Analysis on the market scale and development trend of IVD in China in 2020
Attribute：Industry News Date：2019-09-03 15:39:21
Driven by the improvement of medical quality and technology, the in vitro diagnosis industry in China is developing rapidly. At present, the utilization rate of in vitro diagnosis in clinical is very high, and about 80% of the disease diagnosis depends on in vitro diagnosis. In 2019, the market scale of in vitro diagnosis in China will exceed 70 billion yuan, maintaining a high growth rate. However, compared with foreign developed countries, the per capita cost of IVD in China is still low. With the pilot work of medical device registrant system, it is expected that the industrial layout and social division of labor in the field of IVD in China will be further refined in the future, and the market scale will continue to expand.
In vitro diagnostics (IVD) refers to the detection of samples (blood, body fluid, tissue, etc.) taken out of the human body, through the comparison with the distribution level of normal people, to determine the patient's corresponding functional status and abnormal conditions, as the basis for diagnosis and treatment. In vitro diagnostic products include in vitro diagnostic reagents and in vitro diagnostic instruments. At present, the use rate of in vitro diagnosis is very high, about 80% of the disease diagnosis depends on in vitro diagnosis.
The scale of the industry continues to expand
Driven by the improvement of medical quality and technology, China's in vitro diagnosis industry has developed rapidly, with a market size of more than 60 billion yuan in 2018 and more than 70 billion yuan in 2019.
Immunodiagnosis accounted for the largest share
According to the different technologies used in clinical medical examination items, in vitro diagnostic products can be divided into immune diagnosis, biochemical diagnosis, molecular diagnosis, microbial diagnosis, coagulation diagnosis, tissue diagnosis, blood and body fluid diagnosis, among which the first three are the mainstream in vitro diagnostic methods in medical institutions, accounting for 38%, 19% and 15% respectively. In vitro diagnosis is especially suitable for tumor therapy. The incidence rate of individuals is closely related to genetic information, and each person has different genetic information. Therefore, gene detection and immunohistochemistry have become the core technology of in vitro diagnosis. From the perspective of market demand, there are a large number of cancer patients in China. With the launch of anti-tumor targeted drugs and the improvement of people's awareness of in vitro diagnosis market, there will be a huge market development space in the future.
Broad space for import substitution of domestic products
China's in vitro diagnosis market is developing rapidly, but most of them are occupied by foreign-funded enterprises. Roche, Abbott, Danaher and Siemens occupy a large market share in the domestic in vitro diagnosis field. From the perspective of segmentation, the market share of domestic enterprises in biochemical diagnosis, molecular diagnosis and POCT is relatively low. The market share of domestic enterprises in immunodiagnosis field has reached 50%, and the import substitution space of domestic products is relatively broad.
The epidemic creates huge demand
Since the outbreak of novel coronavirus pneumonia, the demand for COVID-19 reagent has increased sharply. In the first quarter of 2020, most of the listed companies with new coronavirus detection reagents approved by the State Food and drug administration have achieved performance growth. Among them, in terms of operating revenue, the operating revenue of Huada gene and Daan gene increased by 35.7% and 132.8% respectively in the first quarter of 2020; in terms of net profit, the net profit of Daan gene and Yangpu medical increased by 564.3% and 120% respectively in the first quarter of 2020.
Great development potential of in vitro diagnosis in China
At present, the cost of in vitro diagnosis accounts for a low proportion of the total medical and health care expenditure in China, but it maintains a rapid growth trend. Globally, the per capita cost of IVD in North America is 70 US dollars, while that in Europe is about 20 US dollars, of which Switzerland is more than 50 euro, while China is only 7.1 US dollars. China's IVD market still has a large room for growth.
In addition, the medical device registrant system will release the development potential of in vitro diagnosis. In August 2019, the State Food and Drug Administration issued the "notice on expanding the pilot work of medical device registrant system", which specifies that the pilot work of medical device registrant system will be carried out in 21 provinces / cities / autonomous regions including Beijing, Tianjin and Hebei.
Before the pilot work of medical device registrant system was carried out, medical device registration certificate and medical device manufacturing enterprises were bound together. Many enterprises could not obtain medical device registration certificate due to insufficient production capacity, which was not conducive to the development of R & D enterprises. The pilot work of medical device registrant system helps innovators focus on product development, and product production can be directly entrusted to qualified manufacturers. This can avoid low-level repeated construction of medical device industry, reduce early investment, speed up the pace of innovative products on the market, and stimulate the vitality of industrial innovation and development. The registration system of medical devices will further refine the industrial layout and social division of labor in the field of in vitro diagnosis, and optimize the allocation of social resources.
The above data comes from the analysis report on market demand forecast and investment strategic planning of China's in vitro diagnosis Industry issued by foresight Industry Research Institute. Meanwhile, foresight Industry Research Institute provides solutions for industry big data, industry planning, industry declaration, industrial park planning, industry investment promotion, etc.
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