On the day when the covid-19 antigen detection policy was officially implemented, covid-19 detection concept stocks in the relevant A-share market rose sharply. According to the financial Associated Press reporter, compared with the limited use scene and market space of hospital antigen detection products, the market space of home self-test version is broader. A brokerage research report predicts that the monthly scale of China's covid-19 antigen self-test kit market is expected to reach 17.7-26.6 billion yuan. In this way, China's self-test market space may reach 100 billion a year.
The head enterprises and products are the first to be approved for listing, and the enterprises may take a greater lead. Analysts believe that the whole market competition will be relatively fixed in the future, and the share will probably come by region. With the gradual increase of the number of enterprises whose products are approved, the competition will inevitably be fierce.
market space: hospital version PK self-test version
In March 11th, the State Council issued a notice to the integrated group of New Coronavirus pneumonia epidemic prevention and control mechanism, decided to add antigen detection as a supplement on the basis of nucleic acid detection, and formulated the "COVID-19 virus antigen detection application plan (Trial Implementation)" (hereinafter referred to as the "plan").
It is reported that covid-19 antigen detection products are roughly divided into POC professional version and home self-test version. Among them, POC professional edition should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions. In the industry, POC professional edition is also called hospital edition.
A senior person in the testing industry told the financial associated press that at present, under the condition of multi-point distribution and dynamic zeroing in the mainland, "we judge that the nucleic acid detection ability can be fully covered. And the sensitivity of antigen detection is not as good as nucleic acid detection. If antigen detection products are used in hospitals, they are mainly aimed at grass-roots medical institutions without PCR laboratories."
Pharmaceutical industry analysts also approved the hospital version to the Financial Association, which is mainly for grass-roots hospitals, such as community hospitals and township hospitals. However, he believes that only antigen detection for grass-roots hospitals is not a long-term solution. With the sinking of molecular diagnosis ability and the popularization of medical infrastructure in the future, primary medical institutions will certainly be equipped with basic nucleic acid detection ability. At present, a PCR instrument and fluorescence quantitative analyzer are not so expensive, and there are more and more instruments approved by domestic brands. It is only a matter of time for grass-roots hospitals to be equipped in the future.
Compared with the limited use scenarios and market space of hospital antigen detection products, the market space of self-test version is broader.
The basic requirements and procedures for covid-19 virus antigen self-test specify that covid-19 virus antigen self-test is applicable to two categories of people - isolated observers and community residents. Among them, personnel in home isolation, close contact and secondary close contact, entry isolation observation, sealing and control areas shall conduct antigen self-test under the organization and management of relevant management departments.
Zhongtai Securities Co.Ltd(600918) research report believes that if China's antigen self-test kit is officially liberalized, according to grassroots research, the ex factory unit price of China's covid-19 antigen self-test kit is about US $1-1.5. The frequency of use refers to overseas policies, assumes twice a month according to the minimum frequency, calculates according to the total population base of 1.4 billion, and refers to the latest US dollar / RMB exchange rate of the Central Bank of China of 6.33, "We expect that the market scale of covid-19 antigen self-test kit in China is expected to reach 17.7-26.6 billion yuan per month. If considering the purchase at the expense of residents and enterprises, we expect that the purchase demand of covid-19 antigen detection products is expected to further increase."
The above-mentioned people in the testing industry told the financial associated press that from the experience of Europe and the United States, the last largest market is the home self inspection market. Of course, the prospect is very broad, but there is no problem in the general direction if it is to be carried out in an orderly manner, but how to connect effectively still needs some time to explore and observe.
how will the market structure evolve in the future
According to the information of China Central Television Network, on March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, five covid-19 antigen self-test products have been officially launched.
This means that the hospital version and self-test version of covid-19 antigen detection reagent of the above five enterprises in China have been listed.
One of them told the financial associated press that the company's covid-19 antigen detection products include Chinese version and English export version. At present, it is making anti epidemic orders in Hong Kong. The pricing of the company's Hospital version is different in each region.
However, the above pharmaceutical industry analysts believe that pricing will not be a big factor affecting the market share of enterprises, because the price is not very competitive, we all know how much the cost is, and the difference between products will not be too large, because there is no one whose accuracy can be comparable with nucleic acid. Therefore, antigen detection is only used as a supplementary method for screening.
The above testing industry told the financial associated press that the technical barrier of covid-19 antigen detection is not high, the methodology is common, and the products of each enterprise are different in sensitivity and specificity.
In addition to the above five approved enterprises in China, at present, covid-19 antigen self-test kit of a row of in vitro diagnostic manufacturers in China has been registered and approved overseas.
For example, Andon Health Co.Ltd(002432) obtained the listing approval of covid-19 antigen self-test reagent Market in the United States and signed a large order Jiangsu Yuyue Medical Equipment And Supply Co.Ltd(002223) the hospital version of covid-19 antigen detection product independently developed has passed CE certification, and the EU CE certification of home self-test version and FDA emergency use authorization (EUA) Company are still actively promoting; In addition, Maccura Biotechnology Co.Ltd(300463) , Jiangsu Bioperfectus Technologies Co.Ltd(688399) , Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) and other companies have obtained the listing qualification of overseas covid-19 antigen detection reagent.
Zhongtai Securities Co.Ltd(600918) research report said that at present, covid-19 antigen self-test kits of hundreds of in vitro diagnostic manufacturers in China have been registered and approved overseas, and the market competition in Europe, Malaysia and other regions is becoming increasingly fierce. "We believe that if the registration approval of covid-19 antigen self-test products in China is released, the head brands with complete and abundant clinical data and relatively large overseas sales may gain advantages."
Industry insiders predict that with the introduction of the above plan, the number of enterprises whose products are approved to be listed in China will gradually increase. At that time, we should also beware of the risk of intensified market competition.
When the above pharmaceutical industry analysts analyzed "which enterprises can gain advantages" to the financial Associated Press, they believed that: "I think the market will tend to be the same as ordinary epidemic prevention materials in the future. First of all, the competition is about the time of approval, the early time of entering the market, the early establishment of brand influence, and everyone will give priority to purchase, which will certainly have more advantages; second, I think the whole market competition will be relatively fixed in the future, and the share will probably be based on regions. For example, Tianjin should give priority to Andon Health Co.Ltd(002432) products, and Guangdong Maybe Guangzhou Wondfo Biotech Co.Ltd(300482) . Maybe local governments will also give priority to purchasing the products of local enterprises. "
