Companion Diagnostics Market Report 2025

The companion diagnostics market size has grown rapidly in recent years. It will grow from $7.34 billion in 2024 to $8.75 billion in 2025 at a compound annual growth rate (CAGR) of 19.3%. The growth in the historic period can be attributed to increased adoption of personalized medicine, growth of oncology and cancer therapies, increased pharmaceutical r&d collaboration, precision medicine initiatives, and biomarker discovery.

The companion diagnostics market size is expected to see exponential growth in the next few years. It will grow to $19.07 billion in 2029 at a compound annual growth rate (CAGR) of 21.5%. The growth in the forecast period can be attributed to targetedTherapy development, infectious disease diagnostics, increasing rare disease diagnostics, increasing biomarker-based drug development, point-of-care testing, and liquid biopsy applications. Major trends in the forecast period include immunotherapy and immunology advances, ai and machine learning in diagnostics, product innovations, adoption of industry 4.0, strategic collaborations.

The rising number of targeted therapies is anticipated to drive the growth of the companion diagnostics market. Targeted therapy refers to a pharmacological approach that focuses on specific characteristics of cancer cells to slow down the disease's growth and spread. While these medications circulate throughout the body, they have a more precise effect than chemotherapy and often result in fewer side effects. Companion diagnostic testing based on biological markers is becoming a crucial component of personalized cancer care. For example, in February 2024, the Personalised Medicine Coalition, a US-based hospital and healthcare organization, reported that the FDA approved 16 new personalized treatments for patients with rare diseases in 2023, compared to six in 2022. Consequently, the increase in targeted therapies is fueling growth in the companion diagnostics market.

The growth of the companion diagnostics market is further propelled by the rising prevalence of chronic diseases. Companion diagnostics are increasingly used in chronic diseases or non-communicable diseases (NCDs) to tailor treatment plans, monitor disease progression, and predict drug resistance. The World Health Organization reported that 74% of global deaths, equivalent to 41 million, are caused by NCDs annually. Notably, diseases such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes contribute significantly to this burden. The rising incidence of chronic diseases underscores the essential role of companion diagnostics in enhancing patient outcomes and contributing to the overall growth of the market.

A key trend in the companion diagnostics market is technological advancement, particularly the integration of artificial intelligence (AI). AI is being leveraged to develop more efficient drugs and advance companion diagnostics. The extensive genetic profiling data sets, continuously generated, enable the application of AI to identify insights into disease causes. For example, Toronto-based start-up Deep Genomics is utilizing AI to expedite the discovery of better medications for genetic illnesses. Through deep learning, scientists can explore the human genome, analyze billions of chemical compounds, and identify promising formulations for clinical trials. This application of AI in companion diagnostics aligns with the broader trend of technological innovation, driving advancements in the field.

Major players in the companion diagnostics market are joining forces to create innovative treatment solutions aimed at enhancing personalized medicine, improving patient outcomes, and optimizing the effectiveness of targeted therapies. This collaboration among companies will accelerate the development and commercialization of companion diagnostics (CDx) for hematology and oncology treatments. For instance, in January 2024, Agilent Technologies, Inc., a California-based company providing instruments, software, services, and consumables for laboratories, announced a partnership with Incyte, a US-based pharmaceutical company. This collaboration combines Agilent’s expertise and established track record in developing companion diagnostics (CDx) to support Incyte’s hematology and oncology portfolio. As a result, Agilent will expand its CDx portfolio with new biomarkers, while Incyte will leverage Agilent's proficiency in assay development, regulatory approvals, and commercialization to facilitate clinical trials and CDx registration in the U.S. and Europe.

In August 2022, Genome Diagnostics, a UK-based testing company that offers personalized health insights to assist with diagnosis, treatment, and drug discovery, acquired Eurobio Scientific for USD 148.22 million. This acquisition allows GenDx to broaden its global presence, strengthen customer support in transplant diagnostics, and sustain its R&D and educational initiatives. Eurobio Scientific is a France-based company specializing in the research, development, and marketing of diagnostic products and life-science research products.

Major companies operating in the companion diagnostics market include F Hoffmann-La Roche Ltd., Agilent Technologies Inc., Qiagen NV, Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Abnova Corp., Amoy Diagnostics Co. Ltd., ARUP Laboratories, Bayer AG, Biomerieux SA, Danaher Corporation, Guardant Health Inc., Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Caris Life Sciences, Cepheid Inc., Diaceutics plc, Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Precision Therapeutics Inc., Prometheus Laboratories Inc., Sividon Diagnostics GmbH, Sysmex Corporation, Ventana Medical Systems, Vermillion Inc.

Companion diagnostics refer to in vitro diagnostic medical tests employed to assess the safety and effectiveness of a corresponding drug or biological product. These tests play a crucial role in helping healthcare professionals match patients with specific drugs or therapies.

The primary products and services in the companion diagnostics market include assays, kits, reagents, software, and related services. Assays, kits, and reagents find applications in various life science, environmental, and research laboratories. Assays are procedures used to examine substances for composition or quality, kits are collections of equipment and materials for specific purposes, and reagents are chemicals used in laboratory testing. Technologies such as polymerase chain reaction, next-generation sequencing, in situ hybridization, and immunohistochemistry are employed in companion diagnostics. These diagnostic tools are instrumental in identifying various cancer diseases like lung, breast, colorectal, leukemia, and melanoma. The primary users of companion diagnostics include pharmaceutical and biopharmaceutical companies, reference laboratories, and contract research organizations.

The companion diagnostics market research report is one of a series of new reports that provides companion diagnostics market statistics, including companion diagnostics industry global market size, regional shares, competitors with a companion diagnostics market share, detailed companion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics industry. This 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.

North America was the largest region in the companion diagnostics market in 2024. The regions covered in the companion diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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

The companion diagnostics market includes revenues earned by theranostics and monitoring tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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.

This product will be delivered within 3-5 business days.