People's Daily health client reporter Tan Qixin
Read the executive summary:
In the view of Hu Shanlian, a professor at the School of Public Health of Fudan University, in the process of special collection of new crown antigen detection reagents in various places, the concern for "price" should not be overemphasized. Professional testing institutions such as national/local clinical testing centers should be introduced, corresponding kit screening gold standards should be formulated, and the products participating in the declaration should be grouped according to the sensitivity and specificity standards, and the bidding unit grouping rules should be adopted, so as to select the truly "high-quality and high-priced" products.
"On March 26, I received an antigen test kit distributed by a community worker, and the results came out in less than 20 minutes, showing a horizontal bar, which was negative and very convenient." Miss Li, a resident of Shanghai's Xuhui district, told reporters.
Since the release of the "Application Plan for New Coronavirus Antigen Detection (Trial)", as of March 26, in just two weeks, 19 new crown antigen detection reagent products have been intensively approved for marketing.
According to the statistics of the People's Daily health client reporter, at least 8 provinces such as Guangdong, Jilin, Zhejiang, Fujian, Jiangsu, Anhui, Henan, and Shandong have carried out unified procurement or distribution of antigen testing. At the same time, various localities are successively issuing announcements to accelerate the inclusion of antigen detection reagents in the collection and collection, and "temporarily" include them in the scope of medical insurance payment.
Huaan Securities Research Report estimates that under a long-term perspective, assuming that the penetration rate of antigen detection can reach 80% of the reference vaccination rate, according to the country's 1.4 billion people tested twice a month, the terminal retail price of 10 yuan / person to calculate, only the self-test market size can reach 268.8 billion yuan per year.
In the laboratory, R&D personnel are testing reagent sensitivity. Courtesy of respondents.
Incremental capacity expansion
"Anti-epidemic is the first priority at present, and the production capacity at this stage should give priority to meeting the government's urgent procurement needs, and then it will slowly and selectively and orderly open up hospitals, OTC and other channels." On March 26, the relevant person in charge of Oriental Biology revealed in an interview with the People's Daily health client reporter.
On March 15, the novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by Dongfang Bio was officially approved for domestic listing. Prior to this, Oriental Biologics' new crown antigen detection kit was mainly supplied to the European and American markets, and has been widely used in the European and American markets for more than one and a half years.
"The domestic market has just begun to open up, the demand has begun to release, from the time we received the notice (approved for listing), we are preparing production capacity to meet the domestic epidemic prevention needs to the greatest extent." The person in charge of the above-mentioned Oriental Biology revealed to reporters.
Purchase orders from the government and distributors around the world are still growing rapidly. Jilin Province, where the epidemic is still in a state of stalemate, is one of the first provinces to announce procurement needs. On March 14, Song Xiaohui, deputy director of the Department of Industry and Information Technology of Jilin Province, said at the press conference that the Department of Industry and Information Technology of Jilin Province, through the National Health Commission and other channels, urgently communicated with antigen reagent manufacturers such as Beijing Heatscape Biology and Guangzhou Wanfu Biology, and ordered 12 million antigen detection reagents nationwide in a short period of time. Up to now, Jilin Province has allocated more than 40 million antigen test kits and distributed them in key areas such as Changchun City and Jilin City.
However, for kit manufacturers, capacity expansion is difficult to achieve overnight. "Our product production requires dozens of raw materials, including antibodies and other core biological raw materials, core technology formulas, as well as extraction tubes, cotton swabs, aluminum foil bags, packaging cartons and other materials, to be all in place to produce, each material is indispensable; back-end outer packaging because of more product packaging specifications, relatively more manual consumption, the current level of automation is constantly improving; plus we do not have a card is outsourced processing or outsourcing to achieve, the production process is complex, quality control points as many as thirty or forty, Every process and every card needs to be fully inspected. The head of Oriental Bio said.
The market size may exceed 100 billion
Antigen kits on the production line. Courtesy of respondents.
With the approval of a variety of antigen detection kits, consumers who want to try new test methods for the first time are also looking forward to seeing the antigen reagents on the shelves as soon as possible.
"If you arrive at the pharmacy two days ago, you can buy it directly in the store." On March 26, the reporter consulted the staff of Beijing National University Pharmacy, Yifeng Pharmacy, and Jinxiang Pharmacy to learn that at present, the new crown antigen test kit has arrived one after another, can be paid by medical insurance, and consumers in need can purchase it after holding an ID card to the pharmacy for real-name registration, but there are not many types and inventories of antigen detection kits available in the store.
Running faster is e-commerce. The reporter's inquiry found that in the online drug purchase platform, it has been shown that the antigen detection kit products of many manufacturers can be sold in stock, including Wanfu Biology, Heatscape Biology, Beijing Jinwolf, Oriental Biology, etc. However, when the reporter asked whether it was possible to purchase products in large quantities, the answers were that "there is not much spot inventory now, and they are waiting in line for suppliers to ship, and bulk purchases need to be booked in advance." ”
Zhongtai Securities Research Report pointed out that with reference to overseas policies, according to the minimum frequency assumption twice a month, it is expected that the domestic new crown antigen self-test kit market is expected to reach 17.7-266 billion yuan in a single month. If you take into account the purchase situation of residents and enterprises at their own expense, it is expected that the new crown antigen examination will be carried out
The demand for test product procurement is expected to further increase. According to this calculation, the annual market size is expected to exceed 100 billion yuan.
However, for now, the applicable population of mainland antigen detection reagents is still limited. At the press conference of the joint prevention and control mechanism of the State Council on March 15, Li Jinming, deputy director of the Clinical Laboratory Center of the National Health Commission, pointed out that there was a false positive for antigen testing, and called on the general population not to do antigen testing at will.
"Antigen testing cannot be used as a diagnosis of exclusion and as a substitute for 48-hour nucleic acid testing." On March 25, Wang Guiqiang, director of the Department of Infectious Diseases of the First Hospital of Peking University, also stressed at the joint prevention and control conference of the State Council that because there are certain false positives and false negatives in antigen testing, if the antigen test is positive, the nucleic acid review will eventually be carried out.
The selection price is as low as 7.6 yuan, and the collection rules still need to be further improved
The staff is working overtime, and the current daily production capacity of Oriental Bio can reach more than 10 million copies. Courtesy of respondents.
At the same time, the special collection of antigen reagents is also in full swing in various places.
According to the incomplete statistics of the announcement issued by the local government, the reporter found that as of March 26, 7 provinces across the country, including Hubei, Henan, Guangdong, Shandong and other provinces, have quickly completed the special collection of new crown antigen reagents, known as "the fastest collection in history", and the price of antigen reagents has also been reduced from double-digit initial listing price to single digits.
On March 15, the Guangdong Provincial Drug Trading Center issued a notice that Wanfu Bio took the initiative to apply for price reduction, and the selected price of the selected new crown antigen detection kit (colloidal gold method) was adjusted to 9.8 yuan / person, a drop of more than 41%. On March 25, the results of the special centralized procurement of antigen detection reagents for the new crown virus in Shandong were announced, and the lowest selected price was only 7.9 yuan / person.
An industry insider who did not want to be named revealed to reporters, "Everyone may think that it is difficult for a product to be reduced to a few dollars as soon as it is listed, but in fact, for the production cost of the new crown antigen detection reagent products on the market, there is no such thing as 'being priced', and the production cost of this product (material + labor) is also about 10 yuan." Personally, I believe that the pricing system of local collection is still reasonable in general, which is more in line with the market-oriented price mechanism. ”
Will prices continue to fall in the future? The above-mentioned industry insiders believe that when there are more and more entrants, product prices may further decline. However, due to the fact that the market is still in its infancy, the demand is blowing up, the industry heat continues to rise, there is still a lot of uncertainty, and eventually this product will be stable in which price range, and it will be determined until the market is roughly stable.
However, in the view of Professor Hu Shanlian of the School of Public Health of Fudan University, in the process of special collection of new crown antigen detection reagents in various places, the concern for "price" should not be overemphasized. Among the current intensively approved antigen reagent products, the test sensitivity ranges from 75% to 98%, and the specificity ranges from 95% to 99%, which means that there are still certain quality differences in the approved products, and the screening standards are not uniform, which may bring certain challenges to the current anti-epidemic work.
"The situation of the kit is more complicated, and it is difficult to evaluate the consistency of chemical drugs, so it is necessary to explore the corresponding collection rules and accelerate the improvement of the access and bidding mechanism." Hu Shanlian suggested that professional testing institutions such as national/local clinical testing centers should be introduced, the corresponding kit screening gold standards should be formulated, the products participating in the declaration should be grouped according to the sensitivity and specificity standards, and the bidding unit grouping rules should be adopted, so as to select the truly "high-quality and high-priced" products.