North America Breast Cancer Screening Tests Market Size and Share

North America Breast Cancer Screening Tests Market (2025 - 2030)
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North America Breast Cancer Screening Tests Market Analysis by Âé¶¹ÊÓÆµ

The North America Breast Cancer Screening Tests Market size is expected to register a CAGR of 8.17% during the forecast period (2026-2031).

  • The COVID-19 pandemic significantly impacted the breast cancer screening test market. Diagnostic procedures were postponed at the pandemic's beginning as the hospitals and surgeons were advised to postpone or cancel elective courses. For instance, according to a study published by the National Library of Medicine (NLM) in June 2022, mammography rates were more impacted during the pandemic than the number of breast cancer operations. By 2030, the study projects 950 cumulative excess breast cancer deaths related to reduced screening and 1,314 associated with delayed diagnosis of symptomatic cases.
  • The study also stated that the initial pandemic-related disruptions in breast cancer care would have a negligible long-term effect on breast cancer mortality. This has impacted the growth of the breast cancer screening test market during the pandemic. However, the market is gradually stabilizing as COVID-19 cases are declining, resulting in the return of the normal demand levels for diagnostic procedures.
  • The primary factors driving the market growth include the rising incidence of breast cancer and technological advancements in breast cancer screening. For instance, according to the Canadian Cancer Society update, in May 2022, 28,600 Canadian women were diagnosed with breast cancer, representing 25% of all new cancer cases in women in 2022.
  • Furthermore, according to a Center for Disease Prevention (CDC) update in September 2022, the risk of breast cancer increases with age. Most breast cancers are diagnosed after age 50. Thus, with an increase in breast cancer cases due to the rise in the geriatric population, the demand for breast cancer screening tests increases, thereby driving the market's growth.
  • Furthermore, technological advances in imaging are creating new opportunities for improvements in screening and early detection. For instance, according to National Cancer Institute (NCI), in January 2022, NCI funded a large-scale randomized breast screening trial, the tomosynthesis mammographic imaging screening trial (TMIST), to compare the number of advanced cancers detected in women screened for five years with 3-D mammography with the number seen in women screened with 2-D mammography. Such initiatives are expected to increase the demand for breast cancer screening tests, eventually driving the market's growth.
  • Additionally, the rising initiative of critical players in developing innovative strategies is further expected to drive market growth over the forecast period. For instance, in October 2022, the American College of Radiology (ACR) launched the contrast-enhanced mammography imaging screening Trial (CMIST) in collaboration with the Breast Cancer Research Foundation (BCRF) and GE Healthcare. The trial determined whether contrast-enhanced mammography improves breast cancer detection and reduces false-positive exams in women with dense breasts. Such initiatives will lead to increased adoption of breast cancer screening, driving market growth.
  • Therefore, the factors mentioned above, such as the rising incidence of breast cancer and technological advancements in breast cancer screening, are attributed collectively to the studied market growth over the forecast period. However, controversies related to mammography and side effects of radiation during screening tests and errors in screening are the major factors restraining the market's growth.

Note: Market size and forecast figures in this report are generated using Âé¶¹ÊÓÆµâ€™s proprietary estimation framework, updated with the latest available data and insights as of 2026.

Competitive Landscape

The North American breast cancer screening tests market is fragmented in nature due to the presence of several companies operating regionally. The competitive landscape includes an analysis of companies, including Agendia BV, Fujifilm Holdings Corporation, Hologic Inc., Metabolomic Technologies Inc., Myriad Genetics, QIAGEN NV, Quest Diagnostics Incorporated, and Siemens Healthineers, among others.

North America Breast Cancer Screening Tests Industry Leaders

  1. Allengers Medical Systems Limited

  2. Myriad Genetics

  3. Siemens Healthineers

  4. Hologic Inc.

  5. GENERAL ELECTRIC COMPANY

  6. *Disclaimer: Major Players sorted in no particular order
North America Breast Cancer Screening Tests Market Concentration
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Market Opportunities and Future Outlook

The US FDA Mammography Quality Standards Act (MQSA) Final Rule, effective September 2024, standardizes quality requirements and requires reporting of breast density information to patients and providers. This regulatory anchor reinforces upgrade needs and supports workflow improvements to help ensure consistent reporting and communication of breast density across certified mammography sites.

Technology-led opportunities are emerging across automation, artificial intelligence, and point-of-care imaging. Evidence cited across 2026 includes the January 2026 commercial launch of iSono Health's FDA-cleared ATUSA wearable automated breast ultrasound platform; the April 2026 FDA clearance of Lunuts next-generation 3D mammography AI algorithm update; the April 2026 NCCN guideline update that includes an AI mammogram-based risk tool with a five-year risk threshold (>=1.7%) to identify future breast cancer risk missed by traditional methods; Calidar's first-in-human 4D mammography study enrollment completion (April 2026); and March 2026 peer-reviewed evidence on partially autonomous AI-supported mammography screening. Together, these developments point to commercialization whitespace in integrated triage, risk stratification, and throughput-focused screening pathways that span imaging systems, AI software, and complementary genomic and blood-based testing offered through providers and diagnostic labs.

Recent Industry Developments

  • June 2026: Siemens Healthineers received US FDA clearance for contrast-enhanced mammography (CEM) and CEM biopsy capabilities for the Mammomat B.brilliant system. The clearance expands use beyond standard screening into contrast-based workups and image-guided intervention, which can broaden CEM-enabled workflows within mammography suites.
  • April 2026: Lunuts next-generation 3D mammography AI algorithm update received FDA clearance. The update improves integration with imaging platforms and enhances triage and detection workflows across screening programs.
  • January 2026: iSono Health's FDA-cleared ATUSA wearable automated breast ultrasound platform launched commercially. The platform adds a portable adjunct modality for dense-breast pathways and can support triage alongside mammography.

Table of Contents for North America Breast Cancer Screening Tests Industry Report

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Incidence of Breast Cancer
    • 4.2.2 Technological Advancements in Breast Cancer Screening
  • 4.3 Market Restraints
    • 4.3.1 Controversies Related to Mammography
    • 4.3.2 Side Effects of Radiation during Screening Tests and Errors in Screening
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD)

  • 5.1 By Test
    • 5.1.1 Genomic Tests
    • 5.1.2 Imaging Test
    • 5.1.2.1 Mammogram
    • 5.1.2.2 Ultrasound
    • 5.1.2.3 MRI
    • 5.1.2.4 Tomography
    • 5.1.2.5 Other Imaging Tests
  • 5.2 Geography
    • 5.2.1 United States
    • 5.2.2 Canada
    • 5.2.3 Mexico

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Allengers Medical Systems Limited
    • 6.1.2 Fujifilm Holdings Corporation
    • 6.1.3 Hologic Inc.
    • 6.1.4 GE Healthcare
    • 6.1.5 Myriad Genetics
    • 6.1.6 QIAGEN NV
    • 6.1.7 Quest Diagnostics Incorporated
    • 6.1.8 Siemens Healthineers
    • 6.1.9 Analogic Corporation
    • 6.1.10 Aurora Healthcare US Corp
    • 6.1.11 Agendia Inc.
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

Research Methodology Framework and Report Scope

Market Definition and Coverage

This market covers revenues generated from breast cancer screening tests used to identify potential breast cancer in asymptomatic or screening-eligible populations across North America. It includes test kits and screening procedures delivered through clinical settings, where the purchase and performance are captured in screening workflows.

Scope exclusions: Treatment, therapeutics, and broader breast cancer diagnostic workups that start after a suspicious screening result are excluded.

Segmentation Overview

  • By Test
    • Genomic Tests
    • Imaging Test
      • Mammogram
      • Ultrasound
      • MRI
      • Tomography
      • Other Imaging Tests
  • Geography
    • United States
    • Canada
    • Mexico

Data Sources, Market Sizing, and Validation

Desk Research

Desk research starts by mapping the addressable breast cancer screening pathway and the typical places where spending is recorded, then aligning that to North America level coverage. Public sources are used to anchor the demand pool and screening activity, including CDC screening guidance and utilization summaries, National Cancer Institute materials and SEER cancer statistics, FDA device and test-related public databases, and CMS reimbursement and coding references where applicable.

To reduce guesswork, we also read non-paywalled clinical guidelines and peer-reviewed journals that discuss screening intervals, modality mix, and adoption shifts (for example, the move toward 3D mammography in some settings). On the supply side, we review company filings, investor presentations, and credible press to understand portfolio focus and geographic exposure. For select cross-checks, we use paid subscriptions for company financials and patent databases, and we may also reference an import-export shipment-level database when equipment flows help explain modality availability. The sources listed here are illustrative, and many other public documents and references were reviewed to collect data, validate assumptions, and clarify open questions.

Primary Interviews and Surveys

Primary work is used to pressure test the desk view on what is actually ordered, reimbursed, and performed, then to confirm practical splits by test category and care setting. Interviews cover test providers, imaging administrators, lab stakeholders, clinicians, and distribution participants across the United States, Canada, and Mexico, so the model reflects real screening cadence and the pricing behavior observed in those markets.

Distribution of primary research fieldwork respondents

Company typeRespondent positionRegion
Top tier: 29% CXOs: 18%
Mid tier: 53% Functional/Unit leaders: 32%
Smaller Players: 18% Managers: 50%

Market-Sizing & Forecasting

Market sizing is built using a top-down approach where the screening eligible population, screening rate, and modality mix are combined to reconstruct annual test volumes, then converted to value using typical reimbursed price points and observed pricing ranges. Where inputs vary by country, the United States, Canada, and Mexico are sized separately and aggregated to the North America total at the end.

To keep totals realistic, we corroborate results with selective bottom-up approximations, including sampled pricing by modality, channel checks on testing volumes, and supplier-level directional roll-ups that help correct overstatements. Key inputs in the model include screening participation by age band, frequency assumptions by guideline and real practice, the share of imaging versus genomic screening, movement toward tomosynthesis and other imaging tests, and policy or reimbursement signals that change utilization. For forecasting, scenario analysis is used so the base case growth reflects expert consensus on capacity expansion, awareness programs, and technology adoption, with upper and lower cases used to understand sensitivity. When bottom-up signals are incomplete, gaps are handled by applying conservative ranges, then rechecking the implied per capita screening activity for each country.

Data Validation & Update Cycle

Validation is done through multiple checks so totals match independent signals, and any unusual jumps are challenged before numbers are finalized. We compare implied screening volumes and value per test against public utilization references, reimbursement benchmarks, and the interviewed ranges, then document and resolve variances through follow-up.

Before sign-off, the model and assumptions go through a step-by-step analyst review where formulas, unit consistency, and currency timing are rechecked. Reports are refreshed annually, and interim updates are triggered when a material event occurs, such as a guideline change, reimbursement shift, or a major regulatory action affecting screening. Right before delivery, the full dataset is reviewed again so the latest updated view is reflected in the final output.

Âé¶¹ÊÓÆµ's North America Breast Cancer Screening Tests Market Market Size Versus Other Published Estimates

Published market sizes for breast cancer screening tests in North America can look different even when the topic is described similarly, because the counted services and year-to-year pricing logic are not always aligned. Differences also come from how each publisher treats follow-on diagnostic testing, how local pricing is converted into USD, and how recently assumptions were refreshed.

Some external estimates are broader and include breast cancer diagnostics categories like biopsy and blood tests in the same revenue pool. In Âé¶¹ÊÓÆµ, the number is limited to screening tests only (genomic and imaging screening), and it is built by linking screening activity and modality mix to realistic price points that were validated through interviews and cross-checks.

Benchmark comparison

SourceMarket SizeGaps in Research Methodology
Âé¶¹ÊÓÆµ USD 1.10 B (2024)
Industry Publisher A USD 2.18 B (2024)Uses a broader breast cancer diagnostics scope, which typically includes biopsy and other post-screening diagnostic procedures, so the revenue pool is larger than screening-only.
Regional Consultancy B USD 0.90 B (2024)Leans on conservative pricing and a narrower assumed screening uptake, which can understate modality mix shifts and reimbursement-driven value per test in high-coverage geographies.

The table shows that most gaps are explained by what gets counted as screening versus downstream diagnostics, followed by how screening uptake and price per test are treated in the base year. By tying the value build-up to observable screening activity and checked pricing ranges, we can keep the estimate transparent and repeatable even when external scopes are not aligned.

Key Questions Answered in the Report

What is the current North America Breast Cancer Screening Tests Market size?

The North America Breast Cancer Screening Tests Market is projected to register a CAGR of 8.17% during the forecast period (2026-2031)

Who are the key players in North America Breast Cancer Screening Tests Market?

Allengers Medical Systems Limited, Myriad Genetics, Siemens Healthineers, Hologic Inc. and GENERAL ELECTRIC COMPANY are the major companies operating in the North America Breast Cancer Screening Tests Market.

What years does this North America Breast Cancer Screening Tests Market cover?

The report covers the North America Breast Cancer Screening Tests Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the North America Breast Cancer Screening Tests Market size for years: 2026, 2027, 2028, 2029, 2030 and 2031.

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