Focused Ultrasound System Market Report 2025

The focused ultrasound system market size has grown rapidly in recent years. It will grow from $3.9 billion in 2024 to $4.33 billion in 2025 at a compound annual growth rate (CAGR) of 10.9%. The growth in the historic period can be attributed to the rising demand for non-invasive procedures, increasing prevalence of neurological disorders, expanding use of MRI guidance, growing clinical validation, and greater regulatory approvals.

The focused ultrasound system market size is expected to see rapid growth in the next few years. It will grow to $6.46 billion in 2029 at a compound annual growth rate (CAGR) of 10.5%. The growth in the forecast period can be attributed to the increasing incidence of chronic diseases, higher healthcare spending, growing preference for outpatient care, expanding oncology applications, and stronger institutional support. Key trends in the forecast period include integration of AI-driven imaging guidance, expansion of non-invasive oncology treatments, miniaturization for portable applications, development of personalized therapy protocols, and combination with drug delivery systems.

The rising number of chronic diseases is contributing to the expansion of the focused ultrasound system market. Chronic diseases are long-lasting health conditions that develop over time, persist for extended durations, and usually require continuous monitoring and care. This increase is primarily attributed to sedentary lifestyles, which heighten the risk of obesity, diabetes, and cardiovascular conditions. Focused ultrasound systems are important in managing such conditions by non-invasively targeting and destroying diseased tissue, reducing pain, and improving functionality without surgical procedures. For example, in August 2024, Macmillan Cancer Support, a UK-based organization, reported that more than 3 million people in the UK were living with cancer in 2024, with projections indicating an increase to 3.5 million by 2025, 4 million by 2030, and 5.3 million by 2040. This growing prevalence of chronic conditions is supporting the increased adoption of focused ultrasound systems.

Companies in the focused ultrasound system market are developing innovative solutions such as MR-guided focused ultrasound systems to enhance treatment effectiveness, broaden clinical usage, and improve patient care. An MR-guided focused ultrasound system is a medical device that integrates high-intensity focused ultrasound technology with magnetic resonance imaging to treat specific tissues with accuracy in a non-invasive manner. For example, in January 2024, Insightec, an Israel-based medical technology company, introduced Exablate Prime, the latest version of its MR-guided focused ultrasound system. Exablate Prime enhances non-invasive neurosurgical procedures by increasing accuracy, efficiency, and patient comfort. Notable improvements include a user-friendly interface, automated system calculations, sub-millimeter precision in targeting, real-time temperature monitoring, advanced control over lesion shape, and enhanced MRI imaging. The system also features improved cybersecurity measures, integration with imaging archiving systems, and an optional 3T head coil for higher image clarity. These features make Exablate Prime a significant advancement in the field of focused ultrasound treatment for neurological disorders.

In September 2024, Samsung Medison Co. Ltd., a South Korea-based manufacturer of medical equipment, completed the acquisition of Sonio SAS for $92.4 million. This acquisition enhanced Samsung Medison’s ultrasound product range by incorporating AI-based real-time support and quality assurance features, addressing challenges in healthcare staffing and advancing prenatal imaging technology. Sonio SAS is a France-based software company that provides ultrasound solutions integrated with artificial intelligence.

Major players in the focused ultrasound system market are Medtronic plc, Merz Pharmaceuticals GmbH, Samsung Medison Co. Ltd., InSightec Ltd., EDAP TMS S.A., Supersonic Imagine, Image Guided Therapy S.A., Chongqing Haifu Medical Technology Co.Ltd., Blatek Industries Incorporated, Shanghai A&S Technology Development Co.Ltd., Alpinion Medical Systems Co. Ltd., SonaCare Medical LLC, Lynton Lasers Ltd., Profound Medical Inc., Mianyang Sonic Electronic Ltd., Verasonics Inc., Theraclion SA, Focal One, Ultrasound Technologies Ltd., Sonic Concepts Inc.

North America was the largest region in the focused ultrasound system market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in focused ultrasound system report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the focused ultrasound system market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

A focused ultrasound system is a medical device that delivers high-frequency sound waves to a specific point in the body or a material to create a targeted effect. These systems generally include a transducer array to generate and concentrate the waves, imaging guidance to locate and track the target, and a control system to adjust parameters such as intensity, frequency, and duration. Focused ultrasound is applied in various therapeutic areas, including tumor ablation, kidney stone fragmentation, enhancing drug delivery, and temporary opening of the blood-brain barrier.

The primary components of a focused ultrasound system are devices, consumables, software, and accessories. Ultrasound devices form the main hardware used in focused ultrasound procedures, consisting of transducers, control units, and treatment consoles. System types include thermal ablation systems, mechanical ablation systems, microbubble ultrasound systems, and high-intensity focused ultrasound (HIFU) systems. Technology types include ultrasound imaging systems, non-linear ultrasound systems, thermal imaging systems, and diagnostic ultrasound systems. Key application areas cover clinical uses, uterine fibroids, prostate cancer, essential tremor, dermatology, breast cancer, glaucoma, back pain, research applications, and others. These systems are primarily utilized in hospitals, specialty clinics, ambulatory surgical centers, and other settings.

The focused ultrasound system market research report is one of a series of new reports that provides focused ultrasound system market statistics, including the focused ultrasound system industry global market size, regional shares, competitors with the focused ultrasound system market share, detailed focused ultrasound system market segments, market trends, and opportunities, and any further data you may need to thrive in the focused ultrasound system industry. This focused ultrasound system market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The focused ultrasound system market consists of sales of ultrasound devices, imaging and navigation systems, transducers, and associated software. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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