2.14 Stryker 138
9.2.15 Wright Medical 140
9.2.16 Zimmer Holdings 142
9.3 Other Players 145
10 Market Outlooks 148
10.1 Market Share Analysis 148
10.1.1 Global 148
10.2 By Geography 149
10.2.1 Overview 149
10.2.2 Japan 153
10.2.3 China 155
10.2.4 India 157
11 Appendix 160
11.1 Abbreviations 160
11.2 Bibliography 163
11.3 Report Methodology 172
11.3.1 Overview 172
11.3.2 Coverage 172
11.3.3 Secondary Research 172
11.3.4 Forecasting Methodology 173
11.3.5 Primary Research - Key Opinion Leader Interviews 174
11.3.6 Expert Panel Validation 175
11.4 Physicians and Specialists Included in this Study 176
11.5 About the Authors 179
11.5.1 Analysts 179
11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 180
11.6 About MediPoint 181
11.7 About GlobalData 181
11.8 Contact Us 181
11.9 Disclaimer 182

1.1 List of Tables

Table 1: Definition of Bone Growth Mechanisms 21
Table 2: Advantages and Disadvantages of Autografts 23
Table 3: Advantages and Disadvantages of Allografts 24
Table 4: Differences Between INFUSE Bone Graft and OP-1 Products 26
Table 5: Advantages and Disadvantages of BMPs 26
Table 6: Advantages and Disadvantages of DBMs 27
Table 7: Major Types of Synthetic Bone Substitutes 28
Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes 30
Table 9: Advantages and Disadvantages of Cell-Based Matrices 30
Table 10: Usage of BGS by Procedure Type in APAC, 2013 32
Table 11: Currently Marketed Cell-Based Matrices in the US Market 48
Table 12: Differences between the US and EU Regulations for BGS 53
Table 13: Types of Autologous Grafting Commonly Used to Treat Non-Union 58
Table 14: Advanced Biologics' BGS Products 61
Table 15: SWOT Analysis - Advanced Biologics' BGS Portfolio 61
Table 16: AlloSource's BGS Products 62
Table 17: SWOT Analysis - AlloSource's BGS Portfolio 63
Table 18: Bacterin's BGS Products 64
Table 19: SWOT Analysis - Bacterin's BGS Portfolio 64
Table 20: Baxter's BGS Products 65
Table 21: SWOT Analysis - Baxter's BGS Portfolio 66
Table 22: Biomet's BGS Products 67
Table 23: SWOT Analysis - Biomet's BGS Portfolio 68
Table 24: DePuy Synthes' BGS Products 70
Table 25: SWOT Analysis - DePuy Synthes' BGS Portfolio 71
Table 26: Exactech's BGS Products 72
Table 27: SWOT Analysis - Exactech's BGS Portfolio 73
Table 28: Integra LifeSciences' BGS Products 74
Table 29: SWOT Analysis - Integra LifeSciences' BGS Portfolio 75
Table 30: Medtronic's BGS Products 77
Table 31: SWOT Analysis - Medtronic's BGS Portfolio 78
Table 32: MTF's BGS Products 78
Table 33: SWOT Analysis - MTF's BGS Portfolio 79
Table 34: NuVasive's BGS Products 80
Table 35: SWOT Analysis - NuVasive's BGS Portfolio 80
Table 36: Olympus Biotech's BGS Products 82
Table 37: SWOT Analysis - Olympus Biotech's BGS Portfolio 82
Table 38: Orthofix's BGS Products 84
Table 39: SWOT Analysis - Orthofix's BGS Portfolio 84
Table 40: RTI Surgical's BGS Products 86
Table 41: SWOT Analysis - RTI Surgical's BGS Portfolio 87
Table 42: Stryker's BGS Products 89
Table 43: SWOT Analysis - Stryker's BGS Portfolio 90
Table 44: Wright Medical's BGS Products 91
Table 45: SWOT Analysis - Wright Medical's BGS Portfolio 92
Table 46: Zimmer's BGS Products 93
Table 47: SWOT Analysis - Zimmer's BGS Portfolio 93
Table 48: Compelling Questions Regarding the Cell-Based Matrices 101
Table 49: Pipeline Products in the Global BGS Market 104
Table 50: Major Clinical Findings of the YODA Project 107
Table 51: Major Clinical Studies of Augment Bone Graft 108
Table 52: Major Clinical Studies of Trinity Evolution 109
Table 53: Major Clinical Study of AlloStem 109
Table 54: Major Clinical Study of AttraX 110
Table 55: Major Clinical Study of i-FACTOR 110
Table 56: Major Clinical Studies of AMPLEX 111
Table 57: Company Profile - Alphatec Spine 113
Table 58: SWOT Analysis - Alphatec Spine 114
Table 59: Company Profile - AlloSource 115
Table 60: SWOT Analysis - AlloSource 116
Table 61: Company Profile - Bacterin 117
Table 62: SWOT Analysis - Bacterin 118
Table 63: Company Profile - Biomet 119
Table 64: SWOT Analysis - Biomet 120
Table 65: Company Profile - DePuy Synthes 121
Table 66: SWOT Analysis - DePuy Synthes 122
Table 67: Company Profile - Exactech 123
Table 68: SWOT Analysis - Exactech 124
Table 69: Company Profile - Globus Medical 125
Table 70: SWOT Analysis - Globus Medical 126
Table 71: Company Profile - Integra LifeSciences 127
Table 72: SWOT Analysis - Integra LifeSciences 128
Table 73: Company Profile - Medtronic 129
Table 74: SWOT Analysis - Medtronic 130
Table 75: Company Profile - NuVasive 131
Table 76: SWOT Analysis - NuVasive 132
Table 77: Company Profile - Olympus Biotech 133
Table 78: SWOT Analysis - Olympus Biotech 134
Table 79: Company Profile - Orthofix 135
Table 80: SWOT Analysis - Orthofix 136
Table 81: Company Profile - RTI Surgical 137
Table 82: SWOT Analysis - RTI Surgical 137
Table 83: Company Profile - Stryker 138
Table 84:SWOT Analysis - Stryker 139
Table 85: Company Profile - Wright Medical 141
Table 86: SWOT Analysis - Wright Medical 142
Table 87: Company Profile - Zimmer Holdings 143
Table 88: SWOT Analysis - Zimmer Holdings 144
Table 89: Other Players in the Global BGS Market 145
Table 90: APAC BGS Market Sales Forecast ($m), 2011-2020 150
Table 91: Japan BGS Market Sales Forecast ($m), 2011-2020 154
Table 92: China BGS Market Sales Forecast ($m), 2011-2020 156
Table 93: India BGS Market Sales Forecast ($m), 2011-2020 158

1.2 List of Figures
Figure 1: An Overview of BGS Used in Orthopedic Surgeries 22
Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013 32
Figure 3: Bone Grafting Procedure Volumes in APAC, 2011-2020 33
Figure 4: Traditional Allograft Bone Sales Volume in APAC, 2011-2020 34
Figure 5: Bone Grafts Substitutes Sales Volumes in APAC, 2011-2020 35
Figure 6: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 49
Figure 7: Global BGS Competitive Landscape, by Estimated Revenue, 2013 149
Figure 8: Global BGS Market Sales Forecast in 10 Countries, 2011-2020 150
Figure 9: APAC BGS Market by Major Market, 2013 and 2020 151
Figure 10: APAC BGS Market Revenue Distribution, By Segment, 2013 and 2020 152
Figure 11: Japan BGS Market Sales Forecast ($m), 2011-2020 154
Figure 12: Japan BGS Market Revenue Distribution, By Segment, 2011-2020 155
Figure 13: China BGS Market Sales Forecast ($m), 2011-2020 156
Figure 14: China BGS Market Revenue Distribution, By Segment, 2011-2020 157
Figure 15: India BGS Market Sales Forecast ($m), 2011-2020 159
Figure 16: India BGS Market Revenue Distribution, By Segment, 2011-2020 159
Figure 17: Other Primary Research Participants Breakdown, by Country (n=236) 178
Figure 18: Other Primary Research Participants Breakdown, by Institution (n=236) 178

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