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High Intensity Focused Ultrasound (HIFU) Market Analysis & Forecast: 2025-2032

High Intensity Focused Ultrasound (HIFU) Market, By Imaging Technology (Ultrasound- HIFU Therapy, and Magnetic Resonance Imaging- HIFU Therapy), By Indication (Oncology {Prostate cancer, Rectal tumors, Liver tumors, Renal tumors, others}, Skin Care {Anti-aging treatment, Skin Laxity and Tightening, Others}, Neurological Disorders, and Others), By End User (Hospitals, Ambulatory Surgical Centers, Dermatology Clinics, and Others), And by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

  • Published In : 28 Jul, 2025
  • Code : CMI5538
  • Pages :182
  • Formats :
      Excel and PDF
  • Industry : Medical Devices
  • Historical Range: 2020 - 2024
  • Forecast Period: 2025 - 2032

Global High Intensity Focused Ultrasound (HIFU) Market Size and Share Analysis – Growth Trends and Forecasts (2025-2032)

High Intensity Focused Ultrasound (HIFU) Market is estimated to be valued at USD 129.8 Mn in 2025 and is expected to reach USD 210.6 Mn in 2032, exhibiting a compound annual growth rate (CAGR) of 7.16% from 2025 to 2032.

Key Takeaways

  • Based on Imaging Technology, Magnetic resonance imaging- HIFU therapy segment is expected to dominate the global high-intensity focused ultrasound (HIFU) market with 57.3% market share. This is due to increasing R&D activities regarding magnetic resonance imaging- HIFU therapy.
  • North America is expected to dominate the market over the forecast period with 36.5% market share. This is due to the increasing prevalence of vaginal and vulvar cancer in the region.

Market Overview

The High Intensity Focused Ultrasound (HIFU) market is propelled by the growing need for non-invasive and accurate therapeutic solutions for treating cancer, such as prostate, uterine fibroids, and liver tumors. Increasing patient interest in minimally invasive treatments with shorter recovery times and lesser side effects is driving adoption. Advances in MRI-guided system and ultrasound-guided HIFU systems have improved treatment efficacy and broadened clinical indications. The market is also supported by increasing awareness among patients and healthcare providers, as well as increasing healthcare infrastructure in developing economies.

Current Events and Its Impact on High Intensity Focused Ultrasound (HIFU) Market

Current Events

Description and its impact

EDAP TMS Installs Focal One HIFU System in Canadian Hospitals

  • Description: In March 2025, EDAP TMS, a worldwide technology leader, introduced its Focal One Robotic HIFU system at several big Canadian hospitals, including Toronto General Hospital and Vancouver General Hospital. The system is designed for focal treatment of localized prostate cancer, combining improved imaging, planning, and robotic ablation to achieve precise delivery of treatment.
  • Impact: This expansion cements EDAP's North American market position and is a sign of surging demand for minimally invasive, organ-preserving cancer treatment. Robotic accuracy with real-time imaging enhances the success of treatment and reduces hospital stay. It is also a sign of Canada's strategic move towards value-based care and innovation-driven models of oncology care.

Sonablate Corp and Mayo Clinic Collaborate on AI-Directed HIFU Study

  • Description: In April 2025, Sonablate Corp further released a press statement regarding a collaboration with Mayo Clinic to conduct further research into AI-guided HIFU treatment protocols for prostate cancer. The partnership is meant to integrate artificial intelligence into HIFU planning and delivery to enhance accuracy, personalize treatment based on tumor characteristics, and reduce overtreatment.
  • Impact: The initiative highlights the industry's shift toward AI-driven, patient-specific HIFU therapy. The collaboration will improve clinical outcomes while expanding the procedural role of HIFU in precision oncology. It also reflects growing institutional interest in adopting AI to maximize non-invasive cancer treatment, the potential for setting new clinical standards and pushing regulatory approval.

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Pricing Analysis of the High Intensity Focused Ultrasound (HIFU) Market

The High Intensity Focused Ultrasound (HIFU) market exhibits a varied pricing structure influenced by factors such as treatment indication, system sophistication, manufacturer, and service model. The average cost of a HIFU system ranges from $100,000 to over $500,000, depending on the clinical application (e.g., prostate cancer, uterine fibroids, or neurological disorders), imaging integration (MRI or ultrasound-guided), and treatment precision.

In established economies like the U.S., Germany, and Japan, HIFU equipment fetches higher prices because of stricter regulatory requirements, higher-level imaging compatibility, and the need for non-surgical cancer treatments. MRI-guided HIFU machines, for example, are costlier because of the added imaging functionality and typically cost more than $400,000 per machine. Ultrasound-guided HIFU, although less expensive, is still a heavy investment with equipment averaging $150,000 to $250,000.

Procedure prices also differ region by region. Single HIFU procedures in North America and Europe may be priced between $10,000 and $25,000, varying according to the medical condition, type of hospital, and insurance coverage. Lower procedure prices in Asia-Pacific, most notably in China and South Korea, are driving increased uptake through lower-priced treatment packages and state-sponsored programs.

Though the initial cost is high, HIFU is cost-saving in the long run through lower hospitalization, shorter recovery, and fewer complications than invasive surgery. The prices will stabilize as the technology matures and the competition grows, making HIFU available to an increased number of healthcare facilities worldwide.

Consumer Survey, Feedback, and Unmet Needs in the High Intensity Focused Ultrasound (HIFU) Market

Current patient and consumer surveys in the High Intensity Focused Ultrasound (HIFU) market show increasing recognition and interest in non-surgical therapeutic technologies, especially for prostate cancer, uterine fibroids, liver tumors, and neurosurgery. The most common reasons mentioned by patients for preferring HIFU over traditional treatments are less recovery time, lesser pain, and no surgical incisions. In a 2024 North American patient satisfaction survey, more than 85% of HIFU-treated patients reported successful outcomes, with convenience ratings being high and minimal post-treatment side effects.

Yet, consumer responses also identify several unserved needs and issues. Patients report many in being unable to access High Intensity Focused Ultrasound (HIFU) for acne scars treatments, mainly based on limited facilities, particularly in rural or underserved areas. Furthermore, insufficient insurance coverage and high copayments are important obstacles to wider use. Some physicians and patients describe differences in treatment outcomes according to tumor type and stage, necessitating further standardization and long-term results data.

Another highly reported gap is insufficient information on HIFU's relative advantages and disadvantages. Patients are said to often feel uneducated about how HIFU weighs against surgery, chemotherapy, or radiation—implying greater educational outreach. Though HIFU is picking up good momentum because of its minimally invasive procedure and high patient satisfaction rates, cost, accessibility, and awareness remain the prime unmet needs to be fulfilled to realize its maximum market potential.

Global High Intensity Focused Ultrasound (HIFU) Market Driver

  • Company Partnerships

Major companies operating in the global high-intensity focused ultrasound (HIFU) market are focused on inorganic growth strategies such as partnerships, which is expected to drive growth of the global High-Intensity focused ultrasound (HIFU) market over the forecast period.

For instance, in February 2025, Vattikuti Foundation partnered with AIIMS Delhi and InSightec to deploy MR-guided HIFU for treating Parkinson’s disease and essential tremor. The initiative drastically reduced treatment costs and improved access to non-invasive neurological care in India. This collaboration highlights growing global efforts to expand HIFU adoption in emerging markets. It also promotes research into broader neurological applications of the technology.

  • Increasing Prevalence of Prostate Cancer

Increasing prevalence of prostate cancer is expected to drive the market growth over the forecast period as HIFU is used to treat prostate cancer.

For instance, in June 2025, Cleveland Clinic London became the first facility in England to offer robotic focal HIFU for prostate cancer, using a precision-guided robotic arm to ablate only cancerous prostate tissue. The procedure, which preserves healthy tissue and minimizes side effects like incontinence and erectile dysfunction, addresses the growing burden of prostate cancer—which affected over 1.4 million people globally in 2020.

Segmental Insights

High Intensity  Focused Ultrasound (HIFU) Market By Imaging Technology

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Global High-Intensity Focused Ultrasound (HIFU) Market Insights, By Imaging Technology

Based on Imaging Technology, the market is segmented into, ultrasound- HIFU therapy and magnetic resonance imaging- HIFU therapy. Out of which, magnetic resonance imaging- HIFU therapy segment is expected to dominate the global high-intensity focused ultrasound (HIFU) market during the forecast period and this is attributed due to increasing R&D activities regarding magnetic resonance imaging- HIFU therapy.

Global High-Intensity Focused Ultrasound (HIFU) Market Insights, By Indication

Based on Indication, the market is segmented into oncology (Prostate cancer, Rectal tumors, Liver tumors, Renal tumors, others), skin care (Anti-aging treatment, Skin Laxity and Tightening, Others), neurological disorders, and others (Uterine Fibroids, Benign Prostatic Hyperplasia, etc.). Out of which, oncology segment is expected to dominate the market over the forecast period and this is attributed due to increasing usage of High-Intensity focused ultrasound (HIFU) for the treatment of various cancer/tumor types.

Global High-Intensity Focused Ultrasound (HIFU) Market Insights, By End User

Based on End User, global High-Intensity focused ultrasound (HIFU) market is segmented into hospitals, ambulatory surgical centers, dermatology clinics, and others (Research Institutes, Specialty Centers, etc). Hospitals segment is expected to dominate the market over the forecast period and this is attributed to the usage of HIFU in oncology department in hospitals.

Global High-Intensity Focused Ultrasound (HIFU) Market Cross Sectional Analysis

Among imaging technology, Ultrasound- HIFU Therapy held as a dominant segment in 2023 in North America region due to increasing product launches. For instance, in November 2022, TOOsonix A/S, a company in High-Intensity focused ultrasound (HIFU) technology for dermatology, announced that United States Patent and Trademark Office (USPTO) has granted a U.S. patent no. 11/491,351 for its non-invasive treatments of dermatological conditions.

In indication segment, oncology segment is dominant in North America region due to increasing R&D activities. For instance, in November 2022, National Cancer Institute (NCI), a U.S. Government agency for cancer research, initiated a study on Prostate Cancer using radiation therapy. The study is in phase- 2 of clinical trials and is expected to complete by December 2028.

Global High Intensity Focused Ultrasound (HIFU) Market – Regional Insights

High Intensity  Focused Ultrasound (HIFU) Market Regional Insights

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Among regions, North America is expected to dominate the market over the forecast period, due to the increasing prevalence of vaginal and vulvar cancer in that region. For instance, according to the Centers for Disease Control and Prevention, in November 2025, in U.S., 1,368 women were diagnosed with vaginal cancer and 5,579 women were diagnosed with vulvar cancer in 2019.

Europe is expected to hold second position in global high-intensity focused ultrasound (HIFU) market over the forecast period due to increasing collaborations by key players in that region.

High- Intensity Focused Ultrasound (HIFU) Market Dominating countries

United States High- Intensity Focused Ultrasound (HIFU) Market Analysis and Trend

United States leads the market for HIFU due to its advanced healthcare infrastructure, strong research and development, and consequent high use of advanced medical technology. High incidence of prostate cancer and other treatable illnesses, and growing awareness of the use of non-invasive technology, drive demand for HIFU devices in hospitals and specialty clinics.

Germany High- Intensity Focused Ultrasound (HIFU) Market Analysis and Trend

Germany is a leading market in Europe, supported by its well-established healthcare system and early embracement of advanced medical devices. The country has widespread clinical trials as well as political support for minimal invasive procedures, and it is a hub for the development and use of HIFU technology, especially for oncological applications.

Japan High- Intensity Focused Ultrasound (HIFU) Market Analysis and Trend

Japan's population aging and strong interest in advanced medical therapy propel strong demand for HIFU procedures. Japan is at the forefront of combining HIFU with MRI guidance and other imaging modalities to enhance treatment precision and effectiveness in uterine fibroid and cancer cases.

China High- Intensity Focused Ultrasound (HIFU) Market Analysis and Trend

China is one of the fastest-growing HIFU markets, fueled by increased spending on healthcare, increasing hospital infrastructure, and increasing awareness of alternative treatments. Government initiatives to promote new medical technology and improve cancer treatment also propel the adoption of HIFU across key urban cities.

South Korea High- Intensity Focused Ultrasound (HIFU) Market Analysis and Trend

South Korea showcases explosive expansion in the HIFU market due to its strong ecosystem of healthcare technologies and superior emphasis on research and innovation. HIFU's popularity for prostate and liver cancer therapies is a testament to the country's leadership in minimally invasive therapy adoption in Asia.

Market Report Scope

High Intensity  Focused Ultrasound (HIFU) Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 129.8 Mn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 7.16% 2032 Value Projection: USD 210.6 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Imaging Technology: Ultrasound- HIFU Therapy, Magnetic Resonance Imaging- HIFU Therapy
  • By Indication: Oncology (Prostate cancer, Rectal tumors, Liver tumors, Renal tumors, Others (breast cancer, Vaginal Cancer, etc.)), Skin Care (Anti-aging treatment, Skin Laxity and Tightening, Others (Jawline enhancement, Eyelids or Eyebrows lifting, etc.)), Neurological Disorders, Others (Uterine Fibroids, Benign Prostatic Hyperplasia, etc.) 
  • By End User: Hospitals, Ambulatory Surgical Centers, Dermatology Clinics, Others (Research Institutes, Specialty Centers, etc.)
Companies covered:

Koninklijke Philips N.V., Sonic Concepts, Inc., Theraclion, Sonablate, Alpinion Medical Systems Co., Ltd., Shanghai Carnation Medical Technology Co., Ltd., Insightec, FUS Instruments Inc., Mianyang Sonic Electronic, Profound Medical, Merz Pharmaceuticals GmbH, Image Guided Therapy, and Promedica Bioelectronics s.r.l.

Growth Drivers:
  • Increasing product launches and product approval by key players in the market
  • The increasing collaboration, agreements between market players 
Restraints & Challenges:
  • The high cost of HIFU 

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Global High-Intensity Focused Ultrasound (HIFU) Market: Key Developments

  • In January 2024, Kokilaben Dhirubhai Ambani Hospital in India began using an advanced HIFU system for prostate cancer treatment, offering a non-invasive alternative with targeted tumor ablation and quicker recovery.
  • In November 2024, EDAP TMS showcased the first technical feasibility of non-thermal “histotripsy” lesion creation using its Focal One® robotic HIFU platform during the Acoustical Society of America conference.

Analyst View

  • The High Intensity Focused Ultrasound industry is a revolutionary move towards non-invasive therapeutic treatments, fueled by rising demand for minimally invasive treatments in oncology, urology, and beauty treatments. The technology's capability to provide targeted thermal ablation without cutting opens up a new market space as the increased preference for treatment with lower recovery time and fewer side effects resonates with growing patient demands. Increasing incidence of cancer across the globe, most notably prostate and liver cancer, acts as a key growth driver as HIFU provides a valuable alternative to conventional surgical methods.
  • But expansion in the market is severely inhibited by high costs of equipment, reduced coverage under reimbursement, and the necessity for specialized operator education. Also inhibiting market penetration are regulatory issues across various geographies and competition from mature ablation technologies.
  • Barring these hurdles, tremendous opportunities are being unleashed by real-time imaging integration and treatment planning software. The broadening uses outside of oncology to include cosmetic interventions and neurological conditions provide high-value growth pathways. However, addressing High Intensity Focused Ultrasound (HIFU) treatment risks remains essential. Strategic collaboration between medical device companies and healthcare providers is making market uptake broader.
  • North America leads the market today based on sophisticated healthcare infrastructure, positive reimbursement policies, and early adoption of technologies. Yet, Asia-Pacific is the region with the highest growth rate, fueled by growing healthcare spending, cancer incidence, and medical tourism growth. China and India are making huge investments in sophisticated medical technology, holding high growth potential. The region's sheer patient base and enhancing accessibility to healthcare make it an important market to grow into the future.

Market Segmentation

  • Global High Intensity Focused Ultrasound (HIFU) Market, By Imaging Technology
    • Ultrasound- HIFU Therapy
    • Magnetic Resonance Imaging- HIFU Therapy
  • Global High Intensity Focused Ultrasound (HIFU) Market, By Indication
    • Oncology
      • Prostate cancer
      • Rectal tumors
      • Liver tumors
      • Renal tumors
      • Others (Breast Cancer, Vaginal Cancer, etc.)
    • Skin Care
      • Anti-aging treatment
      • Skin Laxity and Tightening
      • Others (Jawline Enhancement, Eyelids or Eyebrows lifting, etc.)
    • Neurological Disorders
    • Others (Uterine Fibroids, Benign Prostatic Hyperplasia, etc.)
  • Global High Intensity Focused Ultrasound (HIFU) Market, By End User
    • Hospitals
    • Ambulatory Surgical Centers
    • Dermatology Clinics
    • Others (Research Institutes, specialty Centers, etc.)
  • Global High Intensity Focused Ultrasound (HIFU) Market, By Region
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Middle East
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
    • Africa
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Koninklijke Philips N.V.
    • Sonic Concepts, Inc.
    • Theraclion
    • Sonablate
    • Alpinion Medical Systems Co., Ltd.
    • Shanghai Carnation Medical Technology Co., Ltd.
    • Insightec
    • FUS Instruments Inc.
    • Mianyang Sonic Electronic
    • Profound Medical
    • Merz Pharmaceuticals GmbH
    • Image Guided Therapy
    • Promedica Bioelectronics s.r.l.

Sources

Primary Research Interviews

  • Medical Device Manufacturers and Equipment Suppliers
  • Healthcare Professionals and Radiologists
  • Hospital Administrators and Clinical Directors
  • Regulatory Affairs Specialists
  • Others

Databases

  • FDA Database (U.S. Food and Drug Administration)
  • WHO Global Health Observatory Data Repository
  • Medical Device Database (MDD)
  • Others

Magazines

  • Medical Device and Diagnostic Industry (MDDI)
  • Healthcare Finance Magazine
  • Radiology Business Magazine
  • Medical Economics Magazine
  • Others

Journals

  • Journal of Medical Ultrasonics
  • Ultrasound in Medicine & Biology
  • International Journal of Medical Robotics
  • Others

Newspapers

  • Healthcare Finance News
  • Medical Device Network
  • Modern Healthcare
  • Fierce Healthcare
  • Others

Associations

  • American Institute of Ultrasound in Medicine (AIUM)
  • International Society for Therapeutic Ultrasound (ISTU)
  • Medical Device Manufacturers Association (MDMA)
  • World Medical Association (WMA)
  • Others

Public Domain Sources

  • National Institutes of Health (NIH) Publications
  • Centers for Disease Control and Prevention (CDC) Reports
  • European Medicines Agency (EMA) Publications
  • Clinical Trial Registry Databases
  • Others

Proprietary Elements

  • CMI Data Analytics Tool
  • Proprietary CMI Existing Repository of information for last 8 years

*Definition: High-Intensity focused ultrasound (HIFU) is a medical procedure that uses ultrasound waves to treat conditions such as tumor. It is a non-invasive procedure and uses focused ultrasound waves to thermally ablate a portion of tissue, by destroying it with intense heat. The intense heat causes tissue coagulation, necrosis, cavitation, and heat shock in the cells, resulting in the destruction of the ablated tissue.

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About Author

Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.

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Frequently Asked Questions

The High Intensity Focused Ultrasound (HIFU) Market size is estimated to be valued at USD 129.8 Mn in 2025, and is expected to reach USD 210.6 Mn by 2032.

The CAGR of the global Market is projected to be 7.16% from 2025 to 2032.

The fundamental principle of HIFU is to use focused ultrasound waves to generate localized heat that destroys targeted tissue non-invasively through thermal ablation.

HIFU treats prostate cancer by precisely focusing ultrasound energy to ablate cancerous tissue within the prostate while sparing surrounding healthy tissue, offering a minimally invasive alternative to surgery.

Yes, HIFU is used to treat benign prostatic hyperplasia by reducing prostate tissue volume and relieving urinary obstruction without the need for invasive surgery.

Increasing product launches by market players, increasing company collaborations between market players, increasing prevalence of prostate cancer, and product approval by regulatory authorities in the market are expected to drive the market.

Ultrasound- HIFU Therapy is the leading imaging technology segment in the market.

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