Orthopedic medical devices among largest sub-sectors in the industry
Orthopedic medical devices are one of the largest sub-sectors in the medical device industry. In addition to severe external forces that can cause fractures or joint dislocation, contusions, etc., the aging of the human body and disease-causing hormonal abnormalities are likely to cause an imbalance between osteoblasts and osteoclasts, resulting in osteoporosis and increased osteoarthritis incidence.
Orthopedic implants are the most important category of orthopedic devices, which are usually partially or totally implanted into the human body to replace, support and locate, or repair bone, joint and cartilage and other tissue devices and materials. Along with the rapid expansion of China’s medical device industry, driven by such factors as the increasing proportion of the aging population, the increase of investment in national health care, the improvement of health insurance coverage and the enhancement of residents’ abilities to pay, the market capacity and industry growth are also considerable for the orthopedic implants as a one-time use high-value medical supplies.
Orthopedic implants for trauma, spine, joint at 80% of market share
Orthopedic implants can be categorized into trauma, spine, joint and others. The first three categories account for more than 80% market share of orthopedic implants.
Traumatic implants are mainly used to reset, fix and stabilize various types of fracture injuries, including bone plate (locking plate and ordinary plate), intramedullary nail, screw, bone pin and other fixation devices. Depending on the site of use, it can be divided into internal fixation and external fixation. In practical applications, the usage rate of internal fixation is around 95%.
Articular implants usually contain artificial joints, used to replace or reconstruct the joints that cause damage or peripheral bone defects due to arthritis, hyper-osteogeny, rheumatism, bone tumors or excessive exercise injuries, restore normal joint function and mobility, reduce joint pain caused by lesions. Because these implants will be kept inside the body for a long period of time, the device needs to simulate as closely as possible the physiological state and function in the human body and have higher stability and bio-tissue compatibility. The hip and knee implants account for about half of all products.
Common spine diseases include various types of dosage forms, tumors and fractures, degeneration, vertebral body and disc dislocation, etc. The main causes can be pathological causes such as osteoporosis and osteoarthritis, chronic injury caused by bad habits or unexpected trauma. In addition to conservative treatment such as drug therapy and physical therapy, spinal diseases can also be treated with surgical internal fixation and vertebroplasty minimally invasive interventional therapy, which is more technically advanced in China.
Innovations wanted for China’s orthopedic implant industry growing annually by more than 10%
China’s orthopedic implants industry has the following characteristics: high growth, high threshold, low permeability and low concentration. The overall penetration rate of the industry and the concentration of domestic brands is still low, but the domestic market is large, with a sufficient space of growth and an enormous potential for future development.
Since the 1980s, China’s domestic orthopedic implant manufactures have learned from and competed with international giants. In recent years, the government has given greater support from the policy level to encourage domestic medical devices to speed up innovation. The State Council and government authorities have issued a series of industrial policies to revitalize the medical device industry.
In July 2016, the issuing of the National Scientific and Technological Innovation Planning for the 13th Five-Year classified the new generation of implants and interventional medical devices as major strategic products, especially those of tissue replacement, functional repair and intelligent regulation. The Guiding Catalogue of Key Products and Services for Strategic Emerging Industries of 2017 explicitly emphasized on the hip, knee, shoulder artificial joint prosthesis, OICPC, artificial/ metal bone fixation materials, artificial disc etc.
A new report from Allied Market Research shows that the global orthopedic implant market reached 47.261 billion U.S. dollars in 2016 and is expected to reach 74.796 billion U.S. dollars by 2023. During the 2017-2023 forecast period, the CAGR is 6.8%.
The data shows that the number of surgical procedures for orthopedic implants in China increased from about 1.7 million in 2012 to 2.9 million in 2016, representing a CAGR of 13.8% and is expected to increase to 4.7 million in 2021. The CAGR of 2021 will be 10.2%.
China Med Device, LLC, provides turn-key solution for medical deivce/IVD companies with commercialization, CFDA regulatory & CRO services. Our services include: China market assessment and due diligence, distribution qualification and management, CFDA premarket approval, legal representation and CRO.