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How can real-time analysis of the PD-L1 testing market boost precision medicine?





In an article for Clinical Lab Products magazine, The Evolution of the PD-L1 Testing Market, Peter Keeling and Ewelina Golebiewska examine how the extraordinarily dynamic PD-L1 space is providing opportunities to undertake real-time market analysis and ultimately improve our understanding of novel biomarker adoption.

This active approach to real-time analysis, combined with the insights of a dedicated prescriber panel established by Diaceutics to observe the situation, has generated predictions based on a hectic first few years of PD-L1 testing market development and an increasingly dynamic landscape.

Diaceutics believes that despite the uncertainties hanging over the first generation of diagnostic tests, PD-L1 will become a hyperconnected oncology biomarker. For instance, by the end of 2020, when the clinical utility of PD-L1 status will be proven, 75 per cent of all NSCLC trials for five PD-1/PD-L1 therapies are likely to require known PD-L1 status, bringing PD-L1 in line with ALK and EGFRm as key disease-based biomarkers. And yet, although it has been nearly 20 years since the launch of the first truly targeted cancer drug and companion biomarker—Herceptin and HER2—we are still suffering from the absence of attention to pre-launch market development for critical biomarkers.

Most of the issues that are detectable in the PD-L1 testing space have also been seen in previous biomarker programs. However, this is the first opportunity that analysts have found to conduct real-time scrutiny in order to track and understand the clinical and competitive impact of such tests as they come to market. The anti-PD-1 therapy class of drugs is slated to achieve $33 billion in annual revenues in 2022. But capturing much of this expected revenue will rely on appropriate application of PD-L1 testing—a field that remains significantly underdeveloped and underpowered to support all that is hoped for anti-PD-1 therapies.

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