Digital Breast Tomosynthesis Equipment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Digital Breast Tomosynthesis Equipment Market is projected to expand from USD 3.52 Billion in 2025 to USD 6.31 Billion by 2031, reflecting a compound annual growth rate of 10.22%. As a diagnostic modality, digital breast tomosynthesis functions by capturing multiple X-ray images from various angles to reconstruct three-dimensional cross-sectional views of breast tissue. The market's growth is largely driven by the increasing prevalence of breast cancer and a strong clinical preference for technologies that provide superior accuracy in detecting lesions within dense breast tissue compared to conventional mammography. Furthermore, the implementation of government initiatives mandating regular screening programs continues to strengthen the demand for these advanced diagnostic systems in healthcare facilities globally.

Despite these positive indicators, a significant hurdle to broader market growth remains the substantial acquisition and operational costs linked to tomosynthesis equipment, which restricts adoption in resource-limited environments. This financial obstacle persists even as the rising disease burden creates an urgent need for advanced early detection capabilities. Highlighting the severity of this demand, the American Cancer Society estimated that in 2024, approximately 310,720 new cases of invasive breast cancer would be diagnosed among women in the United States, underscoring the critical necessity for accessible and effective diagnostic solutions.

Market Drivers

Technological innovations and the integration of artificial intelligence are transforming the Global Digital Breast Tomosynthesis Equipment Market by refining diagnostic precision and optimizing clinical workflows. The incorporation of AI into 3D mammography systems tackles the difficulty of interpreting complex volumetric data, thereby lowering false-positive rates and alleviating radiologist fatigue. By utilizing deep learning algorithms, these systems demonstrate improved proficiency in identifying subtle malignancies within dense tissue that might otherwise be overlooked by traditional methods. As evidence of this advancement, iCAD, Inc. reported in November 2024 that their FDA-cleared ProFound Detection Version 4.0 software achieved a 6.3% improvement in the area under the receiver operating characteristic curve (AUC), highlighting the measurable benefits of modern AI-enhanced solutions.

Simultaneously, the rising global incidence of breast cancer serves as a primary driver for the widespread adoption of tomosynthesis equipment, creating a need for more robust worldwide screening infrastructures. Healthcare providers are increasingly shifting toward 3D modalities to manage expanding patient volumes and secure better survival outcomes through earlier detection. According to the World Health Organization in February 2024, breast cancer was the second most common cancer globally, with roughly 2.3 million new cases diagnosed in 2022. This growing disease burden is further confirmed by long-term market trends; the American Cancer Society noted in October 2024 that breast cancer incidence rates rose by 1% annually from 2012 to 2021, a trajectory that reinforces the continued demand for advanced diagnostic equipment capable of handling higher screening loads with precision.

Market Challenges

The significant capital expenditure necessary to acquire and maintain digital breast tomosynthesis systems acts as a major constraint on market growth. Many healthcare providers, especially community hospitals and facilities in emerging economies, struggle to afford the premium costs of these three-dimensional imaging modalities compared to standard mammography units. This price gap compels many organizations to prolong the lifespan of legacy equipment instead of investing in newer technology, effectively halting widespread adoption in price-sensitive markets.

This economic challenge is further exacerbated by continuous downward pressure on reimbursement rates for imaging services, which restricts funds available for capital equipment upgrades. According to the American College of Radiology, the Medicare Physician Fee Schedule conversion factor decreased by approximately 1.69 percent in 2024 compared to the previous year. Such reductions in reimbursement levels limit the financial capacity of radiology practices to recoup the high acquisition and operational expenses associated with tomosynthesis equipment, thereby directly obstructing the projected expansion of the global market.

Market Trends

A defining trend in the sector is the adoption of personalized screening protocols for dense breast tissue, which is significantly shaping procurement strategies. This shift is largely driven by recently enforced regulations mandating breast density notification, compelling healthcare providers to prioritize Digital Breast Tomosynthesis (DBT) over traditional 2D mammography for patients with fibroglandular tissue. Unlike standard modalities where lesions may be hidden, tomosynthesis provides the depth resolution needed to meet these new patient-care standards. Highlighting the extent of this requirement, Private Health Management noted in October 2024 regarding a new FDA rule that nearly half of women over 40 possesses dense breast tissue, emphasizing the vast population now requiring these advanced 3D imaging capabilities for adequate diagnosis.

In parallel, the market is experiencing a strong shift toward high-performance 3D tomosynthesis systems as facilities replace aging installed bases with more efficient, high-throughput technology. Manufacturers are seeing sustained momentum in capital equipment sales as providers upgrade to premium gantries that offer synthesized 2D imaging and faster scan times, prioritizing these revenue-generating assets despite broader economic pressures. This resilience in hardware investment is reflected in recent corporate results; Hologic, Inc. reported in July 2024 that Breast Health revenue increased by 6.9% year-over-year, a rise primarily driven by robust gantry sales and service revenue. This data signals a continued commitment from healthcare providers to invest in state-of-the-art systems to uphold competitive diagnostic standards.

Key Players Profiled in the Digital Breast Tomosynthesis Equipment Market

• 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

Report Scope

In this report, the Global Digital Breast Tomosynthesis Equipment Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Digital Breast Tomosynthesis Equipment Market.

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