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MediPoint: Bone Grafts and Substitutes - US Analysis and Market Forecasts.

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MediPoint: Bone Grafts and Substitutes - US Analysis and Market Forecasts http://www.reportbuyer.com/pharma_healthcare/treatments/orthopaedic/medipoint_bone_grafts_substitutes_us_analysis_market_forecasts.html

MediPoint: Bone Grafts and Substitutes - US 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 majority of the market revenue for BGS is contributed by the US. Medtronic is considered the top player in the US market due to its strength in multiple segments. In the allograft bone space (including both traditional and machined allograft bone segments), Medtronic and MTF were two of the tier one players in 2013. In the BMP/growth factor segment, Medtronic's dominance is widely considered not replicable despite surgeons' dampened enthusiasm about its INFUSE Bone Graft.

Scope - An overview of BGS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines. - Annualized the US 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 the US BGS Market. - Realize device preferences of physicians who have performed the tests already. - Access market sizing, forecasts and quantified growth opportunities in the US 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 the US BGS market landscape? Identify, understand and capitalize. 1 Table of Contents 1 Table of Contents 7 1.1 List of Tables 13 1.2 List of Figures 17 2 Introduction 18 2.1 Catalyst 19 2.2 Related Reports 19 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 US 33 4.2 Market Access 38 4.2.1 US 38 4.3 Regulatory Issues/Recalls 44 4.3.1 FDA Convened a Dispute Resolution Panel to Discuss Wright Medical's Augment Bone Graft (October 2013) 44 4.3.2 FDA Issued a Warning Letter over Globus Medical's MicroFuse Bone Growth Putty (September 2013) 44 4.3.3 Medtronic and the Australia Therapeutic Goods Administration Recalled Unused Lots of INFUSE LT-Cage Bone Graft Kits (June 2013) 45 4.3.4 Alphatec Spine Voluntarily Stopped Shipping PureGen (February 2013) 45 4.3.5 FDA Rejected Approval of Medtronic's AMPLIFY rhBMP-2 Matrix (March 2011) 45 4.4 Mergers & Acquisitions/Key Partnerships 46 4.4.1 Bacterin Developed Strategic Alliance with DMP Spine Biologics (November 2013) 46 4.4.2 RTI Surgical Entered into a New Distribution Deal with Medtronic Sofamor Danek (October 2013) 46 4.4.3 RTI Biologics Completed Acquisition of Pioneer Surgical Technology (July 2013) 47 4.4.4 Amedica Commenced Distribution of Dynamic Surgical's Dynamic Bone Expandable Allograft (April 2012) 47 4.5 Economic Impacts 47 4.6 Market Drivers 48 4.6.1 Disadvantages of Autografts 48 4.6.2 Continued Increase in the Procedure Volumes of Spinal and Orthopedic Surgeries 49 4.6.3 New Generation of Biological or Synthetic Materials 49 4.6.4 Cross-Selling 50 4.6.5 Improved Patient Awareness 51 4.7 Market Opportunities 52 4.7.1 Stem Cell Therapies 52 4.7.2 Foot and Ankle Market 53 4.7.3 Comprehensive Orthobiologics Platform 54 4.7.4 Antibiotics-Eluting Bone Graft Substitutes 55 4.7.5 Emerging Countries 56 4.8 Market Barriers 57 4.8.1 Variations in Regulations 57 4.8.2 Lingering Questions on rhBMP-2 to Generate Negative Spillover Effects 58 4.8.3 Negative Publicity Concerning Screening and Processing Methods of Allograft 59 4.8.4 Reimbursement and Pricing Pressure 59 4.8.5 Proving Clinical Efficacy 60 4.8.6 Medical Device Excise Tax 61 4.8.7 Substitutes 62 5 Competitive Assessment 64 5.1 Overview 64 5.2 Marketed Products 64 5.2.1 Advanced Biologics 64 5.2.2 AlloSource 65 5.2.3 Bacterin 67 5.2.4 Baxter 69 5.2.5 Biomet 70 5.2.6 DePuy Synthes 73 5.2.7 Exactech 75 5.2.8 Integra LifeSciences 77 5.2.9 Medtronic 79 5.2.10 Musculoskeletal Transplant Foundation (MTF) 83 5.2.11 NuVasive 84 5.2.12 Olympus Biotech 85 5.2.13 Orthofix 87 5.2.14 RTI Surgical 89 5.2.15 Stryker 92 5.2.16 Wright Medical 94 5.2.17 Zimmer 96 6 Unmet Needs 98 6.1 Clinical Data Transparency 98 6.2 Lack of Human Clinical Studies 99 6.3 Optimization of rhBMPs' Dosage and Carrier 101 6.4 Standardization of DBM Products' DBM Concentration across the Bone Banking Industry 102 6.5 Need for Products with Improved Osteoinductivity 103 6.6 Continued Research on Cell-Based Matrices 104 6.7 Need for Improved Medical Education on Bone Substitutes Products 105 6.8 Need for Cost Containment 107 7 Pipeline Products 108 7.1 Overview 108 7.2 Advanced Biologics' OsteoMEM 108 7.3 Aursos' Synthetic Bone Substitute 109 7.4 BioSET's AMPLEX 109 7.5 CeraPedics' i-FACTOR 109 7.6 NuVasive's AttraX 109 7.7 Osiris Therapeutics' OvationOS 110 7.8 Wright Medical' Augment Bone Graft 110 8 Clinical Trials to Watch 111 8.1 Yale's Review of Medtronic's INFUSE Bone Graft 111 8.2 Wright Medical's Augment Bone Graft 112 8.3 Orthofix's Trinity Evolution 113 8.4 AlloSource's AlloStem 114 8.5 NuVasive's AttraX 114 8.6 CeraPedics' i-FACTOR 115 8.7 BioSET's AMPLEX 115 9 Current and Future Players 117 9.1 Trends in Corporate Strategy 117 9.2 Company Profiles 118 9.2.1 Alphatec Spine 118 9.2.2 AlloSource 120 9.2.3 Bacterin 122 9.2.4 Biomet 124 9.2.5 DePuy Synthes 126 9.2.6 Exactech 128 9.2.7 Globus Medical 129 9.2.8 Integra LifeSciences 131 9.2.9 Medtronic 133 9.2.10 NuVasive 136 9.2.11 Olympus Biotech 138 9.2.12 Orthofix 139 9.2.13 RTI Surgical 141 9.2.14 Stryker 143 9.2.15 Wright Medical 145 9.2.16 Zimmer Holdings 147 9.3 Other Players 150 10 Market Outlooks 152 10.1 Market Share Analysis 152 10.1.1 Global 152 10.1.2 US 154 10.2 By Geography 157 10.2.1 US 157 11 Appendix 161 11.1 Abbreviations 161 11.2 Bibliography 164 11.3 Report Methodology 173 11.3.1 Overview 173 11.3.2 Coverage 173 11.3.3 Secondary Research 173 11.3.4 Forecasting Methodology 174 11.3.5 Primary Research - Key Opinion Leader Interviews 175 11.3.6 Expert Panel Validation 176 11.4 Physicians and Specialists Included in this Study 177 11.5 About the Authors 180 11.5.1 Analysts 180 11.5.2 Bonnie Bain, Ph.D., Global Head of Healthcare 181 11.6 About MediPoint 182 11.7 About GlobalData 182 11.8 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 the US, 2013 33 Table 11: Medicare National Average Reimbursement Rates for Major Orthopedic Procedures that Involve the Usage of BGS, 2013-2014 43 Table 12: Currently Marketed Cell-Based Matrices in the US Market 52 Table 13: Differences between the US and EU Regulations for BGS 57 Table 14: Types of Autologous Grafting Commonly Used to Treat Non-Union 62 Table 15: Advanced Biologics' BGS Products 65 Table 16: SWOT Analysis - Advanced Biologics' BGS Portfolio 65 Table 17: AlloSource's BGS Products 66 Table 18: SWOT Analysis - AlloSource's BGS Portfolio 67 Table 19: Bacterin's BGS Products 68 Table 20: SWOT Analysis - Bacterin's BGS Portfolio 69 Table 21: Baxter's BGS Products 70 Table 22: SWOT Analysis - Baxter's BGS Portfolio 70 Table 23: Biomet's BGS Products 71 Table 24: SWOT Analysis - Biomet's BGS Portfolio 72 Table 25: DePuy Synthes' BGS Products 74 Table 26: SWOT Analysis - DePuy Synthes' BGS Portfolio 75 Table 27: Exactech's BGS Products 76 Table 28: SWOT Analysis - Exactech's BGS Portfolio 77 Table 29: Integra LifeSciences' BGS Products 78 Table 30: SWOT Analysis - Integra LifeSciences' BGS Portfolio 79 Table 31: Medtronic's BGS Products 81 Table 32: SWOT Analysis - Medtronic's BGS Portfolio 82 Table 33: MTF's BGS Products 83 Table 34: SWOT Analysis - MTF's BGS Portfolio 83 Table 35: NuVasive's BGS Products 84 Table 36: SWOT Analysis - NuVasive's BGS Portfolio 85 Table 37: Olympus Biotech's BGS Products 86 Table 38: SWOT Analysis - Olympus Biotech's BGS Portfolio 86 Table 39: Orthofix's BGS Products 88 Table 40: SWOT Analysis - Orthofix's BGS Portfolio 88 Table 41: RTI Surgical's BGS Products 90 Table 42: SWOT Analysis - RTI Surgical's BGS Portfolio 92 Table 43: Stryker's BGS Products 93 Table 44: SWOT Analysis - Stryker's BGS Portfolio 94 Table 45: Wright Medical's BGS Products 95 Table 46: SWOT Analysis - Wright Medical's BGS Portfolio 96 Table 47: Zimmer's BGS Products 97 Table 48: SWOT Analysis - Zimmer's BGS Portfolio 97 Table 49: Compelling Questions Regarding the Cell-Based Matrices 105 Table 50: Pipeline Products in the Global BGS Market 108 Table 51: Major Clinical Findings of the YODA Project 111 Table 52: Major Clinical Studies of Augment Bone Graft 112 Table 53: Major Clinical Studies of Trinity Evolution 113 Table 54: Major Clinical Study of AlloStem 114 Table 55: Major Clinical Study of AttraX 114 Table 56: Major Clinical Study of i-FACTOR 115 Table 57: Major Clinical Studies of AMPLEX 116 Table 58: Company Profile - Alphatec Spine 118 Table 59: SWOT Analysis - Alphatec Spine 119 Table 60: Company Profile - AlloSource 120 Table 61: SWOT Analysis - AlloSource 121 Table 62: Company Profile - Bacterin 122 Table 63: SWOT Analysis - Bacterin 123 Table 64: Company Profile - Biomet 124 Table 65: SWOT Analysis - Biomet 125 Table 66: Company Profile - DePuy Synthes 126 Table 67: SWOT Analysis - DePuy Synthes 127 Table 68: Company Profile - Exactech 128 Table 69: SWOT Analysis - Exactech 129 Table 70: Company Profile - Globus Medical 130 Table 71: SWOT Analysis - Globus Medical 131 Table 72: Company Profile - Integra LifeSciences 132 Table 73: SWOT Analysis - Integra LifeSciences 133 Table 74: Company Profile - Medtronic 134 Table 75: SWOT Analysis - Medtronic 135 Table 76: Company Profile - NuVasive 136 Table 77: SWOT Analysis - NuVasive 137 Table 78: Company Profile - Olympus Biotech 138 Table 79: SWOT Analysis - Olympus Biotech 139 Table 80: Company Profile - Orthofix 140 Table 81: SWOT Analysis - Orthofix 141 Table 82: Company Profile - RTI Surgical 142 Table 83: SWOT Analysis - RTI Surgical 142 Table 84: Company Profile - Stryker 143 Table 85:SWOT Analysis - Stryker 144 Table 86: Company Profile - Wright Medical 146 Table 87: SWOT Analysis - Wright Medical 147 Table 88: Company Profile - Zimmer Holdings 148 Table 89: SWOT Analysis - Zimmer Holdings 149 Table 90: Other Players in the US BGS Market 150 Table 91: US BGS Market Sales Forecast ($m), 2011-2020 159

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 the US, 2011-2020 34 Figure 4: Traditional Allograft Bone Sales Volume in the US, 2011-2020 35 Figure 5: Machined Allograft Bone Sales Volume in the US, 2011-2020 36 Figure 6: Bone Grafts Substitutes Sales Volumes in the US, 2011-2020 37 Figure 7: Utilization Trend of Bone Graft in Foot and Ankle Fusion Surgery in North America, 2013 53 Figure 8: Global BGS Competitive Landscape, by Estimated Revenue, 2013 153 Figure 9: US BGS Competitive Landscape, 2013 155 Figure 10: US BGS Competitive Landscape, by Segment, 2013 156 Figure 11: US BGS Market Sales Forecast ($m), 2011-2020 159 Figure 12: US BGS Market Revenue Distribution, By Segment, 2011-2020 160 Figure 13: Other Primary Research Participants Breakdown, by Country (n=236) 179 Figure 14: Other Primary Research Participants Breakdown, by Institution (n=236) 179

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