聚焦超音波系統市場機會、成長動力、產業趨勢分析及 2025 - 2034 年預測

2024年，全球聚焦超音波系統市場規模達2.644億美元，預計到2034年將以9.4%的複合年成長率成長，達到6.424億美元。市場成長的動力源自於慢性病盛行率的上升、技術進步以及對非侵入性治療方案日益成長的需求。聚焦超音波系統，尤其是高強度聚焦超音波 (HIFU) 和低強度聚焦超音波 (LIFU)，因其精準度高、安全性高，且無需手術即可治療各種疾病，正日益受到青睞。癌症發生率的上升、人口老化以及患者對門診手術的偏好，正在加速醫院、影像中心和研究機構對這些系統的採用。

此外，HIFU 在腫瘤科、婦科和神經科領域的臨床療效正不斷提升患者和醫生的認可度，因為與傳統手術方法相比，HIFU 能夠精準消融組織，對周圍健康結構的損傷最小，恢復時間更短，併發症更少。在腫瘤科領域，HIFU 在治療局限性前列腺、肝臟和乳腺腫瘤方面尤其有效，其非侵入性靶向癌組織的能力有助於降低感染、出血和長期副作用的風險。在婦科領域，HIFU 已成為治療子宮肌瘤和子宮肌腺症的首選方法，為女性提供了保留生育能力的子宮切除替代方案。在神經科領域，MRI 引導下的 HIFU 擴大被用於治療特發性震顫和帕金森氏症，無需進行侵入性腦外科手術即可控制震顫。

聚焦超音波系統市場主要按產品類型細分，其中高強度聚焦超音波 (HIFU) 系統在 2024 年佔據領先地位，市場規模達 2.608 億美元，佔總市場佔有率的 98.6%。 HIFU 系統因其能夠利用熱能精確消融組織而廣泛應用，使其成為治療前列腺癌、子宮肌瘤和其他腫瘤的理想選擇。其非侵入性、極短的恢復時間和高精度的特性，吸引了越來越多的臨床關注和各地區監管機構的批准。 MRI 和超音波導引的 HIFU 等技術創新也提高了手術安全性，並擴大了適應症，包括肝癌、腎臟癌和乳癌的治療。

在應用方面，臨床應用領域在2024年創造了2.596億美元的市場規模，這得益於腫瘤科、婦科和神經科領域對微創手術日益成長的需求。即時成像和能量輸送機制的創新正在提高前列腺癌治療的準確性和療效。同時，LIFU技術正在被探索用於治療特發性震顫和非侵入性神經調節，為神經和精神疾病提供新的治療途徑。

按最終用途分類，醫院部門在2024年創造了1.645億美元的收入，這得益於廣泛的基礎設施以及聚焦超音波技術融入患者護理工作流程。醫院是臨床應用的關鍵驅動力，因為它們能夠支援複雜的治療，並提供引導式手術所需的先進成像能力。人們對微創和門診干預措施的日益青睞，促使醫院投資HIFU和LIFU平台，尤其是在腫瘤科、神經科和女性健康領域。影像中心和研究機構也為成長做出了貢獻，利用這些系統進行診斷引導治療和臨床試驗。

2024年，北美聚焦超音波系統市場規模達1.037億美元，這得益於成熟的醫療生態系統、早期的技術應用以及患者的高度認知。由於優惠的報銷政策和支持性的監管環境，美國在腫瘤科和泌尿科領域對HIFU系統的部署有所增加。歐洲緊追在後，德國、英國和法國等國的需求強勁。

聚焦超音波系統市場的領先公司包括Insightec Ltd.、EDAP TMS SA、Profound Medical Corp.、重慶海扶醫療科技有限公司和ILJIN Holdings Co., Ltd.。這些公司正在加強研發、法規核准和策略合作方面的力度，以擴大其產品組合和市場佔有率。攜帶式HIFU設備、增強型成像整合以及在非癌症疾病中的應用等創新正在進一步擴展聚焦超音波技術的臨床實用性和商業可行性。隨著對更安全、更快速、更有效的治療方案的需求日益成長，聚焦超音波系統有望成為精準醫療和非侵入性護理發展的基石。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 慢性病發生率上升
    • 增加監管批准和報銷政策
    • 非侵入性療法日益受到青睞
    • 擴大在非癌症疾病的應用
  • 產業陷阱與挑戰
    • 設備和手術成本高昂
• 成長潛力分析
• 監管格局
• 技術和創新格局
  • 當前的技術趨勢
  • 新興技術
• 未來市場趨勢
• 差距分析
• LIFU 的新興和研究應用
• 波特的分析
• PESTEL分析

第4章：競爭格局

• 介紹
• 公司市佔率分析
• 公司矩陣分析
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 策略儀表板

第5章：市場估計與預測：按產品，2021 - 2034 年

• 主要趨勢
• 高強度聚焦超音波（HIFU）系統
• 低強度聚焦超音波（LIFU）系統

第6章：市場估計與預測：按應用，2021 - 2034 年

• 主要趨勢
• 臨床應用
  • 子宮肌瘤
  • 攝護腺癌
  • 特發性震顫
  • 皮膚科
  • 乳癌
  • 青光眼
  • 背痛
  • 其他應用
• 研究應用

第7章：市場估計與預測：依最終用途，2021 - 2034 年

• 主要趨勢
• 醫院
• 影像中心
• 學術和研究機構
• 其他最終用途

第8章：市場估計與預測：按地區，2021 - 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 沙烏地阿拉伯
  • 南非
  • 阿拉伯聯合大公國

第9章：公司簡介

• Brainsonix
• Chongqing Haifu Medical Technology
• EDAP TMS
• EpiSonic
• FUSMobile
• Insightec
• ILJIN Holdings
• Lynton Lasers
• Profound Medical
• Sonablate
• Theraclion
• Ultraiser
• Verasonics

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.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 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 Regional
  • 2.2.2 Product
  • 2.2.3 Application
  • 2.2.4 End use

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 product
  • 3.3.2 By application
  • 3.3.3 By end use
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technology and innovation landscape
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 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 Product, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 High intensity focused ultrasound (HIFU) systems
• 5.3 Low intensity focused ultrasound (LIFU) systems

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Clinical applications
  • 6.2.1 Uterine fibroids
  • 6.2.2 Prostate cancer
  • 6.2.3 Essential tremor
  • 6.2.4 Dermatology
  • 6.2.5 Breast cancer
  • 6.2.6 Glaucoma
  • 6.2.7 Back pain
  • 6.2.8 Other applications
• 6.3 Research applications

Chapter 7 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Hospitals
• 7.3 Imaging centers
• 7.4 Academic and research institutes
• 7.5 Other end use

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 India
  • 8.4.3 Japan
  • 8.4.4 Australia
  • 8.4.5 South Korea
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
• 8.6 Middle East and Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 South Africa
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 Brainsonix
• 9.2 Chongqing Haifu Medical Technology
• 9.3 EDAP TMS
• 9.4 EpiSonic
• 9.5 FUSMobile
• 9.6 Insightec
• 9.7 ILJIN Holdings
• 9.8 Lynton Lasers
• 9.9 Profound Medical
• 9.10 Sonablate
• 9.11 Theraclion
• 9.12 Ultraiser
• 9.13 Verasonics