Companion Diagnostics Market Boosted by Growth in Targeted Therapies and Regulatory Backing | F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Qiagen N.V., Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc.

The global companion diagnostics market reached US$ 6.1 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 15.0 billion by 2030. The global companion diagnostics market is expected to exhibit a CAGR of 12.2% during the fore

Companion Diagnostics Market Report by DataM Intelligence offers a detailed assessment of the global pharmaceutical and healthcare landscape, highlighting market size, key players, and critical growth drivers. With increasing adoption of personalized treatment strategies, regulatory approvals, and biomarker-driven drug development, the report delivers strategic insights for stakeholders in the companion diagnostics ecosystem from 2025 to 2033.

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Companion diagnostics are tests designed to predict patient responses to specific drugs, enabling targeted therapy. The market is expanding with the growth of personalized medicine, regulatory support, and increasing partnerships between diagnostic firms and pharmaceutical companies.

Companion Diagnostics Market Competitors Overview:

F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Qiagen N.V., Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc., Biomerieux SA, Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Guardant Health and Illumina Inc and others.

Important Industry Updates of 2025:

✅ Roche Tissue Diagnostics partnered with PathAI in 2025 to develop AI-enabled image-based CDx, integrating digital pathology tools into diagnostic workflows

✅ In 2025, Guardant Health's liquid biopsy tests (e.g. Guardant360) received expanded Medicare coverage for CDx uses, boosting adoption for recurrence monitoring and therapy selection in oncology

Methodology and Scope

The Companion Diagnostics Market Report is built on a rigorous research methodology that integrates primary interviews, expert insights, and validated secondary data from company reports, industry publications, and reliable databases. Utilizing both bottom-up and top-down approaches, the analysis ensures high data accuracy through triangulation. The report covers current market dynamics, growth opportunities, and key strategic developments across global and regional markets.

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Companion Diagnostics Market Segments Overview:

∎ By Indications (Oncology (Colorectal Cancer, Leukemia, Breast Cancer, Lung Cancer, Others), Neurology, Others)
∎ By Technology (In-situ Hybridization, Immunohistochemistry, Polymerase Chain Reaction, Next-Generation Sequencing, Others)
∎ By End-User ( Pharmaceutical and Biopharmaceutical Companies, Research Laboratories, Others)

The oncology companion diagnostics segment dominates, driven by the expanding pipeline of targeted cancer therapies that require biomarker-specific testing for patient selection.

Regional Overview for Companion Diagnostics Market:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

North America holds the highest share, supported by FDA-linked drug-diagnostic approvals. Asia Pacific is growing rapidly due to rising targeted therapy adoption.

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The Report Covers:

➡ In-depth analysis of the demand-supply gap, market size estimates, SWOT and PESTEL analysis, along with global market forecasts.
➡ Strategic recommendations with a focused go-to-market approach.
➡ An unbiased evaluation of overall market performance.
➡ Region- and country-specific insights, with customized reports available upon request.
➡ Identification of high-potential and niche segments and regions demonstrating strong growth prospects.

People Also Ask:

➤ What are the current global trends in sales, production, imports, and exports within the Companion Diagnostics market?
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➤ What are the major opportunities and challenges facing vendors in this market?
➤ Which product categories, applications, or end-user segments are contributing most to market growth and share?
➤ What are the primary factors driving and restraining growth in the Companion Diagnostics market?

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✅ Technology Roadmap Analysis
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✅ Positioning, Pricing & Market Access Snapshots
✅ Market Volatility & Emerging Risks Analysis
✅ Competitive Landscape

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