Covid’s rapid testing industry is vying to help prevent the Omicron variant from spreading, with manufacturers expanding production, hiring staff and spreading across entire planes to ship millions of kits at once.
And yet, around the world, anxious customers are queuing up for tests that will allow them to see loved ones, go to school or go to work. French parents were forced to wait for hours in pharmacies, UK websites to order tests collapsed, while Brazilians were warned that there was a “real risk” of a shortage of tests.
The industry, formerly best known for pregnancy tests, was transforming during the pandemic. But the supply chain has struggled to cope as growing Covid cases have increased demand for tests, exacerbated by governments failing to plan well enough.
“All governments suddenly want the same tests at the same time,” said Thomas Schinecker, CEO of Roche Diagnostics. “It’s not like ordering pizza when it comes 30 minutes later. We need a little advance warning. ”
He said the company is in discussions with many governments about providing both rapid antigen tests and more accurate PCR tests that require laboratory processing.
The United Kingdom has pledged to triple its extensive testing program, while the United States requires insurers to pay for eight tests a month while funding free tests for the first time.
The industry was not ready for such a huge jump in demand. William Morris, president of the American Association of Clinical Laboratories, said such fluctuations make it difficult for manufacturers to maintain peak production.
“We didn’t have many of the improved contracts they had for the vaccine that would help,” he said, noting a lack of government procurement.
Abbott, the largest provider of rapid tests in the United States, which had to restart production lines it closed when vaccines were launched, called on the US government to help maintain testing capacity during periods of low demand so that it can answers to future options and services.
In European countries such as Denmark, Germany and the United Kingdom, prices for tests delivered to governments and businesses have fallen since the spring jump in infections weakened last year, according to a former CEO of US-based Innova, which supplies tests to 21 countries.
“There were a lot of shares held by distributors. . . so prices have dropped dramatically, “he said. Now they have increased again as demand has increased, the CEO added.
But many manufacturers continue to expand their capacity by adding new production lines or working with existing 24/7 and recruiting new suppliers. They had to increase the scale by paying more for components: a shortage of tampons and membranes / test strips led to a 25 to 40 percent increase in prices, according to a study by FindDX, a non-governmental organization fighting for greater access to diagnostic testing. .
Some advocates hope that the dramatic expansion of home testing will outlive the pandemic, with diagnostics being used to help distinguish between covid, flu and the common cold, or to identify other diseases.
Christoph Pedine, head of care at Siemens Healthineers, said that even the Biden administration’s recent order for 500 million tests would be about a quarter of the demand for LFTs before the pandemic.
“The scale is really difficult to manage the industry,” he said. “You would not believe all the things that are happening behind the scenes. It starts with getting the right type of wood pulp, the fibers that make up some of the paper, and all the way to transportation.
Omicron hit staff at logistics companies. Carlos Eduardo Gouvea, executive president of the Brazilian Diagnostic Medicine Association, said many flights reserved for import tests had been canceled or postponed.
Paidine said air fares had risen three or four times. ACON, a Chinese manufacturer that produces tests for FlowFlex, one of the main brands used in the UK, said it sends a flight almost every day containing 2m-3m tests.
Kim Jong Cook, director of Seegene, a molecular diagnostic company in Seoul, said it had increased its capacity 18 times in the past two years, but demand had exploded since Omicron.
“We mobilized special charter flights twice last month, one to Europe and the other to Israel, to deliver emergency test kits that can test a total of 4 million people,” he said.
Quick tests are cheaper and easier to do than PCR kits. But they are strictly regulated and complicated to produce: what looks like a piece of paper in the device is actually a special nitrocellulose membrane. It is made in a custom machine, which can take two years to build and nine months more to confirm its consistency. One manufacturer of this membrane told FT that all it can do to increase capacity in the short term is try to reduce the error rate.
In the United States, the Food and Drug Administration has been criticized by the industry for not moving fast enough to approve more manufacturers. Scott Gleeson, interim chief financial officer at Pennsylvania-based rapid test maker Orasure, said the company was cautious about investing in capital projects until the U.S. government intervened as a major buyer late last year.
But Zhang Jialin, a health analyst at Nomura, said volatile demand has prompted Chinese test kit manufacturers to be wary of over-investing in new facilities.
Prashant Yadav, a supply chain expert at the Washington-based Center for Global Development, said demand for tests could always be “feast or hunger”, but planning could be improved. The United States did not begin shipping key components for testing until the fall. “What in God’s name made us wait until October 2021?” He asked.
Yadav said governments and big buyers, such as employers, should encourage producers to invest in the long term by stockpiling for future waves. Even when Covid-19 becomes endemic, tests will be needed to control localized outbreaks.
Increased demand from developing countries, where PCR tests dominate, although rapid tests are cheaper, is also expected to increase, said Emma Hanai, chief access officer at FINDDX.
“Production capacity cannot be increased overnight. “It can’t go from canned to full production in weeks,” she said. “We need oversaturation at times to avoid periods of scarcity.”