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MediPoint: Bone Grafts and Substitutes - South American 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.

All manufacturers outside of Brazil will need to work with a third-party organization to obtain registration and renewals. Requirements include sales certifications, Good Manufacturing Process (GMP) documents, and letters authorizing a Brazilian firm to conduct distribution, clinical trials and details of the device. Due to the extensive paperwork ANVISA requires from foreign manufacturers, market entry is cumbersome for medical devices to enter Brazil, even though there is a huge market potential for orthopedic devices in this country.

Scope

- An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized SA 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 SA BGS Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in SA 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 SA BGS market landscape? Identify, understand and capitalize.

Table Of Contents

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

2 Introduction 17
2.1 Catalyst 18
2.2 Related Reports 19
3 Clinical Outcomes 20
3.1 Overview 20
3.2 Autograft Bone 21
3.3 Allograft Bone 22
3.4 Bone Graft Substitutes 24
3.4.1 BMPs/Growth Factors 24
3.4.2 DBMs 26
3.4.3 Synthetic Bone Substitutes 27
3.4.4 Cell-Based Matrices 29
4 Industry Overview 30
4.1 Procedural Trends 30
4.1.1 Overview 30
4.1.2 South America 31
4.2 Market Access 35
4.2.1 South America 35
4.3 Regulatory Issues/Recalls 37
4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013) 37
4.3.2 FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013) 38
4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 38
4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 38
4.3.5 FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011) 39
4.4 Mergers and Acquisitions/Key Partnerships 39
4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 39
4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 40
4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 40
4.4.4 Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012) 40
4.5 Economic Impacts 41
4.6 Market Drivers 42
4.6.1 Disadvantages of Autografts 42
4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 42
4.6.3 New Generation of Biological or Synthetic Materials 43
4.6.4 Cross-Selling 44
4.6.5 Improved Patient Awareness 44
4.7 Market Opportunities 45
4.7.1 Stem Cell Therapies 45
4.7.2 Foot and Ankle Market 47
4.7.3 Comprehensive Orthobiologics Platform 48
4.7.4 Antibiotics-Eluting Bone Graft Substitutes 48
4.7.5 Emerging Countries 49
4.8 Market Barriers 50
4.8.1 Variations in Regulations 50
4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 51
4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 52
4.8.4 Reimbursement and Pricing Pressure 53
4.8.5 Proving Clinical Efficacy 54
4.8.6 Medical Device Excise Tax 55
4.8.7 Substitutes 56
5 Competitive Assessment 58
5.1 Overview 58
5.2 Marketed Products 58
5.2.1 Advanced Biologics 58
5.2.2 AlloSource 59
5.2.3 Bacterin 61
5.2.4 Baxter 63
5.2.5 Biomet 64
5.2.6 DePuy Synthes 67
5.2.7 Exactech 69
5.2.8 Integra LifeSciences 71
5.2.9 Medtronic 73
5.2.10 Musculoskeletal Transplant Foundation (MTF) 76
5.2.11 NuVasive 77
5.2.12 Olympus Biotech 79
5.2.13 Orthofix 81
5.2.14 RTI Surgical 83
5.2.15 Stryker 86
5.2.16 Wright Medical 88
5.2.17 Zimmer 90
6 Unmet Needs 92
6.1 Clinical Data Transparency 92
6.2 Lack of Human Clinical Studies 93
6.3 Optimization of rhBMPs' Dosage and Carrier 95
6.4 Standardization of DBM Products' DBM Concentration across the Bone Banking Industry 96
6.5 Need for Products with Improved Osteoinductivity 97
6.6 Continued Research on Cell-Based Matrices 98
6.7 Need for Improved Medical Education on Bone Substitutes Products 99
6.8 Need for Cost Containment 100
7 Pipeline Products 102
7.1 Overview 102
7.2 Advanced Biologics' OsteoMEM 102
7.3 Aursos' Synthetic Bone Substitute 103
7.4 BioSET's AMPLEX 103
7.5 CeraPedics' i-FACTOR 103
7.6 NuVasive's AttraX 103
7.7 Osiris Therapeutics' OvationOS 104
7.8 Wright Medical' Augment Bone Graft 104
8 Clinical Trials to Watch 105
8.1 Yale's Review of Medtronic's INFUSE Bone Graft 105
8.2 Wright Medical's Augment Bone Graft 106
8.3 Orthofix's Trinity Evolution 107
8.4 AlloSource's AlloStem 108
8.5 NuVasive's AttraX 108
8.6 CeraPedics' i-FACTOR 109
8.7 BioSET's AMPLEX 109
9 Current and Future Players 111
9.1 Trends in Corporate Strategy 111
9.2 Company Profiles 112
9.2.1 Alphatec Spine 112
9.2.2 AlloSource 114
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 123
9.2.8 Integra LifeSciences 125
9.2.9 Medtronic 127
9.2.10 NuVasive 130
9.2.11 Olympus Biotech 132
9.2.12 Orthofix 133
9.2.13 RTI Surgical 135
9.2.14 Stryker 137
9.2.15 Wright Medical 139
9.2.16 Zimmer Holdings 141
9.3 Other Players 144
10 Market Outlooks 147
10.1 Market Share Analysis 147
10.1.1 Global 147
10.2 By Geography 148
10.2.1 Brazil 148
11 Appendix 151
11.1 Abbreviations 151
11.2 Bibliography 154
11.3 Report Methodology 163
11.3.1 Overview 163
11.3.2 Coverage 163
11.3.3 Secondary Research 163
11.3.4 Forecasting Methodology 164
11.3.5 Primary Research - Key Opinion Leader Interviews 165
11.3.6 Expert Panel Validation 166
11.4 Physicians and Specialists Included in this Study 167
11.5 About the Authors 170
11.5.1 Analysts 170
11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 171
11.6 About MediPoint 172
11.7 About GlobalData 172
11.8 Contact Us 172
11.9 Disclaimer 173

1.1 List of Tables

Table 1: Definition of Bone Growth Mechanisms 20
Table 2: Advantages and Disadvantages of Autografts 22
Table 3: Advantages and Disadvantages of Allografts 23
Table 4: Differences Between INFUSE Bone Graft and OP-1 Products 25
Table 5: Advantages and Disadvantages of BMPs 25
Table 6: Advantages and Disadvantages of DBMs 26
Table 7: Major Types of Synthetic Bone Substitutes 27
Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes 29
Table 9: Advantages and Disadvantages of Cell-Based Matrices 29
Table 10: Usage of BGS by Procedure Type in South America, 2013 31
Table 11: Currently Marketed Cell-Based Matrices in the US Market 46
Table 12: Differences between the US and EU Regulations for BGS 51
Table 13: Types of Autologous Grafting Commonly Used to Treat Non-Union 56
Table 14: Advanced Biologics' BGS Products 59
Table 15: SWOT Analysis - Advanced Biologics' BGS Portfolio 59
Table 16: AlloSource's BGS Products 60
Table 17: SWOT Analysis - AlloSource's BGS Portfolio 61
Table 18: Bacterin's BGS Products 62
Table 19: SWOT Analysis - Bacterin's BGS Portfolio 63
Table 20: Baxter's BGS Products 64
Table 21: SWOT Analysis - Baxter's BGS Portfolio 64
Table 22: Biomet's BGS Products 65
Table 23: SWOT Analysis - Biomet's BGS Portfolio 66
Table 24: DePuy Synthes' BGS Products 68
Table 25: SWOT Analysis - DePuy Synthes' BGS Portfolio 69
Table 26: Exactech's BGS Products 70
Table 27: SWOT Analysis - Exactech's BGS Portfolio 71
Table 28: Integra LifeSciences' BGS Products 72
Table 29: SWOT Analysis - Integra LifeSciences' BGS Portfolio 73
Table 30: Medtronic's BGS Products 75
Table 31: SWOT Analysis - Medtronic's BGS Portfolio 76
Table 32: MTF's BGS Products 76
Table 33: SWOT Analysis - MTF's BGS Portfolio 77
Table 34: NuVasive's BGS Products 78
Table 35: SWOT Analysis - NuVasive's BGS Portfolio 78
Table 36: Olympus Biotech's BGS Products 80
Table 37: SWOT Analysis - Olympus Biotech's BGS Portfolio 80
Table 38: Orthofix's BGS Products 82
Table 39: SWOT Analysis - Orthofix's BGS Portfolio 82
Table 40: RTI Surgical's BGS Products 84
Table 41: SWOT Analysis - RTI Surgical's BGS Portfolio 86
Table 42: Stryker's BGS Products 87
Table 43: SWOT Analysis - Stryker's BGS Portfolio 88
Table 44: Wright Medical's BGS Products 89
Table 45: SWOT Analysis - Wright Medical's BGS Portfolio 90
Table 46: Zimmer's BGS Products 91
Table 47: SWOT Analysis - Zimmer's BGS Portfolio 91
Table 48: Compelling Questions Regarding the Cell-Based Matrices 99
Table 49: Pipeline Products in the Global BGS Market 102
Table 50: Major Clinical Findings of the YODA Project 105
Table 51: Major Clinical Studies of Augment Bone Graft 106
Table 52: Major Clinical Studies of Trinity Evolution 107
Table 53: Major Clinical Study of AlloStem 108
Table 54: Major Clinical Study of AttraX 108
Table 55: Major Clinical Study of i-FACTOR 109
Table 56: Major Clinical Studies of AMPLEX 110
Table 57: Company Profile - Alphatec Spine 112
Table 58: SWOT Analysis - Alphatec Spine 113
Table 59: Company Profile - AlloSource 114
Table 60: SWOT Analysis - AlloSource 115
Table 61: Company Profile - Bacterin 116
Table 62: SWOT Analysis - Bacterin 117
Table 63: Company Profile - Biomet 118
Table 64: SWOT Analysis - Biomet 119
Table 65: Company Profile - DePuy Synthes 120
Table 66: SWOT Analysis - DePuy Synthes 121
Table 67: Company Profile - Exactech 122
Table 68: SWOT Analysis - Exactech 123
Table 69: Company Profile - Globus Medical 124
Table 70: SWOT Analysis - Globus Medical 125
Table 71: Company Profile - Integra LifeSciences 126
Table 72: SWOT Analysis - Integra LifeSciences 127
Table 73: Company Profile - Medtronic 128
Table 74: SWOT Analysis - Medtronic 129
Table 75: Company Profile - NuVasive 130
Table 76: SWOT Analysis - NuVasive 131
Table 77: Company Profile - Olympus Biotech 132
Table 78: SWOT Analysis - Olympus Biotech 133
Table 79: Company Profile - Orthofix 134
Table 80: SWOT Analysis - Orthofix 135
Table 81: Company Profile - RTI Surgical 136
Table 82: SWOT Analysis - RTI Surgical 136
Table 83: Company Profile - Stryker 137
Table 84:SWOT Analysis - Stryker 138
Table 85: Company Profile - Wright Medical 140
Table 86: SWOT Analysis - Wright Medical 141
Table 87: Company Profile - Zimmer Holdings 142
Table 88: SWOT Analysis - Zimmer Holdings 143
Table 89: Other Players in the Global BGS Market 144
Table 90: Brazil BGS Market Sales Forecast ($m), 2011-2020 149

1.2 List of Figures
Figure 1: An Overview of BGS Used in Orthopedic Surgeries 21
Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013 31
Figure 3: Bone Grafting Procedure Volumes in Brazil, 2011-2020 32
Figure 4: Traditional Allograft Bone Sales Volume in Brazil, 2011-2020 33
Figure 5: Machined Allograft Bone Sales Volume in Brazil, 2011-2020 33
Figure 6: Bone Grafts Substitutes Sales Volumes in Brazil, 2011-2020 34
Figure 7: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 47
Figure 8: Global BGS Competitive Landscape, by Estimated Revenue, 2013 148
Figure 9: Brazil BGS Market Sales Forecast ($m), 2011-2020 149
Figure 10: Brazil BGS Market Revenue Distribution, By Segment, 2011-2020 150
Figure 11: Other Primary Research Participants Breakdown, by Country (n=236) 169
Figure 12: Other Primary Research Participants Breakdown, by Institution (n=236) 169

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