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Next-Generation Breast Cancer Diagnostic & Screening Market - Global Forecast 2025-2032

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    Report

  • 192 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5925159
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The next-generation breast cancer diagnostic and screening market is undergoing a profound transformation. Senior healthcare leaders are prioritizing solutions that combine clinical precision with operational efficiency and patient engagement, as disruptive technologies and evolving care pathways reshape the competitive landscape.

Market Snapshot: Next-Generation Breast Cancer Diagnostic & Screening Market

The Next-Generation Breast Cancer Diagnostic & Screening Market grew from USD 21.27 billion in 2024 to USD 23.03 billion in 2025. It is expected to continue growing at a CAGR of 8.69%, reaching USD 41.46 billion by 2032.

Scope & Segmentation

This market research report delivers a detailed outlook, empowering executives to address strategic priorities and identify growth opportunities across key market areas:

  • Offerings: Digital pathology platforms, imaging technologies including breast ultrasound, MRI, and mammography, implantable sensors, liquid biopsy, molecular diagnostics (microarrays, next-generation sequencing, PCR-based assays), and wearable devices.
  • Test Type: Genetic tests (BRCA testing, genomic profiling); pathological tests (cytology, histopathology); and protein marker tests (ER/PR, HER2).
  • Stage: Early stage (Stages I, II) and advanced stage (Stages III, IV) protocols.
  • Application: Early detection—such as routine mammograms and self-exams, monitoring for recurrence or treatment response, and structured screening programs.
  • End User: Academic and research institutes, diagnostic laboratories, hospitals, and specialty oncology clinics.
  • Geography: Coverage spans North America (United States, Canada, Mexico), Latin America (Brazil, Argentina, Chile, Colombia, Peru), Europe (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland), Middle East (United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel), Africa (South Africa, Nigeria, Egypt, Kenya), and Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan).
  • Companies: Analysis extends to leading firms such as Abbott Laboratories, Agendia Inc., Agilent Technologies, Becton Dickinson, BGI Genomics, Bio-Rad Laboratories, Centogene, Danaher Corporation, Epic Sciences, Exact Sciences, F. Hoffmann-La Roche, Fujifilm, GE Healthcare, Hologic, Illumina, Invivoscribe, Koninklijke Philips, Laboratory Corporation of America, Merck, Myriad Genetics, Novartis, Oxford Gene Technology, Pfizer, Siemens Healthineers, and Thermo Fisher Scientific.

Key Takeaways

  • Next-generation breast cancer diagnostics are increasingly shaped by advances in digital pathology, AI-enhanced imaging, and comprehensive molecular analysis for precise risk stratification and monitoring.
  • The push toward noninvasive modalities, such as liquid biopsy and wearable monitoring, is driving care models toward earlier detection and ongoing surveillance rather than episodic or reactive testing paradigms.
  • Strategic partnerships between technology innovators, healthcare providers, and regulatory bodies are accelerating validation and deployment of breakthrough diagnostic solutions, encouraging seamless integration into existing clinical workflows.
  • Customization of screening and diagnostic pathways through genetic profiling and biomarker panels increases alignment with patient-centric care and supports targeted therapy decisions for diverse patient populations.
  • Key market players focus on interoperability and data security, which ensures widespread health system adoption and supports flexibility amid supply chain or tariff disruptions.

Tariff Impact: Navigating Policy Changes

The introduction of new United States tariff measures in 2025 has influenced the breast cancer diagnostics supply chain, prompting adjustments in procurement and the formation of domestic manufacturing partnerships. Extended lead times for molecular diagnostic kits and elevated costs for imported equipment have resulted in intensified efforts to localize production and diversify supply chains. Regulatory bodies have expedited approvals for qualifying domestic technologies, which has further encouraged in-country innovation. Ultimately, these policy changes are supporting greater supply chain resilience and fostering continued technological advancement.

Methodology & Data Sources

This analysis is rooted in direct interviews with industry experts and stakeholders in oncology, pathology, and R&D roles. Rigorous secondary research incorporates peer-reviewed literature, patent filings, regulatory documents, shipment data, and clinical trial registries. Quantitative findings are validated through data triangulation and cross-validation, with expert panels engaged to review core trends and scenario models.

Why This Report Matters

  • Gives senior decision-makers a comprehensive, actionable view on navigating disruptive technologies, regulatory shifts, and regional market strategies in the next-generation breast cancer diagnostic landscape.
  • Enables effective resource allocation and growth targeting by clarifying market segmentation, supply chain dynamics, and competitive positioning among key stakeholders.
  • Equips industry leaders with evidence-based insights for shaping go-to-market strategies, strengthening risk management, and achieving long-term value across care delivery ecosystems.

Conclusion

This report synthesizes pivotal developments, insightful trends, and strategic implications for decision-makers overseeing breast cancer diagnostic and screening investments. It helps leaders anticipate market trajectories and align business priorities for sustained competitive advantage.

 

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 multiomics and artificial intelligence for personalized breast cancer risk stratification across diverse populations
5.2. Adoption of circulating tumor DNA liquid biopsy assays for early detection of minimal residual disease in breast cancer patients
5.3. Implementation of contrast-enhanced mammography to improve diagnostic specificity in women with dense breast tissue
5.4. Deployment of portable digital breast tomosynthesis units with edge-based AI analytics for community screening programs
5.5. Emergence of direct-to-consumer hereditary breast cancer gene panels following streamlined regulatory approvals
5.6. Expansion of reimbursement policies for advanced molecular breast imaging modalities in routine clinical practice
5.7. Development of deep learning algorithms to reduce false positives and optimize recall rates in mammography screening
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Next-Generation Breast Cancer Diagnostic & Screening Market, by Offerings
8.1. Digital Pathology
8.2. Imaging Technologies
8.2.1. Breast Ultrasound
8.2.2. Magnetic Resonance Imaging
8.2.3. Mammography
8.3. Implantable Sensors
8.4. Liquid Biopsy
8.5. Molecular Diagnostics
8.5.1. Microarrays
8.5.2. Next-Generation Sequencing
8.5.3. PCR-Based Assays
8.6. Wearable Devices
9. Next-Generation Breast Cancer Diagnostic & Screening Market, by Test Type
9.1. Genetic Tests
9.1.1. BRCA Testing
9.1.2. Genomic Profiling
9.2. Pathological Tests
9.2.1. Cytology
9.2.2. Histopathology
9.3. Protein Marker Tests
9.3.1. ER/PR Tests
9.3.2. HER2 Tests
10. Next-Generation Breast Cancer Diagnostic & Screening Market, by Stage
10.1. Advanced Stage
10.1.1. Stage III
10.1.2. Stage IV
10.2. Early Stage
10.2.1. Stage I
10.2.2. Stage II
11. Next-Generation Breast Cancer Diagnostic & Screening Market, by Application
11.1. Early Detection
11.1.1. Routine Mammograms
11.1.2. Self-Exams
11.2. Monitoring
11.2.1. Recurrence
11.2.2. Treatment Response
11.3. Screening Programs
12. Next-Generation Breast Cancer Diagnostic & Screening Market, by End User
12.1. Academic & Research Institutes
12.2. Diagnostic Laboratories
12.3. Hospitals
12.4. Specialty Clinics
13. Next-Generation Breast Cancer Diagnostic & Screening Market, by Region
13.1. Americas
13.1.1. North America
13.1.2. Latin America
13.2. Europe, Middle East & Africa
13.2.1. Europe
13.2.2. Middle East
13.2.3. Africa
13.3. Asia-Pacific
14. Next-Generation Breast Cancer Diagnostic & Screening Market, by Group
14.1. ASEAN
14.2. GCC
14.3. European Union
14.4. BRICS
14.5. G7
14.6. NATO
15. Next-Generation Breast Cancer Diagnostic & Screening Market, by Country
15.1. United States
15.2. Canada
15.3. Mexico
15.4. Brazil
15.5. United Kingdom
15.6. Germany
15.7. France
15.8. Russia
15.9. Italy
15.10. Spain
15.11. China
15.12. India
15.13. Japan
15.14. Australia
15.15. South Korea
16. Competitive Landscape
16.1. Market Share Analysis, 2024
16.2. FPNV Positioning Matrix, 2024
16.3. Competitive Analysis
16.3.1. Abbott Laboratories
16.3.2. Agendia Inc.
16.3.3. Agilent Technologies, Inc.
16.3.4. Becton, Dickinson and Company
16.3.5. BGI Genomics Co., Ltd.
16.3.6. Bio-Rad Laboratories, Inc.
16.3.7. Centogene N.V.
16.3.8. Danaher Corporation
16.3.9. Epic Sciences, Inc.
16.3.10. Exact Sciences Corporation
16.3.11. F. Hoffmann-La Roche Ltd.
16.3.12. Fujifilm Holdings Corporation
16.3.13. GE HealthCare Technologies, Inc.
16.3.14. Hologic, Inc.
16.3.15. Illumina, Inc.
16.3.16. Invivoscribe, Inc.
16.3.17. Koninklijke Philips N.V.
16.3.18. Laboratory Corporation of America Holdings
16.3.19. Merck & Co., Inc.
16.3.20. Myriad Genetics, Inc.
16.3.21. Novartis AG
16.3.22. Oxford Gene Technology (OGT) Group
16.3.23. Pfizer Inc.
16.3.24. Siemens Healthineers AG
16.3.25. Thermo Fisher Scientific Inc.

Companies Mentioned

The companies profiled in this Next-Generation Breast Cancer Diagnostic & Screening market report include:
  • Abbott Laboratories
  • Agendia Inc.
  • Agilent Technologies, Inc.
  • Becton, Dickinson and Company
  • BGI Genomics Co., Ltd.
  • Bio-Rad Laboratories, Inc.
  • Centogene N.V.
  • Danaher Corporation
  • Epic Sciences, Inc.
  • Exact Sciences Corporation
  • F. Hoffmann-La Roche Ltd.
  • Fujifilm Holdings Corporation
  • GE HealthCare Technologies, Inc.
  • Hologic, Inc.
  • Illumina, Inc.
  • Invivoscribe, Inc.
  • Koninklijke Philips N.V.
  • Laboratory Corporation of America Holdings
  • Merck & Co., Inc.
  • Myriad Genetics, Inc.
  • Novartis AG
  • Oxford Gene Technology (OGT) Group
  • Pfizer Inc.
  • Siemens Healthineers AG
  • Thermo Fisher Scientific Inc.

Table Information