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Tomosynthesis Market Size, Share, and Industry Analysis, By Product (2D/3D Combination Systems and Standalone 3D Systems), By Application (Oncology, Orthopedics, and Others), By End-user (Hospitals & Clinics, Diagnostic Imaging Centers, and Others), and Regional Forecast, 2026-2034

Last Updated: January 26, 2026 | Format: | Report ID: FBI114818

 

Tomosynthesis Market Overview

The tomosynthesis market is witnessing significant growth due to the continuous improvements in imaging technology that enhance the accuracy and efficiency of tomosynthesis. These advancements are making it more appealing to healthcare providers, thereby increasing its adoption and driving market growth.

  • For instance, according to data from the NCBI in June 2022, 81.0% of the U.S. breast imaging facilities had digital breast tomosynthesis (DBT) as of January 2022.

Tomosynthesis is a medical imaging technique that combines elements of tomography and synthesis to create detailed images of specific body parts. It is particularly noted for its use in breast imaging, which is referred to as digital breast tomosynthesis (DBT) or 3D mammography. 

The regions with well-developed healthcare systems are expected to support the adoption of advanced diagnostic technologies, such as tomosynthesis, which is also projected to boost the market growth.

Tomosynthesis Market Driver

Increasing Incidence of Breast Cancer Boosts Market Growth

The increasing incidence of breast cancer globally is driving the demand for effective diagnostic tools, such as tomosynthesis. This advanced technology enhances detection and treatment capabilities by providing clearer images, particularly in dense breast tissue, than standard mammograms. Such a scenario is increasing tomosynthesis usage among healthcare providers to identify abnormalities, improve patient outcomes, and support early intervention strategies, which is expected to boost market growth.

  • For instance, according to the data published by Breastcancer.org, in February 2025, it is estimated that around 316,950 women will be diagnosed with invasive breast cancer 2025 in the U.S., while an additional 59,080 cases of ductal carcinoma in situ (DCIS), a non-invasive form, are expected to occur in the country.

Estimated New Cases of Breast Cancer in the U.S. Key States, 2025

 

According to the American Cancer Society Report 2025, the U.S. is projected to register 316,950 new breast cancer cases in 2025, with California accounting for the highest cases.

Tomosynthesis Market Restraint

Shortage of Skilled Professionals May Hinder Market Growth

Despite the high demand for tomosynthesis imaging, the dearth of skilled professionals globally is anticipated to hinder market growth during the forecast period. The operation of tomosynthesis equipment requires skilled radiologists or lab technicians. A shortage of these professionals can limit the effective use of such technology, thereby declining or delaying the procedures.

  • For instance, in December 2022, the MICA released data published by the Association of American Medical Colleges (AAMC), indicating a shortfall of nearly 42,000 radiologists and other clinical specialists in the U.S. by 2033.

Tomosynthesis Market Opportunity

Emerging Applications of Tomosynthesis May Spur Market Expansion

In recent years, there has been an increase in applications of tomosynthesis beyond breast cancer detection. The rising cases of rheumatoid arthritis and other musculoskeletal conditions are driving demand for such advanced diagnostic tools and providing the opportunity for prominent players to introduce new products. This may offer the potential for growth in diverse medical specialties and spur market expansion in the coming years.

  • For instance, in December 2024, Nano-X Imaging Ltd. received 510(k) clearance from the FDA for its Nanox.ARC, a stationary X-ray system to produce tomographic images for general use, including human musculoskeletal system, paranasal sinus indications, pulmonary, and intra-abdominal. This system uses high voltage-powered digital X-ray tubes for 3D tomosynthesis imaging.

Key Insights

The report covers the following key insights:

  • Prevalence/Incidence of Breast Cancer, By Key Countries/Region, 2024
  • Technological Advancements in Tomosynthesis
  • Key Industry Developments – (Mergers, Acquisitions & Partnerships, etc.)
  • New Product Launch/Approvals, By Key Players
  • Impact of COVID-19 on the Market

Segmentation

By Product  By Application By End-user By Region
  • 2D/3D Combination Systems
  • Standalone 3D Systems
  • Oncology
  • Orthopedics
  • Others
  • Hospitals & Clinics
  • Diagnostic Imaging Centers
  • Others
  • North America (U.S. and Canada)
  • Europe (U.K., Germany, France, Spain, Italy, Scandinavia, and Rest of Europe)
  • Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)
  • Latin America (Brazil, Mexico, and Rest of Latin America)
  • Middle East & Africa (South Africa, GCC, and Rest of Middle East & Africa)

Analysis by Product

By product, the market is divided into 2D/3D combination systems and standalone 3D Systems.

The standalone 3D systems segment is expected to grow at a substantial rate during the forecast period. This growth can be attributed to the high preference for standalone 3D systems owing to several benefits, such as better visualization, improved cancer detection, and reduced unnecessary follow-up tests.

  • For instance, as per the news by NPR in September 2024, a new study demonstrated that 3D imaging detected potentially serious cancers earlier, reducing the need for callback for further screening.

Analysis by Application

By application, the market is divided into oncology, orthopedics, and others.

The oncology segment is expected to expand at a significant CAGR during the forecast period. The growth can be attributed to the high burden of breast cancer globally, which is driving the demand for effective diagnostic solutions, such as tomosynthesis imaging, for breast cancer screening.

  • For instance, according to the World Health Organization (WHO) report 2024, there were 2.3 million women diagnosed with breast cancer globally.

Analysis by End-user

By end-user, the market is divided into hospitals & clinics, diagnostic imaging centers, and others.

The diagnostic imaging center segment is expected to grow at a significant CAGR in the coming years. The growth can be attributed to the increasing number of diagnostic imaging centers, including freestanding outpatient diagnostic imaging centers globally, which is contributing to the high volume of breast cancer screening, and the diagnosis of musculoskeletal conditions.

  • For instance, according to the 2021 annual report of Akumin, Inc., there were more than 6,000 freestanding outpatient diagnostic imaging centers in the U.S.

Regional Analysis

By region, the market is divided into North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America.

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North America accounted for the largest share of the global tomosynthesis market in 2024. The growth is attributed to the high recommendation of breast mammography screening by the region’s healthcare organizations and authorities. This is encouraging the prominent companies to launch more tomosynthesis systems in the region.

  • For instance, as of 2025, the American Cancer Society recommends that women have the option to start annual breast cancer screenings between the ages of 40 and 44. Regular mammography screenings should begin at age 45. For women between 45 and 54, annual screenings are recommended.

Europe is expected to witness substantial growth during the forecast period. The growth is attributed to the strong presence of major companies ensuring the high availability of tomosynthesis equipment and well-organized healthcare infrastructure in the region. Moreover, the increasing significance of tomosynthesis in musculoskeletal diagnosis in the region is also anticipated to boost the market growth.

Asia Pacific is expected to grow significantly in the coming years. The region’s growth can be attributed to the growing awareness of early disease detection and government initiatives promoting breast cancer screening programs, which is expected to fuel the demand for tomosynthesis equipment.

Key Players Covered

The global tomosynthesis market is fragmented, with a large number of companies offering advanced tomosynthesis equipment. Moreover, the focus of key players on new launches is expected to support their revenue growth.

The report includes the profiles of the following key players:

  • Hologic, Inc. (U.S.)
  • FUJIFILM Corporation (Japan)
  • Siemens Healthineers AG (Germany)
  • GE HealthCare (U.S.)
  • PerkinElmer (U.S.)
  • CANON MEDICAL SYSTEMS CORPORATION (Japan)
  • Analogic Corporation (U.S.)
  • Trivitron Healthcare (India)
  • PLANMED OY (Finland)

Key Industry Developments

  • In September 2024, Siemens Healthineers AG received FDA premarket approval for its Mammomat B.brilliant Mammography System, enhancing diagnostic capabilities and improving patient and technologist comfort.
  • In November 2023, Lunit Inc. received (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. This technology assisted radiologists in detecting breast cancer more accurately.


  • 2021-2034
  • 2025
  • 2021-2024
  • 180
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