頭蓋顎顔面固定(CMF)装置:米国及びヨーロッパ主要国分析

◆英語タイトル:MediPoint: Craniomaxillofacial Devices - US and 5EU Analysis and Market Forecasts
◆商品コード:GDME0207MAR
◆発行会社(リサーチ会社):GlobalData
◆発行日:2014年12月8日
◆ページ数:193
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【レポートの概要】

MediPoint: Craniomaxillofacial Devices – US and 5EU 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.

Overall, the growth of orthopedics in developed markets is being driven by established healthcare infrastructure and expanded insurance coverage, as well as the trend of early intervention, while ongoing macroeconomic pressures continue to influence the healthy growth in the procedure numbers of high-volume surgeries. The current CMF devices market remains a growing space that promises opportunities, primarily due to the non-elective nature of most CMF trauma and neurosurgeries. Although standard/stock titanium plate and screw systems still represent the first choice in managing CMF surgery, the use of patient-specific implants has been expanding in the past decade and becomes particularly useful in situations with challenging anatomy distorted by tumors, post-traumatic reconstruction, or revision cases. Future trends will include continued development in bioabsorbable plating systems and advanced distraction systems, as well as an increased use of virtual planning technologies, patient-specific devices, and cost-effective thoracic fixation devices. In the meantime, additive manufacturing, such as three-dimensional (3D) printing, is taking manufacturing in a whole new direction without the boundaries of shape and structure; the future of custom CMF implants will lie in additive manufacturing, which will widen the spectrum of synthetic substitute materials suitable for this purpose.

Highlights

Key Questions Answered

- Future growth in the plate and screw fixation segment lies in the CMF trauma and reconstruction procedures, as most of these procedures are non-elective. (Q).What are the procedure trends of CMF fracture, reconstruction and orthognathic surgeries? (Q).What is the market revenue of this segment in different geographies?
- Rather than just the latest innovation, virtual surgical planning (VSP) is rapidly becoming an important component in the surgical treatment planning of CMF reconstruction and orthognathic surgeries. (Q).What are the current surgeon adoption trends of the VSP technology in the US and Europe?
- Prosthetic TMJ replacement is currently reserved for patients with end-stage TMJ defects as a salvage option, and hence, has low procedure numbers with a limited number of surgeons performing this surgery worldwide. (Q).Who are the current players in this field? (Q).How will this niche market evolve in the following 10 years?
- While the industry has witnessed increased enthusiasm about rigid fixation for sternal closure in the clinical community, adoption is only expanding at a slow pace, primarily due to the hindrance with reimbursement. (Q).Will there be a paradigm shift in the thoracic fixation field in the future?

Reasons to buy

- “What Do Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

【レポートの目次】

1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 21
3 Practice Patterns and Adoption Trends 22
3.1 Treatment Modalities Overview 22
3.1.1 CMF Plate and Screw Fixation 22
3.1.2 CMF Distraction 22
3.1.3 Cranial Flap Fixation 24
3.1.4 Temporomandibular Joint Replacement 24
3.1.5 CMF Bone Graft Substitutes 25
3.1.6 Thoracic Fixation 26
3.1.7 Dural Repair 27
3.2 Procedure Coverage by Surgical Specialty 27
3.3 CMF Plate and Screw Fixation 28
3.3.1 By Surgery Type 28
3.3.2 Fractures (by Fracture Type, Material, and Anatomic Region) 29
3.3.3 Reconstruction Surgery, by Product Type 33
3.3.4 Orthognathic Surgery (by Surgery Type) 35
3.3.5 Virtual Surgical Planning 36
3.4 CMF Distraction 38
3.4.1 By Anatomic Region 38
3.4.2 Cranium 39
3.4.3 Mandible 39
3.4.4 Midface 40
3.4.5 Alveolar Ridge 41
3.5 Cranial Flap Fixation 42
3.5.1 By Material 44
3.6 TMJ Replacement 45
3.6.1 By Surgery Type 46
3.6.2 By Implant Type 47
3.7 CMF Bone Graft Substitutes 51
3.7.1 By Anatomic Region 51
3.7.2 By Product Type 51
3.7.3 Synthetic Bone Substitutes and Bone Cement (by Anatomic Region, by Clinical Need) 53
3.8 Thoracic Fixation 55
3.8.1 Fracture 55
3.8.2 Sternotomy 56
3.8.3 Minimally Invasive Cardiac Surgeries 57
3.9 Dural Repair 59
3.9.1 Dural Substitutes (by Product Type, by Material) 60
3.9.2 Dural Sealant (by Material) 63
4 Industry Overview 67
4.1 Procedural Trends 67
4.1.1 Overview 67
4.1.2 US 68
4.1.3 5EU 72
4.2 Procurement Trends 75
4.2.1 Hospital Consolidation 75
4.2.2 The Increasing Focus on Cost in Purchasing Decisions 76
4.2.3 Increased Involvement of the C-Level 77
4.3 Market Access 79
4.3.1 US 79
4.3.2 5EU 80
4.4 Reimbursement 80
4.4.1 US 80
4.4.2 5EU 82
4.5 Product Recalls 83
4.5.1 DePuy Synthes Voluntarily Recalled a Craniomaxillofacial Distraction System (August, 2014) 83
4.5.2 Integra LifeSciences Voluntarily Recalled Certain Products Manufactured in its Añasco, Puerto Rico Facility (April, 2013) 83
4.6 Mergers and Acquisitions/Key Partnerships 84
4.6.1 Materialise Acquired OrthoView Holdings for $13.6m (Oct, 2014) 85
4.6.2 DePuy Synthes Entered into a Co-Development Agreement with Tissue Regeneration Systems (June, 2014) 85
4.6.3 Medtronic to Merge with Covidien in Transaction Valued at $42.9m (June, 2014) 85
4.6.4 Zimmer to Combine with Biomet in Transaction Valued at $13.35 Billion (April, 2014) 86
4.6.5 3D Systems Acquired Medical Modeling (April, 2014) 87
4.6.6 KLS Martin LP to Distribute NEOS Surgery’s Cranial LOOP Family (November, 2013) 87
4.6.7 Integra LifeSciences Acquired DuraSeal Product Lines from Covidien for $235m (October, 2013) 87
4.6.8 Biomet to Distribute Oxford Performance Materials’ OsteoFab Product Line (April, 2013) 88
4.6.9 Johnson & Johnson Acquired Synthes for $19.7 Billion (June, 2012) 88
4.6.10 Tissuemed Stopped Co-Marketing Agreement with Medtronic (June, 2012) 88
4.6.11 Baxter International Acquired Synovis Life Technologies (December, 2011) 89
4.6.12 Stryker Acquired Orthovita for $316m (May, 2011) 89
4.6.13 Synthes Partnered with Materialise in CMF Surgery (March, 2011) 90
5 Market Drivers, Opportunities, and Barriers 91
5.1 Driver: Pre-Surgical Virtual Planning Technology 91
5.2 Driver: Rising Demand for Patient-Specific Implants 92
5.3 Driver: Operating Room Supply Standardization Drives Product Bundling 93
5.4 Driver: Extensive Investment in Medical Education 95
5.5 Opportunity: 3D Printing 95
5.6 Opportunity: Advance Rigid Fixation for Sternal Closure 97
5.7 Opportunity: New Biomaterials 100
5.8 Opportunity: Emerging Countries 101
5.9 Barrier: Hospital Cost-Containment Pressures 102
5.10 Barrier: Restricted Reimbursement 103
5.11 Barrier: Burden of Rising Regulation 104
5.12 Barrier: Medical Device Excise Tax 105
6 Unmet Needs 107
6.1 Continued Research on Materials for Cranioplasty Devices 107
6.2 Further Enhancements on Bioabsorbable Plating Systems 108
6.3 Cost-Effectiveness Analysis of Plate and Screw Fixation for Sternal Closure 110
7 Pipeline Products 112
7.1 Overview 112
7.2 Ceremed’s Dural Substitute (US) 112
7.3 HyperBranch Medical Technology’s Adherus Dural Sealant (US) 112
7.4 InVivo Therapeutics’ Dural Substitute and Sealant (US) 113
7.5 NanoNerve’s Dural Substitute (US) 113
8 Current and Future Players 114
8.1 Trends in Corporate Strategy 114
8.2 Established Players in CMF Devices 115
8.2.1 Johnson & Johnson (DePuy Synthes and Ethicon) 115
8.2.2 KLS Martin 119
8.2.3 Medartis 122
8.2.4 OsteoMed 124
8.2.5 Stryker 126
8.2.6 Zimme-Biomet 129
8.3 Established Players in Dural Repair 134
8.3.1 Aesculap 134
8.3.2 Gore Medical 136
8.3.3 Integra LifeSciences 138
8.3.4 Medtronic-Covidien 141
8.4 Emerging Players 145
9 Market Outlooks 147
9.1 Company Share Analysis 147
9.1.1 US 147
9.1.2 5EU Market Share 148
9.1.3 TMJ Replacement 150
9.2 By Market Segment 152
9.2.1 CMF Plate and Screw Fixation 152
9.2.2 CMF Distraction 153
9.2.3 Cranial Flap Fixation 154
9.2.4 TMJ Replacement 155
9.2.5 CMF Bone Graft Substitutes 156
9.2.6 Thoracic Fixation 157
9.2.7 Dural Repair (US Only) 159
9.3 By Geography 160
9.3.1 Overview 160
9.3.2 US 163
9.3.3 France 166
9.3.4 Germany 168
9.3.5 Italy 169
9.3.6 Spain 171
9.3.7 UK 173
10 Appendix 176
10.1 Abbreviations 176
10.2 Bibliography 178
10.3 Report Methodology 183
10.3.1 Overview 183
10.3.2 Coverage 183
10.3.3 Secondary Research 184
10.3.4 Forecasting Methodology 185
10.3.5 Primary Research – Key Opinion Leader Interviews 186
10.3.6 Expert Panel Validation 186
10.4 Physicians and Specialists Included in this Study 187
10.5 About the Authors 190
10.5.1 Analysts 190
10.5.2 Bonnie Bain, PhD, Global Head of Healthcare 191
10.6 About MediPoint 192
10.7 About GlobalData 192
10.8 Disclaimer 192

1.1 List of Tables
Table 1: Common Applications of CMF Distraction 23
Table 2: Common Craniotomy Procedures 24
Table 3: Comparison of Various Bone Graft Materials 25
Table 4: Current Status of Potential Indications for Operative Chest Wall Fracture Fixation 26
Table 5: Major Cranial Flap Fixation Systems on the Market, 2014 43
Table 6: Major Prosthetic TMJ Replacement Systems on the Market, 2014 47
Table 7: Comparison Between Stock and Custom-Made Total TMJ Implants 48
Table 8: Major Types of Synthetic Bone Substitutes 53
Table 9: Major Dural Substitutes on the Market, 2014 61
Table 10: Major Dural Sealants on the Market, 2014 64
Table 11: US and 5EU Procedure Trends for CMF Surgeries, 2011-2020 68
Table 12: US Procedure Trends for CMF Surgeries, 2011-2020 70
Table 13: US Procedure Trends for Dural Repair, 2011-2020 71
Table 14: 5EU Procedure Trends for CMF Surgeries, 2011-2020 73
Table 15: Differences Between US FDA Approval and EU CE Marking 80
Table 16: Mergers and Acquisitions/Key Partnerships (2011-2014) 84
Table 17: Advantages and Disadvantages of Common Craniotomy Materials 108
Table 18: Pipeline Products in the US CMF Market, 2014 112
Table 19: Company Profile - DePuy Synthes 116
Table 20: DePuy Synthes’ CMF Portfolio 117
Table 21: SWOT Analysis - DePuy Synthes 119
Table 22: Company Profile - KLS Martin Group 120
Table 23: KLS Martin’s CMF Portfolio 121
Table 24: SWOT Analysis - KLS Martin 122
Table 25: Company Profile - Medartis 122
Table 26: Medartis’ CMF Portfolio 123
Table 27: SWOT Analysis - Medartis 123
Table 28: Company Profile - OsteoMed 124
Table 29: OsteoMed’s CMF Portfolio 125
Table 30: SWOT Analysis - OsteoMed 126
Table 31: Company Profile - Stryker 127
Table 32: Stryker’s CMF Portfolio 128
Table 33: SWOT Analysis - Stryker 129
Table 34: Company Profile - Zimmer-Biomet 130
Table 35: Zimmer-Biomet’s CMF Portfolio 132
Table 36: SWOT Analysis - Zimmer-Biomet 133
Table 37: Company Profile - Aesculap 134
Table 38: Aesculap’s CMF and Dural Repair Portfolio 135
Table 39: SWOT Analysis - Aesculap 136
Table 40: Company Profile - Gore Medical 137
Table 41: Gore Medical’s Dural Repair Portfolio 138
Table 42: SWOT Analysis - Gore Medical 138
Table 43: Company Profile - Integra LifeSciences 139
Table 44: Integra LifeSciences’ CMF and Dural Repair Portfolio 140
Table 45: SWOT Analysis - Integra LifeSciences 141
Table 46: Company Profile - Medtronic-Covidien 142
Table 47: Medtronic-Covidien’s CMF and Dural Repair Portfolio 143
Table 48: SWOT Analysis - Medtronic-Covidien 144
Table 49: Emerging Players in the CMF Devices and Dural Repair Market in the US and Europe 145
Table 50: US and 5EU CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 153
Table 51: US and 5EU CMF Distraction Market Revenue ($m), 2011-2020 154
Table 52: US and 5EU Cranial Flap Fixation Market Revenue ($m), 2011-2020 155
Table 53: US and 5EU TMJ Replacement Market Revenue ($m), 2011-2020 156
Table 54: US and 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 157
Table 55: US and 5EU Thoracic Fixation Market Revenue ($m), 2011-2020 158
Table 56: US Dural Repair Market Revenue ($m), 2011-2020 159
Table 57: US and 5EU CMF Devices Market Revenue ($m), by Segment, 2011-2020 161
Table 58: US and 5EU CMF Devices Market Revenue ($m), by Geography, 2011-2020 162
Table 59: US CMF Devices Market Revenue ($m), 2011-2020 164
Table 60: France CMF Devices Market Revenue ($m), 2011-2020 166
Table 61: Germany CMF Devices Market Revenue ($m), 2011-2020 168
Table 62: Italy CMF Devices Market Revenue ($m), 2011-2020 170
Table 63: Spain CMF Devices Market Revenue ($m), 2011-2020 172
Table 64: UK CMF Devices Market Revenue ($m), 2011-2020 174
Table 65: Abbrevations 176

1.2 List of Figures
Figure 1: Distribution of CMF Procedure Coverage by Different Surgical Specialties 28
Figure 2: CMF Plate and Screw Fixation, by Surgery Type, 2013 29
Figure 3: CMF Fracture Distribution Pattern, 2013 30
Figure 4: Adoption Trend of CMF Plate and Screw Fixation Devices, by Material 32
Figure 5: CMF Plate and Screw Fixation, by Anatomic Region, 2013 33
Figure 6: Adoption Trend of CMF Plate and Screw Fixation Devices for Reconstruction, by Product Type 34
Figure 7: CMF Plate and Screw Fixation Devices for Orthognathic Procedures, by Surgery Type 35
Figure 8: Adoption Trend of VSP Technology in CMF Plate and Screw Fixation Devices for Reconstruction and Orthognathic Surgeries 36
Figure 9: CMF Distraction Procedures, by Anatomic Region 38
Figure 10: Distribution of CMF Distraction Cases - Cranial Region 39
Figure 11: Adoption Trend of CMF Distraction Devices - Mandibular Region 40
Figure 12: Adoption Trend of CMF Distraction Devices - Midface Region 41
Figure 13: Adoption Trend of CMF Distraction Devices - Alveolar Region 42
Figure 14: Adoption Trend of Cranial Flap Fixation Devices, by Material 45
Figure 15: Adoption Trend of TMJ Replacement Devices, by Surgery Type 47
Figure 16: Adoption Trend of TMJ Replacement Devices, by Product Type 49
Figure 17: Adoption Trend of TMJ Replacement Devices, by Scope 50
Figure 18: Distribution of Bone Graft Substitutes’ Usage in CMF Procedures, by Anatomic Region 51
Figure 19: Distribution of Bone Graft Substitutes’ Usage in CMF Procedures, by Product Type 52
Figure 20: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Anatomic Region 54
Figure 21: Distribution of Synthetic Bone Substitutes and Bone Cement Usage in CMF Procedures, by Clinical Need 55
Figure 22: Adoption Trend of Plate and Screw Fixation in Rib and Sternal Fractures 56
Figure 23: Adoption Trend of Dural Substitutes in Dural Graft 60
Figure 24: Adoption Trend of Dural Substitutes, by Product Type 62
Figure 25: Adoption Trend of Dural Substitutes, by Material 63
Figure 26: Adoption Trend of Dural Sealant, by Material 66
Figure 27: US Procedure Trends for CMF Surgeries, 2011-2020 71
Figure 28: 5EU Procedure Trends for CMF Surgeries, 2011-2020 74
Figure 29: Estimated US Market Share for CMF Devices, 2013 147
Figure 30: Estimated France Market Share for CMF Devices, 2013 148
Figure 31: Estimated Germany Market Share for CMF Devices, 2013 149
Figure 32: Estimated Italy Market Share for CMF Devices, 2013 149
Figure 33: Estimated Spain Market Share for CMF Devices, 2013 150
Figure 34: Estimated UK Market Share for CMF Devices, 2013 150
Figure 35: Estimated US Market Share for TMJ Replacement, 2013 151
Figure 36: Estimated 5EU Market Share for TMJ Replacement, 2013 152
Figure 37: US and 5EU CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020 153
Figure 38: US and 5EU CMF Distraction Market Revenue ($m), 2011-2020 154
Figure 39: US and 5EU Cranial Flap Fixation Market Revenue ($m), 2011-2020 155
Figure 40: US and 5EU TMJ Replacement Market Revenue ($m), 2011-2020 156
Figure 41: US and 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020 157
Figure 42: US and 5EU Thoracic Fixation Market Revenue ($m), 2011-2020 158
Figure 43: US Dural Repair Market Revenue ($m), 2011-2020 159
Figure 44: US and 5EU CMF Devices Market Revenue ($m), 2011-2020 161
Figure 45: CMF Devices Market Revenue ($m), by Geography, 2013 and 2020 163
Figure 46: US CMF Devices Market Revenue ($m), 2011-2020 165
Figure 47: US CMF Devices Market Revenue Distribution, 2013 165
Figure 48: France CMF Devices Market Revenue ($m), 2011-2020 167
Figure 49: France CMF Devices Market Revenue Distribution, 2013 167
Figure 50: Germany CMF Devices Market Revenue ($m), 2011-2020 169
Figure 51: Germany CMF Devices Market Revenue Distribution, 2013 169
Figure 52: Italy CMF Devices Market Revenue ($m), 2011-2020 170
Figure 53: Italy CMF Devices Market Revenue Distribution, 2013 171
Figure 54: Spain CMF Devices Market Revenue ($m), 2011-2020 172
Figure 55: Spain CMF Devices Market Revenue Distribution, 2013 173
Figure 56: UK CMF Devices Market Revenue ($m), 2011-2020 174
Figure 57: UK CMF Devices Market Revenue Distribution, 2013 175
Figure 58: Physician Survey Participants Breakdown, by Geography (n=93) 189
Figure 59: Physician Survey Participants Breakdown, by Surgical Specialty (n=93) 189

【掲載企業】

Johnson & Johnson (DePuy Synthes and Ethicon)
KLS Martin
Medartis
OsteoMed
Stryker
Zimme-Biomet
Aesculap
Gore Medical
Integra LifeSciences
Medtronic-Covidien

【レポートのキーワード】

頭蓋顎顔面固定(CMF)装置、医療機器

【免責事項】
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