High Intensity Focused Ultrasound Market Size, Share and Trends 2025 to 2034

High Intensity Focused Ultrasound Market (By Application / Clinical Indication: Oncology, Gynecology, Urology, Cardiology, Aesthetics & Body Contouring; By Technology / Modality: Thermal Ablation HIFU, Non-thermal / Mechanical HIFU, MR-guided HIFU, Ultrasound-guided HIFU; By End User: Hospitals, Ambulatory Surgery Centers, Specialty Clinics, Academic & Research Institutes; By Product Type: Therapeutic HIFU Systems, Aesthetic HIFU Devices, Portable / Compact HIFU Systems;) - Global Industry Analysis, Size, Trends, Leading Companies, Regional Outlook, and Forecast 2025 to 2034

Last Updated : 26 Sep 2025  |  Report Code : 6863  |  Category : Healthcare   |  Format : PDF / PPT / Excel

List of Contents

  • Last Updated : 26 Sep 2025
  • Report Code : 6863
  • Category : Healthcare

What is High Intensity Focused Ultrasound Market Size?

The global high intensity focused ultrasound market size accounted for USD 1.34 billion in 2024 and is predicted to increase from USD 1.44 billion in 2025 to approximately USD 2.7 billion by 2034, expanding at a CAGR of 7.26% from 2025 to 2034. The growth of the market is driven by rising demand for non-invasive therapeutic and aesthetic procedures, technological advancements, and increasing prevalence of chronic conditions like cancer.

High Intensity Focused Ultrasound Market Size 2025 to 2034

Market Highlights

  • North America held a 39% share of the high intensity focused ultrasound market in 2024.
  • The Asia Pacific region is expected to experience the fastest growth between 2025 and 2034.
  • By application/clinical indication, the oncology segment dominated the market with a 41% share in 2024.
  • By application/clinical indication, the neurology segment is expected to grow at the fastest rate in the coming years. 
  • By technology/modality, the thermal ablation HIFU segment led the market with a 48% share in 2024.
  • By technology/modality, the MR-guided HIFU (MRgHIFU) segment is likely to grow at a rapid pace during the projection period.
  • By end user, the hospitals segment contributed the largest market share of 52% in 2024.
  • By end user, the specialty clinics segment is expected to expand at the highest CAGR over the projection period.
  • By product type, the therapeutic HIFU systems segment led the market with a 63% share in 2024.
  • By product type, the aesthetic HIFU devices segment is expected to grow at the fastest CAGR during the forecast period.

Market Size and Forecast

  • Market Size in 2024: USD 1.34 Billion
  • Market Size in 2025: USD 1.44  Billion
  • Forecasted Market Size by 2034: USD 2.7 Billion
  • CAGR (2025-2034): 7.26%
  • Largest Market in 2024: North America
  • Fastest Growing Market: Asia Pacific

What is the High-Intensity Focused Ultrasound Market?

The high-intensity focused ultrasound (HIFU) market covers non-invasive and minimally invasive therapeutic devices that deliver focused ultrasound energy to target tissues. HIFU generates localized thermal ablation or mechanical effects to destroy diseased tissue while sparing surrounding structures. The technology is used in oncology (solid tumor ablation), urology (prostate cancer, BPH), gynecology (uterine fibroids), neurology (essential tremor, Parkinson’s), cardiology, and aesthetics (skin tightening, body contouring, fat reduction). The growth of the market is driven by demand for non-invasive therapies, increasing approvals across clinical specialties, expanding adoption in Asia and Europe, and emerging applications in neuromodulation and aesthetics.

Impact of AI on the High Intensity Focused Ultrasound Market

Artificial intelligence (AI) is significantly transforming the market by improving treatment precision, real-time monitoring, and patient outcomes. AI algorithms are being integrated into HIFU systems to analyze imaging data, optimize energy delivery, and ensure accurate targeting of tissues, reducing the risk of damage to surrounding areas. This has made procedures safer and more effective, particularly in oncology and aesthetic applications. Additionally, AI supports predictive analytics and personalized treatment planning, which increases clinical efficiency and patient satisfaction. As the demand for non-invasive and data-driven healthcare grows, AI-powered HIFU systems are gaining strong traction across medical and cosmetic sectors.

  • Expansion of HIFU in Oncology Treatments: HIFU is increasingly being used as a non-invasive alternative for treating cancers, particularly prostate, liver, pancreatic, and breast cancer. Its ability to ablate tumors without surgery is gaining favor among patients and clinicians seeking low-risk treatment options.
  • Integration of AI and Imaging Technologies: Advanced HIFU systems now incorporate AI algorithms and real-time imaging (like MRI and ultrasound guidance) to enhance precision, monitor tissue response, and customize energy delivery. This integration boosts safety, efficacy, and treatment confidence.
  • Home-Use HIFU Devices Gaining Popularity: Portable and user-friendly HIFU devices for at-home skincare are entering the market, targeting consumers interested in self-care and anti-aging treatments. These devices are driving segment growth, particularly in beauty-conscious regions like Asia and North America.
  • Increasing Use in Neurological and Chronic Pain Applications: Beyond oncology and aesthetics, HIFU is emerging in the treatment of neurological conditions like essential tremor and chronic pain. Its ability to target deep brain structures non-invasively opens up new therapeutic avenues in neurology and pain management.

Market scope

Report Coverage Details
Market Size in 2024 USD 1.34 Billion
Market Size in 2025 USD 1.44 Billion
Market Size by 2034 USD 2.7 Billion
Market Growth Rate from 2025 to 2034 CAGR of 7.26%
Dominating Region North America
Fastest Growing Region Asia Pacific
Base Year 2024
Forecast Period 2025 to 2034
Segments Covered Application / Clinical Indication, Technology / Modality, End User Material, Product Type, and Region
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Market Dynamics

Drivers

Growing Demand for Non-Invasive and Minimally Invasive Therapies

The growing demand for non-invasive and minimally invasive therapies significantly drive the growth of the high intensity focused ultrasound market. HIFU technology offers a non-invasive alternative to traditional surgery and radiation-based treatments, which appeals to patients seeking reduced recovery times, minimal scarring, and lower complication risks. This demand is particularly evident in oncology, where HIFU is being adopted for prostate, liver, and pancreatic cancers. The aesthetic industry is also fueling growth, with consumers preferring HIFU for skin tightening and facial rejuvenation. As global awareness of non-invasive options rises, healthcare providers are increasingly investing in HIFU systems. This shift in preference toward patient-friendly treatments is a major growth driver for the market.

Technological Advancements in Imaging and Precision Targeting

Ongoing advancements in real-time imaging, AI integration, and robotics have significantly improved the precision and safety of HIFU procedures. Technologies such as MRI-guided and ultrasound-guided HIFU allow clinicians to monitor treatment in real time, adjust focus, and minimize damage to surrounding tissues. This enhanced control is expanding HIFU's clinical use beyond oncology to neurology, urology, and gynecology. In addition, smart algorithms are now being used to tailor energy delivery based on patient-specific anatomy and tissue response. These innovations have boosted physician confidence and widened the scope of HIFU applications.

Restraint

High Equipment Costs and Limited Reimbursement Policies

Despite its clinical benefits, the high upfront cost of HIFU systems and associated maintenance remains a barrier to widespread adoption. Many healthcare facilities, especially in low- and middle-income countries, find it financially challenging to invest in such advanced technology. Moreover, limited insurance coverage and lack of standardized reimbursement for HIFU procedures discourage hospitals from adopting the technology at scale. This financial burden also affects patients directly, especially in aesthetic and outpatient care settings. As a result, cost-related constraints continue to restrict the market’s growth potential in certain regions.

Opportunities

Expanding Applications in Neurological Disorders and Pain Management

HIFU is gaining traction as a promising treatment for neurological conditions like essential tremor, Parkinson’s disease, and neuropathic pain, offering non-invasive alternatives to deep brain stimulation and surgical interventions. Regulatory approvals and clinical trials in these areas are accelerating, particularly in North America and Europe. Its ability to target brain structures with high precision using focused ultrasound is transforming how chronic neurological conditions are treated. This opens up a massive new market segment for manufacturers and healthcare providers. Continued research and awareness could further solidify HIFU’s role in neuromodulation.

Emerging Market Penetration and Medical Tourism

Emerging markets present immense opportunities for high intensity focused ultrasound market. Countries in Asia Pacific, Latin America, and Middle East & Africa are witnessing increased demand for non-invasive treatments due to growing healthcare infrastructure, rising incomes, and medical tourism. Patients from high-cost countries are traveling abroad for affordable HIFU-based cancer and aesthetic treatments. Additionally, governments and private healthcare providers in these regions are investing in modern medical technologies to attract international patients. As awareness grows and costs decline, emerging markets represent a significant growth frontier for HIFU manufacturers. Strategic partnerships and localization can further unlock these untapped markets.

Segment Insights

Application / Clinical Indication Insights

Why Did the Oncology Segment Lead the Market in 2024?

In 2024, the oncology segment led the high intensity focused ultrasound market with a 41% share, driven by the clinical need to noninvasively treat tumors in organs like the prostate, liver, breast, and kidney. HIFU is particularly attractive in oncology because it offers localized ablation without open surgery, reduced recovery time, and fewer side effects. Many institutions have incorporated HIFU into cancer care protocols, boosting the technology’s penetration. Also, ongoing clinical trials and evidence supporting HIFU’s efficacy in tumor ablation further reinforce its leading position.

High Intensity Focused Ultrasound Market Share, By Application, 2024 (%)

The neurology segment is expected to grow at the fastest rate over the projection period as HIFU applications expand into treatments for conditions like essential tremor, Parkinson’s disease, neuropathic pain, and other central nervous system disorders. The ability of focused ultrasound to noninvasively target deep brain structures makes it an appealing alternative to invasive neurosurgery. Regulatory approvals and clinical studies in neuromodulation are encouraging broader adoption. As more neurologic indications receive validation, investments by hospitals and research centers are likely to drive strong expansion in this segment.

Technology / Modality Insights

What Made Thermal Ablation HIFU the Dominant Segment in the Market in 2024?

the thermal ablation HIFU segment dominated the high intensity focused ultrasound market in 2024 with a 48% share because it is the most mature and widely adopted modality for ablating tumors and tissues via controlled heating. Its effectiveness, proven clinical outcomes, and more straightforward implementation compared to newer modalities make it a go-to choice for many practitioners. It is also compatible with multiple organ types and indications, further cementing its usage. Because of its reliability and existing infrastructure, it captured large share during the base year. However, other modes with greater precision and imaging integration are expected to gain ground over time.

High Intensity Focused Ultrasound Market Share, By Technology, 2024 (%)

The MR-guided HIFU (MRgHIFU) segment is expected to grow at the fastest CAGR during the forecast period owing to its advantages in precision, real-time thermal monitoring, and improved safety. MRI guidance allows clinicians to visualize the target and surrounding tissue dynamically, adjust energy application, and verify ablation in real time. This reduces the risk of damage to adjacent structures and enhances efficacy, making it favorable for sensitive or complex anatomical areas. As MRI-compatible HIFU systems become more accessible and cost-effective, MRgHIFU adoption will increase, especially in advanced cancer care and neurology.

End User Insights

Why Did Hospitals Contributed Largest Share in 2024?

Hospitals held a 52% share of the high intensity focused ultrasound market in 2024, as they possess the clinical expertise, infrastructure, and capital to adopt high cost advanced devices. Hospitals also manage complex cases (oncology, neurology) that demand HIFU’s capabilities, and are often involved in clinical research and early adoption of new therapies. Their integrated service models and ability to absorb training, maintenance, and regulatory compliance further cement their dominance. Although hospitals remain central, growth in other settings is expected to complement overall market expansion.

High Intensity Focused Ultrasound Market Share, By End User, 2024 (%)

Specialty clinics are projected to grow at the highest CAGR due to the trend toward outpatient and ambulatory care for less invasive treatments. Clinics focused on aesthetics, dermatology, and non oncologic indications are increasingly acquiring HIFU devices to offer advanced services. The lower operational burden compared to hospitals and ability to market directly to consumers drive their adoption. As device costs decrease and new models become more clinic friendly, specialty clinic uptake will accelerate significantly.

Product Type Insights Insights

How Does the Therapeutic HIFU Systems Segment Lead the Market in 2024?

In 2024, therapeutic HIFU systems held a 63% share of the market because the majority of demand centered on medical applications, especially oncology and related disease interventions. These systems are purpose-built for precise ablation and treatment of pathological tissues, which is currently the core driver of HIFU adoption. Given the strong momentum in non-invasive therapies for cancer and disease, therapeutic systems captured dominant usage.

High Intensity Focused Ultrasound Market Share, By Product Type, 2024 (%)

The aesthetic HIFU devices segment is forecasted to grow at the fastest CAGR as consumer demand for noninvasive cosmetic treatments increases globally. The rise in beauty consciousness, social media influence, and desire for minimally invasive facial and body rejuvenation support this growth. Devices designed for skin tightening, wrinkle reduction, and body contouring are becoming more accessible and affordable, appealing to medspas and cosmetic centers. As efficacy and safety improve, the aesthetic segment is poised for rapid market gains.

Regional insights

U.S. High Intensity Focused Ultrasound Market Size and Growth 2025 to 2034

The U.S. high intensity focused ultrasound market size was exhibited at USD 365.82 million in 2024 and is projected to be worth around 751.88 million by 2034, growing at a CAGR of 10.69% from 2025 to 2034.

U.S. High Intensity Focused Ultrasound Market Size 2025 to 2034

What Makes North America the Dominant Region in the Market in 2024?

North America dominated the high intensity focused ultrasound market by capturing a 39% share in 2024 owing to its advanced healthcare infrastructure, high adoption of cutting-edge medical technologies, and strong presence of key device manufacturers. The region’s established reimbursement systems, early regulatory approvals, and high disease awareness encourage hospitals and medical centers to invest in HIFU solutions. Patients in North America increasingly prefer noninvasive treatments, adding to demand. Going forward, while North America retains a strong base, growth is expected to be outpaced by emerging regions due to saturation and slower incremental expansion.

The U.S. is the major contributor to the North America high intensity focused ultrasound market. This dominance is driven by its advanced healthcare infrastructure, early adoption of innovative medical technologies, and strong presence of leading HIFU device manufacturers. Additionally, supportive regulatory frameworks like FDA approvals, high healthcare expenditure, and widespread awareness of minimally invasive treatment options further boost market growth in the U.S. The country’s robust research ecosystem and growing prevalence of cancer and neurological disorders also contribute significantly to its leading position in the HIFU market.

What Makes Asia Pacific the Fastest-Growing Region?

Asia Pacific is projected to register the fastest CAGR between 2025 and 2034, driven by factors like rising healthcare spending, expanding middle classes, and increasing access to advanced medical care in countries such as China, India, Japan, and South Korea. Rapid urbanization and growing patient demand for minimally invasive therapies support this growth. Also, many governments are investing in modern medical infrastructure and promoting medical tourism, which will further boost HIFU adoption. As cost barriers reduce and local manufacturing scales up, Asia Pacific’s share in the HIFU market is set to climb sharply.

High Intensity Focused Ultrasound Market Share, By Region, 2024 (%)

China is the major contributor to the Asia Pacific high intensity focused ultrasound market. This is due to its rapidly growing healthcare infrastructure, increasing government investments in advanced medical technologies, and a large patient pool with rising incidences of cancer and other chronic diseases. Additionally, China’s expanding medical device manufacturing sector and rising awareness of non-invasive treatment options further drive market growth. The country’s focus on improving healthcare accessibility and affordability also supports the widespread adoption of HIFU technologies.

High Intensity Focused Ultrasound Market Companies

  • Insightec Ltd. (MR-guided HIFU, neurology)
  • EDAP TMS (urology, oncology)
  • Chongqing Haifu Medical Technology (oncology, gynecology)
  • Philips Healthcare (MRgFUS collaboration)
  • SonaCare Medical (urology, oncology)
  • Profound Medical (oncology, prostate treatment)
  • Alpinion Medical Systems (Korea – HIFU platforms)
  • Theraclion (thyroid nodules, breast fibroadenomas, varicose veins)
  • Classys Inc. (aesthetic HIFU devices)
  • Ulthera (Merz Aesthetics – Ultherapy facial tightening)
  • Hironic Co., Ltd. (Korean HIFU aesthetic devices)
  • Bionics Co., Ltd. (Asian HIFU device manufacturer)
  • HIFU Prostate Services (urology)
  • Image Guided Therapy (IGT)
  • Luminis Ltd. (aesthetic ultrasound platforms)
  • Medsonic Ltd. (ultrasound-guided devices)
  • WONTECH Co., Ltd. (aesthetic HIFU systems)
  • ENDYMED Medical Ltd. (RF + ultrasound hybrids)
  • Shenzhen Wikkon (China – oncology HIFU)
  • Shandong Huamei Technology (China – aesthetic HIFU systems)

Recent Developments

  • In April 2025, EDAP TMS SA launched the Focal One i system at the 120th American Urological Association Annual Meeting in Las Vegas. The system featured expanded HIFUsion compatibility with PSMA PET scans, ExactVu Micro-Ultrasound, Unfold AI®, and OnQ Prostate®, along with enhanced support for Koelis 3D biopsy maps and DynaCAD Urology datasets. It offers streamlined workflows with guided, step-by-step procedures to boost efficiency. The system also include onboard video libraries for sharing best practices and enabled treatment streaming, recording, remote proctoring, and collaborative procedures.
    (Source: https://investor.focalone.com)
  • In November 2024, SONIRE Therapeutics announced that the FDA granted Breakthrough Device Designation to its next-gen HIFU system, Suizenji, for pancreatic cancer treatment. With a low five-year survival rate of about 12%, pancreatic cancer remains hard to treat. Suizenji, based on a 2017 Japanese clinical study device, uses cavitation bubbles to enhance heating efficiency and improve ultrasound imaging for precise thermal therapy at lower acoustic energy.
    (Source: https://www.fusfoundation.org)

Segments Covered in the Report

By Application / Clinical Indication

  • Oncology
    • Prostate cancer
    • Liver cancer
    • Kidney cancer
    • Pancreatic cancer
    • Breast cancer
    • Others (bone metastases, sarcomas)
  • Gynecology 
    • Uterine fibroids
    • Adenomyosis
  • Neurology
    • Essential tremor
    • Parkinson’s disease (tremor-dominant)
    • Epilepsy (experimental applications)
  • Urology (Non-cancerous BPH treatment)
  • Cardiology
    • Atrial fibrillation ablation (under development)
  • Aesthetics & Body Contouring
    • Non-surgical skin tightening
    • Facial rejuvenation
    • Fat reduction

By Technology / Modality

  • Thermal Ablation HIFU
    • Continuous wave HIFU for coagulative necrosis
    • Used in solid tumors & fibroids
  • Non-thermal / Mechanical HIFU
    • Cavitation-based approaches
    • Histotripsy 
  • MR-guided HIFU (MRgHIFU)
    • High precision, real-time guidance for fibroids, neurology, and oncology
  • Ultrasound-guided HIFU
    • Portable, cost-effective, higher adoption in Asia

By End User

  • Hospitals
    • Oncology centers
    • Neurology centers
    • Gynecology hospitals
  • Ambulatory Surgery Centers
  • Specialty Clinics (Aesthetics, Urology, Gynecology)
  • Academic & Research Institutes 

By Product Type

  • Therapeutic HIFU Systems
    • Oncology ablation devices
    • Neurology MRgFUS systems
    • Gynecology-focused platforms
  • Aesthetic HIFU Devices 
    • Facial lifting systems
    • Body contouring devices
    • Skin tightening platforms
  • Portable / Compact HIFU Systems 

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa (MEA)

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Frequently Asked Questions

The high intensity focused ultrasound market size is expected to increase from USD 1.34 billion in 2024 to USD 2.7 billion by 2034.

The high intensity focused ultrasound market is expected to grow at a compound annual growth rate (CAGR) of around 7.26% from 2025 to 2034.

The major players in the high intensity focused ultrasound market include Insightec Ltd., EDAP TMS, Chongqing Haifu Medical Technology, Philips Healthcare, SonaCare Medical, Profound Medical, Alpinion Medical Systems, Theraclion, Classys Inc, Ulthera (Merz Aesthetics, Hironic Co., Ltd., Bionics Co., Ltd., HIFU Prostate Services, Image Guided Therapy, Luminis Ltd., Medsonic Ltd., WONTECH Co., Ltd., ENDYMED Medical Ltd, Shenzhen Wikkon, and Shandong Huamei Technology

The driving factors of the high intensity focused ultrasound market are the rising demand for non-invasive therapeutic and aesthetic procedures, technological advancements, and increasing prevalence of chronic conditions like cancer.

North America region will lead the global high intensity focused ultrasound market during the forecast period 2025 to 2034.

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