In 2024, China's artificial organ industry market supply level analysis industrialization, localization level continues to improve

Core data of this paper: cochlear implant and intraocular lens product registration certificate, cochlear implant market share

1. Overview of artificial organ supply in China

Artificial organs are parts made of artificial materials that can partially or completely replace the functions of natural organs of the human body. It is a new discipline in the major of biomedical engineering, which mainly studies the structure and function of human organs, and uses artificial materials and electronic technology to make mechanical devices and electronic devices that partially or completely replace the function of human natural organs. At present, the more famous are artificial heart, artificial liver, artificial kidney (hemodialysis), artificial lens, artificial cochlear, artificial throat and so on.

From the perspective of supply enterprises, the current domestic market imported products occupy the main market share, China's artificial organ industry started late, some domestic products are in the early stage of listing, and the localization rate needs to be improved.

2. Supply level of artificial organ subdivision products in China

-- Artificial heart supply level: the initial stage of industrialization

In order to fill the huge unmet medical needs of patients with advanced heart failure, a number of domestic companies have laid out related artificial heart products in recent years, and as of April 2024, four artificial heart assistance devices have been listed in China. For example, in November 2021, a fully maglev implantable left ventricular assist system developed by Suzhou Concentric Medical was approved for market, and compared with similar international products, the key performance indicators have reached the same level, the blood pump size is smaller, and the implantation is more invasive.

-- Artificial liver supply level: There are no bioartificial liver products on the market

There are three main types of artificial liver, namely biological artificial liver, non-biological artificial liver and mixed artificial liver. In the current artificial liver market, non-biological artificial liver mainly plays a detoxification function and is widely used in clinical practice to adapt to advanced liver failure. Biological and mixed artificial liver in addition to detoxification function and part of the synthetic and metabolic functions, is currently in the small-scale application stage, is the potential direction of the future development of artificial liver, domestic leading enterprises have Tong Gan medical, micro Zhizhuo biological, dry hui biological and Celivir, products are in the declaration stage or clinical stage.

Cochlear implants: imported brands account for 70% of the market

As of January 2024, the State Medical Products Administration has issued a total of 48 registration certificates for cochlear implants, of which 18 registration certificates have expired as of January 2024, and the current valid registration certificates for cochlear implants are 30.

Although China's cochlear implant industry started late, but the development is relatively rapid. At present, domestic cochlear implant brands include Norkang, Lishunte, etc., of which Norkang has occupied about 20% of the domestic market share. However, in terms of the total amount, imported brands still occupy nearly 70% of the market share of China's cochlear implant industry.

注：此为2022年数据。

-- Intraocular lenses: The localization rate fluctuates

As of April 2024, the total number of product registrations of intraocular lens medical devices within the validity period was 203. Among them, there are 57 domestic products, accounting for 28%.

3. Supply trend of China's artificial organ industry

At present, China's artificial organ products can be divided into two categories, one is represented by artificial heart, artificial organs and other products, such products are in the early stage of industrialization, the future, in China's demand side, policy side, social side of the continuous boost, industrialization process will continue to advance; The other category is represented by cochlear implants, intraocular lenses and other products, whose commercialization is relatively mature. Currently, imported brands still occupy the main market share. Under the rapid catch-up of local enterprises, the level of localization continues to improve.