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市场调查报告书
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1965912

乳房病灶定位方法市场－全球产业规模、份额、趋势、机会、预测：按类型、地区和竞争格局划分，2021-2031年

Breast Lesion Localization Methods Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3个工作天内

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简介目录

全球乳房病灶定位技术市场预计将从 2025 年的 4.2 亿美元成长到 2031 年的 6.4 亿美元，复合年增长率为 7.27%。

这些定位技术包括用于精确标记无法触及的乳房肿瘤和异常病变的医疗技术，可在切除过程中指导外科医生。该领域的发展主要受全球乳癌发病率上升以及筛检计画广泛实施的推动，这些筛检计画旨在识别需要精确定位的早期病变。根据美国癌症协会 (ACS) 估计，到 2025 年，美国预计将有 316,950 名女性被诊断出罹患侵袭性乳癌。不断增长的患者群体凸显了对可靠定位设备的迫切需求，以确保有效治疗的同时，最大限度地减少对健康组织的切除。

市场概览
预测期 2027-2031
市场规模：2025年 4.2亿美元
市场规模：2031年 6.4亿美元
复合年增长率：2026-2031年 7.27%
成长最快的细分市场 利用放射性同位素进行定位
最大的市场 北美洲

阻碍市场成长的主要障碍是先进无线技术与传统有线系统之间的显着成本差异。高昂的成本可能会阻碍预算有限的小规模医疗机构和发展中地区医院采用这些技术。因此，儘管新系统具有许多临床优势，但资金限制往往迫使医疗机构继续依赖成本较低的旧技术。

市场驱动因素

全球乳癌发生率的上升是推动市场发展的主要因素。病例的增加直接催生了对精准手术介入的需求。随着筛检率的提高，医疗系统正将早期诊断放在优先位置，而这需要对不可触及的病变进行可靠的定位。根据世界卫生组织（世卫组织）于2025年8月发布的《乳癌最新关键事实》，2022年全球约有230万名女性被诊断出罹患乳癌。国家筛检计画的高参与率进一步推动了诊断病例的增加，这些计画能够有效识别需要手术切除的早期异常病变。例如，英国国家医疗服务体系（NHS）数位部门在其于2025年2月发布的《英格兰乳癌筛检计画（2023-2024）》报告中指出，70.0%的符合条件的女性接受了筛检邀请，这凸显了大量进入诊断流程的患者需要进行精准的病变标记。

同时，先进的无线立体定位技术的快速普及正在改变治疗环境，克服了传统导丝引导方法在后勤和临床方面的挑战。雷达和磁性系统能够实现独立排班，使放射检查和手术可以在不同日期进行，从而提高医院的工作流程效率并提升病患的舒适度。这项技术进步的市场影响体现在专有设备的使用量不断增加。正如 Merritt Medical Systems 在 2025 年 10 月发布的「2025 年第三季收益报告」中所述，该公司 Scout 雷达立体定位技术已在全球范围内用于治疗 75 万名患者，这表明临床上对非放射性、无线解决方案有着强烈的偏好。这种转变不仅有助于提升手术精确度，也符合微创乳房保留手术的整体趋势。

市场挑战

限制全球乳房病灶定位（IST）市场成长的一大挑战是先进无线技术与传统有线系统之间存在显着的成本差距。新型IST设备的购买和营运成本通常较高，这对小规模医疗机构和地区医院构成了巨大的经济负担，尤其是在资本预算有限的发展中地区。因此，许多医疗机构被迫优先考虑成本控製而非技术进步，继续使用过时但成本较低、且工作流程效率低的IST技术。

这些经济限制因素直接阻碍了市场收入成长，降低了预算紧张地区高价值设备的普及率。鑑于疾病负担的严重性，因经济压力而无法进行设备升级的情况尤其令人担忧。根据美国癌症协会预测，到2025年，美国约有42,170名女性将死于乳癌。持续高成本阻碍了更有效技术的广泛普及，并减缓了整体市场的发展势头。

市场趋势

在监管严格的地区，逐步淘汰放射性同位素方法正在从根本上改变市场格局，尤其是在核子医学监管严格的欧洲和亚洲部分地区。医疗机构正越来越多地用非放射性磁性或射频识别（RFID）技术取代碘-125放射性粒子，以规避复杂的安全通讯协定、辐射处理限制和处置义务。这种监管压力正在加速传统技术的淘汰，市场正朝着安全、可植入且不受核能法规约束的设备发展。根据发表于2025年7月英国皇家外科医师学会年度报告《英国乳房护理机构非导丝立体定向设备的采用情况》中的一篇论文，英国英国英国机构英国从2020年的83%下降到2022年的18%，而非导丝设备的使用率则上升到82%，这充分说明了这种替代的规模之大。

同时，无线定位技术的快速发展已超越了最初提高工作流程效率的初衷，其主要驱动力在于提升手术精准度和降低二次切除率。该领域的创新正从简单的标记物发展到针对乳房独特形状量身定制的患者专属引导系统，从而提高肿瘤切除的精准度并减少二次手术的需求。这种对临床疗效的关注推动了定製成型设备的应用，这些设备可在部分乳房切除术中提供精确的切缘引导。正如凯恩外科公司在2026年1月发布的题为“美国一项关键临床试验完成入组”的新闻稿中所述，一项发表于《外科肿瘤学年鑑》的多中心研究表明，外科医生使用该公司的乳癌定位系统，在94%的患者中实现了肿瘤完全切除且切缘阴性。这一成功率远超过标准定位方法的典型结果。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：乳房病灶定位方法的全球市场展望

  • 市场规模及预测
    • 按金额
  • 市占率及预测
    • 依类型（放射性同位素立体定位手术、放射性导引潜在病灶立体定位手术（ROLL）、放射性分段种子立体定位手术（RSL）、磁性示踪手术、其他）
    • 按地区
    • 按公司（2025 年）
  • 市场地图

第六章：北美乳房病灶定位方法市场展望

  • 市场规模及预测
  • 市占率及预测
  • 北美洲：国别分析
    • 我们
    • 加拿大
    • 墨西哥

第七章：欧洲乳房病灶定位方法市场展望

  • 市场规模及预测
  • 市占率及预测
  • 欧洲：国别分析
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙

第八章：亚太地区乳房病灶定位方法市场展望

  • 市场规模及预测
  • 市占率及预测
  • 亚太地区：国别分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳洲

第九章：中东和非洲乳房病灶定位方法市场展望

  • 市场规模及预测
  • 市占率及预测
  • 中东与非洲：国别分析
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 南非

第十章：南美洲乳房病灶定位方法市场展望

  • 市场规模及预测
  • 市占率及预测
  • 南美洲：国别分析
    • 巴西
    • 哥伦比亚
    • 阿根廷

第十一章 市场动态

  • 促进因素
  • 任务

第十二章 市场趋势与发展

  • 併购
  • 产品发布
  • 近期趋势

第十三章 全球乳房病灶定位方法市场：SWOT分析

第十四章：波特五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的议价能力
  • 顾客权力
  • 替代品的威胁

第十五章 竞争格局

  • Argon Medical Devices Inc.
  • Biomedical Srl
  • Elucent Medical
  • GE HealthCare Technologies, Inc.
  • Koninklijke Philips NV
  • MDL SRL
  • Matek Medikal
  • IZI Medical Products LLC
  • IntraMedical Imaging LLC

第十六章 策略建议

第十七章：关于研究公司及免责声明

简介目录
Product Code: 28078

The Global Breast Lesion Localization Methods Market is projected to expand from USD 0.42 Billion in 2025 to USD 0.64 Billion by 2031, registering a compound annual growth rate (CAGR) of 7.27%. These localization methods encompass medical technologies developed to accurately mark non-palpable breast tumors or abnormalities, guiding surgeons during excision procedures. Growth in this sector is largely fueled by the increasing global prevalence of breast cancer and the widespread implementation of screening programs that identify early-stage lesions requiring precise localization. According to the American Cancer Society, an estimated 316,950 women in the United States were expected to be diagnosed with invasive breast cancer in 2025. This escalating patient volume underscores the necessity for dependable localization devices to ensure effective treatment while minimizing the removal of healthy tissue.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 0.42 Billion
Market Size 2031USD 0.64 Billion
CAGR 2026-20317.27%
Fastest Growing SegmentRadioisotope Localization
Largest MarketNorth America

A major obstacle hindering market growth is the significant cost difference between advanced wire-free technologies and traditional wire-guided systems. These higher expenses can impede adoption in smaller healthcare facilities or hospitals within developing regions that operate under limited budgets. Consequently, despite the clinical advantages offered by newer systems, financial limitations frequently force providers to depend on older, less expensive techniques.

Market Driver

The escalating global incidence of breast cancer acts as the main driver for the market, as increased case volumes create a direct demand for precise surgical interventions. With rising detection rates, healthcare systems are prioritizing early diagnosis, which requires reliable localization for non-palpable lesions. According to the World Health Organization's August 2025 update on key breast cancer facts, approximately 2.3 million women were diagnosed with the disease globally in 2022. This increase in diagnoses is further bolstered by strong participation in national screening programs, which successfully identify early-stage abnormalities needing excision. For example, NHS Digital reported in February 2025 regarding the 'Breast Screening Programme, England, 2023-24' that 70.0% of eligible women accepted their screening invitations, emphasizing the significant number of patients entering the diagnostic pathway who require accurate lesion marking.

Concurrently, the swift uptake of advanced wire-free localization technologies is transforming the procedural environment by overcoming the logistical and clinical drawbacks of traditional wire-guided methods. Radar and magnetic systems facilitate decoupled scheduling, permitting radiology and surgery to take place on separate days, which enhances hospital workflow efficiency and improves patient comfort. The market influence of this technological evolution is demonstrated by the rising usage of proprietary devices. As noted by Merit Medical Systems in their October 2025 'Q3 2025 Earnings Call Transcript', the company's Scout Radar Localization Technology has been utilized to treat 750,000 patients globally, indicating a robust clinical preference for non-radioactive, wire-free solutions. This shift not only improves surgical precision but also aligns with the broader movement toward minimally invasive breast-conserving surgeries.

Market Challenge

The central challenge obstructing the growth of the Global Breast Lesion Localization Methods Market is the substantial cost gap between advanced wire-free technologies and traditional wire-guided systems. Newer localization devices frequently involve high procurement and operational costs, creating significant financial hurdles for smaller healthcare facilities and community hospitals, especially in developing regions with constrained capital budgets. As a result, many medical providers are forced to value cost containment over technological advancements, relying on older and less expensive localization techniques despite the workflow inefficiencies inherent in these legacy methods.

This economic limitation directly constrains market revenue growth by dampening the adoption rate of high-value devices in areas where budget sensitivity is high. The inability to upgrade equipment due to financial pressures is particularly alarming given the severity of the disease burden. According to the American Cancer Society, it was projected that approximately 42,170 women in the United States would die from breast cancer in 2025. The persistence of these high costs hinders the widespread standardization of potentially more effective technologies, thereby stalling the overall momentum of the market.

Market Trends

The move away from radioisotope-based methods in strictly regulated regions is fundamentally changing the market landscape, especially in Europe and parts of Asia where nuclear medicine regulations are rigorous. Healthcare providers are increasingly replacing Iodine-125 radioactive seeds with non-radioactive magnetic and RFID-based alternatives to avoid complex safety protocols, radiation handling restrictions, and disposal mandates. This regulatory pressure has accelerated the replacement of legacy techniques, steering the market toward safer, implantable devices that are exempt from nuclear regulatory oversight. According to an article in The Annals of The Royal College of Surgeons of England from July 2025 titled 'Adoption of nonwire localisation devices in UK breast units', the use of wire-guided methods in UK breast units fell from 83% in 2020 to merely 18% in 2022, while non-wire devices increased to comprise 82% of procedures, illustrating the scale of this displacement.

Simultaneously, the rapid transition to wire-free localization technologies is being driven by improvements in surgical precision and lower re-excision rates, advancing beyond the initial motivation of workflow efficiency. Innovations in this sector are progressing from simple markers to patient-specific guidance systems tailored to the unique geometry of the breast, thereby enhancing tumor removal accuracy and reducing the necessity for secondary surgeries. This emphasis on clinical efficacy is fostering the adoption of custom-molded devices that offer detailed margin guidance during lumpectomies. As stated in a January 2026 press release by Cairn Surgical titled 'Cairn Surgical Announces Completion of Enrollment in U.S. Pivotal Trial', a multicenter study published in the Annals of Surgical Oncology showed that the company's Breast Cancer Locator System allowed surgeons to remove the entire tumor with negative margins in 94% of patients, a success rate surpassing typical outcomes for standard localization methods.

Key Market Players

  • Argon Medical Devices Inc.
  • Biomedical Srl
  • Elucent Medical
  • GE HealthCare Technologies, Inc.
  • Koninklijke Philips NV
  • MDL SRL
  • Matek Medikal
  • IZI Medical Products LLC
  • IntraMedical Imaging LLC

Report Scope

In this report, the Global Breast Lesion Localization Methods Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Breast Lesion Localization Methods Market, By Type

  • Radioisotope Localization
  • Radio Guided Occult-Lesion Localization (ROLL)
  • Radioactive-Seed Localization (RSL)
  • Magnetic Tracer
  • Others

Breast Lesion Localization Methods Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Breast Lesion Localization Methods Market.

Available Customizations:

Global Breast Lesion Localization Methods Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Breast Lesion Localization Methods Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Radioisotope Localization, Radio Guided Occult-Lesion Localization (ROLL), Radioactive-Seed Localization (RSL), Magnetic Tracer, Others)
    • 5.2.2. By Region
    • 5.2.3. By Company (2025)
  • 5.3. Market Map

6. North America Breast Lesion Localization Methods Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Breast Lesion Localization Methods Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
    • 6.3.2. Canada Breast Lesion Localization Methods Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
    • 6.3.3. Mexico Breast Lesion Localization Methods Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type

7. Europe Breast Lesion Localization Methods Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Breast Lesion Localization Methods Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
    • 7.3.2. France Breast Lesion Localization Methods Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
    • 7.3.3. United Kingdom Breast Lesion Localization Methods Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
    • 7.3.4. Italy Breast Lesion Localization Methods Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
    • 7.3.5. Spain Breast Lesion Localization Methods Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type

8. Asia Pacific Breast Lesion Localization Methods Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Breast Lesion Localization Methods Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
    • 8.3.2. India Breast Lesion Localization Methods Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
    • 8.3.3. Japan Breast Lesion Localization Methods Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
    • 8.3.4. South Korea Breast Lesion Localization Methods Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
    • 8.3.5. Australia Breast Lesion Localization Methods Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type

9. Middle East & Africa Breast Lesion Localization Methods Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Breast Lesion Localization Methods Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
    • 9.3.2. UAE Breast Lesion Localization Methods Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
    • 9.3.3. South Africa Breast Lesion Localization Methods Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type

10. South America Breast Lesion Localization Methods Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Breast Lesion Localization Methods Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
    • 10.3.2. Colombia Breast Lesion Localization Methods Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
    • 10.3.3. Argentina Breast Lesion Localization Methods Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Breast Lesion Localization Methods Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Argon Medical Devices Inc.
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Biomedical Srl
  • 15.3. Elucent Medical
  • 15.4. GE HealthCare Technologies, Inc.
  • 15.5. Koninklijke Philips NV
  • 15.6. MDL SRL
  • 15.7. Matek Medikal
  • 15.8. IZI Medical Products LLC
  • 15.9. IntraMedical Imaging LLC

16. Strategic Recommendations

17. About Us & Disclaimer