On October 5, 2020 Diaceutics PLC, (AIM: DXRX) reported new research which predicts that the Non-Small Cell Lung Cancer (NSCLC) testing market will expand to $3.6 billion in the United States by 2025 – up considerably from just $125 million today (Press release, Diaceutics, OCT 5, 2020, View Source [SID1234568115]). The findings are published in the 2020 Diaceutics PM Readiness Report.
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Driven by the increased utility of NSCLC testing and testing services, as well as new single and combination treatments – Diaceutics’ research found that currently, there are 714 new precision medicine treatments focused on NSCLC in late-stage clinical trials – this exponential growth represents 40% of the total value for the NSCLC treatment market. The growing market demonstrates the mounting dependence on precision medicine therapies for cancer treatment; and the pharmaceutical sector’s increasing investment in testing to ensure that their new treatments reach the eligible patient population. In doing so, they are closing the gap on the $2-3 billion in potential NSCLC revenues that is currently lost every year due to inefficient testing.
Currently, only half of patients with advanced NSCLC are receiving the right drug
As pharma revenues continue to be lost due to hurdles inherent with current NSCLC testing pathways, analysis in Diaceutics’ PM Readiness Report shows that this has a significant impact on patient treatment. Currently, only half of NSCLC patients who are eligible for precision medicine therapies receive them, with not enough emphasis being placed on the economic value of diagnostic testing. Pharma investment therefore often does not reflect the true value of efficient testing, or the investment is spread too thinly across multiple players. This disincentivises stakeholders within the testing ecosystem from addressing the entire patient journey from cough to precision treatment, leading to a fragmented approach to testing.
Diaceutics’ research found that by investing heavily in the PD-L1 22C3 antibody, Merck has shown how education and investment drives biomarker adoption, with 83% of all PD-L1 testing today using Merck’s associated antibody.
Furthermore, 10% of patients receive NSCLC treatment without relevant testing
Diaceutics’ research shows that even when patients do receive a precision medicine drug, one-in-10 will receive the wrong one. The PM Readiness Report found that 10% of NSCLC patients are receiving precision medicine treatments without having had the relevant biomarker tests, signifying a knowledge gap amongst oncologists around biomarkers and their associated treatments.
Progress is being made with PD-L1
Recent guidance from the FDA states that it is continually approving multiple drugs that are dependent on the same biomarkers, and pharmaceutical companies should therefore focus on promoting multiple tests that lead patients to their specific therapies, rather than focusing on one proprietary test.
Diaceutics analysed the value in multiple pharma competitors simultaneously promoting companion diagnostic tests for specific groups of therapies and found significant revenue benefits for pharma. In the case of PD-L1 testing, this approach has reduced the post-launch time it takes for a new biomarker test to reach 80% of the eligible patient population from seven years to three. In the case of EGFR and ALK, however, the average delay remains high at six years due to poor pre-launch preparation.
The impact of COVID-19
The fragility of the testing ecosystem has been highlighted by the emergence of COVID-19 and Diaceutics has observed the pandemic’s highly disruptive impact on cancer testing. It found that cancer testing in China decreased by as much as 50% in Q2 2020 versus the Q2 2019. The company’s tracker in the US also revealed that there was a 31% drop in newly diagnosed cases of lung cancer between February and March 2020. The research revealed that while patients already diagnosed with cancer and receiving treatment were continuing to be supported, the decrease in testing over this period will result in a backlog of undiagnosed patients. The ramifications of this backlog will be felt in 2021 and beyond. Furthermore, the increased pressure on testing laboratories caused by the demand for COVID testing has seen a decentralisation of cancer testing observed across China with regional laboratories having to manage the fallout. As a result, Diaceutics observed that enhanced planning and investment will be critical to absorb what will be a significant increase in testing needs following COVID-19.
Speaking about the findings of the report, Peter Keeling, CEO and Founder of Diaceutics, said: "Patients simply cannot get the right treatment without efficient testing – COVID-19 has unequivocally proven that model to be true and has presented us with an opportunity to get out in front of a global testing crisis which has this year, been put in the spotlight.
"The era of launching a therapy with a single companion diagnostic partner is definitely behind us. We need to consider the global needs of our patients and the regional restrictions which have been further exacerbated by the pandemic. This calls for pharma to think beyond a one-size-fits-all approach and to embrace the democratisation of testing.
"The time has come to eradicate the hurdles that stand in the way of getting patients the treatment they deserve. Our evidence, our partners and our experience tell us that there is a better way and that the time for that better way is now. We believe that a global platform will enable the collaboration required between stakeholders to overcome the hurdles in today’s testing ecosystem.
"Research from the Report shows that a platform like DXRX has the potential to reduce the time to achieve 50% test adoption in NSCLC from the current average of 4.5 years to just months. That would be transformative for patients and could make the promise of precision medicine a reality for more people."