In 2021, Kalorama Information, sister publication to LabPulse.com, estimates the market for molecular point of care (mPOC) diagnostics will be worth $900 million. Not surprisingly, COVID-19 is the major factor in market growth and is the largest component of the market, with products such as POC immunoassays for COVID-19 expected to see technological advancements.
Molecular POC diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients. The concept of mPOC is to combine the accessibility of POC testing with the accuracy of molecular technology.
Kalorama defines mPOC as near-patient polymerase chain reaction (PCR), sequencing, or other nucleic acid testing (NAT) systems that offer small instrument size, near-patient placement, and fast turnaround of tests. The definition also covers tests that are CLIA-waived or tests that require a lower threshold of operational training so that they may earn CLIA waivers in the next five years.
A few examples of mPOC systems include Cepheid's GeneXpert, Abbot's IDNow, Roche's Cobas Liat, and BioMerieux's BioFire.
Before COVID-19, molecular systems needed to prove marginal worthiness as they are more expensive than other types of POC testing. The report indicates that at present COVID-19 has resulted in a huge acceleration in both system installations and spending on consumables per system. Cepheid's installed base increased by around 30% in 2020 and sales of bioMerieux's systems increased from around 600 per quarter. Spending per system was reported by many companies to have increased around 50%-60%.
Nonetheless, this surge is likely to be temporary. COVID-19 testing volumes should decrease regardless of whether the vaccines are fully effective. Volumes are expected to dip back within two years and taper to a level not very distant from previous forecasts. New systems will lead to increased usage since they provide motivation for additional testing.
Kalorama 's findings are in its report, "Market and Future Potential for Molecular Point of Care."
Kalorama has covered the mPOC segment on a yearly or biyearly basis since 2013. Outside of COVID-19, the mPOC market is overwhelmingly in the respiratory category, with most of that dedicated to influenza testing. Other tests include hemagglutination inhibition (HAIs) tests and those for sexually transmitted infections (STIs), among other conditions.
Less than 10 years since the launch of these systems, Kalorama finds a marketplace with a real foundation in at least one testing segment, respiratory, but still with more potential than markets in other areas. The molecular POC diagnostics market detailed in the report includes sales of clinical IVD systems (tests, consumables, and instruments) used outside of central clinical laboratories such as hospital laboratories and reference or independent laboratories. Molecular diagnostics includes tests that detect or interrogate nucleic acid analyte sequences using processes such as nucleic acid amplification, hybridization with oligonucleotide probes, and nucleic acid sequencing.
The instrument placements that mPOC earned in 2020 should continue to pay dividends for companies in the future. Present in laboratories, mPOC systems can be put to work for influenza and antibiotic reduction even if the COVID-19 threat were to pass, which so far seems a long time away.
Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group. Kalorama's market report on molecular point of care can be found on Kalorama's website.
Disclosure: LabPulse.com is a sister company of Kalorama Information.