Oncology Companion Diagnostics Market Report 2026

Oncology Companion Diagnostics Market Overview

• Oncology Companion Diagnostics market size has reached to $3.79 billion in 2025 • Expected to grow to $6.5 billion in 2030 at a compound annual growth rate (CAGR) of 10.9% • Growth Driver: Rise In Cancer Cases Fuels Growth In Oncology Companion Diagnostics Market • Market Trend: Advancements in c-MET (Mesenchymal-Epithelial Transition) Companion Diagnostics for Precision Oncology in Non-Small Cell Lung Cancer (NSCLC) • North America was the largest region in 2025 and Asia-Pacific is the fastest growing region.

What Is Covered Under Oncology Companion Diagnostics Market?

Oncology companion diagnostics are medical tests that identify specific biomarkers, indicating which patients are most likely to benefit from a particular cancer treatment. These diagnostics are essential for developing and applying targeted therapies, as they help ensure that treatments are tailored to the individual characteristics of a patient's tumor. Companion diagnostics provide insights into the molecular and genetic profile of the cancer, enabling more personalized and effective treatment plans, improving outcomes, and minimizing unnecessary side effects. The main products of the oncology companion diagnostics market are instruments, consumables, and software. Instruments refer to a wide range of tools, devices, or objects used for various purposes across different fields. The various disease types include melanoma, breast cancer, colorectal cancer, leukemia, prostate cancer, and other disease types used by various technologies such as immunohistochemistry (IHC), in situ hybridization (ISH) or fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next-generation sequencing (NGS), and other technologies used by various end users including hospital, pathology or diagnostic laboratory, academic medical center, and others.

What Is The Oncology Companion Diagnostics Market Growth Forecast?

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.

Global Oncology Companion Diagnostics Market Segmentation

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 Is The Driver Of The Oncology Companion Diagnostics Market?

A rise in cancer cases is expected to propel the growth of the oncology companion diagnostics market going forward. Cancer is a complex group of diseases caused by abnormal cells in the body that grow and spread uncontrollably. The increase in cancer cases is due to changes in lifestyle, environmental factors, the obesity epidemic, tobacco use, and genetic factors. Oncology companion diagnostics contribute to precision medicine approaches in oncology, revolutionizing cancer care by enabling personalized treatment selection, improving treatment efficacy, minimizing adverse effects, facilitating clinical trial enrollment, and enhancing treatment monitoring. For instance, in May 2024, according to the National Cancer Institute, a US-based government agency, around 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, and predictions indicate that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Therefore, a rise in cancer cases drives the oncology companion diagnostics industry.

Key Players In The Global 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.

Global Oncology Companion Diagnostics Market Trends and Insights

Major companies operating in the oncology companion diagnostics market are focusing on developing advanced high-throughput sequencing technologies, such as c-MET companion diagnostic assay implementation for therapeutic guidance in advanced non-small cell lung cancer, to enhance precision oncology and individualized treatment selection. c-MET companion diagnostic assay implementation for therapeutic guidance in advanced non-small cell lung cancer refers to the deployment of a targeted diagnostic test designed to detect c-MET gene alterations in patients with advanced non-small cell lung cancer (NSCLC), enabling clinicians to select appropriate therapies, optimize treatment efficacy, 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 Non-Small Cell Lung Cancer (NSCLC). The c-MET CDx Assay is a companion diagnostic test designed to detect c-MET protein overexpression in tumor tissue, providing rapid and accurate results to identify patients who may benefit from MET-targeted therapies. The assay offers high sensitivity and specificity, fast turnaround times, standardized testing procedures, and compatibility with routine clinical workflows, making it ideal for precision oncology and personalized treatment planning.

What Are Latest Mergers And Acquisitions In The Oncology Companion Diagnostics Market?

In January 2024, Agilent Technologies Inc., a US-based diagnostics company, partnered with Incyte Corporation for an undisclosed amount. With this partnership, Agilent aims to enhance its companion diagnostics portfolio and support Incyte’s hematology and oncology treatments with advanced, precision diagnostics. Incyte Corporation is a US-based pharmaceutical company that specializes in the development and commercialization of oncology medications.

Regional Outlook

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 this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Oncology Companion Diagnostics Market?

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.

How is Market Value Defined and Measured?

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.

What Key Data and Analysis Are Included in the Oncology Companion Diagnostics Market Report 2026?

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