In a broad sense, in vitro diagnosis (IVD) refers to the qualitative or quantitative detection of human samples (blood, body fluid, tissue) to assist in disease prevention, diagnosis and treatment, prognosis and health management. In a narrow sense, it refers to in vitro diagnostic products and in vitro diagnostic services. The former includes instruments, reagents and consumables.

The domestic IVD industry chain consists of three parts.

The upstream is raw materials, including reagents, antibodies, diagnostic enzymes, etc., as well as instrument-related components. Since raw materials directly affect the test results and require high stability, 90% of the raw materials in my country depend on imports.

Midstream is an IVD manufacturer-the main research object of this article, outputting instruments, reagents, and services. In my country, the five major overseas giants occupy 50% of the market, while domestic manufacturers as a whole present a small but scattered competition pattern. Among the more than 1,300 IVD manufacturers, most of them are small reagent companies, and there are very few companies with reagent and instrument research and development capabilities.

Downstream are distributors and users: there are more than 20,000 distributors in the industry, not only providing products for end users, but also outputting technical support; end users are mainly medical institutions, third-party laboratories, scientific research institutions, and family individuals. Among them, medical institutions are the main users. There are 33,000 hospitals, 94,000 primary medical institutions, and 18,000 professional public health institutions in China.