Cranial Fixation System Market

Cranial Fixation System Market by Product Type (Implants, Mesh, Plates & Screws, and Others), Absorbability (Non-Absorbable and Absorbable), End-User (Hospitals, Ambulatory Surgical Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to advance at a respectable CAGR forecast till 2030 owing to the increasing incidence of traumatic brain injuries & facial fractures, along with the rising product developmental activities globally. 

The cranial fixation system market was valued at USD 1.56 billion in 2023, growing at a CAGR of 8.48% during the forecast period from 2024 to 2030 to reach 2.54 billion by 2030. The cranial fixation system market is growing significantly due to the high incidence of traumatic brain injuries from motor vehicle accidents, and sports, the considerable prevalence of fractures, rising product developmental activities by key players, availability of a wide range of cranial fixation systems, among others that are expected to drive the market for cranial fixation system during the forecast period from 2024 to 2030.

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Cranial Fixation System Market Dynamics:

According to the International Brain Injury Association (2024), brain injuries result in approximately one million hospital admissions annually within the European Union. Among these, motor vehicle crashes are responsible for 50% of traumatic brain injuries (TBIs). Additionally, sports-related brain injuries contribute significantly to this figure, with an estimated 300,000 injuries occurring each year. Winter sports, particularly skiing and ice skating, are linked to around 20,000 of these brain injuries. Thus the high incidence of brain injuries from motor vehicle crashes and sports-related activities underscores a growing need for effective treatment solutions, highlighting the demand for cranial fixation systems to address these injuries.

According to data from the National Institute of Health (2023), sporting injuries account for a significant portion of facial fractures, ranging from 6% to 33%. A study in New Zealand of 25,000 patients with facial fractures found that a substantial portion involved the midface, at 63.5%, while only 3.3% involved the upper third of the face. A review of 93 patients with facial trauma revealed that the infraorbital foramen was affected in 56.9% of cases, and displacement of the orbital floor was present in 86% of cases based on data from 2019. Thus, the prevalence of facial fractures due to sporting injuries, the significant involvement of the midface, and the high rates of infraorbital foramen and orbital floor displacement highlight the demand for cranial fixation system.

Therefore, the factors stated above collectively will drive the overall cranial fixation system market during the forecast period from 2024 to 2030.

However, mechanical failure of the implant, including bending, loosening, or breakage, temporary or chronic neural damage resulting from pressure or hematomata, and others may limit their end-user base, thus acting as key constraints limiting the growth of the cranial fixation system.

Cranial Fixation System Market Segment Analysis:

Cranial Fixation System Market by Product Type (Implants, Mesh, Plates & Screws, and Others), Absorbability (Non-Absorbable and Absorbable), End-User (Hospitals, Ambulatory Surgical Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the product type segment of the cranial fixation system, the implants category is expected to have a significant revenue share in the year 2023. The rapid growth of this product category is growing due to advancements in materials and their expanded applications.

Biocompatible materials like titanium and bioresorbable polymers offer improved patient outcomes by reducing infection risks, ensuring stability, and eliminating the need for removal surgeries. Enhanced implant designs, such as contoured plates and self-drilling screws, streamline surgical workflows and improve fixation precision. Additionally, the increasing use of 3D-printed, patient-specific implants enables personalized treatment for complex cranial reconstructions. These features, combined with rising neurosurgical procedures for trauma, tumors, and congenital conditions, are driving demand for implant-based solutions.

New product approvals are also likely to upsurge the market for these. For instance, in April 2024, 3D Systems announced that the US Food and Drug Administration (FDA) provided 510(k) clearance for its 3D printed, patient-specific cranial implant solution, VSP PEEK cranial implant.

Therefore, owing to all the above-mentioned factors, the demand for the implants category is expected to witness considerable growth eventually contributing to the overall growth of the cranial fixation system market during the forecast period from 2024 to 2030.

North America is expected to dominate the overall Cranial Fixation System Market:

Among all the regions, North America is expected to dominate the cranial fixation system market in the year 2023 and is expected to do the same during the forecast period from 2024 to 2030. This can be ascribed to the rising incidence of traumatic brain injuries, advancements in product development, and the significant contributions of key market players in the region. The combination of these factors is expected to drive the continued expansion and innovation in the market for cranial fixation systems during the forecast period from 2024 to 2030.

According to data provided by the Centre for Disease Control and Prevention (2024), in 2021, there were more than 586 traumatic brain injury-related hospitalizations per day in the US. Traumatic brain injuries, caused by head trauma from accidents, falls, or sports injuries, require prompt and accurate diagnosis to assess the extent of brain damage and guide treatment decisions. These conditions often lead to fractures that require surgical intervention and stabilization to ensure proper healing. Thus the market for cranial fixation systems has increased in the region.

Rising product launches and commercialization agreements among key manufacturers and other companies are anticipated to boost the market. For instance, in December 2021, Kelyniam Global, a leader in the design and manufacture of custom cranial implants, announced that the United States Patent and Trademark Office issued the company an Issue Notification for a patent covering the company's Integrated Fixation Tabs, which is marketed as IFS Tabs or KwikTabs. The US patent covers the integration of fixation appendages into a cranial implant and their design.

The presence of key market players in the region is significantly bolstering the market for cranial fixation systems. Major companies like Johnson & Johnson Services, Inc., Stryker, Zimmer Biomet, and Medtronic have established strong footholds in the region, driving innovation and market growth. For example, Zimmer Biomet's commitment to developing cutting-edge cranial fixation devices, such as their comprehensive range of fixation plates and screws, has further strengthened its market position. The extensive research and development activities, combined with a robust distribution network, enable these players to deliver high-quality, technologically advanced products to a wide end-user base.

Therefore, the interplay of all the aforementioned factors above would provide a conducive growth environment for the North America region in the cranial fixation system market.

Cranial Fixation System Market Key Players:

Some of the key market players operating in the cranial fixation system market include B. Braun Melsungen AG, Medtronic, Stryker, Johnson & Johnson Services, Inc., Kinamed® Incorporated, Vitalys Surgical, Bioplate, G.SURGIWEAR LTD, Zimmer Biomet, Chengdu MedArt Medical Scientific Co., Ltd., Inion, NEOS Surgery S.L., AGOMED Medizin-Technik GmbH, Jeil Medical Corporation, Changzhou Huida Medical Instrument Co., Ltd., evonos GmbH & Co. KG, Integra LifeSciences, KLS Martin Group, and others.

Recent Developmental Activities in the Cranial Fixation System Market:

• In December 2024, DBV Technologies announced a successful outcome from its communication with the U.S. FDA, establishing a clear regulatory pathway for the Viaskin Peanut patch in toddlers aged 1–3 years. The FDA has provided guidance for Accelerated Approval of the patch and agreed with DBV on key design elements for a post-marketing confirmatory study.
• In December 2024, RevBio, Inc. announced that the FDA approved the expansion of its clinical trial for immediate cranial flap fixation using TETRANITE®, a bone adhesive biomaterial. The company also received reimbursement coverage from the Centers for Medicare and Medicaid Services (CMS) for using TETRANITE to replace metal plates and screws.
• In December 2021, Kelyniam Global, Inc. announced that it entered into a strategic licensing agreement with Fin-ceramica faenza SPA to market the company's hydroxyapatite patient-specific Cranial implant.
• In October 2021, ClearPoint Neuro developed the first navigation system that allowed neurosurgeons to perform minimally invasive procedures under real-time MRI guidance. The bigger potential lies in ClearPoint being the go-to neurosurgical platform that provides the tools needed to solve some of the most devastating neurological disorders.

Key Takeaways from the Cranial Fixation System Market Report Study

• Market size analysis for current cranial fixation system market size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/services developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the cranial fixation system market
• Various opportunities available for the other competitors in the cranial fixation system market space
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current cranial fixation system market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for cranial fixation system market growth in the coming future? 

Target Audience who can be benefited from this Cranial Fixation System Market Report Study

• Cranial fixation system product providers
• Research organizations and consulting companies 
• Cranial fixation system-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in cranial fixation system 
• Various end-users who want to know more about the cranial fixation system market and the latest developments in the cranial fixation system market