고강도 집속 초음파(HIFU) 시장 기회, 성장 촉진요인, 산업 동향 분석 및 예측(2025-2034년)

The Global High Intensity Focused Ultrasound (HIFU) Market was valued at USD 237.1 million in 2024 and is estimated to grow at a CAGR of 5.4% to reach USD 396.7 million by 2034. HIFU is a non-invasive treatment that has gained FDA approval for addressing various chronic conditions, including tumors and tremors. The growing adoption of HIFU is attributed to its ability to treat patients without the need for incisions or long recovery times. With increasing awareness of non-invasive treatment options and the rising prevalence of conditions like cancer, the demand for HIFU is expected to surge globally in the coming years. Patients and healthcare providers alike are showing a growing preference for therapies that minimize surgical risks, reduce hospital stays, and offer faster recovery times-factors that strongly favor the adoption of high-intensity focused ultrasound (HIFU) technologies.

Additionally, as global healthcare systems emphasize early detection and targeted treatment, HIFU presents a compelling solution due to its precision in destroying tumor tissues without damaging surrounding healthy structures. The expanding applications of HIFU beyond oncology, such as in the treatment of uterine fibroids, prostate disorders, and neurological conditions, further boost its market potential. Advancements in imaging guidance, real-time monitoring, and integration with robotic platforms are enhancing HIFU's clinical efficacy and accessibility. Moreover, increased investments in research and favorable regulatory approvals across key markets are expected to accelerate the development and commercialization of next-generation HIFU systems.

The prostate cancer segment generated USD 60.3 million in 2024. Increased awareness around early diagnosis and advancements in HIFU technology have significantly contributed to the segment's expansion. HIFU had emerged as a minimally invasive alternative to conventional treatments like surgery and radiation therapy, offering shorter recovery periods and fewer side effects. These benefits have positioned it as a preferred option for both patients and medical professionals. The segment's growth was further reinforced by continuous research and development initiatives focused on improving the accuracy and effectiveness of HIFU systems.

By end-user, the market is divided into hospitals, imaging centers, and other sectors. In 2024, the hospital segment accounted for the largest share of 57.7%. Hospitals provide comprehensive therapeutic options, making them the primary location for HIFU treatments. The wide acceptance and effectiveness of HIFU across various age groups, including children and adults, has further reinforced its use in these healthcare settings. Moreover, increasing investments in hospital infrastructure and the approval of HIFU devices by regulatory bodies such as the FDA and CE drive further growth within this segment.

U.S. High Intensity Focused Ultrasound (HIFU) Market generated USD 83.8 million in 2024. The high incidence of prostate cancer in the U.S., coupled with the country's advanced healthcare infrastructure, is fueling demand for non-invasive treatment options like HIFU. The strong regulatory environment, combined with increasing investment in healthcare innovations, is contributing to the growing adoption of this technology, ensuring continued market expansion in the coming years.

Several prominent companies are actively shaping the competitive landscape of the High-Intensity Focused Ultrasound (HIFU) Industry. Key participants include Sonablate, Profound Medical, EDAP TMS, Insightec, Chongqing Haifu Medical Technology, ULTRAISER, ILJIN Holdings, Verasonics, Theraclion, FUSMobile, Lynton Lasers, EpiSonic, and EpiSonic. These players are strategically investing in product innovation, clinical research, and global expansion to maintain and grow their market positions. To strengthen their market foothold, companies in the HIFU industry are adopting several key strategies. These include expanding their clinical application portfolio beyond oncology to include neurology, gynecology, and urology. They are forming partnerships with hospitals and research institutes to validate and commercialize new use cases for HIFU technology. Furthermore, many players are focusing on geographical expansion into emerging markets where non-invasive therapies are gaining traction.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Application
  • 2.2.2 End use
  • 2.2.3 Regional

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising incidence 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 Industry pitfalls and challenges
    • 3.2.2.1 High cost of equipment and procedures
• 3.3 Growth potential analysis
  • 3.3.1 By application
  • 3.3.2 By end use
• 3.4 Regulatory landscape
  • 3.4.1 U.S.
  • 3.4.2 Europe
• 3.5 Technology landscape
• 3.6 Future market trends
• 3.7 Gap analysis
• 3.8 Emerging and investigational applications of LIFU
• 3.9 Porter's analysis
• 3.10 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 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 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Uterine fibroids
• 5.3 Prostate cancer
• 5.4 Essential tremor
• 5.5 Dermatology
• 5.6 Breast cancer
• 5.7 Glaucoma
• 5.8 Backpain
• 5.9 Other applications

Chapter 6 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Hospitals
• 6.3 Imaging centers
• 6.4 Other end use

Chapter 7 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 UK
  • 7.3.3 France
  • 7.3.4 Spain
  • 7.3.5 Italy
  • 7.3.6 Netherlands
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 India
  • 7.4.3 Japan
  • 7.4.4 Australia
  • 7.4.5 South Korea
• 7.5 Latin America
  • 7.5.1 Brazil
  • 7.5.2 Mexico
  • 7.5.3 Argentina
• 7.6 Middle East and Africa
  • 7.6.1 Saudi Arabia
  • 7.6.2 South Africa
  • 7.6.3 UAE

Chapter 8 Company Profiles

• 8.1 Chongqing Haifu Medical Technology
• 8.2 EDAP TMS
• 8.3 EpiSonic
• 8.4 FUSMobile
• 8.5 Insightec
• 8.6 ILJIN Holdings
• 8.7 Lynton Lasers
• 8.8 Profound Medical
• 8.9 Sonablate
• 8.10 Theraclion
• 8.11 ULTRAISER
• 8.12 Verasonics