Digital Breast Tomosynthesis Equipment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (2D/3D Combination Mammography Systems, Standalone 3D Mammography Systems), By End-User (Hospitals, Diagnostic Centers, Other End-Users) Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.52 Billion
CAGR (2026-2031)	10.22%
Fastest Growing Segment	2D/3D Combination Mammography Systems
Largest Market	North America
Market Size (2031)	USD 6.31 Billion

Market Overview

The Global Digital Breast Tomosynthesis Equipment Market will grow from USD 3.52 Billion in 2025 to USD 6.31 Billion by 2031 at a 10.22% CAGR. Digital breast tomosynthesis represents a diagnostic imaging modality that captures multiple X-ray images from various angles to reconstruct three-dimensional cross-sectional views of breast tissue. The global market is primarily propelled by the rising prevalence of breast cancer and a distinct clinical preference for modalities that offer superior accuracy in detecting lesions within dense breast tissue compared to conventional mammography. Additionally, widespread government initiatives mandating regular screening programs further bolster the demand for these diagnostic systems across healthcare facilities worldwide.

One significant challenge impeding broader market expansion involves the high acquisition and operational costs associated with tomosynthesis equipment which limits adoption in resource-constrained healthcare settings. This financial barrier persists despite the urgent necessity for advanced early detection capabilities driven by the increasing disease burden. Highlighting this demand, according to the American Cancer Society, in 2024, an estimated 310,720 new cases of invasive breast cancer were projected to be diagnosed in women in the United States.

Key Market Drivers

Technological advancements and AI integration are revolutionizing the Global Digital Breast Tomosynthesis Equipment Market by enhancing diagnostic accuracy and streamlining clinical workflows. The integration of artificial intelligence into 3D mammography systems addresses the critical challenge of analyzing complex volumetric data, thereby reducing false positives and mitigating radiologist fatigue. As manufacturers deploy deep learning algorithms, these systems are becoming more adept at identifying subtle malignancies in dense tissue that traditional methods might miss. Highlighting this progress, according to iCAD, Inc., November 2024, their newly FDA-cleared ProFound Detection Version 4.0 software demonstrated a 6.3% improvement in the area under the receiver operating characteristic curve (AUC), underscoring the tangible gains in detection performance offered by modern AI-enhanced solutions.

The Rising Global Incidence of Breast Cancer acts as the primary catalyst for the widespread adoption of tomosynthesis equipment, necessitating more robust screening infrastructures worldwide. Healthcare providers are increasingly transitioning to 3D modalities to manage the growing volume of patients and ensure earlier detection for better survival outcomes. According to the World Health Organization, February 2024, breast cancer ranked as the second most common cancer globally, with approximately 2.3 million new cases diagnosed in 2022. This escalating disease burden is further evidenced by long-term trends in key markets; according to the American Cancer Society, October 2024, breast cancer incidence rates increased by 1% annually from 2012 to 2021, a trajectory that reinforces the sustained market demand for advanced diagnostic equipment capable of handling higher screening loads with precision.

Download Free Sample Report

Key Market Challenges

The substantial capital expenditure required for acquiring and maintaining digital breast tomosynthesis systems functions as a primary restraint on market expansion. Healthcare providers, particularly community hospitals and facilities in emerging economies, often lack the necessary budget to absorb the high premium of these three-dimensional imaging modalities over standard mammography units. This price disparity forces many organizations to extend the lifecycle of legacy equipment rather than investing in newer technology, effectively stalling widespread adoption across price-sensitive markets.

This economic barrier is intensified by ongoing downward pressure on payments for imaging services, which limits the available funds for capital equipment upgrades. According to the American College of Radiology, in 2024, the Medicare Physician Fee Schedule conversion factor decreased by roughly 1.69 percent relative to the 2023 figure. This reduction in reimbursement levels restricts the financial capacity of radiology practices to recover the high acquisition and operational costs of tomosynthesis equipment, thereby directly impeding the projected growth of the global market.

Key Market Trends

The implementation of personalized screening protocols for dense breast tissue has become a defining trend, significantly influencing procurement strategies across the sector. This shift is largely accelerated by recently enforced regulatory standards requiring mandatory breast density notification, which compels healthcare providers to prioritize Digital Breast Tomosynthesis (DBT) over traditional 2D mammography for women with fibroglandular tissue. Unlike standard modalities where lesions can be obscured, tomosynthesis offers the depth resolution necessary for compliance with these new patient-care mandates. Underscoring the scale of this clinical requirement, according to Private Health Management, October 2024, in the article 'New FDA rule requires breast density information in mammogram results', nearly half of women over 40 have dense breast tissue, a statistic that highlights the vast patient population now necessitating these advanced 3D imaging capabilities to ensure diagnostic adequacy.

Concurrently, the market is witnessing a robust transition toward high-performance 3D tomosynthesis systems, driven by the need to replace aging installed bases with more efficient, high-throughput technology. Manufacturers are observing sustained momentum in capital equipment sales as facilities upgrade to premium gantries that support synthesized 2D imaging and faster scan times, prioritizing these revenue-generating assets despite broader economic constraints. This resilience in hardware investment is evident in recent corporate performances; according to Hologic, Inc., July 2024, in their 'Financial Results for Third Quarter of Fiscal 2024', Breast Health revenue grew by 6.9% compared to the prior year, a surge primarily attributed to strong gantry sales and service revenue. This data indicates a continued commitment from healthcare providers to invest in state-of-the-art gantry systems to maintain competitive diagnostic standards.

Segmental Insights

The 2D/3D Combination Mammography Systems segment currently represents the fastest-growing category within the Global Digital Breast Tomosynthesis Equipment Market. This expansion is primarily driven by the clinical necessity of pairing three-dimensional tomosynthesis with standard two-dimensional images to resolve tissue overlap and improve cancer detection rates, particularly in dense breast tissue. Regulatory frameworks, such as those maintained by the U.S. Food and Drug Administration (FDA), support the use of these combined views to ensure comprehensive interpretation and accurate diagnosis. Consequently, healthcare providers are prioritizing these integrated systems to optimize screening workflows and significantly reduce patient callback rates.

Regional Insights

North America maintains a dominant position in the global digital breast tomosynthesis equipment market, driven by a well-established healthcare infrastructure and widespread technology adoption. This leadership is largely attributed to favorable reimbursement policies established by the Centers for Medicare & Medicaid Services (CMS), which increase patient access to 3D mammography screenings. Additionally, the U.S. Food and Drug Administration (FDA) provides a supportive regulatory environment that facilitates the approval and commercialization of new diagnostic devices. These factors, combined with continuous product development by resident manufacturers, reinforce the region's primary standing in the global sector.

Recent Developments

• In November 2024, GE HealthCare launched the "Pristina Via" mammography system at the Radiological Society of North America Annual Meeting to address operational challenges in breast imaging. The new system was engineered to streamline workflows for technologists by incorporating zero-click acquisition functionality and eliminating wait times between exposures. This innovation allows for a faster image-to-image cycle time compared to previous models, which is critical given the current global shortage of radiologic technologists. The platform builds upon the company's existing "Senographe Pristina" architecture, focusing on improving the screening experience for both patients and healthcare providers through enhanced ergonomic and operational efficiency.
• In November 2024, Hologic revealed the "Envision" Mammography Platform and the "Genius AI Detection PRO" solution during the Scientific Assembly and Annual Meeting of the Radiological Society of North America. The Envision platform was introduced as a new tomography system featuring a rapid 2.5-second scan time designed to minimize patient motion and improve image sharpness. Concurrently, the company debuted its next-generation artificial intelligence software, which utilizes deep learning algorithms to assist radiologists in detecting subtle potential cancers in digital breast tomosynthesis images. These technologies were developed to increase diagnostic confidence and reduce false-positive rates in breast cancer screening.
• In September 2024, Siemens Healthineers announced that it had received premarket approval from the U.S. Food and Drug Administration for the three-dimensional tomosynthesis imaging technology of its "Mammomat B.brilliant" system. This approval specifically covered the "PlatinumTomo" technology, which enables a 50-degree wide-angle acquisition in less than five seconds. The system utilizes flying focal spot technology adapted from computed tomography scanners to reduce image blur and improve depth resolution. This development was significant for the market as it aimed to provide clearer visualization of lesions in dense breast tissue while enhancing patient comfort through faster scan times and ergonomic design features.
• In February 2024, Fujifilm Healthcare Europe unveiled its new digital mammography system, "Amulet Sophinity," during the European Congress of Radiology held in Vienna. This advanced equipment was designed to enhance diagnostic accuracy and patient comfort within the digital breast tomosynthesis sector. The system supports dual-angle tomosynthesis with sharp image reconstruction to better visualize calcifications and overlapping mammary gland structures. Additionally, it features artificial intelligence technology that projects skin lines and nipple positions onto the table surface to assist radiographers in positioning the patient, thereby improving workflow and reproducibility for comparison with previous images.

Key Market Players

• PerkinElmer Inc.
• Hologic, Inc
• GE HealthCare Technologies Inc.
• Fujifilm Holdings Corporation
• Siemens Healthineers
• General Medical Merate SpA
• Varex Imaging Corporation
• Trivitron Healthcare
• Metaltronica Spa
• Analogic Corporation

By Product Type	By End-User	By Region
2D/3D Combination Mammography Systems Standalone 3D Mammography Systems	Hospitals Diagnostic Centers Other End-Users	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Digital Breast Tomosynthesis Equipment Market, By Product Type:

• 2D/3D Combination Mammography Systems
• Standalone 3D Mammography Systems

• Digital Breast Tomosynthesis Equipment Market, By End-User:

• Hospitals
• Diagnostic Centers
• Other End-Users

• Digital Breast Tomosynthesis Equipment 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