Startups devoted to reproductive and women’s health are on the rise. However, most of them deal with women’s fertility: birth control, ovulation and the inability to conceive. The broader field of women’s health remains neglected.
Historically, most of our understanding of ailments comes from the perspective of men and is overwhelmingly based on studies using male patients. Until the early 1990s, women of childbearing age were kept out of drug trial studies, and the resulting bias has been an ongoing issue in healthcare. Other issues include underrepresentation of women in health studies, trivialization of women's physical complaints (which is relevant to the misdiagnosis of endometriosis, among other conditions), and gender bias in the funding of research, especially in research grants.
For example, several studies have shown that when we look at National Institutes of Health funding, a disproportionate share of its resources goes to diseases that primarily affect men -- at the expense of those that primarily affect women. In 2019, studies of NIH funding based on disease burden (as estimated by the number of years lost due to an illness) showed that male-favored diseases were funded at twice the rate of female-favored diseases.
Let’s take endometriosis as an example. Endometriosis is a disease where endometrial-like tissue (‘‘lesions’’) can be found outside the uterus. Endometriosis is a condition that only occurs in individuals with uteruses and has been less funded and less studied than many other conditions. It can cause chronic pain, fatigue, painful intercourse and infertility. Although the disease may affect one out of 10 women, diagnosis is still very slow, and the disease is confirmed only by surgery.
There is no non-invasive test available. In many cases, a woman is diagnosed only due to her infertility, and the diagnosis can take up to 10 years. Even after diagnosis, the understanding of disease biology and progression is poor, as well as the understanding of the relationships to other lesion diseases, such as adenomyosis. Current treatments include surgical removal of lesions and drugs that suppress ovarian hormone (mainly estrogen) production.
However, there are changes in the works. The NIH created the women’s health research category in 1994 for annual budgeting purposes and, in 2019, it was updated to include research that is relevant to women only. In acknowledging the widespread male bias in both human and animal studies, the NIH mandated in 2016 that grant applicants would be required to recruit male and female participants in their protocols. These changes are slow, and if we look at endometriosis, it received just $7 million in NIH funding in the fiscal year 2018, putting it near the very bottom of NIH’s 285 disease/research areas.
It is interesting to note that critical changes are coming from other sources, and not so much from the funding agencies or the pharmaceutical industry. The push is coming from patients and physicians themselves that meet the diseases regularly. We see pharmaceutical companies (such as Eli Lilly and AbbVie) in the women's healthcare space following the lead of their patients and slowly expanding their R&D base and doubling efforts to expand beyond reproductive health into other key women's health areas.
New technological innovations targeting endometriosis are being funded via private sources. In 2020, women’s health finally emerged as one of the most promising areas of investment. These include (not an exhaustive list by any means) diagnostics companies such as NextGen Jane, which raised a $9 million Series A in April 2021 for its “smart tampon,” and DotLab, a non-invasive endometriosis testing startup, which raised $10 million from investors last July. Other notable advances include the research-study app Phendo that tracks endometriosis, and Gynica, a company focused on cannabis-based treatments for gynecological issues.
The complexity of endometriosis is such that any single biotech startup may find it challenging to go it alone. One approach to tackle this is through collaborations. Two companies, Polaris Quantum Biotech and Auransa, have teamed up to tackle the endometriosis challenge and other women’s specific diseases.
Using data, algorithms and quantum computing, this collaboration between two female-led AI companies integrates the understanding of disease biology with chemistry. Moreover, they are not stopping at in silico; rather, this collaboration aims to bring therapeutics to patients.
New partnerships can majorly impact how fast a field like women’s health can advance. Without such concerted efforts, women-centric diseases such as endometriosis, triple-negative breast cancer and ovarian cancer, to name a few, may remain neglected and result in much-needed therapeutics not moving into clinics promptly.
Using state-of-the-art technologies on complex women’s diseases will allow the field to advance much faster and can put drug candidates into clinics in a few short years, especially with the help of patient advocacy groups, research organizations, physicians and out-of-the-box funding approaches such as crowdfunding from the patients themselves.
We believe that going after the women’s health market is a win-win for the patients as well as from the business perspective, as the global market for endometriosis drugs alone is expected to reach $2.2 billion in the next six years.