The global craniomaxillofacial (cmf) devices and equipment market was valued at about $0.9 billion in 2018 and is expected to grow to $1.15 billion at a CAGR of 6.4% through 2022.
The craniomaxillofacial (CMF) devices and equipment market consists of sales of craniomaxillofacial (CMF) devices and equipment related services. Craniomaxillofacial is a special type of orthopedic surgery that focuses completely on the skull and facial disorders. This surgery is generally conducted for the treatment of severe cranial and facial bone injuries. Based on the product type, CMF devices are classified into - Cranial flap fixation, CMF distraction, temporomandibular joint replacement, thoracic fixation, bone graft substitute and MF plate and screw fixation.
North America was the largest region in the craniomaxillofacial (CMF) devices and equipment market in 2016. This region is expected to remain the largest during the next five years. The CMF devices and equipment market in Asia Pacific is forecasted to register the highest CAGR during 2018-2023.
The rise in demand of reconstructive surgery is the driving force for craniomaxillofacial (CMF) devices and equipment market. The demand for reconstructive surgery is attributed to the growing trend of cosmetic treatment amongst millennials. The procedure required to carry out a cosmetic treatment needs CMF devices and equipment. Hence, the demand for craniomaxillofacial devices and equipment increases. For example, according to a report by American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), a rise of 47% has been observed for cosmetic procedures since 2013.
The high cost of surgery is the restraint for the craniomaxillofacial (CMF) devices and equipment market. High cost of the surgery, made it less affordable it becomes for the patients, affecting the demand for CMF devices and equipment. For example, an orthognathic surgery (a jaw corrective surgery) cost in the United States is around $20,000-$40,000.
The trend of usage of 3D Printing technology is on the rise in the craniomaxillofacial (CMF) devices and equipment market. 3D Printing technology is a process of making complex structures which are built by stacking up thin layers on one another and cutting out complex edges. The use of 3D biomedical models during cranial and maxillofacial reconstructive surgery is extremely useful. The 3D models would help in preoperative planning by using 3D biomodeling technique. For example, Reninshaw Company has manufactured LaserImplants that are 3D Printed metal CMF patient specific implants having high strength and flexibility.
EU Medical Devices Regulation (MDR 2017/745) has replaced 2 existing directives. The implementation of new regulations will be completed within 3 years of transition period ending in 2020. CMF devices and equipment are considered as a part of medical devices listed in the EU Medical Devices Regulations, the CMF devices and equipment manufacturers need to maintain a unique device identity to improve device traceability, include aesthetic devices that have same characteristics and risks profile as that of analogous medical devices. Also, the management system standard for medical device - ISO 13485 has been updated. The regulation also directs the manufacturers to introduce implant card for every implant medical device containing its information.
Major players in the market are Stryker Corporation, KLS Martin L.P, Medtronic Plc, Medartis AG and TMJ Concepts.