High Intensity Focused Ultrasound HIFU Market

High Intensity Focused Ultrasound Market Size

The global high intensity focused ultrasound market size was valued at USD 237.1 million in 2024 and is expected to reach USD 396.7 million by 2034, growing at a CAGR of 5.4% 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 forecast period owing to such high disease prevalences.

Moreover, patients prefer non-invasive and minimally invasive procedures, which is also aiding to market growth. For both patients and healthcare practitioners, these are better options in comparison to surgery or radiation owing to 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, significant patients’ benefits in the procedures are expected to bolster market growth during 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 patient visits across outpatient settings. Outpatient HIFU therapies have become common in hospitals and specialized clinics, which minimizes the length of stay and costs associated with care. This trend is expected to be noticeably spurred by the growth of the ambulatory surgical centers (ASC), the market for 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.
  
• A major driver in innovation is the use of artificial intelligence (AI) in HIFU systems. AI algorithms are being used to optimize treatment planning, monitor thermal ablation zones in real time, and improve targeting accuracy. This boosts procedural effectiveness and reduces reliance on the operator. AI-powered HIFU platforms are expected to be key in expanding HIFU applications beyond oncology to fields like neurology, gynecology, and urology.
  

High Intensity Focused Ultrasound Market Analysis

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 237.1 million in 2024. The prostate cancer segment dominated the market with the largest revenue of USD 60.3 million in 2024.

• This dominance can be attributed to the increasing prevalence of prostate cancer globally and the growing adoption of non-invasive treatment options. According to the Global Cancer Observatory (GLOBOCAN) 2023 database, prostate cancer is 4^th most common cancer in the world and the second most common cancer in men, with over 1.46 million new cases reported annually in 2022. The rising awareness of early diagnosis and advancements in HIFU technology have further fuelled the segment's growth.
  
• HIFU offers a minimally invasive alternative to traditional treatments such as surgery and radiation therapy, reducing recovery time and minimizing side effects. These advantages have made it a preferred choice among patients and healthcare providers.
  
• Additionally, the segment's growth is supported by ongoing research and development efforts aimed at enhancing the efficacy and precision of HIFU systems. With the increasing demand for effective and patient-friendly treatment options, the prostate cancer segment is expected to maintain its leadership position during the forecast period.
  

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 57.7% 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 rising approval by U.S. FDA and CE for HIFU devices intended for use across inpatient acute care settings.
  

North America held a significant share of the global high intensity focused ultrasound market in 2024, accounting for 39.2% of the total market. The region has advanced healthcare infrastructure and rate of adoption of innovative medical technologies is also high. Further, there is an increasing prevalence of chronic diseases in U.S. and Canada which includes prostate cancer and uterine fibroids as well. 

The U.S. market was valued at USD 75.9 million and USD 77.8 million in 2021 and 2022, respectively. The market size reached USD 83.8 million in 2024, growing from USD 80.5 million in 2023.

• 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.
  
• As per the U.S. Census Bureau, the number of people aged 65 and older in the U.S. is expected to rise from 56 million in 2020 to 94 million by 2060. This increase is expected to drive the demand for non-invasive and low-risk treatments such as HIFU, specifically for managing age-related issues such as osteoporosis fractures, prostate problems, and spinal degeneration.
  

Europe high intensity focused ultrasound market accounted for USD 64.7 million in 2024 and is anticipated to show lucrative growth over the forecast period.

• The market in Europe is expanding considering the surge in prevalence of chronic diseases, that include cancer and uterine fibroids, coupled with advancements in non-invasive treatment technologies. According to the data from Statista, in 2022, the average incidence of breast cancer across EU-27 was 147.6 per 100,00 population.
  
• Additionally, Germany, France, and the UK are at the forefront of adopting HIFU technology. These countries also have support for favorable healthcare policies and investments in research and development. Public-private partnerships as well as government initiatives that improve healthcare infrastructure are further helping the market's growth in the region.
  

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.

The Asia Pacific region is projected to be valued at USD 59.2 million in 2025 and is expected to reach USD 101.7 million by 2034.

• The HIFU market in this region is projected to experience steady growth, which is supported by an increase in the demand for non-invasive therapeutic alternatives. The governments of various countries in this region are promoting the expansion of healthcare infrastructure and access to advanced medical technologies.
  
• Moreover, it also has 667 focused ultrasound (FUS) devices, which accounts for a significant share of global installations, with China accounting for the majority. This widespread availability reflects growing institutional capacity and regional expertise in delivering non-invasive therapeutic care.
  

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 market in Japan is expected to grow significantly in coming years.
  

Brazil is experiencing significant growth in high intensity focused ultrasound market, driven by its expanding adoption of chronic disease management.

• In Brazil, breast cancer was the most frequently diagnosed cancer among women in 2020. According to the Global Cancer Observatory, an estimated 66,280 new cases were reported throughout the year, representing 29.7% of all cancer types and an incidence rate of 43.7 per 100,000 women. Therefore, there is a growing need for non-invasive solutions to support traditional oncology treatments.
  
• Additionally, Brazil faces a challenge of aging population, which further fuels demand for HIFU in the country. According to the Brazilian Institute of Geography and Statistics, number of individuals aged 65 and older reached 22.17 million in 2022, accounting for 10.9% of the total population in the country. This was a 57.4% increase since the year 2010. Conditions such as prostate cancer and uterine fibroids are observed to be more prevalent in geriatric population. This trend is expected to boost the adoption of non-invasive, outpatient-friendly therapies like HIFU.
  

The high intensity focused ultrasound 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 market are Insightec, Profound Medical, Chongquing Haifu Medical Technology, FUSMobile, and Sonablate 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 ~52% 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 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 high intensity focused ultrasound industry include:

• Chongqing Haifu Medical Technology
• EDAP TMS
• EpiSonic
• FUSMobile
• Insightec
• ILJIN Holdings
• Lynton Lasers
• Profound Medical
• Sonablate
• Theraclion
• ULTRAISER
• Verasonics
  
• Insightec offers Exablate Neuro, which is one of the first and only MR-guided focused ultrasound (MRgFUS) system that has been approved by the U.S. FDA. The company’s product focus on accuracy and visual confirmation that helps to reduce the risk associated with treatment and improves patient outcomes.
  
• Theraclion specializes in robotic HIFU platforms for non-invasive treatment of thyroid nodules and varicose veins, 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 who 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.
  
• In July 2023, EDAP TMS (Focal One) received the reimbursement approval for high-intensity focused ultrasound (HIFU) for prostate cancer treatment was approved in Switzerland.

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 use

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

• North America 
  • 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