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Molecular Oncology Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 191 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5925194
UP TO OFF until Jan 01st 2026
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The molecular oncology diagnostics market is redefining how cancer is detected and managed by offering earlier, more precise clinical insights and paving the way for truly personalized medicine. Senior healthcare leaders are leveraging market advancements to align strategic objectives with improved care delivery and operational efficiency.

Market Snapshot: Molecular Oncology Diagnostics Market Size and Growth

The molecular oncology diagnostics market is projected to grow from USD 9.88 billion in 2024 to USD 11.10 billion in 2025, achieving a compound annual growth rate (CAGR) of 12.17% through 2032 and reaching USD 24.79 billion by the forecast horizon. This expansion is driven by rapid evolution in next-generation genomics, increasing adoption of targeted therapies, and rising global emphasis on early, reliable cancer detection. The market also benefits from the trend toward data-driven diagnostics, opening opportunities across clinical and translational research environments. These dynamics position the sector for strong, sustained demand as healthcare systems worldwide adapt to evolving oncology care needs.

Molecular Oncology Diagnostics Market Scope & Segmentation

  • Product Types: Instruments, reagents and kits, software, and services each support streamlined diagnostics, greater operational efficiency, and advanced analytics for clinical implementation.
  • Technologies: Key solutions include fluorescence in situ hybridization, immunohistochemistry, microarray, next generation sequencing (encompassing targeted sequencing, hotspot and comprehensive panels, whole exome and genome approaches), and real time PCR. These technologies provide broad adaptability to various clinical demands.
  • Test Types: Liquid biopsy, multi gene panel testing, single gene testing, whole exome sequencing, and whole genome sequencing allow for noninvasive and comprehensive assessment, supporting precision in diagnosis.
  • Applications: Companion diagnostics, early detection, personalized medicine, prognosis and monitoring, and research use collectively drive advancement in both clinical and research settings.
  • Cancer Types: Diagnostics center on breast, colorectal, leukemia, lung, and prostate cancers, addressing distinctive needs and ongoing technological progress.
  • End Users: Diagnostic labs, hospitals and clinics, pharma and biotech companies, and research institutes use molecular oncology diagnostics to advance therapies, guide care strategies, and further scientific precision.
  • Sample Types: Plasma-based, tissue-based, saliva, urine, and whole blood specimens enable flexibility and tailoring of diagnostic approaches in varied clinical scenarios.
  • Regional Coverage: This market analysis covers the Americas; Europe, Middle East and Africa; and Asia-Pacific, reporting region-specific regulatory and operational influences shaping adoption and growth.
  • Company Analysis: Profiles highlight major companies including F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Illumina Inc., QIAGEN N.V., Bio-Rad Laboratories, Inc., Agilent Technologies, Inc., Danaher Corporation, Hologic, Inc., Exact Sciences Corporation, and Guardant Health, Inc., with a focus on innovation and emerging competitive trends.

Key Takeaways: Strategic Insights for Decision-Makers

  • Molecular oncology diagnostics enable healthcare executives to implement targeted treatment strategies for optimized patient outcomes and refined intervention.
  • Expanding use of sequencing and liquid biopsy technologies facilitates sensitive detection and effective monitoring, enhancing adaptive patient care pathways.
  • Incorporation of bioinformatics and workflow automation supports productivity in laboratories and delivers actionable interpretations for timely clinical response.
  • Collaboration among labs, industry stakeholders, and pharmaceutical partners accelerates the validation of biomarkers and aligns diagnostics with evolving therapeutic standards.
  • Use of molecular assays promotes more efficient resource allocation, management of overtreatment risks, and supports initiatives toward value-based care and cost controls.
  • Evolving reimbursement and regulatory frameworks underscore the importance of evidence generation and proactive stakeholder engagement for successful market integration.

Tariff Impact: U.S. Trade Policy and Supply Chain Considerations

The introduction of U.S. tariffs on reagents, sequencing consumables, and laboratory instruments has introduced added complexity to the molecular oncology diagnostics supply chain. Healthcare leaders are responding through updated procurement approaches, expanded domestic manufacturing, and strategic regional partnerships to maintain cost control and safeguard access to vital diagnostic resources.

Molecular Oncology Diagnostics Market Research Methodology & Data Sources

The research foundation integrates direct engagements with industry leaders, clinical and laboratory experts, and comprehensive secondary intelligence from regulatory and clinical datasets. Structured triangulation and robust quality assurance are used, ensuring insights meet the practical needs of senior decision-makers.

Why This Report Matters

  • Delivers evidence-based guidance for strategic planning, enabling healthcare executives to strengthen competitive positioning and capitalize on molecular oncology diagnostics opportunities.
  • Provides actionable recommendations for navigating evolving supply chain and technological dynamics, supporting effective decision-making across mature and high-growth regions.
  • Equips stakeholders with timely, relevant insights to drive investment decisions and operational execution as the industry landscape transforms.

Conclusion

This report empowers executive decision-makers with the knowledge to establish priorities, respond to industry shifts, and support high-value operations as molecular oncology diagnostics continue to reshape cancer care globally.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of AI-driven bioinformatics platforms for complex tumor profiling and targeted therapy selection
5.2. Emergence of CRISPR-based liquid biopsy diagnostics for real-time monitoring of minimal residual disease in oncology
5.3. Expansion of multi-omics assays integrating genomics, transcriptomics, and proteomics for personalized oncology diagnosis
5.4. Rising adoption of next-generation sequencing panels targeting actionable cancer biomarkers in clinical practice
5.5. Development of digital pathology and AI-powered image analysis tools for more accurate molecular oncology diagnostics
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Molecular Oncology Diagnostics Market, by Product Type
8.1. Instruments
8.2. Reagents & Kits
8.3. Software & Services
9. Molecular Oncology Diagnostics Market, by Technology
9.1. Fluorescence In Situ Hybridization
9.2. Immunohistochemistry
9.3. Microarray
9.4. Next Generation Sequencing
9.4.1. Targeted Sequencing
9.4.1.1. Comprehensive Panel
9.4.1.2. Hotspot Panel
9.4.2. Whole Exome Sequencing
9.4.3. Whole Genome Sequencing
9.5. Real Time PCR
10. Molecular Oncology Diagnostics Market, by Test Type
10.1. Liquid Biopsy
10.2. Multi Gene Panel Testing
10.3. Single Gene Testing
10.4. Whole Exome Sequencing
10.5. Whole Genome Sequencing
11. Molecular Oncology Diagnostics Market, by Application
11.1. Companion Diagnostics
11.2. Early Detection
11.3. Personalized Medicine
11.4. Prognosis & Monitoring
11.5. Research Use
12. Molecular Oncology Diagnostics Market, by Cancer Type
12.1. Breast Cancer
12.2. Colorectal Cancer
12.3. Leukemia
12.4. Lung Cancer
12.5. Prostate Cancer
13. Molecular Oncology Diagnostics Market, by End User
13.1. Diagnostic Laboratories
13.2. Hospitals & Clinics
13.3. Pharmaceutical & Biotech Companies
13.4. Research Institutes
14. Molecular Oncology Diagnostics Market, by Sample Type
14.1. Plasma Based
14.2. Saliva & Urine
14.3. Tissue Based
14.4. Whole Blood
15. Molecular Oncology Diagnostics Market, by Region
15.1. Americas
15.1.1. North America
15.1.2. Latin America
15.2. Europe, Middle East & Africa
15.2.1. Europe
15.2.2. Middle East
15.2.3. Africa
15.3. Asia-Pacific
16. Molecular Oncology Diagnostics Market, by Group
16.1. ASEAN
16.2. GCC
16.3. European Union
16.4. BRICS
16.5. G7
16.6. NATO
17. Molecular Oncology Diagnostics Market, by Country
17.1. United States
17.2. Canada
17.3. Mexico
17.4. Brazil
17.5. United Kingdom
17.6. Germany
17.7. France
17.8. Russia
17.9. Italy
17.10. Spain
17.11. China
17.12. India
17.13. Japan
17.14. Australia
17.15. South Korea
18. Competitive Landscape
18.1. Market Share Analysis, 2024
18.2. FPNV Positioning Matrix, 2024
18.3. Competitive Analysis
18.3.1. F. Hoffmann-La Roche Ltd
18.3.2. Thermo Fisher Scientific Inc.
18.3.3. Illumina Inc.
18.3.4. QIAGEN N.V.
18.3.5. Bio-Rad Laboratories, Inc.
18.3.6. Agilent Technologies, Inc.
18.3.7. Danaher Corporation
18.3.8. Hologic, Inc.
18.3.9. Exact Sciences Corporation
18.3.10. Guardant Health, Inc.

Samples

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Companies Mentioned

The key companies profiled in this Molecular Oncology Diagnostics market report include:
  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific Inc.
  • Illumina Inc.
  • QIAGEN N.V.
  • Bio-Rad Laboratories, Inc.
  • Agilent Technologies, Inc.
  • Danaher Corporation
  • Hologic, Inc.
  • Exact Sciences Corporation
  • Guardant Health, Inc.

Table Information