It’s time to broaden Women’s Health as a Therapeutic Area

Alcimed, an innovation and new business consulting firm, describes the resurgence of women’s health as a therapeutic area and examines the future of women’s health.

In the US in the past decade, various issues with the way women’s health has been addressed including a trend of misdiagnoses and late diagnoses have come to light. With this, there has been a renewed focus on the importance and expansion of women’s health as a therapeutic area.

What are the current trends and issues with the way women’s health is addressed and why is improvement sorely needed?

 The hundreds of thousands of women receiving delayed diagnoses or misdiagnoses have come to light in the past decade with these women sharing their stories. To take just a few examples, endometriosis affects 1 in 10 women of reproductive age yet on average it takes 6-10 years to receive a correct diagnosis once symptoms appear[i][ii]. In the realm of heart disease, women have a 50% higher chance of receiving an incorrect diagnosis than men even after having had a myocardial infarction. For stroke, women are 30% more likely than men to have stroke symptoms and then be misdiagnosed and sent home. It takes women with autoimmune disorders 5 years and 5 doctors on average to receive a correct diagnosis. Late diagnoses and misdiagnoses in conditions such as these allows disease to progress and decreases women’s’ quality of life. There are even more concerning statistics showing inadequate healthcare for women of color². Although the WHO states that gender does have significant impact on health, it is evident that our healthcare system is not adequately taking gender into account. Just over half of the US population is made up of women, so why is there such a discrepancy in women’s healthcare compared to men’s, and how did we get here?

In order to move forward and improve this therapeutic area, it is important to understand how we have arrived at the state women’s health is in.

In the past, men were used as the standard for our understanding of human health and for medical research. In 1991, the U.S. Department of Health and Human Services’ established the Office of Women’s Health to bring more awareness to women’s health issues. Then in 1993, the US Congress passed a law requiring clinical trials to include women as well, however recent studies have concluded that there has not been enough progress in including women in research trials. This means we are still not understanding how being a woman affects health and therefore how to treat diseases in women. In addition, there is a broad notion that women are making pain up, are being too emotional, or symptoms being dismissed as just part of a menstrual cycle. Research has shown that women are less likely to receive pain meds or have to wait longer for them to be prescribed. For example, Serena Williams in 2017, shortly after the birth of her birth of her daughter, began having pain in her legs, like that of a pulmonary embolism she suffered in 2011, but struggled to receive the right care upon arrival to the emergency room, highlighting how unprepared the healthcare system is to recognized and deal effectively with post-pregnancy complications. The WHO also cites various socioeconomic factors that prevent women from obtaining quality health services, including unequal power status between men and women and an exclusive focus on women’s reproductive roles. Fortunately, through understanding the perspectives of the past and the increased focus on women’s health in the present, there is now a trend toward taking action to improve and expand women’s health as a therapeutic area.

The recent resurgence in women’s health comes from increased scrutiny on the shortcomings in how women’s health is addressed and new investment by pharma and biotech companies in women’s health as a therapeutic area.

 The women’s health market is now estimated to reach over $50B by 2025. The movement to improve and focus on women’s health is currently very pressing and will continue to gain momentum in the coming years. “Currently, there are more than 45 startups, with $1.1 B of capital raised, and over 250 ongoing clinical trials in the space, from a mixture of major pharma players and smaller biotechs,” says Jessica Canavan, a Senior Consultant at Alcimed. Whereas 20 years ago the main players in women’s health were only a handful of specialists including Bayer, Merck, Schering Plough, Serono, and Ethicon, it is no surprise with the spotlight on women’s health that many new companies are being founded and other large pharmaceutical players are investing into R&D and drug commercialization, such as Allergan, Amgen, AstraZeneca, BMS, and Pfizer. An example of a newer player is Theramex, launched in 2018 who covers a multitude of women’s health issues including fertility, contraception, menopause, osteoporosis, and more. Including women in clinical trials has also picked up steam, with various companies focusing solely on connecting women with relevant trials. Within the field of women’s health, R&D and innovation around fertility and pregnancy alone has exploded in the past decade with the taboo of the topic of women’s health and menstruation being slowly lifted. Innovations are taking many forms, from apps to track menstrual cycles and plan pregnancy to detecting early biomarkers for conditions such as endometriosis or cervical cancer. Some new players in this field include Natural Cycles creating a digital form of birth control, to Ava Women designing a wearable fertility tracker, to NextGen Jane who is using blood from tampons to detect early biomarkers for various diseases. There is significant value to be captured in Women’s Health.  For example, AbbVie’s Orlissa, approved in 2018 for the treatment of endometriosis, is projected to gain $2B USD in global sales by 2025,” says Danna Hargett, a Project Manager at Alcimed.

What shape will the future of women’s health take?

Women’s health as a therapeutic area will continue to grow and be of interest to the general public and industry. In the more classical segments of women’s health, such as fertility, osteoporosis, endometriosis, and contraception, much innovation and activity are already visible.  Yet, as women’s health is a large and successful market with many unmet needs, there is still lots of room for innovation and more players, especially for expanding women’s health to think more innovatively about how to close the care cap for women in other areas, such as autoimmunity, cardiovascular, and pain management. To this end, there is now a market for companies such as ICON helping to specifically recruit women for clinical trials, which can aid this transition to a more expansive focus on women’s health.

[i] Parasar (2017) Endometriosis: Epidemiology, Diagnosis, and Clinical Management. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5737931/

[ii] Shaw (2018) WedMD Health News Article: Why Women Struggle to get the Right Diagnosis https://www.webmd.com/women/news/20180607/why-women-are-getting-misdiagnosed