Companion diagnostics market seen hitting $11.25 billion by 2030

The Business Research Company says the market for companion diagnostics used in targeted therapies will grow from $5.76 billion in 2025 to $11.25 billion by 2030, powered by precision medicine, molecular diagnostics and AI tools. North America led in 2025, while Asia-Pacific is projected to grow fastest.

Why it matters: - Companion diagnostics help match patients to targeted therapies by identifying biomarkers, mutations and other molecular traits. - The market’s growth signals broader adoption of precision medicine, which aims to improve outcomes and reduce use of ineffective treatments. - A larger companion diagnostics market could also speed biomarker-based drug development and regulatory approvals.

What happened: - The Business Research Company published a market outlook on the companion diagnostics for targeted therapies sector. - The report estimates the market will rise from $5.76 billion in 2025 to $6.57 billion in 2026. - The same forecast puts the market at $11.25 billion by 2030. - The report says the sector will grow at a 14.1% CAGR in the historical period and 14.4% over the forecast period.

The details: - Growth in 2025-2026 is linked to rising cancer and chronic disease cases, along with broader use of precision oncology protocols. - The report also points to expansion in molecular diagnostic laboratories, genomic sequencing research and early biomarker detection tools. - Future growth is expected to come from AI-driven diagnostic analytics, clinical decision support tools, wider use of personalized medicine, pharma partnerships in companion diagnostic development, and next-generation sequencing plus multi-omics platforms. - The report flags AI-powered biomarker discovery, multi-omics integration, automated molecular testing and liquid biopsy techniques as major trends. - Companion diagnostics test for biomarkers, genetic mutations or molecular traits to help determine whether a patient is likely to benefit from a specific targeted therapy. - The report says these tests support precision medicine by improving treatment selection and reducing unnecessary exposure to therapies that are unlikely to work. - In February 2024, the Personalized Medicine Coalition said the FDA approved 16 new personalized therapies for rare diseases in 2023, up from six in 2022. - In 2025, North America held the largest share of the market. - Asia-Pacific is expected to post the fastest growth during the forecast period. - The report covers Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, the Middle East and Africa.

Between the lines: - The forecast reflects a shift from broad treatment models toward more customized care based on patient-specific data. - Stronger regulatory support for biomarker-based approvals suggests companion diagnostics are becoming more central to drug development and commercialization. - The regional split suggests mature adoption in North America and faster catch-up growth in Asia-Pacific as healthcare investment and diagnostic infrastructure expand.

What's next: - The report expects continued momentum from next-generation sequencing, multi-omics and automated testing workflows. - Wider clinical use of AI tools could make biomarker interpretation faster and more scalable. - More pharmaceutical partnerships around companion diagnostics could further tie testing to therapy launches. - The company also added new 2026 report features, including TAM analysis, company scoring matrices, Excel forecasting dashboards, hotspots infographics and updated graphics and tables.

The bottom line: - Companion diagnostics for targeted therapies are moving from a niche tool to a core part of precision medicine, with the market projected to nearly double by 2030.