Companion Diagnostics Market Innovations and Competitive Outlook 2025-2034

How Does the Growth Projection for the Companion Diagnostics Market Look?
The Companion diagnostics market size has grown significantly in recent years. It escalated from $7.34 billion in 2024 to $8.75 billion in 2025 at a compound annual growth rate (CAGR) of 19.3%. The growth during the historic period resulted mainly from the burgeoning adoption of personalized medicine, growth in oncology and cancer therapies, amplified pharmaceutical R&D collaborations, precision medicine initiatives and biomarker discovery.

Furthermore, the Companion diagnostics market size is set to witness exponential growth in the upcoming years, ballooning to $19.07 billion in 2029 at a compound annual growth rate (CAGR) of 21.5%. This growth during the forecast period can be predominantly attributed to the advancement in targeted therapy development, improvement in infectious disease diagnostics, surge in rare disease diagnostics, increasing biomarker-based drug development, proliferation of point-of-care testing and liquid biopsy applications. The major market trends for the forecast period include advancements in immunotherapy and immunology, the use of AI and machine learning in diagnostics, product innovations, adoption of industry 4.0 initiatives and strategic collaborations.

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What is Driving the Growth of the Companion Diagnostics Market?
The marked increase in targeted therapies is a significant driver of the companion diagnostics market. Targeted therapy is a specialized pharmaceutical therapy designed to target specific characteristics of cancer cells, inhibiting their growth and spread. These medications circulate throughout the body but are more pointed in their effect than chemotherapy, often resulting in fewer side effects. Biomarker-based companion diagnostic testing for targeted cancer therapy is becoming an integral part of personalized cancer care. For instance, according to the US-based Personalised Medicine Coalition, the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from just six in 2022. Hence, the surge in targeted therapies fuels the growth of the companion diagnostics market.

What are the Key Segments Within The Companion Diagnostics Market?
The companion diagnostics market presents the following major segments:

1) By Product And Service: Assays, Kits And Reagents, Software And Services
2) By Technology: Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry
3) By Indication: Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma
4) By End-User: Pharmaceutical And Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations

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Which Major Players are Dominating the Companion Diagnostics Market?
Significant 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, and others.

What Market Trends are Dominating the Companion Diagnostics Market?
A key trend in the companion diagnostics market is the technological advancement. For instance, artificial intelligence is being utilized to develop efficient drugs for companion diagnostics. The widespread application of artificial intelligence has been made possible due to continuously gathered extensive data sets from diverse genetic profiling. For example, Deep Genomics, a start-up based out of Toronto, is using artificial intelligence to discover better medications for genetic diseases and speeding up their admission into clinical trials. Implementing deep learning allows the scientists to test billions of compounds in a computer model and identify promising formulations, which can be converted into lifesaving medicines.

Which Region is leading the Companion Diagnostics Market?
In 2024, North America was the largest region in the companion diagnostics market, followed by Asia-Pacific, Western Europe, Eastern Europe, South America, and the Middle East and Africa.

What Does The Companion Diagnostics Market Report 2025 Offer?
Companion diagnostics is an in vitro diagnostic medical test that evaluates the safety and efficacy of a corresponding drug or biological product. The test assists a medical professionals in matching a patient to a specific drug or therapy. The Companion Diagnostics Market research report from The Business Research Company provides a global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.

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