The global ultrasound devices market size was valued at USD 11.12 billion in 2025 and is projected to grow from USD 11.73 billion in 2026 to USD 18.00 billion by 2034, registering a CAGR of 5.5% during the forecast period (2026–2034). North America dominated the ultrasound devices market with a share of 37.6% in 2025.
The ultrasound devices market is classified under HSN Code 90181200 (ultrasonic scanning apparatus), covering diagnostic ultrasound equipment used for medical imaging, and SIC Code 3845 (electromedical and electrotherapeutic apparatus), which includes the manufacturing of ultrasound systems and other medical diagnostic devices used in hospitals, clinics, and healthcare facilities.
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Automated Fetal Biometry Is Streamlining Prenatal Examinations
The ultrasound devices market analysis shows that the need for consistent and efficient prenatal assessments is encouraging healthcare providers to adopt automated fetal biometry tools that measure fetal structures from ultrasound images. For example, AI-enabled ultrasound systems can automatically identify standard fetal anatomical planes and estimate measurements such as head circumference, abdominal circumference, and femur length. This development reduces manual measurement workload, supports consistent examination workflows, and helps healthcare professionals assess fetal growth during routine prenatal care.
Therapeutic Ultrasound Is Expanding Beyond Diagnostic Imaging
The demand for non-invasive treatment options is encouraging the use of therapeutic ultrasound technologies for applications such as focused ultrasound ablation, pain management, and targeted tissue treatment. For example, focused ultrasound systems use concentrated acoustic energy to treat selected tissues, and the FDA has approved focused ultrasound technology for certain conditions, including essential tremor. This development expands ultrasound applications beyond imaging, supports less invasive treatment approaches, and creates opportunities for specialized therapeutic devices across healthcare settings.
Chronic Disease Burden Increases Ultrasound Demand and Drives Market
The increasing prevalence of chronic conditions such as cardiovascular disease, liver disorders, and kidney disease supports demand for ultrasound examinations. Regular disease monitoring encourages healthcare providers to use ultrasound systems for assessing organ function and tracking changes without ionizing radiation. This need increases procurement of diagnostic ultrasound equipment across hospitals, specialty clinics, and outpatient centers. For instance, echocardiography systems help clinicians assess heart structure and function in patients with cardiovascular conditions.
Point-of-Care Healthcare Expansion Is Increasing Demand for Portable Ultrasound Devices The expansion of point-of-care healthcare increases demand for portable ultrasound devices that provide rapid imaging near the patient. Emergency departments, intensive care units, and remote clinics require compact equipment to support timely clinical decisions without transferring patients to imaging departments. This demand encourages manufacturers to supply lightweight ultrasound systems suited to bedside examinations and mobile healthcare services. For instance, emergency physicians use handheld ultrasound devices to assess internal bleeding, fluid accumulation, and cardiac function during initial patient evaluation.
High Acquisition, Maintenance, and Repair Costs of Ultrasound Equipment Restrain Market Expansion.
High acquisition costs of advanced ultrasound systems, particularly 3D/4D and high-resolution imaging equipment, create financial barriers for hospitals and diagnostic centers. Limited budgets and high upfront investments can delay equipment upgrades and prevent smaller healthcare facilities from adopting advanced systems. These affordability constraints slow technology adoption and limit the expansion of ultrasound services in resource-constrained settings.
High maintenance and repair costs increase the total cost of ownership for ultrasound devices, especially systems with advanced imaging features and specialized components. Regular servicing, probe replacement, software updates, and technical support add recurring expenses for healthcare providers. These costs can delay equipment replacement, reduce investment in newer technologies, and restrict adoption among smaller clinics and diagnostic facilities.
Integration With Surgical Navigation Systems and Expansion in Emergency and Trauma Care Offer Growth Opportunities.
Medical imaging manufacturers, surgical equipment developers, and hospital technology providers can integrate ultrasound imaging with navigation systems to help surgeons visualize internal structures during procedures. Revenue opportunities include integrated system sales, software licensing, and hospital procurement contracts for image-guided surgery. Companies such as Medtronic and GE HealthCare operate in surgical navigation and medical imaging, respectively, creating potential opportunities for technology integration.
Ultrasound equipment manufacturers, emergency care providers, and hospital suppliers can expand the use of portable ultrasound systems for rapid bedside assessment of internal bleeding, cardiac function, and traumatic injuries. Revenue avenues include portable device sales, emergency department equipment contracts, and training services for point-of-care ultrasound use. Companies such as FUJIFILM Sonosite and Philips offer ultrasound systems suited to emergency and critical care settings.
The diagnostic ultrasound systems segment accounted for a share of 31.4% in 2025, supported by its widespread use in routine examinations, disease assessment, and real-time internal imaging. Its role in abdominal, obstetric, and general diagnostic procedures supports its leading position.
The high-intensity focused ultrasound (HIFU) segment is expected to grow at a CAGR of 8.26% during the forecast period, driven by interest in non-invasive treatment approaches that use focused ultrasound energy for targeted therapeutic applications.
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The color ultrasound devices segment is expected to grow at a CAGR of 7.04% during the forecast period, supported by demand for detailed imaging and color Doppler capabilities that help clinicians assess blood flow and vascular conditions.
The black & white (B/W) ultrasound devices segment is expected to grow at a CAGR of 4.96% during the forecast period, supported by demand for affordable imaging equipment in healthcare facilities that require basic diagnostic examinations and cost-effective ultrasound solutions.
The trolley/cart-based ultrasound devices segment is expected to grow at a CAGR of 6.18% during the forecast period, supported by continued use in hospitals and imaging departments that require advanced imaging capabilities and comprehensive examination workflows.
The compact/handheld ultrasound devices segment is expected to grow at a CAGR of 8.31% during the forecast period, driven by demand for point-of-care imaging, bedside examinations, emergency assessments, and portable diagnostic solutions.
The radiology/general imaging segment accounted for a share of 29.5% in 2025, supported by the use of ultrasound for examining abdominal organs, soft tissues, and other structures during routine diagnostic assessments. Its versatility across clinical departments supports demand.
The cardiology segment is expected to grow at a CAGR of 7.21% during the forecast period, driven by demand for echocardiography to assess heart structure, pumping function, and blood flow.
The direct tenders segment accounted for a share of 52.8% in 2025, supported by procurement practices in which hospitals and public healthcare organizations purchase ultrasound equipment through formal tendering processes. These purchases allow buyers to evaluate technical specifications, costs, and service agreements.
The third party distribution segment is expected to grow at a CAGR of 7.14% during the forecast period, driven by distributors' ability to expand geographic reach, improve equipment availability, and provide local installation, maintenance, and technical support.
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The north america region accounted for the largest regional share of 37.6%, supported by advanced diagnostic imaging infrastructure, established healthcare systems, and growing use of ultrasound in hospital, emergency, and point-of-care settings.
The u.s. continues to advance diagnostic imaging through new ultrasound system clearances and improvements in portable imaging technology. In 2026, the food and drug administration cleared multiple ultrasound systems, including the Sonosite iLOOK system in march and the Voluson Expert 18, 20, and 22 systems in october, supporting the availability of diagnostic imaging equipment for clinical applications.
Canada is strengthening ultrasound device safety and regulatory oversight through health canada's updated industry notice issued on january 19, 2026. The notice provides manufacturers with guidance for class iii and class iv diagnostic ultrasound systems and transducers, including acceptable acoustic output levels and considerations for device licensing, supporting the safe introduction of advanced imaging equipment.
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The europe region is expected to grow at a CAGR of 7.65% during the forecast period, showcasing the fastest-growing regional market. Growth is supported by expanding diagnostic imaging capabilities, regulatory improvements, and continued demand for advanced ultrasound systems across hospitals and outpatient facilities.
The u.k. is expanding diagnostic imaging capacity through national health service initiatives aimed at improving access to diagnostic tests and reducing waiting times. In 2026, the government reaffirmed its commitment to increasing diagnostic capacity, including ultrasound services, supporting demand for imaging equipment across hospitals and diagnostic centres.
Germany benefits from an established medical technology industry and continued adoption of advanced diagnostic imaging equipment. In 2026, the european union made four modules of its european database on medical devices mandatory from may 28, strengthening device registration, certification transparency, and market surveillance for medical devices supplied across germany and other member states.
France supports the availability and monitoring of medical imaging equipment through european union medical device regulations. In 2026, the implementation of mandatory european database modules covering device registration, certificates, and market surveillance strengthened regulatory transparency, supporting healthcare providers and manufacturers involved in diagnostic ultrasound systems.
The asia pacific region held a share of 24.8% and is projected to register a CAGR of 7.28% during the forecast period, supported by expanding healthcare infrastructure, growing access to diagnostic imaging, and investment in domestic medical device manufacturing.
Japan continues to invest in diagnostic imaging equipment to support clinical services and hospital modernisation. In july 2026, the national hospital organisation in kanagawa issued a procurement notice for one set of ultrasound diagnostic imaging equipment for sagamihara hospital, demonstrating continued institutional demand for diagnostic ultrasound systems.
China is strengthening medical device manufacturing standards through revised good manufacturing practice requirements scheduled to take effect on november 1, 2026. The updated framework reinforces quality management and risk control throughout the medical device lifecycle, supporting the production of reliable ultrasound equipment and other diagnostic imaging technologies.
India is expanding domestic medical device manufacturing through the production-linked incentive scheme for medical devices, which has an outlay of ₹3,420 crore. In july 2026, the government reported that 27 projects had been approved under the scheme and that actual investment had reached ₹1,153.07 crore, with domestic production including ultrasound equipment, supporting local supply capabilities for diagnostic imaging systems.
The ultrasound devices market competitive landscape is moderately consolidated, with competition comprising multinational medical imaging manufacturers, diagnostic equipment suppliers, and specialized ultrasound technology developers. Key players such as General Electric Company, Koninklijke Philips N.V., and Siemens Healthineers collectively are estimated to account for approximately 40–50% of the global ultrasound devices market share.
Established players compete primarily on imaging accuracy, product reliability, technological innovation, clinical applications, regulatory compliance, and global distribution networks. Emerging and specialized players in the ultrasound devices market ecosystem compete through portable and handheld systems, affordable imaging solutions, artificial intelligence integration, point-of-care diagnostics, and application-specific technologies that improve accessibility and diagnostic efficiency across healthcare settings.
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Author's Details
Senior Research Associate
Dhanshee Bhapkar is a healthcare research professional with 4+ years of experience in market intelligence, specializing in market analysis, secondary research, market estimation, and forecasting across the pharmaceutical, biopharmaceutical, and medical device sectors. She provides actionable insights into market dynamics, competitive intelligence, industry trends, and growth opportunities to support strategic business decision-making.
Her expertise includes assessing market size, growth potential, and revenue opportunities through structured market estimation and forecasting methodologies, including top-down, bottom-up, and epidemiology (EPI)-based approaches. She has hands-on experience analyzing disease epidemiology, treatment landscapes, market trends, competitive scenarios, and industry developments to develop robust market forecasts.
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