The molecular diagnostics market, including new tests for COVID-19, will exceed 13 billion dollars by year’s end, according to market research firm Kalorama Information. Kalorama, a market research firm specializing in the in vitro diagnostics market, is part of Science and Medicine Group. This market volume is due to the sheer volume of PCR tests being conducted worldwide. These tests generate revenues for the major molecular IVD players, such as Roche, Abbott, Biofire, Cepheid and Hologic, and also for hundreds of smaller global or regional companies.
Kalorama Information’s report Molecular Diagnostics Markets in the COVID-19 Era (Markets for Molecular COVID-19 IVD Tests, Respiratory Tests, Blood Screening, Cancer Markers and Other IVD Tests) lists over 200 companies currently making COVID-19 Tests and estimates market sizes and forecasts.
In addition to the now well-known RT-PCR tests developed for the pandemic, there are many more marketed molecular tests, including tests for HIV, hepatitis, cancer and inherited diseases. Molecular was already a large and growing market, edging on ten billion dollars in revenue, when Kalorama last published its report in 2019.
Kalorama Information finds that the market for all molecular tests sold for a clinical diagnostic purpose will exceed 13.5 billion dollars in 2020, with 4.5 billion of the amount from COVID-19 tests using DNA-based diagnostics. This tilt to molecular systems is sudden and Kalorama says, it may even outlast the pandemic.
“In 2019, there was still a degree to which vendors were persuading laboratories of the benefits of molecular approaches over immunoassays,” said Bruce Carlson, Publisher of Kalorama Information. “Flu is an example — you had some healthcare systems still deciding if adoption of molecular point of care for flu seasons would cover their demand.”
Now, Kalorama notes, the challenge has been how fast systems can be set up and how much throughput they can offer as a war-like mentality develops in global labs. RT-PCR systems have been highly utilized and supplies strained. New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods. As governments loosened requirements for authorization of tests, there was a sudden surge in global demand and an unprecedented flood of new products. Scores of companies entered the fray, some of which have rushed or cut corners and produced tests with low accuracy.
“There is no shortage of competitors entering this market, and even if there is a solution to COVID-19, we expect many of these new vendors to stay, and develop other products,” said Carlson. “they will make tests for other conditions and some will be on standby with production knowledge and facilities for the next pandemic.”