COVID test kits see surge in sales
Devices made by Chinese companies in high demand overseas on innovation, speed of adaptation
Thanks to much-improved research and development capabilities, Chinese companies able to quickly develop a myriad of nucleic acid, antigen and antibody test kits after the outbreak of COVID-19 have seen a spike in orders for the products in recent months.
As the global COVID-19 pandemic drags well into a third year, demand for related test products keeps growing both at home and abroad, especially with the fast spread of the highly transmissible Omicron strain.
Chinese manufacturers’ increased production is making great contributions to global anti-pandemic efforts. Their endeavors to meet huge test kit demand worldwide over the years have also driven them to climb up the industrial value chain, analysts said.
“China’s in vitro diagnostic device (IVD) producers have been producing various test kits in large volumes to help not only China but also other countries deal with the disease properly, due to their solid manufacturing capacity. Their efficiency in organizing development and production of urgently needed test products is very impressive,” said Shi Lichen, founder of medical consultancy Beijing Dingchen Consultancy.
“Boosted by both the huge domestic market and a supportive regulatory environment, they have become even better prepared for innovationdriven growth to design and produce high-quality and original products and take a bigger share in high-end markets,” Shi said.
IVD is a knowledge-intensive area that features interdisciplinary research and development, manufacturing and laboratory applications involving biology, physics, chemistry, optoelectronics and genetics, and it is very difficult to develop high-end products, he added.
According to the General Administration of Customs, the export value of China-made COVID-19 test kits reached 18 billion yuan ($2.83 billion) in February, with a month-on-month growth of 9.4 percent.
In January, the export value was 16.48 billion yuan, growing 33 percent from December.
As of March 8, more than 700 enterprises in China had received the Conformite Europeenne (CE) mark, while more than 30 enterprises had earned market entry approval from the US Food and Drug Administration, according to a report by Guotai Junan Securities.
Guangzhou Wondfo Biotech Co Ltd said it had provided numerous test kits to around 100 countries and regions worldwide, including those in Europe, Asia, Latin America and the Middle East.
The successive launch of a series of test products in domestic and foreign markets and the substantial sales figures have been driving the rapid growth of the company, Wondfo said.
During the first half of 2021, its sales of COVID detection kits hit more than 660 million yuan. In 2020, sales totaled around 1.05 billion yuan.
Shenzhen, Guangdong provincebased BGI Group, one of the world’s largest genomics sequencing companies, said it had developed a rich portfolio of COVID test products for nucleic acid, antibody, antigen and neutralizing antibody detection with various testing technologies to meet diversified testing demand amid disease control efforts.
It had obtained 37 market entry certificates as of June last year for COVID test kits around the world, and its test products have been exported to more
than 180 countries and regions.
Its antigen detection kit using fluorescence immuno-chromatography technology is about 10 times more sensitive than the traditional colloidal
gold chromatography detection technology-based test kits.
The company’s COVID rapid nucleic acid test kits, which can also be applied in self-use scenarios, are also much more sensitive than antigen detection products, and have obtained CE certification.
In addition, to meet demand for rapid tests in front-line work scenarios such as Customs, airports and ports that lack professional laboratory facilities and personnel, BGI has come up with a solution called PM Easy LAB — a fully enclosed rapid integrated detection system that can detect 16 common respiratory pathogens simultaneously, including COVID-19.
Apart from overseas demand, the high-level test demand in the domestic market has also been presenting ample growth opportunities for COVID test producers and service providers.
Adicon, a leading third-party independent clinical laboratory company in China, has seen a significant surge in both revenue and profit over the years.
The company recently announced it will seek an initial public offering in Hong Kong again, after a failed attempt last year.
Its prospectus showed the company’s revenue in 2019, 2020 and last year at, respectively, around 1.73 billion yuan, 2.74 billion yuan and 3.38 billion yuan. Nucleic acid test services accounted for about one-third of total revenue during the period.
The company operates 26 fully owned diagnostic laboratories in China. It has established a cold-chain logistics network covering more than 17,000 medical institutions in 31 provincial-level regions, or more than 1,500 cities and counties.
The tests it conducted increased from 46 million in 2019 to 60 million in 2020, or grew by 30.7 percent. Last year, the number further increased 33.9 percent year-on-year to 80.5 million.
As for nucleic acid tests, the company has conducted more than 43 million since the outbreak of the pandemic.
While nucleic acid tests have become widely used among Chinese people, applications of antigen test products have also been on the rise amid the recent resurgences of local cases in many places across China.
On March 11, the central authorities decided to add antigen detection as a supplement to the nucleic acid test in the fight against COVID-19 in China to improve early detection capability.
As of April 2, 24 antigen test products had been approved for market launches in China, according to the National Health Products Administration.
Beijing Savant Biotechnology, Nanjing Vazyme Biotech, Guangzhou Wondfo Biotech, and Shenzhen-based BGI PathoGenesis Pharmaceutical Technology, a subsidiary of BGI Group, are among the very first local enterprises approved on March 12 to revise their COVID-19 antigen test kit certificates to allow self-test use.
The antigen test kits can be used by people who have had a fever or respiratory symptoms within five days, by people under quarantine and by other residents who simply want to take a test. Those who have self-testing demand can access antigen test products via shops or online channels.
While a nucleic acid test result is still required to confirm the novel coronavirus infection, people who test positive with COVID-19 antigen kits are asked to immediately contact local authorities regardless of whether they show symptoms, the National Health Commission said in a notice on March 11.
In another notice issued by the National Healthcare Security Administration on March 21, provincial-level healthcare security authorities were asked to temporarily include COVID-19 antigen test kits in the catalog of medical services covered by basic healthcare.
A report by Huaan Securities said the market for self-use antigen test kits is forecast to reach 268.8 billion yuan annually in China, if such a test is priced at 10 yuan and 80 percent of Chinese have antigen tests twice a month.
However, Shi, with the consultancy firm, said although homegrown antigen tests have ample market opportunities abroad, he believes the domestic market is quite limited as China adopts a stringent COVID-19 control approach and is capable of containing the current outbreak soon.