Companion Diagnostics in Oncology Market to Reach USD 16.2 Billion by 2034

Pune, India, November 11, 2025 - The global Companion Diagnostics (CDx) in Oncology Market is projected to grow from USD 8.9 billion in 2024 to USD 16.2 billion by 2034, registering a CAGR of 6.2 %, according to Exactitude Consultancy. Rising demand for personalized cancer treatments, growth in biomarker-based drug approvals, and increased collaboration between pharmaceutical and diagnostic companies are driving significant expansion worldwide.

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Key Takeaways
• Market Size (2024): USD 8.9 billion
• Forecast (2034): USD 16.2 billion
• CAGR (2025-2034): 6.2 %
• Leading Companies: F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., QIAGEN N.V., Agilent Technologies Inc., Abbott Laboratories, Illumina Inc., Myriad Genetics Inc., Bio-Rad Laboratories Inc., Guardant Health Inc., and Siemens Healthineers AG.
• Core Applications: Breast Cancer (HER2, BRCA) | Lung Cancer (EGFR, ALK, ROS1) | Colorectal Cancer (KRAS, NRAS) | Melanoma (BRAF) | Prostate and Ovarian Cancers.

Market Story
Companion diagnostics are redefining oncology by linking diagnostic precision with therapeutic efficacy. These tests identify genetic mutations or protein expressions to match patients with targeted drugs-transforming cancer from a generic disease treatment model to a personalized, molecular-driven one.

The rapid integration of next-generation sequencing (NGS) and liquid biopsy technologies has enabled faster, minimally invasive testing. Meanwhile, partnerships between diagnostic developers and pharma giants are accelerating the co-development of CDx assays alongside novel cancer drugs, ensuring simultaneous regulatory approvals.

Market Segmentation
• By Technology: Polymerase Chain Reaction (PCR) | Immunohistochemistry (IHC) | Next-Generation Sequencing (NGS) | In Situ Hybridization (ISH) | Others (Microarray, Flow Cytometry)

• By Indication: Lung Cancer | Breast Cancer | Colorectal Cancer | Melanoma | Prostate Cancer | Others

• By End User: Hospitals & Reference Labs | Pharmaceutical & Biotech Companies | Academic Research Institutes

• By Region:
o North America: Largest market; strong regulatory support from FDA for simultaneous drug-diagnostic approvals.
o Europe: Growing biomarker research and adoption of NGS-based companion tests.
o Asia Pacific: Fastest-growing region; rising cancer prevalence and government genomics initiatives in China and Japan.
o Latin America & MEA: Increasing partnerships for diagnostic infrastructure development.

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Recent Developments
• 2025: Roche launched a new NGS-based CDx panel for multi-tumor genomic profiling.
• 2024: Thermo Fisher Scientific introduced an integrated platform combining molecular testing with AI-assisted oncology analytics.
• 2023: QIAGEN partnered with AstraZeneca for co-development of EGFR mutation testing for lung cancer therapy.
• 2022: Guardant Health expanded its liquid biopsy portfolio with FDA clearance for tumor-agnostic applications.

Expert Quote
"Precision oncology depends on diagnostics that deliver certainty at the molecular level. As biomarker-guided therapies multiply, companion diagnostics are becoming the bridge between innovation and individualized patient outcomes," said Irfan Tamboli, Business Development Executive at Exactitude Consultancy.

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Market Drivers
1. Rising Prevalence of Cancer and Demand for Personalized Therapies.
2. Advances in NGS and Liquid Biopsy Technologies.
3. Regulatory Support for Drug-Diagnostic Co-Development.
4. Increasing Pharma-Diagnostic Collaborations for Targeted Drug Launches.

Forecast Outlook
Between 2025 and 2034, the market will witness large-scale adoption of AI-driven biomarker interpretation, multiplex CDx panels, and cloud-based diagnostic-drug data integration. Precision medicine networks in Asia and North America are expected to fuel global demand.

Conclusion
The Companion Diagnostics in Oncology Market stands at the center of the precision-medicine revolution. As genetic profiling becomes standard care, CDx solutions will continue to guide oncologists toward the right drug, at the right dose, for the right patient.

This report is also available in the following languages : Japanese (コンパニオン診断腫瘍学市場), Korean (동반 진단 종양학 시장), Chinese (伴随诊断肿瘤市场), French (Marché des tests compagnons en oncologie), German (Markt für Begleitdiagnostik in der Onkologie), and Italian (Mercato oncologico della diagnostica di accompagnamento), etc.

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