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MediPoint: Craniomaxillofacial Devices - US Analysis and Market Forecasts

Summary

Craniomaxillofacial (CMF) surgery is a highly specialized branch of orthopedic surgery that focuses on all aspects of facial and skull disorders. In this report, GlobalData covers the following segments: CMF plate and screw fixation, CMF distraction, cranial flap fixation, temporomandibular joint (TMJ) replacement, CMF bone graft substitutes, and thoracic fixation (rigid fixation only). Throughout the report, adoption patterns, procedure volumes, and market revenues for all the aforementioned segments are included. In addition, GlobalData included an analysis on the dural repair market, which consists of dural substitutes and dural sealants. However, procedure numbers and market revenues for dural repair are provided only for the US market.

GlobalData estimates that DePuy Synthes currently contributes to about 34% of the US market for CMF devices. Following DePuy Synthes is Stryker, Biomet, KLS Martin, and OsteoMed. Moving forward, DePuy Synthes’ dominance is widely considered not replicable due to its long history in the CMF field, its significant presence in orthopedic core markets, as well as its aggressive marketing efforts. Beyond these multinational players, the rest of the US CMF market is occupied with a wide range of companies either focusing on specific segments, such as cranial flap fixation, or targeting the low-end market with me-too products.

Scope

- An overview of CMF, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the US CMF market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for CMF.
- 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 CMF sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

- Understand the trends shaping and driving the US CMF market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US CMF market through 2018.
- 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 CMF market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Craniomaxillofacial Devices - US Analysis and Market Forecasts
1 Table of Contents

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
3 Practice Patterns and Adoption Trends 18
3.1 Treatment Modalities Overview 18
3.1.1 CMF Plate and Screw Fixation 18
3.1.2 CMF Distraction 18
3.1.3 Cranial Flap Fixation 20
3.1.4 Temporomandibular Joint Replacement 20
3.1.5 CMF Bone Graft Substitutes 21
3.1.6 Thoracic Fixation 22
3.1.7 Dural Repair 23
3.2 Procedure Coverage by Surgical Specialty 23
3.3 CMF Plate and Screw Fixation 24
3.3.1 By Surgery Type 24
3.3.2 Fractures (by Fracture Type, Material, and Anatomic Region) 25
3.3.3 Reconstruction Surgery, by Product Type 29
3.3.4 Orthognathic Surgery (by Surgery Type) 31
3.3.5 Virtual Surgical Planning 31
3.4 CMF Distraction 33
3.4.1 By Anatomic Region 33
3.4.2 Cranium 34
3.4.3 Mandible 35
3.4.4 Midface 36
3.4.5 Alveolar Ridge 37
3.5 Cranial Flap Fixation 38
3.5.1 By Material 40
3.6 TMJ Replacement 41
3.6.1 By Surgery Type 42
3.6.2 By Implant Type 43
3.7 CMF Bone Graft Substitutes 47
3.7.1 By Anatomic Region 47
3.7.2 By Product Type 47
3.7.3 Synthetic Bone Substitutes and Bone Cement (by Anatomic Region, by Clinical Need) 48
3.8 Thoracic Fixation 50
3.8.1 Fracture 50
3.8.2 Sternotomy 52
3.8.3 Minimally Invasive Cardiac Surgeries 52
3.9 Dural Repair 54
3.9.1 Dural Substitutes (by Product Type, by Material) 55
3.9.2 Dural Sealant (by Material) 59
4 Industry Overview 63
4.1 Procedural Trends 63
4.1.1 CMF Procedures 63
4.1.2 Dural Repair 65
4.2 Procurement Trends 66
4.2.1 Hospital Consolidation 66
4.2.2 The Increasing Focus on Cost in Purchasing Decisions 67
4.2.3 Increased Involvement of the C-Level 68
4.3 Market Access 70
4.3.1 US 70
4.4 Reimbursement 70
4.4.1 US 70
4.4.2 5EU 72
4.5 Product Recalls 73
4.5.1 DePuy Synthes Voluntarily Recalled a Craniomaxillofacial Distraction System (August, 2014) 73
4.5.2 Integra LifeSciences Voluntarily Recalled Certain Products Manufactured in its Añasco, Puerto Rico Facility (April, 2013) 73
4.6 Mergers and Acquisitions/Key Partnerships 74
4.6.1 Materialise Acquired OrthoView Holdings for $13.6m (Oct, 2014) 75
4.6.2 DePuy Synthes Entered into a Co-Development Agreement with Tissue Regeneration Systems (June, 2014) 75
4.6.3 Medtronic to Merge with Covidien in Transaction Valued at $42.9m (June, 2014) 75
4.6.4 Zimmer to Combine with Biomet in Transaction Valued at $13.35 Billion (April, 2014) 76
4.6.5 3D Systems Acquired Medical Modeling (April, 2014) 77
4.6.6 KLS Martin LP to Distribute NEOS Surgery's Cranial LOOP Family (November, 2013) 77
4.6.7 Integra LifeSciences Acquired DuraSeal Product Lines from Covidien for $235m (October, 2013) 77
4.6.8 Biomet to Distribute Oxford Performance Materials' OsteoFab Product Line (April, 2013) 78
4.6.9 Johnson and Johnson Acquired Synthes for $19.7 Billion (June, 2012) 78
4.6.10 Tissuemed Stopped Co-Marketing Agreement with Medtronic (June, 2012) 78
4.6.11 Baxter International Acquired Synovis Life Technologies (December, 2011) 79
4.6.12 Stryker Acquired Orthovita for $316m (May, 2011) 79
4.6.13 Synthes Partnered with Materialise in CMF Surgery (March, 2011) 80
5 Market Drivers, Opportunities, and Barriers 81
5.1 Driver: Pre-Surgical Virtual Planning Technology 81
5.2 Driver: Rising Demand for Patient-Specific Implants 82
5.3 Driver: Operating Room Supply Standardization Drives Product Bundling 83
5.4 Driver: Extensive Investment in Medical Education 85
5.5 Opportunity: 3D Printing 85
5.6 Opportunity: Advance Rigid Fixation for Sternal Closure 87
5.7 Opportunity: New Biomaterials 90
5.8 Opportunity: Emerging Countries 91
5.9 Barrier: Hospital Cost-Containment Pressures 92
5.10 Barrier: Restricted Reimbursement 93
5.11 Barrier: Burden of Rising Regulation 94
5.12 Barrier: Medical Device Excise Tax 95
6 Unmet Needs 97
6.1 Continued Research on Materials for Cranioplasty Devices 97
6.2 Further Enhancements on Bioabsorbable Plating Systems 98
6.3 Cost-Effectiveness Analysis of Plate and Screw Fixation for Sternal Closure 99
7 Pipeline Products 102
7.1 Overview 102
7.2 Ceremed's Dural Substitute (US) 102
7.3 HyperBranch Medical Technology's Adherus Dural Sealant (US) 102
7.4 InVivo Therapeutics' Dural Substitute and Sealant (US) 103
7.5 NanoNerve's Dural Substitute (US) 103
8 Current and Future Players 104
8.1 Trends in Corporate Strategy 104
8.2 Established Players in CMF Devices 105
8.2.1 Johnson and Johnson (DePuy Synthes and Ethicon) 105
8.2.2 KLS Martin 109
8.2.3 Medartis 112
8.2.4 OsteoMed 114
8.2.5 Stryker 116
8.2.6 Zimme-Biomet 119
8.3 Established Players in Dural Repair 124
8.3.1 Aesculap 124
8.3.2 Gore Medical 126
8.3.3 Integra LifeSciences 128
8.3.4 Medtronic-Covidien 131
8.4 Emerging Players 135
9 Market Outlooks 137
9.1 Company Share Analysis 137
9.1.1 US 137
9.1.2 TMJ Replacement 138
9.2 Market Revenue Forecast 139
9.2.1 Overall 139
9.2.2 CMF Plate and Screw Fixation 141
9.2.3 CMF Distraction 142
9.2.4 CMF Bone Graft Substitutes 143
9.2.5 Thoracic Fixation 144
9.2.6 Dural Repair 146
10 Appendix 147
10.1 Abbreviations 147
10.2 Bibliography 149
10.3 Report Methodology 154
10.3.1 Overview 154
10.3.2 Coverage 154
10.3.3 Secondary Research 155
10.3.4 Forecasting Methodology 156
10.3.5 Primary Research - Key Opinion Leader Interviews 157
10.3.6 Expert Panel Validation 157
10.4 Physicians and Specialists Included in this Study 158
10.5 About the Authors 161
10.5.1 Analysts 161
10.5.2 Bonnie Bain, PhD, Global Head of Healthcare 162
10.6 About MediPoint 163
10.7 About GlobalData 163
10.8 Disclaimer 163

1.1 List of Tables

Table 1: Common Applications of CMF Distraction 19
Table 2: Common Craniotomy Procedures 20
Table 3: Comparison of Various Bone Graft Materials 21
Table 4: Current Status of Potential Indications for Operative Chest Wall Fracture Fixation 22
Table 5: Major Cranial Flap Fixation Systems on the Market, 2014 39
Table 6: Major Prosthetic TMJ Replacement Systems on the Market, 2014 43
Table 7: Comparison Between Stock and Custom-Made Total TMJ Implants 44
Table 8: Major Types of Synthetic Bone Substitutes 49
Table 9: Major Dural Substitutes on the Market, 2014 56
Table 10: Major Dural Sealants on the Market, 2014 60
Table 11: US Procedure Trends for CMF Surgeries, 2011-2020 64
Table 12: US Procedure Trends for Dural Repair, 2011-2020 65
Table 13: Mergers and Acquisitions/Key Partnerships (2011-2014) 74
Table 14: Advantages and Disadvantages of Common Craniotomy Materials 98
Table 15: Pipeline Products in the US CMF Market, 2014 102
Table 16: Company Profile - DePuy Synthes 106
Table 17: DePuy Synthes' CMF Portfolio 107
Table 18: SWOT Analysis - DePuy Synthes 109
Table 19: Company Profile - KLS Martin Group 110
Table 20: KLS Martin's CMF Portfolio 111
Table 21: SWOT Analysis - KLS Martin 112
Table 22: Company Profile - Medartis 112
Table 23: Medartis' CMF Portfolio 113
Table 24: SWOT Analysis - Medartis 113
Table 25: Company Profile - OsteoMed 114
Table 26: OsteoMed's CMF Portfolio 115
Table 27: SWOT Analysis - OsteoMed 116
Table 28: Company Profile - Stryker 117
Table 29: Stryker's CMF Portfolio 118
Table 30: SWOT Analysis - Stryker 119
Table 31: Company Profile - Zimmer-Biomet 120
Table 32: Zimmer-Biomet's CMF Portfolio 122
Table 33: SWOT Analysis - Zimmer-Biomet 123
Table 34: Company Profile - Aesculap 124
Table 35: Aesculap's CMF and Dural Repair Portfolio 125
Table 36: SWOT Analysis - Aesculap 126
Table 37: Company Profile - Gore Medical 127
Table 38: Gore Medical's Dural Repair Portfolio 128
Table 39: SWOT Analysis - Gore Medical 128
Table 40: Company Profile - Integra LifeSciences 129
Table 41: Integra LifeSciences' CMF and Dural Repair Portfolio 130
Table 42: SWOT Analysis - Integra LifeSciences 131
Table 43: Company Profile - Medtronic-Covidien 132
Table 44: Medtronic-Covidien's CMF and Dural Repair Portfolio 133
Table 45: SWOT Analysis - Medtronic-Covidien 134
Table 46: Emerging Players in the CMF Devices and Dural Repair Market in the US and Europe 135
Table 47: US CMF Devices Market Revenue ($m), 2011-2020 140
Table 48: US CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 141
Table 49: US CMF Distraction Market Revenue ($m), 2011-2020 142
Table 50: US and 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 144
Table 51: US Thoracic Fixation Market Revenue ($m), 2011-2020 145
Table 52: US Dural Repair Market Revenue ($m), 2011-2020 146
Table 53: Abbrevations 147

1.2 List of Figures

Figure 1: Distribution of CMF Procedure Coverage by Different Surgical Specialties 24
Figure 2: CMF Plate and Screw Fixation, by Surgery Type, 2013 25
Figure 3: CMF Fracture Distribution Pattern, 2013 26
Figure 4: Adoption Trend of CMF Plate and Screw Fixation Devices, by Material 28
Figure 5: CMF Plate and Screw Fixation, by Anatomic Region, 2013 29
Figure 6: Adoption Trend of CMF Plate and Screw Fixation Devices for Reconstruction, by Product Type 30
Figure 7: CMF Plate and Screw Fixation Devices for Orthognathic Procedures, by Surgery Type 31
Figure 8: Adoption Trend of VSP Technology in CMF Plate and Screw Fixation Devices for Reconstruction and Orthognathic Surgeries 32
Figure 9: CMF Distraction Procedures, by Anatomic Region 34
Figure 10: Distribution of CMF Distraction Cases - Cranial Region 35
Figure 11: Adoption Trend of CMF Distraction Devices - Mandibular Region 36
Figure 12: Adoption Trend of CMF Distraction Devices - Midface Region 37
Figure 13: Adoption Trend of CMF Distraction Devices - Alveolar Region 38
Figure 14: Adoption Trend of Cranial Flap Fixation Devices, by Material 41
Figure 15: Adoption Trend of TMJ Replacement Devices, by Surgery Type 43
Figure 16: Adoption Trend of TMJ Replacement Devices, by Product Type 45
Figure 17: Adoption Trend of TMJ Replacement Devices, by Scope 46
Figure 18: Distribution of Bone Graft Substitutes' Usage in CMF Procedures, by Anatomic Region 47
Figure 19: Distribution of Bone Graft Substitutes' Usage in CMF Procedures, by Product Type 48
Figure 20: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Anatomic Region 49
Figure 21: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Clinical Need 50
Figure 22: Adoption Trend of Plate and Screw Fixation in Rib and Sternal Fractures 51
Figure 23: Adoption Trend of Dural Substitutes in Dural Graft 55
Figure 24: Adoption Trend of Dural Substitutes, by Product Type 58
Figure 25: Adoption Trend of Dural Substitutes, by Material 59
Figure 26: Adoption Trend of Dural Sealant, by Material 62
Figure 27: US Procedure Trends for CMF Surgeries, 2011-2020 65
Figure 28: Estimated US Market Share for CMF Devices, 2013 137
Figure 29: Estimated US Market Share for TMJ Replacement, 2013 138
Figure 30: US CMF Devices Market Revenue ($m), 2011-2020 140
Figure 31: US CMF Devices Market Revenue Distribution, 2013 141
Figure 32: US CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 142
Figure 33: US CMF Distraction Market Revenue ($m), 2011-2020 143
Figure 34: US CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 144
Figure 35: US Thoracic Fixation Market Revenue ($m), 2011-2020 145
Figure 36: US Dural Repair Market Revenue ($m), 2011-2020 146
Figure 37: Physician Survey Participants Breakdown, by Geography (n=93) 160
Figure 38: Physician Survey Participants Breakdown, by Surgical Specialty (n=93) 160

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