Craniomaxillofacial Devices Market

Market Overview

The global craniomaxillofacial devices market size was valued at USD 1.7 billion in 2022. It is estimated to reach USD 3.84 billion by 2031, rising at a CAGR of 9.5% during the forecast period (2023–2031).

The craniomaxillofacial devices specialize in medical implants and instruments to treat cranial, facial, and skull-related disorders or injuries. These devices are designed to restore the structure and function of the craniomaxillofacial region, which includes the skull, facial bones, and jaws. The global market is experiencing significant growth due to several factors. Craniomaxillofacial devices are specialized medical implants and instruments used to treat complex cranial, facial, and skull-related disorders or injuries. These devices are crucial in reconstructive surgeries, trauma cases, and orthognathic surgeries.

The market is witnessing advancements in materials used for craniomaxillofacial implants. Bioresorbable materials, such as polymers and ceramics, are gaining popularity as they eliminate the need for implant removal surgeries and reduce the risk of complications. Additionally, the development of patient-specific implants using 3D printing technology allows for precise and personalized treatment options.

Highlights

• Cranial Flap dominates the products segment.
• Metal dominates the material segment.
• Neurosurgery and ENT dominate the application segment.
• North America holds the largest percentage of global market share.

Market Dynamics

Market Drivers

Increasing Incidence of Sports and Facial Fractures

Growing incidence of road accidents due to urbanization and industrialization and growing demand for effective reconstructive surgeries are expected to boost the adoption of Craniomaxillofacial (CMF) devices. The increasing incidence of facial fractures, mainly from combat sports (approximately 80%), resulted in nose and teeth injuries, which accounted for the most injured structures. Out of all combat sports, kickboxing was found to be the most dangerous sport because it resulted in the highest instances of MF trauma.

Additionally, the demand for craniomaxillofacial devices has increased in response to the rising incidence of sports and facial fractures. These devices are used in the surgical treatment and management of facial fractures, providing stability and support to the affected bones and tissues. They aid in properly aligning and healing the fractures, allowing for optimal functional and aesthetic outcomes.

Rising Demand for Minimal Invasive Surgeries

CMF devices are used in minimally invasive surgeries, such as facial reconstruction and jaw replacement procedures. The benefits of these procedures, such as minimum recovery time, fewer incisions, lesser trauma, and lower associated complications and risks, contribute to the market growth. In addition, due to growing awareness about deformity correction surgeries and increasing instances of facial fractures and injuries, demand for minimally invasive surgeries is increasing, which is expected to aid further growth of this market over the forecast period. In order to increase awareness of CMF surgeries, organizations such as the American Society of Craniofacial Surgery and the International Society of Craniofacial Surgery are conducting various awareness programs, aiding the market growth.

Additionally, the growing inclination of youth toward improved aesthetic appeal can also be attributed to the growth of this market. The benefits of minimally invasive techniques, such as lower recovery time, painless procedures, higher safety and efficacy, and shorter hospital stay, are other factors expected to fuel demand for minimally invasive aesthetic surgeries over the forecast period. As stated in a report by the American Society of Plastic Surgeons, the number of minimally invasive cosmetic procedures was 13,945,388 in 2014 and is expected to grow by 4% yearly. This represents growth in cosmetic procedures, which is expected to boost demand for cranial implants in the coming years.

Market Restraint

Lack of Reimbursement Policies

The regulatory framework for approval has always been the most critical restraining factor in the pharmaceutical, biotechnology, and medical industry. The presence of discrete and uncertain scenarios creates confusion among manufacturers regarding commercialization. In addition, the lack of a robust reimbursement framework in mature markets, such as the U.S., is expected to restrain market growth by limiting buyers’ purchasing power. The lack of favorable reimbursement policies for patient-specific devices is an important growth-limiting factor for this industry. Further, patients may face difficulties obtaining coverage for craniomaxillofacial devices, making it challenging to afford necessary treatments. This can result in delayed or suboptimal care, negatively impacting patient outcomes and quality of life.

Market Opportunities

Increasing Awareness Programs Funded by Government Authorities

The market for craniomaxillofacial devices has expanded significantly because of rising awareness campaigns supported by government agencies. Government organizations and healthcare authorities have recognized the importance of creating awareness about craniofacial conditions, available treatment options, and the benefits of using craniomaxillofacial devices. These awareness programs aim to educate the public, healthcare professionals, and policymakers about the significance of early detection, diagnosis, and appropriate management of craniofacial disorders and facial fractures. They emphasize the potential benefits of using craniomaxillofacial devices in improving patient outcomes, restoring facial aesthetics, and enhancing the quality of life.

Additionally, the funding provided by government authorities helps expand the reach of these awareness programs, ensuring that information reaches a wide range of individuals, including patients, caregivers, healthcare professionals, and the public. It enables the development of comprehensive educational materials, resources, and initiatives that effectively convey the importance of early intervention and the benefits of craniomaxillofacial devices. By funding and organizing awareness programs, government authorities contribute to increasing knowledge and understanding among the target audience. These programs may include public campaigns, educational seminars, conferences, and workshops that focus on raising awareness about craniomaxillofacial conditions, available treatment options, and the role of devices in surgical interventions.

Regional Analysis

North America Dominates the Global Market

Based on region, the global craniomaxillofacial devices market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global craniomaxillofacial devices market shareholder and is estimated to grow at a CAGR of 8.1% over the forecast period. North America comprises the U.S. and Canada. Important variables influencing this region's market growth include the availability of technologically advanced implants and the increased volume of craniomaxillofacial (CMF) procedures. In addition, factors such as increased awareness about deformity correction surgeries and the presence of established Health care facilities are anticipated to boost the market growth in North America. Supportive government initiatives, such as establishing the American Society of Craniofacial Surgery (ASCFS), to create awareness about CMF surgeries and associated advantages are likely to boost the demand for CMF devices during the forecast period. Furthermore, rising demand for minimally invasive surgeries is estimated to contribute to the regional market growth over the forecast period.

Europe is estimated to grow at a CAGR of 9.03% over the forecast period. The UK and Germany are the major contributors to the market growth in Europe. Due to the region's established healthcare system and rising demand for minimally invasive operations, the CMF devices market in Europe is predicted to rise significantly over the projected period. It is expected that factors, including the growing elderly population and technical developments in reconstructive procedures, will increase demand for CMF devices in the upcoming years. Increasing adoption of customized CMF devices and the rising volume of CMF surgeries will likely drive market growth in Europe. Moreover, independent organizations, such as the European Association of Neurosurgical Societies (EANS), which provide neurosurgery training and help increase awareness about these surgeries, are also expected to propel the CMF devices market growth in this region.

Asia-Pacific is the most lucrative CMF device market due to the increasing incidence of orthopedic conditions and the growing geriatric population. This market is anticipated to increase significantly over the forecast period due to the growing use of novel orthopedic surgical methods and improved healthcare infrastructure. Additionally, rising consumer awareness of CMF devices and rising demand for minimally invasive operations are anticipated to fuel market expansion in the area.

Latin America includes Mexico, Brazil, and other LATAM countries. Due to Mexico's swift economic growth, the Latin American market is anticipated to expand greatly during the next years. The market for CMF devices in this region is expanding due to the rising traffic incidents. Road accidents are higher in low-to-middle-income countries due to a lack of proper traffic infrastructure. According to a global urban safety and security report, 18 fatalities per 10,000 vehicles are registered annually in Latin American countries. Increasing healthcare expenditure and growing disposable income are also anticipated to drive market growth in this region.

In the Middle East and Africa, road traffic accidents are a primary cause of head injuries and facial fractures in the MEA region. According to Road Safety UAE, road traffic accidents account for 70% of the total instances of brain and head injuries in this region. They are also a leading reason of death in the country. Road accidents account for ~ 63% of the total instances of facial fractures in the Middle East and Africa. In addition, increasing road accidents have also been a matter of concern in this region. Fatalities due to road accidents are higher in this region than in Western countries. The abovementioned factors are anticipated to propel growth in the region in the coming years. In addition, the growing number of healthcare reimbursement policies owing to several initiatives taken by the Gulf Cooperation Council is expected to fuel the growth of the Middle East and Africa CMF devices market during the forecast period.

Segmental Analysis

The global market is bifurcated into products, materials, and applications.

Based on products, the global market is bifurcated into cranial flap fixation, CMF distraction, temporomandibular joint replacement, thoracic fixation, bone graft substitute, CMF plate, and screw fixation. 

The cranial flap fixation segment dominates the global market and is estimated to exhibit a CAGR of 7.1% over the forecast period. The cranial flap is the section of a skull that is excised and replaced. It is used after craniotomy and is made for one-time use. Cranial flap fixation devices replace the cranial flap in craniotomy procedures. This system includes a bad disk, connecting rod, and superior disc. Technological advancements such as the introduction of titanium cranial fixation systems and the increased efficacy of these devices are also anticipated to contribute to the growth of the cranial flap fixation segment over the forecast period.

Cranial flap fixation devices are composed of metals or bioresorbable materials. The metal flap fixation market held the largest market share due to its superior strength to bioresorbable materials. Bioresorbable devices are expected to be better treatment options than metallic flap fixation devices due to their biocompatible nature, ease of use, resorbable nature, and higher reliability. Moreover, with Medtronic's launch of screwless cranial flap fixation devices, products like the INVISx system are projected to drive the industry in the upcoming years. A significant benefit of this method is a shorter procedural time. Owing to these advantages and the development of newer systems, the cranial flap fixation segment is expected to grow over the forecast period.

Based on material, the global market is bifurcated into metal, bioresorbable material, and ceramics.

The metal segment owns the highest market share and is estimated to grow at a CAGR of 8.2% over the forecast period. In the material segment of the global market, metallic materials dominate as the top category. Metallic materials, particularly titanium, and its alloys, are widely used in manufacturing craniomaxillofacial devices due to their excellent mechanical properties, biocompatibility, and long-term stability. Furthermore, titanium and its alloys offer high strength-to-weight ratios, corrosion resistance, and the ability to integrate with the surrounding bone tissue. These properties make them ideal for fabricating implants used in craniofacial surgeries. Metallic craniomaxillofacial devices, such as plates, screws, and meshes, provide stability, support, and fixation during surgical procedures.

Based on application, the global market is bifurcated into neurosurgery and ENT, orthognathic and dental surgery, and plastic surgery.

The neurosurgery and ENT segment dominates the global market and is estimated to grow at a CAGR of 9.3% over the forecast period. Neurosurgery and ENT surgery segment is expected to show lucrative growth due to the increased volume of surgical procedures about trauma and the adoption of deep brain stimulation procedures. In deep brain stimulation, implants cover the skull after inserting an electrode. Neurosurgical application of CMF devices enables skull and Otolaryngol surgeries. CMF devices assist in treating neuro-oncology conditions, neurovascular diseases, and spinal disorders. They also help in dura mater repair, transnasal skull-base surgery, deep brain stimulation, pelvic or cranial trauma repair, and CSF management. Medpor bioabsorbable implants are most used for neurosurgeries. The introduction of surgical navigation technology for ENT procedures is expected to propel growth over the forecast period. Various advantages of this technology, such as ease of use, 3D display, and real-time virtual anatomy updates, can be attributed to the growth.

Recent Developments

• March 2022- DePuy Synthes announced the launch of a new surgical navigation system for craniomaxillofacial surgeries. The system is designed to improve the accuracy and efficiency of craniomaxillofacial surgeries.
• May 2022- B. Braun announced the launch of a new line of craniomaxillofacial bone cement. The abonnements are designed to improve the outcomes of craniomaxillofacial surgeries.