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    1. Industry News
      Industry News

      Development status of IVD in China

      Attribute:Industry News Date:2019-09-03 16:10:41

      The development of the in vitro diagnostic reagents in China is analyzed. COVID-19 detection reagent plays an important role in COVID-19. In vitro diagnosis (IVD) has been an important part of clinical practice. In vitro diagnosis refers to the products and services that obtain clinical diagnosis information through the detection of human samples (blood, body fluid, tissue, etc.), and then judge the disease or body function. Its detection principles and methods involve immunology, microbiology, molecular biology and other disciplines, and there are a variety of products, and the manufacturing involves medicine, machinery, electronics, composite materials and other industries. IVD products are mainly composed of diagnostic equipment and diagnostic reagents. This paper focuses on IVD reagents.

      In vitro diagnostic reagents can be divided into biochemical diagnosis, immunodiagnosis, molecular diagnosis, blood diagnosis, microbiological diagnosis and immediate detection (POCT) according to the test principle (Fig. 1). Chart 1. Classification of in vitro diagnostic reagents: the global in vitro diagnostic reagent market is monopolized by five giants. Roche, Abbott, Danaher, Siemens and semefei occupy more than 50% of the global market share, and Johnson & Johnson, hysenmecon, Beckman Kurt, bole and other enterprises have relatively strong strength in the IVD field. It is expected that the monopoly pattern will continue in the next few years. The current situation of China's market is similar. Overseas giants, with their high-quality IVD products and the way of binding machines with reagents, occupy about 40% of the market share in China. In China's biochemical diagnosis market, the listed enterprises are concentrated, and the competition is the most intense. Among them, Zhongsheng Beikong and Kehua biology are the longest listed IVD enterprises. There are more than 1000 IVD enterprises in China, but the market share of Mike biology, Wanfu biology, Antu biology, Meikang biology, Kehua biology and other companies can still achieve stable growth. In chart 2, the growth rate of the four enterprises is relatively stable, and the operating revenue in 2019 is 2-3 times higher than that in 2015. Immunodiagnosis is the largest market segment of IVD industry. Chemiluminescence in immunodiagnosis is a fast-growing market segment, and magnetic particle chemiluminescence reagents remain the main position. It is noteworthy that, with the trend of global spread of COVID-19, as of March 17, 2020, China has 64 IVD enterprises' COVID-19 testing products, which have obtained EU accession qualification or CE certificates, including Wanfu biology, Antu biology, KELONG biology, Mei Kangsheng, Mike biology, egg laying organisms, Sannuo biology, Da'an gene, Dean's diagnosis and Chinese big gene. Shengxiang biological and other enterprises have entered the international new crown detection market. As the technical basis of precision medicine, molecular diagnosis benefits from the development of precision medicine and the continuous upgrading of molecular diagnosis technology, as well as the increasing demand for prenatal diagnosis and tumor gene detection, the market potential of molecular diagnosis is constantly improving, and there will be a rapid growth trend in the next few years. As shown in Figure 2, Dean diagnostics is the fastest growing enterprise in the field of molecular diagnostics, with its operating revenue increasing from RMB 1.858 billion in 2015 to RMB 8.437 billion in 2019. POCT diagnosis is a fast developing field in recent years, with high gross profit rate, represented by sannuo biology, Wanfu biology and Jidan biology, which has outstanding performance in blood glucose detection, cardiac markers, inflammation and infection detection.

      1. It is imperative to control the cost of medical insurance. The core of controlling the cost of medical insurance is to improve the use efficiency of drugs or medical devices, reduce the cost of circulation, and reduce the cost of purchasing with quantity. At the beginning of 2020, zero bonus and two ticket system of hospital drugs have been fully implemented in the field of drugs, and the "4 + 7" medical insurance negotiation will be fully launched. On August 27, 2019, the State Food and Drug Administration issued the "rules for the unique identification system of medical devices", which will come into effect on October 1, 2019. The unification of medical device coding has cleared the way for the implementation of the two vote system in the field of medical devices. Perhaps the zero bonus and medical insurance negotiation in hospitals are not far away.

      2. Limitation of upstream raw materials: upstream core raw materials mainly include diagnostic enzymes, primers, antigens, antibodies, microspheres, etc. in addition, there are various fine chemical raw materials, including sodium chloride, sodium carbonate, various amino acids and organic acids, which are used to prepare buffer solutions of diagnostic reagents. Diagnostic enzymes and antibodies still rely on imports, and the production process and purity of domestic raw materials need to be further improved.

      3. The market share is scattered, the profit is not high, the biochemical diagnosis market has already entered the mature stage, and the overall gross profit rate is not high; although molecular diagnosis is in the rising stage, the profit of traditional detection projects, such as hepatitis B detection, is not high; the new detection project market of cancer screening, tumor gene detection and non-invasive prenatal screening has yet to be developed, and the initial investment is large.

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