Oncology Companion Diagnostics Market Report 2026

The oncology companion diagnostics market size has grown rapidly in recent years. It will grow from $3.79 billion in 2025 to $4.29 billion in 2026 at a compound annual growth rate (CAGR) of 13%. The growth in the historic period can be attributed to rising prevalence of cancer types such as breast, colorectal, and melanoma, increasing focus on personalized medicine, growing demand for targeted therapy selection, expansion of diagnostic laboratories and hospitals, development of molecular and genetic testing technologies.

The oncology companion diagnostics market size is expected to see rapid growth in the next few years. It will grow to $6.5 billion in 2030 at a compound annual growth rate (CAGR) of 10.9%. The growth in the forecast period can be attributed to 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, increasing use of bioinformatics and decision support software in diagnostics. Major trends in the forecast period include 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, increasing iot-enabled monitoring of diagnostic instruments and reagents.

The rising number of cancer cases is expected to drive the growth of the oncology companion diagnostics market in the coming years. Cancer comprises a complex group of diseases in which abnormal cells grow uncontrollably and spread throughout the body. The increase in cancer incidence is attributed to lifestyle changes, environmental factors, obesity, tobacco use, and genetic predisposition. Oncology companion diagnostics play a crucial role in precision medicine by enabling personalized treatment selection, improving therapeutic efficacy, minimizing adverse effects, facilitating clinical trial participation, and enhancing ongoing treatment monitoring. For example, in May 2024, the National Cancer Institute, a US-based government agency, reported approximately 20 million new cancer cases and 9.7 million cancer-related deaths annually in 2022. Projections indicate that by 2040, there will be 29.9 million new cases and 15.3 million deaths per year. Consequently, the rising incidence of cancer is contributing to the expansion of the oncology companion diagnostics market.

Leading companies in the oncology companion diagnostics market are concentrating on the development of advanced high-throughput sequencing technologies, including c-MET companion diagnostic assays, to improve precision oncology and enable individualized treatment selection in advanced non-small cell lung cancer (NSCLC). c-MET companion diagnostic assays detect c-MET gene alterations in patients with advanced NSCLC, allowing clinicians to select the most effective therapies, optimize outcomes, and support precision medicine approaches. For instance, in May 2025, NeoGenomics, Inc., a US-based oncology testing company, launched its c-MET CDx Assay to guide treatment decisions in patients with advanced NSCLC. This companion diagnostic test identifies c-MET protein overexpression in tumor tissue, providing rapid and accurate results to determine which patients may benefit from MET-targeted therapies. The assay offers high sensitivity and specificity, fast turnaround times, standardized procedures, and compatibility with routine clinical workflows, making it well-suited for precision oncology and personalized treatment planning.

In January 2024, Agilent Technologies Inc., a US-based diagnostics company, entered into a partnership with Incyte Corporation for an undisclosed amount. Through this collaboration, Agilent aims to enhance its companion diagnostics portfolio and support Incyte’s hematology and oncology treatments with advanced precision diagnostic solutions. Incyte Corporation is a US-based pharmaceutical company focused on the development and commercialization of oncology medications.

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.

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. The countries covered in the oncology companion diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Tariffs have impacted the oncology companion diagnostics market by increasing import costs for instruments, reagents, and software used in biomarker testing, affecting hospitals, pathology laboratories, and academic medical centers primarily in north america, europe, and asia-pacific. While tariffs may increase operational costs, they also encourage local manufacturing, sourcing diversification, and investment in domestic diagnostic facilities, which can enhance supply chain resilience and reduce reliance on imports.

The oncology companion diagnostics market research report is one of a series of new reports that provides oncology companion diagnostics market statistics, including oncology companion diagnostics industry global market size, regional shares, competitors with a oncology companion diagnostics market share, detailed oncology companion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the oncology companion diagnostics industry. This oncology companion diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Oncology companion diagnostics are medical tests that detect specific biomarkers to determine which patients are most likely to respond to a particular cancer treatment. These diagnostics play a crucial role in the development and application of targeted therapies by ensuring treatments are tailored to the unique characteristics of a patient’s tumor. They provide insights into the molecular and genetic profile of the cancer, enabling more personalized and effective treatment plans, improving patient outcomes, and reducing unnecessary side effects.

The primary products in the oncology companion diagnostics market include instruments, consumables, and software. Instruments encompass a variety of tools and devices used across different applications. The diagnostics cover disease types such as melanoma, breast cancer, colorectal cancer, leukemia, prostate cancer, and others, and utilize technologies including immunohistochemistry (IHC), in situ hybridization (ISH) or fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next-generation sequencing (NGS), and more. These products are used by end users including hospitals, pathology or diagnostic laboratories, academic medical centers, and other healthcare facilities.

The oncology companion diagnostics market consists of revenues earned by entities by providing services such as biomarker testing, patient stratification, monitoring treatment response, predicting drug resistance, clinical trial enrollment, comprehensive genomic testing, therapy resistance testing, hereditary cancer testing, and risk assessment. The market value includes the value of related goods sold by the service provider or included within the service offering. The oncology companion diagnostics market also includes sales of polymerase chain reaction instruments, immunohistochemistry (IHC) staining kits, companion diagnostic test kits, liquid biopsy platforms, gene expression profiling kits, mass spectrometry systems, flow cytometry analyzers, tissue microarray instruments, and electrochemical biosensors. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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