As the COVID-19 crisis surfaced in the United States, molecular diagnostic manufacturers went to work with new RT-PCR testing kits. The worldwide demand for COVID tests has materialized rapidly from zero and already on course become a 1.3 billion-dollar market in the first half of 2020.  There have been hundreds of tests on the market receiving EUAs from the Food and Drug Administration, but a survey from the Association of Molecular Pathology demonstrated that only a few are used by laboratories.  As part of a survey for the Association for Molecular Pathololgy (AMP) : https://www.amp.org/advocacy/sars-cov-2-survey/  labs were asked their top ten testing methods. Among them: Abbott m2000, Roche cobas were the top two vendors in most labs’ top tens.

This makes sense, these systems are the ones in most laboratories and the ones that are set up for other RT-PCR uses such as testing for HIV. Other tests in labs’ Top Tens included: Cepheid Gene Xpert Roche cobas, Hologic Panther, DiaSorin Simplexa, Quidel Lyra, Thermo Fisher Taq Path, Abbott IDNOW, CDC Test. There’s still a market for innovators.  (Labs also were in many cases citing their own LDTs as top test).

There is debate regarding how early the first cases appeared in various parts of the world, but in the first quarter there were only a small number of countries with sufficient cases to prompt serious actions.

Kalorama’s report updates with detail on both COVID-19 molecular testing markets and non-COVID-19 testing: https://kaloramainformation.com/product/molecular-diagnostics-markets-in-the-covid-19-era/

Kalorama estimates a 4.5 billion dollar market for COVID-19 testing by year’s end. Unique near-patient tests, sample collection methods such as saliva or self-test, NGS and mass spectrometry testing, multiple PCR test targets, improved antibody tests, high throughputs, extraction kit workarounds – these are all examples of areas that innovators can improve. The worldwide demand for COVID tests has materialized rapidly from zero and is on course to become a multi-billion dollar market in 2020.

In different regions, there are different situations with respect to COVID-19 testing:

US: The United States has been the largest market in terms of both tests and revenues. In the US, testing has followed a fairly consistent, linear trajectory as the new cases plateaued, then declined, then rose again. This is not entirely unique, but represents a sort of “middle” situation where the curve was greatly diminished but was not completely squashed. The overall pattern actually represents the combination of multiple regions – the Northeast, the focus of the initial spike, is now seeing new cases reduced to close to 90% of the peak, while areas of the South are rising rapidly and some other regions are relatively flat.

Europe: Western Europe experienced a large surge in cases just after the initial spike in Asia. Like Asia, many of the Western European countries were also mostly successful in squashing the curve to a manageable level. With some exceptions, the number of new daily cases is well under 90% of its volume at the peak. To provide one example, Italy has seen its new cases drop to almost none while its testing volume remains flat.

Asia: While many Asian countries such as Japan and South Korea were mostly successful in eliminating the virus, there is now a surge in several high population countries including India, Bangladesh, and Pakistan. In these South Asian countries, the initial spike arrived a few months later and is still running its course. Testing resources are much more scarce, causing some labs to resort to serology testing for diagnostic purposes.

Latin America: While Latin America and ROW are experiencing high growth right now, significantly increasing their shares, the impact on this market is diminished due to lower per capita testing; in addition, the revenues are significantly affected by lower prices. Europe’s share is anticipated to drop off gradually due to many countries appearing to contain the virus; however, Eastern Europe is still experiencing a surge.

The news is not all positive from a revenue perspective.  Molecular testing on COVID is paired with declines in more traditional molecular tests as patients avoided doctors and continue to reduce in person doctor visits during lockdown.  Down but not out segments include cancer, histology and inherited diseases which are expected to continue to grow, perhaps surge, later in the year and into 2021. Prior to COVID-19, liquid biopsy was one of the stars of this segment. Favorable regulatory policies in the United States and promising studies will enhance companion testing. New LDT tests in Inherited disease testing in particular, using IVD supplies which includes non-invasive prenatal testing (NIPT), is driven by the demand in China. Even though the demand is for laboratory test services and not for IVD products, the demand for instruments, kits and consumables that are approved by regulatory agencies is driving the segment. However, the market opportunities may be challenging to access by foreign IVD companies due to the regulations promoting domestic companies.

Kalorama’s report updates with detail on both COVID-19 molecular testing markets and non-COVID-19 testing: https://kaloramainformation.com/product/molecular-diagnostics-markets-in-the-covid-19-era/

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