Companion Diagnostics Market Worth USD 15.6 Bn by 2030 Growing at 12.4% CAGR, says Mordor Intelligence

HYDERABAD, India, Nov. 5, 2025 /PRNewswire/ -- According to Mordor Intelligence, the global companion diagnostics market is valued at USD 8.70 billion in 2025 and is projected to surpass USD 15.62 billion by 2030, growing at a CAGR of 12.42% during the forecast period (2025–2030). The market is primarily driven by the growing applications of precision medicine in oncology and rare diseases, and the increasing need for biomarker-based testing to improve drug efficacy and safety.

Regional Segment Insights

North America continues to dominate the companion diagnostics market, supported by a robust pharmaceutical pipeline, favorable reimbursement policies, and early adoption of molecular testing technologies. The region's regulatory clarity from the FDA for co-development of drugs and diagnostics has also streamlined commercialization pathways.

Asia-Pacific is emerging as the fastest-growing region, driven by an increasing cancer burden, expansion of genetic testing services, and the rapid development of localized diagnostic solutions in China, Japan, and India. National initiatives to integrate precision medicine into healthcare systems are further strengthening regional demand.

Major Trends Shaping Market Dynamics

Rising Demand for Precision and Targeted Therapies
The growing emphasis on personalized medicine is reshaping treatment paradigms. Pharmaceutical companies increasingly rely on companion diagnostics to identify patient subgroups based on genetic or molecular profiles. This trend is particularly evident in oncology, where companion diagnostics guide the use of targeted therapies such as EGFR, HER2, and PD-L1 inhibitors.

Integration of Next-Generation Sequencing (NGS) Technologies
The use of NGS-based testing platforms is transforming how we discover biomarkers and perform multiplex testing. By enabling comprehensive genomic profiling across multiple mutations, NGS helps reduce both turnaround time and cost per sample. This technology is also moving beyond oncology, finding new applications in infectious diseases, neurology, and cardiovascular research.

Strategic Collaborations Between Pharma and Diagnostic Developers
Pharmaceutical and diagnostic firms are increasingly forming strategic alliances to co-develop companion diagnostics alongside drug pipelines. These collaborations help align regulatory submissions and accelerate market entry timelines. Additionally, the integration of AI and bioinformatics tools is improving the interpretation of complex genomic data, supporting faster clinical decision-making.