NEW YORK – Diagnostics research and development is systematically underfunded, particularly in comparison to other healthcare sectors, according to a report released this week by FIND and Policy Cures Research.
"A Need for Novel Diagnostics: Meeting the Moment" looks into historical funding for diagnostics R&D up to 2020 — using a decade of data from Policy Cures Research's G-FINDER project, which tracks annual investments into R&D for new healthcare products and technologies — and notes the areas of progress, as well as where funding lags behind and what the COVID-19 pandemic response "can tell us about the level of R&D funding we really need," the authors wrote.
One of the report's key findings is that diagnostics receive a small share of overall global health R&D funding. According to the report, the share of global funding going to diagnostics R&D ranged from less than 5 percent in 2013, totaling $142 million, to 7 percent in 2017 at $272 million before peaking in 2020 due to the more than $200 million spent on COVID-19 diagnostics R&D. Despite that increase, there was still a significant gap between diagnostics and vaccine and therapeutic funding: For every dollar invested in COVID-19 diagnostics, $5.20 was spent on developing therapeutics and $11.00 was spent on vaccine R&D, the report found.
The authors noted that "although differences in development costs mean we would not necessarily expect equal funding across different product areas, the size of the gap in diagnostic funding appears too large to be explained solely by more expensive trials for vaccines and therapeutics."
The G-FINDER project tracks three global health areas — neglected diseases, such as tuberculosis and HIV, emerging infectious diseases, and sexual and reproductive health issues, including sexually transmitted infections and pregnancy-related conditions — and the small share of investment in Dx R&D is consistent across all three areas, as well as for COVID-19. The authors found that diagnostics receive less than a tenth of the total R&D funding in those areas.
The share of neglected disease funding has remained relatively consistent over the past 10 years, averaging about 5 percent, while the share of non-COVID-19 emerging infectious disease R&D has been about 6 percent since the G-FINDER project started tracking the area in 2014.
Since 2018, when the project been tracking sexual and reproductive health issues, the share of diagnostics R&D in that area has averaged about 8 percent, the report said. Between 2018 and 2020, 10 percent of product development funding for sexual and reproductive health issues was invested in Dx R&D, compared to 48 percent for therapeutics, 27 percent for vaccines, and 14 percent for devices. The actual dollar values are also much smaller than the other two areas, averaging $26 million per year compared to $71 million per year for emerging infectious diseases and $155 million for neglected diseases, the report found.
As for investments in products that target more than one global health area, more than a quarter went to Dx R&D, despite the "absolute amounts remain[ing] comparatively small," the report said. That funding was "exclusively via investments in general diagnostic platforms and multi-disease diagnostics." Investments in diagnostic platforms and multi-disease diagnostics grew from less than $13 million in 2015 to $77 million in 2019, although it declined slightly in 2020 as funders moved to COVID-19 diagnostics development.
Diagnostic platforms that targeted both neglected diseases and emerging infectious diseases received 47 percent of all funding for Dx platforms in 2020, the report said.
"Platform-based product development can help equip health systems with the tools to respond rapidly to outbreaks of new or forgotten diseases and can allow much of the initial cost of product development to be spread across multiple pathogens," the authors wrote.
Another key finding of the report is that the biggest funders of diagnostics R&D are also some of the largest funders of global health R&D overall: The US National Institutes of Health, US Department of Defense, and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, as well as the Bill and Melinda Gates Foundation, the European Commission, and the industry together account for 69 percent of diagnostics funding in the past 10 years, the authors wrote.
BARDA was the largest single funder of COVID-19 diagnostics R&D, the report noted, with committed funding totaling $265 million to the 25 diagnostic products that ultimately received Emergency Use Authorization from the US Food and Drug Administration for the period covered by the report. However, the US NIH is "by far the biggest funder" of Dx R&D in total, providing a third of all funding — $712 million — over the last 10 years, the report said.
The authors noted that while some of the healthcare investment gap could be due to "genuine differences in cost" between vaccines, therapeutics, and diagnostics, the limited share of R&D funding going to diagnostics "may also be representative of the persistent difficulty in demonstrating impact and return-on-investment of diagnostic products." The report's authors noted that while the benefits of improved diagnostics "extend beyond the patient," they can be hard to measure formally and that metrics for measuring that impact "need to evolve to capture the vital role of diagnostics in management of population health, pandemic preparedness, and public health response at the national and global levels."
As a result of the report's findings, FIND and Policy Cures Research emphasized the need for a coordinated global approach to provide the funding to address the investment gap, saying that "we need better mechanisms for funding product development in the absence of an obvious crisis," such as COVID-19 or Ebola. Those mechanisms will need to be accompanied by "better, less resource-intensive means of estimating the true impact of diagnostics on global health."
The authors added that "while the global R&D response to COVID-19 shows that, with sufficient resources, dozens of novel diagnostics can be developed in a matter of months, it also shows that in the absence of ongoing coordination … product developers may end up engaged in duplicative research and wasting limited investment that could otherwise have been spent in collaborative and mutually reinforcing efforts."