Annual data of China’s medical device industry in 2021

A.Industry scale

The number of production enterprises reaches to 28278

From 2017 to 2021, the number of medical device manufacturers in China continued to grow. In 2020, the number of manufacturers affected by the epidemic increased significantly, from 18070 in 2019 to 26465.

 The number of operating enterprises exceedes 900000

In the past five years, the growth rate of the number of medical device operating enterprises has basically maintained at 15%, of which the growth rate in 2018 and 2020 is as high as more than 30%. By 2021, there were 925553 class II and III medical device enterprises in China, with a year-on-year increase of 17.4%. Among them, 175343 enterprises are engaged in class II and III medical device products at the same time, 682280 enterprises are only engaged in class II and 67930 enterprises are only engaged in class III.

 36989 products were filed / registered for the first time

In 2021, a total of 36989 domestic medical device products were first filed and registered, a decrease of 9688 or 20.8% compared with 46677 in 2020.
From 2017 to 2021, the number of first-time registrations (hereinafter referred to as “initial registrations”) of domestic medical device Class II and III products in the country generally showed an upward trend, with an average annual increase of 2,332. 2018 was the period with the lowest number of registrations, 5070, and then reached the highest number in 2020, 14656. In addition to the renewal of registration and information change, the first registration of class II and III products in 2021 were 13726, a year-on-year decrease of 14.3%.

 B.Industry concentration has increased year by year

From the perspective of the proportion of the total revenue of the top 20 listed medical device enterprises in the industry, the proportion of the total revenue of listed enterprises in 2016 increased from 5.80% to 14.16% in 2020 year by year. The proportion of the total revenue of listed enterprises continues to increase, and the industry concentration has been increased year by year.

High-tech enterprises account for 22.2%

The number of medical device high-tech enterprises has increased steadily.

The number of medical device high-tech enterprises in China has gradually increased from 2593 in 2017 to 6279 in 2021, accounting for 22.2%.

The number of innovative devices approved increased by 35% year-on-year

The number of national innovative products on the market has increased year by year, from 10 in 2016 to 35 in 2021, with a year-on-year increase of 34.64% compared with 26 in 2020.

There are 51 medical device industrial parks at all levels recognized by governments and departments at all levels, including 28 national medical device industrial parks, 18 provincial medical device industrial parks and 5 municipal medical device industrial parks.
The quantitative analysis is carried out according to 5 or more medical device manufacturers and the theme park whose Park name includes medical devices (mainly through the matching between the address of the manufacturer and the address range of the park), Agglomeration degree of medical device Industrial Park (number of medical device manufacturers in medical device Industrial Park / agglomeration area / theme park / incubator in that year) ÷ number of medical device manufacturers in that year × 100%) from 72.82% in 2016 to 90.23% in 2019 and 68.1% in 2021. This is mainly because a large number of enterprises not in the medical device industrial park have crossed the border into the field of medical devices and began to produce epidemic prevention products since 2020, resulting in the decline of the agglomeration of China’s medical device industrial park.

C.International competitiveness is further enhanced

During the period from 2011 to 2021, China’s foreign trade in medical devices has transformed from a deficit to a surplus. Relevant data show that in 2021, the total foreign trade of China’s medical devices reached 134.94 billion US dollars, with an import value of 50.21 billion US dollars and an export value of 84.73 billion US dollars.
In 2021, China’s foreign trade import and export volume of medical devices dropped by 18.8% year-on-year compared with 2020. Mainly due to the normalization of the prevention and control of the new crown epidemic, the demand for import and export of epidemic prevention materials such as masks and medical protective clothing declined. Among them, the export value of medical consumables reached 46.72 billion US dollars, accounting for 43.3% of the total export value, followed by IVD reagents, with an export value of 13.36 billion US dollars. China’s export products are still dominated by low-end products, but the penetration rate of mid-to-high-end products continues to increase.
The number of product registrations of Chinese products in the United States, Canada, New Zealand and Australia was 5,484 in 2018. In 2020, the number of overseas product registrations increased significantly, with 8,644 product registrations, a year-on-year increase of 36.23%.

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