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

Rapid and accurate infectious diseases diagnostics are essential to guide antimicrobial stewardship, combat antimicrobial resistance, and improve patient outcomes. However, the availability, adoption, and sustainability of in vitro diagnostics (IVDs) are challenged by high upfront costs, inconsistent coverage and reimbursement policies, and an evolving regulatory landscape. Market access, payor and health policy, and advocacy are pivotal in shaping whether these technologies reach the patient. It is essential to understand the key components of the market access process-regulatory pathways, coverage, reimbursement, evidence generation, and stakeholder engagement-and to recognize how healthcare providers, payors, patients, and policymakers influence diagnostic accessibility. Clinicians, pharmacists, and laboratory professionals must actively participate in advocacy efforts, leveraging clinical insight and evidence to inform regulation, reimbursement, and guideline inclusion. This article presents a practical overview for advancing IVDs through policy and market access engagement, emphasizing the need for coordinated, evidence-based communication with regulatory bodies, payors, and professional societies.