Bringing In Vitro Diagnostics To Market With Real-World Evidence

By Kanchana Iyer

In vitro diagnostic (IVD) devices constitute a distinct category within the realm of medical devices. While falling under the classification of medical devices, they are not designed to directly treat diseases or conditions. Instead, they serve as tools or agents for analyzing patient samples. Although generally less invasive than traditional medical devices, IVDs still entail potential risks to patients.

The onset of the COVID-19 pandemic witnessed a significant surge in the utilization of IVDs, particularly for rapid testing methodologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and serology. The demand for faster and higher volume testing prompted a notable increase in molecular assays, notably real-time polymerase chain reaction (RT-PCR) testing. Projections from 2019 anticipated a consistent annual growth rate exceeding six percent for the molecular diagnostics market in the U.S. over the subsequent five years.

Responding to the urgent need to meet heightened demand, there was a rapid development and deployment of additional diagnostic technologies, including NGS and CRISPR, under emergency authorization. While NGS had previously been prominent in precision medicine, the pandemic facilitated its application in large-scale, high-volume diagnostics.

Forecasts suggest that by 2027, the IVD market will surpass $140 billion. Notably, cancer diagnostic testing emerges as one of the fastest-growing segments, with advancements in cancer biomarkers, immunohistochemistry, and molecular testing driving growth. Other areas experiencing expansion include substance abuse testing, immunoassays, cardiac markers, and Point of Care tests for inherited diseases.

This white paper delves into the distinctive attributes of IVDs within a regulatory landscape that is constantly evolving. It explores the potential of real-world evidence (RWE) in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.