Driving and restricting factors of in vitro diagnostic reagent industry development
1. Driving factors
The rapid development of downstream in vitro diagnostic reagent industry feeds the transformation and upgrading of raw material industry. The development of in vitro diagnostic reagent raw material industry depends on the iteration of in vitro diagnostic reagent products and the expansion of 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, which will not only replace the traditional product application in the terminal market, but also further force the transformation and upgrading of in vitro diagnostic reagent raw material suppliers. On the other hand, as disposable consumables for diagnostic applications, in vitro diagnostic reagents cannot be used for repeated consumption, which has a rigid market demand. The increasing market consumption of in vitro diagnostic reagents will drive the expansion of raw material market capacity.
The rapid development of third-party medical testing institutions and other demand terminals will indirectly drive the market expansion of in vitro diagnostic reagents raw materials industry. With the implementation of the hierarchical diagnosis and treatment policy, primary medical and health institutions without the ability of testing have become more dependent on third-party medical testing institutions. In addition, the number of Chinese medical and health care visits has increased, with the number of third-party medical testing institutions increasing from 216 in 2014 to 731 in 2018. It is expected to continue to grow at a compound growth rate of 15.3% in the future, and the demand for diagnostics will also increase, driving the market application of in vitro diagnostic reagents and promoting the expansion of the raw material industry.
2. Constraints
The regulation of in vitro diagnostic reagents is becoming stricter, and the entry threshold of diagnostic reagent raw material industry is higher. According to the regulations of In Vitro Diagnostic Reagents Registration Administration, the development of in vitro diagnostic reagents shall include the selection and preparation of main raw materials, and the technical requirements of the third type of in vitro diagnostic reagents shall be clearly defined in the form of appendix for main raw materials, production process and semi-finished products. The strict monitoring of in vitro diagnostic reagents has forced the quality of reagent raw materials to rise, and also further raised the entry threshold of diagnostic reagent raw materials industry.
The competitive pattern of upstream multinational monopoly deprives local raw material suppliers of development opportunities and further intensifies the import dependence of midstream reagent product developers. The research and development of in vitro diagnostic reagent raw materials is difficult, and the production technology route and process flow are complex. Domestic raw materials have a gap with imported ones in terms of quality control, production process, purity and quality. Limited by insufficient research and development technology and production process, downstream reagent product developers are highly dependent on imported raw materials, and domestic raw materials have a very low market share in China, restricting the development of local raw materials suppliers.
