United States Companion Diagnostics Market Insight
Published: 24 June 2026 | Report Format: Electronic (PDF) | Author: Govind and Krishna
The United States Companion Diagnostics Market is projected to expand at a CAGR of around 10.8%, driven by the growing adoption of precision medicine, increasing prevalence of cancer and rare diseases, rising demand for biomarker-based testing, expanding use of targeted therapies, and continued regulatory support for personalized treatment approaches across the healthcare sector.
United States Companion Diagnostics Market Forecasts to 2035
- The United States Companion Diagnostics Market Size Was Estimated at USD 4.82 Billion in 2025.
- The Market Size is Expected to Grow at a CAGR of around 10.8% from 2025 to 2035.
- The United States Companion Diagnostics Market Size is Expected to Reach around USD 13.44 Billion by 2035.
Notable Insights for the United States Companion Diagnostics Market
- Segmentation Based on Technology, Polymerase Chain Reaction (PCR) held the leading position in 2025 with nearly 34.8% share, supported by its high accuracy, widespread clinical adoption, rapid turnaround time, and strong utilization in oncology-focused companion diagnostic applications.
- Segmentation Based on Indication, Cancer accounted for approximately 67.5% share in 2025, driven by the increasing use of targeted oncology therapies, growing biomarker testing volumes, and expanding approvals of precision medicine treatments.
- F. Hoffmann-La Roche Ltd. reported approximately USD 74.89 billion revenue in FY2025, supported by strong demand for molecular diagnostics, companion diagnostic assays, oncology testing solutions, and continued expansion of precision medicine programs globally.
- Thermo Fisher Scientific Inc. generated nearly USD 43.21 billion revenue in FY2025, driven by increasing adoption of genomic testing platforms, biomarker analysis technologies, clinical research services, and partnerships supporting companion diagnostic development activities.
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Research Methodologies Used to Analyze the United States Companion Diagnostics Market
This study employs a combination of primary and secondary research methodologies to analyze the United States Communication Market. Primary research includes interviews and discussions with telecommunications operators, communication service providers, network infrastructure vendors, enterprise customers, cloud communication platform providers, industry specialists, technology consultants, and regulatory authorities. Secondary research involves company annual reports, investor presentations, telecommunications industry publications, government databases, regulatory filings, trade journals, and reliable market intelligence sources. Market estimations are derived using both top-down and bottom-up approaches, while data triangulation and validation techniques ensure the accuracy and reliability of market forecasts, competitive assessments, and industry trends.
Decisions Advisors Research Methodology: Trusted Insights for Strategic Decision-Making
What is Decisions Advisors Research?
Decisions Advisors research delivers comprehensive market intelligence through detailed industry analysis, competitive benchmarking, trend forecasting, and data-driven business insights. Our research methodology combines advanced analytical frameworks with extensive primary and secondary research to help organizations make informed and strategic business decisions.
Competitive Analysis:
The report offers the appropriate analysis of the key organizations/companies involved within the United States companion diagnostics market, along with a comparative evaluation primarily based on their product of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.
Top Companies in United States Companion Diagnostics Market
• F. Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc.
• Agilent Technologies, Inc.
• QIAGEN N.V.
• Abbott Laboratories
• Illumina, Inc.
• Danaher Corporation
• Guardant Health, Inc.
• Myriad Genetics, Inc.
• Bio-Rad Laboratories, Inc.
Recent Developments:
- In October 2025, QIAGEN N.V. launched an advanced companion diagnostic assay designed to identify actionable biomarkers in solid tumors, supporting more precise patient selection for targeted oncology therapies.
- In August 2025, Thermo Fisher Scientific Inc. collaborated with Agilent Technologies, Inc. to accelerate the development of next-generation companion diagnostic solutions for biomarker-driven cancer treatment programs across the United States.
Market Segmentation:
United States Companion Diagnostics Market, By Technology
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• In-Situ Hybridization (ISH)
• Other Technologies
United States Companion Diagnostics Market, By Indication
• Cancer
• Cardiovascular Diseases
• Neurological Disorders
• Infectious Diseases
• Other Indications
United States Companion Diagnostics Market, By Product & Service
• Assays, Kits, and Reagents
• Instruments and Systems
• Software and Analytics
• Services
United States Companion Diagnostics Market, By End User
• Hospitals
• Diagnostic Laboratories
• Academic and Research Institutes
• Pharmaceutical and Biotechnology Companies
• Other End Users
United States Companion Diagnostics Market, By Technology Platform
• Genomics-Based Diagnostics
• Proteomics-Based Diagnostics
• Molecular Diagnostics
• Immunodiagnostics
United States Companion Diagnostics Market, By Region
• Northeast
• Midwest
• South
• West
Expert Views:
The United States Companion Diagnostics Market is expected to witness strong growth through 2035 as precision medicine becomes increasingly integrated into routine clinical practice. Rising investments in biomarker discovery, expanding targeted therapy pipelines, and growing adoption of genomic testing are expected to support market expansion. Additionally, increasing collaborations between pharmaceutical and diagnostic companies, coupled with advancements in next-generation sequencing and molecular diagnostics, are likely to create substantial growth opportunities for industry participants over the forecast period.
Author: Govind and Krishna By Decisions Advisors and Consulting