Market Overview: The global market size for Automated Breast Ultrasound Systems (ABUS) was valued at USD 1.7 billion in 2022 and is projected to reach USD 5.11 billion by 2032, with a forecasted revenue Compound Annual Growth Rate (CAGR) of 13%. The significant rise in breast cancer prevalence worldwide and the increasing demand for swift and accurate diagnosis are primary drivers fostering the growth of market revenue. Breast cancer stands as the most common cancer among women globally, as reported by the World Health Organization (WHO), with an estimated 2.3 million new cases anticipated in 2020 alone.

The surge in ABUS system utilization as a dependable screening tool, coupled with growing awareness regarding the importance of breast cancer screening, contributes substantially to market revenue growth. ABUS devices offer a more comprehensive and precise image of breast tissue compared to traditional Mammography, particularly beneficial for women with dense breast tissue. Research has shown that adopting ABUS systems enhances cancer detection rates and reduces the occurrence of false-positive findings.

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Moreover, market revenue growth is propelled by advancements in 3D imaging and the integration of artificial intelligence (AI) technology into ABUS systems. 3D imaging enhances cancer detection accuracy by providing detailed breast tissue images, while AI technology facilitates automated breast image analysis, enhancing diagnostic accuracy and reducing interpretation time and effort.

Government Regulations: The U.S. Food and Drug Administration (FDA) has approved automated breast ultrasound systems as an adjunct to mammography screening for women at high risk of developing breast cancer or with dense breast tissue that may obscure tumors on traditional mammograms. Manufacturers of ABUS systems are required by FDA regulations to furnish evidence of the safety and efficacy of their systems before marketing them in the U.S. The American College of Radiology (ACR) has established standards and guidelines for the safe utilization of ABUS systems, encompassing adequate training, qualifications, and reporting requisites. The Centers for Medicare & Medicaid Services have approved reimbursement for certain types of ABUS examinations conducted in hospitals and outpatient settings as an adjunct to mammography screening. The National Comprehensive Cancer Network (NCCN) has issued guidelines advocating for annual ABUS screenings in addition to routine mammograms for women at high risk of breast cancer or with dense breast tissue. Key Insights: Product Types Overview: The global automated breast ultrasound system market is segmented into hand-held, automated, and other categories based on product type. The automated segment is anticipated to hold the largest revenue share during the forecast period due to its numerous benefits. Automated ABUS systems are replacing traditional mammography in breast cancer screening due to their speed, precision, and effectiveness in detecting breast abnormalities. Moreover, automated ABUS systems provide clear breast tissue images, facilitating radiologists in anomaly detection and diagnosis.

Regional Overview: The North American market is expected to dominate in terms of revenue share during the forecast period, attributed to the region's increasing breast cancer incidence. Breast cancer ranks as the most common cancer among women in the U.S., with an estimated 281,550 new cases projected in 2021 alone, according to the American Cancer Society. The high prevalence of breast cancer in the region is anticipated to drive demand for ABUS technology due to its role in early detection and diagnosis. Additionally, favorable government programs and reimbursement policies for breast cancer screening are expected to fuel market revenue growth in North America.

The European market is anticipated to hold a significantly large revenue share during the forecast period. Breast cancer is the most prevalent cancer among women in Europe, with an estimated 562,500 new cases projected in 2021, according to the European Breast Cancer Coalition. Demand for ABUS technology in the region is expected to rise with the implementation of breast cancer screening programs by the European Breast Cancer Screening Network (EBCSN) across various European nations. Moreover, market revenue growth in Europe is anticipated to be driven by technological advancements and supportive governmental initiatives for breast cancer diagnosis and treatment.

Competitive Landscape: Key players in the global ABUS market include General Electric Company, Siemens Healthcare GmbH, Hitachi, Ltd., Koninklijke Philips N.V., Fujifilm Holdings Corporation, SonoCine Inc., Delphinus Medical Technologies, Inc., Hologic, Inc., and QT Ultrasound LLC.

Strategic Developments: On October 11, 2018, GE Healthcare received FDA clearance for its latest ABUS system, the Invenia ABUS 2.0, offering enhanced diagnostic accuracy and workflow efficiency compared to previous versions. On July 21, 2020, Hologic, Inc. acquired SuperSonic Imagine, a French medical imaging company, for USD 85 million, aiming to expand its product offerings in the ultrasound market, including ABUS. On June 22, 2018, Siemens Healthcare GmbH launched the ACUSON Sequoia ultrasound system, featuring advanced imaging technology and workflow efficiency, including Automated Breast Volume Scanner (ABVS) technology for improved breast cancer screening. On July 15, 2021, Fujifilm Holdings Corporation acquired Hitachi’s Diagnostic Imaging-related business, including its ABUS products, to broaden its product portfolio in the medical imaging market.

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