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

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    Report

  • 192 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5925159
UP TO OFF until Jan 01st 2026
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The next-generation breast cancer diagnostics market is transforming clinical practice and operational priorities for healthcare leaders. Rapid advances in diagnostic technology, along with shifting models for patient care, require a strategic approach to maintaining competitiveness in this dynamic sector.

Market Snapshot: Next-Generation Breast Cancer Diagnostics Market

The global next-generation breast cancer diagnostics and screening market is on a steady trajectory of expansion. Currently valued at USD 21.27 billion in 2024, it is projected to reach USD 23.03 billion in 2025 and forecasted to achieve USD 41.46 billion by 2032, representing a CAGR of 8.69%. Innovation in medical technology, evolving regulatory frameworks, and diversification of care delivery are key factors influencing market momentum. Healthcare organizations, suppliers, and investors are challenged to strategically align technology adoption, resource planning, and competitive differentiation. As diverse health infrastructures evolve, understanding the interaction between emerging trends and operational imperatives is crucial for global competitiveness and effective patient care.

Scope & Segmentation of the Next-Generation Breast Cancer Diagnostic Market

  • Offerings: Digital pathology systems, advanced imaging modalities such as ultrasound, MRI, and mammography; implantable patient sensors; molecular diagnostics including next-generation sequencing and PCR-based assays; liquid biopsy; and wearable medical devices.
  • Test Types: Genetic assessments, encompassing BRCA mutations and genomic profiling; tissue characterization through cytology and histopathology; and key biomarker analysis, such as ER/PR and HER2 evaluation.
  • Stages: Solutions extend from early-stage screening to advanced disease case management, supporting personalized clinical pathways and adaptive operational strategies across care settings.
  • Applications: Encompasses routine mammography screening, patient-enabled self-examination, ongoing condition monitoring, and initiatives for population health risk reduction.
  • End Users: Academic medical centers, research organizations, diagnostic labs, tertiary care hospitals, and outpatient clinics—each with unique workflows and adoption criteria influencing market behavior.
  • Regional Coverage: Includes the Americas, Europe, Middle East & Africa, and Asia-Pacific, accounting for distinct regulatory conditions, clinical practices, and drivers influencing diagnostic adoption.
  • Company Coverage: Features analysis of key industry participants such as Abbott Laboratories, Agendia Inc., Becton Dickinson and Company, Bio-Rad Laboratories, Danaher Corporation, Epic Sciences, Exact Sciences Corporation, F. Hoffmann-La Roche, Fujifilm Holdings, GE HealthCare Technologies, Hologic, Illumina, Invivoscribe, Philips, Laboratory Corporation of America, Merck, Myriad Genetics, Novartis, OGT Group, Pfizer, Siemens Healthineers, Thermo Fisher Scientific, and other leading contributors.

Key Takeaways for Senior Decision-Makers

  • Digital imaging and molecular diagnostics are enhancing diagnostic clarity and streamlining resource allocation, supporting more tailored patient care models.
  • Adoption of AI accelerates diagnostic workflows, encourages collaboration among clinical teams, and contributes to improved cost controls throughout healthcare operations.
  • Regional inconsistencies in healthcare provision and compliance necessitate highly localized market strategies for effective implementation and regulatory adherence.
  • Collaboration between technology providers, health systems, and regulatory bodies is critical for efficient adoption of novel diagnostic solutions and management of emerging risks.
  • Emergent diagnostic tools, including liquid biopsy and wearable devices, are driving greater patient engagement and facilitating earlier intervention, strengthening system-wide care efficiency.

Tariff Impact on the Breast Cancer Diagnostic Market

Forthcoming changes to United States tariff policies for 2025 are intensifying cost pressures and increasing complexity in supply chains for imaging equipment and diagnostic reagents. In response, providers are adapting procurement frameworks, expanding supplier partnerships, and exploring domestic manufacturing options. These strategic moves are designed to reinforce supply chain resilience while enabling organizations to navigate regionally distinct regulatory environments effectively.

Methodology & Data Sources

This report’s findings are grounded in primary expert interviews, structured literature reviews, and robust quantitative modeling. Insights are validated through advisory panels, shipment analysis, and scenario testing, offering senior stakeholders a dependable resource for evidence-based decision-making.

Why This Report Matters in the Next-Generation Breast Cancer Diagnostics Market

  • Provides senior leadership with clear, actionable intelligence on emerging diagnostic technologies, competitive positioning, and changes in the regulatory landscape.
  • Clarifies the impact of evolving tariffs and compliance requirements, enabling organizations to manage risk and optimize procurement in the face of regional complexities.
  • Supports informed choices on investments, partnerships, and operational strategy through detailed market segmentation, targeted competitor analysis, and comprehensive sector insights.

Conclusion

This analysis empowers senior decision-makers with focused, actionable market intelligence to inform strategy, strengthen resilience, and advance operational goals within the next-generation breast cancer diagnostics sector.

 

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.

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Companies Mentioned

The key 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