The $1 Trillion Gender Gap in Medical Research
This week in the Guardrail, Michael Bronfman of Metis Consulting Services tackles the $1 Trillion Data Gender Gap in medical research, arguing that the persistent exclusion and merging of female data in R&D not only results in dangerous health outcomes but also represents the single largest untapped market opportunity for Pharma and MedTech
This week in the Guardrail, Michael Bronfman of Metis Consulting Services tackles the $1 Trillion Data Gap in healthcare, arguing that the persistent exclusion and merging of female data in R&D not only results in dangerous health outcomes but also represents the single largest untapped market opportunity for Pharma and MedTech.
By Michael Bronfman, for Metis Consulting Services
Monday, November 17, 2025
Introduction: The Default Patient Problem
Imagine a world where closing a major health gap could boost the global economy by as much as one trillion dollars by 2040. That is the magnitude of opportunity when we stop treating women as simply smaller men in healthcare research and innovation. The medical industry’s long-standing habit of assuming the default patient is male has created dangerous health outcomes for women and represents one of the largest untapped markets in healthcare R&D.
But this is not simply a matter of “including women” in trials; it is about systematically collecting and analysing sex-disaggregated data at every stage of development.
The Historical & Ongoing Disparity in Research
For decades, the underlying default in medical research was that “male = normal,” and women were treated as deviations from that norm. The origin of this exclusion lies in the 1977 guideline from the U.S. Food & Drug Administration (FDA), which excluded women of child-bearing potential from early-phase clinical trials, a policy born from fears following tragedies like Thalidomide.1 In 1993, the FDA reversed course and mandated inclusion of women in research unless scientifically justified otherwise.2 Yet more than 20 years later, women remain under-represented in trials for diseases that affect them most.3
A 2025 Nature commentary reported that fewer than 30 percent of early-phase trial participants are women, and most published studies still fail to analyse results by sex.3 Even when women are included, their data is often merged with men’s, concealing real biological differences. This persistent “female data gap” means we still lack a complete understanding of how women respond to drugs, devices, and diagnostic algorithms.1,2
Case Studies: The Human Cost of Data Blindness
A. Failure in Medical Devices: The Vaginal Mesh Scandal
Transvaginal mesh implants were once marketed as quick, minimally invasive fixes for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Yet many devices reached the market through the FDA’s 510(k) clearance pathway, which only requires proof of “substantial equivalence” to an existing product — not new clinical trials.4
Because early mesh devices were rarely tested specifically in women, thousands suffered devastating complications: organ perforation, mesh erosion, chronic pain, and sexual dysfunction. The FDA has since issued multiple warnings and product withdrawals.5 Investigations by the International Consortium of Investigative Journalists found that women were indeed more likely to experience harm because testing and reporting did not account for female anatomy and tissue response.6
This case shows how insufficient sex-specific data and fast-track approvals can combine into catastrophic outcomes avoidable with rigorous, sex-aware testing.
B. The Diagnostic Blind Spot: Cardiovascular Disease (CVD)
Cardiovascular disease is the leading cause of death among women.7 Yet for decades, public campaigns and medical education focused on “classic” male symptoms, crushing chest pain and left-arm discomfort, while overlooking the subtler signs common in women: nausea, jaw pain, shortness of breath, and fatigue.8
As a result, women are less likely to be correctly diagnosed or receive timely intervention. Fewer than half of women in the U.S. even recognise heart disease as their top health threat.9 The failure to design diagnostic criteria, awareness campaigns, and treatment pathways around female physiology has cost countless lives.
When clinical models, algorithms, and medical devices are trained on male data, women’s symptoms fall outside the expected range, leading to delayed care or misdiagnosis. This is not a small oversight; it is systemic data blindness.
The Opportunity: Leveraging Data for Innovation
If the problem is large, the opportunity is larger. Closing the women’s health data gap is both a moral and commercial imperative.
In the era of precision medicine, we understand that sex is a biological variable in every cell. Differences in hormones, metabolism (pharmacokinetics and pharmacodynamics), and organ size mean drugs and devices designed around men often behave differently in women. Accounting for these differences improves safety, efficacy, and patient trust.
1. Sex-Disaggregated R&D
Clinical trials should mandate sex-specific subgroup analysis from Phase I through Phase III.10 Protocols must recruit adequate numbers of women and predefine endpoints that reflect both male and female physiology. Even preclinical animal and cell research should include both sexes, as early exclusion compounds the downstream data gap.
2. Next-Generation Diagnostics & Analytics
Artificial intelligence and machine learning hold enormous potential, but only if trained on diverse, representative datasets. AI tools must be exposed to female-specific data for cardiovascular disease, autoimmune disorders, chronic pain, and menopausal transitions.10
Real-world data from wearables, telemedicine, and patient-reported outcomes can further reveal unique female health patterns. Building algorithms that “see” women accurately will save lives and reduce liability.
3. Underserved Markets: Female-Specific Conditions
Endometriosis, Polycystic Ovary Syndrome (PCOS), and menopause-related disorders have historically received a fraction of the research funding allocated to male-dominant conditions. McKinsey & Company estimates that endometriosis alone represents a $180–250 billion market in unmet medical need.10
Investing in women’s health is not a niche play, it is a high-growth sector that directly improves half the population’s quality of life while offering strong returns.
Beyond Equity to Economic Value
Closing the women’s health data gap is not only ethically right; it is economically smart.
When pharma and MedTech companies prioritise sex-disaggregated research, they reduce liability (as shown in the mesh crisis), improve outcomes (as in CVD awareness), and open vast new markets in female-specific conditions.
Executives and regulators should embed sex- and gender-based analysis into every layer of R&D governance. Success should be measured not just in total enrollment, but in how effectively male and female outcomes are understood and optimised.
Ethical innovation and commercial success are aligned. The future of precision medicine is sex-specific medicine, one that finally recognises that women are not smaller men.
Footnotes
Association of American Medical Colleges (AAMC) – “Why We Know So Little About Women’s Health,” 2025.
https://www.aamc.org/news/why-we-know-so-little-about-womens-healthUniversity of Utah Health – “Why We Know So Little About Women’s Health,” 2025.
https://uofuhealth.utah.edu/notes/2025/01/why-we-know-so-little-about-womens-healthNature – “Closing the Gender Data Gap in Clinical Research,” 2025.
https://www.nature.com/articles/d44151-025-00036-yCenter for Research on Women & Families – “FDA Lets Women Down,” 2024.
https://www.center4research.org/drugwatch-fda-lets-women-down/U.S. Food and Drug Administration (FDA) – “Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence,” 2024.
https://www.fda.gov/media/152350/downloadInternational Consortium of Investigative Journalists (ICIJ) – “Are Women More Likely to Be Harmed by Medical Device Failures?” 2023.
https://www.icij.org/investigations/implant-files/are-women-more-likely-to-be-harmed-by-medical-device-failures/Centers for Disease Control and Prevention (CDC) – “Women and Heart Disease,” 2024.
https://www.cdc.gov/heart-disease/about/women-and-heart-disease.htmlCleveland Clinic – “Women and Cardiovascular Disease,” 2024.
https://my.clevelandclinic.org/health/diseases/17645-women–cardiovascular-diseaseAmerican Heart Association (AHA) – “The Slowly Evolving Truth About Heart Disease and Women,” 2024.
https://www.heart.org/en/news/2024/02/09/the-slowly-evolving-truth-about-heart-disease-and-womenMcKinsey & Company – “Closing the Women’s Health Gap: Biopharma’s Untapped Opportunity,” 2024.
https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-womens-health-gap-biopharmas-untapped-opportunity.
Transform this ethical imperative into a commercial advantage. Your organization must operationalize sex-disaggregated data and AI readiness. Contact Metis Consulting Services today: hello@metisconsultingservices.com