Numerous stubborn hurdles continue to impede drug development targeting a wide range of menopausal symptoms in women. In recent years, menopause has stepped out of the shadows and into the public spotlight. People are increasingly willing to discuss issues such as hot flashes and night sweats, while a wave of telehealth startups promising relief for multiple symptoms have sprung up, giving rise to a menopause therapeutics market valued at USD 17 billion [1-2].
Yet therapeutic demands remain far out of reach of scientific advances, with deep-rooted structural obstacles plaguing women’s health. Kim Dalla Torre, Global and Americas Health Leader at EY, notes that stakeholders are stepping up and seeking to make an impact in specific areas.
Research funding has historically been inadequate for women’s health [3]. According to the World Economic Forum, even today only around 6% of private healthcare funding is directed toward women’s health, stifling innovation [4]. Dalla Torre points out that women remain underrepresented in clinical research [5], leaving physicians constrained by a limited evidence base when making treatment decisions. Pharmaceutical companies have stepped in to try to fill this gap. While some major healthcare providers have expanded care options for menopause [6], a large number of smaller firms have entered the space, selling unproven dietary supplements and products that account for the bulk of spending in the menopause market [7].
A recent article published in The BMJ raised concerns over the growing popularity of expensive hormone test panels. Multiple medical societies, including the American College of Obstetricians and Gynecologists (ACOG), deem such tests unnecessary [8]. These tests can cost hundreds of US dollars yet offer limited clinical value, as there is no clear time window for hormone therapy. Even so, these unnecessary tests are used to justify personalized hormone treatment regimens lacking validated efficacy and safety profiles. Researchers argue that this phenomenon reflects broader issues stemming from commercialization in women’s health, marking a drift away from evidence-based medicine. With insufficient pharmaceutical investment in R&D, this will likely remain a major challenge for the field.
Menopause drug development has been a bumpy journey for many pharma companies, partly due to the heterogeneity of symptoms. An estimated 6,000 women enter menopause every day in the United States, yet their experiences vary widely [9]. Some develop debilitating vasomotor symptoms such as hot flashes and night sweats, while others suffer from brain fog and sleep disturbances. “There isn’t one disease that companies can invest in and say, ‘This is where I get return on investment in women’s health’… There is no single drug that can solve this,” Dalla Torre states. Hormone replacement therapy (HRT) remains one of the primary treatments physicians use to relieve symptoms. After falling out of favor, it has seen a resurgence. In the 1990s, HRT was widely hailed as a remedy for many menopausal complaints. However, the landscape shifted dramatically in 2002, when researchers halted the large Women’s Health Initiative (WHI) trial over concerns that HRT raised risks of serious conditions including breast cancer, heart disease and stroke [10]. New analyses of those findings have since painted a more complex picture of HRT, including recognition that the benefit-risk profile is closely tied to treatment timing [11].
Dalla Torre is eager to see biotech companies focus on this field. Once this momentum builds, large pharmaceutical firms can take the baton and further expand development. Several drug developers are already hard at work here. Most recently, Bayer secured approval in October 2025 for Lynkuet, a new medicine for hot flashes [12]. Targeting NK1 and NK3 receptors, this drug will compete with Veozah, an NK3 receptor inhibitor launched by Astellas in 2023. Bayer forecasts that Lynkuet will generate annual sales exceeding USD 1 billion. Veozah recently received an FDA safety warning for rare but serious liver complications [13], with sales below expectations [14] and complex reimbursement hurdles. More candidates are in the pipeline, such as an AbCellera NK3R-targeted agent in Phase II development [15]. Still, Dalla Torre notes that hot flashes represent an easier target for drug developers because treatment response can be quantified more readily in clinical trials. For other manifestations, women will need more personalized therapies. “If we approach women’s health the way we approach CAR-T therapy — as personalized medicine, tailoring solutions to patients’ specific needs and symptoms — we can make much greater progress,” Dalla Torre says.
Dalla Torre argues that the field needs to better unpack the connections between interrelated diseases that disproportionately affect women, such as autoimmune disorders and Alzheimer’s disease, and conduct deeper research to identify solutions. Meanwhile, women are doing what they can to manage menopausal symptoms and seek answers on their own. Dalla Torre observes that women care about real-world outcomes. They read blogs and talk to friends and family, relying on anecdotal evidence, because relevant research remains sparse. Delivering better options for them means generating more evidence, which requires lowering barriers to clinical trial participation. Women often have limited free time due to work and caregiving responsibilities for children and aging parents, so trials need to become more accessible to female participants. More efforts are also needed to raise awareness that menopausal symptoms are not something women simply have to endure. According to the Mayo Clinic, roughly 80% of women with these symptoms do not seek medical help. Pharmaceutical enterprises also have a role to play [16].
Dalla Torre hopes more biotech companies will dedicate their efforts to this space. Once this trend takes hold, large pharma can carry the work forward and scale up, creating a broader global impact.