Oncology Companion Diagnostics Market Report 2025

This Oncology Companion Diagnostics market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The oncology companion diagnostics market size has grown rapidly in recent years. It will grow from $3.35 billion in 2024 to $3.8 billion in 2025 at a compound annual growth rate (CAGR) of 13.4%. The growth in the historic period can be attributed to increasing cases of adverse drug reactions, increasing demand for comprehensive genomic testing, the increasing global incidence of cancer, the growing need for targeted therapy, and the growing number of clinical trials.

The oncology companion diagnostics market size is expected to see rapid growth in the next few years. It will grow to $6.21 billion in 2029 at a compound annual growth rate (CAGR) of 13%. The growth in the forecast period can be attributed to the rising importance of personalized medicine, increasing diagnostic tests, increasing focus on personalized cancer therapy, increasing healthcare expenditure, and increasing cancer incidence and awareness. Major trends in the forecast period include advancements in diagnostic technologies, next-generation sequencing (NGS), integration of artificial intelligence (AI), liquid biopsy technologies, the development of point-of-care companion diagnostic devices, and innovative testing technologies.

The increasing prevalence of cancer is expected to drive the growth of the oncology companion diagnostics market in the future. Cancer is a complex group of diseases characterized by abnormal cell growth that spreads uncontrollably. The rise in cancer cases can be attributed to factors such as lifestyle changes, environmental influences, the obesity epidemic, tobacco use, and genetic predispositions. Oncology companion diagnostics play a critical role in precision medicine, transforming cancer care by enabling personalized treatment selection, improving treatment effectiveness, reducing side effects, facilitating clinical trial participation, and enhancing treatment monitoring. For example, the National Cancer Institute, a US-based government agency, reported in May 2024 that approximately 20 million new cancer cases and 9.7 million cancer-related deaths occurred annually in 2022. By 2040, predictions suggest that the number of new cancer cases will rise to 29.9 million, with 15.3 million cancer-related deaths annually. As a result, the increasing cancer incidence is driving the growth of the oncology companion diagnostics market.

Leading companies in the oncology companion diagnostics market are concentrating their efforts on developing innovative products, particularly in vitro diagnostic tests, to maintain their competitive edge. In vitro diagnostic tests, conducted on samples obtained from patients outside of the body in controlled laboratory environments, provide critical insights into tumor biology and guide treatment decision-making. For example, Illumina Inc., a prominent biotechnology company, introduced a pan-cancer companion diagnostic (CDx) indication for its TruSight Oncology (TSO) Comprehensive (EU) test in May 2022. This diagnostic assay offers a comprehensive tumor profile by evaluating multiple tumor genes and biomarkers, empowering healthcare providers to tailor targeted therapy for patients with various solid malignant neoplasms. By assessing essential parameters such as tumor mutational burden (TMB) and microsatellite instability (MSI) status, this test enhances treatment precision and effectiveness.

In January 2024, Agilent Technologies Inc., a US-based diagnostics company, entered into a partnership with Incyte Corporation for an undisclosed amount. This collaboration aims to strengthen Agilent's companion diagnostics portfolio and support Incyte’s hematology and oncology treatments through advanced, precision diagnostics. Incyte Corporation, a US-based pharmaceutical company, specializes in the development and commercialization of oncology medications.

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Bayer Diagnostic, 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 2024. 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, 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, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Oncology companion diagnostics are medical tests designed to identify specific biomarkers, indicating which patients are most likely to respond favorably to a particular cancer treatment. These diagnostics play a crucial role in the development and application of targeted therapies, ensuring that treatments are customized to match the unique characteristics of a patient's tumor. By providing insights into the molecular and genetic profile of cancer, companion diagnostics enable more personalized and efficient treatment strategies, leading to improved outcomes and reduced adverse effects.

The primary products within the oncology companion diagnostics market include instruments, consumables, and software. Instruments encompass a diverse array of tools and devices utilized for various purposes across different fields. These diagnostics cater to a range of disease types such as melanoma, breast cancer, colorectal cancer, leukemia, prostate cancer, among others. They leverage various technologies including immunohistochemistry (IHC), in situ hybridization (ISH) or fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next-generation sequencing (NGS), and others. End users of oncology companion diagnostics include hospitals, pathology or diagnostic laboratories, academic medical centers, and others.

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 an 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 research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

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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