Companion Diagnostics Market Size to Exceed USD 19.73 Bn by 2032

The Companion Diagnostics Market, estimated at USD 8.76 Bn in 2025, is expected to exhibit a CAGR of 12.3% and reach USD 19.73 Bn by 2032.

The market growth is driven by rising demand for accurate and early disease detection, supported by advances in molecular diagnostics, imaging, and point-of-care testing. Growing focus on personalized medicine, supportive healthcare policies, and ongoing R&D investments are creating new opportunities for industry players.

The demand for personalized medicine has been steadily increasing over the past decade. With advancements in fields like genomics and proteomics, medical professionals have a more comprehensive understanding of the molecular characteristics of diseases. This is driving the growth of targeted therapies that are developed for specific patient populations, which are based on biomarkers. Companion diagnostics help identify whether a patient is likely to respond well or poorly, to a particular targeted therapy that is based on the presence or absence of certain biomarkers.

Global Companion Diagnostics Market– Impact of Coronavirus (COVID-19) Pandemic

The World Health Organization (WHO) designated the illness caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which first appeared in Wuhan (province of Hubei, China), in the last months of 2025, as "coronavirus disease 2025" or COVID-19. This virus spreads quickly and had a serious negative impact on the economies, social behaviors, and healthcare of every country in the world.

COVID-19 affected the economy in three main ways: by directly affecting production and demand, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to the lockdown, several countries, such as India, China, Brazil, and others, faced problems regarding the transportation of drugs from one place to another.

COVID-19 had a positive impact on the global companion diagnostics market, due to the increase in spread of COVID-19 infection. For instance, in May 2025, according to an article published in Bioanalysis Zone by Quadram Institute for Biotechnology, U.K., the companion diagnostics is used to guide in understanding, management and interventioning in COVID-19, which is still having an immense and growing role in gaining greater understanding of the disease and its short- and long-term impact on health.

Global Companion Diagnostics Market: Key Developments

Increasing inorganic growth strategies such as collaboration by key market players are expected to aid in the growth of the global companion diagnostics market. For instance, in August 2022, BD a medical device company, collaborated with Labcorp, a life science company, to develop, manufacture, market, and commercialize flow cytometry that is based on companion diagnostics (CDx) which is intended to match patients with life-changing treatments for cancer and other diseases.

Browse 35 Market Data Tables and 35 Figures spread through 160 Pages and in-depth TOC on “Global Companion Diagnostics Market”- Forecast to 2030, Global Companion Diagnostics Market, By Technology Type (Real Time-Polymerase Chain Reactions (PCR), Gene Sequencing, Fluorescence in situ Hybridization, and Others), By Application (Oncology, Cardiovascular Diseases, Infectious Diseases, Neurological Diseases and Others), By End User ( Hospitals, Research Laboratories, Biopharmaceutical companies, and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

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Key Takeaways of the Global Companion Diagnostics Market:

Global companion diagnostics market is expected to exhibit a CAGR of 12.3% during the forecast period due to the increasing inorganic gtowth strategies such as partnership by market players. For instance, on January 05, 2023, QIAGEN a molecular diagnostics manufacturer, enter into strategic partnership with Helix a genomics company, to launch next-generation sequencing companion diagnostics for hereditary diseases. These diagnostics helps to guide in clinical decision-making by identifying patients who are most likely to benefit or be at increased risk from a particular therapeutic product.
Among technology type, the real time-polymerase chain reactions (PCR) segment is estimated to hold a dominant position in the global companion diagnostics market over the forecast period. For instance, in June 2022, Hoffmann-La Roche Ltd. a pharmaceutical company, received U.S. Food and Drug Administration (FDA) approval of the cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK (tazemetostat) treatment. This molecular test detects abnormalities in the Enhancer of Zeste Homolog 2 (EZH2) gene, in patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK.
Among region, North America is expected to be the dominant region in the global companion diagnostics market, due to several factors supporting the widespread adoption of real time-PCR technologies across clinical laboratories and diagnostic centers in the region, which is expected to drive segment growth over the forecast period. Real time-PCR assays offer high throughput, sensitivity, and accuracy that is needed for companion diagnostic applications. They have become the gold standard for detecting gene variations responsible for medication responses. For example, F. Hoffmann-La Roche Ltd a pharmaceutical company’s cobas system that is used to detect EGFR mutations in lung cancer patients aiding targeted therapy decisions, processes over 1000 samples daily across major hospitals in the US.. and Canada using real time-PCR. Similarly, Thermo Fisher Scientific Inc. a biotechnology company’s QuantStudio real time-PCR instruments are used in over 80% of clinical molecular diagnostic labs as per the College of American Pathologists, due to their ability to quickly analyze numerous patient samples on a single run.
Major players operating in the global companion diagnostics market include F. Hoffmann-La Roche AG, Agilent Technologies, Inc., QIAGEN N.V, Abbott Laboratories, Inc., Almac Group, Danaher Corporation, Illumina, Inc., bioMérieux SA, Myriad Genetics, Inc., Sysmex Corporation, Thermo Fisher Scientific Inc., Abnova Corporation, Guardant Health, Inc., Icon Plc., and Biogenex Laboratories, Inc.