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MediPoint: Craniomaxillofacial Devices - US and 5EU Analysis and Market Forecasts

Published: Dec-2014 | Format: PDF | GlobalData | Number of pages: 194 | Code: MRS - 2001

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.

 

Questions Answered in this Report

 

  • 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. What are the procedure trends of CMF fracture, reconstruction and orthognathic surgeries 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. 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. Who are the current players in this field 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. Will there be a paradigm shift in the thoracic fixation field in the future

 

Table of Contents

 

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

 

2 Introduction
2.1 Catalyst
2.2 Related Reports

 

3 Practice Patterns and Adoption Trends
3.1 Treatment Modalities Overview
3.1.1 CMF Plate and Screw Fixation
3.1.2 CMF Distraction
3.1.3 Cranial Flap Fixation
3.1.4 Temporomandibular Joint Replacement
3.1.5 CMF Bone Graft Substitutes
3.1.6 Thoracic Fixation
3.1.7 Dural Repair
3.2 Procedure Coverage by Surgical Specialty
3.3 CMF Plate and Screw Fixation
3.3.1 By Surgery Type
3.3.2 Fractures (by Fracture Type, Material, and Anatomic Region)
3.3.3 Reconstruction Surgery, by Product Type
3.3.4 Orthognathic Surgery (by Surgery Type)
3.3.5 Virtual Surgical Planning
3.4 CMF Distraction
3.4.1 By Anatomic Region
3.4.2 Cranium
3.4.3 Mandible
3.4.4 Midface
3.4.5 Alveolar Ridge
3.5 Cranial Flap Fixation
3.5.1 By Material
3.6 TMJ Replacement
3.6.1 By Surgery Type
3.6.2 By Implant Type
3.7 CMF Bone Graft Substitutes
3.7.1 By Anatomic Region
3.7.2 By Product Type
3.7.3 Synthetic Bone Substitutes and Bone Cement (by Anatomic Region, by Clinical Need)
3.8 Thoracic Fixation
3.8.1 Fracture
3.8.2 Sternotomy
3.8.3 Minimally Invasive Cardiac Surgeries
3.9 Dural Repair
3.9.1 Dural Substitutes (by Product Type, by Material)
3.9.2 Dural Sealant (by Material)

 

4 Industry Overview
4.1 Procedural Trends
4.1.1 Overview
4.1.2 US
4.1.3 5EU
4.2 Procurement Trends
4.2.1 Hospital Consolidation
4.2.2 The Increasing Focus on Cost in Purchasing Decisions
4.2.3 Increased Involvement of the C-Level
4.3 Market Access
4.3.1 US
4.3.2 5EU
4.4 Reimbursement
4.4.1 US
4.4.2 5EU
4.5 Product Recalls
4.5.1 DePuy Synthes Voluntarily Recalled a Craniomaxillofacial Distraction System (August, 2014)
4.5.2 Integra LifeSciences Voluntarily Recalled Certain Products Manufactured in its Añasco, Puerto Rico Facility (April, 2013)
4.6 Mergers and Acquisitions/Key Partnerships
4.6.1 Materialise Acquired OrthoView Holdings for $13.6m (Oct, 2014)
4.6.2 DePuy Synthes Entered into a Co-Development Agreement with Tissue Regeneration Systems (June, 2014)
4.6.3 Medtronic to Merge with Covidien in Transaction Valued at $42.9m (June, 2014)
4.6.4 Zimmer to Combine with Biomet in Transaction Valued at $13.35 Billion (April, 2014)
4.6.5 3D Systems Acquired Medical Modeling (April, 2014)
4.6.6 KLS Martin LP to Distribute NEOS Surgery's Cranial LOOP Family (November, 2013)
4.6.7 Integra LifeSciences Acquired DuraSeal Product Lines from Covidien for $235m (October, 2013)
4.6.8 Biomet to Distribute Oxford Performance Materials' OsteoFab Product Line (April, 2013)
4.6.9 Johnson & Johnson Acquired Synthes for $19.7 Billion (June, 2012)
4.6.10 Tissuemed Stopped Co-Marketing Agreement with Medtronic (June, 2012)
4.6.11 Baxter International Acquired Synovis Life Technologies (December, 2011)
4.6.12 Stryker Acquired Orthovita for $316m (May, 2011)
4.6.13 Synthes Partnered with Materialise in CMF Surgery (March, 2011)

 

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

 

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

 

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

 

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

 

9 Market Outlooks
9.1 Company Share Analysis
9.1.1 US
9.1.2 5EU Market Share
9.1.3 TMJ Replacement
9.2 By Market Segment
9.2.1 CMF Plate and Screw Fixation
9.2.2 CMF Distraction
9.2.3 Cranial Flap Fixation
9.2.4 TMJ Replacement
9.2.5 CMF Bone Graft Substitutes
9.2.6 Thoracic Fixation
9.2.7 Dural Repair (US Only)
9.3 By Geography
9.3.1 Overview
9.3.2 US
9.3.3 France
9.3.4 Germany
9.3.5 Italy
9.3.6 Spain
9.3.7 UK

 

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

 

List of Table

 

Table 1: Common Applications of CMF Distraction
Table 2: Common Craniotomy Procedures
Table 3: Comparison of Various Bone Graft Materials
Table 4: Current Status of Potential Indications for Operative Chest Wall Fracture Fixation
Table 5: Major Cranial Flap Fixation Systems on the Market, 2014
Table 6: Major Prosthetic TMJ Replacement Systems on the Market, 2014
Table 7: Comparison Between Stock and Custom-Made Total TMJ Implants
Table 8: Major Types of Synthetic Bone Substitutes
Table 9: Major Dural Substitutes on the Market, 2014
Table 10: Major Dural Sealants on the Market, 2014
Table 11: US and 5EU Procedure Trends for CMF Surgeries, 2011-2020
Table 12: US Procedure Trends for CMF Surgeries, 2011-2020
Table 13: US Procedure Trends for Dural Repair, 2011-2020
Table 14: 5EU Procedure Trends for CMF Surgeries, 2011-2020
Table 15: Differences Between US FDA Approval and EU CE Marking
Table 16: Mergers and Acquisitions/Key Partnerships (2011-2014)
Table 17: Advantages and Disadvantages of Common Craniotomy Materials
Table 18: Pipeline Products in the US CMF Market, 2014
Table 19: Company Profile - DePuy Synthes
Table 20: DePuy Synthes' CMF Portfolio
Table 21: SWOT Analysis - DePuy Synthes
Table 22: Company Profile - KLS Martin Group
Table 23: KLS Martin's CMF Portfolio
Table 24: SWOT Analysis - KLS Martin
Table 25: Company Profile - Medartis
Table 26: Medartis' CMF Portfolio
Table 27: SWOT Analysis - Medartis
Table 28: Company Profile - OsteoMed
Table 29: OsteoMed's CMF Portfolio
Table 30: SWOT Analysis - OsteoMed
Table 31: Company Profile - Stryker
Table 32: Stryker's CMF Portfolio
Table 33: SWOT Analysis - Stryker
Table 34: Company Profile - Zimmer-Biomet
Table 35: Zimmer-Biomet's CMF Portfolio
Table 36: SWOT Analysis - Zimmer-Biomet
Table 37: Company Profile - Aesculap
Table 38: Aesculap's CMF and Dural Repair Portfolio
Table 39: SWOT Analysis - Aesculap
Table 40: Company Profile - Gore Medical
Table 41: Gore Medical's Dural Repair Portfolio
Table 42: SWOT Analysis - Gore Medical
Table 43: Company Profile - Integra LifeSciences
Table 44: Integra LifeSciences' CMF and Dural Repair Portfolio
Table 45: SWOT Analysis - Integra LifeSciences
Table 46: Company Profile - Medtronic-Covidien
Table 47: Medtronic-Covidien's CMF and Dural Repair Portfolio
Table 48: SWOT Analysis - Medtronic-Covidien
Table 49: Emerging Players in the CMF Devices and Dural Repair Market in the US and Europe
Table 50: US and 5EU CMF Plate and Screw Fixation Market Revenue ($m), 2011-2020
Table 51: US and 5EU CMF Distraction Market Revenue ($m), 2011-2020
Table 52: US and 5EU Cranial Flap Fixation Market Revenue ($m), 2011-2020
Table 53: US and 5EU TMJ Replacement Market Revenue ($m), 2011-2020
Table 54: US and 5EU CMF Bone Graft Substitutes Market Revenue ($m), 2011-2020
Table 55: US and 5EU Thoracic Fixation Market Revenue ($m), 2011-2020
Table 56: US Dural Repair Market Revenue ($m), 2011-2020
Table 57: US and 5EU CMF Devices Market Revenue ($m), by Segment, 2011-2020
Table 58: US and 5EU CMF Devices Market Revenue ($m), by Geography, 2011-2020
Table 59: US CMF Devices Market Revenue ($m), 2011-2020
Table 60: France CMF Devices Market Revenue ($m), 2011-2020
Table 61: Germany CMF Devices Market Revenue ($m), 2011-2020
Table 62: Italy CMF Devices Market Revenue ($m), 2011-2020
Table 63: Spain CMF Devices Market Revenue ($m), 2011-2020
Table 64: UK CMF Devices Market Revenue ($m), 2011-2020
Table 65: Abbrevations

 

List of Figures

 

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

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