US Markets for Craniomaxillofacial Devices 2011

Published by: Millennium Research Group

Published: Dec. 22, 2010


Table of Contents

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)

Abstract

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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