Digital Mammography Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (2D Full Field Digital Mammography Tomosynthesis, 3D Full Field Digital Mammography Tomosynthesis), By End-User (Hospitals, Ambulatory Surgical Centers, Other End-Users), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.19 Billion
CAGR (2026-2031)	9.49%
Fastest Growing Segment	3D Full Field Digital Mammography Tomosynthesis
Largest Market	North America
Market Size (2031)	USD 2.05 Billion

Market Overview

The Global Digital Mammography Market will grow from USD 1.19 Billion in 2025 to USD 2.05 Billion by 2031 at a 9.49% CAGR. Digital mammography is a specialized diagnostic imaging modality that utilizes solid-state detectors to capture and convert X-ray energy into electrical signals for the detection of breast abnormalities. The market is primarily supported by the rising global prevalence of breast malignancies, which necessitates robust early detection capabilities, alongside the expansion of government-mandated screening programs globally. This demand is further amplified by an aging female population, as age remains a primary risk factor for the disease. According to the American Cancer Society, in 2025, an estimated 316,950 new cases of invasive breast cancer were expected to be diagnosed in women in the United States, underscoring the critical need for widely accessible screening technologies.

Despite the strong drivers for adoption, the market faces a significant challenge regarding the high acquisition and operational costs associated with digital imaging systems. These financial requirements can pose a substantial barrier to market expansion, particularly in developing nations where healthcare budgets are constrained and reimbursement policies for advanced diagnostic procedures may be inadequate. Consequently, this economic factor limits the penetration of digital mammography units in resource-limited settings, impeding the technology's universal reach.

Key Market Drivers

The integration of Artificial Intelligence (AI) in breast imaging serves as a critical catalyst for the Global Digital Mammography Market, fundamentally reshaping diagnostic precision and operational throughput. By augmenting human interpretation with deep learning algorithms, healthcare providers can significantly reduce false positives and improve early detection rates, which encourages the adoption of advanced digital systems capable of supporting these sophisticated software tools. This technological value is evidenced by recent clinical data; according to RadNet, Inc., November 2025, in the 'AI-Supported Safeguard Review Evaluation' study, the application of AI-enabled workflows increased the breast cancer detection rate by 21.6% compared to standard 3D mammography. Such improvements drive clinics to upgrade their installed base, ensuring they can offer the highest standard of care while managing increasing patient volumes efficiently.

Concurrently, the implementation and expansion of government-funded breast cancer screening programs provide a sustained foundation for market demand. These national mandates necessitate the widespread deployment of digital mammography units to handle large-scale population screening effectively, ensuring consistent procurement cycles for equipment manufacturers. For example, according to NHS Digital, February 2025, in the 'Breast Screening Programme, England, 2023-24' report, the service screened 1.95 million women aged 45 and over, demonstrating the substantial equipment utilization driven by public health policy. This volume is essential to address the growing disease burden; according to the Canadian Cancer Society, in 2025, an estimated 31,900 women in Canada were expected to be diagnosed with breast cancer, reinforcing the global imperative for accessible and robust digital screening infrastructure.

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Key Market Challenges

The substantial capital investment required for digital mammography systems constitutes a significant impediment to the growth of the Global Digital Mammography Market. High acquisition costs for Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) units create high barriers to entry, particularly in low- and middle-income countries where healthcare budgets are severely restricted. Beyond the initial hardware purchase, the total cost of ownership is elevated by the necessity for expensive high-resolution workstations, robust data storage infrastructure, and specialized maintenance contracts. Consequently, many facilities in resource-limited settings are forced to rely on older analog technology, directly stifling the broader adoption of digital solutions.

This economic pressure is intensified by unfavorable reimbursement policies that fail to adequately cover the operational expenses associated with advanced imaging. When payment rates decline, the return on investment for upgrading equipment diminishes, causing providers to delay or cancel procurement plans. According to the American College of Radiology, in 2025, the implementation of updated federal fee schedules resulted in a reimbursement reduction of approximately 2.83% for physician services, a financial contraction that further hampers the ability of imaging centers to invest in modern mammography technologies.

Key Market Trends

The widespread transition from 2D systems to 3D Digital Breast Tomosynthesis (DBT) is the primary hardware evolution reshaping the market. Facilities are aggressively replacing legacy units with DBT platforms to enhance accuracy, boosting manufacturer revenue. This upgrade cycle is substantial; according to Hologic, Inc., November 2024, in the 'Financial Results for Fourth Quarter of Fiscal 2024' report, Breast Health revenue increased by 6.4%, with product margin expansion explicitly attributed to higher sales of 3D Dimensions systems. As clinics prioritize these systems, the installed base of tomosynthesis units grows, rendering 2D-only configurations obsolete.

The implementation of density-based screening protocols has accelerated following regulatory changes mandating transparent patient communication regarding tissue composition. These updates compel providers to inform women about mammography limitations in dense tissue, driving the adoption of adjunct modalities. This regulatory shift was formalized recently; according to the U.S. Food and Drug Administration (FDA), September 2024, in the 'Final Rule to Amend the Mammography Quality Standards Act (MQSA)' announcement, enforcement began for requirements mandating facilities provide specific breast density assessments in patient lay letters. This federal standardization stimulates the market for supplemental imaging technologies required for dense tissue management.

Segmental Insights

The 3D Full Field Digital Mammography Tomosynthesis segment currently represents the fastest growing category within the global market due to its ability to improve diagnostic accuracy in dense breast tissue. This technology is increasingly adopted because it addresses the limitations of conventional 2D imaging by layering images to visualize overlapping structures. The US Food and Drug Administration acknowledges that these systems significantly reduce false positives and unnecessary patient callbacks. Consequently, hospitals are prioritizing this equipment to enhance workflow efficiency and improve cancer detection rates, driving the segment's rapid expansion.

Regional Insights

North America maintains a leading position in the global digital mammography market, driven by the increasing incidence of breast cancer and a robust healthcare infrastructure. The region benefits from favorable reimbursement policies and extensive government initiatives that promote regular screening programs. Additionally, the presence of major manufacturers facilitates the rapid adoption of digital imaging technologies. Continuous product clearances by the U.S. Food and Drug Administration (FDA) further support market expansion by ensuring the accessibility of reliable diagnostic systems for early detection.

Recent Developments

• In November 2024, GE HealthCare launched the Pristina Via mammography system, a significant evolution of its established Senographe Pristina platform. Debuting at a prominent North American radiological meeting, this new system was engineered to streamline workflows for technologists and improve the screening experience for patients in the Global Digital Mammography Market. Key features included zero-click image acquisition and the elimination of wait times between exposures, allowing for faster operation. The company emphasized that these enhancements were designed to mitigate repetitive tasks and address workforce shortages by enabling technologists to focus more on personalized patient care during breast cancer screenings.
• In November 2024, Hologic, Inc. unveiled the Envision Mammography Platform and the Genius AI Detection PRO solution, significantly advancing its portfolio in the Global Digital Mammography Market. The new platform was introduced as the company’s fastest and highest-resolution 3D mammography system, featuring a scan time of less than three seconds to minimize motion artifacts and improve patient comfort. Concurrently, the company launched its next-generation artificial intelligence software, which utilizes deep learning to analyze both current and prior exams. This technology aims to assist radiologists by improving specificity and reducing false-positive rates, thereby enhancing overall diagnostic confidence and workflow efficiency.
• In September 2024, Siemens Healthineers received premarket approval from the U.S. Food and Drug Administration for the three-dimensional imaging capabilities of its Mammomat B.brilliant system. This regulatory milestone marked the introduction of a completely redesigned mammography platform featuring wide-angle tomosynthesis technology intended to improve the detection of breast cancer. The approval covered new image acquisition and reconstruction methods that work alongside the system's existing features for full-field digital mammography and breast biopsy. The Vice President of X-ray Products at the company highlighted that this innovation addresses the critical need for improved diagnostic capabilities and patient comfort in breast screening.
• In February 2024, Fujifilm Healthcare Europe introduced a new digital mammography system known as Amulet Sophinity during a major radiology congress in Vienna. This advanced platform was designed to enhance diagnostic accuracy and patient comfort within the Global Digital Mammography Market. The system features innovative projection technology that utilizes artificial intelligence to map skin lines and nipple positions from previous exams, facilitating precise positioning for radiographers. Additionally, the equipment includes a specially designed comfort function aimed at reducing the pressure applied to the breast during compression, thereby addressing a common patient concern regarding pain during screening procedures.

Key Market Players

• Hologic Inc
• GE Healthcare
• Koninklijke Philips NV
• Siemens Healthcare GmBH
• Fujifilm Corporation
• Planmed Oy
• Toshiba Medical Systems
• Metaltronica S.p.A

By Product	By End-User	By Region
2D Full Field Digital Mammography Tomosynthesis 3D Full Field Digital Mammography Tomosynthesis	Hospitals Ambulatory Surgical Centers Other End-Users	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Digital Mammography Market, By Product:

• 2D Full Field Digital Mammography Tomosynthesis
• 3D Full Field Digital Mammography Tomosynthesis

• Digital Mammography Market, By End-User:

• Hospitals
• Ambulatory Surgical Centers
• Other End-Users

• Digital Mammography 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