Numerous stubborn obstacles continue to hinder drug development for a wide range of menopausal symptoms. In recent years, menopause has stepped out of the shadows and into public discourse. People are increasingly willing to talk about issues such as hot flashes and night sweats, while a wave of telehealth start-ups promising relief for multiple symptoms has sprung up, fuelling a menopause therapeutics market valued at USD 17 billion[1-2].
Yet therapeutic demand remains far out of reach of scientific advances, with deep-rooted structural barriers plaguing women’s health. Kim Dalla Torre, Global and Americas Health Leader at EY, says people have stepped forward and are attempting to make an impact in specific areas.
Research funding has historically been inadequate in women’s health[3]. According to the World Economic Forum, even today only around 6% of private medical funding goes to women’s health, stifling innovation[4]. Dalla Torre notes 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 menopause care options[6], numerous smaller firms have flooded the market selling unproven health supplements and products, which account for the bulk of spending in the menopause market[7].
A recent article in the British Medical Journal (BMJ) raises concerns over the growing popularity of expensive hormone test panels. Multiple medical associations, including the American College of Obstetricians and Gynecologists, 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 personalised hormone treatment regimens whose efficacy and safety have not been verified. Researchers argue this phenomenon reflects broader issues stemming from the commercialisation of women’s health and signals a drift away from evidence-based medicine in the field. Insufficient pharmaceutical R&D investment may remain a major challenge ahead.
Menopause drug development has long been a rocky road for many pharma firms, partly due to symptom heterogeneity. 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 experience brain fog and sleep disturbances. “There isn’t a single disease where companies can put money in and say ‘this is where I can get a return on investment in women’s health’… No single drug can solve this,” Dalla Torre states. Hormone replacement therapy (HRT) remains one of the primary treatments physicians use to ease symptoms, regaining popularity after falling out of favour. In the 1990s, HRT was widely hailed as a remedy for many menopausal complaints. That changed abruptly 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 its benefit-risk profile is strongly tied to treatment timing[11].
Dalla Torre is eager to see biotech companies focus on this space. Once that happens, large pharmaceutical firms can take the baton and expand the field. Several drug developers are already working diligently here. Most recently, Bayer secured approval in October 2025 for Lynkuet, a new medicine for hot flashes[12]. Targeting NK1 and NK3 receptors, it will compete with Astellas’ Veozah, an NK3 receptor drug launched in 2023. Bayer forecasts Lynkuet’s annual sales to exceed USD 1 billion. Veozah has recently received an FDA safety warning for rare but severe liver complications[13], with sales underperforming expectations[14] and complicated reimbursement issues. More candidates are in the pipeline, such as AbCellera’s NK3R-targeting Phase II asset[15]. Still, Dalla Torre points out that hot flashes are an easier target for drug developers, as treatment efficacy can be quantified more readily in clinical trials. For other conditions, women will need more personalised therapies. “If we approach women’s health the way we approach CAR-T therapy, as personalised medicine with solutions tailored to individual patients’ needs and symptoms, we can make far greater progress,” Dalla Torre says.
Dalla Torre argues the field needs better characterisation of interconnected diseases that disproportionately affect women, such as autoimmune disorders and Alzheimer’s disease, followed by deeper research to find solutions. Meanwhile, women are doing what they can to manage menopausal symptoms and seek answers on their own. Dalla Torre observes women rely on anecdotal evidence, reading blogs and consulting friends and family, because relevant research remains insufficient. Delivering better options means generating more evidence, which requires lowering barriers to clinical trial participation. Women often have little free time due to work and care responsibilities for children and ageing parents, so trials need to become more accessible to female participants. More must also be done to raise awareness that menopausal symptoms are not something women simply have to endure. Per Mayo Clinic data, roughly 80% of women with these symptoms do not seek medical help. Pharma also has a role to play[16].
Dalla Torre hopes more biotech firms will focus on this area. Once this trend gains traction, large pharmaceutical companies can take over and scale up, creating broader global impact.