Inside the Lab Industry

COVID-19 Surge Lifts Overall Molecular Point of Care Testing Market to $900 Million

To the uninitiated, the term molecular point-of-care (POC) testing might sound like an oxymoron. After all, the science of molecular microbiology is all about detecting targeted bits of microbial genetic material from DNA or RNA that must be extracted directly from a patient sample. This seems like the kind of thing that can only be done in a lab. This is especially true for molecular tests that utilize polymerase chain reaction (PCR) technology to amplify and generate copies of the targeted genetic material. However, advances in technology have made it possible to perform these functions in any CLIA-waived settings, including at the point of care.

While molecular POC diagnostics had already been growing at a rapid rate for a long time, it has really taken off during the pandemic. Lab industry financial consulting firm Kalorama Institute estimates that demand for COVID-19 products will push the market for molecular POC testing to $900 million in 2021. While demand for COVID-19 products, which has become the largest segment of the market, will drive growth, other sectors, particularly respiratory and influenza test will also benefit from it.

The Molecular POC Market

Kalorama has been issuing annual or biannual reports on the molecular POCT market since 2013. Its newest report for 2021, “Market and Future Potential for Molecular Point of Care,” defines molecular POC as near-patient PCR sequencing or other nucleic acid testing (NAT) testing utilizing small instrument size, near-patient placement and rapid test turnaround. The definition also includes CLIA-waived or tests requiring a lower threshold of operational training positioning them to earn CLIA waivers over the next five years. Notable examples of molecular POC systems listed in the report include:

  • Abbott’s IDNow;
  • BioMérieux’s BioFire;
  • Cepheid’s GeneXpert; and
  • Roche’s Cobas Liat.

The Pandemic Factor

 Of course, all of these systems were well established before the pandemic. But, as Kalorama notes, because they’re more expensive than other types of POC testing, molecular systems needed to demonstrate marginal worthiness to secure adoption. When COVID-19 hit, the dynamics changed. As molecular PCR assays became the COVID-19 assay modality of choice, testing labs felt more pressure to install molecular POC systems driving significant spikes in sales. Examples:

  • Cepheid placed “a record number” of new GeneXpert systems in 2020, increasing its installed base 35 percent to more than 30,000 instruments globally;
  • Roche’s overall POC molecular business grew by 152 percent year over year;
  • BioMérieux’s BioFire product line grew 76 percent with the installation of nearly 1,400 FilmArray instruments in the fourth quarter alone.

The other way COVID-19 lifted the market was in accelerating the development and sales of PCR-based POC molecular tests for SARS-CoV-2. On March 1, Cepheid’s Xpert Xpress SARS-CoV-2 test for use in moderate- and high-complexity CLIA labs became the first to secure FDA Emergency Use Authorization (EUA) for a rapid, near-patient test. Dozens would follow, including products from Abbott, Becton Dickinson, Bio-Rad, BioMérieux, LabCorp and Quest, to name just a few. As a result, as Kalorama notes, many companies reported increases in spending on consumables per system in the range of 50 percent to 60 percent.

Is It Sustainable?

The molecular POC testing market is likely to continue growing but not at nearly the same rates, according to Kalorama. Although most experts believe that steady demand for COVID-19 testing will continue for at least the next two years, the surge of 2020 was and is unsustainable. However, there’s much more to molecular POC testing than COVID-19. Influenza and other respiratory testing is, by far, the biggest segment of the non-coronavirus market. Other notable segments include tests for hemagglutination inhibition (HAIs) and sexually transmitted infections (STIs).

Meanwhile, as technology gets smaller, cheaper and more sophisticated, new forms of POC innovation continue to emerge. One notable example is the lab-on-a-chip (LOC) requiring just a few drops of blood, which is currently in use and likely to become more widely deployed, especially in rural and other areas with limited healthcare resources. In addition, diagnostics companies are increasingly combining different technologies into single platforms enabling users to run multiple tests on a single sample. Thus, for example, Abbott’s i-STAT 1 POC blood analyzer can perform tests for cardiac markers, coagulation, blood gases, chemistries, electrolytes and hematology on one cartridge. Roche’s Cobas Liat PCR System can test for influenza A/B, respiratory syncytial virus and group A strep in about 20 minutes.

Takeway

 Molecular POC testing was growing before the pandemic and will continue to do so after the pandemic, even as COVID-19 test volume recedes. “Less than 10 years since the launch of these systems,” notes Kalorama, there’s a marketplace with a real foundation in at least one testing segment, respiratory,” and many more potential markets in other areas. At the same time, while not sustainable in the long-term, the COVID-19 surges of 2020 will sow the seeds of new growth in the future as companies reap the rewards of the molecular POC systems they placed during the year.

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