Development drivers and constraints of in vitro diagnostic reagent industry
1. Driving factors
The rapid development of the downstream in vitro diagnostic reagent industry has fed back the transformation and upgrading of the raw material industry. The development of the in vitro diagnostic reagent raw material industry depends on the iteration of in vitro diagnostic reagent products and the expansion of the market space. On the one hand, the innovation of in vitro diagnostic reagent application technology will introduce more new in vitro diagnostic reagent products to the market. While replacing the traditional product end market application, it will also further force the transformation and upgrading of in vitro diagnostic reagent raw material suppliers. On the other hand, in vitro diagnostic reagents, as disposable consumables for diagnostic applications, cannot be reused for repeated consumption and have rigid market demands. The increase in market consumption of in vitro diagnostic reagent products will drive the expansion of the raw material market capacity.
The rapid development of demand terminals such as third-party medical testing institutions will indirectly drive the market expansion of the in vitro diagnostic reagent raw material industry. With the implementation of the hierarchical diagnosis and treatment policy, grassroots medical and health institutions that do not have the ability to test have become more reliant on third-party medical testing institutions. In addition, due to the increase in the number of medical and health care visits in my country, the number of third-party medical testing institutions in China has increased from 216 in 2014. By 2018, there are 731 companies, and it is expected to continue to grow at a compound growth rate of 15.3% in the future, and the demand for diagnosis will also increase, which will not only promote the application of the in vitro diagnostic reagent market, but also promote the expansion of the raw material industry.
2. Constraints
The supervision of in vitro diagnostic reagents has become stricter, and the entry threshold of the diagnostic reagent raw material industry has increased. According to the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents", the development of in vitro diagnostic reagent products needs to include the selection and preparation of main raw materials, and the product technical requirements for the third category of in vitro diagnostic reagents shall specify the main raw materials, production process and semi-finished product requirements in the form of an appendix. The strict monitoring of in vitro diagnostic reagents has forced the improvement of the quality of reagent raw materials, and further raised the entry threshold of the diagnostic reagent raw material industry.
The monopolistic competition pattern of upstream multinational companies deprives local raw material suppliers of development opportunities, further intensifying the import dependence of midstream reagent product developers. The research and development of in vitro diagnostic reagent raw materials is difficult, the production technology route and process flow are complex, and the domestic raw materials are far from imported in terms of quality control, production technology and purity quality. It is highly dependent on imported raw materials, and domestic raw materials have a very low market share in the domestic market, which restricts the development of local raw material suppliers.
