
Focused Ultrasound Systems Market, Opportunity, Growth Drivers, Industry Trend Analysis and Forecast, 2025-2034
Description
The Global Focused Ultrasound Systems Market was valued at USD 264.4 million in 2024 and is estimated to grow at a CAGR of 9.4% to reach USD 642.4 million by 2034. The market growth is driven by the increasing prevalence of chronic diseases, technological advancements, and the growing demand for non-invasive therapeutic solutions. Focused ultrasound systems—particularly high-intensity focused ultrasound (HIFU) and low-intensity focused ultrasound (LIFU)—are gaining traction due to their precision, safety, and ability to treat various medical conditions without the need for surgery. Rising cancer rates, aging populations, and patient preference for outpatient procedures are accelerating the adoption of these systems across hospitals, imaging centers, and research institutions.
Moreover, HIFU’s clinical efficacy in oncology, gynecology, and neurology is driving both patient and practitioner acceptance, as it offers precise tissue ablation with minimal damage to surrounding healthy structures, reduced recovery time, and fewer complications compared to traditional surgical methods. In oncology, HIFU is proving especially valuable in treating localized prostate, liver, and breast tumors, where its ability to target cancerous tissues non-invasively helps lower the risk of infection, bleeding, and long-term side effects. In gynecology, HIFU has become a preferred option for the treatment of uterine fibroids and adenomyosis, providing women with a fertility-preserving alternative to hysterectomy. In the field of neurology, MRI-guided HIFU is being increasingly adopted for the management of essential tremor and Parkinson’s disease, offering tremor control without the need for invasive brain surgery.
The focused ultrasound systems market is primarily segmented by product type, with high-intensity focused ultrasound (HIFU) systems leading in 2024, generating USD 260.8 million and accounting for 98.6% of the total market share. HIFU systems are widely utilized for their capability to precisely ablate tissue using thermal energy, making them ideal for applications in treating prostate cancer, uterine fibroids, and other tumors. Their non-invasive nature, minimal recovery time, and high accuracy are attracting increasing clinical interest and regulatory approvals across regions. Technological innovations such as MRI- and ultrasound-guided HIFU are also enhancing procedure safety and expanding indications, including liver, kidney, and breast cancer treatments.
In terms of application, the clinical applications segment generated USD 259.6 million in 2024, driven by the growing demand for minimally invasive procedures across oncology, gynecology, and neurology. Innovations in real-time imaging and energy delivery mechanisms are improving the accuracy and outcomes of prostate cancer treatments. In parallel, LIFU technologies are being explored in the management of essential tremors and for non-invasive neuromodulation, offering new therapeutic avenues for neurological and psychiatric disorders.
By end use, the hospitals segment generated USD 164.5 million in 2024, benefiting from extensive infrastructure and integrated focused ultrasound technologies into patient care workflows. Hospitals are key drivers in clinical adoption due to their ability to support complex therapies and offer advanced imaging capabilities essential for guided procedures. The growing preference for minimally invasive and outpatient-based interventions is encouraging hospitals to invest in both HIFU and LIFU platforms, especially for oncology, neurology, and women's health applications. Imaging centers and research institutions are also contributing to growth, leveraging these systems for diagnostic-guided therapy and clinical trials.
North America Focused Ultrasound Systems Market generated USD 103.7 million in 2024, bolstered by a mature healthcare ecosystem, early technology adoption, and high patient awareness. The U.S. has seen increased deployment of HIFU systems in oncology and urology due to favorable reimbursement policies and supportive regulatory environments. Europe follows closely, with strong demand from countries like Germany, the UK, and France.
Leading companies in the Focused Ultrasound Systems Market include Insightec Ltd., EDAP TMS S.A., Profound Medical Corp., Chongqing Haifu Medical Technology Co., Ltd., and ILJIN Holdings Co., Ltd. These firms are intensifying their efforts in R&D, regulatory approvals, and strategic partnerships to expand their product portfolios and market presence. Innovations such as portable HIFU devices, enhanced imaging integration, and applications in non-cancerous conditions are further expanding the clinical utility and commercial viability of focused ultrasound technologies. As the demand for safer, faster, and more effective therapeutic options grows, focused ultrasound systems are positioned to become a cornerstone in the evolution of precision medicine and non-invasive care.
Moreover, HIFU’s clinical efficacy in oncology, gynecology, and neurology is driving both patient and practitioner acceptance, as it offers precise tissue ablation with minimal damage to surrounding healthy structures, reduced recovery time, and fewer complications compared to traditional surgical methods. In oncology, HIFU is proving especially valuable in treating localized prostate, liver, and breast tumors, where its ability to target cancerous tissues non-invasively helps lower the risk of infection, bleeding, and long-term side effects. In gynecology, HIFU has become a preferred option for the treatment of uterine fibroids and adenomyosis, providing women with a fertility-preserving alternative to hysterectomy. In the field of neurology, MRI-guided HIFU is being increasingly adopted for the management of essential tremor and Parkinson’s disease, offering tremor control without the need for invasive brain surgery.
The focused ultrasound systems market is primarily segmented by product type, with high-intensity focused ultrasound (HIFU) systems leading in 2024, generating USD 260.8 million and accounting for 98.6% of the total market share. HIFU systems are widely utilized for their capability to precisely ablate tissue using thermal energy, making them ideal for applications in treating prostate cancer, uterine fibroids, and other tumors. Their non-invasive nature, minimal recovery time, and high accuracy are attracting increasing clinical interest and regulatory approvals across regions. Technological innovations such as MRI- and ultrasound-guided HIFU are also enhancing procedure safety and expanding indications, including liver, kidney, and breast cancer treatments.
In terms of application, the clinical applications segment generated USD 259.6 million in 2024, driven by the growing demand for minimally invasive procedures across oncology, gynecology, and neurology. Innovations in real-time imaging and energy delivery mechanisms are improving the accuracy and outcomes of prostate cancer treatments. In parallel, LIFU technologies are being explored in the management of essential tremors and for non-invasive neuromodulation, offering new therapeutic avenues for neurological and psychiatric disorders.
By end use, the hospitals segment generated USD 164.5 million in 2024, benefiting from extensive infrastructure and integrated focused ultrasound technologies into patient care workflows. Hospitals are key drivers in clinical adoption due to their ability to support complex therapies and offer advanced imaging capabilities essential for guided procedures. The growing preference for minimally invasive and outpatient-based interventions is encouraging hospitals to invest in both HIFU and LIFU platforms, especially for oncology, neurology, and women's health applications. Imaging centers and research institutions are also contributing to growth, leveraging these systems for diagnostic-guided therapy and clinical trials.
North America Focused Ultrasound Systems Market generated USD 103.7 million in 2024, bolstered by a mature healthcare ecosystem, early technology adoption, and high patient awareness. The U.S. has seen increased deployment of HIFU systems in oncology and urology due to favorable reimbursement policies and supportive regulatory environments. Europe follows closely, with strong demand from countries like Germany, the UK, and France.
Leading companies in the Focused Ultrasound Systems Market include Insightec Ltd., EDAP TMS S.A., Profound Medical Corp., Chongqing Haifu Medical Technology Co., Ltd., and ILJIN Holdings Co., Ltd. These firms are intensifying their efforts in R&D, regulatory approvals, and strategic partnerships to expand their product portfolios and market presence. Innovations such as portable HIFU devices, enhanced imaging integration, and applications in non-cancerous conditions are further expanding the clinical utility and commercial viability of focused ultrasound technologies. As the demand for safer, faster, and more effective therapeutic options grows, focused ultrasound systems are positioned to become a cornerstone in the evolution of precision medicine and non-invasive care.
Table of Contents
131 Pages
- Chapter 1 Methodology
- 1.1 Market segmentation
- 1.2 Market definitions
- 1.3 Research design
- 1.4 Market size estimates and calculations
- 1.4.1 Approach 1: Company share analysis
- 1.4.2 Approach 2: Prevalence based approach
- 1.4.3 Approach 3: Data mining approach (Investor presentations)
- 1.5 Key trends for market estimates
- 1.6 Forecast model
- 1.7 Primary research & validation
- 1.7.1 Primary sources
- 1.7.2 Data mining sources
- 1.7.2.1 Paid sources
- 1.7.2.2 Public sources
- Chapter 2 Executive Summary
- 2.1 Industry 360° synopsis, 2021 - 2034
- 2.2 Product trends
- 2.3 Application trends
- 2.4 End use trends
- 2.5 Regional trends
- Chapter 3 Focused Ultrasound Systems Market Industry Insights
- 3.1 Industry ecosystem analysis
- 3.2 Industry impact forces
- 3.2.1 Growth drivers
- 3.2.1.1 Rising prevalence of chronic diseases
- 3.2.1.2 Increasing regulatory approvals and reimbursement policies
- 3.2.1.3 Increasing preference for non-invasive therapies
- 3.2.1.4 Expanding applications in non-cancer diseases
- 3.2.2 Growth drivers Industry pitfalls and challenges
- 3.3 Growth potential analysis
- 3.3.1 By product
- 3.3.2 By application
- 3.3.3 By end use
- 3.4 Regulatory landscape
- 3.4.1 U.S.
- 3.4.1.1 HIFU
- 3.4.1.2 LIFU
- 3.4.2 Europe
- 3.4.2.1 HIFU
- 3.4.2.2 LIFU
- 3.5 Trump administration tariff analysis
- 3.5.1 Trade impact
- 3.5.1.1 Trade volume disruptions
- 3.5.1.2 Country-wise response
- 3.5.2 Industry impact
- 3.5.2.1 Supply-side impact (Cost of manufacturing)
- 3.5.2.1.1 Price volatility in key materials
- 3.5.2.1.2 Supply chain restructuring
- 3.5.2.1.3 Production cost implications
- 3.5.2.2 Demand-side impact (Cost to consumers)
- 3.5.2.2.1 Price transmission to end markets
- 3.5.2.2.2 Market share dynamics
- 3.5.2.2.3 Consumer response patterns
- 3.5.3 Strategic industry responses
- 3.5.3.1 Supply chain reconfiguration
- 3.5.3.2 Pricing and product strategies
- 3.5.3.3 Policy engagement
- 3.5.4 Outlook and future considerations
- 3.6 Technology landscape
- 3.7 Future market trends
- 3.8 Gap analysis
- 3.9 Emerging and investigational applications of LIFU
- 3.10 Porter's analysis
- 3.11 PESTEL analysis
- Chapter 4 Competitive Landscape, 2024
- 4.1 Introduction
- 4.1.1 Insightec Ltd.
- 4.1.2 Iljin Holdings Co.,Ltd. (ALPINION MEDICAL SYSTEMS)
- 4.1.3 Chongqing Haifu Medical Technology Co., Ltd.
- 4.2 Company market share analysis
- 4.3 Company matrix analysis
- 4.4 Competitive analysis of major market players
- 4.5 Competitive positioning matrix
- 4.6 Strategy dashboard
- Chapter 5 Focused Ultrasound Systems Market, By Product
- 5.1 High intensity focused ultrasound (HIFU) systems
- 5.1.1 MR-guided HIFU systems
- 5.1.2 Ultrasound-guided HIFU systems
- 5.2 Low intensity focused ultrasound (LIFU) systems
- Chapter 6 Focused Ultrasound Systems Market, By Application
- 6.1 Clinical applications
- 6.1.1 Uterine fibroids
- 6.1.2 Prostate cancer
- 6.1.3 Essential tremor
- 6.1.4 Dermatology
- 6.1.5 Breast cancer
- 6.1.6 Glaucoma
- 6.1.7 Backpain
- 6.1.8 Other applications
- 6.2 Research applications
- Chapter 7 Focused Ultrasound Systems Market, By End Use
- 7.1 Hospitals
- 7.2 Imaging centers
- 7.3 Academic and research institutes
- 7.4 Other end users
- Chapter 8 Focused Ultrasound Systems Market, By Region
- 8.1 North America
- 8.2 Europe
- 8.3 Asia Pacific
- 8.4 Latin America
- 8.5 Middle East and Africa
- Chapter 9 Company Profile
- 9.1 BRAINSONIX
- 9.1.1 Financial data
- 9.1.2 Product landscape
- 9.1.3 SWOT analysis
- 9.2 Chongqing Haifu Medical Technology Co., Ltd.
- 9.2.1 Financial data
- 9.2.2 Product landscape
- 9.2.3 Strategic outlook
- 9.2.4 SWOT analysis
- 9.3 EDAP TMS S.A
- 9.3.1 Financial data
- 9.3.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.3.2 Product landscape
- 9.3.3 SWOT analysis
- 9.4 EpiSonic
- 9.4.1 Financial data
- 9.4.2 Product landscape
- 9.4.3 Strategic outlook
- 9.4.4 SWOT analysis
- 9.5 FUSMobile Inc.
- 9.5.1 Financial data
- 9.5.2 Product landscape
- 9.5.3 Strategic outlook
- 9.5.4 SWOT analysis
- 9.6 Insightec Ltd
- 9.6.1 Financial data
- 9.6.2 Product landscape
- 9.6.3 Strategic outlook
- 9.6.4 SWOT analysis
- 9.7 ILJIN Holdings Co Ltd
- 9.7.1 Financial data
- 9.7.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.7.2 Product landscape
- 9.7.3 Strategic outlook
- 9.7.4 SWOT analysis
- 9.8 Lynton Lasers Limited
- 9.8.1 Financial data
- 9.8.2 Product landscape
- 9.8.3 SWOT analysis
- 9.9 Profound Medical Corp
- 9.9.1 Financial data
- 9.9.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.9.2 Product landscape
- 9.9.3 SWOT analysis
- 9.10 Sonablate Corp
- 9.10.1 Financial data
- 9.10.2 Product landscape
- 9.10.3 Strategic outlook
- 9.10.4 SWOT analysis
- 9.11 Theraclion
- 9.11.1 Financial data
- 9.11.1.1 Sales revenue, 2021-2024 (USD Million)
- 9.11.2 Product landscape
- 9.11.3 SWOT analysis
- 9.12 ULTRAISER
- 9.12.1 Financial data
- 9.12.2 Product landscape
- 9.12.3 SWOT analysis
- 9.13 Verasonics, Inc.
- 9.13.1 Financial data
- 9.13.2 Product landscape
- 9.13.3 Strategic outlook
- 9.13.4 SWOT analysis
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