Companion Diagnostic Test Market is Set to Grow at an Impressive CAGR of 8.6% Through 2032 | USD 15.0 Billion

WiseGuy Reports, Oct. 2025 (Press Release) – The Companion Diagnostic Test Market Global Outlook:

Global Companion Diagnostic Test Market Growth Analysis and Trends Report Test Type (Genetic Tests, Proteomic Tests, Immunohistochemistry Tests, In Situ Hybridization Tests), By Technology (Polymerase Chain Reaction, Next-Generation Sequencing, Microarray, Mass Spectrometry), By Indication (Oncology, Infectious Diseases, Cardiovascular Diseases, Neurological Disorders), By End User (Hospitals, Diagnostic Laboratories, Research Institutions) and By Regions - Global Industry Forecast 2025 to 2035

Companion Diagnostic Test Market Overview

The Companion Diagnostic Test Market is experiencing rapid growth due to the rising demand for personalized medicine and targeted therapies. Valued at USD 6.04 billion in 2024, the market is projected to reach USD 15.0 billion by 2035, expanding at a CAGR of 8.6% from 2025 to 2035. Companion diagnostics are critical for identifying patients likely to benefit from specific therapeutic interventions and minimizing adverse effects. Their integration into clinical practice enhances precision medicine approaches across oncology, cardiology, and other chronic disease areas. Advancements in genomic technologies, coupled with regulatory support, are enabling faster approvals and broader adoption of these tests, particularly in developed markets.

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Market Dynamics and Growth Drivers

The Companion Diagnostic Test Market is driven by several key factors. Increasing prevalence of chronic diseases, particularly cancer, fuels the demand for personalized therapies that require companion diagnostics for patient stratification. Technological advancements in genomics, next-generation sequencing (NGS), and biomarker identification are expanding the scope and accuracy of these tests. Regulatory approval processes have become more streamlined, encouraging collaboration between biopharma and diagnostics companies. Growing investments in R&D by pharmaceutical and biotech firms are facilitating the development of innovative diagnostic tools, while increasing awareness among healthcare professionals and patients is driving adoption.

Market Segmentation

The Companion Diagnostic Test Market is segmented by test type, technology, indication, end user, and region:

• By Test Type:
• Molecular Diagnostics – Dominant segment due to high sensitivity and specificity in identifying genetic mutations.
• Immunoassays – Widely used for protein-based biomarker detection.
• In Vitro Diagnostics (IVD) – Supports drug selection and therapy monitoring.
• By Technology:
• Next-Generation Sequencing (NGS) – Enables comprehensive genomic profiling for precision medicine.
• Polymerase Chain Reaction (PCR) – Rapid and cost-effective technique for detecting specific genetic markers.
• Microarray & Other Genomic Platforms – Facilitate high-throughput analysis for multiple biomarkers.
• By Indication:
• Oncology – Leading segment as companion diagnostics are critical for targeted cancer therapies.
• Cardiovascular Disorders – Increasing use in patient stratification for drug response.
• Infectious Diseases – Emerging segment focusing on pathogen-specific diagnostics.
• Others – Includes autoimmune and rare diseases where personalized treatment is gaining traction.
• By End User:
• Hospitals – Primary adopters due to in-house testing facilities and patient access.
• Diagnostic Laboratories – Specialized centers providing high-throughput testing solutions.
• Research Institutes – Conduct clinical trials and biomarker discovery programs.
• By Region:
• North America – Dominates due to advanced healthcare infrastructure, high R&D investments, and early adoption of companion diagnostics.
• Europe – Growth supported by government healthcare initiatives, regulatory support, and clinical research networks.
• Asia-Pacific (APAC) – Rapidly emerging with increasing healthcare access, rising chronic disease prevalence, and expanding laboratory infrastructure.
• South America & MEA – Gradual adoption due to improving healthcare systems and international collaborations.

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Regional Insights

North America leads the Companion Diagnostic Test Market due to strong research infrastructure, presence of major diagnostics and biopharma companies, and favorable reimbursement policies. The U.S. holds the largest share, driven by technological innovation and integration of diagnostics into personalized treatment protocols. Europe exhibits steady growth, supported by countries like Germany, the UK, and France, which are investing in genomic testing and precision medicine. The Asia-Pacific region is expected to experience rapid expansion, fueled by increasing awareness, government support, and a growing patient pool. Emerging markets in South America and MEA are gradually adopting companion diagnostics through international collaborations and improved healthcare infrastructure.

Key Market Opportunities

The Companion Diagnostic Test Market presents numerous opportunities:

• Increasing prevalence of cancer and chronic diseases driving demand for precision medicine.
• Expanding applications of next-generation sequencing and genomic technologies.
• Rising demand for targeted therapies requiring companion diagnostics for patient selection.
• Strategic collaborations between pharmaceutical companies and diagnostics providers to co-develop personalized treatment solutions.
• Advancements in biomarker discovery supporting innovative diagnostic test development.

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Competitive Landscape

The market is highly competitive with major players focusing on technological innovation, strategic partnerships, and global expansion. Key companies include:

• MediGene
• Bristol Myers Squibb
• Illumina
• Hologic
• Thermo Fisher Scientific
• Amgen
• Roche
• Agilent Technologies
• Abbott Laboratories
• Qiagen
• Dako
• Merck KGaA
• Sysmex Corporation
• BioMérieux
• F. Hoffmann-La Roche
• GE Healthcare

These companies are investing in R&D, expanding test portfolios, and forming strategic collaborations to drive market growth and enhance adoption of companion diagnostics globally.

Reasons To Buy The Companion Diagnostic Test Market Report:

➼ In-depth analysis of the Companion Diagnostic Test Market on the global and regional levels.

➼ Major changes in market dynamics and competitive landscape.

➼ Segmentation on the basis of type, application, geography, and others.

➼ Historical and future market research in terms of size, share growth, volume, and sales.

➼ Major changes and assessment in market dynamics and developments.

➼ Emerging key segments and regions

➼ Key business strategies by major market players and their key methods

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