Countries covered: United States
Introduction:
The market for craniomaxillofacial (CMF) devices in the US-which includes plate and screw fixation, bone graft substitutes (BGS), cranial flap fixation devices, CMF distraction devices, and temporomandibular joint (TMJ) replacement devices-will continue to experience strong growth through 2015. Revenue increases in this market will be driven by procedural increases across all market segments. Several factors will contribute to this rise in procedure volumes, including motor vehicle accidents, sports-related fractures, and improved detection and treatment of brain lesions. In addition, the ongoing US military involvement in Iraq and Afghanistan will result in some soldiers sustaining CMF injuries. This will thus spur surgeon uptake of custom plates and screws, which garner substantial price premiums over stock plates due to the level of preoperative planning inherent of custom plate design and development. Nonetheless, market growth will be curbed by hospital budgetary constraints and low levels of reimbursement, which will have a marked impact on surgeon adoption of premium-priced devices. Furthermore, the rise of minimally invasive techniques in neurosurgery, such as stereotactic radiosurgery, will hinder the adoption of cranial plating systems and cranial flap fixation devices. Improving awareness of CMF devices and surgeon adoption of novel resorbable polymers and plate fixation techniques will, however, offset some of these limiting factors, allowing for robust growth of the CMF device market over the forecast period.
Questions Answered in This Report:
- Surgeons in the US are increasingly using KLS Martin's SonicWeld Rx system in CMF plate fixation in both the pediatric and adult population. What advantages does the SonicWeld Rx system offer surgeons over traditional methods of plate fixation? What strategies are competitors devising in order to maintain a competitive position in the CMF plate and screw fixation market?
- In 2004, TMJ Implants, which designs and develops TMJ replacement devices, was issued a warning letter by the Food and Drug Administration regarding adverse events associated with its implants. During the first half of 2010, TMJ Implants filed for Chapter 7 bankruptcy. How has TMJ Implants' departure from the market impacted the total market for TMJ replacement devices? How will this incident affect surgeon confidence in TMJ replacement devices overall in terms of treating TMJ disorders? What implications does this have for potential market entrants?
- Patients with congenital midface defects show a distinct preference for internal over external distraction osteogenesis devices. This is despite the body of clinical literature available highlighting the benefits of external distraction over internal distraction. What is driving surgeon uptake of internal distraction osteogenesis? How will adoption of internal distractors grow relative to external distractors over the forecast period? What advances are companies making in the distraction osteogenesis space?
Scope:
Regions covered: US
Procedure segmentation: Our analysis uses the following breakdown of procedures:
- CMF plate and screw fixation procedures
- Stock plate and screw fixation procedures by material (metal and resorbable)
- Stock plate and screw fixation procedures by location (facial, cranial/neuro, and intermaxillary facial [IMF])
- Custom plate and screw fixation procedures
- CMF BGS procedures
- By location (cranial, facial, and maxillary)
- Craniotomy procedures
- Cranial flap fixation procedures
- By material (metal and resorbable)
- CMF distraction procedures
- By location (mandible, midface, and alveolar process)
- TMJ replacement procedures
- By replacement type (total and partial)
- By number of sides (bilateral and unilateral)
- By implant type (custom and stock)
Market segmentation: Our analysis uses the following breakdown of the market:
- CMF plates and screws
- Stock plates and screws by material (metal and resorbable)
- Stock plates and screws by location (facial, cranial/neuro, and IMF)
- Custom plates and screws
- CMF BGS
- By location (cranial, facial, and maxillary)
- By material (first-generation synthetics, second-generation synthetics, nonproprietary allografts, demineralized bone matrices, and growth factors)
- Cranial flap fixation devices
- By material (metal and resorbable)
- CMF distraction devices
- Mandible distraction devices by type (internal [metal and resorbable] and external)
- Midface distraction devices by type (internal and external)
- Midface distraction devices by location (LeFort I and LeFort III)
- Alveolar process distraction devices by location (intraosseous and extraosseous)
- TMJ replacement devices
- By replacement type (total and partial)
- By number of sides (bilateral and unilateral)
- By implant type (custom and stock)
Market forecast features: Based on primary research with industry professionals, we use our proprietary forecasting model to provide an in-depth examination of current and future trends in procedure volumes, unit sales, average selling prices, and market values over a 7-year period (2009-2015).
Competitive analysis: We provide a detailed analysis of the competitive landscape in the market, as well as market shares and qualitative discussions of the leading competitors in each market segment.
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- EXECUTIVE SUMMARY
- METHODOLOGY
- 1.0 CRANIOMAXILLOFACIAL DEVICE OVERVIEW
- 1.1 Overview of Skull Anatomy
- 1.2 Overview of Craniomaxillofacial Plate and Screw Fixation
- 1.3 Overview of Bone Grafts
- 1.3.1 Autograft
- 1.3.2 Nonproprietary Allograft
- 1.3.3 Demineralized Bone Matrix
- 1.3.4 First-Generation Synthetics
- 1.3.5 Second-Generation Synthetics
- 1.3.6 Growth Factors
- 1.3.7 Orthopedic Stem Cell Products
- 1.4 Overview of Cranial Flap Fixation
- 1.5 Overview of Craniomaxillofacial Distraction
- 1.5.1 Midface Distractors
- 1.5.1.1 External Midface Distractors
- 1.5.1.2 Internal Midface Distractors
- 1.5.2 Mandibular Distractors
- 1.5.2.1 External Mandibular Distractors
- 1.5.2.2 Internal Mandibular Distractors
- 1.5.3 Alveolar Distractors
- 1.6 Overview of Temporomandibular Joint Replacement
- 2.0 US CRANIOMAXILLOFACIAL DEVICE MARKET OVERVIEW
- 2.1 Market Overview
- 2.2 Market Analysis
- 2.2.1 Procedures
- 2.2.1.1 Craniomaxillofacial Procedures by Segment
- 2.2.2 Market Forecast
- 2.2.2.1 Craniomaxillofacial Device Market by Segment
- 2.2.3 Market Drivers and Limiters
- 2.2.3.1 Market Drivers
- 2.2.3.2 Market Limiters
- 2.3 Competitive Analysis
- 2.3.1 Competitive Landscape
- 2.3.2 Market Shares
- 2.3.3 Competitor Discussions (in Alphabetical Order)
- Biomet Microfixation
- KLS Martin
- OsteoMed
- Stryker
- Synthes
- Other
- 3.0 CRANIOMAXILLOFACIAL PLATE AND SCREW FIXATION MARKET
- 3.1 Market Overview
- 3.2 Market Analysis
- 3.2.1 Procedures
- 3.2.1.1 Craniomaxillofacial Plate and Screw Fixation Procedures by Type
- 3.2.1.2 Craniomaxillofacial Plate and Screw Fixation Procedures by Material
- 3.2.1.3 Craniomaxillofacial Plate and Screw Fixation Procedures by Location
- 3.2.2 Market Forecast
- 3.2.2.1 Craniomaxillofacial Plate and Screw Fixation Market by Type
- Stock Craniomaxillofacial Plate and Screw Fixation Market by Material
- Stock Craniomaxillofacial Plate and Screw Fixation Market by Location
- 3.3 Competitive Analysis
- 3.3.1 Competitive Landscape
- 3.3.2 Market Shares
- 4.0 CRANIOMAXILLOFACIAL BONE GRAFT SUBSTITUTE MARKET
- 4.1 Market Overview
- 4.2 Market Analysis
- 4.2.1 Procedures
- 4.2.2 Procedures by Location
- 4.2.3 Market Forecast by Location and Material
- 4.3 Competitive Analysis
- 4.3.1 Competitive Landscape
- 4.3.2 Market Shares
- 5.0 CRANIAL FLAP FIXATION MARKET
- 5.1 Market Overview
- 5.2 Market Analysis
- 5.2.1 Procedures
- Cranial Flap Fixation Procedures by Material
- 5.2.2 Market Forecast
- 5.2.2.1 Cranial Flap Fixation Device Market by Material
- 5.3 Competitive Analysis
- 5.3.1 Competitive Landscape
- 5.3.2 Market Shares
- 6.0 CRANIOMAXILLOFACIAL DISTRACTION DEVICE MARKET
- 6.1 Market Overview
- 6.2 Market Analysis
- 6.2.1 Procedures
- 6.2.2 Procedures by Location
- 6.2.3 Market Forecast
- 6.2.3.1 Mandibular Distraction Device Market
- Mandibular Distraction Device Market by Type
- Mandibular Distraction Device Market by Material
- 6.2.3.2 Midface Distraction Device Market
- Midface Distraction Device by Type
- Midface Distraction Device by Location
- 6.2.3.3 Alveolar Distraction Device Market
- 6.3 Competitive Analysis
- 6.3.1 Competitive Landscape
- 6.3.2 Market Shares
- 7.0 TEMPOROMANDIBULAR JOINT REPLACEMENT DEVICE MARKET
- 7.1 Market Overview
- 7.2 Market Analysis
- 7.2.1 Procedures
- 7.2.1.1 Procedures By Replacement Type
- 7.2.1.2 Procedures By Implant Type
- 7.2.2 Market Forecast
- 7.2.2.1 Temporomandibular Joint Replacement Market by Replacement Type
- 7.2.2.2 Temporomandibular Joint Replacement Market by Number of Sides
- 7.2.2.3 Temporomandibular Joint Replacement Market by Implant Type
- 7.3 Competitive Analysis
- 7.3.1 Competitive Landscape
- 7.3.2 Market Shares
- APPENDIX A: MRG ACRONYMS AND INITIALISMS
- APPENDIX B: SUPPLEMENTAL FIGURES
- LIST OF FIGURES AND TABLES
- EXECUTIVE SUMMARY
- Figure 1: CMF Device Market, by Segment, US (US$), 2009-2015
- Figure 2: CMF Plate and Screw Fixation Market, by Type, as a % of Total, US, 2009-2015
- Figure 3: CMF BGS Market, by Material, US (US$), 2009-2015
- Figure 4: Cranial Flap Fixation Device Market, US (US$), 2009-2015
- Figure 5: CMF Distraction Device Market Growth, by Location, US, 2010-2015
- Figure 6: TMJ Replacement Device Market, by Implant Type, as a % of Total, US, 2010 and 2015
- Table 1: Companies Mentioned in This Report
- METHODOLOGY
- Table 2: ICD-9-CM Procedure Codes and Descriptions
- 1.0 CRANIOMAXILLOFACIAL DEVICE OVERVIEW
- Table 3: Characteristics of Bone Graft Materials
- Table 4: Advantages and Disadvantages of Bone Graft Materials
- Table 5: Select Nonproprietary Allograft Providers, US, 2010
- Table 6: Select DBM Companies and Products, US, 2010
- Table 7: Select First-Generation Synthetic BGS Materials
- Table 8: Select Synthetic BGS Companies and Products, US, 2010
- Table 9: Possible Complications Associated with TMJ Replacement
- 2.0 US CRANIOMAXILLOFACIAL DEVICE MARKET OVERVIEW
- Figure 7: CMF Device Market, by Segment, US (US$), 2009-2015
- Table 10: CMF Device Procedures, by Segment, US, 2009-2015
- Table 11: CMF Device Market, by Segment, US (US$), 2009-2015
- Table 12: Drivers and Limiters of the CMF Device Market, US
- Table 13: Leading Competitors in the CMF Device Market, by Segment, as a % of Total, US, 2010
- 3.0 CRANIOMAXILLOFACIAL PLATE AND SCREW FIXATION MARKET
- Figure 8: CMF Plate and Screw Fixation Market, US (US$), 2009-2015
- Table 14: CMF Plate and Screw Fixation Procedures, by Type, 2009-2015
- Table 15: Stock CMF Plate and Screw Fixation Procedures, by Material, US, 2009-2015
- Table 16: Stock CMF Plate and Screw Fixation Procedures, by Location, US, 2009-2015
- Table 17: CMF Plate and Screw Fixation Units, by Type, US, 2009-2015
- Table 18: CMF Plate and Screw Fixation Market, by Type, US (US$), 2009-2015
- Table 19: CMF Plate and Screw Fixation Market Growth, by Type, US, 2010-2015
- Table 20: CMF Plate and Screw Fixation Market, by Type, as a % of Total, US, 2009-2015
- Table 21: Stock CMF Plate and Screw Fixation Units, by Material, US, 2009-2015
- Table 22: Stock CMF Plate and Screw Fixation Market, by Material, US (US$), 2009-2015
- Table 23: Stock CMF Plate and Screw Fixation Market Growth, by Material, US, 2010-2015
- Table 24: Stock CMF Plate and Screw Fixation Market, by Type, as a % of Total, US, 2009-2015
- Table 25: Stock CMF Plate and Screw Fixation Units, by Location, US, 2009-2015
- Table 26: Stock CMF Plate and Screw Fixation Market, by Location, US (US$), 2009-2015
- Table 27: Stock CMF Plate and Screw Fixation Market Growth, by Location, US, 2010-2015
- Table 28: Stock CMF Plate and Screw Fixation Market, by Location, as a % of Total, US, 2009-2015
- Table 29: Leading Competitors in the CMF Plate and Screw Fixation Market, by Material, as a % of Total, US, 2010
- 4.0 CRANIOMAXILLOFACIAL BONE GRAFT SUBSTITUTE MARKET
- Figure 9: CMF BGS Market, by Location, as a % of Total, US, 2009-2015
- Table 30: CMF Bone Graft Procedures, by Location, US, 2009-2015
- Table 31: CMF BGS Procedures and Units, by Location, US, 2009-2015
- Table 32: CMF BGS Market, by Location, US (US$), 2009-2015
- Table 33: CMF BGS Market Growth, by Location, US, 2010-2015
- Table 34: CMF BGS Market, by Location, as a % of Total, US, 2009-2015
- Table 35: CMF BGS Market, by Material, US (US$), 2009-2015
- Table 36: CMF BGS Market Growth, by Material, US, 2010-2015
- Table 37: CMF BGS Market, by Material, as a % of Total, US, 2009-2015
- Table 38: Leading Competitors in the CMF BGS Market, as a % of Total, US, 2010
- 5.0 CRANIAL FLAP FIXATION MARKET
- Figure 10: Cranial Flap Fixation Device Market, by Material, US (US$), 2009-2015
- Table 39: Procedures that Require a Craniotomy
- Table 40: Craniotomy Procedures, US, 2009-2015
- Table 41: Cranial Flap Fixation Procedures, by Material, US, 2009-2015
- Table 42: Cranial Flap Fixation Units, by Material, US, 2009-2015
- Table 43: Cranial Flap Fixation Market, by Material, US (US$), 2009-2015
- Table 44: Cranial Flap Fixation Market Growth, by Material, US, 2010-2015
- Table 45: Cranial Flap Fixation Market, by Type, as a % of Total, US, 2009-2015
- Table 46: Leading Competitors in the Cranial Flap Fixation Device Market, as a % of Total, US, 2010
- 6.0 CRANIOMAXILLOFACIAL DISTRACTION DEVICE MARKET
- Figure 11: CMF Distraction Device Market, by Location, US (US$), 2009-2015
- Table 47: CMF Distraction Procedures, by Location, US, 2009-2015
- Table 48: CMF Distraction Device Units, by Location, US, 2009-2015
- Table 49: CMF Distraction Market, by Location, US (US$), 2009-2015
- Table 50: CMF Distraction Market Growth, by Location, US, 2010-2015
- Table 51: CMF Distraction Market, by Location, as a % of Total, US, 2009-2015
- Table 52: Mandible Distraction Market, by Type, US (US$), 2009-2015
- Table 53: Internal Mandible Distraction Market, by Material, US (US$), 2009-2015
- Table 54: Midface Distraction Market, by Type, US (US$), 2009-2015
- Table 55: Midface Distraction Market, by Location, US (US$), 2009-2015
- Table 56: Alveolar Distraction Market, by Location, US (US$), 2009-2015
- Table 57: Leading Competitors in the CMF Distraction Market, as a % of Total, 2010
- 7.0 TEMPOROMANDIBULAR JOINT REPLACEMENT DEVICE MARKET
- Figure 12: TMJ Replacement Device Market, US (US$), 2009-2015
- Table 58: TMJ Replacement Procedures, by Replacement Type, US, 2009-2015
- Table 59: TMJ Replacement Procedures, by Procedure Type, US, 2009-2015
- Table 60: TMJ Replacement Procedures, by Implant Type, US, 2009-2015
- Table 61: TMJ Replacement Device Market, by Replacement Type, US (US$), 2009-2015
- Table 62: TMJ Replacement Device Market Growth, by Replacement Type, US, 2009-2015
- Table 63: TMJ Replacement Device Market, by Replacement Type, as a % of Total, US, 2009-2015
- Table 64: TMJ Replacement Device Market, by Procedure Type, US (US$), 2009-2015
- Table 65: TMJ Replacement Device Market Growth, by Procedure Type, US (US$), 2009-2015
- Table 66: TMJ Replacement Device Market Growth, by Procedure Type, as a % of Total, US, 2009-2015
- Table 67: TMJ Replacement Device Market, by Implant Type, US (US$), 2009-2015
- Table 68: TMJ Replacement Market Growth, by Implant Type, US, 2010-2015
- Table 69: TMJ Replacement Market, by Implant Type, as a % of Total, US, 2009-2015
- Table 70: Leading Competitors in the TMJ Replacement Device Market, as a % of Total, US, 2010
- APPENDIX A: MRG ACRONYMS AND INITIALISMS
- MRG Acronyms and Initialisms
- APPENDIX B: SUPPLEMENTAL FIGURES
- Figure 13: CMF Device Market, by Segment, US (US$), 2009-2015 (Detailed Format)
- Figure 14: CMF Plate and Screw Market, by Type, as a % of Total, US, 2009-2015 (Detailed Format)
- Figure 15: CMF BGS Market, by Material, US (US$), 2009-2015 (Detailed Format)
- Figure 16: Cranial Flap Fixation Device Market, US (US$), 2009-2015 (Detailed Format)
- Figure 17: CMF Distraction Device Market Growth, by Location, US, 2010-2015 (Detailed Format)
- Figure 18: TMJ Replacement Device Market, by Implant Type, as a % of Total, US, 2010 and 2015 (Detailed Format)
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