COVID-19 testing at point of care peaked in Q1 2022. Is testing waning? What is COVID-19's lasting effect on point-of-care testing?
COVID-19 cases peaked in Europe and North America over January 2022 yet revenue from point-of-care testing did not all peak across the board. Some market leaders continued to see rapid growth in Q1 sales from this wintertime peak, and companies that launched their first diagnostic platform via COVID-19 testing continued to grow their platform install bases. Yet others began to feel the decline throughout Q1, indicating a waning pandemic. As COVID-19 cases fall from their wintertime peak, companies are moving to prepare for the following clinical need for flu/COVID-19 multiplexed testing before the onset of the next flu season. In the report "Biosensors for Point-of-Care Diagnostics 2022-2032: Technology, Opportunities, Players and Forecasts", IDTechEx investigates how the point-of-care market has been shaped by COVID-19. IDTechEx explores the emerging technologies that are enabling point-of-care, and what applications will drive the market beyond COVID-19.
Peak quarter for POC COVID-19 tests
COVID-19 has been a colossal injection of sales revenue for the point-of-care industry over the last two years, with a massive expansion of the lateral flow assay market and integrated cartridges market. In the winter of 2021/2022, COVID-19 grew to its all-time global high number of cases, peaking at over 23 million per week in January 2022. This was driven by rising cases mostly in Europe and North America. Due to this climb in cases, many players reported continued rapid growth of testing revenues for Q1 of 2022. In its first quarter, market leaders announced sales between 150 and 182% over the same quarter in the previous year, exceeding their projections. The most significant sale of the quarter was a $1 billion contract awarded to Abbott Laboratories by the US Army for rapid antigen COVID-19 tests.
Continued success for newly launched technologies
During this pandemic, several startups have been able to launch their first platform and products by pivoting their technologies toward COVID-19 testing. These companies have been able to use the opportunity to establish footholds on the market, buoyed by government grants to develop capacity as well as faster regulatory pathways via the Emergency Use Authorization (EUA). Further, new sources of sales have emerged from large corporations transitioning from remote working back towards conventional office work, using testing to safeguard employees. Airports, events, and venues too have been new sources of revenue for test manufacturers. As such, in 2020 and 2021, these startups have been able to grow their total earnings and business operations rapidly. In the first quarter of 2022, these companies have continued to see the same success. For their technologies, COVID-19 is demonstrating the effectiveness and value of new point-of-care technologies, such as miniaturized PCRs and other point-of-care nucleic acid amplification techniques. The rapid growth of install bases will help these companies establish repeated sales beyond COVID-19 and is a launchpad from which test menus can expand to other infectious diseases.
COVID-19 testing: A cooling market?
Yet, the pandemic has been declining globally throughout 2022 since the January peak. The total testing in the US in May is a tenth of the peak in January. In the UK, it is a sixth. Consequently, companies are expecting this source of revenue to drop rapidly. Abbott Laboratories, for instance, projects total revenue from COVID-19 related sales this year to be 58% of the total revenue the year before. For Becton, Dickinson, and Company (BD), this shrinking of testing has already begun; in their first quarter, BD reported a decline in revenue from COVID-19-only testing.
A large enabling factor for the success of COVID-19 diagnostics revenue has been the emergency use authorization (EUA) regulation adopted by the FDA (the USA food and drugs administration). This has allowed device manufacturers access to the market with EUA approval rather than the full and far more stringent full 510k authorization. However, as the US moves out of a public health emergency, the FDA will remove the EUA. When this period arrives, companies will need to further invest in submitting premarket applications for conventional regulatory authorization. The FDA has published drafts of the transitionary plan for this period, although this is yet to be finalized.
"COVID-19 plus" market approaching
As the pandemic wanes and the next flu season approaches, there is an emerging need for "COVID-19 plus" tests. COVID-19 and other respiratory viruses, particularly influenza, share clinical symptoms. The exception is the loss of taste for SARS-CoV-2 infections, but this symptom is only present in 17% of positive cases with the omicron variant. Therefore, there is a clinical need for a multiplex test to precisely diagnose the infectious disease which cannot be identified on symptoms alone. Both Roche and BD have already launched their SARS-CoV-2 & Flu A/B lateral flow antigen assays, and indeed BD reported that their base diagnostics business in the first quarter was driven by demand for this flu/COVID-19 test. Like many other players that launched new platforms, Cue Health are now advancing to development of a flu/COVID-19 test on theirs. The company announced that they began clinical trials in Q1.
COVID-19 continues to be a critical driver in 2022 and beyond but is not the only driver affecting the shift towards point-of-care for the diagnostics industry. Point-of-care solves pain points for other infectious diseases as well as chronic diseases like diabetes and cardiovascular diseases; these pain points will worsen with population growth and aging. Consequently, IDTechEx expects the point-of-care industry to grow over the next ten years, with a forecast of $29.5 billion by 2032. The IDTechEx report "Biosensors for Point-of-Care Diagnostics 2022-2032: Technology, Opportunities, Players and Forecasts" explores in detail other key drivers and applications for point-of-care technology and examines the emerging technologies that are enabling the shift to point-of-care.
For more information on this report, please visit www.IDTechEx.com/Biosensors or for the full portfolio of healthcare research available from IDTechEx please visit www.IDTechEx.com/Research/Healthcare.