Complete 2025 Companion Diagnostics Market Analysis – For Market Entry and Expansion

For business leaders, corporate strategists, and growth-focused teams – this report delivers deep market intelligence, forecasts, segmentation, and competitor insights to guide your decisions through 2034._x000D_

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How does the forecasted CAGR of the companion diagnostics industry compare to other sectors?_x000D_

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._x000D_

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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._x000D_

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What market trends are acting as primary growth drivers for the companion diagnostics sector?_x000D_

The increasing number of targeted therapies is expected to propel the growth of the companion diagnostics market. Targeted therapy is a pharmacological therapy that targets particular characteristics of cancer cells to inhibit the growth and spread of the disease. The medications circulate throughout the body but have a more targeted effect than chemotherapy and frequently have fewer adverse effects. Biological marker-based companion diagnostic testing for targeted cancer therapy is becoming an essential part of personalized cancer care. For instance, in February 2024, according to the Personalised Medicine Coalition, a US-based hospital and health care organization, in 2023, the FDA approved 16 new personalized treatments for rare disease patients, up from six in 2022. Therefore, the surge in targeted therapies drives growth in the companion diagnostics market._x000D_

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What are the fastest-growing segments in the companion diagnostics market forecast period?_x000D_

The companion diagnostics market covered in this report is segmented –_x000D_

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1) By Product And Service: Assays, Kits And Reagents, Software And Services_x000D_

2) By Technology: Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry_x000D_

3) By Indication: Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma_x000D_

4) By End-User: Pharmaceutical And Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations_x000D_

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Subsegments:_x000D_

1) By Assays: Polymerase Chain Reaction (PCR) Assays, Immunohistochemistry (IHC) Assays, Next-Generation Sequencing (NGS) Assays, In Situ Hybridization (ISH) Assays_x000D_

2) By Kits And Reagents: Diagnostic Kits, Detection Reagents, Control Reagents_x000D_

3) By Software And Services: Data Analysis Software, Interpretation Software, Custom Development Services, Consulting and Support Services_x000D_

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How are emerging trends transforming the companion diagnostics market dynamics?_x000D_

Technological advancement is a key trend in the companion diagnostics market. Artificial intelligence is used to develop more efficient drugs for companion diagnostics. The continuously gathered massive data sets from diverse genetic profiling have enabled the widespread application of AI. For instance, Deep Genomics, a Toronto-based start-up, is utilizing artificial intelligence to uncover better medications for genetic illnesses and speed up their introduction into clinical trials. The goal is to employ deep learning to explore the human genome for knowledge about the causes of diseases and to create and test chemical compounds that can be used as remedies. In a computer model, deep learning enables scientists to test billions of chemical compounds in search of promising formulations that they can turn into medicines that save lives for people worldwide._x000D_

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Which major players hold significant market share in the companion diagnostics sector?_x000D_

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._x000D_

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Which regional segments are forecasted to witness the fastest growth in the companion diagnostics market?_x000D_

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._x000D_

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How Can Companies Use The Companion Diagnostics Market Report to Drive Business Results?_x000D_

This report provides actionable insights tailored for business use—not academic analysis. Companies can leverage the data to:_x000D_

• Time market entry or expansion using growth forecasts and CAGR trends._x000D_

• Develop competitive products by tracking key technology shifts and user preferences._x000D_

• Tailor regional strategies with in-depth geographic data and local market dynamics._x000D_

• Benchmark and plan partnerships using competitive landscape insights._x000D_

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