Immunoassay Outlook

Immunoassay is the largest subdivision in in vitro diagnosis and is in rapid develop-ment, in which chemiluminescence has gradually replaced enzyme-linked immuno-sorbent assay as the mainstream immune diagnosis in China. The market size of chemiluminescence accounts for more than 70% of the total market of immune diagnosis, with an annual growth rate of 20%-30%. Imported chemiluminescence products account for most of the Chinese chemiluminescence market, and there is an accelerating trend of Chinese products replacing imported products, which reveals an inevitable business logic. First, with the development and accumulation of Chinese medical devices, an overall breakthrough in the R&D and production of hardware equipment and supporting reagents has been realized. At present, the Chinese chemiluminescence equipment on the market has a qualitative leap in the stability of hardware and the accuracy of detection results, so as to prepare for the replacement of imported products by domestic products from the aspect of technical quality; second, with the restriction of national medical reform, the end customers pay increasingly more attention to the ratio of consumables to costs, while Chinese products have a great price advantage compared with imported products, which is also an important contributor for domestic products replacing imported products.

As mentioned in the section "Production Technology of In vitro Diagnostic Equipment and Reagents" of the pharmaceuticals part of the Guidelines for the Development of Industrial Key Common Technologies (2017) printed and issued by the Ministry of Industry and Information Technology in 2017, the main technologies include the production technology of high-speed automatic biochemical equipment, immunoanalyzer and molecular diagnostic equipment, the development of new reagents, and the technology for accuracy and quality stability of reagents. Either from market performance or from relevant government guidelines, it is possible to foresee several important trends in the future development of chemiluminescence products.

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