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Orthopedic implantable devices are one of the important subdivisions of high-value consumables. The market size is second only to that of vascular interventional high-value consumables. The safety and effectiveness supervision requirements are strict, and the market entry barriers are relatively high. The domestic orthopedic implant device industry is in a stage of rapid development. There are shortcomings in the upstream materials of the industrial chain. High-end materials rely on imports. Domestic companies need to speed up their breakthrough. In terms of midstream products, trauma implants have basically achieved domestic substitution, and will develop in the direction of improving quality in the future; spine and joint products are currently occupied by foreign varieties in the main market, and future development opportunities will be greater. After years of development, high-quality domestic companies such as Dabo, Weigao, Akcome, and Chunli have emerged in the field of orthopedic implant devices in China, helping to increase the localization rate of orthopedic implant devices, thereby helping to reduce product prices and realize benefits. The country benefits the people.

one,

Development status of orthopedic implant device industry

According to public data, the global orthopedics market reached 51.2 billion U.S. dollars in 2018. It has basically maintained a growth rate of about 3% in the past few years, and the market is in a state of steady growth. Developed economies such as Europe, the United States and Japan have leading technological advantages in the field of orthopedic implant devices, with a relatively high degree of industrialization and a relatively mature market. Among them, North America is the world's largest orthopedic medical device market, accounting for 53.4% ​​of the global market share, and the growth rate is close to that of the global orthopedics market; the European market ranks second in size, accounting for 22.3% of the market share, and the European market is growing more rapidly Low, mainly due to the pressure of fiscal austerity policies and price reductions, the market share has gradually decreased; the Asia-Pacific region has become the fastest growing regional market in the world with the economic growth of China and India and the increase in health awareness, with a market share of 20.5%. The population of the Asia-Pacific region accounts for more than 60% of the world's population, and there is a broad market space in the future.

The development of my country's orthopedic device manufacturers started in the 1980s. The domestic orthopedics theory and clinical research have a certain foundation, but they are still in the initial stage in terms of product development, production technology and market development. gap. After entering the 21st century, as foreign giants enter the domestic market to seize the market, domestic companies have achieved rapid growth in the process of competing and learning with multinational companies. The level of technology, technology, R&D and management has been greatly improved, and gradually Break the competitive landscape monopolized by foreign giants. The proportion of domestic products has continued to increase. By 2019, domestic enterprises accounted for 40% of the market share of my country's orthopedic implanted medical device market. According to online public data, my country's orthopedic implant device market has also been in a stage of rapid growth in recent years, with sales revenue increasing from 16.4 billion yuan in 2015 to 30.8 billion yuan in 2019, with a compound growth rate of 17.03%. It is estimated that by 2020, the national orthopedic implanted medical device market will reach 36 billion yuan.

two,

Analysis of the subdivision of orthopedic implant devices

Orthopedic medical equipment can be divided into subdivisions such as joints, spine, trauma, sports medicine, and orthopedic repair materials. Among them, joints, spine and trauma are the most important subdivisions, and they are all orthopedic devices implanted in the human body. From the global market, in 2018, joints, spine and trauma orthopedic implants accounted for 37%. , 18% and 14% of the market share, are the three major subdivisions of orthopedic equipment.

Figure 1 The proportion of global orthopedic medical device segments in 2018

Data source: Flint Creation is compiled based on public information

The domestic orthopedic implant device market is different from developed countries. At present, the market share of trauma, spine, and joint implant devices is similar. In 2019, the proportion of trauma, spine, and joints in the orthopedic implant device market They were 29.8%, 28.23% and 27.77% respectively. The main reason is that the application of orthopedic implanted devices in China started late, the penetration rate and the level of residents' medical expenditure consumption are far from those of developed countries, and the industry structure is in a stage of adjustment. In the future, with the improvement of residents' spending power, the improvement of the medical insurance system and the overall improvement of clinicians' treatment level, the proportion of each segment will converge with the mature international market, and the proportion of joint and spinal implant devices will further increase.

Figure 2 Proportion of the subdivision of orthopedic implant devices in my country in 2019

Data source: Chunli Medical Prospectus

At present, the penetration rate of each segment of the domestic orthopedic implant device market is less than 5%, which is far lower than the 40%-70% in the United States. There is huge room for development, and the orthopedic implant device is expected to maintain a relatively high growth rate. According to relevant data, it is estimated that from 2019 to 2024, in the three major segments of orthopedic implant devices, the compound growth rate of the traumatic market is about 12%, the compound growth rate of the spine is about 14%, and the compound growth rate of artificial joints is about At 15%, the market growth rate of joint implant device products is better than that of trauma and spine products. Joint orthopedic implanted devices are mainly used in osteoarthritis, femoral head necrosis, rheumatoid arthritis and other diseases. According to the "Investigation on the Prevalence of Primary Osteoarthritis in People Over 40 Years Old in China", the incidence of osteoarthritis Increasing with age, the prevalence of primary osteoarthritis in people over 60 years old has reached 62.0%. It can be seen that osteoarthritis is a relatively common disease among the elderly. China is entering a stage of population aging, and the demand for joint orthopedic implant devices will increase significantly. On the subdivision track, joint orthopedic implant devices are obvious. It is superior to spine and trauma orthopedic implanted devices.

Three.

Weak domestic foundation for upstream raw materials

The development of orthopedic implant devices is inseparable from the advancement of upstream disciplines such as medicine, physiology, materials science, and chemistry. Related products require high raw materials in the upstream of the industrial chain, and the materials need to have good safety, high strength, and good biocompatibility. , Mechanical compatibility is close to bone, good workability, wear resistance and other characteristics. From the early use of steel, iron, copper and other materials, it gradually began to develop in metal alloys, ceramics, polymer materials and even absorbable materials, and iterated continuously. At present, the main materials involved can be divided into two categories: medical metal materials (such as stainless steel, metal alloys, medical titanium materials, etc.) and medical biological materials (such as inorganic non-metallic materials, polymer materials, etc.). So far, no matter what kind of orthopedic implant, it is more or less difficult to perfectly fit the human body in terms of compatibility, strength, corrosion resistance, abrasion resistance, and non-toxicity.

Table 1 Orthopedic implant materials and characteristics

Data source: Flint Creation is compiled based on public information

In terms of upstream materials, bioabsorbable materials are the mainstream research and development direction of orthopedic materials. At present, orthopedic implant devices on the market are still dominated by metal materials, and some of the characteristics of metal materials are difficult to replace in a short time in some orthopedic treatment scenarios, such as the treatment of the long bones of the limbs and the weight-bearing area. In recent years, the application of bioabsorbable materials in orthopedic implant devices has also been rapidly developed. Currently, it is mainly used in non-weight bearing areas, small joints, metacarpal and phalanges, lateral malleolus and other parts. At this stage, the most widely used orthopedic bioabsorbable materials are mainly composite biodegradable internal fixation materials; PLA (polylactic acid) combined with other materials (polymer L-/racemic polylactic acid) (PLDLA), PLLA/PGA copolymer; others Composite materials (polyethylene terephthalate) (PET), etc. Among them, the combination of PLA and other materials is currently the most widely used.

Domestic orthopedic implant equipment lacks leading companies in raw materials, and the foundation is weak. High-end core materials are still imported, such as bioceramics used in artificial joints and polyether ether ketone (PEEK) materials used in intervertebral fusion areas. The main sources are Rely on imports. Domestic companies mainly provide general metal alloys or metal surface treatment processes, and there are few companies with core competitiveness.

Four.

Domestic companies in midstream products in some subdivisions have achieved breakthroughs

According to Flint's data, there are 354 midstream manufacturers of orthopedic implant devices in the country, mainly located in economically developed provinces and cities such as Beijing, Jiangsu, Shanghai, and Guangdong, and the industry has formed a certain concentration.

Figure 3 Distribution of orthopedic implant device companies in my country (unit: family)

Data source: Flint database data

Among the above-mentioned 354 companies, there are 248 companies involved in traumatic implants such as bone plates and orthopedic nails. The competition is relatively sufficient, and it is the subdivision of orthopedic implant devices with the highest localization rate. In 2019, traumatic orthopedic implants The localization rate of equipment has reached more than 60%, basically achieving domestic substitution, but the industry concentration is low. The foreign giant Johnson & Johnson has the highest market share, with a market share of only 14.2%, and the domestic leading trauma company Dabo Medical has a market share of 7.8 %. Due to the low technical threshold of trauma products, artificial joints and spine products, there are more companies participating in the industry. With the promotion of national and local orthopedic consumables collection policies, companies with low technical levels and poor competitiveness in the industry will be eliminated and integrated , The industry concentration is expected to increase in the future.

Figure 4 my country's traumatic implant device market structure in 2019

Data source: Flint Creation is compiled based on public information

The degree of localization of spinal implants is lower than that of trauma. In 2019, the localization rate was 40.2%. The main market share was occupied by foreign products. Foreign companies Johnson & Johnson and Medtronic accounted for more than half of the market. The domestic company Weigao Orthopedics is the domestic spine The leader in implantable devices, ranking third, with a market share of 7.9%.

Figure 5 The market structure of spinal implant devices in my country in 2019

Data source: Compilation of public information from Firestone Creation

According to data from the Flint database, as of the end of January 2021, my country has 97 domestic manufacturers of joint implant devices, mainly located in Beijing (32) and Shanghai (20). The degree of localization of joint products is low, with a localization rate of 27.5% in 2019. According to relevant reports on punctuation information, the top five companies in the joint implantable medical device market in my country in 2019 are Zimmer, Johnson & Johnson, Akcome Medical, Chunli Medical and Link Orthopedics. Among them, domestic companies Akcome Medical and Chunli Medical have It has achieved a breakthrough in the competition and is the leading domestic enterprise in joint implant products at this stage, and its future development prospects are promising.

At present, high-quality domestic enterprises such as Dabo, Weigao, Akcome, and Chunli have emerged in the field of domestic orthopedic implant devices. In the future, with the improvement of the domestic industrial chain and technological progress, the implantation of artificial joints and spine devices The aspect will also gradually realize domestic substitution.

Author | Liu Guoming