For all the advances in scientific research showing sex-linked differences in medicine, the category of "women's health" remains stubbornly stuck on treatments targeting diseases and organs typically hidden by a popular two-piece bathing suit. That attitude has shown signs of change as investors wise up to the broader untapped opportunity, according to Seema Kumar, CEO of Cure, speaking at the 2024 BioFuture conference in New York.
"Until recently, women's health was always connected to the 'bikini areas' - the breast, the ovaries," Kumar stated. "We're now realizing there's something far beyond that traditional definition when we think of the health of women."
Kumar was joined on stage for the discussion by moderator Matthew Arnold of Clarivate; Jessica Federer, Investor & Board Member at Angelini Ventures; Stacey Seltzer, MBA, Managing Partner & Founder of Pontiva Healthcare Partners; and Stella Vnook, PhD, Co-Founder & Board Member of Kaida BioPharma. The group explored how women's health extends far beyond reproductive care, as well as shifts in investment strategies to capture the differences present in how men and women are affected by disease and therapies.
Federer shared striking statistics: women represent two-thirds of Alzheimer's patients and 80 percent of autoimmune disease patients, and they are 50 percent more likely to die in the year following a heart attack compared to men.
Still, clinical trial research historically hasn't differentiated between the sexes, leading to adverse events and drug recalls when real-world patients take approved medicines. The issue is even present in preclinical work – female mice often aren't used in preclinical experiments, limiting understanding of sex-based differences in drug development.
"Eight of the last 10 drugs withdrawn from the market had to be removed because of side effects seen in women that weren't sufficiently detected in clinical trials," stated Federer.
Not until 1993 did the NIH start requiring clinical trials to include women and minorities. While women now make up roughly half of clinical trial participants, significant gaps remain in crucial disease areas. A recent study that analyzed more than 20,000 U.S. clinical trials involving more than 5.1 million patients between 2000 and 2020 found that women are notably underrepresented in cancer trials, making up only 43 percent of participants despite accounting for 47 percent of cases. Similar disparities exist in neurology and heart disease research.
The diagnostic tools themselves reflect this bias. Federer pointed out that for ovarian cancer, the current gold standard for diagnosis requires removing the ovary itself.
"Imagine if the way to diagnose testicular cancer was to remove the testicle," she said. "You would see the delay and the deaths that are happening because we are lacking an appropriate diagnostic."
Vnook experienced how men and women are treated differently firsthand as a young medical intern at an emergency room 25 years ago. A woman arrived at the hospital with classic symptoms of a heart attack – shortness of breath, fatigue and shoulder pain – but was put in triage instead of seeing a physician immediately.
"I was very young, and I asked very stupid questions – 'why is she waiting?'" Vnook stated. "We all know that heart disease is a leading cause of death."
Vnook has a much more personal connection to the different ways men and women are impacted by healthcare -- she grew up in the USSR, within the blast range of the 1986 Chernobyl nuclear disaster. A 2017 study found that children, especially girls at the time of the explosion, were nearly four times more likely than men to have thyroid cancers decades later.
Despite the historic disparities, more industry observers are highlighting the potential opportunity to expand research and investment. Consulting firm McKinsey published a report in February noting women spend 25 percent more of their lives in poor health than men, and that addressing these disparities could add $1 trillion to the global economy annually by 2040. In particular, the McKinsey analysis estimated the global market potential for endometriosis treatments at $180 to $220 billion, while menopause treatments represent a $120 to $230 billion opportunity.
"We're still learning a lot, but the big categories that I see really are brain and autoimmune, and that's probably the most attractive space for investors right now," Vnook said. "But also the space where we're really seeing a tremendous amount of difference is the sex-based presentation of the diseases."
Yet among the 5,600 biopharma deals struck during the past decade worth more than $1 trillion, only 917 involved women's health worth $257 billion, according to Clarivate's Arnold. The recent market downturn in biotech hasn't helped funding -- during the 2021 peak, 184 deals worth $10.2 billion were struck, but this year, that had fallen to only 26 deals worth $1.7 billion. Still, despite the plummeting funding, 2024 has already marked several breakthrough moments in women's health research.
"This is the first year we've ever seen a pregnant person's brain because one researcher decided to have her brain scanned every single week," Federer said. "It's also the first year we've seen publications on the effects of hormones in the brain throughout perimenopause and menopause."
For every $1 invested in women's health, approximately $3 is projected in economic growth, according to the McKinsey report. While many shortcomings pervade medicine and healthcare investing when it comes to women's health, the panelists expressed optimism about the future. Companies are starting to focus on the disparities and making changes – AstraZeneca issued a study in March comparing their clinical trial participants by gender and race to census data.
"There are companies coming through the pipeline that are being seeded, that are novel and differentiated, whereas 10 years ago, there was almost nothing," Seltzer stated. However, she noted that challenges remain in securing funding for later-stage clinical trials, typically costing $20 to $100 million.
"We're seeing a wave that it's not going to change in a day or even a year, but over the next five or 10 years, it's going to be fundamentally different," Seltzer said. "That's what excites me."
With growing awareness and increasing investment, the field appears poised for transformation – provided it can maintain momentum and secure the necessary funding for clinical development.
"We're trying to turn the tide on a tsunami that has been biased against women for centuries," Kumar stated. "So it's not going to be overnight."