[Hyderabad, May 5th, 2025] — The global companion diagnostics (CDx) market is undergoing a dynamic transformation, projected to grow from USD 6.4 billion in 2023 to USD 15.8 billion by 2031, registering a CAGR of 12.1% ClearView Market Insights, 2024. This surge is being driven by the rapid expansion of personalized medicine and the rising number of targeted therapies across oncology, immunology, infectious diseases, and pharmacogenomics.

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Market Drivers: Unlocking the Power of Precision Medicine

Precision Oncology and Targeted Therapies

• Lung Cancer (EGFR Testing): Reduces trial-and-error treatment by 35%, improving patient response.
• Breast Cancer (HER2 Testing): Tools like the Dako HercepTest® enable earlier detection, boosting survival rates by up to 30%.
• Colorectal Cancer (KRAS/BRAF Testing): Helps avoid unnecessary treatments, optimizing patient outcomes.

Immunotherapy & Autoimmune Disorders

• PD-L1 Profiling: Improves checkpoint inhibitor response rates by 40% in NSCLC and melanoma.
• Rheumatoid Arthritis: CDx tools predict biologic responders, reducing disease progression by 50%.
• Multiple Sclerosis: Biomarker-based tests accelerate therapy decisions for neurologists.

Infectious Diseases & Pharmacogenomics

• HIV & HCV Genotyping: Guides antiviral selection, cutting resistance risk by 25%.
• COVID-19 CDx Tools: Enable patient stratification for tailored treatment responses.
• Pharmacogenomics (CYP450): Impacts over 60% of psychiatric and cardiac prescriptions, minimizing adverse drug reactions.

2024 Breakthroughs & Innovation Milestones

Investment and R&D Trends

• Startup Ecosystem: USD 3.1 billion raised in 2023, primarily for liquid biopsy and AI-based platforms.
• Corporate R&D Leaders:
• Qiagen: Scaling NGS companion tests for solid tumors.
• Illumina: Developing tumor-agnostic, pan-genomic CDx solutions.

Expert Commentary

“Companion diagnostics are the linchpin of precision medicine—they ensure the right therapy reaches the right patient at the right time.”
— Dr. Elena Novak, Head of Translational Medicine, Genentech

“As the number of targeted therapies grows, companion diagnostics will become mandatory for drug approvals—not optional.”
— Prof. Raj Mehta, Institute of Molecular Pathology, London

Regional Market Highlights

North America (46% Market Share)

• FDA’s fast-track approvals of CDx-linked drugs.
• Strong partnerships between diagnostics firms and pharma companies.

Europe (28% Market Share)

• EMA support for biomarker-driven treatments.
• CDx reimbursement policies in Germany, UK, and France.

Asia-Pacific (18% Market Share)

• Accelerated regulatory approvals in China and Japan.
• Rising cancer incidence and genomic research boost demand.

Future Roadmap

• 2025: Integration of CDx into national cancer programs in Europe and Asia.
• 2027: AI-driven decision support platforms linked to real-time CDx data.
• 2030: Global harmonization of regulatory approval for co-developed drug-CDx therapies.

Company Spotlight

Roche Diagnostics

• Leadership Position: Over 25 FDA-approved companion diagnostics.
• 2024 Highlight: Launch of NAVIFY® Decision Support for personalized oncology.
• Growth Strategy: Expansion into digital pathology and AI-based testing.

Thermo Fisher Scientific

• Innovation: Oncomine Dx Target Test — first FDA-approved multi-CDx for NSCLC.
• Strategic Partnerships: Collaborations with AstraZeneca, Pfizer, and Merck.

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