High Intensity Focused Ultrasound HIFU Market

High Intensity Focused Ultrasound Market Size

The global high intensity focused ultrasound market size was valued at USD 684 million in 2024 and is expected to reach USD 1.81 billion in 2034, growing at a CAGR of 10.4% from 2025 to 2034. The high intensity focused ultrasound is a non-invasive medical treatment, approved by FDA, used for various chronic conditions such as tumors and tremors. The high focused sound waves as well as very high intensity interact with targeted tissues in the body to modify or destroy them.

Chronic diseases have been growing globally, which is a major factor contributing to the demand for this market. For instance, in 2022, the World Health Organization (WHO), estimated that 20 million new cancer cases were reported around the world. Further, prostate cancer’s burden is also growing, which is one of the key indications for HIFU. The International Agency for Research on Cancer has reported that in 2022, prostate cancer ranked fourth overall and was 2^nd most prevalent cancer among men in the world. Thus, the HIFU market is expected to expand in the future owing to such high disease prevalences.

Moreover, the patients are preferring non-invasive and minimally invasive procedures, which is also aiding in the market growth. For both patients and healthcare practitioners, these are better options than surgery or radiation because of lower complication levels, quicker recovery periods, and shorter hospital stays. HIFU is used in prostate cancer, uterine fibroids, essential tremor, and skin tightening without the need for scarring or radiation, making it an outpatient-friendly procedure. For instance, according to Statista, 831,583 skin tightening procedures were performed globally in 2023. Thus, owing to patients’ benefits in the procedures, the market is expected to bolster in the forecast period.

 High Intensity Focused Ultrasound Market Trends

• HIFU is increasingly used for treating essential tremor, Parkinson’s disease, and neuropathic pain. Increasing regulatory approvals are supporting market expansion. For instance, Insightec’s Exablate Neuro system has received regulatory approvals in multiple countries for treating medication-refractory essential tremor, contributing to the growing adoption of non-invasive neurosurgery.
  
• There is an increase in patients in the outpatient settings. Outpatient HIFU therapies are now common in hospitals and specialized clinics, which minimizes the length of stay and costs associated with care. This trend will also be noticeably spurred by the growth of the ambulatory surgical centers (ASC) market, which is expected to reach USD 93.8 billion by 2032.
  
• Further, real-time imaging, AI components, and HIFU have made treatment more accurate. There are improvements in ultrasound beam focusing as well as in the personalized treatments, further fostering the growth of this market.
  

High Intensity Focused Ultrasound Market Analysis

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Based on application, the market is segmented into uterine fibroids, prostate cancer, essential tremor, dermatology, breast cancer, glaucoma, backpain and other applications. The global market for high intensity focused ultrasound was valued at USD 631.8 million in 2023. The dermatology segment dominated the market with the largest revenue of USD 145.7 million in 2024.

• The non-invasive facelift, wrinkle removing, and skin tightening procedures done with the help of HIFU technology has led the dermatology segment dominate the market.
  
• According to The International Society of Aesthetic Plastic Surgery (ISAPS), over 19.1 million non-surgical procedures were performed across the globe in 2023. Out of which skin tightening procedures done without engaging any form of surgery, were among the most performed procedures. Further, for the past four years, they concluded an accumulating total increase of 40% for both surgical and non-surgical procedures in that period.
  
  
• The increasing growth of the segment can also be credited to the HIFU's ability to stimulate collagen production and improve skin elasticity without downtime. These aspects receive preference from clinics and aesthetic centers further supporting this segment growth.
  
  
  

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Based on end use, the high intensity focused ultrasound market is segmented into hospitals, imaging centers and other end users. Hospitals segment accounted for the largest revenue share of 42.8% in 2024.

• Patients are able to receive advanced therapeutic measures in hospitals, making them primary centers for HIFU treatments.
  
• Further, the successful application of HIFUs in children and adults is extensively contributing to maintaining the segment’s dominance. For instance, in February 2022, Children’s National Hospital based in Washington D.C. made a huge achievement when they completed the first ever HIFU surgery on a child with neurofibromatosis (NF) which demonstrates the growing adoption of HIFU by hospitals for such specialized procedures.
  
• Moreover, there are additional factors that propel the segment growth, such as the increased funding in hospital infrastructure and the greater issuance of FDA and CE approvals of HIFU devices.
  

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The U.S. high intensity focused ultrasound market revenue has increased considerably from USD 223.9 million in 2023 and is expected to grow significantly, reaching USD 604.5 million by 2034.

• The country faces a high burden of prostate cancer. According to the U.S. Centers for Disease Control and prevention, in 2021, 236,659 new prostate cancers were reported and in 2022, 33,363 males died from prostate cancer.
  
• Moreover, U.S. has a strong healthcare infrastructure, which benefits in rising adoption of non-invasive therapies, strong regulatory approvals, and increasing investment in healthcare innovation. Thus, the country foresees a strong boost in the revenue generated from HIFU in upcoming years.
  

Europe: The UK high intensity focused ultrasound market is projected to experience steady growth between 2025 and 2034.

• In the UK, initiatives designed to enhance the reach of HIFU are being put into practice by government as well as non-profit organizations.
  
• For instance, Graham Fulford Charitable Trust (GFCT) is executing a strategy to expand the availability of the HIFU machine in NHS hospitals by offering them on a rental basis. One fully sponsored facility already being installed at Northampton General Hospital and few units are being used in King’s Lynn and Bath. Further units are planned for installation in Leeds, Fife, and Plymouth/Truro. This will improve access to HIFU treatment for the residents of the Midlands, East Anglia, and the Southwestern parts of England.
  

Asia Pacific: Japan high intensity focused ultrasound market is poised to witness lucrative growth between 2025 – 2034.

• The adoption of HIFU technology in Japan is continually growing as it is already being used in prostate enlargement, Parkinson’s, and essential tremor conditions. HIFU research and clinical applications are now being directed towards pancreatic cancer treatment, which is one of the most difficult and deadly cancers. It is estimated that approximately 70 percent of all pancreatic cancer cases in Japan are diagnosed at an advanced stage where surgery becomes impossible. Thus, the 3-year survival rate is observed only in 3.2% of patients. Even after surgery, nearly 80 percent of patients experience recurrence.
  
• Unlike conventional radiation treatment, which requires daily sessions spanning over six weeks, HIFU reduces the number of sessions required to achieve the same results. This increases patient outcomes and acceptance of the technology in Japan’s oncology landscape. Therefore, HIFU industry in Japan is expected to grow significantly in coming years.
  

Middle East and Africa: The HIFU market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.

• Saudi government healthcare spending under the Saudi Vision 2030 initiative has increased access to sophisticated medical technologies. In 2023, the Saudi government set aside more than USD 1.5 billion towards the expansion for medical technology which is expected to boost the use of HIFU as well. HIFU is now being adopted in cancer treatment protocols at major hospitals such as King Faisal Specialist Hospital & Research Centre.
  
• Moreover, Saudi Arabia's elderly population is rising at a much faster pace than any other segment. It is estimated that the population aged 60 years and above will grow from 2 million (5.9 percent of the total population) in 2020 to 10.5 million by 2050. This population shift will lead to greater demand for HIFU treatment for prostate cancer as well as other applications in the foreseeable future.
  

High Intensity Focused Ultrasound Market Share

The top five players competing in the HIFU industry are Insightec, Profound Medical, Chongquing Haifu Medical Technology, Theraclion, and Sonablate Corp which focus on technological devices and innovation, clinical trials, and regulatory processes for HIFU applicators in different fields such as oncology, neurology, and urology. These account for about 40% of the revenue share in the market. To improve the adoption as well as reimbursement coverage, they are increasing their collaborations and partnerships.

Emerging entrants, including ULTRAISER, Arrayus Technologies, and FUSMobile are developing next generation HIFU systems with more precise imaging and guidance ultrasound such as portable systems which are aimed at increasing accessibility and precision of treatment. These techniques are anticipated to aid in the growth of the market in the proceeding years.

High Intensity Focused Ultrasound Market Companies

Some of the eminent market participants operating in the wound care biologics industry include:

• ALPINION MEDICAL SYSTEMS
• Arrayus Technologies
• Chongqing Haifu Medical Technology
• Focal One
• FUSMobile
• Insightec
• Lynton Lasers
• Profound Medical
• Sonablate
• Theraclion
• ULTRAISER
• Verasonics
  

• Theraclion specializes in robotic HIFU platforms for non-invasive treatment of varicose veins and thyroid nodules, leveraging innovative automation to improve treatment efficiency and precision.
  
• EDAP TMS has expertise in ultrasound-based therapies ensures effective tumor ablation with minimal side effects. The company offers a comprehensive HIFU portfolio, including its flagship Focal One, which provides precise and non-invasive treatment for localized prostate cancer.
  

High Intensity Focused Ultrasound Industry News:

• In January 2025, Theraclion, reported its achievement in the FDA approved pivotal study of SONOVEIN (non-invasive HIFU therapy for varicose veins) for the year 2024. The pivotal clinical study for SONOVEIN was done in four top centers located in the U.S. and Europe. The marketing authorization application is planned for submission during the second half of 2025 and the FDA approval is expected in the first half of 2026.
  
• In January 2024, Insightec, one of the key players in the focused ultrasound technology, has been issued a positive recommendation from the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) regarding the reimbursement for the use of MR-guided Focused Ultrasound (MRgFUS) treatment for essential tremor (ET). This was a major advancement in enabling the use of this non-invasive treatment within the Netherlands. This recommendation was published in December 2023, stating that for patients that suffer from moderate to severe medication resistant essential tremor and do not qualify for deep brain stimulation, MRgFUS or high intensity focused ultrasound (HIFU) therapy is a viable treatment option.
  
• In January 2024, Kokilaben Dhirubhai Ambani Hospital in India adopted the HIFU technology for treating prostate cancer. HIFU uses high-frequency sound waves to target and destroy prostate cancer cells, thus proposing a minimally invasive approach to treat localized prostate cancer.
  

The high intensity focused ultrasound market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Application

• Uterine fibroids
• Prostate cancer
• Essential tremor
• Dermatology
• Breast cancer
• Glaucoma
• Backpain
• Other applications

Market, By End Use

• Hospitals
• Imaging centers        
• Other end users

The above information is provided for the following regions and countries:

• North Americ 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE