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Companion Diagnostics Market to Grow from USD 6.31 Billion in 2026 to USD 11.57 Billion by 2031, at a CAGR of 12.9% – MarketsandMarkets™

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AGNC Agilent Technologies is mentioned as a leading player in the moderately consolidated companion diagnostics market, indicating its involvement and potential growth in this sector. TMO Thermo Fisher Scientific Inc. is identified as a leading player in the companion diagnostics market, suggesting its significant role and potential for growth in this sector. DHR Danaher is mentioned as a leading player in the companion diagnostics market, suggesting its established presence and potential for growth in this sector. ABT Abbott is identified as a leading player in the companion diagnostics market, indicating its significant involvement and potential for growth in this sector. ILMN Illumina is listed as a leading player in the companion diagnostics market, suggesting its established position and potential for growth in this sector.

Companion Diagnostics Market to Grow from USD 6.31 Billion in 2026 to USD 11.57 Billion by 2031, at a CAGR of 12.9% – MarketsandMarkets™ Delray Beach, FL, Aug. 25, 2026 (GLOBE NEWSWIRE) -- MarketsandMarkets™ projects the global companion diagnostics market will grow from USD 6.31 billion in 2026 to USD 11.57 billion by 2031, at a CAGR of 12.9% during the forecast period. Market growth 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. Increasing regulatory emphasis on personalized therapeutics, growing pharma-diagnostic partnerships, and expanding approvals of targeted drugs are further accelerating market growth globally.

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Key Market Highlights

Why This Market Matters

The growing adoption of precision medicine and targeted therapies is significantly driving demand for companion diagnostics. Healthcare providers increasingly rely on biomarker-based testing to personalize treatment decisions, while the rising number of targeted therapy approvals, particularly in oncology, is accelerating the integration of companion diagnostics into clinical workflows. Pharmaceutical companies are also increasingly partnering with diagnostic developers to improve patient stratification and treatment efficacy.

Companion diagnostics are becoming essential tools for identifying patients most likely to benefit from specific therapies. Their applications extend across oncology, autoimmune diseases, and rare genetic disorders, while growing regulatory emphasis on personalized therapeutics and drug–diagnostic co-development is supporting broader adoption.

Market Overview

The companion diagnostics market is rapidly transforming through advances in precision medicine, next-generation sequencing, liquid biopsy, and AI-enabled biomarker discovery. The integration of companion diagnostics into targeted drug development and clinical trial stratification is increasing demand for highly accurate and personalized diagnostic solutions across oncology and rare disease applications.

The market encompasses diagnostic assays, NGS, PCR-based testing, immunohistochemistry, in situ hybridization, liquid biopsy technologies, bioinformatics platforms, and associated analytical services. Advances in digital pathology, multiplex biomarker analysis, cloud-based bioinformatics, and AI-driven clinical interpretation are improving diagnostic precision, turnaround time, and treatment decision support.

Analyst Perspective

The increasing integration of companion diagnostics into precision medicine and targeted drug development presents significant growth opportunities for market participants. Pharmaceutical and diagnostic companies are increasingly collaborating to co-develop companion diagnostics alongside targeted therapies, supporting patient selection, clinical trial stratification, regulatory submissions, and commercialization.

The expansion of liquid biopsy and non-invasive companion diagnostics is another important opportunity. Liquid biopsy-based companion diagnostics can support minimally invasive cancer detection, real-time assessment of tumor mutations, and treatment-response monitoring. Advances in circulating tumor DNA (ctDNA), multi-cancer early detection, and AI-driven biomarker analysis are further expanding the scope of precision diagnostics.

However, high development, clinical validation, and regulatory approval costs remain important restraints. Companion diagnostics require substantial investment in biomarker discovery, assay development, clinical validation, and regulatory compliance. Simultaneous approval requirements for therapeutics and diagnostics can increase development complexity and extend commercialization timelines, while reimbursement variability can restrict market penetration.

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Segment Analysis

By product & service, assays, kits & reagents are expected to account for the largest share of the companion diagnostics market. These consumables are repeatedly used across PCR, NGS, IHC, and ISH-based testing workflows, unlike instruments that represent capital purchases with longer replacement cycles. Increasing biomarker testing volumes in oncology, particularly for lung, breast, and colorectal cancers and hematologic malignancies, are supporting demand for CDx assay kits and reagents.

By technology, PCR is expected to hold the largest share of the companion diagnostics market. Its wide clinical use, faster turnaround time, lower cost, and established adoption across targeted mutation testing workflows support its leading position. PCR-based CDx assays are widely used for actionable biomarkers such as EGFR, KRAS/NRAS, BRAF, and BRCA mutations, as well as MSI-related testing and selected oncology-linked molecular targets.

By indication, cancer is expected to dominate the companion diagnostics market, accounting for the vast majority of demand. Within cancer, lung cancer is likely to hold the largest share, supported by a broad range of actionable biomarkers, including EGFR, ALK, ROS1, BRAF, MET, RET, NTRK, KRAS, and PD-L1, along with increasing use of NGS-based profiling. Breast cancer and colorectal cancer are also major CDx indications, supported by HER2, ER/PR, BRCA/HRD, RAS, BRAF, and MSI/MMR testing.

By sample, tissue samples are expected to hold the largest share of the market because most approved and reimbursed CDx workflows remain tissue-based. Tissue testing is central to IHC, ISH/FISH, and many NGS assays used in solid tumors, particularly for HER2, PD-L1, ALK, MMR, and comprehensive tumor profiling.

By end user, pharmaceutical & biopharmaceutical companies are expected to account for the largest share of the companion diagnostics market. These companies play a central role in CDx co-development, clinical trial patient selection, regulatory submissions, and commercialization of targeted therapies. Demand is particularly strong across oncology, immunotherapy, and precision medicine pipelines.

Regional Analysis

Asia Pacific is expected to be the fastest-growing region in the companion diagnostics market during the forecast period. Growth is driven by rising cancer incidence, expanding adoption of precision oncology, increasing use of PCR- and NGS-based biomarker testing, and improving access to targeted therapies across China, Japan, South Korea, Australia, and India.

Japan and South Korea are advancing reimbursement and clinical adoption of comprehensive genomic profiling, while China and India are experiencing rapid expansion of molecular diagnostics infrastructure, oncology reference laboratories, and pharma-led biomarker testing programs. Growing clinical trial activity, increasing approvals of targeted therapies, and broader use of liquid biopsy and multi-gene testing are expected to further support regional growth.

Key Industry Trends

Competitive Landscape

The companion diagnostics market is moderately consolidated, with leading players including F. Hoffmann-La Roche AG, Agilent Technologies, Inc., QIAGEN, Thermo Fisher Scientific Inc., Guardant Health, Inc., Danaher, Abbott, and Illumina. These companies are strengthening their market positions through FDA-approved CDx assays, oncology testing platforms, pharmaceutical partnerships, NGS-based companion diagnostic development, and geographic expansion.

The market is characterized by strong collaboration between pharmaceutical and biopharmaceutical companies, diagnostic assay developers, sequencing and pathology platform providers, reference laboratories, hospitals, oncology centers, academic institutions, and regulatory bodies. These participants work together to develop and commercialize companion diagnostics alongside targeted therapies, immunotherapies, and emerging cell and gene therapies.

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