Women’s Health has been historically underfunded which has hindered innovation greatly both in diagnosis and treatment. This critical imbalance persists despite the widespread prevalence of conditions such as endometriosis, which afflicts an astonishing 10% of females worldwide, and represents a pressing need for more effective diagnostic and treatment options.
A stark disparity becomes evident when comparing Women’s Health to other therapeutic areas within the biopharmaceutical industry. The market is dominated by generics, primarily hormone- targeting drugs, leading to fierce pricing competition. Additionally, regulatory guidance from FDA and EMA on several of these conditions remains conspicuously absent contributing to the already high R&D hurdles for clinical trial sponsors (e.g., lack of clinical trial endpoints, low recruitment rates, inadequate animal models). Furthermore, there is a profound lack of comprehension surrounding the underlying pathophysiology of these diseases, a deficiency in basic research that significantly constrains the development of novel mechanisms of action and/ or bringing innovative treatments from other therapeutic areas into Women’s Health.
Nevertheless, there is a growing number of initiatives aimed at supporting early-stage innovative developments. One example of a funding model that encourages transformative research is the BioInnovation Institute (BII). BII provides financial support for innovations that propel the creation of novel solutions, particularly by early-stage life science start-ups operating in diverse areas, including Women’s Health.
Another example is Repro Grants, which is a program that awards grants to scientists or academic institutions dedicated to the advancement of Women’s Health research. While these initiatives undeniably play a pivotal role in propelling early-stage research aimed at unraveling the underlying pathophysiology of diseases, it is imperative to acknowledge that realizing substantial progress in this field will necessitate significantly larger investments.