China's orthopedic medical device industry ushered in a high momentum

Orthopaedic medical devices are one of the major sub-industries in the entire medical device industry. According to public data, the sales volume of the global medical device market in 2020 was 477.4 billion US dollars, an increase of 4.6% over the same period of the previous year (the same below); It is estimated that the sales volume will reach 594.5 billion US dollars by 2024, and the compound annual growth rate will reach 5.6% from 2018 to 2024. From the perspective of segmentation, the global orthopedic medical device market sales in 2020 was US $36.5 billion, accounting for 9% of the total sales of the global medical device market.

The total sales of medical devices in China in 2020 was 734.1 billion yuan, up 18.36% year on year; Among them, the orthopedic implant market scale is 36 billion yuan, up 16.44% year-on-year, accounting for 4.90% of the total scale of medical devices, far lower than the proportion of orthopedic devices in the global medical device market. The orthopedic medical device industry has a broad development prospect.

Many segments

The medical device industry can be divided into four categories: high value medical consumables, low value medical consumables, medical equipment and in vitro diagnosis (IVD). According to different uses, high-value medical consumables can be subdivided into orthopedic implants, vascular intervention, neurosurgery, ophthalmology, stomatology, blood purification, non-vascular intervention, electrophysiology and pacemaker, and other sub-categories.

Orthopedic medical devices generally refer to clinical orthopedic medical materials used for human bone replacement, support, repair and filling, which can completely or partially replace joints, bones, cartilage or musculoskeletal systems, involving parts including shoulder, elbow, hip, knee, spine, etc. Due to the high value of this category of products and the important impact on human life and health, many links such as production and use must be strictly controlled, which is generally classified as the management of high-value medical consumables.

Orthopedic implant products can be divided into trauma, spine, joint and others according to different parts of use. The market share of the first three companies accounts for more than 80% of the orthopedic implant market, and their products mainly include bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal internal fixation implants, artificial joints, etc.

Rapid market growth

China's orthopedic consumables industry experienced a difficult development process before the 1980s, laying a certain foundation for the development of orthopedic medical device industry. With the rapid improvement of national economic strength and scientific research strength, domestic medical device enterprises have developed rapidly. After entering the 21st century, many multinational enterprises have entered the Chinese market. In the continuous learning and competition, domestic orthopedic medical device enterprises have made considerable progress in all aspects.

Under the background of China's huge population base and the accelerating process of social aging, the market size of orthopedic implants has increased from 11.7 billion yuan in 2013 to 36 billion yuan in 2020, with a CAGR of 17.14%. It is expected that the market size will exceed 57 billion yuan by 2023 (see the figure for details). Today, China has become the second largest orthopaedic implant market in the world. With the continuous increase of the incidence rate of bone diseases (such as osteoporosis, lumbar disc herniation, femoral neck fracture, etc.) among the elderly, coupled with the growth of people's demand for health and the improvement of their ability to pay, it is expected that the growth rate of the orthopaedic implant market in China will be far higher than that in the world.

R&D innovation breakthrough

In terms of technology and technology, spine implants will usher in new development. Due to the impact of high R&D threshold, complex production process, difficult market access, strict quality supervision and other factors, the development of early domestic orthopedic spine and joint implant manufacturers is relatively slow. In recent years, with the improvement of the research and development level of domestic artificial joint implants and the improvement of the manufacturing process and quality control level, local enterprises have occupied more markets with the advantages of high quality and low price.

At present, the development of spine orthopedics has been relatively mature, new technologies and new therapies are still emerging, and the means of disease diagnosis, treatment and evaluation are gradually improving. At present, mainstream products of spine implants are mainly divided into two categories: one is internal fixation system of spine, which is composed of bone plate, fixation rod, screw, etc. alone or in combination, and the other is intervertebral fusion cage. With the continuous education of doctors, academic promotion and the development of imaging technology, more and more secondary and tertiary hospitals have the ability to carry out spinal surgery, which is minimally invasive surgery. In the future, spinal surgery will continue to develop towards precision, minimally invasive and intelligent.

In terms of safety, infection, exclusion and release of harmful metal ions are major problems in the development of implant medical devices, which have not been effectively solved worldwide. Patient infection is one of the serious clinical complications in the early stage after the operation of most orthopedic implants. Its results include difficulty, great pain, long time, high cost, easy disability and even death. The rejection reaction caused by the implant is more than a few months after the operation. The clinical manifestation is local swelling and pain, often accompanied by infection. The release of harmful metal ions mostly occurs several years after surgery, which may lead to osteoporosis, rash, cardiovascular disease, nervous system disease, cancer and other diseases. For example, the carcinogenic incubation period of metal element nickel is 23-27 years.

The research and application of new materials is expected to promote breakthroughs in the safety of implants and medical devices. For example, calcium phosphate ceramics are a kind of important bone substitute materials, among which hydroxyapatite (HAP) and tricalcium phosphate (TCP) ceramics are mostly studied. HAP has a lamellar microcrystalline structure, which is similar to human and vertebrate bones and teeth in composition and structure, and has good biocompatibility. For example, the HAP coating of composite bone-induced biomaterials can effectively prevent the formation of bacterial biofilm, reduce the risk of infection after orthopedic/dental implants, reduce bacterial drug resistance, promote the biological healing function of bone and soft tissue, shorten the postoperative rehabilitation time and hospital stay of patients, reduce the cost of surgical treatment, reduce the physiological, psychological and economic burden of patients, and effectively save medical resources.

Tantalum is a rare and precious metal with physical and chemical properties such as acid resistance, alkali resistance, corrosion resistance and high temperature resistance. Due to its good biocompatibility, tantalum is used as an implant material in international clinical practice. However, the properties of high hardness and high melting point (up to 2996 ℃) make tantalum difficult to process, making it difficult to popularize in medical device production and clinical application, and also becoming one of the research directions of orthopedic medical device materials.

In addition, biomedical inorganic nonmetallic bone repair materials have many advantages, such as wide source of raw materials, easy preparation, low cost, good chemical stability, biocompatibility and biological activity, and controllable structure and chemical composition. Therefore, this kind of bone repair materials has a large market space.