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.

Get PDF Brochure - Market Data & Segmentation: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=155571681

Key Market Highlights

• Market size, 2026: USD 6.31 billion
• Market forecast, 2031: USD 11.57 billion
• Growth rate: CAGR of 12.9% (2026–2031)
• Largest product & service segment: Assays, kits & reagents
• Largest technology segment: PCR
• Largest indication segment: Cancer
• Largest cancer indication: Lung cancer
• Largest sample segment: Tissue
• Largest end-user segment: Pharmaceutical & biopharmaceutical companies
• Fastest-growing region: Asia Pacific
• Key players: F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US), Danaher (US), Guardant Health, Inc. (US), Abbott (US), and Illumina, Inc. (US).

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.

Speak to Our Analyst - Get Custom Insights: https://www.marketsandmarkets.com/Enquiry_Before_BuyingNew.asp?id=155571681

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

• Increasing adoption of precision medicine
• Growing use of targeted therapies
• Rising integration of biomarker-based testing into clinical decision-making
• Increasing use of companion diagnostics in oncology
• Growing adoption of NGS and PCR-based testing
• Expansion of liquid biopsy and non-invasive diagnostics
• Increasing use of AI-enabled biomarker discovery
• Growing adoption of digital pathology
• Increasing use of multiplex biomarker analysis
• Expansion of cloud-based bioinformatics
• Growing adoption of AI-driven clinical interpretation
• Increasing pharma-diagnostic partnerships
• Growing use of companion diagnostics beyond oncology
• Increasing applications across rare and infectious diseases
• Growing adoption of multi-gene testing.

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.

Related Reports
North America Companion Diagnostics Market
Europe Companion Diagnostics Market

About MarketsandMarkets™:

MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report.

MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe.

Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem.

The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts.

To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter , LinkedIn and Facebook .

Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA: +1-888-600-6441
Email: sales@marketsandmarkets.com
Visit Our Website: https://www.marketsandmarkets.com/