Navigating and Advancing Market Access for In Vitro Diagnostics: Understanding the Roles of Key Stakeholders and Policy

The article argues that for in-vitro diagnostics (IVDs) to meaningfully support antimicrobial stewardship and combat antimicrobial resistance, it’s not enough just to develop good tests — manufacturers, regulators, payors, clinicians, laboratories and patient advocates must all coordinate on evidence generation, regulatory pathways, reimbursement strategies, and advocacy. It outlines the complex landscape of market access — including demonstrating clinical and economic value, aligning with reimbursement systems, engaging with stakeholders early, and influencing policy — and stresses that active involvement of healthcare professionals in advocacy and policy is essential to ensure diagnostics reach the patients who need them.