聚焦超音波系统市场机会、成长动力、产业趋势分析及 2025 - 2034 年预测

2024年，全球聚焦超音波系统市场规模达2.644亿美元，预计到2034年将以9.4%的复合年增长率成长，达到6.424亿美元。市场成长的动力源自于慢性病盛行率的上升、技术进步以及对非侵入性治疗方案日益增长的需求。聚焦超音波系统，尤其是高强度聚焦超音波 (HIFU) 和低强度聚焦超音波 (LIFU)，因其精准度高、安全性高，且无需手术即可治疗各种疾病，正日益受到青睐。癌症发生率的上升、人口老化以及患者对门诊手术的偏好，正在加速医院、影像中心和研究机构对这些系统的采用。

此外，HIFU 在肿瘤科、妇科和神经科领域的临床疗效正不断提升患者和医生的认可度，因为与传统手术方法相比，HIFU 能够精准消融组织，对周围健康结构的损伤最小，恢復时间更短，并发症更少。在肿瘤科领域，HIFU 在治疗局限性前列腺、肝臟和乳腺肿瘤方面尤其有效，其非侵入性靶向癌组织的能力有助于降低感染、出血和长期副作用的风险。在妇科领域，HIFU 已成为治疗子宫肌瘤和子宫肌腺症的首选方法，为女性提供了保留生育能力的子宫切除替代方案。在神经科领域，MRI 引导下的 HIFU 越来越多地被用于治疗特发性震颤和帕金森氏症，无需进行侵入性脑外科手术即可控制震颤。

聚焦超音波系统市场主要按产品类型细分，其中高强度聚焦超音波 (HIFU) 系统在 2024 年占据领先地位，市场规模达 2.608 亿美元，占总市场份额的 98.6%。 HIFU 系统因其能够利用热能精确消融组织而广泛应用，使其成为治疗前列腺癌、子宫肌瘤和其他肿瘤的理想选择。其非侵入性、极短的恢復时间和高精度的特性，吸引了越来越多的临床关注和各地区监管机构的批准。 MRI 和超音波导引的 HIFU 等技术创新也提高了手术安全性，并扩大了适应症，包括肝癌、肾臟癌和乳癌的治疗。

在应用方面，临床应用领域在2024年创造了2.596亿美元的市场规模，这得益于肿瘤科、妇科和神经科领域对微创手术日益增长的需求。即时成像和能量输送机制的创新正在提高前列腺癌治疗的准确性和疗效。同时，LIFU技术正在被探索用于治疗特发性震颤和非侵入性神经调节，为神经和精神疾病提供新的治疗途径。

按最终用途划分，医院部门在2024年创造了1.645亿美元的收入，这得益于广泛的基础设施以及聚焦超音波技术融入患者护理工作流程。医院是临床应用的关键驱动力，因为它们能够支援复杂的治疗，并提供引导式手术所需的先进成像能力。人们对微创和门诊干预措施的日益青睐，促使医院投资HIFU和LIFU平台，尤其是在肿瘤科、神经科和女性健康领域。影像中心和研究机构也为成长做出了贡献，利用这些系统进行诊断引导治疗和临床试验。

2024年，北美聚焦超音波系统市场规模达1.037亿美元，这得益于成熟的医疗生态系统、早期的技术应用以及患者的高度认知。由于优惠的报销政策和支持性的监管环境，美国在肿瘤科和泌尿科领域对HIFU系统的部署有所增加。欧洲紧追在后，德国、英国和法国等国的需求强劲。

聚焦超音波系统市场的领先公司包括Insightec Ltd.、EDAP TMS SA、Profound Medical Corp.、重庆海扶医疗科技有限公司和ILJIN Holdings Co., Ltd.。这些公司正在加强研发、监管审批和策略合作方面的力度，以扩大其产品组合和市场份额。便携式HIFU设备、增强型成像整合以及在非癌症疾病中的应用等创新正在进一步扩展聚焦超音波技术的临床实用性和商业可行性。随着对更安全、更快速、更有效的治疗方案的需求日益增长，聚焦超音波系统有望成为精准医疗和非侵入性护理发展的基石。

目录

第一章：方法论与范围

第二章：执行摘要

第三章：行业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 慢性病发生率上升
    • 增加监管批准和报销政策
    • 非侵入性疗法日益受到青睐
    • 扩大在非癌症疾病的应用
  • 产业陷阱与挑战
    • 设备和手术成本高昂
• 成长潜力分析
• 监管格局
• 技术和创新格局
  • 当前的技术趋势
  • 新兴技术
• 未来市场趋势
• 差距分析
• LIFU 的新兴和研究应用
• 波特的分析
• PESTEL分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第五章：市场估计与预测：按产品，2021 - 2034 年

• 主要趋势
• 高强度聚焦超音波（HIFU）系统
• 低强度聚焦超音波（LIFU）系统

第六章：市场估计与预测：按应用，2021 - 2034 年

• 主要趋势
• 临床应用
  • 子宫肌瘤
  • 摄护腺癌
  • 特发性震颤
  • 皮肤科
  • 乳癌
  • 青光眼
  • 背痛
  • 其他应用
• 研究应用

第七章：市场估计与预测：依最终用途，2021 - 2034 年

• 主要趋势
• 医院
• 影像中心
• 学术和研究机构
• 其他最终用途

第八章：市场估计与预测：按地区，2021 - 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 沙乌地阿拉伯
  • 南非
  • 阿联酋

第九章：公司简介

• 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