With the changes in the structure of Chinese population, the improvement of consumption levels and the enhancement of health awareness, the medical device industry has ushered in unprecedented development opportunities. From high-value consumables to precision medical equipment, from basic research and development to international market expansion, every leap forward in the industry is the result of the perfect integration of scientific and technological innovation and market demand. This briefing is intended to provide professionals with a comprehensive and in-depth industry analysis of the current situation, challenges and future trends of China's medical device industry.
As one of the most important segments in the entire medical and health field, the scale of China's medical device market has exceeded one trillion yuan and is showing a steady growth trend. With the aging of the Chinese population, consumption upgrading, health awareness and other factors, the demand for medical devices is increasing, especially for high-end, accurate and personalized products.
With the improvement of living standards, the aging of the population, and the increasing demand for medical care, China's medical device industry has maintained rapid growth and the domestic market has expanded rapidly. In 2022, the overall operating income of China's medical device industry will reach 13 trillion yuan, of which the revenue of production enterprises above designated size has reached 757.7 billion yuan, with a compound growth rate of 17 from 2015 to 20225%, which has jumped to become the second largest market in the world outside the United States. The global market share has also gradually increased from 1 8 in 2015 to 1 3 in 2022. From the perspective of drug-to-device ratio, China's current drug-to-device ratio level is only 29, with the global average drug-device ratio of 1There is still a certain gap in the level of 4, and there is still a large growth space in China's medical device market in the future.
The industrial chain of the medical device industry mainly includes three links: upstream raw materials and parts, midstream medical device R&D, manufacturing, sales and service, and downstream medical and health industry and household users. The domestic production rate of China's medical device products is not high, mainly limited by upstream raw materials and core components, centralized procurement promotion and hierarchical diagnosis and treatment, domestic product market space expansion, engineer dividends and other factors have also accelerated the high-precision technology to overcome and promote domestic substitution.
Due to the backwardness of relevant basic disciplines and manufacturing processes, China's medical devices are still concentrated in low-end varieties, and high-end medical devices mainly rely on imports. In addition to coronary stents and artificial valves, most of the domestic high-end device fields are still dominated by foreign capital. Domestic substitution has been further accelerated in the field of medical devices, and the technology of some consumables is relatively mature, and the import substitution is relatively complete, such as the localization rate of coronary stents for cardiovascular disease has reached 75%, and the localization rate of orthopedic trauma consumables has reached 68%. In recent years, the localization rate of medical equipment has also been greatly improved, such as the localization rate of molecular biology analysis equipment has increased by 2137 percentage points rose to 7598%。
In the second half of 2023, the national policy requires strengthening the construction of clinical specialties in ** general hospitals and county hospitals; Propose a reasonable allocation of equipment, facilities, drugs and devices; It also supports the allocation and upgrading of medical equipment in township health centers in the western region, which are far away from the county seat, serve a large population, and need to improve the diagnosis and treatment conditions. In addition, the state attaches great importance to the promotion and application of domestic medical equipment, and issued a new policy in October to promote the iterative upgrading of domestic medical equipment. In October, Guangdong issued the "Equipment Leasing Pilot Work Plan" to further stimulate the enthusiasm of medical and health institutions that currently use fiscal funds to obtain medical equipment and promote the prosperity of the medical device market.
In the first three quarters of 2023, orthopedic consumables, reagent consumables and vascular interventional products will be the top three in terms of the number of winning bids. The results of the fourth batch of high-consumption national centralized procurement have been announced, the centralized procurement rules are more perfect, the selection rate of enterprises is high (98%), the demand for products is large, and the overall price reduction is moderate. At present, the scope of centralized procurement of high-value consumables has expanded from more mature orthopedic devices and coronary stents to electrophysiology and drug balloons in the rapid introduction period, while consumer devices such as orthokeratology lenses, dental implants, and orthodontics have also sounded the clarion call for centralized procurement; The regional alliance centralized procurement and the national centralized procurement complement each other, and medical devices are similar to drugs, and have formed a working pattern from the national to the inter-provincial alliance, and the provincial and municipal centralized procurement with mutual cooperation and coordinated promotion.
In the past few years, with the continuous improvement of regulatory policies, the speed of review and approval of Class III certificates for medical devices has been accelerating, and the field of AI medical devices has developed rapidly. China's AI medical device field is developing slower than the global market, but the overall development trend is high-speed, with a market size of 1155 in 20226 million yuan, which is expected to reach 75,568 by 20308 million yuan, with a compound annual growth rate of 392%。In the future, with the development of artificial intelligence technology and the continuous updating of the underlying algorithm, the ability of artificial intelligence medical device analysis technology will continue to improve, and the field of "artificial intelligence + medical health" is expected to be further expanded, and AI will be more widely used in major fields.
Innovation in medical devices is one of the biggest drivers for the future development of medical device enterprises, and its innovation is divided into two categories, innovative single products and iterative innovation, innovative large single products can help enterprises open up the next growth curve, and iterative innovation is relatively more in medical devices, this kind of innovation can generally expand the indications or improve safety, or reduce the difficulty of operation for doctors, etc., and can also help enterprises raise future performance expectations. From 2018 to Q3 2023, the R&D expenses of A-share medical devices continued to increase, with an annual growth rate of more than 25% from 2019 to 2021, and the growth began to slow down in 2022. After excluding new crown enterprises, R&D expenses in Q1-3 in 2022 and 2023 will still grow by more than 15%.
The State Food and Drug Administration has set up a special approval channel for innovative medical devices that have invention patents, are technically the first in China and are at the international leading level, and have significant clinical application value. According to the innovation announcement issued by the Instrument Review Center, since the implementation of the special approval procedure in 2014, the number of products approved by innovative medical devices has been increasing, and from January to November 2023, the number of products entering the special approval procedure for national innovative medical devices is 69, the highest number in the past years. From the perspective of approval time, compared with 2014, the market time of innovative devices has been stable at 2 in recent yearsIn about 5 years, the time to market has been greatly shortened, which reflects the normalization of the "green channel" for the approval of innovative devices.
From 2019 to 2022, the overseas annual revenue of many medical equipment, high-value consumables and IVD companies in the medical device sector exceeded 1 billion yuan, accounting for more than 20% of overseas revenue. The medical device products going overseas show a change from the bottom end to the middle and high-end. In addition to Mindray Medical, Nanwei Medical, and some low-value consumables and new crown testing companies that benefited from the epidemic, the overseas business revenue of companies listed in recent years, such as United Imaging Medical, Yirui Technology, and Adoption Co., Ltd., has also grown rapidly, and the proportion of overseas business revenue of many companies has gradually increased.
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