The Business Research Company’s 2026 market reports include new capabilities such as market attractiveness scoring and analysis, total addressable market analysis, company scoring matrix, interactive excel data dashboard, improved supply chain analysis, upcoming startups in the market, and overview of key products, aimed at improving the depth, usability, and strategic value of the insights delivered.
What Market Value Is Anticipated For The Oncology Companion Diagnostics Market Over The Period 2026–2030?
The oncology companion diagnostics market has experienced significant expansion in recent years. This market is projected to grow from $3.79 billion in 2025 to $4.29 billion in 2026, showing a compound annual growth rate (CAGR) of 13.0%. The growth observed in the historical period can be attributed to several factors, including the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a heightened focus on personalized medicine, a rising demand for targeted therapy selection, the expansion of diagnostic laboratories and hospitals, and the development of molecular and genetic testing technologies.
The oncology companion diagnostics market is anticipated to undergo significant expansion over the next few years, with its size projected to reach $6.5 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 10.9%. This growth during the forecast period is fueled by the increasing adoption of next-generation sequencing (NGS) and PCR-based diagnostics, a rise in collaborations between pharmaceutical and diagnostic firms, a growing number of regulatory approvals for companion diagnostics, escalating demand for precision oncology, and the broader application of bioinformatics and decision support software in diagnostics. Key trends expected in this period involve the increasing use of digital platforms for managing companion diagnostic data, greater integration of artificial intelligence (AI) in biomarker analysis and patient stratification, expanding utilization of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and enhanced internet of things (IoT)-enabled monitoring of diagnostic instruments and reagents.
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What Underlying Factors Are Accelerating The Growth Of The Oncology Companion Diagnostics Market?
The anticipated increase in cancer occurrences is projected to stimulate the expansion of the oncology companion diagnostics market moving forward. Cancer is a complex set of illnesses characterized by abnormal cells that grow and spread uncontrollably within the body. This surge in cancer cases is attributable to shifts in lifestyle, environmental elements, the obesity epidemic, tobacco consumption, and genetic predispositions. Oncology companion diagnostics are integral to precision medicine strategies in oncology, revolutionizing 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, data from the National Cancer Institute, a US-based government agency, indicated that roughly 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, with forecasts suggesting that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Hence, the growing number of cancer cases propels the oncology companion diagnostics market.
How Is The Oncology Companion Diagnostics Market Divided Into Its Major Segments?
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
What Major Market Trends Are Driving Changes In The Oncology Companion Diagnostics Market?
Key players in the oncology companion diagnostics sector are concentrating on advancing high-throughput sequencing technologies, including the application of c-MET companion diagnostic assays for therapeutic direction in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment choices. The implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer specifically involves deploying a targeted diagnostic tool to identify c-MET gene alterations in patients with advanced NSCLC, thereby empowering clinicians to select appropriate therapies, maximize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., an oncology testing company located in the US, launched its c-MET CDx Assay to aid treatment decisions for individuals with advanced Non-Small Cell Lung Cancer. This c-MET CDx Assay serves as a companion diagnostic test engineered to identify c-MET protein overexpression in tumor tissue, delivering quick and accurate outcomes to ascertain patients who may benefit from MET-targeted therapies. The assay boasts high sensitivity and specificity, swift turnaround times, standardized testing procedures, and seamless integration with routine clinical workflows, making it exceptionally suitable for precision oncology and personalized treatment planning.
Who Are The Prominent Organizations Shaping 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 Projected To Dominate The Oncology Companion Diagnostics Market During The Forecast Period?
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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