마이크로 초음파 시스템 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the Micro-Ultrasound systems market size is expected to grow from USD 2.35 billion in 2025 to USD 2.53 billion in 2026 and is forecast to reach USD 3.68 billion by 2031 at 7.75% CAGR over 2026-2031.

Global Micro-Ultrasound Systems Market Trends and Insights

Increasing Adoption Of High-Resolution, Real-Time Imaging

The Micro-ultrasound systems market is supported by systems that combine 29 MHz to 70 MHz operating frequencies with real-time processing at the point of examination. This range helps clinicians visualize fine superficial anatomy during an assessment rather than waiting for a later imaging review. These systems can show microanatomical detail that previously required MRI or histopathology in selected workflows. Still, they remain designed for defined clinical indications rather than broad replacement of every imaging method. A 2026 review reported that AI-enabled models for prostate cancer detection achieved an area under the curve of up to 0.871, with 92.5% sensitivity and 68.1% specificity.

AI tools can make interpretation more consistent, reduce dependence on a small group of highly specialized users, and give hospitals a clearer basis for training clinicians across several sites. This matters in musculoskeletal and ophthalmology care, where high-resolution imaging may improve diagnostic assessment without the capital cost, scheduling requirements, or separate physical space associated with MRI. As multisite AI models move into commercial use, more referring physicians may direct suitable patients to office-based micro-ultrasound, which can reduce diagnostic delays, simplify patient movement between departments, and raise procedure volumes.

Expansion Of Targeted Prostate Biopsy Workflows

Targeted prostate biopsy is a central demand driver for the Micro-ultrasound systems market because it fits the clinical workflow that urologists already use for transrectal procedures. The OPTIMUM randomized trial included 802 biopsy-naive men across 20 centers and found that micro-ultrasound-guided biopsy was non-inferior to MRI fusion-guided biopsy for the detection of Gleason Grade Group 2 or higher prostate cancer.

A 29 MHz system allows the physician to perform targeted imaging and biopsy without a separate MRI scheduling cycle, which can remove a practical delay between a clinical concern and a diagnostic procedure. This can improve throughput where radiology departments face long queues, and it can make scheduling easier for patients who would otherwise need several appointments. Exact Imaging expanded its North American commercial team in 2026 as it built momentum with major health systems. The PRI-MUS scoring protocol, which is included in clinical guidelines, can support more consistent diagnostic performance across institutions and can give providers a common method for discussing imaging findings.

Limited Penetration Depth At Ultra-High Frequencies

Limited penetration depth restricts the Micro-ultrasound systems market in deep-tissue care settings and remains a physical constraint rather than a short-term commercial issue. Above 40 MHz, usable penetration depth falls below 10 mm to 15 mm, which limits use in deep abdominal, pelvic floor, and cardiac wall imaging, where clinicians need a view beyond superficial structures. High-frequency devices, therefore, do not directly replace MRI, CT, or conventional ultrasound in these procedures, even where the image detail at shallower depths is valuable.

Intravascular delivery can address the depth issue for lesion assessment, but it adds procedure cost, device requirements, and clinical complexity that limit use to selected high-risk cases. The European Federation of Societies for Ultrasound in Medicine and Biology noted that vascular ultrasound elastography was not recommended for routine clinical decision-making. Signal-processing methods such as compounding and coherent plane-wave imaging can partly improve the trade-off at 15 MHz to 30 MHz. Still, they do not remove the structural limit on deep-tissue imaging or open every conventional ultrasound application to micro-ultrasound.

Other drivers and restraints analyzed in the detailed report include:

1. Growth Of Preclinical And Translational Imaging Research
2. CMUT And PMUT Miniaturization For High-Frequency Imaging
3. Clinical Evidence And Reimbursement Uncertainty Outside Urology

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

High-frequency probes and transducers held 39.31% of the micro-ultrasound systems market share in 2025. Their leading position reflects recurring procurement because transducers require replacement, and multiprobe workflows add spending beyond the original console purchase. In practice, a department can need different probes for different anatomy, patient positioning, and procedural requirements, which makes the probe portfolio important after the first system sale. Probe specialization is becoming an important competitive consideration in clinical imaging because buyers assess resolution, ease of handling, compatibility, and service support together. Kolo Medical's commercially available CMUT-based probes operate at frequencies up to 38+ MHz for high-resolution dermatology, ophthalmology, and musculoskeletal imaging. This product mix favors suppliers that can tailor probe design to individual clinical uses and help users select the right tool for a defined examination. Accessories and consumables also benefit as more preclinical imaging centers add systems and require routine supplies, positioning aids, and replacement components during long research programs.

Software platforms are forecast to grow at a 12.65% CAGR through 2031, the highest rate among product types. The Micro-ultrasound systems market size for software platforms is supported by demand for automated lesion scoring, PRI-MUS risk assessment, and MRI-fusion overlays. These functions increasingly influence system selection in competitive tenders because buyers want an imaging system that can be used consistently by different clinicians and linked to existing documentation practices. Software can help users manage operator variation and integrate images into existing clinical workflows, including review, reporting, and follow-up discussions. The Micro-ultrasound systems industry is moving toward a model where software licensing can supplement hardware revenue and support a continuing commercial relationship after installation. Higher software attachment can improve recurring revenue even when equipment unit growth is uneven, especially where providers add modules after gaining experience with a system. Suppliers that combine validated image analysis with dependable workflow support are better placed to benefit from this shift.

Cart-based systems held 35.24% of the Micro-ultrasound systems market in 2025. Their established position is tied to the computing stability and fixed-aperture arrays needed for prostate imaging and intravascular procedures. Cart-based installations are common in tertiary hospitals and academic centers that manage complex procedures, maintain dedicated imaging rooms, and can support regular use by a specialist team. They can support consistent imaging in settings where a dedicated clinical room, trained staff, and established technical support are available. These systems also suit facilities that need to connect imaging data with a wider group of clinicians and electronic records. Tabletop research systems serve a different but steady role in pharmaceutical and academic studies. FUJIFILM VisualSonics positions the Vevo F2xc as a wide-frequency research platform for cardiovascular and oncology work.

Handheld systems are forecast to grow at a 13.42% CAGR through 2031, making them the fastest-growing form factor. Portability can bring high-resolution assessment closer to the point of care and reduce the capital commitment needed for office-based adoption, particularly where a practice has limited space or a smaller equipment budget. CMUT-on-ASIC integration creates a possible path for smaller, purpose-built devices that retain useful image quality while reducing the size of the hardware platform. The opportunity that was mentioned above is particularly relevant to independent urology practices that may not be a cart-based purchase but can use a portable system within a focused diagnostic pathway. Current handheld options have not yet combined a sub-USD 10,000 price point, 29 MHz imaging capability, and a validated AI scoring protocol in one device. The Micro-ultrasound systems market may therefore see competition focus on the balance between compact design, image quality, clinical validation, and the practical demands of cleaning, storage, and data management. A portable device must still meet the reliability and workflow needs of specialist users before it can replace more established equipment in a routine setting.

Complete Report Scope:

• By Product Type
  • Imaging Consoles
  • High-Frequency Probes and Transducers
  • Software Platforms
  • Accessories and Consumables
• By Form Factor
  • Cart-Based Systems
  • Handheld Systems
  • Tabletop Research Systems
  • Others
• By Technology
  • High-Frequency Ultrasound
  • 2D Micro-Ultrasound
  • 3D and 4D Micro-Ultrasound
  • Doppler Micro-Ultrasound
  • Elastography
  • Other Technologies
• By Application
  • Urology and Prostate Imaging
  • Oncology Research
  • Cardiovascular and Intravascular Imaging
  • Ophthalmology and Anterior-Segment Imaging
  • Obstetrics and Gynecology
  • Musculoskeletal and Rheumatology Imaging
  • Neurology and Neurovascular Research
  • Other Applications
• By End User
  • Hospitals and Health Systems
  • Diagnostic Centers
  • Specialized Clinics and Ambulatory Surgery Centers
  • Academic and Research Institutions
  • Pharmaceutical and Biotechnology Companies
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 36.21% of the Micro-ultrasound systems market in 2025. The region's position is supported by established reimbursement infrastructure, leading equipment manufacturers, and an active FDA clearance environment for ultrasound devices, which can make new systems easier for providers to evaluate and procure. The United States is the largest national market because its urology community has rapidly considered the clinical evidence for micro-ultrasound-guided prostate biopsy. Canada contributes through procurement by academic medical centers and Exact Imaging's home-market presence in Toronto. Mexico remains at an earlier stage, although specialty urology clinics are building demand through distributor relationships and introducing the technology within focused prostate care services. Long MRI wait times and high procedure costs can increase the appeal of office-based micro-ultrasound for initial prostate cancer assessment, particularly where providers can perform imaging and biopsy within a coordinated local pathway.

Europe remained the second-largest regional base for the Micro-ultrasound systems market, with Germany, the United Kingdom, and France as key procurement countries. The EU Medical Device Regulation has standardized market access requirements while increasing post-market surveillance responsibilities, creating greater administrative demands for suppliers and health care providers. The United Kingdom's NHS Shared Business Services framework and Germany's IQWiG process can create different reimbursement timelines for new imaging technologies. European urology bodies have made more guideline progress for prostate biopsy than comparable Asian systems, which supports earlier adoption where providers can connect clinical guidance to payment pathways. Italy and Spain are gaining demand through oncology screening activity and private health care networks. The Nordics and the Netherlands contribute through preclinical research purchases. Philips launched the Alturion ultrasound system in July 2026 with AI-powered workflows, FDA 510(k) clearance, and a CE mark, and received FDA clearance for Elevate Plus in June 2026.

Asia-Pacific is forecast to grow at a 12.15% CAGR through 2031, the fastest regional rate. China's health care modernization is extending diagnostic infrastructure into tier-2 and tier-3 cities, where mid-tier systems can meet cost-sensitive demand and help providers offer imaging services closer to patients outside the largest metropolitan areas. India's Production Linked Incentive scheme for medical devices is building local capacity for ultrasound components and can reduce import dependence. This local manufacturing focus can also support more competitive institutional pricing when hospitals compare imported equipment with systems assembled through domestic supply chains. South Korea and Australia serve as early-adoption and reference-site markets for new releases from GE HealthCare, Philips, and Siemens. Japan's aging population remains relevant to demand for diagnostic services, although reimbursement review and clinical adoption can take time. The Middle East, Africa, and South America are earlier-stage regions, with GCC countries investing in tertiary-care imaging and Brazil building specialist oncology workflows through distribution relationships, local training, and more focused engagement with urology providers.

1. ACULAB Co., Ltd.
2. Bruker
3. Butterfly Network, Inc.
4. Canon
5. Esaote S.p.A.
6. Exact Imaging Inc.
7. FUJIFILM
8. GE HealthCare Technologies Inc.
9. Hologic
10. Kolo Medical, LLC
11. Koninklijke Philips
12. Revvity, Inc.
13. Samsung Group
14. Mindray
15. Siemens Healthineers
16. Verasonics, Inc.
17. Vermon S.A.S.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Adoption of High-Resolution, Real-Time Imaging
  • 4.2.2 Expansion of Targeted Prostate Biopsy Workflows
  • 4.2.3 Growth of Preclinical and Translational Imaging Research
  • 4.2.4 CMUT and PMUT Miniaturization for High-Frequency Imaging
  • 4.2.5 Procedure-Level Economics of MRI-Alternative Screening Pathways
• 4.3 Market Restraints
  • 4.3.1 Limited Penetration Depth at Ultra-High Frequencies
  • 4.3.2 Clinical Evidence and Reimbursement Uncertainty Outside Urology
  • 4.3.3 Shortage of Specialized Acoustic Engineering and Clinical-Applications Talent
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Imaging Consoles
  • 5.1.2 High-Frequency Probes and Transducers
  • 5.1.3 Software Platforms
  • 5.1.4 Accessories and Consumables
• 5.2 By Form Factor
  • 5.2.1 Cart-Based Systems
  • 5.2.2 Handheld Systems
  • 5.2.3 Tabletop Research Systems
  • 5.2.4 Others
• 5.3 By Technology
  • 5.3.1 High-Frequency Ultrasound
  • 5.3.2 2D Micro-Ultrasound
  • 5.3.3 3D and 4D Micro-Ultrasound
  • 5.3.4 Doppler Micro-Ultrasound
  • 5.3.5 Elastography
  • 5.3.6 Other Technologies
• 5.4 By Application
  • 5.4.1 Urology and Prostate Imaging
  • 5.4.2 Oncology Research
  • 5.4.3 Cardiovascular and Intravascular Imaging
  • 5.4.4 Ophthalmology and Anterior-Segment Imaging
  • 5.4.5 Obstetrics and Gynecology
  • 5.4.6 Musculoskeletal and Rheumatology Imaging
  • 5.4.7 Neurology and Neurovascular Research
  • 5.4.8 Other Applications
• 5.5 By End User
  • 5.5.1 Hospitals and Health Systems
  • 5.5.2 Diagnostic Centers
  • 5.5.3 Specialized Clinics and Ambulatory Surgery Centers
  • 5.5.4 Academic and Research Institutions
  • 5.5.5 Pharmaceutical and Biotechnology Companies
  • 5.5.6 Other End Users
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 ACULAB Co., Ltd.
  • 6.3.2 Bruker Corporation
  • 6.3.3 Butterfly Network, Inc.
  • 6.3.4 Canon Medical Systems Corporation
  • 6.3.5 Esaote S.p.A.
  • 6.3.6 Exact Imaging Inc.
  • 6.3.7 Fujifilm Holdings Corporation
  • 6.3.8 GE HealthCare Technologies Inc.
  • 6.3.9 Hologic, Inc.
  • 6.3.10 Kolo Medical, LLC
  • 6.3.11 Koninklijke Philips N.V.
  • 6.3.12 Revvity, Inc.
  • 6.3.13 Samsung Medison Co., Ltd.
  • 6.3.14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 6.3.15 Siemens Healthineers AG
  • 6.3.16 Verasonics, Inc.
  • 6.3.17 Vermon S.A.S.

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment