Automated Whole-Breast Ultrasound Market to Expand at 16.1% CAGR by 2033

Trishita Deb
Trishita Deb

Updated · Feb 10, 2025

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Introduction

The Automated Whole-Breast Ultrasound (AWBU) Market is projected to grow significantly, reaching USD 10.7 billion by 2033 from USD 2.4 billion in 2023, with a CAGR of 16.1% (2024-2033). The rising need for early breast cancer detection is a key driver of this market expansion. Traditional mammography has limitations, especially in detecting cancer in women with dense breast tissue. AWBU serves as a complementary imaging tool, improving detection rates and making it a preferred option in screening programs worldwide.

Technological advancements are playing a crucial role in expanding the AWBU market. High-resolution imaging enables better detection and more accurate diagnoses, boosting confidence among healthcare professionals. The integration of artificial intelligence (AI) in breast imaging has further improved diagnostic accuracy. AI-based automated detection systems help identify abnormalities quickly, increasing efficiency and reliability in screenings. These technological improvements drive the adoption of AWBU systems in hospitals and diagnostic centers.

Support from health organizations and regulatory bodies has also contributed to market growth. The World Health Organization (WHO) promotes the use of advanced imaging technologies to improve breast cancer detection. In addition, the U.S. Food and Drug Administration (FDA) has acknowledged automated imaging techniques for their role in preventive healthcare. Regulatory approvals encourage wider adoption of AWBU in clinical settings, ensuring more women have access to effective cancer screening solutions.

Another factor fueling market expansion is patient comfort and acceptance. Unlike traditional mammography, AWBU procedures do not require breast compression, making them less painful and more comfortable. This improved patient experience encourages higher participation rates in breast cancer screening programs. Increased awareness and accessibility to non-invasive screening options further drive the demand for AWBU systems globally.

In summary, the AWBU market is growing due to increased demand for early breast cancer detection, technological advancements, and strong regulatory support. The integration of AI, improved imaging quality, and enhanced patient comfort are key factors driving wider adoption in healthcare settings. With these advancements, AWBU is set to become a leading solution for breast cancer screening in the coming years.

Automated Whole-Breast Ultrasound Market Size

Key Takeaways

  • Market Expansion: The global Automated Whole-Breast Ultrasound market is set to reach USD 10.7 billion by 2033, growing at a 16.1% CAGR from 2024.
  • Product Leadership: Automated Breast Ultrasound Systems (ABUS) dominated in 2023, capturing over 61% market share due to rising demand for efficient breast cancer screening solutions.
  • Application Trends: The Evaluation segment led applications in 2023, securing more than 49% share, driven by increasing adoption for precise breast cancer detection and diagnosis.
  • End-User Share: Hospitals dominated the market in 2023, holding over 52% share, attributed to high patient inflow and advanced diagnostic infrastructure.
  • Regional Dominance: North America led with a 45.8% share in 2023, valued at USD 1.1 billion, fueled by advanced healthcare systems and rising breast cancer cases.

Emerging Trends

  • AI Integration in Breast Cancer Detection: Artificial Intelligence (AI) is transforming AWBU by improving breast cancer detection. The UK’s National Health Service (NHS) has launched an £11 million trial to test AI’s effectiveness in screening nearly 700,000 women. AI compares new scans with past images, identifying abnormalities earlier. This speeds up diagnosis and enhances accuracy. AI also reduces the workload on radiologists, allowing one specialist to handle more cases. With improved early detection, AI in AWBU has the potential to spot cancers in their early stages, increasing survival rates. The integration of AI makes screening more efficient and helps detect cancers missed by traditional mammography.
  • Improved Detection Rates with AWBU: AWBU significantly enhances cancer detection, especially for women with dense breast tissue. Traditional mammograms struggle to differentiate between dense tissue and tumors, leading to missed diagnoses. Studies show that combining AWBU with mammography increases detection rates. In a study of 4,419 women, AWBU detected 3.6 additional cancers per 1,000 women screened. The sensitivity of AWBU alone was 67%, much higher than the 40% seen with mammography alone. When both methods were combined, sensitivity reached 81%. This demonstrates that AWBU is a powerful tool in early breast cancer detection, ensuring more women receive timely treatment and better outcomes.
  • Standardization and Faster Screening Process: AWBU provides a standardized examination process, improving efficiency and reliability in breast cancer screening. Unlike traditional ultrasound, which depends on an operator’s skill, AWBU ensures consistent image quality. This reduces variability in cancer detection. Standardization also helps streamline workflows, cutting down examination time. Faster screening means more women can be tested in less time, reducing long wait periods. The improved workflow benefits both patients and healthcare providers. With its ability to enhance accuracy and efficiency, AWBU is becoming a key component in breast cancer screening, particularly for women with dense breast tissue.

Use Cases

  • Screening in Dense Breast Tissue: AWBU is highly effective for women with dense breast tissue, where traditional mammograms may not be enough. Dense tissue can make it harder to detect small tumors, increasing the risk of missed diagnoses. AWBU creates detailed 3D images, allowing doctors to see through dense areas more clearly. This improves the detection of small, invasive cancers that might go unnoticed with mammography alone. By offering a clearer view of breast tissue, AWBU enhances early detection, which is key to successful treatment. Women with dense breasts can benefit from this advanced screening method to ensure more accurate results.
  • Supplemental Screening Tool: When combined with mammography, AWBU significantly improves cancer detection rates. A large study of 6,425 screenings showed that AWBU increased breast cancer detection from 3.6 to 7.2 per 1,000 women. This means more cases were caught early, improving patient outcomes. Notably, the number of detected invasive cancers measuring 10 mm or smaller tripled, rising from 7 to 21 cases. These findings highlight AWBU’s importance as a supplemental screening tool. Women at higher risk or with dense breast tissue can benefit from this added layer of detection. Early detection saves lives, making AWBU a valuable addition to routine breast exams.
  • Improved Detection of Small Invasive Cancers: Adding AWBU to standard breast screening helps detect more small invasive cancers. Research shows that 67% of invasive cancers smaller than 10 mm were only found with the use of AWBU. This is crucial because smaller tumors are easier to treat and have better survival rates. AWBU’s ability to provide high-resolution images enhances its effectiveness in finding cancers that mammography alone might miss. Women undergoing breast cancer screening, especially those at higher risk, can benefit from this improved detection capability. By increasing early diagnosis rates, AWBU plays a key role in better treatment outcomes.

Regional Analysis

In 2023, North America dominated the Automated Whole-Breast Ultrasound (AWBU) market with a 45.8% share, valued at USD 1.1 billion. This dominance is due to advanced healthcare infrastructure and high adoption of innovative medical technologies. Additionally, growing awareness about breast cancer screening has increased the demand for AWBU systems. The region’s strong focus on early disease detection further fuels market growth. These factors collectively establish North America as a key player in the global AWBU market.

The presence of leading market players has significantly contributed to North America’s AWBU market expansion. Companies are investing heavily in research and development to enhance imaging technologies and improve diagnostic accuracy. Favorable reimbursement policies also support the widespread adoption of AWBU systems. Government initiatives promoting early breast cancer detection further drive market penetration. These factors ensure a steady demand for AWBU technologies, strengthening North America’s market position in the coming years.

A well-regulated medical device framework in North America ensures the safety and efficacy of AWBU technologies. Stringent regulatory approvals build consumer confidence and encourage healthcare providers to integrate AWBU into routine screenings. The availability of technologically advanced ultrasound systems enhances patient outcomes and diagnostic precision. Additionally, strategic collaborations between healthcare institutions and industry players further accelerate market adoption. These elements create a favorable environment for sustained growth in the AWBU sector.

North America is expected to maintain its market dominance in the future due to continuous technological advancements and rising healthcare expenditures. Preventive healthcare measures are gaining traction, further increasing AWBU adoption. However, cost-effectiveness and accessibility remain critical challenges for market players. Companies must navigate evolving regulatory requirements while ensuring affordable solutions for broader adoption. Addressing these concerns will be essential for sustaining long-term growth in the competitive AWBU market landscape.

Key Players Analysis

Hitachi Ltd.

Hitachi Ltd. has developed the SOFIA™ 3D breast ultrasound system to improve breast cancer detection, especially in women with dense breast tissue. This system performs a fully automated scan in approximately 30 seconds per breast, allowing for bilateral exams to be scheduled in 10-minute intervals. Patients lie face down during the scan, which enhances comfort and privacy. The SOFIA system provides high-resolution 3D images, aiding in the identification of breast abnormalities. Its design also allows for efficient integration into existing medical practices, as it does not require a dedicated room and can be used for various diagnostic procedures.

Siemens Healthcare Gmbh

Siemens Healthcare GmbH has developed the ACUSON S2000™ Automated Breast Volume Scanner (ABVS), a system that automatically captures detailed 3D images of the breast. This technology enhances early detection of breast cancer, especially in women with dense breast tissue. The ABVS provides standardized, reproducible images, improving diagnostic accuracy and streamlining workflows. Its unique coronal view offers a comprehensive perspective of breast anatomy, aiding in better assessment and surgical planning. By integrating advanced imaging techniques, Siemens aims to improve patient outcomes in breast cancer care.

Canon Medical Systems Corporation

Canon Medical Systems Corporation is a key player in the automated whole-breast ultrasound sector. Their Aplio a-series integrates advanced imaging technologies and intuitive controls, aiding clinicians in detailed breast examinations. Features like Automatic Tissue Specific Optimization (TSO) adjust settings with a single touch to enhance image clarity across different tissue types. Additionally, Superb Micro Vascular Imaging (SMI) improves the visualization of blood flow, assisting in the diagnosis of breast lesions. These innovations contribute to more accurate and efficient breast cancer detection.

General Electric Company

General Electric’s healthcare division has developed the Invenia™ ABUS 2.0, an automated breast ultrasound system designed to detect cancer in dense breast tissue. When used alongside mammography, this system increases cancer detection sensitivity by 57%. The Invenia ABUS 2.0 provides a comprehensive 3D view of the breast, allowing for a complete review in approximately 3 minutes. This technology offers standardized workflows and intelligent imaging algorithms, ensuring exceptional image quality and reproducibility across different operators.

Koninklijke Philips N.V.

Koninklijke Philips N.V. has developed advanced solutions in automated whole-breast ultrasound to enhance breast cancer detection. Their AI Breast system integrates with ultrasound machines like the EPIQ and Affiniti series, offering features such as real-time transducer tracking and automatic image annotation. This integration aims to improve workflow efficiency and diagnostic accuracy. Additionally, Philips’ collaboration with SonoCiné Inc. has led to the incorporation of automated whole-breast ultrasound imaging into their systems, providing comprehensive breast assessments.

Hologic Inc.

Hologic Inc. has developed the SuperSonic™ MACH™ ultrasound system, which offers high-resolution imaging and ShearWave™ PLUS elastography. This system includes a 3D breast application that provides unique visualizations of breast anatomy and detailed characterization of lesions. The system is equipped with a volumetric transducer that rapidly acquires 3D volumes of the breast. The 3D imaging capability enhances diagnostic certainty by providing detailed views of breast tissue, which is particularly beneficial for patients with dense breasts.

Conclusion

The Automated Whole-Breast Ultrasound (AWBU) market is growing rapidly due to rising demand for early breast cancer detection. Traditional mammography has limitations, especially for women with dense breast tissue. AWBU offers a reliable screening method, improving detection rates and enhancing diagnostic accuracy. Technological advancements, including AI integration and high-resolution imaging, are increasing its adoption in hospitals and diagnostic centers. Regulatory support and favorable healthcare policies further drive market expansion. The comfort and efficiency of AWBU make it a preferred choice for both patients and healthcare providers. With continuous innovations and wider acceptance, AWBU is set to play a key role in improving breast cancer screening and diagnosis globally.

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Trishita Deb

Trishita Deb

Trishita has more than 8+ years of experience in market research and consulting industry. She has worked in various domains including healthcare, consumer goods, and materials. Her expertise lies majorly in healthcare and has worked on more than 400 healthcare reports throughout her career.

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