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Global Companion Diagnostics Market Research 2025, Forecast To 2034

27 Feb, 2025

How Has the Companion Diagnostics Market Size Evolved in Recent Years?

The companion diagnostics market has seen considerable growth due to a variety of factors.
• The market for companion diagnostics has seen considerable expansion in the past few years. It is set to escalate from $7.34 billion in 2024 to an impressive $8.75 billion in 2025, exhibiting a compound annual growth rate (CAGR) of 19.3%.
The substantial growth observed in the past can be attributed to factors like the rising acceptance of personalized medicine, expansion of oncology and cancer treatments, enhanced collaboration in pharmaceutical research and development, initiatives in precision medicine, and discoveries in biomarkers.

What are the Market Size and Expected Growth Rates for the Companion Diagnostics Market?

The companion diagnostics market is expected to maintain its strong growth trajectory in upcoming years.
• The market for companion diagnostics is set to experience a significant growth surge over the forthcoming years, reaching a value of $19.07 billion in 2029 with a compound annual growth rate (CAGR) of 21.5%.
This predicted growth during the forecast period is linked to developments in targeted therapy, diagnostics for infectious diseases, rising diagnoses for rare diseases, increased use of biomarker-driven drug development, point-of-care testing, and applications of liquid biopsy. Key trends to watch during the forecast period will be advancements in immunotherapy and immunology, application of AI and machine learning in diagnostics, innovations in products, transitioning to industry 4.0, and strategic partnerships.

Which Key Drivers Are Propelling The Companion Diagnostics Market's Growth?

The growth of the companion diagnostics market is likely to be fueled by the rising number of targeted therapies. Such therapies are pharmacological interventions that specifically focus on certain cancer cell properties, thus restricting the disease's proliferation and diffusion. These treatments circulate throughout the patient’s system, yet their impact is more specific than that of chemotherapy and they often result in fewer side effects. Companion diagnostic testing, which is based on biological markers for targeted cancer therapy, is increasingly becoming a crucial component of personalized cancer treatment. For instance, the Personalised Medicine Coalition, a healthcare organization based in the US, revealed in February 2024, that in 2023, the FDA approved 16 new personalized treatments for patients with rare diseases, marking a significant increase from the six approved in 2022. Consequently, the rise in targeted therapies is stimulating the growth of the companion diagnostics market.

What Are The Key Segments Within The Global Companion Diagnostics Market?

The companion diagnostics market covered in this report is segmented –
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 Subsegments:
1) By Assays: Polymerase Chain Reaction (PCR) Assays, Immunohistochemistry (IHC) Assays, Next-Generation Sequencing (NGS) Assays, In Situ Hybridization (ISH) Assays
2) By Kits And Reagents: Diagnostic Kits, Detection Reagents, Control Reagents
3) By Software And Services: Data Analysis Software, Interpretation Software, Custom Development Services, Consulting and Support Services

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How Are New Trends Impacting The Size Of The Companion Diagnostics Market?

The progress in technology is a major trend observed in the companion diagnostics industry. Artificial intelligence is employed in the creation of more productive drugs in this sector. The copious data sets continuously collected from a variety of genetic profiles have facilitated the extensive use of AI. Take for example, Deep Genomics, a start-up hailing from Toronto, is leveraging artificial intelligence to discover superior drug remedies for genetic diseases, accelerating their progression to clinical trials. The objective is to harness the power of deep learning to scrutinize the human genome for insights into disease causation, and to design and screen chemical compounds that could serve as cures. Through a computational model, deep learning allows scientists to experiment with countless chemical compounds, seeking out potential formulas that could be developed into life-saving medicines on a global scale.

Who Are the Key Players in the Companion Diagnostics Market?

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.

What are the Regional Insights into the Companion Diagnostics Market?

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