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.

The 5EU market remains an important arena for CMF devices. Market shares by country are included in the figures below for each of the EU markets covered in this report. The competitive landscape in the CMF space in Europe is similar to that in the US, with DePuy Synthes taking the lead. Given that the marketplace is dominated by global orthopedic devices manufacturers, with very few pioneering startup companies, the market shares were found to be very similar among the 5EU countries.

Scope

• An overview of Craniomaxillofacial Devices, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
• Annualized EU Craniomaxillofacial Devices market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
• Investigation of current and future market competition for Craniomaxillofacial Devices.
• 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 Craniomaxillofacial Devices 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 EU Craniomaxillofacial Devices market.
• Realize device preferences of physicians who have performed the tests already.
• Access market sizing, forecasts and quantified growth opportunities in EU Craniomaxillofacial Devices 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 EU Craniomaxillofacial Devices market landscape? Identify, understand and capitalize.

Table of Contents

1 Table of Contents 6
1.1 List of Tables 12
1.2 List of Figures 15

2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19

3 Practice Patterns and Adoption Trends 20
3.1 Treatment Modalities Overview 20
3.1.1 CMF Plate and Screw Fixation 20
3.1.2 CMF Distraction 20
3.1.3 Cranial Flap Fixation 22
3.1.4 Temporomandibular Joint Replacement 22
3.1.5 CMF Bone Graft Substitutes 23
3.1.6 Thoracic Fixation 24
3.1.7 Dural Repair 25
3.2 Procedure Coverage by Surgical Specialty 25
3.3 CMF Plate and Screw Fixation 26
3.3.1 By Surgery Type 26
3.3.2 Fractures (by Fracture Type, Material, and Anatomic Region) 27
3.3.3 Reconstruction Surgery, by Product Type 31
3.3.4 Orthognathic Surgery (by Surgery Type) 33
3.3.5 Virtual Surgical Planning 33
3.4 CMF Distraction 36
3.4.1 By Anatomic Region 36
3.4.2 Cranium 37
3.4.3 Mandible 37
3.4.4 Midface 38
3.4.5 Alveolar Ridge 39
3.5 Cranial Flap Fixation 40
3.5.1 By Material 42
3.6 TMJ Replacement 43
3.6.1 By Surgery Type 44
3.6.2 By Implant Type 45
3.7 CMF Bone Graft Substitutes 49
3.7.1 By Anatomic Region 49
3.7.2 By Product Type 49
3.7.3 Synthetic Bone Substitutes and Bone Cement (by Anatomic Region, by Clinical Need) 51
3.8 Thoracic Fixation 53
3.8.1 Fracture 53
3.8.2 Sternotomy 54
3.8.3 Minimally Invasive Cardiac Surgeries 55
3.9 Dural Repair 57
3.9.1 Dural Substitutes (by Product Type, by Material) 58
3.9.2 Dural Sealant (by Material) 62

4 Industry Overview 66
4.1 Procedural Trends 66
4.1.1 5EU 66
4.2 Procurement Trends 69
4.2.1 Hospital Consolidation 69
4.2.2 The Increasing Focus on Cost in Purchasing Decisions 70
4.2.3 Increased Involvement of the C-Level 71
4.3 Market Access 73
4.3.1 5EU 73
4.4 Reimbursement 74
4.4.1 5EU 74
4.5 Product Recalls 75
4.5.1 DePuy Synthes Voluntarily Recalled a Craniomaxillofacial Distraction System (August, 2014) 75
4.5.2 Integra LifeSciences Voluntarily Recalled Certain Products Manufactured in its Añasco, Puerto Rico Facility (April, 2013) 75
4.6 Mergers and Acquisitions/Key Partnerships 76
4.6.1 Materialise Acquired OrthoView Holdings for $13.6m (Oct, 2014) 77
4.6.2 DePuy Synthes Entered into a Co-Development Agreement with Tissue Regeneration Systems (June, 2014) 77
4.6.3 Medtronic to Merge with Covidien in Transaction Valued at $42.9m (June, 2014) 77
4.6.4 Zimmer to Combine with Biomet in Transaction Valued at $13.35 Billion (April, 2014) 78
4.6.5 3D Systems Acquired Medical Modeling (April, 2014) 79
4.6.6 KLS Martin LP to Distribute NEOS Surgery's Cranial LOOP Family (November, 2013) 79
4.6.7 Integra LifeSciences Acquired DuraSeal Product Lines from Covidien for $235m (October, 2013) 79
4.6.8 Biomet to Distribute Oxford Performance Materials' OsteoFab Product Line (April, 2013) 80
4.6.9 Johnson & Johnson Acquired Synthes for $19.7 Billion (June, 2012) 80
4.6.10 Tissuemed Stopped Co-Marketing Agreement with Medtronic (June, 2012) 80
4.6.11 Baxter International Acquired Synovis Life Technologies (December, 2011) 81
4.6.12 Stryker Acquired Orthovita for $316m (May, 2011) 81
4.6.13 Synthes Partnered with Materialise in CMF Surgery (March, 2011) 82

5 Market Drivers, Opportunities, and Barriers 83
5.1 Driver: Pre-Surgical Virtual Planning Technology 83
5.2 Driver: Rising Demand for Patient-Specific Implants 84
5.3 Driver: Operating Room Supply Standardization Drives Product Bundling 85
5.4 Driver: Extensive Investment in Medical Education 87
5.5 Opportunity: 3D Printing 87
5.6 Opportunity: Advance Rigid Fixation for Sternal Closure 89
5.7 Opportunity: New Biomaterials 92
5.8 Opportunity: Emerging Countries 93
5.9 Barrier: Hospital Cost-Containment Pressures 94
5.10 Barrier: Restricted Reimbursement 95
5.11 Barrier: Burden of Rising Regulation 96
5.12 Barrier: Medical Device Excise Tax 97

6 Unmet Needs 99
6.1 Continued Research on Materials for Cranioplasty Devices 99
6.2 Further Enhancements on Bioabsorbable Plating Systems 100
6.3 Cost-Effectiveness Analysis of Plate and Screw Fixation for Sternal Closure 101

7 Pipeline Products 104
7.1 Overview 104
7.2 Ceremed's Dural Substitute (US) 104
7.3 HyperBranch Medical Technology's Adherus Dural Sealant (US) 104
7.4 InVivo Therapeutics' Dural Substitute and Sealant (US) 105
7.5 NanoNerve's Dural Substitute (US) 105

8 Current and Future Players 106
8.1 Trends in Corporate Strategy 106
8.2 Established Players in CMF Devices 107
8.2.1 Johnson & Johnson (DePuy Synthes and Ethicon) 107
8.2.2 KLS Martin 111
8.2.3 Medartis 114
8.2.4 OsteoMed 116
8.2.5 Stryker 118
8.2.6 Zimme-Biomet 121
8.3 Established Players in Dural Repair 126
8.3.1 Aesculap 126
8.3.2 Gore Medical 128
8.3.3 Integra LifeSciences 130
8.3.4 Medtronic-Covidien 133
8.4 Emerging Players 137

9 Market Outlooks 139
9.1 Company Share Analysis 139
9.1.1 5EU Market Share 139
9.1.2 TMJ Replacement 142
9.2 By Market Segment 143
9.2.1 CMF Plate and Screw Fixation 143
9.2.2 CMF Distraction 144
9.2.3 Cranial Flap Fixation 145
9.2.4 TMJ Replacement 146
9.2.5 CMF Bone Graft Substitutes 147
9.2.6 Thoracic Fixation 149
9.3 By Geography 150
9.3.1 France 150
9.3.2 Germany 152
9.3.3 Italy 154
9.3.4 Spain 155
9.3.5 UK 157

10 Appendix 160
10.1 Abbreviations 160
10.2 Bibliography 162
10.3 Report Methodology 167
10.3.1 Overview 167
10.3.2 Coverage 167
10.3.3 Secondary Research 168
10.3.4 Forecasting Methodology 169
10.3.5 Primary Research - Key Opinion Leader Interviews 170
10.3.6 Expert Panel Validation 170
10.4 Physicians and Specialists Included in this Study 171
10.5 About the Authors 174
10.5.1 Analysts 174
10.5.2 Bonnie Bain, PhD, Global Head of Healthcare 175
10.6 About MediPoint 176
10.7 About GlobalData 176
10.8 Disclaimer 176

List of Tables

Table 1: Common Applications of CMF Distraction 21
Table 2: Common Craniotomy Procedures 22
Table 3: Comparison of Various Bone Graft Materials 23
Table 4: Current Status of Potential Indications for Operative Chest Wall Fracture Fixation 24
Table 5: Major Cranial Flap Fixation Systems on the Market, 2014 41
Table 6: Major Prosthetic TMJ Replacement Systems on the Market, 2014 45
Table 7: Comparison Between Stock and Custom-Made Total TMJ Implants 46
Table 8: Major Types of Synthetic Bone Substitutes 51
Table 9: Major Dural Substitutes on the Market, 2014 59
Table 10: Major Dural Sealants on the Market, 2014 63
Table 11: 5EU Procedure Trends for CMF Surgeries, 2011-2020 67
Table 12: Differences Between US FDA Approval and EU CE Marking 74
Table 13: Mergers and Acquisitions/Key Partnerships (2011-2014) 76
Table 14: Advantages and Disadvantages of Common Craniotomy Materials 100
Table 15: Pipeline Products in the US CMF Market, 2014 104
Table 16: Company Profile - DePuy Synthes 108
Table 17: DePuy Synthes' CMF Portfolio 109
Table 18: SWOT Analysis - DePuy Synthes 111
Table 19: Company Profile - KLS Martin Group 112
Table 20: KLS Martin's CMF Portfolio 113
Table 21: SWOT Analysis - KLS Martin 114
Table 22: Company Profile - Medartis 114
Table 23: Medartis' CMF Portfolio 115
Table 24: SWOT Analysis - Medartis 115
Table 25: Company Profile - OsteoMed 116
Table 26: OsteoMed's CMF Portfolio 117
Table 27: SWOT Analysis - OsteoMed 118
Table 28: Company Profile - Stryker 119
Table 29: Stryker's CMF Portfolio 120
Table 30: SWOT Analysis - Stryker 121
Table 31: Company Profile - Zimmer-Biomet 122
Table 32: Zimmer-Biomet's CMF Portfolio 124
Table 33: SWOT Analysis - Zimmer-Biomet 125
Table 34: Company Profile - Aesculap 126
Table 35: Aesculap's CMF and Dural Repair Portfolio 127
Table 36: SWOT Analysis - Aesculap 128
Table 37: Company Profile - Gore Medical 129
Table 38: Gore Medical's Dural Repair Portfolio 130
Table 39: SWOT Analysis - Gore Medical 130
Table 40: Company Profile - Integra LifeSciences 131
Table 41: Integra LifeSciences' CMF and Dural Repair Portfolio 132
Table 42: SWOT Analysis - Integra LifeSciences 133
Table 43: Company Profile - Medtronic-Covidien 134
Table 44: Medtronic-Covidien's CMF and Dural Repair Portfolio 135
Table 45: SWOT Analysis - Medtronic-Covidien 136
Table 46: Emerging Players in the CMF Devices and Dural Repair Market in the US and Europe 137
Table 47: 5EU CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 144
Table 48: 5EU CMF Distraction Market Revenue ($m), 2011-2020 145
Table 49: 5EU Cranial Flap Fixation Market Revenue ($m), 2011-2020 146
Table 50: 5EU TMJ Replacement Market Revenue ($m), 2011-2020 147
Table 51: 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 148
Table 52: 5EU Thoracic Fixation Market Revenue ($m), 2011-2020 149
Table 53: France CMF Devices Market Revenue ($m), 2011-2020 151
Table 54: Germany CMF Devices Market Revenue ($m), 2011-2020 153
Table 55: Italy CMF Devices Market Revenue ($m), 2011-2020 154
Table 56: Spain CMF Devices Market Revenue ($m), 2011-2020 156
Table 57: UK CMF Devices Market Revenue ($m), 2011-2020 158
Table 58: Abbrevations 160

List of Figures

Figure 1: Distribution of CMF Procedure Coverage by Different Surgical Specialties 26
Figure 2: CMF Plate and Screw Fixation, by Surgery Type, 2013 27
Figure 3: CMF Fracture Distribution Pattern, 2013 28
Figure 4: Adoption Trend of CMF Plate and Screw Fixation Devices, by Material 30
Figure 5: CMF Plate and Screw Fixation, by Anatomic Region, 2013 31
Figure 6: Adoption Trend of CMF Plate and Screw Fixation Devices for Reconstruction, by Product Type 32
Figure 7: CMF Plate and Screw Fixation Devices for Orthognathic Procedures, by Surgery Type 33
Figure 8: Adoption Trend of VSP Technology in CMF Plate and Screw Fixation Devices for Reconstruction and Orthognathic Surgeries 34
Figure 9: CMF Distraction Procedures, by Anatomic Region 36
Figure 10: Distribution of CMF Distraction Cases - Cranial Region 37
Figure 11: Adoption Trend of CMF Distraction Devices - Mandibular Region 38
Figure 12: Adoption Trend of CMF Distraction Devices - Midface Region 39
Figure 13: Adoption Trend of CMF Distraction Devices - Alveolar Region 40
Figure 14: Adoption Trend of Cranial Flap Fixation Devices, by Material 43
Figure 15: Adoption Trend of TMJ Replacement Devices, by Surgery Type 45
Figure 16: Adoption Trend of TMJ Replacement Devices, by Product Type 47
Figure 17: Adoption Trend of TMJ Replacement Devices, by Scope 48
Figure 18: Distribution of Bone Graft Substitutes' Usage in CMF Procedures, by Anatomic Region 49
Figure 19: Distribution of Bone Graft Substitutes' Usage in CMF Procedures, by Product Type 50
Figure 20: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Anatomic Region 52
Figure 21: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Clinical Need 53
Figure 22: Adoption Trend of Plate and Screw Fixation in Rib and Sternal Fractures 54
Figure 23: Adoption Trend of Dural Substitutes in Dural Graft 58
Figure 24: Adoption Trend of Dural Substitutes, by Product Type 61
Figure 25: Adoption Trend of Dural Substitutes, by Material 62
Figure 26: Adoption Trend of Dural Sealant, by Material 65
Figure 27: 5EU Procedure Trends for CMF Surgeries, 2011-2020 68
Figure 28: Estimated France Market Share for CMF Devices, 2013 139
Figure 29: Estimated Germany Market Share for CMF Devices, 2013 140
Figure 30: Estimated Italy Market Share for CMF Devices, 2013 140
Figure 31: Estimated Spain Market Share for CMF Devices, 2013 141
Figure 32: Estimated UK Market Share for CMF Devices, 2013 141
Figure 33: Estimated 5EU Market Share for TMJ Replacement, 2013 143
Figure 34: 5EU CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 144
Figure 35: 5EU CMF Distraction Market Revenue ($m), 2011-2020 145
Figure 36: 5EU Cranial Flap Fixation Market Revenue ($m), 2011-2020 146
Figure 37: 5EU TMJ Replacement Market Revenue ($m), 2011-2020 147
Figure 38: 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 148
Figure 39: 5EU Thoracic Fixation Market Revenue ($m), 2011-2020 150
Figure 40: France CMF Devices Market Revenue ($m), 2011-2020 151
Figure 41: France CMF Devices Market Revenue Distribution, 2013 152
Figure 42: Germany CMF Devices Market Revenue ($m), 2011-2020 153
Figure 43: Germany CMF Devices Market Revenue Distribution, 2013 154
Figure 44: Italy CMF Devices Market Revenue ($m), 2011-2020 155
Figure 45: Italy CMF Devices Market Revenue Distribution, 2013 155
Figure 46: Spain CMF Devices Market Revenue ($m), 2011-2020 156
Figure 47: Spain CMF Devices Market Revenue Distribution, 2013 157
Figure 48: UK CMF Devices Market Revenue ($m), 2011-2020 158
Figure 49: UK CMF Devices Market Revenue Distribution, 2013 159
Figure 50: Physician Survey Participants Breakdown, by Geography (n=93) 173
Figure 51: Physician Survey Participants Breakdown, by Surgical Specialty (n=93) 173