Oncology diagnostics is the highest-growth and highest-value application segment in IVD, at the intersection of molecular diagnostics, immunoassay, and digital pathology. The cancer diagnostics market is projected to reach $10 billion by 2026. Liquid biopsy — detecting circulating tumor DNA, circulating free RNA, and other cancer biomarkers in blood — is creating an entirely new segment with the potential to enable multi-cancer early detection at population scale. Labcorp agreed to acquire oncology and clinical-testing assets from BioReference Health in March 2025. In May 2023, Freenome acquired Oncimmune, developing a CE-IVD lung cancer blood test. Companion diagnostics — IVD tests required for the prescription of targeted therapies — represent a structurally growing segment as precision oncology drug approvals accelerate.
92 countries — 38 European, 18 Asia-Pacific, 22 Latin American, 11 Middle Eastern, and 3 North American countries.
This report provides significant competitor information, analysis, and insight critical to the development and implementation of effective marketing and R&D programs.
Topics Covered
• Oncology IVD Market Size and Forecast 2025-2030 by Application and Technology
• Companion Diagnostics — FDA/EMA Co-Development, Market Size, and Leading CDx Suppliers
• Liquid Biopsy — ctDNA, cfRNA, CTCs, and Multi-Cancer Early Detection
• Somatic Mutation Testing — NGS Panels, PCR-Based Testing, and Tumor Profiling
• Germline Hereditary Cancer Testing — BRCA, Lynch Syndrome, and Expanded Panels
• Digital Pathology and Anatomic Pathology — Tissue Diagnostics and AI-Powered Image Analysis
• Tumor Markers and Immunoassay — PSA, CA-125, CEA, and Novel Biomarkers
• Competitive Landscape — Roche, Illumina, Guardant, Exact Sciences, Foundation Medicine
• Investment and Partnership Opportunities
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Table of Contents
1. Executive Summary
- Key findings and strategic implications
- Highest-priority oncology IVD opportunities
- Competitive landscape summary
- Strategic recommendations
2. Market Overview
- Market definition, scope and segmentation
- Key demand drivers and restraints
- Regulatory environment
3. Companion Diagnostics
- FDA and EMA CDx co-development pathway
- CDx market by cancer type and therapy class
- Leading CDx suppliers and competitive dynamics
4. Liquid Biopsy
- ctDNA and cfRNA detection platforms
- Multi-cancer early detection — Grail Galleri and competitors
- Monitoring and residual disease detection applications
5. Somatic Mutation Testing
- NGS-based tumor profiling panels
- PCR-based hotspot testing
- Comprehensive genomic profiling — Foundation Medicine and competitors
6. Germline Hereditary Cancer Testing
- BRCA1/2 and Lynch syndrome testing
- Expanded hereditary cancer panels
- Competitive landscape — Myriad, Ambry, Invitae
7. Digital Pathology and Tissue Diagnostics
- AI-powered image analysis in oncology pathology
- HER2, PD-L1, and MSI scoring algorithms
- Platform competition — Roche, Philips, Leica, Paige
8. Tumor Markers and Immunoassay
- PSA, CA-125, CEA, and established tumor markers
- Novel biomarkers and emerging assays
- High-volume immunoassay platform competition
9. Competitive Landscape
- Roche, Illumina, Guardant, Exact Sciences, Foundation Medicine, and challengers
- New entrants and biotech companies entering clinical oncology testing
- M&A and partnership activity 2023-2025
10. Regional Market Analysis
- 10.1 North America (U.S., Canada, Mexico)
- 10.2 Europe (38 countries)
- 10.3 Asia-Pacific (18 countries)
- 10.4 Latin America (22 countries)
- 10.5 Middle East (11 countries)
- 10.6 Africa and Rest of World
11. Strategic Conclusions and Recommendations
- Highest-priority opportunities by application and region
- Market entry and expansion strategies
- M&A, partnership and investment priorities
12. Appendix
- Research methodology
- Abbreviations and definitions
- List of tables and figures
List of Tables
Table 1. Companion Diagnostics — Approved CDx Tests by Drug and Platform 2025
Table 2. Liquid Biopsy — Platform Comparison and Leading Suppliers 2025
Table 3. Somatic Mutation Testing — NGS Panel Comparison 2025
Table 4. Germline Hereditary Cancer Testing — Platform and Provider Comparison 2025
Table 5. Digital Pathology — AI Algorithm Approvals and Clinical Status 2025
Table 6. Tumor Markers and Immunoassay — Key Tests and Leading Suppliers 2025
Table 7. Leading Suppliers and Competitive Positioning — Oncology IVD 2025
Table 8. M&A and Partnership Activity in Oncology IVD 2023-2025
Table 9. Regulatory Pathway Summary by Application and Region 2025
Table 10. Key Risks and Mitigation Strategies
Abbott Diagnostics
Bio-Rad Laboratories
bioMérieux
Danaher (Beckman Coulter, Cepheid, Radiometer)
DiaSorin
Hologic
QuidelOrtho
Roche Diagnostics
Siemens Healthineers
Sysmex
