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The High Intensity Focused Ultrasound Therapy Market size is projected to reach US$ 879.87 million by 2031 from US$ 505.49 million in 2024. The market is expected to register a CAGR of 8.3% during 2025–2031.
High Intensity Focused Ultrasound Therapy Market Analysis
The rising cases of cancer and neurological disorders, increasing demand for noninvasive treatments, the rapid technological advancements, such as real?time imaging and AI integration, and the widening applications in women's health and aesthetics are the major contributing factors to the market growth.
High Intensity Focused Ultrasound Therapy Market Overview
High intensity focused ultrasound therapy is becoming increasingly popular among healthcare providers and patients. High intensity focused ultrasound (HIFU) technology is implemented in oncology, neurology, gynecology (such as uterine fibroids), and aesthetics. The main markets are North America, which is the highest in terms of adoption, and APAC, where the rate of growth is the fastest due to the improvement of healthcare infrastructure and the rising awareness. The regulatory approvals and the increase in reimbursement policies have made it easier for the integration of HIFU systems in hospitals and outpatient centers globally.
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High Intensity Focused Ultrasound Therapy Market: Strategic Insights
Market Size Value in US$ 417.98 Million in 2018 Market Size Value by US$ 755.46 Million by 2027 Growth rate CAGR of 7.1% from 2019-2027 Forecast Period 2019-2027 Base Year 2019
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High Intensity Focused Ultrasound Therapy Market Drivers and Opportunities
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High Intensity Focused Ultrasound Therapy Market: Strategic Insights
| Market Size Value in | US$ 417.98 Million in 2018 |
| Market Size Value by | US$ 755.46 Million by 2027 |
| Growth rate | CAGR of 7.1% from 2019-2027 |
| Forecast Period | 2019-2027 |
| Base Year | 2019 |
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Market Drivers:
Rising Prevalence of Chronic Diseases and Cancer:
The number of prostate cancer cases is expected to grow from 1.4 million in 2020 to 2.9 million in 2040. HIFU and other focused therapies are becoming more and more in demand due to conditions such as uterine fibroids, kidney stones, and heart disease.Soaring Preference for Noninvasive Procedures:
Noninvasive therapy is more widely accepted among patients with the hope of quicker recovery, less pain, and no anesthesia needed. HIFU therapists prefer these surgical methods.Aging Population and Heightened Awareness:
Growing awareness of early diagnosis, driven by advancements in the pharmaceutical and clinical trial industries, is increasing demand—particularly influenced by the aging population and expanding medical knowledge.
Market Opportunities:
Expansion into Emerging Applications:
HIFU is becoming a common practice among dermatological doctors as a treatment for skin firming and wrinkle lessening, as it is an effective noninvasive method. The aesthetic application is rapidly growing along with the medical applications in neurology (e.g., tremor, Parkinson’s), gynecology (fibroids, endometriosis), and pain management.Geographic Penetration in Emerging Markets:
The growing healthcare investment in emerging economies is driving HIFU adoption, especially in APAC and Latin America. Medical tourism, the influx of new incomes, and the improvement of infrastructures in these developing markets are the main sources of their underestimated potential.Shift Toward Outpatient and Day Surgery Centers:
Outpatient procedures are gaining traction, and HIFU is now being used in day surgery centers for its noninvasive nature and reduced recovery times. The development of ambulatory surgical centers facilitates same-day HIFU treatment with lower costs and faster recovery times. In the US, the FDA-approved Sonablate HIFU device has become popular among outpatient clinics as more urologists suggest the use of HIFU as a first-line therapy in case of low-to-moderate risk prostate cancer patients, particularly those who are not surgical candidates.
High Intensity Focused Ultrasound Therapy Market Report Segmentation Analysis
The high intensity focused ultrasound therapy market is segmented into distinct categories to provide a clearer understanding of its operations, growth potential, and current trends. Below is the standard segmentation approach used in industry reports:
By Modality:
MRI Guided Focused Ultrasound Therapy:
MRI-guided high-intensity focused ultrasound is known for its high precision, which allows the accurate monitoring of the process and targeting of the tumor. It is a noninvasive procedure, it is safer and, therefore, yields better results.Ultrasound Guided Therapy:
Ultrasound-guided therapy is gaining popularity at a very fast pace due to its cheaper price, portability, and shorter time for preparation time when compared to MRI. Due to the fact that it is a perfect solution for outpatient clinics, it is accessible to a large number of patients.
By Application:
- Breast Cancer
- Prostate Cancer
- Liver Cancer
- Pancreatic Cancer
- Breast Lifting and Aesthetic Application
- Nipple and Areola Preservation
- Post Surgical Applications
- Others
By End User:
- Healthcare Facilities
- Diagnostic Imaging Centers
- Research Centers
By Geography:
- North America
- Europe
- Asia Pacific
- South & Central America
- Middle East & Africa
Market Report ScopeHigh Intensity Focused Ultrasound Therapy Market Share Analysis by Geography
Asia Pacific is expected to grow the fastest in the next few years. Emerging markets in South America, the Middle East, and Africa have untapped opportunities for HIFU therapy providers to expand.
The growth of the high intensity focused ultrasound therapy market varies across regions due to factors such as the rise in cancer prevalence, the increased healthcare spending, the progression of technology, and the more significant presence of patient awareness for the noninvasive treatment option. Below is a summary of market share and trends by region:
1. North America
Market Share:
Holds a significant portion of the global marketKey Drivers:
Strong healthcare infrastructure, high cancer and neurological disorder incidences, along with robust reimbursement policies, are the main reasons for HIFU adoption.
Trends:
Outpatient/ambulatory surgery center use, the incorporation of AI?and imaging-guided HIFU, and growing cosmetic and aesthetic applications.
2. Europe
Market Share:
Substantial market shareKey Drivers:
The established healthcare systems and increasing demand for noninvasive treatments (oncology, fibroids, and neurology) are the main factors for regional market expansion.Trends:
The adoption of MRI-guided HIFU systems and increasing aesthetic applications (skin tightening, wrinkle reduction).
3. Asia Pacific
Market Share:
Fastest-growing region with a rising market share every yearKey Drivers:
Rapid healthcare infrastructure investment, a large and aging patient population, a rising middle class, and medical tourism.
Trends:
Local manufacturing is lowering the cost of devices, there is strong growth in aesthetic/cosmetic uses (especially in China, South Korea, Japan), and regulatory approvals are speeding up new indications.
4. South and Central America
Market Share:
Growing market with steady progressKey Drivers:
Non-invasive treatments demand is emerging, and there is an increasing awareness of HIFU in oncology and aesthetic segments in Brazil, Argentina, etc.Trends:
Apart from the treatment of cancers, aesthetic and cosmetic procedures (skin tightening, body shaping) are progressively becoming popular with the help of the device's import, which is becoming more feasible in private healthcare.
5. Middle East and Africa
Market Share:
Although small, it is growing quicklyKey Drivers:
Investments in advanced medical infrastructure in Gulf countries, rising aesthetic treatment demand, and medical tourism are the main reasons pushing HIFU uptake.Trends:
Rapid growth in aesthetic and dermatology HIFU applications (there is a very strong demand for noninvasive cosmetic procedures in the GCC markets), and a gradual increase in the oncology applications.
High Intensity Focused Ultrasound Therapy Market Players Density: Understanding Its Impact on Business Dynamics
High Market Density and Competition
Competition is strong due to the presence of established players such as Koninklijke Philips NV and EDAP TMS SA. Regional and niche providers add to the competitive landscape across regions.
The high level of competition urges companies to stand out by offering:
- Product Innovation
- Product Approvals
- Compliance with Regulatory Guidelines
Opportunities and Strategic Moves
- HIFU therapy offers noninvasive treatment with fewer side effects, creating rising demand across oncology, aesthetics, and chronic disease management sectors globally.
- Leading firms invest in clinical trials, global regulatory approvals, AI integration, and partnerships to expand indications, adoption, and market share.
Other companies analyzed during the course of research:
- Chongqing Haifu Medical Technology Co., Ltd
- Theraclion
- Image Guided Therapy
- Verasonics, Inc.
- Lynton Lasers Ltd
- WON TECH Co., Ltd.
- Jeisys Global
- Alpinion?Medical?Systems?Co.,?Ltd.
- EpiSonica,?Inc.
High Intensity Focused Ultrasound Therapy Market News and Recent Developments
THERACLION revealed that it has been granted MDR (Medical Device Regulation, EU 2017/745) certification for Sonovein.
The independent evaluation confirmed that the Sonovein device and Theraclion's quality management system are fully compliant with the MDR requirements, thereby allowing long-term commercialization of the latest generation of Sonovein.EDAP TMS SA announced that the French Ministry of Health has given the green light to reimbursement of the HIFU procedure for the treatment of prostate cancer in France.
In France, reimbursement will be specifically allocated for the use of the Focal One Robotic HIFU procedure in primary treatment of localized prostate cancer for a first line of therapy, in addition to a salvage treatment option after radiotherapy, for patients eligible to receive this care.
High Intensity Focused Ultrasound Therapy Market Report Coverage and Deliverables
The "High Intensity Focused Ultrasound Therapy Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:
- High Intensity Focused Ultrasound Therapy Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- High Intensity Focused Ultrasound Therapy Market trends, as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- High Intensity Focused Ultrasound Therapy Market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the High Intensity Focused Ultrasound Therapy Market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Modality ; Method ; Application ; End User , and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina
Frequently Asked Questions
EDAP TMS SA, Sonablate Corp, Koninklijke Philips NV, CLASSYS Inc., Insightec, Hironic Co. Ltd, FUS Instruments Inc., Chongqing Haifu Medical Technology Co. Ltd, Theraclion, and Image Guided Therapy are among the key players operating in the high intensity focused ultrasound therapy market.
The high intensity focused ultrasound therapy market is projected to reach a value of US$ 879.87 million by 2031.
The high intensity focused ultrasound therapy market is estimated to register a CAGR of 8.3% during the forecast period.
The soaring preference for noninvasive procedures, and aging population, and heightened awareness are noteworthy factors contributing to market growth.
North America dominated the market in 2024.
The List of Companies - High Intensity Focused Ultrasound Therapy Market
- Edap Tms SA
- Sonablate Corp.
- Insightec Ltd.
- Koninklijke Philips NV
- FUS Instruments Inc.
- CLASSYS Inc.
- Chongqing Haifu Medical Technology Co., Ltd.
- Hironic Co., Ltd.
- Image Guided Therapy SA
- Verasonics Inc.
- THERACLION S.A.
- Lynton Lasers Ltd
- Jeisys Global
- WON TECH Co., Ltd.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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