IWD25 Special: Women's Health – An Untapped Major Market
A recent analysis by the World Economic Forum and the McKinsey Health Institute shows that women experience 25% more instances of poor health compared to men. In addition, over the past 40 years, 30% of drug recalls have been linked to safety risks associated with women. Addressing this significant unmet need could contribute over USD 1 trillion to global GDP annually by 2040 and create new market opportunities.
Women's health is not merely about reproductive health; McKinsey’s broader definition encompasses not only diseases specific to female reproductive or other physiological features but also common health issues that may affect women differently or more significantly.
Most pharmaceutical companies have already ventured into the field of women's health. McKinsey’s analysis indicates that among the top 20 global pharmaceutical companies, the majority derive over 60% of their revenue from products that treat diseases affecting women. A significant portion of this revenue comes from treatments for autoimmune diseases, mental disorders, osteoporosis, cardiovascular diseases, and cancers related to women.
However, drug development in women's health remains significantly underfunded. Excluding oncology, investments in new drug development for women’s health-related diseases account for only 1% of total clinical development expenditures by pharmaceutical companies, with assets primarily focused on reproductive, gynecological diseases, and infections. McKinsey believes there is tremendous growth potential in three areas: maternal health, endometriosis, and menopausal health.
A Pressing Need for Safer New Drugs
Endometriosis affects approximately 170 million women worldwide, causing severe pain and fertility issues. Current treatments include short-term pain relief with NSAIDs, oral contraceptives or progestins, and some second-line therapies such as GnRH agonists and the levonorgestrel-releasing intrauterine system (LNG-IUS).
Perimenopausal symptoms—such as hot flashes, night sweats, mood swings, and an increased risk of osteoporosis and cardiovascular diseases—are typically managed with hormone replacement therapy (HRT).
Both conditions, which significantly impact women’s health, involve hormonal changes; consequently, hormone therapy has long been the primary treatment. However, these therapies come with side effects. For example, GnRH agonists can lead to estrogen deficiency and ovulation suppression, while HRT is associated with risks including breast cancer, heart attacks, strokes, and blood clots. Therefore, the common direction for drug development in these areas is to seek non-hormonal or safer new hormonal medications to improve patients' quality of life.
Despite the need, only a limited number of companies have ventured into this field.
In 2018, the FDA approved AbbVie’s GnRH antagonist Orilissa (elagolix) for endometriosis pain, making it the first oral therapy for this indication in a decade. However, this new hormonal drug still presents issues with bone loss. Another GnRH antagonist, linzagolix, is currently in Phase III trials for the same indication, with its domestic rights held by Baozheng Pharmaceutical.
In the realm of non-hormonal drug development, a PRL monoclonal antibody—introduced from Bayer by Heqirui—is undergoing Phase II studies both domestically and internationally. In October last year, positive interim results were announced. Previously, Bayer had attempted to develop a P2X3 receptor antagonist, eliapixant, for endometriosis but ultimately abandoned the project due to safety concerns.
Recent research in perimenopausal treatments has shifted its focus towards non-hormonal therapies for hot flashes. In 2023, the FDA approved Astellas’ Veozah (fezolinetant), making it the first NK3 receptor antagonist approved for perimenopausal hot flash symptoms. However, due to potential liver damage risks, patients receiving this treatment must have their liver function monitored, and post-market sales have not met expectations.
Bayer has since submitted a marketing application to the FDA for its NK1/3 receptor antagonist, elinzanetant. Theoretically, targeting the NK1 receptor may offer better liver safety than Veozah, which targets only NK3.
Gender Differences in Drug Development
Some studies have found that the beneficial role of the second X chromosome in women’s immune responses—particularly in fat distribution and metabolism—can influence the efficacy and safety of certain drugs, especially those for cardiovascular and metabolic diseases.
For instance, Novartis observed that its heart failure drug, Entresto (sacubitril/valsartan), is more effective in women, as they are twice as likely as men to develop heart failure with preserved ejection fraction (HFpEF). After conducting clinical trials targeting this patient subgroup, the company successfully expanded the drug’s indication, increasing patient coverage by more than 2 million individuals.
A similar example is Youshibi’s Ximinjia (paseilizumab). Youshibi found that this drug is present in only minimal amounts in the placenta and breast milk, leading to its FDA approval in 2024 for use in pregnant women, thereby allowing patients to continue treatment during pregnancy.
McKinsey's analysis indicates that addressing gender differences in treatment for female patients can improve medication adherence, benefit more women, and prevent the loss of disability-adjusted life years (DALYs), ultimately having a profound impact on the entire healthcare system.