In recent years, menopause issues have moved from behind the scenes into the public eye. Celebrities have openly discussed hot flashes and night sweats, and a wave of telehealth startups promising to alleviate a range of symptoms has emerged, helping to create a$17 billion menopause market。

However, the demand for treatment still far exceeds scientific progress, and structural barriers continue to plague the field of women's health.

"People have taken responsibility and are trying to make an impact in specific areas," said Kim Dalla Torre, EY's Global and Americas Health Sector Leader.

In research, women's health has historically beenunderfunded. According toWorld Economic Forumdata, even today, only about 6% of private healthcare funding goes to women's health, hindering innovation. Women remainunderrepresentedin clinical research, and doctors lack an evidence base to guide treatment decisions, Dalla Torre said.

Various companies have stepped in to fill the gap. Some mainstream healthcare institutions have expandedmenopause care options, while a large number of small companies have flooded the field, selling unproven supplements and products thatmake up the majority of spending in the menopause market。

For example,an article in the British Medical Journalrecently expressed concern about the increase in expensive hormone panel testing, which many medical societies, including the American College of Obstetricians and Gynecologists, consider unnecessary. These tests cost hundreds of dollars but have limited clinical value because there is no clear starting window for hormone therapy. Nevertheless, they are used to justify customized hormone regimens that have not been tested for efficacy or safety.

The study's authors say this is a symptom of a larger problem in the commercialization of women's health and a tendency to deviate from evidence-based practice. In the absence of R&D investment from the pharmaceutical industry, this may remain a major challenge for the field in the future.

What progress is the pharmaceutical industry making?

Menopause drug development has been a difficult battle for many pharmaceutical companies, partly due to the heterogeneity of symptoms. It is estimated that6,000 womenenter menopause each day, but experiences vary. Some suffer from debilitating vasomotor symptoms such as hot flashes and night sweats, while others experience brain fog and sleep disorders.

"There is no single condition that a company can invest in and say, 'This is where I get my return on investment in women's health'... because no one drug solves everything," Dalla Torre said.

Hormone replacement therapy remains one of the main treatments prescribed by doctors, having made a comeback after falling out of favor. In the 1990s, HRT was widely promoted as a panacea for menopause-related issues. In 2002, researchershalted a major study(the Women's Health Initiative) over concerns that HRT increased the risk of serious diseases such as breast cancer, heart disease, and stroke, and the situation quickly changed.

Butnew analyses of these findingspaint a more nuanced picture, including the recognition that the benefits and risks of treatment are related to timing.

"I would like to see biotech companies focus on this area. Once they start, big pharma can take over and keep expanding."

— Kim Dalla Torre, EY's Global and Americas Health Sector Leader

Some drug developers are also making ongoing efforts in this area. Recently, Bayer in Octoberreceived approvalfor a new drug to treat hot flashes. This NK1- and NK3-targeting therapy, Lynkuet, will directly compete with Astellas' Veozah, an NK3-targeting drug launched in 2023.

Bayer estimates Lynkuet's annual sales could exceed $1 billion. Veozah recently receivedan FDA safety warning about rare but serious liver complications, and its sales havefallen short of expectations, and it faces reimbursement issues. More hot flash treatment options may be on the way, such asAbCellera's Phase 2 NK3R receptor-targeting drug。

However, hot flashes are an easier target for drug developers because the condition has clearer clinical measurements, Dalla Torre said.

In other areas, women need more personalized approaches.

"If we could think about women's health the way we think about CAR-T, which is personalized medicine, tailoring solutions to individual specific needs and symptoms, we could make greater progress," Dalla Torre said.

She said the field needs to better connect the dots between interrelated diseases that affect women, such as autoimmune diseases and Alzheimer's disease, and conduct more in-depth research to find solutions.

Meanwhile, women are doing their best to manage menopause symptoms and find their own answers.

"Women look at real outcomes, read blogs, and talk with friends and family," Dalla Torre said. "They act on anecdotal evidence because research is again lacking."

To provide better options, more evidence needs to be collected, which requires reducing barriers to clinical trial participation. Trials need to be more convenient for women, as they often have limited free time due to work and caring for children and aging parents.

There is also a need to raise awareness among women that menopause symptoms should not be silently endured. According toMayo Clinicdata, about 80% of women experiencing these symptoms do not seek help from a doctor. Pharmaceutical companies also need to play a role.

"I would like to see some biotech companies focus on this area. Once they start, big pharma can take over and keep expanding to have a greater impact globally," she said.