Companion Diagnostics Market Aligned with FDA Breakthrough Therapy and Accelerated Approval Pathways

The U.S. companion diagnostics (CDx) development market reached USD 412.84 million in 2024, with a projected CAGR of 7.8% anticipated over the forecast period from 2025 to 2034. This expansion is being driven by distinct segment-level dynamics across product types, end-user industries, and application areas. By technology, next-generation sequencing (NGS)-based assays have emerged as the fastest-growing segment, capturing significant traction due to their ability to analyze multiple biomarkers simultaneously, making them ideal for use in immuno-oncology and rare disease applications. Polymerase chain reaction (PCR) remains the most widely used platform, especially for single-gene testing in solid tumors such as lung and breast cancer.

From an application standpoint, oncology dominates the CDx market, accounting for over 80% of total revenue in 2024. This is primarily attributed to the growing number of targeted therapies approved by the FDA that require a companion diagnostic for patient stratification. Non-small cell lung cancer (NSCLC), melanoma, and breast cancer represent the largest indications, with CDx tests playing a critical role in guiding treatment decisions around EGFR, BRAF, HER2, and PD-L1 inhibitors. Segment-wise performance outside oncology is gaining momentum, particularly in infectious diseases and cardiovascular conditions, where pharmacogenomics is driving personalized treatment approaches.

End-user segmentation reveals a growing presence of biopharmaceutical companies in the CDx value chain, with increasing partnerships between pharmaceutical firms and diagnostic developers to co-develop companion tests alongside new drugs. Diagnostic laboratories and hospital-based pathology departments remain key adopters, though there is a noticeable shift toward decentralized testing models enabled by point-of-care platforms and digital pathology integrations. Value chain optimization efforts are focused on improving turnaround times, reducing assay complexity, and enhancing data interoperability with electronic health records (EHRs). Companies are leveraging product differentiation strategies by developing proprietary platforms that offer multiplexing capabilities, automation, and integrated bioinformatics support. As the market matures, firms that align innovation with regulatory clarity and commercial scalability are poised to capture disproportionate market share.

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