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By 2030, What Market Size Is The Oncology Companion Diagnostics Market Expected To Reach Based On Its 2026 Value?
The oncology companion diagnostics market size has experienced rapid growth in recent years. It is expected to expand from $3.79 billion in 2025 to $4.29 billion in 2026, demonstrating a compound annual growth rate (CAGR) of 13.0%. The expansion observed historically is attributable to the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a stronger emphasis on personalized medicine, the rising need for targeted therapy selection, the growth of diagnostic laboratories and hospitals, and the evolution of molecular and genetic testing technologies.
The oncology companion diagnostics market size is anticipated to undergo significant growth in the coming years. It is projected to expand to $6.5 billion by 2030, at a compound annual growth rate (CAGR) of 10.9%. The market’s expansion during this forecast period is attributable to the rising adoption of next-generation sequencing (ngs) and pcr-based diagnostics, increasing collaboration between pharma and diagnostic companies, growth in regulatory approvals for companion diagnostics, rising demand for precision oncology, and increasing use of bioinformatics and decision support software in diagnostics. Key trends in the forecast period include the rising adoption of digital platforms for companion diagnostic data management, increasing integration of AI in biomarker analysis and patient stratification, growing use of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and increasing IoT-enabled monitoring of diagnostic instruments and reagents.
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What Major Factors Are Driving The Oncology Companion Diagnostics Market Forward?
The increasing incidence of cancer is anticipated to drive the future expansion of the oncology companion diagnostics market. Cancer encompasses a complex group of illnesses stemming from abnormal cells in the body that proliferate and spread uncontrollably. This escalation in cancer cases is attributable to shifts in lifestyle, environmental influences, the prevalence of obesity, tobacco use, and inherited genetic factors. Oncology companion diagnostics are integral to precision medicine strategies in oncology, transforming cancer care by enabling customized treatment selection, enhancing therapeutic effectiveness, minimizing adverse reactions, facilitating enrollment in clinical trials, and improving treatment monitoring. For instance, in May 2024, the National Cancer Institute, a US-based government agency, reported approximately 20 million new cases and 9.7 million cancer-related deaths annually in 2022, with projections indicating a rise to 15.3 million deaths and 29.9 million new cases per year by 2040. Thus, an increase in cancer cases is a key driver for the oncology companion diagnostics market.
What Are The Different Segment Types In The Oncology Companion Diagnostics Market Segment Breakdown?
The oncology companion diagnostics market covered in this report is segmented –
1) By Product: Instrument, Consumables, Software
2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types
3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies
4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users
Subsegments:
1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms
2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples
3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software
Which Trends Are Impacting The Progress Of The Oncology Companion Diagnostics Market?
Leading companies within the oncology companion diagnostics market are concentrating on developing advanced high-throughput sequencing technologies, such as the implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment selection. The application of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer involves deploying a targeted diagnostic test to detect c-MET gene alterations in patients with advanced non-small cell lung cancer (NSCLC), enabling clinicians to choose appropriate therapies, optimize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., a US-based oncology testing company, launched its c-MET CDx Assay to guide treatment decisions for patients with advanced Non-Small Cell Lung Cancer (NSCLC). This c-MET CDx Assay is a companion diagnostic test specifically designed to detect c-MET protein overexpression in tumor tissue, offering rapid and accurate results to identify patients who could benefit from MET-targeted therapies. The assay provides high sensitivity and specificity, fast turnaround times, standardized testing procedures, and is compatible with routine clinical workflows, making it highly suitable for precision oncology and personalized treatment planning.
Who Are The Well-Known Companies In The Oncology Companion Diagnostics Market?
Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.
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Which Region Is The Top Contributor To The Oncology Companion Diagnostics Market By Share?
North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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