Nearly half of the global population—and 80 percent of patients in therapeutic areas such as immunology—are women.1 And yet, treatments are frequently developed without tailored insights for female patients. Too often, researchers have viewed “women’s health” narrowly through the lens of reproductive organs, treated women as “small men” for other conditions, and ignored critical biological differences such as cellular sex (every cell in the body has a sex), hormonal impacts, and genetic factors. Addressing these differences is not just about equity—it drives more precise and effective healthcare for everyone.
A recent analysis by the World Economic Forum, in collaboration with the McKinsey Health Institute (MHI), revealed that women, on average, spend 25 percent more of their lives in poor health compared with men, partially because of a lack of sex-based treatment development and delivery. Addressing this disparity could improve quality of life for women and unlock more than $1 trillion in annual global GDP by 2040 and create new market opportunities for conditions with significant unmet needs.
Four key factors contribute to the health outcome gap between women and men. First, a limited understanding of sex-based biological differences persists, rooted in the exclusion of women of childbearing age from early clinical trials between 1977 and 1993,2 which established male physiology as the default. Second, healthcare delivery systems are often designed around men, with diagnostics and interventions frequently overlooking women’s unique symptoms. Third, clinical decisions rely on incomplete or underused data, which is often not disaggregated by sex, leading to a significant underestimation of disease burden in women. Finally, women’s health research remains severely underfunded: Female-only conditions account for just 4 percent of pharmaceutical pipelines, and in 2019 only 7 percent of NIH funding for rheumatoid arthritis—a condition that predominantly affects women—targeted female-focused studies,3 even though women account for 78 percent of the US rheumatoid arthritis patient population.
The biopharmaceutical industry has a clear opportunity to close the health gap by investing in women’s health. Pharma companies can drive innovation for female-specific conditions such as endometriosis, improve outcomes and reduce risks for shared conditions such as heart disease, and tap into high-growth markets to accelerate near-term growth. With public and private funding for women’s health on the rise,4 the industry is well positioned to deliver equitable, tailored healthcare solutions by implementing sex-specific strategies from the outset. This approach could enhance therapeutic outcomes while addressing safety risks—30 percent of drug recalls over the past four decades were tied to women-related safety issues.
Most biopharma companies are already in women’s health
Beyond expanding into areas of high unmet needs for women, pharma companies can also close the health gap by simply recognizing and amplifying the substantial role women’s health already plays in their portfolios. The majority of the top 20 pharma companies derive more than 60 percent of their revenue from treatments for conditions that uniquely, differently, or disproportionately affect women (Exhibit 1). A substantial portion of revenue for 16 of these players comes from treatments for such conditions as autoimmune diseases, mental health disorders, osteoporosis, cardiovascular disease, and certain cancers. Additionally, more than 55 percent of assets in Phase II and III clinical trials target conditions that disproportionately, or more intensely, affect women.
Why sex-based drug development matters
Emerging evidence about sex-based disease differences5 highlights the need for more targeted R&D for therapeutic interventions. Such differences include the active role of the second X chromosome in women, particularly in immune responses,6 and physiological distinctions between women and men in fat distribution and metabolism that affect drug efficacy and safety in cardiometabolic treatments.7
Recent prominent examples illustrate the importance of understanding sex-based differences in medical treatments. Novartis discovered that its heart failure drug ENTRESTO, launched in 2015, was particularly effective for women, who are twice as likely as men to develop heart failure with preserved ejection fraction (HFpEF). After conducting clinical trials on target subgroups, a 2019 Phase III trial revealed that the drug reduced hospital stays for women by 33 percent. This finding led to expanded FDA approval, enabling Entresto to reach more than two million additional patients.8
Similarly, UCB found that CIMZIA, its therapy for chronic inflammatory diseases, passes minimally into the placenta and breast milk. As a result, the FDA approved an indication expansion in 2024 for pregnant women. This approval was significant, as 17 percent of the medication’s eligible patient population are women aged 18 to 45, who can now continue treatment throughout pregnancy.9
Closing the sex gap can have a profound impact on treatment adoption and efficacy for women. For instance, asthma is more prevalent in women, yet they experience lower efficacy of treatments and lower adherence rates. Inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) inhalers, for example, demonstrate roughly 40 percent lower efficacy in women,10 and adoption rates are only half that of men,11 partly due to hormonal fluctuations and access barriers. Achieving sex parity in asthma treatment could result in a 27 to 35 percent increase in the number of women effectively treated,12 benefiting an additional 16 million female patients and preventing approximately 1.6 million disability-adjusted life years (DALYs)13 (Exhibit 2).
Similar benefits can be achieved across other conditions (Exhibit 3). Addressing sex-based adoption gaps in atrial fibrillation and tuberculosis treatment could collectively prevent 1.4 million DALYs. These figures underscore the substantial health impact of addressing sex disparities across the pharmaceutical value chain.
New regulations are also targeting women’s health. For example, the US Center for Devices and Radiological Health now requires sex-specific testing for medical devices, recognizing the impact of physiological and anatomical differences on safety and efficacy. Such new standards foster accountability, transparency, and innovation, ensuring safer, more effective interventions.14
What pharma companies can do to close the sex gap
Pharma companies can make significant contributions to closing the health gap between women and men while embracing a new framework for value creation. To do so, they should adopt explicit strategies to address sex-based differences across R&D, commercial, and medical affairs. From rethinking R&D approaches to enhancing the patient journey and refining commercialization strategies, companies can incorporate a women’s health lens into existing practices and unlock significant value while improving health outcomes for women.
Data generation and analysis, which play a cross-cutting role across R&D and commercialization functions, can provide the foundation for informed decision-making and effective women’s health strategies. For example, data on drug adoption rates, efficacy, and safety outcomes disaggregated by both sex and gender are sparse. There is limited information on how medical treatments affect different populations, particularly the LGBTQ+ community, including those undergoing hormonal treatment, who may experience unique effects and require specialized care.
Enhancing therapeutic effectiveness and safety through R&D
R&D organizations can help close the women’s health gap by embedding a sex-specific approach at every stage of research and development. Incorporating these insights can enhance the effectiveness and safety of treatments for all patients, ultimately advancing the goal of truly personalized medicine.
Five levers can help R&D organizations drive this change:
- Conduct sex-specific preclinical research. In-vitro testing should use female cell lines. Researchers should move beyond standard male animal models to better understand female responses, especially in sex-specific conditions, and partner with government research agencies and academia to develop more representative models.
- Increase basic research into female-specific conditions with high unmet needs and significant market potential. Conditions such as endometriosis and polycystic ovary syndrome affect millions of women, yet they remain underfunded and understudied. Endometriosis, for example, affects one in ten women globally and represents a market potential of $180 billion to $250 billion, which is comparable to high-investment areas such as immunology and diabetes. By joining forces directing more research to these conditions, R&D organizations can address large unmet needs, create targeted treatments for women, and achieve substantial economic returns from these high-potential markets.
- Develop an asset strategy with a women’s health lens. R&D organizations can tailor their development strategy and target product profile (TPP) based on how conditions affect women differently than men. This includes accounting for the relative prevalence of men versus women, the desired effect, and the safety profile, accounting for sex-specific thresholds.
- Design trials to include and account for sex-specific differences and to achieve appropriate sex balance in participation. Protocols should be designed to reflect potentially different inclusion and exclusion criteria based on different disease manifestations in men versus women. They should also reflect sex-specific differences and should include end points to assess sex-specific effects such as changes to hormonal balance or to the menstrual cycle. Women are often underrepresented in trials due to such barriers as transportation, childcare, and rigid scheduling. Trial managers could offer flexible solutions such as remote monitoring and logistical support to improve access for women and to accelerate recruitment and completion times. They can also collaborate with women’s health organizations and medical institutions to identify and address barriers for women. They can then refine recruitment and retention strategies to ensure that trials reflect real-world female populations and broaden reach across diverse groups. And they could partner with digital health companies to collect valuable, real-world sex-specific insights from telemedicine and wearables data.
- Closeout and reporting. Clinical trial reports and analyses are critical areas in which sex differences need to be considered. Disaggregated trial data enables researchers and healthcare providers to measure sex-based treatment outcomes and create virtuous feedback loops for continuous improvement in addressing sex-specific health needs.
Closing the knowledge gap about women’s health through commercialization
Pharma companies can deliver improved outcomes immediately by applying a women’s health perspective to their current portfolios. They can do so by deepening their understanding of a female’s patient journey and integrating that knowledge into their commercialization strategies. Such an approach can help close sex- and gender-based gaps, particularly in diagnosis, therapy escalation, and adherence. Key strategies include the following:
- Segmented marketing approaches. Commercial teams can develop marketing strategies specifically tailored for women, especially in areas where awareness gaps are prevalent, such as autoimmune diseases and cardiovascular conditions. Highlighting how these conditions affect women can increase engagement, reduce delays in diagnosis, and support women in prioritizing their health.
- Targeted awareness and educational campaigns. Medical education currently provides limited exposure to data about sex-based differences, leaving many providers underinformed about how these differences affect diagnosis and treatment. Commercial teams can fill this knowledge gap by offering educational resources and programs about sex-specific symptoms and management strategies for conditions that affect women differently or disproportionately, like cardiovascular disease, autoimmune disorders, and mental health. Training programs, webinars, and workshops can help providers recognize how conditions manifest differently in women, ensuring more accurate and timely diagnoses. For example, greater awareness about the different symptoms women experience during heart attacks—such as nausea, fatigue, and back pain, rather than the more commonly recognized chest pain—can lead to earlier diagnosis and timely treatment, which is critical, given that women are more than twice as likely to die after a heart attack as men.15
- Customized patient support programs. Commercial leaders could design patient support initiatives that recognize women’s unique healthcare needs and that offer strategies for supporting them in their health journeys. They can partner with digital health platforms to build content and tools that address health-related issues more pervasive for women and foster treatment adherence. Real-world evidence (RWE) data from these digital platforms (including wearables and telemedicine engagements) can be useful for monitoring metrics relevant to women’s health, such as hormone levels and menstrual-cycle-related variations. RWE can also be particularly valuable for refining drug treatments postlaunch, allowing pharma companies to continually adjust approaches based on data-driven insights.
Embedding sex-based perspectives into pharma’s mission
Pharma companies can drive meaningful change in women’s health by placing a strong focus on change management, starting with leadership. Leaders must actively champion an approach that acknowledges sex-based differences, not just in patient care but also across all organizational processes. This commitment sends a signal throughout the organization that advancing the health of women is a strategic priority embedded into the company’s mission.
To create lasting change, companies should integrate a sex-based lens into their culture and their decision-making frameworks. This begins with comprehensive training and awareness programs that empower employees across R&D, commercial, and patient-facing teams to understand the importance of sex-based considerations.
Accountability mechanisms are equally important to sustain progress. Leaders should establish clear metrics that track the incorporation of sex-based approaches and hold teams accountable for meeting these objectives. Companies can also commit to transparent reporting on these efforts, reinforcing their commitment to health equity and building trust with stakeholders.
Finally, embedding sex-based considerations into core governance processes is essential to ensure systematic change. This means making sex-based considerations a standard agenda item for governance bodies overseeing key deliverables, such as asset teams discussing target product profiles or clinical teams designing trials. Companies can be better positioned to drive sustainable and measurable results by institutionalizing these practices and weaving women’s health perspectives into their operational fabric.
The pharmaceutical industry has reached a pivotal moment, and it has an urgent opportunity to reshape its approach to improving the health of women. Prioritizing the health of women is not just a moral imperative—it is a substantial economic opportunity because closing the uptake gap could considerably expand patient access to treatments across various diseases. By embedding the understanding of sex-based differences across the value chain, from R&D through commercialization to internal policies, companies can make a profound difference. This approach enhances lives, drives health equity, and unlocks sustainable value for generations to come. In this moment, the pharma industry can lead the way in closing the women’s health gap and can help build a future where all patients, regardless of sex or gender, receive the care they deserve.
