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Companion Diagnostics Market to Reach US$ 15.0 Billion by 2030, Expanding at a CAGR of 12.2% on Rising Precision Oncology and Targeted Therapy Adoption | DataM Intelligence
Companion Diagnostics Market
United States: Recent Industry Developments
✅ In October 2025, Roche Diagnostics expanded its U.S. companion diagnostics portfolio with a new next-generation sequencing (NGS)-based assay for multiple solid tumors, partnering with major oncology centers to accelerate precision medicine adoption and improve targeted therapy matching by 25%.
✅ In September 2025, Abbott Laboratories launched the Vysis ALK Break Apart FISH Probe Kit update certified for non-small cell lung cancer (NSCLC), targeting hospital labs via e-commerce platforms amid rising demand for ALK inhibitor companion testing.
✅ In August 2025, Agilent Technologies introduced an enhanced PD-L1 IHC 22C3 pharmDx assay compliant with FDA guidelines, distributed through Thermo Fisher channels for immunotherapy patient selection in melanoma and head & neck cancers.
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Japan: Recent Industry Developments
✅ In October 2025, Sysmex Corporation adopted advanced NGS companion diagnostic tech in its Japanese facilities, improving mutation detection sensitivity by 18% for export-grade oncology assays to Asia-Pacific precision medicine markets.
✅ In September 2025, Riken Genesis collaborated with local cancer institutes to develop HER2 companion diagnostics for breast cancer, focusing on high-accuracy IHC and FISH under national cancer control reforms.
✅ In August 2025, Japan's Ministry of Health, Labour and Welfare subsidized companion diagnostic R&D for 4,000 test kits of annual output, supporting EGFR and BRAF testing in lung and melanoma therapies.
Asia-Pacific: Recent Industry Developments
✅ In October 2025, Guardant Health Asia opened a new liquid biopsy companion diagnostics lab in Singapore, supplying B2B clients in oncology with non-invasive ctDNA assays for real-time therapy monitoring.
✅ In September 2025, India's MedGenome imported record volumes of NGS-based companion diagnostic panels from the U.S., driven by rising targeted therapy adoption during national cancer screening programs.
✅ In August 2025, Foundation Medicine (Roche) launched tissue-agnostic companion diagnostics in Southeast Asia, integrating with telemedicine for rare mutation detection in underserved regions.
Market Trends & Drivers
The Global Companion Diagnostics Market is thriving due to surging demand for precision oncology amid rising targeted therapy approvals and biomarker-driven treatment decisions, expanding applications in oncology (NSCLC, breast, colorectal, melanoma), neurology, and rare diseases for patient stratification, and increasing awareness around personalized medicine and regulatory co-approvals. Key trends include innovation in technologies (e.g., NGS panels, liquid biopsy ctDNA, multiplex IHC), growth in decentralized testing (point-of-care CDx, lab-developed tests), and increasing adoption in emerging markets (affordable PCR and IHC-based assays). The rise of oncology drug pipelines, premiumization in companion testing, and regulatory pushes for co-development (FDA, EMA, PMDA) are significantly accelerating market expansion amid shifting healthcare preferences for effective, biomarker-guided, and cost-efficient therapeutic matching solutions.
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Competitive Landscape
The market is moderately consolidated among North American, European, and Asia-Pacific producers, with intense competition in NGS and IHC innovation, regulatory co-approvals, and oncology focus.
» Roche Diagnostics dominates globally with vertically integrated companion diagnostics (VENTANA IHC, FoundationOne CDx) for multiple oncology indications.
» Abbott Laboratories leads in FISH and PCR-based assays, supplying ALK, ROS1, and BRAF tests for targeted therapies.
» Agilent Technologies excels in PD-L1 and HER2 diagnostics, focusing on immunotherapy and breast cancer companion testing.
» Thermo Fisher Scientific specializes in NGS Oncomine Dx panels for multi-biomarker detection.
» Guardant Health drives liquid biopsy leadership with Guardant360 for real-time monitoring.
» Sysmex Corporation strengthens APAC presence with high-sensitivity oncology assays.
» Qiagen focuses on PCR and digital PCR companion diagnostics for global markets.
» Illumina targets sequencing-based CDx for broad tumor profiling.
» BioMérieux innovates in infectious disease and oncology companion tests.
» Myriad Genetics pioneers BRCA and HRD companion diagnostics for PARP inhibitors.
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Segmentation
☛ By Technology
The companion diagnostics market is segmented into Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), In Situ Hybridization (ISH), and Others. Next-Generation Sequencing (NGS) dominates global consumption due to its multi-biomarker capabilities and tumor-agnostic approvals. Meanwhile, Immunohistochemistry (IHC) is rapidly growing for PD-L1 and HER2 companion testing.
☛ By Indication
Indications of companion diagnostics span Oncology, Neurology, and Others. The Oncology segment leads due to high targeted therapy approvals in NSCLC, breast, colorectal, and melanoma. Additionally, Neurology is expanding with emerging biomarkers for Alzheimer's and rare diseases.
☛ By End-User
Based on end-user, the market is bifurcated into Hospitals & Clinics, Diagnostic Laboratories, and Others. The Diagnostic Laboratories segment dominates, driven by centralized testing and NGS capabilities. The Hospitals & Clinics channel is also growing, with rising in-house companion testing.
Regional Analysis
» North America leads the global companion diagnostics market, with the U.S. as the largest consumer driven by FDA co-approvals, high oncology drug pipelines, and advanced NGS adoption. Expansions in liquid biopsy bolster regional dominance.
» Asia-Pacific exhibits robust growth as the fastest-expanding region, supported by rising targeted therapy use in China and Japan, and increasing diagnostic infrastructure in India.
» Europe shows steady demand fueled by EMA approvals and precision medicine initiatives. Countries such as Germany, France, and the UK prioritize IHC and NGS for oncology.
» The Middle East and Africa hold potential amid cancer care investments, focusing on PCR-based testing. Meanwhile, South America is emerging with imports for breast and lung cancer companion diagnostics.
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✅ Competitive Landscape
✅ Biomarker Innovation Tracker
✅ Export vs. Domestic Consumption Analysis
✅ Oncology Expert Insights
✅ Regulatory & Accuracy Benchmarks
✅ Yield & Pricing Dynamics
✅ Live Retail & E-commerce Trends
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DataM Intelligence is a full-service market research and consulting firm, guiding organizations from initial insight to strategic implementation. We transform proprietary data, emerging trends, and market developments into agile, actionable solutions.
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