Over the past few days, many places across the country have optimized and improved measures to prevent and control the epidemic. With the gradual optimization of epidemic prevention and control policies, antigen detection is expected to become an important means of detection, including Chengdu, Guangzhou, Beijing, Chongqing and other places announced that no longer according to the administrative region to carry out a full nucleic acid test, and to encourage families to prepare their own antigen kit. Stage demand outbreak may drive the release of antigen products, manufacturers and related channels are expected to play an important role in this process.
Before this (November 21), the national level issued the latest version of the "new coronary pneumonia epidemic prevention and control of nucleic acid testing implementation measures" clearly indicated that there is no outbreak of the region, generally not according to the administrative region to carry out the full nucleic acid test, on the buildings and compounds have been found to be positive for infected people can be preceded by antigen detection, negative and then ordered to carry out nucleic acid testing.
New crown antigen test demand rise, is expected to become an important means of detection. China for the world's major antigen exporting countries, in the past to cope with overseas antigen demand at the same time accumulated a wealth of production capacity, the reporter according to the State Food and Drug Administration data incomplete statistics, as of December 5, the domestic new crown antigen test registration certificate has been approved by 36, contains colloidal gold, latex and immunochromatography, magnetic particles chemiluminescence method and other methodologies, the approved manufacturers The region is more decentralized, is expected to protect the stage burst demand.
CIC scorching knowledge consulting manager Liu Xin said in an interview with the 21st Century Business Herald reporter, recently, the new crown antigen detection reagents orders are growing rapidly, antigen products are once again valued by the market, is expected to usher in a phased outbreak. At present, the State Drug Administration has approved 36 new coronavirus antigen detection reagent product layout companies, including Wanfu Biological, Novozymes, Hot King Biologicals, Otai Biologicals, Aikang Biologicals, Huada Ingenics, Huakotai, Yi Rui Biologicals, etc., the market competition is fierce.
"With the continued optimization of epidemic prevention and control policies, enterprises in the new crown antigen detection industry chain will usher in benefits, including downstream reagent kit suppliers, and upstream raw material suppliers of antigens, sampling swabs, droppers, etc." Liu Xin said.
Surge in demand
The antigen test, which measures the protein of the outer layer of the new coronavirus, is used as a supplement to the nucleic acid test, widely used in the home, because it requires no special testing equipment, can produce results in 10 to 20 minutes, is convenient and inexpensive. test is widely used in home testing scenarios because it can produce results in 10 to 20 minutes without the need for special testing equipment and is inexpensive.
The antigen test has been used in Guangzhou, Beijing, Chongqing and Nanjing, based on the fact that the Omicron strain has adapted to the environment and stabilized.
On Dec. 1, Zhang Yi, deputy director and spokesman for the Guangzhou Municipal Health and Wellness Commission, said districts have set up a reasonable number of convenient sampling points based on the distribution of people in the district, population density and other actual situations, and encouraged families to bring their own antigen kits.
On the same day, the Hebei Provincial Bureau of Pharmaceutical Supervision issued a consumer tip on shopping for new coronavirus antigen detection reagents. The Beijing Municipal Health Commission announced measures to optimize daily access to health care, mentioned that for patients without 48-hour negative nucleic acid results, supplementary antigen testing during triage, according to the results of the test for triage. The following day (December 2), the Beijing Municipal Commission of Health also issued an article mentioning, "do a good job of personal protection and health monitoring, use of nucleic acid testing, antigen self-testing."
The current antigen self-testing has attracted the attention of the public and the market. Liu Xin pointed out that with the continued optimization of the national epidemic prevention and control policies, a large number of antigen reagent manufacturers across the country orders are rising rapidly, the overall market demand is rising rapidly in the short term. In the short term, the antigen detection market will usher in a new wave of rapid development. But in the long run, whether the market heat is short-lived remains to be seen.
Accelerating the layout of antigen detection
With the continuous optimization of measures for the twenty measures around the world, as well as the dynamic adjustment of preventive and control measures, the new crown antigens are expected to play an important role in the subsequent prevention and control and self-monitoring.
According to the 21st Century Business Herald reporter combing, at present, China's new crown virus antigen test kits approved for marketing there are four types, colloidal gold method, latex method, fluorescence immunochromatography and magnetic particles chemiluminescence method. Among them, the magnetic particle chemiluminescence method has the advantages of high sensitivity, stable detection results, rapid and easy automation of magnetic separation technology, easy operation, etc., which is one of the more advanced labeling immunoassay technology; the latex method is suitable for on-site testing, and is widely used in clinical testing; the fluorescence method requires testing instruments, and is generally used for larger-scale isolation points or public **** places to centralize the test; the colloidal gold method, similar to the The colloidal gold method, similar to pregnancy tests, does not require testing instruments and is more suitable for home testing. In terms of testing accuracy, the accuracy of using the instrument is relatively higher.
And from the current domestic approval of 36 kinds of new coronavirus antigen detection reagent product classification, colloidal gold method layout more enterprises, including Guangzhou Wanfu Biological, Nanjing Novozymes, Beijing Thermal King Biological, Beijing Wantai Biological, Wuhan Mind Biological, Zhejiang Orient Genetics, Shanghai Berger Medical, Fosun Diagnostics, Zhijiang Biological, etc.; Latex method layout enterprises, including Beijing Jinwuofu, Hangzhou Aotai Biological, Aikang Bio, Innotek, Zhuhai Lizhu Reagent, Jingshuo Bio, Haihatch Medical, Wuxi Kezhida, etc.; fluorescence immunochromatography layout of enterprises involved in Shenzhen Huada Ingen, Beijing Huakotai, Shenzhen Yirui Biological; magnetic particle chemiluminescence layout of enterprises, including Xiamen Vantage Keri Biological, approved by the State Drug Administration on December 2, the listing.
When talking about the market layout of antigen detection enterprises, Wang Wenhua, a partner of CIC Cognition Consulting, told the 21st Century Business Herald that, unlike nucleic acid detection, the operation of the kit is very simple, and the results can also be produced quickly, for a large number of screening is very efficient. From the application scenario, the scattered testing needs of the C-end is greater, and the centralized screening G-end unified purchase to cope with is also a volume of demand that can not be ignored. As for the B end, it depends more on the characteristics of the population flow of the enterprise, there is a very big difference.
Whether G-end, B-end or C-end market, for the layout of the enterprise, the market size are considerable. Also under the stimulation of market demand, there are many companies are accelerating the listing process on the road, such as Anxu Biological, base egg biological and so on. But some industry insiders pointed out that, for late entrants, the regulatory authorities will be the new crown antigen detection reagent product registration application for enterprises to put forward higher audit requirements.
Wang pointed out that national regulators need at least two to three years to approve a Class III medical device license. There's also a long road from R&D to commercialization, which for startups can miss the fastest growth phase for test kits.
"If the company itself has enough technical accumulation and a team of fast license reporting and rich experience to make products and report product registration certificates in a short period of time, there is still a chance to gain a certain market share for a new demand market that is still in the stage of running." Wang Wenhua emphasized.
Capacity creep
For the antigen products market outlook, China Pacific Securities analysis that if the domestic antigen self-testing kits formally liberalized, it is expected that the domestic market for new crown antigen self-testing kits is expected to reach a scale of 28 billion yuan in a single month, and then combined with the Chinese residents, enterprises have a habit of stockpiling the situation, the purchase of new crown antigen detection products Demand for a single month or 56 billion yuan, annual demand will reach 600 billion yuan.
And right now, the domestic antigen self-test kits are also accelerating into the ordinary family. For example, Guangzhou City, Haizhu District since November 7, has been in key areas to carry out antigen detection work; Liwan District, the direct emergency procurement of 5 million copies of antigen reagents, in accordance with the five copies per person, and successively distributed to the residents of the region.
In addition, the 21st Century Business Herald reporter inquired about Jingdong, Tmall, Meituan to buy drugs, hungry, and other e-commerce platforms, are already new crown antigen self-testing products on the shelves, to 20 people / each box, for example, the retail unit price in the 68-78 yuan / box ranging. According to data from Dingdang Express Drugs, in late November, Dingdang Express Drugs on antigen kit weekly order volume compared to the first half of the weekly order volume growth of more than 8 times.
In the residents of the choice of self-purchase, the Guangzhou Municipal Health Commission emphasized that online sales of new coronavirus antigen test reagents through the network should have a "medical device business license", the scope of business contains "6840 in vitro diagnostic reagents", and for the record of the network sales of medical equipment. E-commerce platforms need to provide new coronavirus antigen test reagents network trading services should be handled by the third-party platform for medical device network trading services for the record.
In the case of increased orders for antigen kits, guaranteeing the supply of antigen products has also been put on the agenda, and a number of manufacturers are laying out for this purpose. According to the Guangzhou Municipal Health Commission data, Guangdong Province *** there are five new coronavirus antigen detection reagent manufacturers (Guangzhou Wanfu Biotechnology Co., Ltd, Shenzhen Yafei Long Bio-technology Co., Ltd, Shenzhen Huada Ingen Pharmaceutical Science and Technology Co., Ltd, Shenzhen Yirui Bio-Technology Co., Ltd, Zhuhai Lizhu Reagent Co., Ltd.), *** to obtain five product registration certificates, the product of daily production capacity The daily production capacity of the products is more than 30 million copies.
Shenzhen Yafei Long company said that since Guangzhou adjusted the epidemic prevention and control policy, the market demand for antigen kits increased, and its new Coronavirus antigen detection kit (colloidal gold method) capacity to expand. "At present, the company has no stock, the company daily production of 7.5 million kits, are the same day production on the same day delivery, the number of orders is high. The future production of the kits will also be adjusted according to the orders."
Zhejiang Dongfang Genetics also said that the market demand for antigen detection reagents, the company's production capacity is in the state of "climbing", the company still has inventory, but it did not provide specific stocking and sales data.
"The price will definitely be reduced in the future, on the one hand, with the increasing number of market participants, the new crown antigen test kit market competition will be more intense. On the other hand, the State Drug Administration has clearly stated that it will 'further strengthen the supervision of product quality and safety of the new coronavirus antigen detection reagents', and the possibility of incorporating them into the medical insurance and collective purchasing will continue to increase as the standardized management of antigen detection continues to be strengthened." Wang Wenhua believes that, with reference to the price reduction history of nucleic acid detection reagents since their launch, there is more room for antigen detection kit price reduction.
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