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MediPoint: Bone Grafts and Substitutes - EU 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.

Due to the economic uncertainty and severe budgetary restrictions in the Eurozone, most 5EU countries have put in place measures to prevent excessive healthcare budget deficits and ration high-volume surgeries, such as joint reconstruction. As the market continues to recover from the economic turmoil, expanding patient population for orthopedic surgical treatments and the steady domestic supply of orthopedic devices in the European countries will all contribute to a steady increase in the bone grafting procedure volume in the next decade.

Scope

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

Table Of Contents

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

2 Introduction 19
2.1 Catalyst 20
2.2 Related Reports 21
3 Clinical Outcomes 22
3.1 Overview 22
3.2 Autograft Bone 23
3.3 Allograft Bone 24
3.4 Bone Graft Substitutes 26
3.4.1 BMPs/Growth Factors 26
3.4.2 DBMs 28
3.4.3 Synthetic Bone Substitutes 29
3.4.4 Cell-Based Matrices 31
4 Industry Overview 32
4.1 Procedural Trends 32
4.1.1 Overview 32
4.1.2 5EU 33
4.2 Market Access 38
4.2.1 5EU 38
4.3 Regulatory Issues/Recalls 42
4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013) 42
4.3.2 FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013) 42
4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 42
4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 43
4.3.5 FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011) 43
4.4 Mergers and Acquisitions/Key Partnerships 44
4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 44
4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 44
4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 44
4.4.4 Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012) 45
4.5 Economic Impacts 45
4.6 Market Drivers 46
4.6.1 Disadvantages of Autografts 46
4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 46
4.6.3 New Generation of Biological or Synthetic Materials 47
4.6.4 Cross-Selling 48
4.6.5 Improved Patient Awareness 49
4.7 Market Opportunities 50
4.7.1 Stem Cell Therapies 50
4.7.2 Foot and Ankle Market 51
4.7.3 Comprehensive Orthobiologics Platform 52
4.7.4 Antibiotics-Eluting Bone Graft Substitutes 53
4.7.5 Emerging Countries 54
4.8 Market Barriers 55
4.8.1 Variations in Regulations 55
4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 56
4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 57
4.8.4 Reimbursement and Pricing Pressure 57
4.8.5 Proving Clinical Efficacy 58
4.8.6 Medical Device Excise Tax 59
4.8.7 Substitutes 60
5 Competitive Assessment 62
5.1 Overview 62
5.2 Marketed Products 62
5.2.1 Bacterin 62
5.2.2 Baxter 64
5.2.3 Biocomposites 65
5.2.4 Biomet 66
5.2.5 DePuy Synthes 69
5.2.6 Exactech 71
5.2.7 Integra LifeSciences 73
5.2.8 Medtronic 75
5.2.9 NuVasive 78
5.2.10 Olympus Biotech 80
5.2.11 Orthofix 82
5.2.12 RTI Surgical 84
5.2.13 Stryker 86
5.2.14 Wright Medical 88
5.2.15 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 101
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 Osiris Therapeutics' OvationOS 103
7.7 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 Bacterin 114
9.2.3 Biomet 116
9.2.4 DePuy Synthes 118
9.2.5 Exactech 120
9.2.6 Globus Medical 121
9.2.7 Integra LifeSciences 123
9.2.8 Medtronic 125
9.2.9 NuVasive 128
9.2.10 Olympus Biotech 130
9.2.11 Orthofix 131
9.2.12 RTI Surgical 133
9.2.13 Stryker 135
9.2.14 Wright Medical 137
9.2.15 Zimmer Holdings 139
9.3 Other Players 142
10 Market Outlooks 145
10.1 Market Share Analysis 145
10.1.1 Global 145
10.1.2 5EU 147
10.2 By Geography 149
10.2.1 Overview 149
10.2.2 France 153
10.2.3 Germany 156
10.2.4 Italy 158
10.2.5 Spain 160
10.2.6 UK 162
11 Appendix 164
11.1 Abbreviations 164
11.2 Bibliography 167
11.3 Report Methodology 176
11.3.1 Overview 176
11.3.2 Coverage 176
11.3.3 Secondary Research 176
11.3.4 Forecasting Methodology 177
11.3.5 Primary Research - Key Opinion Leader Interviews 178
11.3.6 Expert Panel Validation 179
11.4 Physicians and Specialists Included in this Study 180
11.5 About the Authors 183
11.5.1 Analysts 183
11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 184
11.6 About MediPoint 185
11.7 About GlobalData 185
11.8 Disclaimer 185

1.1 List of Tables

Table 1: Definition of Bone Growth Mechanisms 22
Table 2: Advantages and Disadvantages of Autografts 24
Table 3: Advantages and Disadvantages of Allografts 25
Table 4: Differences Between INFUSE Bone Graft and OP-1 Products 27
Table 5: Advantages and Disadvantages of BMPs 27
Table 6: Advantages and Disadvantages of DBMs 28
Table 7: Major Types of Synthetic Bone Substitutes 29
Table 8: Advantages and Disadvantages of Synthetic Bone Substitutes 31
Table 9: Advantages and Disadvantages of Cell-Based Matrices 31
Table 10: Usage of BGS by Procedure Type in 5EU, 2013 33
Table 11: Currently Marketed Cell-Based Matrices in the US Market 50
Table 12: Differences between the US and EU Regulations for BGS 55
Table 13: Types of Autologous Grafting Commonly Used to Treat Non-Union 60
Table 14: Bacterin's BGS Products 63
Table 15: SWOT Analysis - Bacterin's BGS Portfolio 64
Table 16: Baxter's BGS Products 65
Table 17: SWOT Analysis - Baxter's BGS Portfolio 65
Table 18: Biocomposites' BGS Products 66
Table 19: Biomet's BGS Products 67
Table 20: SWOT Analysis - Biomet's BGS Portfolio 68
Table 21: DePuy Synthes' BGS Products 70
Table 22: SWOT Analysis - DePuy Synthes' BGS Portfolio 71
Table 23: Exactech's BGS Products 72
Table 24: SWOT Analysis - Exactech's BGS Portfolio 73
Table 25: Integra LifeSciences' BGS Products 74
Table 26: SWOT Analysis - Integra LifeSciences' BGS Portfolio 75
Table 27: Medtronic's BGS Products 77
Table 28: SWOT Analysis - Medtronic's BGS Portfolio 78
Table 29: NuVasive's BGS Products 79
Table 30: SWOT Analysis - NuVasive's BGS Portfolio 79
Table 31: Olympus Biotech's BGS Products 81
Table 32: SWOT Analysis - Olympus Biotech's BGS Portfolio 81
Table 33: Orthofix's BGS Products 83
Table 34: SWOT Analysis - Orthofix's BGS Portfolio 83
Table 35: RTI Surgical's BGS Products 84
Table 36: SWOT Analysis - RTI Surgical's BGS Portfolio 86
Table 37: Stryker's BGS Products 87
Table 38: SWOT Analysis - Stryker's BGS Portfolio 88
Table 39: Wright Medical's BGS Products 89
Table 40: SWOT Analysis - Wright Medical's BGS Portfolio 90
Table 41: Zimmer's BGS Products 91
Table 42: SWOT Analysis - Zimmer's BGS Portfolio 91
Table 43: Compelling Questions Regarding the Cell-Based Matrices 99
Table 44: Pipeline Products in the Global BGS Market 102
Table 45: Major Clinical Findings of the YODA Project 105
Table 46: Major Clinical Studies of Augment Bone Graft 106
Table 47: Major Clinical Studies of Trinity Evolution 107
Table 48: Major Clinical Study of AlloStem 108
Table 49: Major Clinical Study of AttraX 108
Table 50: Major Clinical Study of i-FACTOR 109
Table 51: Major Clinical Studies of AMPLEX 110
Table 52: Company Profile - Alphatec Spine 112
Table 53: SWOT Analysis - Alphatec Spine 113
Table 54: Company Profile - Bacterin 114
Table 55: SWOT Analysis - Bacterin 115
Table 56: Company Profile - Biomet 116
Table 57: SWOT Analysis - Biomet 117
Table 58: Company Profile - DePuy Synthes 118
Table 59: SWOT Analysis - DePuy Synthes 119
Table 60: Company Profile - Exactech 120
Table 61: SWOT Analysis - Exactech 121
Table 62: Company Profile - Globus Medical 122
Table 63: SWOT Analysis - Globus Medical 123
Table 64: Company Profile - Integra LifeSciences 124
Table 65: SWOT Analysis - Integra LifeSciences 125
Table 66: Company Profile - Medtronic 126
Table 67: SWOT Analysis - Medtronic 127
Table 68: Company Profile - NuVasive 128
Table 69: SWOT Analysis - NuVasive 129
Table 70: Company Profile - Olympus Biotech 130
Table 71: SWOT Analysis - Olympus Biotech 131
Table 72: Company Profile - Orthofix 132
Table 73: SWOT Analysis - Orthofix 133
Table 74: Company Profile - RTI Surgical 134
Table 75: SWOT Analysis - RTI Surgical 134
Table 76: Company Profile - Stryker 135
Table 77:SWOT Analysis - Stryker 136
Table 78: Company Profile - Wright Medical 138
Table 79: SWOT Analysis - Wright Medical 139
Table 80: Company Profile - Zimmer Holdings 140
Table 81: SWOT Analysis - Zimmer Holdings 141
Table 82: Other Players in the Global BGS Market 142
Table 83: 5EU BGS Market Sales Forecast ($m), 2011-2020 150
Table 84: France BGS Market Sales Forecast ($m), 2011-2020 154
Table 85: Germany BGS Market Sales Forecast ($m), 2011-2020 156
Table 86: Italy BGS Market Sales Forecast ($m), 2011-2020 158
Table 87: Spain BGS Market Sales Forecast ($m), 2011-2020 160
Table 88: UK BGS Market Sales Forecast ($m), 2011-2020 162

1.2 List of Figures
Figure 1: An Overview of BGS Used in Orthopedic Surgeries 23
Figure 2: Usage of Autograft, Allograft, and Bone Graft Substitutes, by Country, 2013 33
Figure 3: Bone Grafting Procedure Volumes in 5EU, 2011-2020 34
Figure 4: Traditional Allograft Bone Sales Volume in 5EU, 2011-2020 35
Figure 5: Machined Allograft Bone Sales Volume in 5EU, 2011-2020 36
Figure 6: Bone Grafts Substitutes Sales Volumes in 5EU, 2011-2020 38
Figure 7: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 51
Figure 8: Global BGS Competitive Landscape, by Estimated Revenue, 2013 146
Figure 9: France BGS Competitive Landscape, 2013 147
Figure 10: Germany BGS Competitive Landscape, 2013 147
Figure 11: Italy BGS Competitive Landscape, 2013 148
Figure 12: Spain BGS Competitive Landscape, 2013 148
Figure 13: UK BGS Competitive Landscape, 2013 149
Figure 14: 5EU BGS Market Sales Forecast, 2011-2020 150
Figure 15: BGS Market by Major Market, 2013 and 2020 151
Figure 16: 5EU BGS Market Revenue Distribution, By Segment, 2013 and 2020 152
Figure 17: France BGS Market Sales Forecast ($m), 2011-2020 154
Figure 18: France BGS Market Revenue Distribution, By Segment, 2011-2020 155
Figure 19: Germany BGS Market Sales Forecast ($m), 2011-2020 157
Figure 20: Germany BGS Market Revenue Distribution, By Segment, 2011-2020 157
Figure 21: Italy BGS Market Sales Forecast ($m), 2011-2020 159
Figure 22: Italy BGS Market Revenue Distribution, By Segment, 2011-2020 159
Figure 23: Spain BGS Market Sales Forecast ($m), 2011-2020 161
Figure 24: Spain BGS Market Revenue Distribution, By Segment, 2011-2020 161
Figure 25: UK BGS Market Sales Forecast ($m), 2011-2020 163
Figure 26: UK BGS Market Revenue Distribution, By Segment, 2011-2020 163
Figure 27: Other Primary Research Participants Breakdown, by Country (n=236) 182
Figure 28: Other Primary Research Participants Breakdown, by Institution (n=236) 182

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