AI In Breast Imaging Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component (Hardware and Software), By Imaging Modality (Mammography, Ultrasound Imaging, and MRI), By Application (Screening, Diagnostics, and Image-guided Biopsy), By End Use (Hospitals & Clinics, Diagnostic Imaging Centers, and Research Institutes), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 320.32 MIllion
CAGR (2026-2031)	5.47%
Fastest Growing Segment	Screening
Largest Market	North America
Market Size (2031)	USD 440.92 MIllion

Market Overview

The Global AI In Breast Imaging Market will grow from USD 320.32 MIllion in 2025 to USD 440.92 MIllion by 2031 at a 5.47% CAGR. AI in breast imaging refers to the application of machine learning and deep learning algorithms designed to assist radiologists in the analysis of medical images such as mammograms, ultrasound, and MRI scans for improved anomaly detection. The primary drivers supporting market growth include the rising global prevalence of breast cancer, which necessitates robust screening programs, and the critical need to mitigate the workload of overburdened radiologists. By automating routine tasks and prioritizing suspicious cases, these tools address the widening disparity between the escalating volume of medical images and the limited availability of specialized imaging professionals, thereby enhancing clinical workflow efficiency.

This demand for operational support is reflected in the increasing utilization of these technologies among practitioners. According to the European Society of Radiology, in 2024, 48% of surveyed members reported currently using AI, with the technology's impact anticipated to be most significant in breast and oncologic imaging. Nevertheless, a significant challenge impeding market expansion is the high cost of implementation and integration into existing systems. These financial barriers, often coupled with complex regulatory requirements, can deter resource-constrained healthcare facilities from adopting these diagnostic solutions, effectively restricting broader market penetration.

Key Market Drivers

The Growing Shortage of Radiologists and Increasing Diagnostic Workload represents the most urgent catalyst for adoption in the breast imaging sector. Healthcare systems globally are grappling with a critical imbalance where the volume of imaging studies far outpaces the available workforce, leading to burnout and diagnostic delays. AI solutions are consequently being integrated to triage scans and automate reporting, acting as a force multiplier for strained departments. According to The Royal College of Radiologists, June 2024, in the 'Clinical Radiology Census 2023 Report', the UK healthcare system currently faces a 30% shortfall of clinical radiologists, a deficit projected to worsen to 40% by 2028. This scarcity has accelerated the commercialization of automated tools; according to Axis Imaging News, May 2024, the U.S. FDA added 191 new AI-enabled medical devices to its approved list, with 128 of these specifically focused on radiology, underscoring the industry's aggressive response to workforce limitations.

Concurrently, the Increasing Global Incidence of Breast Cancer necessitates more robust screening protocols, further amplifying the need for efficient technologies. As screening programs expand to catch the disease earlier, the sheer number of mammograms requiring interpretation is surging. This rising disease burden places immense pressure on diagnostic infrastructure to maintain accuracy without compromising throughput. According to the American Cancer Society, January 2024, in 'Breast Cancer Facts & Figures 2024-2025', an estimated 310,720 new cases of invasive breast cancer are projected to be diagnosed in women in the US alone during 2024. This escalating prevalence drives the deployment of AI algorithms capable of flagging high-risk anomalies, thereby ensuring that rising case volumes do not result in missed diagnoses or delayed treatments.

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Key Market Challenges

The high cost of implementation and integration constitutes a substantial impediment to the expansion of the global AI in breast imaging market. Deploying these advanced diagnostic tools requires significant capital investment, covering not only the acquisition of sophisticated software but also the necessary hardware upgrades and complex IT infrastructure integration. Beyond the initial outlay, healthcare facilities face ongoing expenses for system maintenance, regular software updates, and specialized staff training. For many organizations, particularly smaller independent practices and resource-constrained clinics, these financial demands are prohibitive, especially given the current lack of comprehensive reimbursement models to ensure a clear return on investment.

This financial strain is a primary reason for the hesitation observed across the industry. According to the European Society of Radiology, in 2024, 49.5% of surveyed members identified costs or lack of budget as the main potential barrier to AI implementation in clinical practice. Consequently, market growth remains skewed toward well-funded academic centers, while broader adoption across the general healthcare landscape is stalled. This economic disparity effectively limits the market's reach and decelerates the overall trajectory of global industry expansion.

Key Market Trends

The Proliferation of AI Solutions for Digital Breast Tomosynthesis is addressing the complexities of analyzing volumetric imaging data. As 3D mammography generates larger datasets than traditional 2D modalities, AI algorithms are increasingly deployed to enhance lesion conspicuity and reduce false negatives, particularly in dense breast tissue. This efficacy was substantiated by recent large-scale clinical data; according to RadNet Inc., November 2025, in the 'Landmark Nature Health Study Demonstrates the Effectiveness of DeepHealth's Novel AI-Powered Breast Cancer Detection Workflow' press release, an evaluation involving over 579,000 women revealed that their AI-supported screening protocol achieved a 21.6% increase in the cancer detection rate compared to standard 3D mammography.

Simultaneously, Strategic Alliances Between AI Vendors and Imaging OEMs are accelerating market penetration by embedding analytics directly into radiology reading environments. These collaborations allow healthcare providers to access advanced diagnostic tools within their existing infrastructure rather than investing in fragmented, standalone software solutions. A notable instance involves major institutions securing comprehensive access to such technologies; according to Radiology Business, April 2025, in the 'Big-name healthcare orgs tap AI to improve breast imaging workflows' article, Therapixel’s partnership to integrate its MammoScreen software at Mayo Clinic was reported to increase radiologist interpretation speeds by approximately 35%, underscoring the operational value driving these commercial agreements.

Segmental Insights

The Screening segment is currently experiencing the fastest growth within the Global AI in Breast Imaging Market, driven by a heightened global focus on early disease detection and preventative care. This expansion is significantly supported by an increasing number of product clearances from regulatory bodies such as the U.S. Food and Drug Administration, which facilitates the adoption of AI-based detection software in clinical settings. Furthermore, the rising prevalence of breast cancer has prompted healthcare institutions to integrate these automated tools into standard workflows to manage high patient volumes effectively and reduce interpretation errors, thereby fueling the demand for screening-focused AI solutions.

Regional Insights

North America maintains a leading position in the global AI in breast imaging market, driven by established healthcare infrastructure and high adoption rates of advanced diagnostic technologies. The region's dominance is significantly supported by the U.S. Food and Drug Administration (FDA), which actively grants regulatory clearances for artificial intelligence algorithms used in mammography and radiology. Additionally, the concentration of key market players and research institutions within the United States fosters continuous product development, ensuring the rapid integration of automated detection tools into standard clinical practices.

Recent Developments

• In November 2025, GE HealthCare and DeepHealth, Inc. announced a significant expansion of their strategic collaboration to advance the integration of artificial intelligence across medical imaging modalities. Building on an initial partnership that combined AI-powered screening workflows with mammography systems, this new phase focused on broadening global access to breast cancer detection solutions and enhancing clinical support tools. The companies aimed to leverage their combined expertise in imaging hardware and health informatics to develop smart technologies that improve decision-making accuracy and operational efficiency for breast imaging providers worldwide.
• In April 2025, SimonMed Imaging entered into a partnership with Lunit to deploy advanced artificial intelligence software across its extensive network of outpatient imaging centers. The collaboration focused on the implementation of the Lunit INSIGHT DBT solution, which utilizes deep learning algorithms to assist in the detection of breast cancer within 3D mammography exams. This initiative was a key component of a new service launch designed to offer personalized breast cancer detection and risk assessment to patients. By integrating this AI technology, the organization aimed to improve diagnostic sensitivity, facilitate earlier detection of malignancies, and optimize the productivity of its radiologists.
• In November 2024, Hologic, Inc. introduced the Genius AI Detection PRO solution, a next-generation deep-learning technology developed for digital breast tomosynthesis. Unveiled at a major industry conference, this advanced software was engineered to assist radiologists by delivering higher detection accuracy while significantly reducing false-positive marks. The system features a sophisticated algorithm that is capable of analyzing a patient’s current mammogram in the context of their prior exams to improve specificity. This product launch underscored the company's ongoing commitment to leveraging artificial intelligence to enhance clinical confidence and streamline reading workflows in breast cancer screening.
• In April 2024, iCAD, Inc. and Densitas, Inc. announced a strategic partnership aimed at enhancing precision care in the breast imaging market. The collaboration involved integrating iCAD’s AI-powered cancer detection and risk evaluation technologies with Densitas’s solutions for automated mammography quality and breast density assessment. By combining these distinct capabilities, the companies sought to provide a comprehensive, end-to-end portfolio that supports radiologists from the point of image acquisition through to diagnosis. This partnership was designed to improve operational efficiency in imaging centers and support personalized patient management by addressing critical factors such as image quality and density stratification.

Key Market Players

• Visage Imaging, Inc.
• CureMetrix, Inc.
• DeepHealth, Inc.
• GE HealthCare Technologies Inc.
• Hologic, Inc.
• Siemens Healthineers AG
• Fujifilm Holdings Corporation
• Koninklijke Philips N.V.
• iCAD, Inc.
• Medicalgorithmics SA

By Component	By Imaging Modality	By Application	By End Use	By Region
Hardware and Software	Mammography Ultrasound Imaging and MRI	Screening Diagnostics and Image-guided Biopsy	Hospitals & Clinics Diagnostic Imaging Centers and Research Institutes	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global AI In Breast Imaging Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• AI In Breast Imaging Market, By Component:

• Hardware and Software

• AI In Breast Imaging Market, By Imaging Modality:

• Mammography
• Ultrasound Imaging
• and MRI

• AI In Breast Imaging Market, By Application:

• Screening
• Diagnostics
• and Image-guided Biopsy

• AI In Breast Imaging Market, By End Use:

• Hospitals & Clinics
• Diagnostic Imaging Centers
• and Research Institutes

• AI In Breast Imaging Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE