Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space.
“People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.
When it comes to research, women’s health has been historically underfunded. Even today, only an estimated 6% of private healthcare funding goes toward women’s health, which hinders innovation, according to the World Economic Forum. Women are still underrepresented in clinical research, and doctors are hamstrung by a limited evidence base to guide treatment decisions, Dalla Torre said.
A mix of companies has stepped in to fill the gap. While some mainstream healthcare organizations have expanded menopause-specific care options, there’s also been a proliferation of smaller companies moving into the space, selling unproven supplements and products that make up the majority of spending in the menopause market.
A BMJ article, for example, recently raised concerns about the rise in costly hormone panel testing, which is considered unnecessary by many medical societies, including the American College of Obstetricians and Gynecologists. The tests cost hundreds of dollars but are of limited clinical use because there’s no defined window for hormone therapy. Despite this, they’re being used to justify custom hormone regimens that are not tested for efficacy or safety.
The study’s authors said it’s a symptom of a larger problem in the commercialization of women’s health, and a push away from evidence-based practice. In the absence of R&D investments from the pharma industry, it could also remain a major challenge in the field going forward.
Where’s pharma at?
Drug development for menopause has been an uphill battle for many drug companies, in part, because of the heterogeneity of symptoms. The estimated 6,000 women a day who reach menopause experience it differently. Some have debilitating, vasomotor symptoms such as hot flashes and night sweats, while for others it’s brain fog and sleep disturbances.
“There’s not one condition to go after that a company can put their dollars behind to say this is where I’m going to be able to get ROI in women’s health ... because [there’s] not one drug that is going to solve the problem,” Dalla Torre said.
Hormone replacement therapy remains one of the main treatments doctors prescribe to manage symptoms, and it’s risen again after falling out of favor. In the 1990s, HRT was widely lauded as a means to solve many of the problems associated with menopause. That changed rapidly in 2002 when researchers halted a large study, the Women’s Health Initiative, amid concerns that HRT increased the risk of serious conditions like breast cancer, heart disease and stroke.
But a new analysis of those findings painted a more nuanced picture of HRT, including an understanding that the benefits and risks of treatment are linked to timing.
“I would love to see biotech companies focus on the space. Once that starts happening, then bigger drug companies can take on the charge and keep expanding it."
Kim Dalla Torre
EY Global and Americas Health leader
Some drug developers are also plugging away in the space. Most recently, Bayer gained approval in October for a new drug to treat hot flashes. The NK1 and NK3-targeting treatment Lynkuet will now go head to head in the hot flash space with Astellas’ Veozah, an NK3-targeting drug that became available in 2023.
Bayer estimates Lynkuet could see sales of more than $1 billion annually. Veozah, which recently received an FDA safety warning for rare but serious liver complications, has seen slower-than-expected sales and faced reimbursement complications. More hot flash options could be on the way, such as AbCellera’s phase 2 NK3R receptor targeting drug.
Hot flashes, however, are an easier target for drug developers because they are an indication with more clearly measurable outcomes in the clinic, Dalla Torre said.
In other areas, women will need a more individualized approach.
“If we could think about women's health the way we think about CAR-T, like personalized medicine, and tailor the solution to the person for their particular needs and their symptoms, we could get a lot further,” Dalla Torre said.
The field, she said, needs to get better at connecting the dots between interrelated conditions that disproportionately affect women, such as autoimmune diseases and Alzheimer’s, and then study them more closely to find solutions.
In the meantime, women are doing what they can to manage menopause symptoms and find their own answers.
“Women are looking at real outcomes, and they're reading the blogs, they're talking to their friends and their family,” Dalla Torre said. “They're acting on anecdotal evidence, because, once again, the research isn't there.”
To give them better options means gathering more evidence, which requires fewer barriers to clinical trial participation, she said. Trials need to be more convenient for women, who often have little free time due to work and caretaking responsibilities for their children and elderly parents.
More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.
“I would love to see some of our biotech companies focus on the space. Once that starts happening, then the bigger drug companies can take on the charge and keep expanding it to make more of an impact globally,” she said.
