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.
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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.
- 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)
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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.
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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 Medicals Augment Bone Graft (October 2013) 44
4.3.2 FDA Issued a Warning Letter over Globus Medicals 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 Medtronics 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 Surgicals 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
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