Oncology Companion Diagnostic Market to Value USD 14.65 Billion by 2035, Registering 11.09% CAGR – SNS Insider
U.S. Market Valued at USD 2.17 Billion in 2025 While Europe Reaches USD 1.47 Billion as Biomarker-Based Cancer Testing Expands.
Austin, United States, June 08, 2026 (GLOBE NEWSWIRE) — “The Oncology Companion Diagnostic Market was valued at USD 5.09 Billion in 2025 and is projected to reach USD 14.65 Billion by 2035, growing at a CAGR of 11.09% from 2026 to 2035, according to SNS Insider.”
The market is growing due to an increasing adoption of precision oncology, rising demand for biomarker-guided therapies, and the increasing pipeline of targeted cancer drugs that need the companion diagnostic test to select patients.
Oncology companion diagnostics are specific in vitro test that are evaluated in conjunction with a targeted cancer therapy to identify the patients who would respond to the therapy and help guide personalized treatment decisions. With precision medicine moving into the mainstream of oncology, the demand trends for advanced companion diagnostics solution as molecular profiling and biomarker testing requirement at the diagnosis stage is boosting.
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Targeted Therapy Development Fuels Market Expansion
The market is benefiting from the rapid development of targeted oncology therapies and biomarker-driven drug development. More than 1,000 oncology drugs are now in clinical development, many targeting biomarker-defined patient populations; as such companion diagnostics have become a key component in regulatory approval and commercialization strategy. The continued adoption of testing is driven by growing regulatory requirements for co-approved diagnostics and targeted therapies and our solutions are used across hospitals, cancer centers, and diagnostic laboratories worldwide.
Leading Market Players Listed in the Oncology Companion Diagnostic Market Report are:
- F. Hoffmann-La Roche Ltd.
- QIAGEN N.V.
- Thermo Fisher Scientific Inc.
- Illumina, Inc.
- Agilent Technologies, Inc.
- Abbott Laboratories
- Bio-Rad Laboratories, Inc.
- Guardant Health, Inc.
- Exact Sciences Corporation
- Myriad Genetics, Inc.
- NeoGenomics, Inc.
- Foundation Medicine, Inc.
- Sysmex Corporation
- Natera, Inc.
- Invivoscribe, Inc.
- Danaher Corporation (Cepheid)
- PERSONALIS, Inc.
- Adaptive Biotechnologies Corporation
- Biocartis Group NV
- Genomic Health, Inc. (Exact Sciences)
Segmentation Analysis:
By Technology
Polymerase Chain Reaction (PCR) dominated the Oncology Companion Diagnostic Market in 2025 due to its high accuracy, rapid turnaround time, cost-effectiveness, and widespread use in identifying established cancer biomarkers. Next-Generation Sequencing (NGS) is the fastest-growing segment with a CAGR of approximately 12.64% during the forecast period, driven by increasing demand for comprehensive genomic profiling, and multi-gene testing capabilities globally.
By Product
Assay Kits & Reagents dominated the Oncology Companion Diagnostic Market with the largest share in 2025 owing to recurring demand for testing consumables, rising cancer diagnostic volumes, and increasing use of biomarker-based treatment selection. Others is the fastest-growing segment, driven by increasing outsourcing of specialized diagnostic testing, expansion of reference laboratory services, and rising demand for advanced biomarker analysis and genomic testing solutions.
By Cancer Type
Non-Small Cell Lung Cancer (NSCLC) dominated the Oncology Companion Diagnostic Market with approximately 31% share in 2025 due to the high prevalence of actionable genetic mutations, extensive biomarker testing requirements, and the availability of numerous targeted therapies. Breast Cancer is the fastest-growing segment during the forecast period, fueled by expanding adoption of genomic testing globally.
By End User
Pharmaceutical & Biopharmaceutical Companies dominated the Oncology Companion Diagnostic Market with approximately 46.27% share in 2025 owing to significant investments in targeted drug development, biomarker discovery programs, and companion diagnostic co-development activities. Contract Research Organizations (CROs) are witnessing strong growth during the forecast period, driven by rising outsourcing of clinical trial services globally.
Regional Insights:
North America held the largest revenue share of over 42.86% in 2025 in the global oncology companion diagnostic market. The United States represents approximately 82.5% of North American revenues, driven by its leadership in approvals of targeted oncology drugs requiring companion diagnostic co-approval, and its holding the highest commercial cancer diagnostic laboratory infrastructure density in the world.
- The U.S. Oncology Companion Diagnostic Market was valued at approximately USD 2.17 Billion in 2025 and is expected to reach approximately USD 6.24 Billion by 2035, growing at a CAGR of approximately 11.12%. The US market is fueled by the FDA’s regulatory leadership in precision oncology, with the companion diagnostic approval pathway being established through seminal co-approvals.
The Europe Oncology Companion Diagnostic Market is estimated to be USD 1.47 Billion in 2025 and is projected to reach USD 4.07 Billion by 2035, growing at a CAGR of 10.72% during 2026–2035. In 2025, Europe dominated the global market for companion diagnostics in oncology. The leading national markets, Germany, France, the UK, Italy and Spain, with their universal healthcare cancer care programmes, academic oncology centres and progressive EMA regulatory framework for companion diagnostic co-approval, create consistent molecular diagnostic demand.
The Asia Pacific market is growing at the fastest CAGR of 12.34% due to increasing healthcare infrastructure investment, rising adoption of precision oncology, and evolving regulatory scenarios in China, India, Japan, and South Korea.
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Recent Developments:
- 2025: Roche launched an advanced companion diagnostic assay to detect novel biomarker signatures across multiple oncology indications, allowing detailed molecular tumor profiling from a single tissue sample to support the choice of first-line targeted therapies and inform subsequent treatment options.
- 2024: Thermo Fisher Scientific expanded the coverage of its Oncomine Dx Target Test NGS-based companion diagnostic test to include more actionable genomic alterations in NSCLC as well as other solid tumor types, furthering the clinical utility of comprehensive NGS companion diagnostic testing beyond single-gene PCR alternatives.
Exclusive Sections of the Report (The USPs):
- COMPANION DIAGNOSTIC TECHNOLOGY ADOPTION METRICS – helps you understand the adoption trends of NGS, PCR, IHC, ISH, and other biomarker testing technologies across oncology diagnostics.
- PRECISION MEDICINE & TARGETED THERAPY ANALYSIS – helps you evaluate the utilization of companion diagnostics in targeted therapies, immunotherapies, molecular profiling, and personalized cancer treatment programs.
- LIQUID BIOPSY & ADVANCED DIAGNOSTIC INSIGHTS – helps you identify growth opportunities in liquid biopsy testing, ctDNA-based diagnostics, treatment monitoring, and minimally invasive cancer detection technologies.
- CLINICAL TRIALS & BIOMARKER DEVELOPMENT METRICS – helps you assess companion diagnostic integration in oncology clinical trials, drug-diagnostic co-development programs, biomarker validation studies, and precision medicine research activities.
- HEALTHCARE ADOPTION & CANCER BURDEN ANALYSIS – helps you understand regional demand patterns driven by cancer incidence, molecular testing utilization, healthcare spending, and precision oncology adoption.
- COMPETITIVE LANDSCAPE – helps you gauge the competitive strength of key players in the market backed by an analysis of their companion diagnostic portfolios, biomarker technologies, strategic collaborations, regulatory approvals, geographic presence, and recent developments.
Oncology Companion Diagnostic Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 5.09 Billion |
| Market Size by 2035 | USD 14.65 Billion |
| CAGR | CAGR of 11.09% From 2026 to 2035 |
| Base Year | 2025 |
| Forecast Period | 2026-2035 |
| Historical Data | 2022-2024 |
| Key Segments | • By Technology (Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Others) • By Product (Assay Kits & Reagents, Instruments, Others) • By Cancer Type (Non-Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, Melanoma, Leukaemia, Others) • By End User (Pharmaceutical & Biopharmaceutical Companies, Contract Research Organizations, Hospitals & Diagnostic Laboratories) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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