The global ultrasound-guided breast biopsy market is poised for significant expansion, with market size projected to grow from USD 907.0 million in 2025 to USD 1,958.1 million by 2035, at a compound annual growth rate (CAGR) of 8.0%, according to a new industry forecast. This growth underscores the rising demand for minimally invasive diagnostic procedures and technological advances in imaging systems, particularly in regions such as North America, Asia-Pacific, and Europe.
Market Drivers and Industry Trends
Breast cancer remains one of the most prevalent cancers globally, and the emphasis on early detection and preventive screening is a critical growth driver for the ultrasound-guided breast biopsy market. Unlike traditional surgical biopsies, ultrasound-guided procedures offer real-time visualization, minimal invasiveness, faster recovery, and reduced cost, making them increasingly preferred by clinicians and patients alike.
Another key trend reshaping the market is the integration of artificial intelligence (AI) into ultrasound platforms, enabling improved diagnostic accuracy and faster decision-making. Healthcare systems worldwide are also investing heavily in advanced imaging infrastructure and breast care units, further supporting biopsy adoption.
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Segmental Highlights
- By Procedure: The core needle (CN) ultrasound-guided breast biopsy segment is projected to lead with 49.6% of market share in 2025, owing to its diagnostic precision and minimal invasiveness. Clinicians favor core needle biopsies for both benign and malignant lesion evaluations, as the procedure balances efficiency with safety.
- By End User: Hospitals are expected to dominate with 52.3% market share in 2025, driven by comprehensive diagnostic facilities, specialized staff, and policy-backed screening initiatives. Hospitals’ ability to integrate multidisciplinary care continues to make them the primary diagnostic hub.
- By Region:
- North America remains a growth leader, supported by high breast cancer incidence rates, robust healthcare investment, and advanced imaging adoption.
- Asia-Pacific is forecast to see rapid expansion, fueled by rising awareness campaigns, growing healthcare access, and government-supported breast cancer screening programs.
Competitive Landscape
The market is competitive, with leading players such as Hologic, Medsurge, Ethicon Endo Surgery, Leica Biosystems, Becton Dickinson Company, Cook Medical, Argon Medical Devices, and Galini actively expanding product portfolios. Strategic collaborations, product commercialization, and pipeline innovation are central to maintaining market leadership.
Recent industry benchmarks show that companies are increasingly focusing on cost-efficient biopsy devices and advanced needle designs, as well as integrating AI-based diagnostic insights to differentiate their offerings. Compared to other imaging-led biopsy methods, ultrasound-guided biopsy continues to gain share due to its no-radiation advantage, ease of use, and improved patient comfort.
Opportunities and Challenges
The market outlook is supported by strong growth factors such as:
- Rising global incidence of breast cancer (with the American Cancer Society estimating 287,850 new cases in 2025 in the U.S. alone).
- Growing awareness and adoption of preventive healthcare practices.
- Expansion of outpatient and day-care settings offering cost-effective biopsy services.
However, challenges persist. Procedure-related risks such as hematomas, patient discomfort, and the high cost of ultrasound systems may hinder adoption in certain regions. Nonetheless, ongoing innovation in biopsy needles, imaging systems, and AI integration is expected to offset these limitations and sustain momentum.
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Outlook Through 2035
The ultrasound-guided breast biopsy market is expected to remain on a strong growth trajectory as global healthcare systems continue to prioritize early cancer detection and patient-centered diagnostics. With hospitals and clinics ramping up investment in imaging technologies, and manufacturers focusing on AI-powered platforms, the market is positioned to become a critical component of breast health diagnostics.
Report Scope
- Market Value (2025): USD 907.0 million
- Forecast Value (2035): USD 1,958.1 million
- Growth Rate: 8.0% CAGR (2025–2035)
- Key Segments: Procedure, End User, Region
- Top Regions: North America, Asia-Pacific, Europe
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