Companion Diagnostics Market to Reach USD 18 Billion by 2035, Growing at 9.9% CAGR | Adaptive Biotechnologies, Agilent Technologies, Inc., Almac Group

According to the report, the companion diagnostics market is anticipated to grow from USD 7 Billion in 2025 to USD 18 Billion in 2035 at a CAGR of 9.9% during the forecast. The companion diagnostics (CDx) industry is changing rapidly. Due to the implementation of precision medicine and targeted therapies in oncology and rare diseases, numerous new business opportunities are probable. Advances in genomics and next-generation sequencing (NGS) technologies have potential for better, more precise therapeutic actions as the pharmaceutical industry begins to favor biomarker-led decisions in treatment from regulators and payers alike.

Further, pharma companies likely to increasingly enter into strategic partnerships with diagnostic companies in North America and Western Europe. There are also pilot studies emerging in China and the UAE that are testing population-scale genomic screening platforms mapped to national databases, which inform early stages of developing CDx for modifiers in treatment pathways.

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Regional Analysis of Companion Diagnostics Market

North America occupies the lead position in the companion diagnostics market, primarily guided by a lot of investments made to advance precision medicine, robust workflows associated with built environment for healthcare, and early adoption of newer technologies. The U.S. pharmaceutical and diagnostic companies benefit from favorable regulatory environments and mutual collaborations.

Furthermore, Europe is also growing, in part due to government initiatives promoting personalized healthcare. The Asia-Pacific region, particularly China and Japan, is an emerging region growing rapidly due to increasing cancer rates, evidence of genomic studies, and expanding access improved multi-platform usage of molecular diagnostics. However, challenges do exist in lower-income countries because of access to testing or affordability.

Key players in the global companion diagnostics market include prominent companies such as Abbott Laboratories, Adaptive Biotechnologies, Agilent Technologies, Inc., Almac Group, ArcherDX (a part of Invitae), bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Exact Sciences Corporation, Foundation Medicine, Inc., Guardant Health, Inc., Illumina, Inc., Invitae Corporation, Myriad Genetics, Inc., Qiagen N.V., Roche Diagnostics, Siemens Healthineers, Sysmex Corporation, Thermo Fisher Scientific Inc., ThermoGenesis Holdings, Inc., and other key players along with several other key players contributing to market growth through innovation, strategic partnerships, and global expansion.

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Key Driver, Restraint, and Growth Opportunity Defining the Global Companion Diagnostics Market

Personalized medicine, particularly in oncology, is the central thrust of the companion diagnostics market, where biomarker identification is an integral factor in treatment efficacy. The increasing utilization of next-generation sequencing (NGS) and targeted therapies necessitates the use of accurate diagnostic tools to stratify patient populations to improve treatment outcomes and limit unnecessary exposure to drugs.

A key restraint factors is that there is no harmonized requirements for regulatory pathways between therapeutics and diagnostics. This can adversely affect the co-approval and market access of drugs and diagnostic tools for the same indications. The high costs and the validation requirements of development may also discourage smaller companies. Also, there are restrictions stemming from variability in test availability and lack of reimbursement for diagnostic procedural tests can dissuade adoption in some instances across different clinical settings and low resources settings.

There is potential for growth from the expansion of multi-gene panel testing and liquid biopsy technologies as these testing approaches are often viewed as less invasive and allow for quicker diagnostic turnaround time. Collaboration between pharmaceutical companies and diagnostics companies are resulting in strategic partnerships allowing co-development models that provide expedited market access. In addition, there are supportive government initiatives focused on precision medicine and genomic research that provide a solid springboard for increased implementation of CDx in the management of chronic and rare diseases.

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Recent Development and Strategic Overview:

In April 2025, Agilent Technologies demonstrated its most recent developments in companion diagnostics at the American Association for Cancer Research (AACR) Annual Meeting. Agilent released the Avida DNA Cancer Panels which allow for simultaneous DNA and methylation profiling from a single sample. The capability likely to facilitate further detection of genomic alterations from cancer-related DNA. Agilent also released the SureSelect Cancer Pan Heme Assay co-developed with Roswell Park Comprehensive Cancer Center for genomic profiling of hematologic malignancies.

In March 2025, Abbott Laboratories recently announced the expansion of its Alinity m molecular diagnostics platform to include a new series of assays intended for companion diagnostics development. These assays likely to enable identification of patients that may benefit from the use of targeted therapies in oncology. The new assays include improved sensitivity and a faster turnaround time for helping providers make important treatment decisions. Abbott recognizes the importance of expanding companion diagnostics as part of its continual efforts to advance personalized medicine and ultimately improve patient outcomes.

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Key Trend: Rise of AI‐Driven Biomarkers and Imaging Integration Enhances Precision and Streamlines Diagnostic Pathways

The growing demand for precision medicine is changing the companion diagnostics market with the increased use of AI-based technologies that can analyze intricate, multivariate genomic, proteomic, and imaging data. AI is driving the rapid discovery of novel and more accurate biomarkers, and is integrating diagnostic imaging and molecular tests toward more rapid and targeted treatment decisions.

Further, an illustration of AI advancements is discovering patterns in x-rays, CT and MRI scans or pathology images that would have simply been overlooked by humans, and these advances are already helping clinicians make better decisions about which patients are likely to do better with which treatments. More intelligent, integrated diagnostics are reduced time to treatment, improving clinical outcomes and scaling personalized medicine in both developed and developing healthcare system.

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