Companion Diagnostics Market worth $11.57 billion by 2031 | MarketsandMarkets™

MarketsandMarkets projects the companion diagnostics market will grow from about USD 6.31 billion in 2026 to USD 11.57 billion by 2031, a compound annual growth rate of 12.9 percent. The study covers 2025-2031, highlighting the assays, kits and reagents segment which captured 67.3% of the market in 2025, and the preeminence of pharmaceutical and biotechnology firms in driving demand. North America accounted for the largest regional share at 44.7% in 2025, reflecting advanced precision medicine adoption, robust oncology testing infrastructure, and supportive regulatory frameworks. The market encompasses diagnostic assays, next-generation sequencing (NGS), PCR-based testing, immunohistochemistry, in situ hybridization, liquid biopsy technologies, bioinformatics platforms, and related services. Market growth is propelled by increased regulatory emphasis on personalized therapeutics, growing pharma-diagnostic partnerships, and expanding approvals of targeted therapies across oncology, autoimmune, and rare genetic diseases. In 2025, PCR held a dominant share in the technology segment, while NGS is expected to grow faster due to multi-gene testing and comprehensive genomic profiling. Cancer was the leading indication in 2025, with rising incidence and continued approvals of biomarker-driven therapies sustaining demand for companion diagnostics. North America remains the largest market due to advanced precision medicine adoption, strong testing infrastructure, and favorable regulatory pathways.