Oncology Companion Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product & Service (Product (Instrument, Consumables, Software), Service), By Technology (Polymerase chain reaction (PCR), Next-generation sequencing (NGS), Immunohistochemistry (IHC), In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH), Others), By Disease Type (Breast cancer, Non-small cell lung cancer, Colorectal cancer, Leukemia, Melanoma, Prostate cancer, Others), By End Use (Hospitals, Pathology/Diagnostic laboratory, Academic medical center), By Region, and By Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.21 Billion
CAGR (2026-2031)	7.92%
Fastest Growing Segment	Next Generation Sequencing
Largest Market	North America
Market Size (2031)	USD 5.07 Billion

Market Overview

The Global Oncology Companion Diagnostic Market will grow from USD 3.21 Billion in 2025 to USD 5.07 Billion by 2031 at a 7.92% CAGR. Oncology companion diagnostics are medical devices utilized to identify patients eligible for specific therapeutic products or those at risk of serious adverse reactions. The market is fundamentally driven by the global transition toward personalized healthcare and the increasing prevalence of cancer requiring targeted intervention. This growing reliance on biomarker dependent therapy is substantiated by regulatory data. According to the Personalized Medicine Coalition, in 2024, the FDA approved 18 new personalized medicines, representing approximately 38 percent of all newly approved therapeutic molecular entities.

Despite these growth catalysts, the sector encounters a significant challenge regarding reimbursement frameworks. A primary impediment is the misalignment between diagnostic coding structures and payer coverage policies which creates financial uncertainty for developers. Inconsistent reimbursement determinations across healthcare systems complicate commercialization and restrict patient access to necessary testing. These economic barriers delay the adoption of novel diagnostic technologies and limit the addressable market for emerging oncology biomarkers while impeding overall expansion.

Key Market Drivers

The escalating global prevalence of cancer necessitates the widespread deployment of companion diagnostics to optimize treatment pathways and reduce ineffective prescriptions. As the incidence of malignancy rises, healthcare systems are increasingly mandating genomic testing to ensure that high-cost therapies are administered only to patients with the requisite genetic profile. This volume-based demand serves as a fundamental engine for market expansion, pushing laboratories to scale their testing capabilities. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, it is projected that over 2 million new cancer cases will be diagnosed in the United States alone, underscoring the critical need for diagnostic stratification tools to manage this growing patient burden.

Concurrently, the accelerating adoption of precision oncology is reshaping clinical workflows and driving the proliferation of targeted therapies. Pharmaceutical developers are shifting focus from broad-spectrum cytotoxics to biomarker-driven drugs, creating a symbiotic reliance on diagnostic assays for clinical trial enrollment and commercial administration. This strategic pivot ensures that diagnostics are frequently co-developed alongside therapeutics, effectively binding the market growth of diagnostics to the pharmaceutical pipeline. According to AstraZeneca, February 2024, in the 'Full Year 2023 Results' announcement, the company confirmed that 90 percent of its clinical pipeline comprises targeted therapies, reflecting the industrial prioritization of biomarker-dependent mechanisms. This shift is translating into tangible volume growth. According to Guardant Health, in 2024, the company reported a 21 percent year-over-year increase in clinical test volume, evidencing the expanding utilization of oncology diagnostic solutions.

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Key Market Challenges

The misalignment between diagnostic coding structures and payer coverage policies constitutes a formidable financial barrier that directly restricts the expansion of the global oncology companion diagnostic market. When reimbursement frameworks fail to keep pace with rapid technological advancements, developers face substantial revenue uncertainty, which discourages investment in novel biomarker validation. This economic disconnect means that even clinically proven diagnostics often lack clear payment pathways, forcing clinical laboratories to absorb costs or decline testing for eligible patients. Consequently, the commercial viability of these essential tools is compromised, limiting their availability in standard clinical practice and hindering the broader transition to personalized medicine.

This financial friction profoundly impacts market uptake by creating obstacles at the point of care. According to the International Association for the Study of Lung Cancer (IASLC), in its 2024 Global Survey on Biomarker Testing, 27.2 percent of respondents identified cost as a primary obstacle to the implementation of necessary testing. Such economic hurdles effectively cap the addressable market by preventing widespread adoption. As healthcare providers struggle with inconsistent reimbursement determinations, patient access to targeted therapies is delayed, thereby stifling the overall growth potential of the precision oncology sector.

Key Market Trends

The market is undergoing a structural migration from iterative single-biomarker assays to multiplex Next-Generation Sequencing panels. This shift is driven by the need to conserve limited biopsy tissue while maximizing genomic insights for complex targeted therapies. Unlike traditional methods that analyze one gene sequentially, multiplex panels enable simultaneous interrogation of hundreds of alterations, reducing diagnostic turnaround times and resolving tissue exhaustion challenges. This consolidation is evident in laboratory throughput metrics. According to NeoGenomics, February 2025, in the 'Fourth Quarter and Full Year 2024 Results' report, the company confirmed that its Next-Generation Sequencing test volume grew 34 percent in 2024, illustrating the rapid industrial pivot toward comprehensive genomic profiling.

Concurrently, the integration of Artificial Intelligence and Machine Learning is redefining diagnostic precision. As datasets become exponentially complex, computational algorithms are essential for interpreting multi-omics data and correlating genomic findings with clinical outcomes. This technological convergence identifies novel biomarkers and refines patient stratification beyond standard pathology. The commercial traction of these algorithmic solutions is accelerating as partners seek data-driven insights. According to Tempus AI, February 2025, in the 'Fourth Quarter and Full Year 2024 Results' announcement, the company reported that revenue from its Data and Services segment, which utilizes AI-enabled platforms, increased 44.6 percent from the previous year, underscoring the growing value of computational diagnostics.

Segmental Insights

Next Generation Sequencing constitutes the fastest growing segment in the Global Oncology Companion Diagnostic Market due to its capacity to detect multiple genetic alterations in a single test. Unlike traditional methods that analyze genes individually, this technology enables comprehensive tumor profiling to match patients with specific targeted therapies. The US Food and Drug Administration has increasingly approved these multi-gene panels, validating their clinical utility and driving adoption. Consequently, pharmaceutical companies prioritize this approach to streamline drug development and ensure patients receive treatments tailored to their unique genomic profiles.

Regional Insights

North America holds a dominant position in the Global Oncology Companion Diagnostic Market due to the widespread adoption of personalized medicine and substantial investment in healthcare infrastructure. The region benefits from a high concentration of major pharmaceutical and biotechnology companies that actively drive research in targeted cancer therapies. Furthermore, the U.S. Food and Drug Administration (FDA) provides clear regulatory pathways that facilitate the efficient approval and commercialization of these diagnostic tests. This supportive framework, combined with a strong focus on genomic research, sustains North America's leadership in the sector.

Recent Developments

• In October 2024, Roche announced that it had obtained approval from the U.S. Food and Drug Administration for the VENTANA Claudin 18 (43-14A) RxDx Assay. This immunohistochemistry test was authorized as the first companion diagnostic to determine CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction adenocarcinoma. The assay was developed to aid clinicians in identifying patients eligible for a newly approved targeted treatment targeting this specific protein. This regulatory achievement expanded Roche's extensive portfolio of precision oncology tools, aiming to improve clinical outcomes by ensuring that patients receive therapies tailored to the specific biological characteristics of their cancer.
• In August 2024, Illumina, Inc. received approval from the U.S. Food and Drug Administration for its TruSight Oncology Comprehensive test as a companion diagnostic. This approval marked a significant milestone, authorizing the test to identify adult and pediatric patients with solid tumors harboring specific gene fusions who may benefit from targeted therapies. The diagnostic kit was designed to detect variants across more than 500 genes, providing comprehensive genomic profiling to guide precision oncology decisions. This development represented the first distributable genomic profiling kit with pan-cancer companion diagnostic claims, facilitating broader access to personalized cancer care for diverse patient populations.
• In March 2024, Thermo Fisher Scientific Inc. entered into a collaboration agreement with a multinational life sciences enterprise to develop next-generation sequencing-based companion diagnostic assays. The partnership focused on utilizing Thermo Fisher's Ion Torrent Genexus Dx System to create decentralized genomic testing solutions that deliver rapid results for precision cancer therapies. This initiative aimed to identify patients who would benefit from specific oncology treatments by analyzing tumor and liquid biopsy samples with a quick turnaround time. The collaboration underscored a mutual commitment to advancing personalized medicine and improving patient access to targeted care through innovative and accessible diagnostic technologies.
• In January 2024, Agilent Technologies Inc. announced a strategic partnership with a pharmaceutical company to advance the development of companion diagnostics for hematology and oncology treatments. This agreement allowed the entities to collaborate on designing new diagnostic tests that identify patients most likely to benefit from specific targeted therapies. By leveraging Agilent's established expertise in assay development and global regulatory approvals, the collaboration aimed to support clinical trials and potential product registration in the United States and Europe. The initiative highlighted the growing importance of precision medicine in matching cancer patients with appropriate therapeutic interventions based on their unique disease biomarkers.

Key Market Players

• Agilent Technologies Inc
• Illumina Inc
• QIAGEN NV
• Thermo Fisher Scientific Inc
• F Hoffmann-La Roche AG
• ARUP Laboratories Inc
• Abbott Laboratories Inc
• Myriad Genetics Inc
• bioMérieux SA
• Invivoscribe Inc

By Product & Service	By Technology	By Disease Type	By End Use	By Region
Product (Instrument, Consumables, Software) Service	Polymerase chain reaction (PCR) Next-generation sequencing (NGS) Immunohistochemistry (IHC) In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH) Others	Breast cancer Non-small cell lung cancer Colorectal cancer Leukemia Melanoma Prostate cancer Others	Hospitals Pathology/Diagnostic laboratory Academic medical center	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Oncology Companion Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oncology Companion Diagnostic Market, By Product & Service:

• Product (Instrument, Consumables, Software)
• Service

• Oncology Companion Diagnostic Market, By Technology:

• Polymerase chain reaction (PCR)
• Next-generation sequencing (NGS)
• Immunohistochemistry (IHC)
• In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH)
• Others

• Oncology Companion Diagnostic Market, By Disease Type:

• Breast cancer
• Non-small cell lung cancer
• Colorectal cancer
• Leukemia
• Melanoma
• Prostate cancer
• Others

• Oncology Companion Diagnostic Market, By End Use:

• Hospitals
• Pathology/Diagnostic laboratory
• Academic medical center

• Oncology Companion Diagnostic Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE