Abstract
INTRODUCTION: In Vitro Diagnostic (IVD) tests play a fundamental role across the healthcare continuum by enabling early detection, guiding treatment decisions, and supporting disease monitoring. Despite representing a small fraction of health expenditure, IVD tests generate substantial clinical, social and economic value. This study aims to generate evidence on the contribution of IVD tests to health, society and economy, considering its impact at different stages of diagnosis or follow-up, in four pathologies with high or increasing incidence or prevalence, and public health relevance in 2021: COVID-19, diabetes, heart failure, and lung cancer. METHODS: A Social Return on Investment (SROI) methodology was applied to evaluate the social and economic return obtained for each euro invested in IVD tests over a 1-year period, across the selected conditions. The analysis was supported by scientific articles, official data, grey sources, and perspectives gathered from stakeholders through interviews and focus groups. For each pathology, an impact map was developed to identify inputs, outputs and outcomes from the perspective of patients, family/caregivers, healthcare professionals, healthcare providers, healthcare systems and society. A consistently conservative approach was adopted in estimating quantities and monetary valuations. RESULTS: The estimated SROI ratios revealed substantial returns: €8.2 for every €1 invested in PCR tests and professional Ag-RDTs for COVID-19, highlighting their importance in the diagnosis and transmission control; €6 for every €1 invested in glycated hemoglobin and glucose self-monitoring tests for diabetes; €12.6 for every €1 invested in B-type natriuretic peptide tests after prescription in primary care; and €14.9 for every €1 invested in molecular testing, specifically next-generation sequencing, in stage IV lung adenocarcinoma. These returns reflect improvements in health outcomes, healthcare efficiency, and productivity. DISCUSSION: The case studies revealed economic and social returns ranging from six to fifteen times the initial investment. The findings demonstrated that investing in IVD tests improves clinical decision-making, enhances quality of life, and reduces healthcare costs. Policymakers should recognize IVD tests not merely as diagnostic tools, but as strategic levers to improve public health and economic resilience. These four case studies demonstrate IVD tests value and provide a snapshot of the wider benefits of its applications.