Market segment analysis of China's in vitro diagnostics industry in 2024 Immunodiagnostics is the largest segment (Group)

       Core data of this paper: in vitro diagnosis market segmentation pattern; Segment market size, etc

In vitro diagnostics market segmentation pattern

In vitro diagnosis can be divided into biochemical diagnosis, immune diagnosis, molecular diagnosis, microbial diagnosis, blood diagnosis, POCT(instant diagnosis) and so on. From the perspective of market structure, immunodiagnostics, biochemical diagnostics, POCT and molecular diagnostics are the main segments of in vitro diagnostics at present. According to the Blue Book of China Medical Device Industry (2024), immunodiagnostics will be the largest market segment in China's in vitro diagnostics market in 2023, accounting for 42.45% of the market share. The market size of biochemical diagnosis in 2023 will be 19 billion yuan, accounting for 16.03%; POCT market accounted for 13.67%, compared with more than 30% in developed countries, there is still a large space for development. The market size of molecular diagnostics in 2023 will be 14.8 billion yuan, accounting for 12.49%.

Key market: Immunodiagnostics

Market status: The largest segment of in vitro diagnostics, which has long occupied a mainstream position

Immunodiagnosis is the largest subdivision of in vitro diagnosis in China, and chemiluminescence has become the mainstream of immunization. According to the diagnostic needs of different diseases, the immunodiagnostic market can be further segmented by subdivided test items. Among them, tumor markers, thyroid function and infectious diseases are the three segments with the largest market size in immunodiagnosis at present, and the high-speed growth markets such as cardiac markers and inflammatory factors are not large at present, but they also have a certain share in the market. In addition, other sections such as sex hormones and eugenics will continue to grow in the future with the popularization of immunodiagnostic technologies such as chemiluminescence and the improvement of the medical system.

In recent years, the market size of China's immune diagnostic reagents has increased year by year, which can be summarized as the following two points: First, the sensitivity and accuracy of immune diagnostic reagents products are high, and the cost gap with biochemical detection is reduced, forming a partial replacement for immune products in clinical biochemical products. In addition, "immune and molecular diagnosis" is the focus of new product development, and molecular diagnosis is affected by technology and cost, it is difficult to quickly spread in the short term, so the mainstream status of immune diagnosis will remain for a long time. According to the "China Medical Device Industry Blue Book (2024)" data, in 2023, China's immunological diagnosis market size of 50.3 billion yuan, an increase of 13%.

Competition pattern: more than half of the share is occupied by foreign enterprises, and the domestic substitution space is broad

In terms of market share, more than half of China's immunological diagnosis market in 2023 will be occupied by foreign companies, of which Roche's market share is more than a quarter, reaching 25.4%. Followed by Abbott, accounting for 13.5% of China's immunodiagnostic market share, Siemens, Beckmann two companies accounted for 5.3%, 5.2% of the share. The market share of domestic enterprises is relatively small, even Mindray Medical, a leading enterprise in the domestic immune diagnosis industry, has a market share of only about 7.5%. Overall, the domestic substitution space of China's immune diagnosis industry is quite broad.

Key market: Molecular diagnostics

Market status: The dividend of the epidemic has subsided, and the market size has declined in 2023

Compared with mature immunodiagnosis, biochemical diagnosis and other technologies, molecular diagnosis is in a period of rapid growth and is the fastest developing subdivision in the field of in vitro diagnosis. It has the advantages of short detection time, high sensitivity and strong specificity, and is widely used in infectious diseases, eugenics and fertility, blood screening, genetic diseases, tumor concomitancy diagnosis and other fields. Among them, infectious diseases account for the highest proportion and have the most significant clinical value.

In 2020, the novel coronavirus epidemic has brought in vitro testing and molecular diagnosis to the public's vision. The outbreak of COVID-19 has led to a surge in demand for testing reagents for the new coronavirus. The State Food and Drug Administration has opened up a rapid approval channel for nucleic acid test kits, and many products have been quickly listed, and the performance of molecular diagnostics companies has also "skyrocketed". However, with the fading of the epidemic dividend, the molecular diagnostics industry has experienced a round of contraction, and the market size has declined to a certain extent, according to the "Blue Book of China Medical Device Industry (2024)" data, the market size of China's molecular diagnostics in 2023 is 14.8 billion yuan, down 43% year-on-year.

Competition pattern: small scale and low concentration, has not yet formed a monopoly pattern

The molecular diagnostic industry in China is led by foreign enterprises, led by domestic leading companies, and developed by domestic small and medium-sized enterprises. The first echelon of the molecular industry competition pattern is composed of foreign companies such as Roche, Abbott and Siemens. Such foreign-funded enterprises have business all over the world, strong scientific research strength, and are the first to enter the Chinese market and drive the development of China's molecular diagnostics market. The second echelon is mainly composed of domestic leading enterprises BGI and Dean Diagnostics. Such enterprises rely on domestic policy support, talent return and other dividends, have a high market share in the domestic market, but also rely on their own price advantages to occupy the middle and low-end market abroad. The third echelon includes small and medium-sized enterprises such as Kehua Biology and Berry Gene. There are more enterprises in this echelon, and the market share is not high, and the competition pattern is more dispersed.

Overall, the domestic molecular diagnosis industry is still in the early stage of development, small scale and low concentration, mainly because molecular diagnosis involves many and complex clinical needs, each has its own areas of expertise, difficult to achieve comprehensive coverage, has not yet formed a monopoly pattern.