2.1 Overview

Biochemical diagnostic reagents, as one of the main categories of diagnostic reagents, are characterized by a large population coverage, a high proportion of services and service users and a huge market size. From 2015 to 2020, the market size of biochemical diagnostic reagents has increased year by year in China; in 2020, the market size of biochemical diagnostic reagents is about 16.1 billion CNY in China. The localization of biochemical reagents has been basically realized and they have been sold to Grade IlI Level A hospitals, and the import monopoly has been broken by domestic enterprises. Presently, about 70% of the market share has been occupied by domestic brands, and the rest is occupied by some powerful multinational corporations (such as Beckman, RANDOX, Toagosei). The domestic leaders of biochemical reagents mainly include BSBE, Medicalsystem, Leadman, Maccura, Zybio, and other open reagent R&D manufacturers.

Taking homocysteine as an example, the abnormal blood homocysteine metabolism leads to the elevated concentration of homocysteine, which will greatly increase the risk of coronary heart disease, peripheral vascular disease, and cerebrovascular disease. Therefore, homocysteine is an important parameter of human health condition. Based on the data of CFDA, there are 12 foreign enterprises and 207 domestic enterprises that produce the homocysteine kit (enzymatic cycling assay) in 2020. 

The above figure shows that the main manufacturers are distributed in Zhejiang, Guangdong, Beijing, Jiangsu, Shanghai, etc. Geographically, these manufacturers of biochemical reagents are mainly located in the eastern and southern coastal areas. The top 7 provinces and cities in terms of the number of enterprises account for more than 70% of the national market share, revealing a high degree of geographic concentration in the industry. The production and operation enterprises are mainly distributed in the Pearl River Delta, the Yangtze River Delta, and the Beijing-Tianjin-Hebei region, with the number of enterprises ranking the top nationwide.

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