Distraction osteogenesis (DO), also called callus distraction, callotasis, osteodistraction, and distraction histogenesis, is a surgical process used to reconstruct skeletal deformities and lengthen the bones of the body. As per the site of usage, DO devices can be classified as mandibular (lower law), maxillary (upper jaw), alveolar (in teeth bearing region of the jaws), palatal (roof of the mouth) or craniofacial (skull). Distraction osteogenesis devices aid in orthopedics, maxillofacial, and oral surgery. Distraction osteogenesis devices are used for, treating rising number of bone defect cases and craniofacial anomalies such as cleft palate, craniosynostosis, hemifacial microsomia, and others.
The global distraction osteogenesis devices market was valued at US$ 228.3 million in 2018 and is expected to exhibit a CAGR of 4.9% over the forecast period (2019-2027).
Figure 1. Global Distraction Osteogenesis Devices Market Value (US$ Mn), by Region, 2018
Source: Coherent Market Insights Analysis (2020)
The rising number of pediatric bone defects is expected to boost growth of the distraction osteogenesis devices market
The recent advancements such as fixator and pin design that have reduced the complexity of external distraction devices and have provided oral and maxillofacial surgeons with easily placeable and miniaturized distraction devices that can be efficiently used for bone lengthening and rising number of bone defects in pediatric patients are major factors that are expected to drive growth of the distraction osteogenesis devices market. According to the research published in National Center for Biotechnology Information (NCBI), 2019, the prevalence of craniosynostosis is around 1 in 2,000/2,500 births, globally. According to the Centers for Disease Control and Prevention, 2015, around 2,650 babies are born with cleft palate and around 4,440 babies are born with cleft lip each year in the U.S. Also, according to the study by Medical Futurist, 2013, skull and bone defects, foot deformities, and cleft palate account for 34% of the birth defects in the U.S., thus, leading to increasing demand for distraction osteogenesis devices in medical settings to efficiently treat facial deformities.
The rising product approvals and launches by market players is expected to bolster the distraction osteogenesis devices market growth over the forecast period. For instance, in August 2018, Stryker Corp. announced the launch of first-ever, post-free hip distraction system, the Pivot Guardian, at the American Academy of Orthopaedic Surgeons annual meeting. This device was designed to mitigate groin complications related to hip arthroscopy.
Moreover, rising incidence of genetic disorders such as cleft defects is expected to augment the market growth. According to the National Institute of Dental and Craniofacial Research, 2017, around 30% of cleft defects are associated with a genetic syndrome including Waardenburg, Pierre Robin, and Down’s syndrome.
Figure 2. Global Distraction Osteogenesis Devices Market Share (%), by Placement,2019 and 2027
Source: Coherent Market Insights Analysis (2020)
Distraction Osteogenesis Devices Market - Regional Analysis
North America held dominant position in the global distraction osteogenesis devices market in 2018, owing to increasing number of procedures for treating facial abnormalities in the U.S. For instance, according to the survey by American Society of Plastic Surgeons, 2016, around 220,000 maxillofacial and craniofacial procedures were performed in the U.S. in 2016. Also, certain hospitals in the region are focusing on offering required care for facial defects, which is expected to aid in growth of the market. For instance, Cleft and Craniofacial Anomalies Clinic at American Family Children's Hospital and Children's Hospital of Wisconsin in the U.S. provides expert care for infants, children, and teens with congenital facial defects.
Asia Pacific is expected to gain significant traction over the forecast period, as key players are focused on setting up subsidiaries in the region, to expand its customer base and geographic presence. For instance, in 2016, KLS Martin Group opened its Indian subsidiary, KLS Martin India Private Limited in Chennai, with an aim to enhance its presence in Asia Pacific, as it is one of the fastest growing economies. Also, the Inga Health Foundation operating in the region runs three centers to treat skull & facial deformities for children across the country, thereby aiding in reducing prevalence of craniofacial deformities. According to the survey by INGA Health Foundation, 2016, craniofacial abnormalities occurs in one of every 2,000 births and around 15,000 infants with craniofacial deformities are born every year, whereas cleft palate affects one in every 600 births in India.
Also, the initiatives by several organizations for providing surgical care for facial deformities is a major factor propelling the market growth. Inga Health Foundation, a charitable organization in India, aims to treat the underprivileged children born with facial deformities such as cleft lip and palate. Inga runs three state?of?the?art centers for skull & facial deformities and is equipped with a highly trained team to provide surgical treatment. The foundation has improved the lives of more than 7,500 children by giving them a normal face and training over 40 surgeons.
Major players operating in the global distraction osteogenesis devices market include Johnson & Johnson, Zimmer Biomet Holdings, Inc., Stryker Corporation, KLS Martin Group, Acumed LLC, OsteoMed, and Titamed.
Distraction osteogenesis devices are classified as internal and external distractors based on the placement of the device. The external distractor allows bone distraction in three planes and aids surgeon to alter the direction or vector of the distraction process. Moreover, the miniaturized internal distraction devices have made surgical procedure clinically feasible and practical, providing higher comfort to the patients.
The factors impacting growth of the distraction osteogenesis devices market include rising number of pediatric bone defects coupled with development of novel solutions by distraction osteogenesis device manufacturers to treat facial asymmetries, mandibular hypoplasia, and other indications. For instance, according to the National Institute of Dental and Craniofacial Research, 2017, around 30% of cleft defects are associated with genetic syndrome such as Waardenburg, Pierre Robin, and Down syndrome.
Moreover, key players are focusing on research and development to introduce innovative products for enhancing patient satisfaction, procedure efficiency, and clinical outcomes, thus rising adoption of these technologically advanced devices and aiding in growth of the global distraction osteogenesis devices market. For instance, in October 2017, DePuy Synthes introduced MAXFRAMETM Multi-Axial Correction System, an external circular fixation device with a 3D planning software that helps improve accuracy of the deformity correction plan, which could reduce overall treatment time while improving procedural efficiency and reducing costs. The system is indicated for fracture fixation, limb lengthening, and bone deformity correction in adults and children.
However, the complications of the devices of forming marginal mandibular nerve and scars at external pin sites, requirement of second surgical procedure for removal of internal distractors, and high cost of total treatment are factors hindering growth of the distraction osteogenesis devices market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.