Latest statistics! There are 2,320 IVD enterprises in China

Enterprises are the main carriers of all market economic activities, and in the IVD industry, they are the sole carriers. Therefore, mastering the geographical distribution and list of IVD enterprises across the country (especially manufacturing enterprises) is the foundation for conducting all business. This article mainly presents to industry friends the latest geographical distribution map and specific list of IVD manufacturing enterprises in 25 provinces, municipalities and autonomous regions of Chinese mainland (excluding Hong Kong, Macao and Taiwan).

The source of the list integrates several major channels: the NMPA registration certificate database of the National Medical Products Administration, the CACLP exhibitor list, ArteryNet, etc. The main body of the list is IVD production-oriented manufacturers, and it also includes a small number of upstream biological raw material and component suppliers, as well as IVD consumables manufacturers. If there are any mistakes or omissions, everyone is welcome to leave a message to point them out. The editor will correct and release them in the 2024 version.

The spatio-temporal distribution of 2,320 IVD enterprises

The above chart represents the establishment timeline of the 2,320 IVD manufacturing enterprises that are still in operation at present. The last two decades at the end of the 20th century were a period when China's IVD industry grew from its inception to growth, and there were bound to be numerous IVD enterprises emerging. However, up to now, many of them have vanished, either been deregistered or acquired, and thus have not been presented in the above chart to restore the actual appearance of the industry's development. This is somewhat regrettable.

In 1978, China began its reform and opening up. The achievements of IVD technology were gradually transformed into industries, growing from nothing to something and from weak to strong. Having gone through the process from the initial formation to the rapid development of the industry, from the workshop style of research and development to the fully automatic system integrating instruments and reagents, from the introduction from abroad to the realization of import substitution for some products, and from the absence of industrial supervision to standardized management, the enterprise has accelerated the development of its products, and the industrial scale has gradually expanded and improved.

From 1978 to 1990, the IVD industry evolved from its nascent stage to a basically formed industrial structure. In 1978, the State Pharmaceutical Administration was established. In 1979, the first committee of the Laboratory Medicine Branch of the Chinese Medical Association was established. In 1982, the Clinical Laboratory Center of the Ministry of Health was established. In 1984, The State Council issued the "Order on the Uniform Implementation of Legal Units of Measurement in China", stipulating the measurement format for inspection reports. In 1988, the National Technical Committee for Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Exchanges was established. Among the IVD enterprises established during this period, representative ones include: Shanghai Kehua Biological in 1981; 1984, Guilin Youlite In 1988, Guangzhou Da 'an Gene, Beijing Zhongsheng Beikong; In 1989, Zhuhai Lihua Reagent, Shanghai Fosun Diagnostics, and Xiamen Intco New Creation.

From 1991 to 2000, the IVD industry developed rapidly and entered a stage of standardized management. In 1991, the "National Clinical Laboratory Operating Procedures" (First Edition), edited by the Ministry of Health, was issued. In 1991, the first National Medical Laboratory Supplies Production, Supply and Marketing Association, the predecessor of CACLP, was held in Haikou. In the following years, it was held respectively in Zhuhai, Panyu, Hangzhou, Chengdu, Haikou, Beihai, Changsha, Yantai and Taiyuan. In 1998, the State Medical Products Administration was established. The IVD industry has been incorporated into the national standardized management and quality supervision system.

Among the IVD enterprises established during this period, representative ones include: Shenzhen Mindray Medical in 1991 and Beijing Wantai Biological. In 1992, Guangzhou Wondfo Biotech, Yantai Ausbon, Zhengzhou Bosai Biotech; In 1993, Shanghai Rongsheng Biology, Meizhou Kangli, Beijing Wanhua Puman; In 1994, Chengdu Mike Bio, Changchun Dirui Medical, Shanghai Aopu Bio, Beijing Huadaji Biai; In 1995, Shenzhen New Industry, Shenzhen Ruibang Instruments, Hangzhou Aikang Biology, Tianjin Jiuan Medical; In 1996, Guangdong Yangpu Medical, Shandong Kanghua Biological, Zhejiang Yilikang, Beijing Pulang, Hebei Kangtai Medical; In 1997, Beijing Lideman, Xi 'an Tianlong, Shenzhen Lanyun Group, Suzhou Beckman, Suzhou Hitachi Instruments; In 1998, Nanchang Baxter Bio, Beijing Shouyi, Shenzhen Kaijie Bio, Chengdu Ruiqi Medical; 1999, Zhengzhou Antu Biology, Shanghai Runda Medical, Shenzhen Dakewe, Guangzhou Fenghua, Zhuhai Beso, Changchun Sinomade; In 2000, Beijing Boao Biotechnology, Changsha Aiwei Technology, Shanghai Lanyi Technology, Giant Medical, Hefu China, etc.

From 2001 to 2010, the IVD industry witnessed rapid development, with an average of 50 enterprises established each year, growing at a fast pace. And reached the peak of the stage in 2010. There are too many enterprises established in the 21st century, so they are not listed here for now. For detailed information, please refer to the list or add the wechat of the editor below to get the Excel table. From 2011 to 2019, the IVD industry expanded rapidly, with over 100 enterprises registered each year. It reached its peak in 2015, approaching 200. Among the enterprises established that year, the majority mainly engaged in multi-omics and NGS genetic testing services. Since 2020, a once-in-a-century global pandemic has hit, pressing the accelerator for the development of China's IVD industry, with capital and talent flowing in at an accelerated pace. The whole nation has become aware of "nucleic acid testing" and has gained a deeper understanding of the IVD industry. In summary, since the 21st century, the IVD industry has generally shown a rapid upward growth trend. After the pandemic, it will experience a certain degree of correction, but the long-term positive fundamentals remain unchanged. We believe that the future of IVD in China will be even brighter. Let's work together for this vision.