Focusing on Women’s Health

Women have been severely underserved when it comes to their health,” says Oriana Papin-Zoghbi, CEO and co-founder of AOA Dx, which is based in Boulder, CO. Bold as that statement sounds, many experts and organizations around the world point out reasons to apply more effort and investment to the health of women. For example, a recent report from the United Nations noted that “gender inequalities across the world make women and girls more vulnerable to poor health, often putting them at higher risks of death, including from a maternal cause.”

Although this magazine focuses on precision medicine, the concept can extend beyond accurate and effective treatments based on molecular targets and attacks on disease. Here, we explore a different sort of healthcare precision: companies dedicated to developing new tools, treatments, and tactics that can improve the health of women.

“It’s time for the industry to give women, who make approximately 80% of healthcare decisions for their families, the attention they deserve,” says Juan Camilo Arjona Ferreira, MD, chief medical officer at New Jersey-based Organon. “By listening to women and their providers’ needs and investing in innovation to meet them, we can advance progress in the field and prevent negative health outcomes for women.”

A collection of women-focused companies

Even now, many healthcare companies work only on improving the health of women. From its headquarters in San Antonio, TX, Hera Biotech reports that it is “developing and commercializing the world’s 1st non-surgical test for definitive diagnosis and staging of endometriosis.” In the U.K., Theramex is all in on women’s health, describing itself as “a global speciality pharmaceutical company solely committed to supporting the health needs of women through every stage of life.”

Other companies also make women’s health a priority, even when working in other areas. For instance, Atossa Therapeutics, headquartered in Seattle, WA, is developing breast cancer-related drugs. In July, Atossa announced that it had enrolled 170 patients in a Phase II trial of Z-Endoxifen to test its impact on reducing mammographic breast density. According to Atossa, “Between 40% and 50% of all women are estimated to have mammographically dense breasts, which makes mammography less sensitive and more difficult to interpret, since cancer and dense breast tissue both appear white on a mammogram [and] mammographic breast density is a strong, independent predictor of breast cancer risk.” In Georgia, Sebela Pharmaceuticals directs much of its efforts toward women’s health. Earlier this year, Sebela announced positive data from a Phase III clinical trial of a hormone-free, low-dose copper intrauterine device.

This summary of companies prioritizing women’s health is probably just the beginning of empowering roughly half of the world’s population to receive better healthcare.

Women’s health market on the move

The financial factors affecting biotechnology and pharmaceutical companies cannot be ignored. Without profits, these companies fail. However, even from an economic standpoint alone experts highlight reasons to focus on women’s health.

In 2020, BCC Research reported that the “global market for women’s health therapeutics should grow from $31.5 billion in 2019 to $41.2 billion by 2025, at a compound annual growth rate (CAGR) of 4.7% for the period of 2019-2025.”

Experts from McKinsey & Company, a consulting group based in New York City, reported that “Women’s health is not a niche market, and it includes much more than just maternal or reproductive care. Indeed, women’s healthcare presents enormous opportunities for value creation and for improving the lives and livelihoods of women.”

Women may also make up more of the overall market for drugs. As a team of scientists in Italy noted: “Several studies have shown that females generally use medicines more often than males.”

Beyond new drugs, sex-specific diagnostic molecules could improve healthcare for women. As one example, Giulia Lombardo, PhD, a research associate in psychological medicine at King’s College London, and her colleagues studied sex differences in the role of inflammation in the response to antidepressant treatments. From this work, the scientists concluded that their “findings highlight the need of sex-specific inflammatory biomarkers in predicting antidepressant response to anti-inflammatories in [treatment resistant depression] patients.” Consequently, diagnostic markers developed for women’s healthcare could expand the market opportunities even more.

Taken together, the potential for growth alone makes developing new drugs for women attractive for a company, either in part or as a dedicated focus. Moreover, many diseases affect only women and lack the desired capabilities in detection and treatment.

Breaking the silence around ovarian cancer

According to the Ovarian Cancer Research Alliance, “ovarian cancer is the fifth leading cause of cancer-related death among women.” Nonetheless, many opportunities exist for improving healthcare for this disease. As Papin-Zoghbi recalls, “My co-founders and I were surprised, but not shocked, to learn that there is currently no early detection tool for ovarian cancer.”

In the past, scientists might have shied away from seeking a diagnostic for ovarian cancer, which was considered hard to detect at an early stage. “Unfortunately, even though ovarian cancer is known as the silent killer, it’s actually not so silent,” Papin-Zoghbi says. As an example, she points out an article from the University of Washington, which reported that “more than 90% of women with early-stage ovarian cancer reported having symptoms prior to diagnosis.”⁸

As with all cancers, early detection of ovarian cancer is crucial. “Survival rates would drastically increase if there was a way to detect ovarian cancer in early stages,” Papin-Zoghbi says. “After speaking with various ovarian cancer patients and survivors, my co-founders and I were equally passionate about bringing the first early detection tool to market.”

Beyond being the first, Papin-Zoghbi and her colleagues plan to develop a very powerful diagnostic tool. “AOA Dx is currently working on refining and optimizing its assay to detect ovarian cancer,” Papin-Zoghbi explains. “Our goals are to increase sensitivity and specificity and ensure they are higher than current diagnostics available on the market.” In October, AOA Dx raised $17 million to fund the development of its diagnostic test.

In the next few years, Papin-Zoghbi  and her colleagues hope to receive FDA approval of their diagnostic tool, the AKRIVIS GD test. She says, “We want both women and their doctors to feel comfortable identifying these key early indicators so they can make proactive choices about their health.”

Although working from its Colorado headquarters, AOA Dx plans to help all women. As Papin-Zoghbi puts it, “We remain committed to a distributable kit so that women across the globe are able to access this diagnostic tool regardless of the healthcare system or resources.”

FemTech’s bull market

Improving the health of women around the world goes beyond diagnostics and new treatments. Anyone who wears any sort of fitness tracker knows that other forms of technology play a role in overall health.

In 2016, Danish entrepreneur Ida Tin coined the term FemTech. Today, that term applies to companies that design any healthcare tool that could improve women’s health. For example, Tin’s company Clue created a period-tracking app. As noted in Clue’s vision statement, “Everyone with a cycle is empowered to make informed choices for themselves around menstrual, sexual, and reproductive health and well-being.”

Although many FemTech companies focus on reproductive health, others work on a wide range of indications. For example, as the World Health Organization (WHO) reported, “Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020.” San Francisco-based Teal Health hopes to expand the screening of cervical cancer with a free, at-home test, which would be requested online and whose results would be explained in a tele-health visit.

Teal Health is not the only FemTech company leveraging an online-ordering approach. U.K.-based Juno Bio developed a vaginal microbiome test that can be ordered from the company’s website. A sample collected at home is sent back to the company, which advertises that they “identify all the bacteria present, not just a few.” Testing the vaginal microbiome makes medical sense. As Douglas S. Kwon, MD, PhD, a physician scientist at Harvard Medical School, and his colleagues noted in a study, “Vaginal microbiota composition affects many facets of reproductive health.”

Some FemTech teams take on more general health problems that are prominent among women. For example, osteoporosis, which weakens bones, arises in about 23% of women and only about 12% of men around the world. To help women keep their bones stronger, experts at the New York-based company Wellen create personalized exercise programs for woman aged 50 and older. Their artificial intelligence-based chat app answers questions about bone health.

Although the field of FemTech is already strong, expansion lies ahead. “Depending on scope, estimates for FemTech’s current market size range from $500 million to $1 billion,” stated o a McKinsey & Company report. “Forecasts suggest opportunities for double-digit revenue growth.”

Working around the world

Arjona Ferreira and his colleagues at Organon take a very broad view of improving women’s health, especially maternal health. “Organon has a portfolio of programs, collaborations, and investments designed to lift women for generations to come through family planning education and contraceptive access,” Arjona Ferreira says. “Organon—working alongside partners—aims to expand contraception availability to the 73 lowest-income countries through our Her Promise Access Initiative, which has already helped to prevent 57 million unintended pregnancies—and this is just the beginning.”

Unintended or not, pregnancy creates complex health challenges, such as the risk of postpartum hemorrhage (PPH) during childbirth. According to the WHO, around 14 million women experience PPH each year, resulting in about 70,000 maternal deaths globally. To address this maternal-health crisis, in 2021 Organon acquired Alydia Health, a medical device company that developed the JADA System, a device intended to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Recently, Organon announced the results of the RUBY study, the first large real-world, observational, post-market registry review study of JADA, which evaluated use among 800 patients. The study reinforced the device’s effectiveness as an important tool for PPH management.

Arjona Ferreira says, “The type of change we are aiming to deliver cannot be accomplished by Organon alone.” He adds, “We believe that an ecosystem involving public and private sectors, policymakers, advocacy groups, and patients overall, is necessary to build momentum and transform the space.”

Going grassroots

Many women-focused biotechnology and pharmaceutical companies are developing new treatments and medical devices for reproductive-health issues. In some cases, though, crucial benefits to women do not depend on developing new treatments, but just on providing access to existing ones.

After being diagnosed with cancer, Amanda Rice learned that she could end up infertile from the treatment and that her insurance company did not cover fertility preservation such as collecting and freezing eggs for future in vitro fertilization. Appalled by this healthcare gap, Rice started the Chick Mission after her third cancer diagnosis.

This organization provides financial support through “Hope Grants” for fertility preservation for women diagnosed with cancer as young adults. Rice, now CEO of the Chick Mission, and her colleagues also educate women about possible fertility-based side effects of treatment and advocate for better insurance coverage of fertility-preserving opportunities. So far, the Chick Mission has helped more than 400 women freeze more than 4,000 eggs.

Rice says, “We remain steadfast in our commitment to advocate for legislative change that secures insurance coverage for fertility preservation in cancer patients.” In fact, Rice and her colleagues have already made an impact on that insurance coverage. “With significant headway already made in 16 states, our ambition is to increase that number to 30 within the next 5 years,” she explains. “Considering that insurance providers already cover many treatment side effects, it only makes sense for fertility preservation to receive the same support.”

From biotechnology and pharmaceutical companies to FemTechs and grassroots efforts, many healthcare experts intend to make sure that women are no longer severely underserved by healthcare. That change is underway and the momentum promises even bigger gains ahead.

References:

1. United Nations Department of Economic and Social Affairs, Population Division (2022). World Population Prospects 2022: Summary of Results. (2022).

2. Atossa Therapeutics. Atossa Therapeutics provides enrollment update for ongoing Phase 2 Karisma-Endoxifen clinical trial. 2023.

3. BCC Research. Pharmaceuticals for women’s health: global markets. (2020).

4. Kemble, E., Pérez, L., Sartori, V., Tolub, G., Zheng, A. Unlocking opportunities in women’s healthcare (2022).

5. Orlando, V., Mucherino, S., Guarino, I., et al. Gender differences in medication use: a drug utilization study based on real world data. International Journal of Environmental Research and Public Health. 17(11): 3926. (2020).

6. Lombardo, G., Nettis, M.A., Hastings, C. et al. Sex differences in a double-blind randomized clinical trial with minocycline in treatment-resistant depressed patients: CRP and IL-6 as sex-specific predictors of treatment response. Brain, Behavior, & Immunity – Health. 26: 100561 (2022).

7. OCRA. Ovarian cancer statistics.

8. UW Medicine. Ovarian cancer is not a silent killer. (2022).

9. World Health Organization. Cervical cancer. (2022).

10. Bloom, S.M., Mafunda, N.A., Woolston, B.M., et al. Cysteine dependence of Lactobacillus iners is a potential therapeutic target for vaginal microbiota modulation. Nature Microbiology. 7:434–450. (2022).

11. Salari, N., Ghasemi, H., Behzadi, M.H., et al. The global prevalence of osteoporosis in the world: a comprehensive systematic review and meta-analysis. Journal of Orthopaedic Surgery and Research,  16: 609. (2021).

12. Kemble, E., Pérez, L., Sartori, V., Tolub, G., Zheng, A. The dawn of the FemTech Revolution. (2022).

13. World Health Organization. WHO postpartum hemorrhage summit. (2023).

14. Goffman, D., Rood, K., Bianco, A., et al. Real-world utilization of an intrauterine, vacuum-induced, hemorrhage-control device. Obstetrics & Gynecology, 142(5):1006–1016. (2023).

Mike May is a freelance writer and editor with more than 30 years of experience. He earned an MS in biological engineering from the University of Connecticut and a PhD
in neurobiology and behavior from Cornell University. He worked as an associate editor at American Scientist, and he is the author of more than 1,000 articles for clients that include GEN, Nature, Science, Scientific American, and many others. In addition, he served as the editorial director of many publications, including several Nature Outlooks and Scientific American Worldview.

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