Companion Diagnostics Market Research Report 2026 | Analysis, Size, Share and Forecast to 2031

Companion Diagnostics Market Overview:

The global companion diagnostics market is projected to grow at a robust CAGR of approximately 13% through 2031. This growth is driven by the increasing demand for personalized medicine, continuous advancements in diagnostic and therapeutic technologies, declining costs of genetic-based companion diagnostic (CDx) tests that enhance market accessibility, rising incidences of adverse drug reactions, and the growing adoption of next-generation sequencing (NGS) technologies.

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Companion diagnostics are tests developed alongside therapeutic drugs to determine their suitability for individual patients. These diagnostics employ various monitoring approaches to generate clinically meaningful insights, enabling patients, healthcare providers, and payers to make more informed decisions regarding treatment efficacy and care pathways.

Rising Adoption of NGS Technologies Accelerates Market Growth

The expanding use of next-generation sequencing, particularly its ability to identify rare genetic variants, is a key factor supporting the widespread adoption of companion diagnostics. NGS enables the simultaneous detection of multiple biomarkers associated with different drug therapies within a shorter timeframe. The application of NGS panels in a single test offers significant potential for improving treatment outcomes across multiple cancer types.

For example, in September 2022, Thermo Fisher Scientific received FDA approval for the Oncomine Dx Target Test, the first NGS-based companion diagnostic designed to guide therapy selection for patients with RET mutations or fusions in thyroid cancer. Similarly, in July 2022, Almac Diagnostic partnered with AstraZeneca to develop and commercialize several NGS- and qPCR-based companion diagnostic products.

Demand for Targeted Cancer Therapies Drives CDx Utilization

Advancements in cancer biology have shifted oncology treatment toward more precise, targeted approaches. Clinical studies suggest that up to 75% of cancer patients may not respond effectively to standard cancer therapies. Companion diagnostics help identify molecular targets, predict potential toxicities, and assess off-target drug effects, enabling more effective and safer treatment selection.

Currently, more than 90% of approved companion diagnostic tests worldwide are linked to targeted oncology drugs. By enabling comprehensive genomic characterization, CDx tests help clinicians identify cancer-driving mutations and uncover targeted treatment options that might otherwise remain undetected.

Role of Companion Diagnostics in Advancing Precision Medicine

Precision medicine focuses on delivering the right drug at the right dose to the right patient at the right time. As a result, it has become a strategic priority for pharmaceutical and diagnostics companies. Companion diagnostics play a pivotal role by identifying patients most likely to benefit from specific therapies, thereby supporting personalized treatment decisions.

Early integration of CDx development alongside drug discovery enhances the likelihood of faster regulatory approvals and deeper insights into drug-diagnostic pairings. As adoption continues to expand across therapeutic areas, companion diagnostics are expected to significantly accelerate the broader implementation of precision medicine.

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Market Challenges

Despite its growth potential, the companion diagnostics market faces challenges, including high drug development costs, expensive clinical trials, and increasingly stringent regulatory requirements related to analytical and clinical performance of in-vitro diagnostics (IVDs). These factors may constrain market expansion over the forecast period.

Regional Outlook

North America currently dominates the companion diagnostics market, driven by a high prevalence of cancer and HIV, favorable regulatory frameworks, increasing demand for targeted therapies, and economic incentives for early drug-diagnostic co-development. Meanwhile, the Asia-Pacific region is anticipated to register the fastest CAGR, supported by growing adoption of precision medicine, rising cancer incidence, increased PCR testing, and a rapidly aging population requiring customized therapeutics.

Competitive Landscape

Key players operating in the global companion diagnostics market include:

• Thermo Fisher Scientific Inc.
• Illumina Inc.
• Bayer AG
• F. Hoffmann-La Roche AG
• Siemens Healthineers AG
• Danaher Corporation
• Invitae
• Agilent Technologies, Inc.
• Almac Diagnostics
• QIAGEN Inc.
• Abbott Laboratories
• bioMérieux SA
• Bio-Rad Laboratories
• Quidel Corporation
• Foundation Medicine, Inc.
• Myriad Genetics, Inc.

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Growth Strategies Adopted by Market Leaders

Leading companies are actively pursuing both organic and inorganic growth strategies, including product launches, partnerships, collaborations, and acquisitions, to strengthen their market presence.

For instance, in October 2022, Roche received FDA approval for the first companion diagnostic designed to identify patients with HER2-low metastatic breast cancer. In May 2022, Illumina expanded its CE-marked TruSight™ Oncology Comprehensive test to include a pan-cancer CDx indication, enabling the identification of NTRK gene fusions across solid tumors.

Overall, the companion diagnostics market is poised for sustained growth, supported by increasing R&D investments, advancements in low-cost NGS technologies, rising demand for predictive diagnostics, and aggressive expansion strategies adopted by industry leaders.

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