Compliance vs. Cash Flow: The Market Access Crisis in Women's Health

54% of life sciences organizations identify payer reimbursement as their biggest commercial hurdle when launching a new sex-specific therapeutic.

Boston MA -- October 7: Despite significant advances in women's health innovation, biopharma organizations are struggling to translate clinical success into commercial adoption.

The Women's Health Infrastructure Report 2026 reveals that market access—not regulatory compliance or clinical adoption—is the primary bottleneck for new therapeutics.

Survey respondents overwhelmingly ranked reimbursement strategy above FDA diversity compliance, clinical end-user adoption, and patient recruitment. Increasingly, life sciences organizations are recognizing that market success depends not only on demonstrating efficacy but also on building a clear, frictionless pathway to payment.

"The path from target identification to clinical proof of concept in many women's health indications remains underdeveloped. Too often we lack validated biomarkers, predictive preclinical models, and clear regulatory pathways. As a result, many conditions that disproportionately affect women remain biologically under-characterized and under-invested..."

Fiona Marshall

President, Biomedical Research, Novartis

This finding represents just one of dozens of insights uncovered through the Women's Health Infrastructure Report 2026, a cross-sector study bringing together perspectives from health plans, providers, employers, clinicians, life sciences organisations and innovators.

The full report features detailed findings, expert commentary, benchmark data and practical implications for healthcare leaders looking to understand where women's health is heading next.

Lead Research Partner