Despite women comprising over half of the global population, medical research and treatments have historically been centered on male physiology, neglecting the unique health needs of women. This disparity is particularly significant in areas like immunology, where women make up 80% of patients. The assumption that male biology is the default model has led to healthcare solutions that often fail to address key biological and hormonal differences. This oversight not only affects women’s health but also limits the development of more effective treatments for all populations. Addressing this gap is essential for improving healthcare precision and outcomes for everyone.

The Health Outcome Gap between Men and Women

Women, on average, spend 25% more of their lives in poor health compared to men, partly due to the lack of sex-based treatment development and delivery. According to a 2024 World Economic Forum analysis, addressing this health disparity could significantly improve women’s quality of life and boost global GDP by over $1 trillion annually by 2040. This economic opportunity comes from tapping into high-growth markets for conditions that predominantly affect women.

Four primary factors contribute to this health gap:

1.   Limited Understanding of Sex-Based Biological Differences: Historical exclusion of women of childbearing age from clinical trials led to male physiology being considered the default for medical research.

2.   Healthcare Systems Designed Around Male Physiology: Diagnostics and interventions often fail to account for women’s unique health needs.

3.   Incomplete Data on Sex-Specific Health Outcomes: Many studies fail to disaggregate data by sex, leading to the underestimation of diseases that predominantly affect women.

4.   Underfunding of Women's Health Research: Female-specific conditions such as endometriosis, polycystic ovary syndrome, and rheumatoid arthritis have received limited funding despite affecting millions of women.

Opportunities for Biopharmaceutical Industry

The biopharmaceutical industry has a clear opportunity to close the health gap by investing in women’s health. Not only can pharmaceutical companies drive innovation for female-specific conditions such as endometriosis and improve outcomes for shared conditions like heart disease, but they can also tap into high-growth markets to accelerate growth.

In fact, many top global pharmaceutical companies already derive a substantial portion of their revenue from treating conditions that disproportionately affect women, such as autoimmune diseases, cardiovascular diseases, and mental health disorders. Additionally, more than 55% of assets in Phase II and III clinical trials target conditions that disproportionately affect women.

The Importance of Sex-Based Drug Development

Emerging research reveals significant sex-based differences in disease progression and drug efficacy. For example, women have distinct immune responses due to the second X chromosome, and differences in fat distribution affect how women metabolize certain drugs, particularly in cardiometabolic treatments. These differences highlight the need for tailored R&D to improve the effectiveness and safety of medical treatments.

Recent case studies have demonstrated the benefits of sex-based drug development:

• Novartis’s ENTRESTO: This heart failure drug proved to be particularly effective for women, who are twice as likely as men to develop heart failure with preserved ejection fraction (HFpEF). A 2019 Phase III trial revealed that the drug reduced hospital stays for women by 33%, leading to expanded FDA approval and reaching millions of additional patients.
  
  
• UCB’s CIMZIA: A treatment for chronic inflammatory diseases, CIMZIA showed minimal transfer into the placenta and breast milk, which led to a 2024 FDA approval for use during pregnancy. This decision was crucial, as 17% of the eligible patient population are women aged 18-45.

Closing the Sex Gap in Drug Adoption and Efficacy

Closing the sex gap in drug adoption and efficacy can have profound effects on health outcomes. For example, women with asthma experience significantly lower efficacy of treatments compared to men, partly due to hormonal fluctuations and access barriers. Research suggests that improving sex parity in asthma treatment could increase the number of women effectively treated by 27-35%, benefiting 16 million female patients and preventing 1.6 million disability-adjusted life years (DALYs).

Such improvements can extend to other conditions as well, such as atrial fibrillation and tuberculosis, where addressing sex-based gaps could prevent substantial losses in healthy life years.

New Regulations and Standards

Recent regulations are driving change in the pharmaceutical industry, particularly regarding sex-specific testing for medical devices. The US Center for Devices and Radiological Health now mandates that medical devices be tested with consideration for sex-based differences, which will ensure more effective and safer interventions.

Strategies for Pharma Companies

To close the sex gap in healthcare, pharmaceutical companies must adopt a comprehensive strategy that includes adjustments across research and development, commercialization, and medical affairs. By incorporating a sex-specific approach throughout the product development and commercialization processes, companies can create more effective treatments and reach untapped markets.

R&D Strategies:

1.   Sex-Specific Preclinical Research: Pharma companies should use female cell lines in in-vitro testing and move beyond male-centric animal models to improve understanding of female responses to drugs.

2.   Research Into Female-Specific Conditions: There is a significant market potential for conditions such as endometriosis, which is severely underfunded despite affecting millions of women globally.

3.   Tailored Asset Strategy: Companies should develop asset strategies that account for how conditions affect women differently than men, focusing on factors like safety profiles and prevalence.

4.   Sex-Balanced Clinical Trials: Clinical trials should be designed to reflect sex-specific differences in disease manifestations and include appropriate sex balance in participant selection. Offering flexible solutions for trial participation could increase female representation in research.

5.   Sex-Specific Reporting: Clinical trial data should be disaggregated by sex to assess treatment outcomes and provide valuable feedback to improve future research.

Commercialization Strategies:

1.   Segmented Marketing Approaches: Marketing efforts should be tailored specifically to women, especially for conditions such as autoimmune diseases and cardiovascular conditions where awareness gaps exist.

2.   Targeted Awareness Campaigns: By providing education on how conditions manifest differently in women, pharmaceutical companies can help healthcare providers offer more accurate and timely diagnoses.

3.   Customized Patient Support Programs: Companies can design patient support initiatives that address women’s unique health needs, such as programs that promote treatment adherence and provide targeted health information. Collaborating with digital health platforms could provide valuable real-world insights into hormone-related health variations and improve treatment outcomes.

Embedding Sex-Based Perspectives into Pharma’s Mission

For meaningful and lasting change, pharmaceutical companies must prioritize women’s health at the organizational level. Leadership should champion the integration of sex-based differences into all company processes, from R&D to commercialization. Comprehensive training programs can ensure that employees across all departments are equipped with the knowledge to incorporate these insights into their work.

Accountability mechanisms must be put in place to track progress, ensuring that companies stay committed to advancing women’s health. Transparent reporting on these efforts will build trust with stakeholders and demonstrate the company's commitment to health equity.

Conclusion

The pharmaceutical industry is at a pivotal moment where it can reshape healthcare by addressing the health gap between men and women. By embedding sex-based considerations throughout the research and development processes, as well as in commercialization strategies, companies can not only improve health outcomes for women but also unlock significant economic opportunities. Closing the health gap for women is not just an ethical imperative—it is a strategic move that can enhance lives, drive health equity, and generate sustainable value for the global population.