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1965912

乳房病灶定位方法市場－全球產業規模、佔有率、趨勢、機會、預測：按類型、地區和競爭格局分類，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個工作天內

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簡介目錄

全球乳房病灶定位技術市場預計將從 2025 年的 4.2 億美元成長到 2031 年的 6.4 億美元，複合年成長率為 7.27%。

這些定位技術包括用於精確標記無法觸及的乳房腫瘤和異常病變的醫療技術，可在切除過程中指導外科醫生。該領域的發展主要受全球乳癌發病率上升以及篩檢計畫廣泛實施的推動，這些篩檢計畫旨在識別需要精確定位的早期病變。根據美國癌症協會 (ACS) 估計，到 2025 年，美國預計將有 316,950 名女性被診斷出罹患侵襲性乳癌。不斷成長的患者群體凸顯了對可靠定位設備的迫切需求，以確保有效治療的同時，最大限度地減少對健康組織的切除。

市場概覽
預測期 2027-2031
市場規模：2025年 4.2億美元
市場規模：2031年 6.4億美元
複合年成長率：2026-2031年 7.27%
成長最快的細分市場 利用放射性同位素進行定位
最大的市場 北美洲

阻礙市場成長的主要障礙是先進無線技術與傳統有線系統之間的顯著成本差異。高昂的成本可能會阻礙預算有限的小規模醫療機構和發展中地區醫院採用這些技術。因此，儘管新系統具有許多臨床優勢，但資金限制往往迫使醫療機構繼續依賴成本較低的舊技術。

市場促進因素

全球乳癌發生率的上升是推動市場發展的主要因素。病例的增加直接催生了對精準手術介入的需求。隨著篩檢率的提高，醫療系統正將早期診斷放在優先位置，而這需要對不可觸及的病變進行可靠的定位。根據世界衛生組織（世衛組織）於2025年8月發布的《乳癌最新關鍵事實》，2022年全球約有230萬名女性被診斷出罹患乳癌。國家篩檢計畫的高參與率進一步推動了診斷病例的增加，這些計畫能夠有效識別需要手術切除的早期異常病變。例如，英國國家醫療服務體系（NHS）數位部門在其於2025年2月發布的《英格蘭乳癌篩檢計畫（2023-2024）》報告中指出，70.0%的符合條件的女性接受了篩檢邀請，這凸顯了大量進入診斷流程的患者需要進行精準的病變標記。

同時，先進的無線立體定位技術的快速普及正在改變治療環境，克服了傳統導絲引導方法在後勤和臨床方面的挑戰。雷達和磁性系統能夠實現獨立排班，使放射檢查和手術可以在不同日期進行，從而提高醫院的工作流程效率並提升病患的舒適度。這項技術進步的市場影響體現在專有設備的使用量不斷增加。正如 Merritt Medical Systems 在 2025 年 10 月發布的「2025 年第三季收益報告」中所述，該公司 Scout 雷達立體定位技術已在全球範圍內用於治療 75 萬名患者，這表明臨床上對非放射性、無線解決方案有著強烈的偏好。這種轉變不僅有助於提升手術精確度，也符合微創乳房保留手術的整體趨勢。

市場挑戰

限制全球乳房病灶定位（IST）市場成長的一大挑戰是先進無線技術與傳統有線系統之間存在顯著的成本差距。新型IST設備的購買和營運成本通常較高，這對小規模醫療機構和地區醫院構成了巨大的經濟負擔，尤其是在資本預算有限的發展中地區。因此，許多醫療機構被迫優先考慮成本控制而非技術進步，繼續使用過時但成本較低、且工作流程效率低的IST技術。

這些經濟限制因素直接阻礙了市場收入成長，降低了預算緊張地區高價值設備的普及率。鑑於疾病負擔的嚴重性，因經濟壓力而無法進行設備升級的情況尤其令人擔憂。根據美國癌症協會預測，到2025年，美國約有42,170名女性將死於乳癌。持續高成本阻礙了更有效技術的廣泛普及，並減緩了整體市場的發展勢頭。

市場趨勢

在監管嚴格的地區，逐步淘汰放射性同位素方法正在從根本上改變市場格局，尤其是在核子醫學監管嚴格的歐洲和亞洲部分地區。醫療機構正擴大用非放射性磁性或射頻識別（RFID）技術取代碘-125放射性粒子，以規避複雜的安全通訊協定、輻射處理限制和處置義務。這種監管壓力正在加速傳統技術的淘汰，市場正朝著安全、可植入且不受核能法規約束的設備發展。根據發表於2025年7月英國皇家外科醫師學會年度報告《英國乳房護理機構非導絲立體定向設備的採用情況》中的一篇論文，英國英國英國機構英國從2020年的83%下降到2022年的18%，而非導絲設備的使用率則上升到82%，這充分說明了這種替代的規模之大。

同時，無線定位技術的快速發展已超越了最初提高工作流程效率的初衷，其主要驅動力在於提升手術精準度和降低二次切除率。該領域的創新正從簡單的標記物發展到針對乳房獨特形狀量身定做的患者專屬引導系統，從而提高腫瘤切除的精準度並減少二次手術的需求。這種對臨床療效的關注推動了定製成型設備的應用，這些設備可在部分乳房切除術中提供精確的切緣引導。正如凱恩外科公司在2026年1月發布的題為“美國一項關鍵臨床試驗完成入組”的新聞稿中所述，一項發表於《外科腫瘤學年鑑》的多中心研究表明，外科醫生使用該公司的乳癌定位系統，在94%的患者中實現了腫瘤完全切除且切緣陰性。這一成功率遠超過標準定位方法的典型結果。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：乳房病灶定位方法的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依類型（放射性同位素立體定位手術、放射性導引潛在病灶立體定位手術（ROLL）、放射性分段種子立體定位手術（RSL）、磁性示蹤手術、其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美乳房病灶定位方法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲乳房病灶定位方法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區乳房病灶定位方法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲乳房病灶定位方法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲乳房病灶定位方法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章 全球乳房病灶定位方法市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • 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16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
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