Core view
Rapid detection of covid-19 antigen has become a new idea for epidemic prevention in Europe and America. In order to achieve effective prevention and control of covid-19 epidemic, it is necessary to detect covid-19 infection. At present, two detection paths are mainly formed based on molecular (genetic material) and Immunology (protein). RT-PCR in molecular has become the gold standard for covid-19 infection due to its high sensitivity, specificity and moderate cost, The detection of covid-19 antigen based on immunology is less sensitive than PCR, but there is little difference between its characteristics and PCR ratio, and the detection time is faster (self-test products are generally 15 ~ 30min) and the cost is low. It is more suitable for the screening of covid-19 positive patients. At present, American CDC has taken covid-19 antigen detection combined with nucleic acid amplification technology as an important means of screening, and who and ECDC have also recognized the role of rapid antigen detection. If the follow-up epidemic is further influenza, more regions around the world are expected to receive antigen testing.
Covid-19 antigen home self-test is expected to become an important detection method of “coexistence with virus” epidemic prevention strategy in Europe and America. OTC home self-test products are expected to become the mainstream of antigen detection in Europe and the United States by virtue of convenience, reducing crowd aggregation, low cost and fast time. At present, the US FDA has approved 45 covid-19 antigen detection EUA numbers, of which 14 are household self-test products, involving 13 enterprises. All self-test products are based on side flow immunochromatography technology, which is very convenient to use, and the specificity is very high, basically 98% +, the sensitivity is basically 80 ~ 95%, and the mainstream detection time is 15min.
The European market has entered a steady state, the US market is in short supply, and China can also look forward to it. Except for a few countries (such as Iceland), mainstream European countries allow the sales of covid-19 antigen household self-test products. The European supply market is relatively sufficient, and the price is significantly lower than that at the initial stage of listing. At present, the terminal price is about 2-3 euros. Take Germany as an example. At present, there are 43 approvals of covid-19 antigen for household self-test approved by the German Drug Administration, including 34 in China (30 enterprises). It is expected that the follow-up market is expected to be relatively stable. The U.S. market was only recognized by CDC at the end of 2021. Since January 15, 2022, the government requires insurance companies to reimburse OTC covid test kits, allowing up to eight tests per person per month, and is expected to become an important part of the U.S. epidemic detection link in the next stage. At present, supply is in short supply and the price system is good, As the FDA of the United States strictly approves covid-19 antigen household self-test reagent, it is expected to maintain a good price system for a long time in the future. Therefore, the U.S. market has become a major incremental market. With the repeated outbreaks in China, the domestic self-test of covid-19 antigen in China can also be expected to become an important supplement to the test in the future.
Related enterprises: domestic enterprises that have obtained covid-19 antigen home self-test US EUA certificate include Aikang biology, Andon Health Co.Ltd(002432) , Zhejiang Orient Gene Biotech Co.Ltd(688298) (Siemens licensed brand, Zhejiang Orient Gene Biotech Co.Ltd(688298) as the manufacturer). Pay attention to domestic enterprises that are expected to obtain certificates in the United States, as well as changes in China’s epidemic prevention policies and enterprises that are expected to obtain covid-19 antigen home self-test in China.
Risk warning: price decline risk and policy risk, and the volume is less than expected.
