North America Mammography Devices Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

 Mammography Devices Market  Size

• The North America Mammography Devices Market Treatment market was valued at USD 108.11 million in 2024 and is expected to reach USD 140.17 Million by 2032, at a CAGR of 3.3%, during the forecast period
• The rising incidence of breast cancer and the growing emphasis on early detection are driving demand for the Mammography Devices Market in North America. Additionally, increasing awareness about routine breast screening, coupled with technological advancements in digital and 3D mammography systems, is further propelling market growth.

Mammography Devices Market  Analysis

• Mammography devices are specialized imaging systems used for the early detection and diagnosis of breast cancer through low-dose X-rays. These devices play a critical role in identifying abnormal growths and changes in breast tissue, facilitating timely medical intervention. Advanced mammography technologies, including digital mammography and 3D tomosynthesis, enhance image accuracy, reduce false positives, and contribute to improved patient outcomes and survival rates.
• The U.S. emerges as a leading region in the North America Mammography Devices Market, supported by a well-established healthcare infrastructure, high awareness of breast cancer screening, and favorable reimbursement policies for diagnostic imaging procedures.
• Ongoing investments in innovative imaging technologies, including AI-enhanced diagnostics and portable mammography units, along with a rising geriatric population and increased public health initiatives, continue to drive growth and technological advancement in the region’s mammography devices market.

Report Scope and Mammography Devices Market Segmentation

Mammography Devices Market  Trends

“Integration of Artificial Intelligence and Machine Learning in Breast Imaging”

• A prominent trend in the North America Mammography Devices Market is the growing integration of artificial intelligence (AI) and machine learning (ML) algorithms into mammography systems to enhance diagnostic accuracy and efficiency.
• AI-powered tools are being used to assist radiologists in detecting subtle abnormalities, prioritizing cases, reducing reading time, and minimizing false positives and negatives.

• For instance, AI-based computer-aided detection (CAD) systems can highlight suspicious areas on mammograms, helping clinicians focus on high-risk findings and improve early cancer detection rates.

• These technologies also support workflow optimization by automating image sorting, reporting, and data management, which is particularly valuable in high-volume screening environments.
• The increased adoption of AI in breast imaging is also fostering the development of personalized screening protocols based on individual risk profiles, further aligning with precision medicine approaches.
• This digital transformation is expected to revolutionize breast cancer diagnostics, reduce radiologist workload, and drive long-term growth and competitiveness in the North America Mammography Devices Market.

Mammography Devices Market  Dynamics

Driver

“Rising Prevalence of Breast Cancer and Demand for Early Detection”

• As the North American population ages and risk factors such as obesity, hormonal imbalance, alcohol consumption, and family history become more common, the incidence of breast cancer is increasing significantly. Breast cancer remains one of the leading causes of cancer-related deaths among women, underscoring the urgent need for effective, early diagnostic tools like mammography devices.

• Mammography devices, particularly digital breast tomosynthesis (3D mammography), offer a non-invasive solution for early detection, allowing clinicians to identify tumors at an earlier and more treatable stage. These technologies are favored over conventional methods due to improved accuracy, reduced false positives, and greater patient comfort.

For instance,

• In October 2023, the American Cancer Society reported that nearly 300,000 new cases of invasive breast cancer were expected in the U.S. for 2024, with early detection being crucial for survival.
• According to the CDC (2024), routine mammography screening has contributed to a 40% reduction in breast cancer mortality among women aged 40–74 in the United States.
• The growing burden of breast cancer is driving demand for accessible and reliable imaging systems. Simultaneously, heightened awareness through public health campaigns and improved physician referral rates are accelerating adoption.
• As clinical outcomes improve through advancements in imaging resolution, software-driven diagnostics, and portable screening units, healthcare providers are increasingly recommending mammography as a frontline diagnostic approach. This synergy of clinical need, awareness, and technology is fostering a strong growth environment for the North America Mammography Devices Market.

Opportunity

“Technological Advancements in Digital Imaging and AI-Driven Diagnostics”

• Significant innovations in mammography systems—such as 3D tomosynthesis, contrast-enhanced spectral mammography (CESM), and AI-integrated computer-aided detection (CAD) software—are transforming the landscape of breast cancer diagnostics. These advancements offer higher image clarity, enhanced lesion detection, and reduced need for biopsies, improving clinical outcomes and patient confidence.
• Cutting-edge technologies, including portable mammography units and cloud-connected imaging platforms, are expanding access to breast screening, particularly in remote and underserved areas. These improvements align with the North American healthcare system's shift toward preventative care and early intervention.

For instance,

• Companies like Hologic, GE Healthcare, and Siemens Healthineers have introduced AI-powered mammography platforms that support radiologists with real-time analysis, risk stratification, and workflow optimization.
• In early 2024, peer-reviewed studies in Radiology and JAMA Oncology highlighted that AI-assisted mammography systems demonstrated up to 10% greater sensitivity in detecting early-stage cancers compared to traditional reads.

• These technological leaps meet the growing demand for precision diagnostics and patient-centric care in both urban and rural settings.
• Firms investing in smart imaging, mobile diagnostic services, and risk-adaptive screening algorithms are well-positioned to capitalize on the North American push for scalable, accessible, and high-quality breast health solutions—making the Mammography Devices Market a high-value sector for strategic investment and innovation.

Restraint/Challenge

“High Equipment Costs and Disparities in Screening Access”

• The high cost of acquiring and maintaining advanced mammography equipment, especially 3D tomosynthesis systems and AI-driven platforms, poses a significant barrier to widespread adoption—particularly in community hospitals and rural clinics with limited capital budgets. Even in wealthier regions, disparities in insurance coverage and access to care persist, creating inequities in screening participation.
• While digital mammography improves diagnostic accuracy, the associated costs of installation, technician training, and ongoing system upgrades often deter smaller practices from transitioning from analog systems.
• Further, follow-up imaging, diagnostic biopsies, and specialist consultations can compound the financial burden on patients, especially those without comprehensive insurance coverage. This often leads to delayed diagnosis and worsened outcomes.

For instance,

• A 2023 report from the American College of Radiology noted that the cost of digital breast tomosynthesis equipment can exceed USD 400,000, excluding operational and maintenance expenses.
• In January 2024, The Lancet Regional Health – Americas emphasized that women in rural areas of North America are 25–40% less likely to receive regular mammograms compared to their urban counterparts due to equipment shortages and travel constraints.
• Major manufacturers acknowledge that pricing disparities, maintenance requirements, and inconsistent reimbursement policies are limiting market penetration in certain regions.
• To overcome these barriers, initiatives such as expanded telemammography services, public-private partnerships, mobile screening units, and broader insurance reforms will be vital to ensuring equitable access and sustained growth in the North America Mammography Devices Market.

Mammography Devices Market  Scope

The market is segmented on the product, technology, end user.

In 2025, the Breast Tomosynthesis Segmentis Projected to Dominate the Market with the Largest Share in the technology Segment

The Breast Tomosynthesis segment is expected to dominate the North America Mammography Devices Market in 2025, accounting for the largest market share of approximately 68.7%. This leadership is primarily driven by its superior cancer detection capabilities and increasing adoption in routine breast cancer screening programs.

In 2025, Film Screen are Expected to Account for the Largest Share During the Forecast Period in product  segment

In 2025, Film Screen are projected to dominate the North America Mammography Devices Market , accounting for the largest market share of approximately 64.9%. This segment's dominance is fueled by the the widespread availability of conventional systems and cost-effectiveness in resource-limited or rural healthcare settings.

Mammography Devices Market  Regional Analysis

“Estados Unidos es el país dominante en el mercado de dispositivos de mamografía en América del Norte”

• Estados Unidos lidera el mercado de dispositivos de mamografía en América del Norte, impulsado por su infraestructura de atención médica altamente avanzada, altos volúmenes de detección y amplia disponibilidad de tecnologías de mamografía de última generación, como la tomosíntesis mamaria digital y las imágenes asistidas por IA.
• Estados Unidos posee la mayor participación en el mercado debido a una creciente incidencia del cáncer de mama, un envejecimiento creciente de la población femenina y un fuerte énfasis de la salud pública en la detección temprana a través de mamografías regulares.
• Los marcos de reembolso favorables, la amplia cobertura de seguros y el fuerte apoyo federal a los programas de concientización y detección del cáncer contribuyen significativamente al dominio del mercado.
• Además, la presencia de importantes actores de la industria como Hologic, GE Healthcare y Siemens Healthineers, junto con continuas inversiones en I+D, innovaciones de productos y colaboraciones clínicas, acelera la adopción de sistemas de mamografía de próxima generación en todo el país.

“Se proyecta que EE. UU. registre la tasa de crecimiento más alta”

• Se prevé que Estados Unidos experimente el crecimiento más rápido en el mercado de dispositivos de mamografía, impulsado por la creciente concientización sobre el cáncer de mama, la expansión del acceso a la atención médica preventiva y la rápida adopción de modalidades de imágenes avanzadas.
• El mercado se está beneficiando de las campañas de detección pública a gran escala, los cambios demográficos como el retraso en los partos y el aumento de la esperanza de vida, y la creciente demanda de los pacientes de opciones de diagnóstico precisas y no invasivas.
• Iniciativas gubernamentales sólidas, como el Programa Nacional de Detección Temprana de Cáncer de Mama y de Cuello Uterino (NBCCEDP) de los CDC, están impulsando aún más las tasas de detección entre las poblaciones marginadas.
• Además, se espera que la creciente integración de la IA en los flujos de trabajo de diagnóstico, junto con las unidades de detección móviles en áreas rurales y remotas, mejore la detección temprana e impulse la expansión continua del mercado en los EE. UU.

Cuota de mercado de dispositivos de mamografía

El panorama competitivo del mercado proporciona detalles por competidor. Se incluye información general de la empresa, sus estados financieros, ingresos generados, potencial de mercado, inversión en investigación y desarrollo, nuevas iniciativas de mercado, presencia en Norteamérica, plantas de producción, capacidad de producción, fortalezas y debilidades de la empresa, lanzamiento de productos, alcance y variedad de productos, y dominio de las aplicaciones. Los datos anteriores se refieren únicamente al enfoque de mercado de las empresas.

Los principales líderes del mercado que operan en el mercado son:

• Hologic, Inc. (Estados Unidos)
• GE HealthCare Technologies Inc. (Estados Unidos)
• Siemens Healthineers AG (Alemania)
• FUJIFILM Holdings Corporation (Japón)
• Koninklijke Philips NV (Países Bajos)
• Canon Medical Systems Corporation (Japón)
• Planmed Oy (Finlandia)
• Metaltronica SpA (Italia)
• IMS Giotto SpA (Italia)
• Analogic Corporation (Estados Unidos)

Últimos avances en el mercado de dispositivos de mamografía en América del Norte

• En mayo de 2023, TGH Imaging mejoró el acceso de las pacientes a la detección del cáncer de mama con la introducción de los exámenes de mamografía 3D Genius de Hologic en 18 centros de los condados de Pasco, Hillsborough, Pinellas y Palm Beach. También conocida como tomosíntesis, la mamografía 3D genera una imagen tridimensional de la mama, lo que mejora la detección del cáncer de mama.
• En junio de 2023, el Hospital Amrita implementó un nuevo sistema de mamografía con contraste que detecta el cáncer de mama antes de que sea visible en las mamografías estándar. Este sistema cuenta con autoestabilización, lo que mejora la usabilidad, reduce el tiempo de examen y aumenta la comodidad del paciente. Sus capacidades de imagen 3D con contraste proporcionan imágenes de alta resolución que pueden identificar incluso las anomalías más pequeñas. 

SKU-1434