Oncology Companion Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Oncology Companion Diagnostic Market is projected to expand from USD 3.21 Billion in 2025 to USD 5.07 Billion by 2031, registering a compound annual growth rate of 7.92%. These diagnostics act as critical medical devices designed to determine patient eligibility for specific treatments or to identify individuals at risk of severe adverse reactions. The sector's growth is primarily fueled by the global shift toward personalized healthcare and the rising incidence of cancer necessitating targeted interventions. This increasing dependence on biomarker-guided therapy is supported by regulatory trends; according to the Personalized Medicine Coalition, 18 new personalized medicines were approved by the FDA in 2024, accounting for roughly 38 percent of all newly authorized therapeutic molecular entities.

Despite these positive catalysts, the industry faces substantial hurdles related to reimbursement structures. A major obstacle involves the misalignment between diagnostic coding systems and payer coverage policies, which generates financial instability for product developers. Such inconsistent reimbursement decisions across various healthcare systems create complexities in commercialization and restrict patient access to essential testing services. These economic barriers not only delay the integration of innovative diagnostic technologies but also constrain the potential market for emerging oncology biomarkers, thereby hindering the sector's overall growth trajectory.

Market Drivers

The increasing global burden of cancer underscores the necessity for widespread companion diagnostic implementation to refine treatment strategies and minimize ineffective prescriptions. As malignancy rates climb, healthcare systems are progressively requiring genomic testing to ensure that expensive therapies are delivered exclusively to patients possessing the specific genetic profiles required for efficacy. This demand, driven by case volume, acts as a primary engine for market growth, compelling laboratories to expand their testing capacities. According to the American Cancer Society's 'Cancer Facts & Figures 2024' report released in January 2024, projections indicate that over 2 million new cancer cases will be diagnosed within the United States alone, highlighting the urgent requirement for diagnostic stratification tools to address this escalating patient load.

Simultaneously, the rapid adoption of precision oncology is transforming clinical workflows and stimulating the increase of targeted therapies. Pharmaceutical companies are pivoting away from broad-spectrum cytotoxic agents toward biomarker-driven medications, establishing a mutual dependency on diagnostic assays for both clinical trial recruitment and commercial delivery.

This strategic realignment ensures that diagnostics are often co-developed with therapeutics, linking diagnostic market expansion directly to pharmaceutical pipelines. For instance, AstraZeneca confirmed in its 'Full Year 2023 Results' announcement in February 2024 that 90 percent of its clinical pipeline consists of targeted therapies, demonstrating the industry's focus on biomarker-dependent mechanisms. This trend is resulting in measurable volume increases; Guardant Health reported a 21 percent year-over-year rise in clinical test volume in 2024, confirming the growing application of oncology diagnostic solutions.

Market Challenges

The discrepancy between diagnostic coding frameworks and payer coverage policies represents a significant financial impediment that directly curbs the growth of the global oncology companion diagnostic market. As reimbursement systems struggle to match the pace of rapid technological innovation, developers encounter considerable revenue unpredictability, which deters investment in the validation of new biomarkers. This economic misalignment results in situations where even clinically validated diagnostics frequently lack defined payment channels, compelling clinical laboratories to either absorb the associated costs or refuse testing for eligible patients. As a result, the commercial sustainability of these critical tools is undermined, restricting their availability in routine clinical practice and impeding the wider shift toward personalized medicine.

This financial strain significantly affects market uptake by establishing barriers 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 highlighted cost as a major hindrance to implementing essential testing. Such economic challenges effectively limit the total addressable market by precluding widespread adoption. As healthcare providers navigate inconsistent reimbursement rulings, patient access to targeted therapies is postponed, which subsequently suppresses the overall expansion potential of the precision oncology sector.

Market Trends

The market is experiencing a structural transition from iterative single-biomarker assays to multiplex Next-Generation Sequencing panels. This evolution is propelled by the necessity to preserve limited biopsy tissue while extracting maximum genomic information for complex targeted therapies. In contrast to traditional methods that examine genes sequentially, multiplex panels facilitate the simultaneous analysis of hundreds of genetic alterations, thereby shortening diagnostic turnaround times and addressing issues related to tissue exhaustion. This industry consolidation is reflected in laboratory performance metrics; according to the 'Fourth Quarter and Full Year 2024 Results' report by NeoGenomics in February 2025, the company observed a 34 percent growth in its Next-Generation Sequencing test volume during 2024, demonstrating the rapid industrial shift toward comprehensive genomic profiling.

Concurrently, the incorporation of Artificial Intelligence and Machine Learning is transforming diagnostic precision. As biological datasets grow exponentially more complex, computational algorithms have become indispensable for interpreting multi-omics data and linking genomic discoveries with clinical results. This technological convergence aids in the identification of novel biomarkers and enhances patient stratification beyond the capabilities of standard pathology. The commercial momentum of these algorithmic solutions is increasing as partners actively seek data-driven insights. For example, Tempus AI reported in its 'Fourth Quarter and Full Year 2024 Results' announcement in February 2025 that revenue from its Data and Services segment, which leverages AI-enabled platforms, rose by 44.6 percent compared to the prior year, highlighting the escalating value of computational diagnostics.

Key Players Profiled in the Oncology Companion Diagnostic Market

• 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.
• bioMerieux SA
• Invivoscribe Inc.

Report Scope

In this report, the Global Oncology Companion Diagnostic Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Oncology Companion Diagnostic Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.