US Markets for Craniomaxillofacial Devices 2011

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.