A Trillion-Yuan Blue-Ocean Market: COVID-19 Antigen Self-Testing
Release Date:
2022-05-08 11:03
To further optimize COVID-19 testing strategies in light of epidemic prevention and control needs, the Comprehensive Group of the State Council Joint Prevention and Control Mechanism has decided to advance “ Antigen screening, nucleic acid diagnosis a monitoring model that supplements nucleic acid testing with antigen testing. On March 11, the Comprehensive Group of the Mechanism formulated and issued the “Trial Implementation Plan for the Application of COVID-19 Antigen Testing” (hereinafter referred to as the “Plan”), requiring all localities to conscientiously organize and implement it.
On the morning of March 12, the National Medical Products Administration issued an announcement approving Nanjing Novozymes, Beijing Jinwofu, Shenzhen BGI InnoSource, Guangzhou Wanfu Biotech, Beijing Huaketai Biotech Applications for changes to the self-testing use of COVID-19 antigen products have been submitted. As a result, five COVID-19 antigen self-testing products are now officially on the market.
Currently, COVID-19 antigen self-test products listed on the Meituan platform are priced between RMB 29.8 and RMB 32.8 per test kit, with each brand employing a slightly different detection principle. The primary methods used include the latex agglutination assay, the colloidal gold immunoassay, and the fluorescent immuno-chromatographic assay.
Image source: Meituan platform’s COVID-19 antigen self-test products
Latex method It is an indirect agglutination assay that uses latex particles as carriers. Specifically, soluble antigens are adsorbed onto the surface of these particles; upon binding with specific antibodies, an agglutination reaction is produced. Colloidal gold method Gold particles of a specific size can be synthesized by reducing chloroauric acid (HAuCl4) using reducing agents such as white phosphorus, ascorbic acid, sodium citrate, tannic acid, and others. Due to electrostatic repulsion, these particles remain in a stable colloidal state, forming a negatively charged hydrophobic colloid solution. This stable colloidal state is maintained by electrostatic forces, which is why the resulting product is referred to as colloidal gold. Fluorescence Immunochromatography Yes A novel membrane-based detection technology based on antigen–antibody-specific immune reactions. This technology uses strip-shaped fibrous chromatographic materials immobilized with a test line (coated with antibody or coated with antigen) and a quality-control line (anti-antibody) as the stationary phase. , the test solution is The mobile phase, along with fluorescently labeled antibodies or antigens immobilized on the conjugate pad, drives the analyte to migrate across the chromatographic strip via capillary action.
According to an analytical report by Minsheng Securities: In the short term, we expect COVID-19 antigen testing to be piloted in eastern regions. Given the current situation of supply falling short of demand and a favorable competitive landscape, we assume a factory-gate price of RMB 6–10 per test kit. Based on a penetration rate range of 10%–50%, with the median value set at 30%, the corresponding monthly domestic market potential for COVID-19 antigen testing would be 80.6–134.4 hundred million yuan. However, given that the current market price for COVID-19 antigen self-test kits is RMB 20–40 per test, the estimated monthly domestic market potential for such products is 268.7–537.6 With sales reaching hundreds of millions of yuan, it has become a hot consumer-grade product that has ignited the market. At the same time, industry insiders’ feedback suggests that the market pricing is clearly too high, and the pricing strategy is open to debate.
First, from a scientific standpoint, the sensitivity and accuracy of COVID-19 antigen self-test products still fall short of those of pharyngeal swab nucleic acid tests. Moreover, the current reimbursement rate for pharyngeal swab nucleic acid tests under national medical insurance is RMB 40 per test. It is hoped that the State Administration for Market Regulation will adopt a scientifically sound and reasonable pricing approach, given that ordinary citizens have been significantly impacted by the pandemic in both their personal lives and work over the past few years. Meanwhile, IVD diagnostic reagent companies have experienced explosive growth in both corporate performance and stock prices over the past two years due to the COVID-19 pandemic; it is therefore expected that these companies will fulfill their social responsibilities.
(Reposted from E-Pharmacy Barometer )
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