High Intensity Focused Ultrasound Therapy Market Size

ID: MRFR/MED/0383-HCR

110 Pages

Kinjoll Dey

October 2025

High Intensity Focused Ultrasound Therapy Market Research Report Information By Method (Non-Invasive Method and Minimal Invasive Method), By Application (Prostate Cancer, Uterine Fibroids, Neurological Disorders, Cosmetic Medicine, and Others), By End User (Diagnostic Centers, Hospitals, Research Centers, and Others), and By Region (North America, Europe, Asia-Pacific, and Rest Of The World) – HIFU Industry Forecast 2035

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High Intensity Focused Ultrasound Therapy Size

High Intensity Focused Ultrasound Therapy Market Growth Projections and Opportunities

Increased global usage of high-intensity focused ultrasound (HIFU) has been seen in recent years. Because they are customized and painless, more cancer patients are using high-intensity focused ultrasound (HIFU) treatments to a large extent. HIFU's longevity benefits are becoming well acknowledged all over the world. It is good for elderly patients since it doesn't harm healthy cells. Technology is increasing medical imaging usage of high-intensity focused ultrasound (HIFU). HIFU works better now since MRI and ultrasound procedures are superior. With these changes, doctors can now target tissue and keep an eye on it while it's being treated. As more individuals seek safe remedies, HIFU therapy is growing in popularity. Patients choose high-frequency ultrasound (HIFU) for cancer and uterine fibroids because it heals faster and requires fewer incisions. Prostate cancer and solid tumor specialists are using HIFU more. High-intensity focused ultrasound (HIFU) can target malignant regions without pain as an alternative or complement. Government subsidies and regulatory authorization fuel HIFU treatment. More doctors will employ this technology to improve patient health. partly because government agencies are finding HIFU safe and beneficial for many pharmaceutical needs. Around the world, the cost of health care is going up, but high-frequency ultrasound (HIFU) treatment is getting cheaper. Hospitals buy new medicines to help their patients get better, which fuels the HIFU treatment business. High-frequency ultrasound (HIFU) equipment is becoming more user-friendly and compact due to technical advances, which benefits the company. These developments have made high-frequency ultrasound (HIFU) therapies more accessible in more medical settings. Because of this, more people utilize them. High-frequency ultrasound (HIFU) therapy is being studied as a treatment for several diseases, including cancer. because of its versatility. Researchers and doctors focus on the skin, the brain, as well as the heart and as a result, the market for HIFU treatments will get bigger in the years to come. As more people learn about HIFU treatment and how well it works, the market changes. Makers and people who work in healthcare put on events for customers that teach them and help them make better decisions. This makes them trust HIFU more as an easy and effective way to help them.

High Intensity Focused Ultrasound Therapy Market Size Graph

Market Highlights

Author

Kinjoll Dey

Research Analyst Level I

He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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FAQs

What is the projected growth of the High Intensity Focused Ultrasound Therapy market?

The High Intensity Focused Ultrasound Therapy market is the expected increase in total market value of 0.62 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

What is the size of the High Intensity Focused Ultrasound Therapy market?

High Intensity Focused Ultrasound Therapy market size was valued at approximately 0.13 billion USD in 2024. This figure will reach 0.62 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

What is the CAGR of the High Intensity Focused Ultrasound Therapy market?

High Intensity Focused Ultrasound Therapy market is expected to grow at a CAGR of 15.5% between 2025 and 2035.

How much will the High Intensity Focused Ultrasound Therapy market be worth by 2035?

High Intensity Focused Ultrasound Therapy market is expected to be worth of 0.62 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

How will the High Intensity Focused Ultrasound Therapy market perform over the next 10 years?

Over the next 10 years the High Intensity Focused Ultrasound Therapy market is expected to shift from usd billion 0.13 to 0.62 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

Which region held the largest market share in the High Intensity Focused Ultrasound (HIFU) Therapy market?

North America had the largest share in the market

1. Market Overview

2. Market Trends

3. Market Segment Insights

4. Key Players and Competitive Insights

5. Industry Developments

6. Market Segmentation

7. Report Scope

8. Market Highlights

9. FAQs

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Market Summary

As per MRFR analysis, the High Intensity Focused Ultrasound Therapy Market was estimated at 127.05 USD Million in 2024. The High Intensity Focused Ultrasound Therapy industry is projected to grow from 146.75 USD Million in 2025 to 620.11 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 15.5 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The High Intensity Focused Ultrasound Therapy Market is poised for substantial growth driven by technological advancements and increasing patient demand.

Technological advancements in HIFU devices are enhancing treatment efficacy and safety.
North America remains the largest market, while Asia-Pacific is emerging as the fastest-growing region.
The tumor ablation segment dominates the market, whereas pain management is witnessing rapid growth.
Rising demand for non-invasive treatments and supportive regulatory frameworks are key drivers of market expansion.

High Intensity Focused Ultrasound Therapy Market

CAGR

15.5%

Market Size & Forecast

2024 Market Size	127.05 (USD Million)
2035 Market Size	620.11 (USD Million)
CAGR (2025 - 2035)	15.5%
Largest Regional Market Share in 2024	North America

Major Players

EDAP TMS (FR), InSightec (IL), FUS Instruments (CA), SonaCare Medical (US), HIFU Prostate Services (US), Focus Surgery (AU), Mermaid Medical (DK), Chongqing Haifu Medical Technology (CN)

Market Trends

The High Intensity Focused Ultrasound Therapy Market is currently experiencing a notable evolution, driven by advancements in technology and increasing awareness of non-invasive treatment options. This innovative therapy utilizes focused ultrasound waves to target and destroy tissue, offering a promising alternative to traditional surgical methods. As healthcare providers and patients alike seek less invasive solutions, the demand for High Intensity Focused Ultrasound Therapy is likely to grow, reflecting a shift towards more patient-centered care. Furthermore, ongoing research and clinical trials are expanding the applications of this therapy, suggesting a bright future for its integration into various medical fields. In addition to technological advancements, the High Intensity Focused Ultrasound Therapy Market is influenced by regulatory developments and the growing emphasis on personalized medicine. Regulatory bodies are increasingly recognizing the potential of this therapy, leading to more streamlined approval processes. This trend may encourage further investment in research and development, fostering innovation and enhancing treatment options. As the market continues to mature, collaboration between industry stakeholders, including medical professionals and technology developers, appears essential for maximizing the benefits of High Intensity Focused Ultrasound Therapy and ensuring its successful adoption across diverse healthcare settings.

Technological Advancements

Recent innovations in ultrasound technology are enhancing the efficacy and precision of High Intensity Focused Ultrasound Therapy. These advancements may lead to improved treatment outcomes and broaden the scope of applications, making this therapy more appealing to healthcare providers.

Regulatory Support

The evolving regulatory landscape is increasingly favorable towards High Intensity Focused Ultrasound Therapy. Streamlined approval processes and recognition of its potential benefits could facilitate market growth and encourage further research.

Patient-Centric Approaches

There is a growing trend towards personalized medicine, with High Intensity Focused Ultrasound Therapy aligning well with this movement. As patients seek less invasive treatment options, the therapy's non-invasive nature may drive its adoption in various medical fields.

High Intensity Focused Ultrasound Therapy Market Market Drivers

Technological Advancements

The Global High Intensity Focused Ultrasound Therapy Market Industry is currently experiencing rapid technological advancements that enhance treatment efficacy and patient outcomes. Innovations in ultrasound technology, such as improved imaging techniques and more precise targeting capabilities, are likely to drive market growth. For instance, the development of real-time imaging systems allows practitioners to monitor treatment progress more effectively. This not only increases the safety of procedures but also boosts patient confidence in non-invasive therapies. As a result, the market is projected to maintain a steady valuation of 0.13 USD Billion in 2024, with expectations of similar figures through 2035.

Growing Awareness and Education

The Global High Intensity Focused Ultrasound Therapy Market Industry is experiencing a surge in awareness and education regarding the benefits of ultrasound therapy. Healthcare professionals and patients alike are becoming more informed about the advantages of non-invasive treatments, leading to increased acceptance and utilization of High Intensity Focused Ultrasound Therapy Market. Educational campaigns and professional training programs are instrumental in disseminating knowledge about this technology, thereby fostering its adoption in clinical settings. As awareness continues to grow, the market is likely to see sustained interest, maintaining its valuation of 0.13 USD Billion in 2024 and beyond.

Government Initiatives and Funding

The Global High Intensity Focused Ultrasound Therapy Market Industry benefits from various government initiatives aimed at promoting advanced medical technologies. Governments across the globe are increasingly investing in healthcare infrastructure and funding research and development in non-invasive treatment options. These initiatives not only enhance the availability of High Intensity Focused Ultrasound Therapy Market but also encourage clinical trials and innovation in treatment protocols. Such support is likely to bolster market growth, as healthcare providers adopt these technologies to improve patient care. The market is expected to remain stable at a valuation of 0.13 USD Billion in 2024, reflecting the positive impact of these initiatives.

Rising Incidence of Chronic Diseases

The Global High Intensity Focused Ultrasound Therapy Market Industry is significantly influenced by the increasing prevalence of chronic diseases, such as cancer and cardiovascular disorders. As these conditions become more common, there is a corresponding rise in the demand for effective treatment modalities. High Intensity Focused Ultrasound Therapy Market has emerged as a promising option for targeting tumors and other pathological tissues with minimal side effects. The growing patient population requiring such interventions is likely to sustain market growth. Despite the challenges posed by economic fluctuations, the market is projected to maintain its valuation of 0.13 USD Billion in 2024, with a CAGR of 0.0% anticipated from 2025 to 2035.

Increasing Demand for Non-Invasive Treatments

The Global High Intensity Focused Ultrasound Therapy Market Industry is witnessing a growing preference for non-invasive treatment options among patients. This trend is largely driven by the desire to avoid the risks and recovery times associated with traditional surgical procedures. High Intensity Focused Ultrasound Therapy Market offers a compelling alternative, providing effective treatment for various conditions, including tumors and fibroids, without the need for incisions. As awareness of these benefits spreads, the market is likely to attract more patients seeking safer and less invasive options. This shift in patient preference is expected to contribute to a stable market valuation of 0.13 USD Billion in 2024.

Market Segment Insights

By Application: Tumor Ablation (Largest) vs. Pain Management (Fastest-Growing)

In the High Intensity Focused Ultrasound (HIFU) Therapy Market, the application segment is primarily dominated by tumor ablation, which commands the largest share among its peers. This segment is well-established, benefiting from a long track record of efficacy in treating various tumor types. Meanwhile, pain management is rapidly catching up as the fastest-growing application area, driven by increasing awareness and acceptance of non-invasive therapeutic options for chronic pain relief. These applications play a pivotal role in advancing HIFU technology and improving patient outcomes.

Tumor Ablation: Dominant vs. Pain Management: Emerging

Tumor ablation stands out as the dominant application in the HIFU market, primarily due to its proven success in obliterating malignant tissues with precision, thus minimizing damage to surrounding healthy structures. It offers a less invasive alternative to traditional surgical methods with shorter recovery times. Conversely, pain management is an emerging segment, showing promising growth trends as patients and practitioners alike seek adjunct therapies to manage chronic pain. The escalating incidence of conditions necessitating pain relief, combined with advancements in HIFU technology that enhance treatment efficacy, positions pain management as a key area of interest moving forward. Both applications thus highlight the versatility and adaptability of HIFU in addressing varied medical needs.

By End Use: Hospitals (Largest) vs. Ambulatory Surgical Centers (Fastest-Growing)

In the High Intensity Focused Ultrasound Therapy Market, hospitals represent the largest segment, accounting for a considerable share of the overall market. This dominance is largely due to their extensive resources, advanced technology, and ability to provide comprehensive patient care. On the other hand, ambulatory surgical centers are emerging as a notable segment, benefiting from the rising demand for outpatient procedures that require less complex care strategies, thus expanding their market presence. Growth in the ambulatory surgical centers segment is particularly significant as more patients prefer outpatient treatment options, which are often associated with quicker recovery times and lower costs. This shift in preference is fueled by advancements in technology that enhance the safety and efficacy of ultrasound therapies. Furthermore, increasing regulatory support and the growth of minimally invasive surgical techniques are substantial drivers for this segment’s expansion in the coming years.

Hospitals (Dominant) vs. Research Institutions (Emerging)

Hospitals are currently the dominant force in the High Intensity Focused Ultrasound Therapy Market, utilizing the technology for a wide range of therapeutic applications. They have the advantage of established infrastructure and a multidisciplinary approach, which facilitates comprehensive treatment options for patients. In contrast, research institutions are an emerging segment largely focused on innovation and development of new applications for ultrasound technology. They are crucial for advancing clinical research and pushing the boundaries of current treatment methodologies. Research institutions are increasingly collaborating with hospitals to translate their findings into practical applications, thereby improving treatment efficacy and patient outcomes. As they continue to secure funding and forge partnerships, their role in shaping the future of this market will become increasingly vital.

By Technology: Ultrasound Imaging (Largest) vs. Focused Ultrasound Surgery (Fastest-Growing)

The High Intensity Focused Ultrasound Therapy Market is characterized by a diverse range of technologies, with Ultrasound Imaging holding a dominant position among the segment values due to its widespread applicability and crucial role in diagnostics. This segment is critical for accurate treatment delivery and has garnered significant market share, attributed to advancements in imaging technology that enhance precision and efficacy. In contrast, Focused Ultrasound Surgery is emerging rapidly, recognized for its innovative approach in treating various conditions non-invasively. Its growing adoption signifies a shift towards more patient-friendly options, contributing to its rapid ascension in market share.

Technology: Ultrasound Imaging (Dominant) vs. Focused Ultrasound Surgery (Emerging)

Ultrasound Imaging, as the dominant segment in the High Intensity Focused Ultrasound Therapy Market, stands out for its essential role in guiding treatments with enhanced accuracy and visualization. The increasing preference for non-invasive procedures has led to greater investment in imaging technologies, which play a vital part in treatment planning and monitoring. On the other hand, Focused Ultrasound Surgery represents an emerging segment that is gaining traction owing to its capability to treat tumors and other conditions without the need for incisions. This method not only reduces recovery times but also improves patient outcomes, leading to its increasing recognition and utilization across medical disciplines.

By Patient Type: Adult Patients (Largest) vs. Pediatric Patients (Fastest-Growing)

In the High Intensity Focused Ultrasound Therapy Market, Adult Patients represent the largest segment, capturing a significant share of the patient demographics. This is largely due to the prevalence of chronic conditions among adults, which necessitate advanced therapeutic options. Pediatric patients, while a smaller segment, are emerging rapidly as the fastest-growing group, driven by increasing recognition of focused ultrasound's potential in treating various pediatric conditions such as tumors and neurological disorders. Growth trends in this market segment are influenced by advancements in ultrasound technologies and an increasing acceptance of non-invasive treatments. The rise in lifestyle-related health issues among adults fosters continuous demand, while pediatric patient growth is fueled by innovative applications and ongoing research highlighting safety and efficacy in children. As both patient types receive more focused marketing and tailored therapies, the market is likely to see robust expansion across these demographic groups.

Adult Patients (Dominant) vs. Geriatric Patients (Emerging)

Adult Patients stand out as the dominant segment in the High Intensity Focused Ultrasound Therapy Market due to the higher incidence of diseases such as cancer and obesity-related health issues, which require effective therapeutic solutions. In contrast, Geriatric Patients are emerging as a significant demographic due to the aging population and the increasing prevalence of age-related ailments. The unique position of adult patients, combined with their established treatment protocols, gives them a competitive edge. Meanwhile, geriatric patients are witnessing a rise in interest from healthcare providers due to their susceptibility to conditions that can benefit from the non-invasive nature of high-intensity focused ultrasound treatments. This shift towards geriatric care indicates a growing recognition of the need for specialized treatment options tailored for older adults.

By Procedure Type: Minimally Invasive Procedures (Largest) vs. Non-Invasive Procedures (Fastest-Growing)

In the High Intensity Focused Ultrasound Therapy Market, the segment distribution reflects a significant preference for Minimally Invasive Procedures, which dominate the market share due to their efficient outcomes and reduced recovery times. Non-Invasive Procedures, while holding a smaller share, are rapidly gaining traction as consumers increasingly seek non-surgical options for treatment. Surgical Procedures account for a smaller portion, as developments in ultrasound technology enhance the efficacy and safety of less invasive interventions. Growth in the High Intensity Focused Ultrasound Therapy segment is primarily driven by advancements in ultrasound technology, coupled with a rising demand for patient-centric treatment options. Minimally Invasive Procedures are popular due to their shorter hospital stays and reduced complication rates. Meanwhile, Non-Invasive Procedures are emerging swiftly, fueled by technological innovations and increased awareness of their benefits. Overall, the landscape is evolving towards less invasive options, reshaping patient care dynamics in the healthcare market.

Minimally Invasive Procedures (Dominant) vs. Non-Invasive Procedures (Emerging)

Minimally Invasive Procedures stand out as the dominant approach within the High Intensity Focused Ultrasound Therapy Market, characterized by their effectiveness and reduced postoperative complications. These procedures leverage advanced ultrasound technology to deliver targeted treatment with minimal disruption to surrounding tissues, attracting a broad patient demographic due to quicker recovery times and lower risk profiles. Conversely, Non-Invasive Procedures are emerging rapidly, recognized for their appeal to patients seeking alternatives to surgery. Although they currently hold a smaller market share, their growth is propelled by ongoing technological advancements and a societal shift towards less invasive healthcare options. Together, these two segments highlight the industry’s trend towards prioritizing patient comfort and safety.

Get more detailed insights about High Intensity Focused Ultrasound (HIFU) Therapy Market Research Report - Forecast till 2035

Regional Insights

North America : Market Leader in Innovation

North America continues to lead the High Intensity Focused Ultrasound (HIFU) Therapy market, holding a significant share of 63.52% in 2024. The growth is driven by increasing healthcare expenditure, advancements in medical technology, and a rising prevalence of chronic diseases. Regulatory support from agencies like the FDA has further catalyzed market expansion, ensuring safety and efficacy in HIFU applications. The United States is the primary contributor, with key players such as SonaCare Medical and HIFU Prostate Services leading the charge. The competitive landscape is characterized by innovation and strategic partnerships, enhancing service delivery and patient outcomes. The presence of established companies and ongoing clinical trials are expected to bolster market growth in the coming years.

Europe : Emerging Market with Potential

Europe's High Intensity Focused Ultrasound Therapy market is projected to grow, currently holding a market size of €35.0 million. The region benefits from a robust healthcare infrastructure and increasing awareness of non-invasive treatment options. Regulatory bodies are actively promoting HIFU technologies, which are seen as effective alternatives to traditional surgical methods, thus driving demand. Leading countries such as Germany and France are at the forefront, with companies like EDAP TMS and InSightec making significant contributions. The competitive landscape is evolving, with a focus on research and development to enhance treatment efficacy. The presence of innovative startups alongside established firms is expected to foster a dynamic market environment.

Asia-Pacific : Rapidly Growing Market

The Asia-Pacific region is experiencing rapid growth in the High Intensity Focused Ultrasound Therapy market, currently valued at $24.53 million. Factors such as increasing healthcare investments, a growing aging population, and rising incidences of cancer are driving demand. Governments are also implementing favorable policies to promote advanced medical technologies, which is expected to further enhance market growth. Countries like China and Australia are leading the charge, with companies such as Chongqing Haifu Medical Technology and Focus Surgery playing pivotal roles. The competitive landscape is marked by collaborations and technological advancements, positioning the region as a key player in The High Intensity Focused Ultrasound Therapy. The increasing focus on research and development is likely to yield innovative solutions in the near future.

Middle East and Africa : Emerging Market Opportunities

The Middle East and Africa region, while currently holding a smaller market size of $3.0 million, presents significant growth potential for High Intensity Focused Ultrasound Therapy. The increasing prevalence of chronic diseases and a growing demand for non-invasive treatment options are key drivers. Additionally, government initiatives aimed at improving healthcare infrastructure are expected to facilitate market expansion in the coming years. Countries like South Africa and the UAE are emerging as key players in this market. The presence of international companies and local startups is fostering a competitive environment. As awareness of HIFU technologies increases, the region is likely to see a rise in adoption rates, paving the way for future growth.

Key Players and Competitive Insights

The High Intensity Focused Ultrasound Therapy Market is characterized by a dynamic competitive landscape, driven by technological advancements and increasing demand for non-invasive treatment options. Key players such as EDAP TMS (FR), InSightec (IL), and SonaCare Medical (US) are at the forefront, each adopting distinct strategies to enhance their market presence. EDAP TMS (FR) focuses on innovation in its HIFU systems, emphasizing clinical efficacy and patient safety, while InSightec (IL) is leveraging partnerships with leading medical institutions to expand its research capabilities and clinical applications. SonaCare Medical (US) appears to be concentrating on regional expansion, particularly in North America, to capitalize on the growing acceptance of HIFU therapies.

The market structure is moderately fragmented, with several players vying for market share. Key business tactics include localizing manufacturing to reduce costs and optimize supply chains, which is becoming increasingly vital in a competitive environment. The collective influence of these companies shapes a landscape where innovation and operational efficiency are paramount, allowing them to respond swiftly to market demands and regulatory changes.

In November 2025, InSightec (IL) announced a strategic partnership with a prominent cancer research center to develop advanced HIFU applications for treating pancreatic cancer. This collaboration is significant as it not only enhances InSightec's research capabilities but also positions the company as a leader in addressing complex oncological challenges, potentially expanding its market reach and therapeutic offerings.

In October 2025, SonaCare Medical (US) launched a new HIFU device designed specifically for prostate cancer treatment, which incorporates AI-driven imaging technology. This innovation is crucial as it enhances precision in targeting tumors, thereby improving patient outcomes. The introduction of this device reflects SonaCare's commitment to integrating cutting-edge technology into its product line, which may strengthen its competitive edge in the market.

In December 2025, EDAP TMS (FR) secured a significant investment to further develop its HIFU technology for gynecological applications. This funding is likely to accelerate the company's R&D efforts, enabling it to diversify its treatment portfolio and cater to a broader patient demographic. Such strategic moves indicate a proactive approach to capturing emerging market opportunities and addressing unmet medical needs.

As of December 2025, current competitive trends in the High Intensity Focused Ultrasound Therapy Market include a pronounced shift towards digitalization and AI integration, which are reshaping operational efficiencies and patient engagement strategies. Strategic alliances are increasingly pivotal, fostering innovation and expanding therapeutic applications. Looking ahead, competitive differentiation is expected to evolve, with a greater emphasis on technological advancements and supply chain reliability, moving away from traditional price-based competition. This evolution suggests that companies that prioritize innovation and operational excellence will likely emerge as leaders in this burgeoning market.

Key Companies in the High Intensity Focused Ultrasound Therapy Market market include

Industry Developments

Q2 2024: EDAP TMS Receives FDA 510(k) Clearance for Focal One® Robotic HIFU System for Prostate Tissue Ablation EDAP TMS announced it received FDA 510(k) clearance for its Focal One® Robotic High Intensity Focused Ultrasound (HIFU) system, allowing its use for prostate tissue ablation in the United States.
Q2 2024: Insightec Announces FDA Approval of Exablate Prostate for Treatment of Prostate Disease Insightec received FDA approval for its Exablate Prostate system, a high intensity focused ultrasound device for the treatment of prostate disease, expanding its clinical indications in the U.S.
Q2 2024: Sonablate Corp. Announces Strategic Partnership with Siemens Healthineers to Advance HIFU Technology Sonablate Corp. entered a strategic partnership with Siemens Healthineers to integrate HIFU technology with advanced imaging solutions, aiming to enhance precision in non-invasive therapies.
Q3 2024: Theraclion Raises €10 Million in Series C Funding to Accelerate HIFU Platform Development Theraclion, a French medtech company specializing in HIFU, closed a €10 million Series C funding round to support the development and commercialization of its next-generation HIFU platforms.
Q3 2024: EDAP TMS Announces Opening of New Manufacturing Facility in Lyon, France EDAP TMS inaugurated a new manufacturing facility in Lyon to expand production capacity for its HIFU devices, supporting growing global demand.
Q3 2024: Haifu Medical Receives CE Mark for New HIFU System for Uterine Fibroids Haifu Medical obtained CE Mark approval for its latest high intensity focused ultrasound system designed for the non-invasive treatment of uterine fibroids in Europe.
Q4 2024: Profound Medical Announces First Patient Treated in Pivotal TULSA-PRO® HIFU Study for Prostate Cancer Profound Medical announced the treatment of the first patient in its pivotal clinical study evaluating the TULSA-PRO® HIFU system for whole-gland ablation of prostate cancer.
Q4 2024: Insightec and Mayo Clinic Expand Collaboration to Advance HIFU for Neurological Disorders Insightec and Mayo Clinic expanded their collaboration to further research and clinical adoption of HIFU for the treatment of neurological disorders, including essential tremor and Parkinson’s disease.
Q1 2025: EDAP TMS Appoints New Chief Commercial Officer to Drive Global HIFU Expansion EDAP TMS appointed a new Chief Commercial Officer to lead the company’s global commercial strategy and accelerate the adoption of its HIFU technologies.
Q1 2025: Theraclion Signs Distribution Agreement with Medtronic for HIFU Systems in Asia-Pacific Theraclion entered into a distribution agreement with Medtronic to market and distribute its HIFU systems across the Asia-Pacific region.
Q2 2025: Profound Medical Receives Health Canada Approval for TULSA-PRO® HIFU System Profound Medical received regulatory approval from Health Canada for its TULSA-PRO® HIFU system, enabling commercialization for prostate disease treatment in Canada.
Q2 2025: EDAP TMS Announces Strategic Partnership with Philips to Integrate HIFU with Advanced Imaging EDAP TMS announced a strategic partnership with Philips to integrate its HIFU technology with Philips’ advanced imaging platforms, aiming to improve treatment precision and outcomes.

Future Outlook

High Intensity Focused Ultrasound Therapy Market Future Outlook

The High Intensity Focused Ultrasound Therapy Market is projected to grow at a 15.5% CAGR from 2024 to 2035, driven by technological advancements and increasing demand for non-invasive treatments.

New opportunities lie in:

Development of portable ultrasound devices for outpatient settings.
Expansion into emerging markets with tailored treatment solutions.
Partnerships with healthcare providers for integrated therapy programs.

By 2035, the market is expected to solidify its position as a leader in non-invasive therapeutic solutions.

Market Segmentation

High Intensity Focused Ultrasound Therapy Market End Use Outlook

Hospitals
Ambulatory Surgical Centers
Specialty Clinics
Research Institutions

High Intensity Focused Ultrasound Therapy Market Technology Outlook

Ultrasound Imaging
Thermal Ablation
Non-Thermal Ablation
Focused Ultrasound Surgery

High Intensity Focused Ultrasound Therapy Market Application Outlook

Tumor Ablation
Pain Management
Cosmetic Treatment
Neurological Disorders
Cardiovascular Disorders

High Intensity Focused Ultrasound Therapy Market Patient Type Outlook

Adult Patients
Pediatric Patients
Geriatric Patients
Pregnant Patients

High Intensity Focused Ultrasound Therapy Market Procedure Type Outlook

Minimally Invasive Procedures
Non-Invasive Procedures
Surgical Procedures

Report Scope

MARKET SIZE 2024	127.05(USD Million)
MARKET SIZE 2025	146.75(USD Million)
MARKET SIZE 2035	620.11(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)	15.5% (2024 - 2035)
REPORT COVERAGE	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR	2024
Market Forecast Period	2025 - 2035
Historical Data	2019 - 2024
Market Forecast Units	USD Million
Key Companies Profiled	EDAP TMS (FR), InSightec (IL), FUS Instruments (CA), SonaCare Medical (US), HIFU Prostate Services (US), Focus Surgery (AU), Mermaid Medical (DK), Chongqing Haifu Medical Technology (CN)
Segments Covered	Application, End Use, Technology, Patient Type, Procedure Type
Key Market Opportunities	Advancements in non-invasive treatment technologies enhance growth potential in the High Intensity Focused Ultrasound Therapy Market.
Key Market Dynamics	Technological advancements and regulatory changes drive growth in High Intensity Focused Ultrasound Therapy applications and market adoption.
Countries Covered	North America, Europe, APAC, South America, MEA