Issue 161  /  September 4, 2026  /  Feature

What Happens When a Market Outruns its Own Evidence

Money is moving into women's health, but almost none of it reaches the biology or the treatment. The conditions with the widest gap between prevalence and evidence are the ones nobody owns.

What Happens When a Market Outruns its Own Evidence

In the past few months, two companies launched wearables they describe as tracking hormones. Neither has published a validated hormone concentration result in its public materials.

And it is what a market does when it outruns the science it would otherwise stand on.

Money is moving into women's health, and it is going to care delivery, benefits administration, access, and consumer devices, for conditions the field already knows how to describe from the outside.

It is not going to the biology, the clinical validation that would make a measurement mean something, or the treatments that would follow.

Fibroids show the shape of it.

Impact Global Health runs G-FINDER, an annual survey that tracks research and development funding for new products and technologies across global health. Its 2025 report Flying Blind found that in 2023, endometriosis attracted $28 million in R&D funding globally, uterine fibroids $12 million, and PCOS $10 million. The three together came to $50 million, or 6% of total investment in sexual and reproductive health R&D that year.

Within the fibroids figure, the report found no investment reported at all for diagnostics, and a non-existent development pipeline for that category. The only diagnostics available for uterine fibroids are ultrasound and MRI.

Fibroids are the leading cause of hysterectomy in the United States, ahead of endometrial, ovarian, or cervical cancer, as Erica Marsh of the University of Michigan Medical School noted at a National Academies workshop in 2024. Hysterectomy remains the only definitive treatment. Minutes from an October 2024 meeting of the NIH Advisory Committee on Research on Women's Health record the annual economic impact at roughly $34 billion.

Marsh put annual NIH funding for fibroids at about $17 million, higher than the G-FINDER figure because it measures something wider. The NIH system counts every funded project matched to a disease category, including training and infrastructure. G-FINDER counts only what is directed toward new products and technologies.

None of this is a story about rare disease. In July, the National Center for Health Statistics published nationally representative estimates from the 2022 to 2023 National Survey of Family Growth. Among women aged 20 to 49 in the United States, 7.8% had ever been diagnosed with uterine fibroids, 8.7% with polycystic ovary syndrome, and 6.2% with endometriosis. The survey captures diagnosis rather than disease, so each figure is a floor. Fibroid diagnosis was highest among Black non-Hispanic women at 12.5%.

Three findings from the G-FINDER survey explain how conditions this common end up with research budgets this small.

Nearly all funding across the three came from public sources, with no industry participant reporting any R&D spending at all. Fourteen funders exist in the space, twelve of which contributed less than a million dollars.

And the US National Institutes of Health alone accounts for between 86% and 99% of all global funding for them.

This is not a field with a diversified funding base and a public sector that leads it. It is a field with one funder. Every product built on this science, every company raising against it, and every clinician waiting for a better test depends on the appropriations of a single US agency.

The 2024 National Academies report A New Vision for Women's Health Research explains why that base is so narrow. NIH investment in women's health research fell from 9.7% of total research grant spending in 2013 to 7.9% in 2023, while total NIH grant spending rose from $26.3 billion to $43.7 billion.

The committee also found that endometriosis, PCOS, uterine fibroids, and vulvodynia sit outside the stated purview of all 27 NIH institutes and centers, and that the Office of Research on Women's Health has no authority to direct any institute to fund them. It recommended Congress create a new institute with at least $4 billion appropriated over five years.

These conditions are not underfunded because they lost a competition for grant money.

There was no competition. No institute owns them, and the office that advocates for them cannot compel anyone to act.

The condition-level spending table on NIH RePORT, republished on 23 June 2026, now carries a further note. Estimates for fiscal years 2026 and 2027 are not provided by category, which the NIH attributes to evolving changes in administration priorities.

The series that would show whether any of this is improving has stopped.

Women's health is described as underfunded. That description is too flat. The gaps inside it come in three shapes, and each produces a different problem for anyone trying to build.

The first is a measurement gap, where a condition is counted but not consistently. Nygaard and colleagues, in JAMA in 2008 using NHANES data, found that 23.7% of non-pregnant women aged 20 and over had symptoms of at least one pelvic floor disorder. CDC surveillance through the Pregnancy Risk Assessment Monitoring System put self-reported postpartum depressive symptoms at 13.2% across 31 sites in 2018. Harlow and colleagues, in the American Journal of Obstetrics and Gynecology in 2014, estimated that 7% to 8% of women will have experienced symptoms consistent with vulvodynia by age 40. Those figures, alongside the NCHS estimates, use four different definitions across four different populations.

Nobody can rank these conditions by burden without choosing a methodology that favors one of them.

The second is an evidence gap, where numbers exist but are too old or too thin to act on. The most cited economic estimate for vulvodynia comes from Xie and colleagues in Current Medical Research and Opinion in 2012, who surveyed patients recruited through the National Vulvodynia Association between 2009 and 2010. Of 302 who entered any data, 97 completed six months.

The authors imputed the remainder and extrapolated across a reported 3% to 7% prevalence range, arriving at an annual national burden between $31 billion and $72 billion. A range that wide, from a self-selected sample that small, built on data now more than fifteen years old, is not a figure to build a policy case on. It remains the most cited estimate available, which is the point. Menstrual health is in the same position, its circulating figure drawn from Medical Expenditure Panel Survey data from 2000 to 2002.

The third is a category gap, where a condition does not appear in the accounting at all. Luca and colleagues, in the American Journal of Public Health in 2020 through work conducted at Mathematica, put the cost of untreated perinatal mood and anxiety disorders at approximately $14 billion for the 2017 United States birth cohort followed to five years postpartum, an average of about $31,800 per affected pair that went untreated. CDC data from Maternal Mortality Review Committees identify mental health conditions as a leading underlying cause of pregnancy-related death, accounting for 22.5% of such deaths in the 2021 data released in August 2025, of which 87% were determined preventable. Maternal mental health does not appear as a funding category in any femtech taxonomy reviewed for this piece.

Menopause sits across all three. Faubion and colleagues surveyed 4,440 employed women aged 45 to 60 at Mayo Clinic in 2021 and published in Mayo Clinic Proceedings in 2023, estimating $1.8 billion in annual lost work time in the United States and $26.6 billion once medical expenses are added. The cohort was 93% white and drawn from a single health system, which the authors flag. It is the category where private capital has arrived fastest and the evidence base is thinnest relative to the money.

Where the funding does land is instructive. Impact Global Health found that basic research absorbs 85.5% of uterine fibroids funding and 74% of PCOS funding. That is not a criticism of basic research. It is a measure of how early the field still is, because a portfolio dominated by basic research means the underlying disease mechanism is still unknown.

The consequence shows up in the products. Of 106 marketed products across the three conditions, 95% are repurposed from other indications, mostly contraceptives, hormone-dependent cancer drugs, and pain medication. None address the underlying cause of any of the three. There is no cure for any of them.

Against all of that, private capital has a clear and consistent shape.

Across the twelve months to June 2026, New Market Pitch counted roughly $413 million across 23 disclosed femtech rounds in five categories. Women's primary care took 37.2% of capital across 7 deals. Hormonal health platforms took 28.5% across 6, though a single $100 million round accounts for most of that. Fertility care platforms took 28.3% across 5. Menstrual health tools took 3.7% across 3 deals, and pregnancy care solutions took 2.3% across 2. These are aggregator-computed figures on one publisher's definition of the category, and the universe is smaller than other trackers report, so the shares carry more signal than the absolute dollars.

Consumer measurement is the part of this that attracts capital. Of the two hormone-tracking wearables unveiled since June, one reports cycle phase classification benchmarked against daily urine samples and one rests on a pilot of twelve women across thirty-one cycles. Both will ship as general wellness devices rather than regulated ones.

That is not a criticism of either company. It is a description of where the science ends.

A sensor can be demonstrated and sold. The validation that would make its output clinically meaningful is slow and expensive and shows nothing on a product page, and the biology that would make the validation interpretable was never funded.

Wei Gao's group at Caltech published an aptamer-based sweat estradiol sensor in Nature Nanotechnology in 2024, which is what a directly measured hormone looks like and how long it takes to get there.

Inference is faster. Inference is what a market underwrites when the biology underneath it was never commissioned.

Diagnostic delay is what all three gaps produce at the level of a patient. Nnoaham and colleagues, working through the World Endometriosis Research Foundation Global Study of Women's Health, recruited 1,418 premenopausal women at sixteen clinical centers across ten countries and published in Fertility and Sterility in 2011. They found a delay of 6.7 years between symptom onset and surgical diagnosis of endometriosis, occurring principally in primary care.

That study is fifteen years old and remains the reference point, which says something on its own.

A delay of that length is not a failure of patient persistence or clinician attention. It is what happens when the only definitive test is surgery.

Ida Tin's generation of founders built this field on self-reported data because self-reported data was the only data available.

A decade on, the sensor layer has improved and the biology has not. Endometriosis still requires surgery to confirm. Hysterectomy is still the only definitive treatment for fibroids. Nothing on the market for either addresses what causes it.

What has changed is that a product can now be built and sold in that gap.

Money keeps going to products with no evidence behind them, while the conditions with the clearest evidence of need go unfunded.

The Luteal covers the business, science, and policy of women's health. Nothing here is medical advice.

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Sources

Research funding

Prevalence

Economic burden

Diagnostic delay Nnoaham et al., "Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries," Fertility and Sterility, 2011;96(2):366–373.e8.

Measurement science Ye et al., "Wearable aptamer nanobiosensor for non-invasive female hormone monitoring," Nature Nanotechnology 19, 330–337 (2024).

Aggregator-computed New Market Pitch, femtech funding analysis, trailing twelve months to June 2026. One publisher's five-category definition, universe of $412.6M across 23 disclosed deals.

— Keisha, Editor of The Luteal