DELRAY BEACH, Fla., June 15, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Companion Diagnostics Market is projected to grow from about USD 6.31 billion in 2026 to USD 11.57 billion by 2031, at a CAGR of 12.9%.

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Companion Diagnostics Market Size & Forecast:

• Market Size Available for Years: 2025–2031
• 2026 Market Size: USD 6.31 billion
• 2031 Projected Market Size: USD 11.57 billion
• CAGR (2026–2031): 12.9%

Companion Diagnostics Market Trends & Insights:

• The assays, kits & reagents segment captured 67.3% of the total market in 2025.
• Pharmaceutical & biotechnology companies dominated the companion diagnostics market in 2025.
• North America accounted for the largest share of 44.7% in 2025.

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The market is driven by the rapid adoption of precision medicine, targeted therapies, and biomarker-based treatment approaches. Companion diagnostics (CDx) are essential for identifying patient populations most likely to benefit from specific therapies, particularly in oncology, autoimmune diseases, and rare genetic disorders. The market encompasses diagnostic assays, next-generation sequencing (NGS), PCR-based testing, immunohistochemistry, in situ hybridization, liquid biopsy technologies, bioinformatics platforms, and associated analytical services. Increasing regulatory emphasis on personalized therapeutics, growing pharma-diagnostic partnerships, and expanding approvals of targeted drugs are accelerating market growth globally.

In 2025, the polymerase chain reaction (PCR) captured a major share in the technology segment.

PCR held a major share in 2025 due to its high sensitivity, faster turnaround time, established regulatory acceptance, and broad use in mutation detection and therapy-related testing. However, next-generation sequencing (NGS) is expected to grow faster over the forecast period, supported by elevated demand for multi-gene testing, comprehensive genomic profiling, and broader precision oncology applications.

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In 2025, cancer was the leading indication segment in the companion diagnostics market.

Cancer was the largest segment in 2025, as most companion diagnostics are linked to oncology therapies. Rising cancer incidence, increasing approvals of targeted therapies and immunotherapies, and the growing need to identify biomarker-positive patients continue to support this segment's dominance.

North America was the largest market for companion diagnostics in 2025.

North America accounted for the highest share in 2025, driven by advanced adoption of precision medicine, a strong oncology testing infrastructure, favorable regulatory pathways, high healthcare spending, and the presence of leading diagnostic and pharmaceutical companies. Meanwhile, the Asia Pacific is expected to grow faster, driven by expanding oncology care, rising adoption of molecular diagnostics, and increasing healthcare investments.

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Top Companies in Companion Diagnostics Market:

The Top Companies in Companion Diagnostics Market include F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US), Guardant Health, Inc (US), Danaher (US), Abbott (US), Illumina, Inc. (US), Almac Group (UK), bioMérieux (France), Myriad Genetics, Inc. (US), Sysmex Corporation (Japan), ARUP Laboratories (UK), Icon Plc (Ireland), Quest Diagnostics(US), Amoy Diagnostics Co., Ltd (China), Tempus AI, Inc (US), Caris Life Sciences, Inc (US), Arup Laboratories(US), Abnova Corporation (Taiwan), Invivoscribe Technologies (US), Q2 Solutions(US), Pillar Biosciences(US), Creative Biolabs(US), EntroGen, Inc.(US), and Biocartis (Belgium).

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