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市场调查报告书
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1744604

2032 年乳房病变定位市场预测：按类型、定位技术、应用、最终用户和地区进行的全球分析

Breast Lesion Localization Market Forecasts to 2032 - Global Analysis By Type, Localization Technique, Application, End User, and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，全球乳房病变定位市场预计在 2025 年将达到 3.053 亿美元，预计到 2032 年将达到 4.682 亿美元，预测期内的复合年增长率为 6.3%。

乳房病变定位是一种医疗程序，用于在手术切除前精确识别和标记乳房内的异常组织或肿瘤。导丝定位、放射性粒子定位和磁性标记等技术可引导外科医师找到病灶的精确位置，确保精准切除，同时保留健康组织。这个过程在乳癌的诊断和治疗中至关重要，可以改善手术效果，并最大限度地减少不必要的乳房组织切除。

根据美国癌症协会 (ACS) 统计，预计 2023 年美国将新增超过 28 万例浸润性乳癌病例，凸显了精确定位病变以指导手术介入的迫切需求。

乳癌发生率上升

乳癌仍然是女性最常见的癌症之一，对早期发现和准确定位病变的需求正在快速增长。病例激增提高了人们对乳癌的认识，并扩大了筛检计画的覆盖范围，促使人们采用先进的定位技术来提高诊断准确性和治疗效果。此外，影像和切片检查方法的技术进步确保了及时有效的干预，从而支持了这个市场的扩张。

有限的报销政策

严格的支付法规和先进在地化流程的有限覆盖范围阻碍了创新技术的广泛应用。这项挑战在开发中国家和资源受限的医疗保健环境中尤其严峻，因为现代设备的高昂前期成本进一步限制了其普及。此外，复杂的监管核准流程和缺乏统一的报销框架也阻碍了市场准入，并阻碍了对新本地化解决方案的投资，最终影响了患者获得尖端医疗服务的管道。

人工智慧与数位健康的融合

人工智慧影像和数据分析技术能够改善病变检测、分类和手术规划，从而改善患者预后并提高工作流程效率。此外，数位健康平台还能促进远距会诊和多专业团队之间的即时协作。随着医疗服务提供者越来越多地采用这些先进技术，技术创新、诊断准确性的提高以及更加个人化、以患者为中心的医疗服务潜力，市场有望加速成长。

对辐射暴露的担忧

许多定位技术，尤其是乳房X光摄影和基于放射性同位素的方法，会使患者暴露于电离辐射，这引发了患者和医疗保健提供者的安全疑虑。这种担忧可能导致患者在采用某些技术时犹豫不决，尤其是在重复手术和对辐射风险敏感的人群中。此外，监管监督和不断发展的安全指南可能会进一步限制基于辐射的定位技术的应用，并促使人们转向不使用辐射的替代技术。

COVID-19的影响：

新冠疫情严重扰乱了乳房病变定位市场，主要原因是择期手术延后，筛检量减少。许多乳房摄影影像机构的患者数量下降了80%至100%，大多数诊所推迟了乳房X光摄影筛检检查。这导致诊断延迟、就诊时肿瘤体积增大，以及放宽管制后病例暂时积压。此外，患者不愿前往医疗机构就诊，以及恢復常规护理的后勤挑战，也导致乳房摄影影像和定位服务恢復缓慢。

电线本地化细分市场预计将成为预测期内最大的细分市场

预计导丝定位技术将在预测期内占据最大的市场占有率。这项优势归功于其长期的临床认可度、经验证的有效性和成本效益。导丝定位技术被广泛用于引导外科医生找到难以触及的乳房病变，为大多数外科团队提供了一种可靠、简单且易于操作的方法。儘管新技术层出不穷，导丝定位技术凭藉其简便易行、易于操作且报销范围广等特点，仍受到全球医疗保健提供者的青睐。

预计门诊手术中心部分在预测期内将实现最高的复合年增长率。

预计门诊手术中心细分市场将在预测期内实现最高成长率，这得益于微创乳房手术越来越多地转向门诊，因为门诊手术可缩短患者恢復时间并降低费用。为了满足日益增长的高效、患者友善治疗需求，门诊手术中心越来越多地配备了先进的定位技术。此外，有限的医院预算和对优化手术室利用率的重视，进一步推动了这些中心乳房病变局部手术的采用。

占比最大的地区：

预计北美将在预测期内占据最大市场占有率，这得益于其强大的医疗基础设施、先进影像处理和定位技术的广泛采用以及主要行业参与者的参与。美国尤其受益于广泛的筛检项目、优惠的报销政策以及在研发方面的大量投资。此外，乳癌意识的提高和发病率的上升，持续推动对精准定位技术的需求，从而巩固了北美市场的主导地位。

复合年增长率最高的地区：

预计亚太地区在预测期内将呈现最高的复合年增长率。该地区的快速增长可归因于医疗基础设施的扩张、可支配收入的提高以及对乳癌早期发现意识的不断增强。中国、印度和日本等国家乳癌发生率的急剧上升，促使人们采用了先进的在地化技术。此外，政府措施、医疗旅游业的蓬勃发展以及对医疗可近性的重视，也推动市场的强劲扩张。

免费客製化服务：

订阅此报告的客户可享有以下免费自订选项之一：

  • 公司简介
    • 全面分析其他市场参与者（最多 3 家公司）
    • 主要企业的SWOT分析（最多3家公司）
  • 地理细分
    • 根据客户兴趣对主要国家市场进行估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 研究范围
  • 调查方法
    • 资料探勘
    • 数据分析
    • 数据检验
    • 研究途径
  • 研究材料
    • 主要研究资料
    • 次级研究资讯来源
    • 先决条件

第三章市场走势分析

  • 驱动程式
  • 限制因素
  • 机会
  • 威胁
  • 应用分析
  • 最终用户分析
  • 新兴市场
  • COVID-19的影响

第四章 波特五力分析

  • 供应商的议价能力
  • 买家的议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争对手之间的竞争

5. 全球乳房病变定位市场（按类型）

  • 电线位置
  • 放射性同位素的定位
    • 无线电引导隐匿性病变定位（ROLL）
    • 放射性种子定位（RSL）
  • 磁定位
  • 电磁定位
  • 其他类型

6. 全球乳房病变定位市场（依定位技术）

  • 超音波引导定位
  • MRI导引定位
  • 立体定位定位
  • 其他技术

7. 全球乳房病变定位市场（依应用）

  • 肿瘤识别
  • 前哨淋巴结检测
  • 切片检查指导
  • 其他用途

8. 全球乳房病变定位市场（依最终用户）

  • 医院
  • 门诊手术中心
  • 肿瘤诊所
  • 诊断中心
  • 学术研究所

9. 全球乳房病变定位市场（按地区）

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲地区

第十章 重大进展

  • 协议、伙伴关係、合作和合资企业
  • 收购与合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十一章 公司概况

  • Hologic, Inc.
  • Becton, Dickinson and Company
  • Merit Medical Systems, Inc.
  • Cianna Medical, Inc.
  • Cook Medical
  • Endomagnetics Ltd
  • Somatex Medical Technologies GmbH
  • Argon Medical Devices, Inc.
  • STERILAB Srl
  • Leica Biosystems Nussloch GmbH
  • GE Healthcare
  • Koninklijke Philips NV
  • Ambu A/S
  • Medline Industries Inc.
  • SurgicEye GmbH
  • Intra-Medical Imaging LLC
  • IsoAid, LLC
  • Mammotome
Product Code: SMRC29652

According to Stratistics MRC, the Global Breast Lesion Localization Market is accounted for $305.3 million in 2025 and is expected to reach $468.2 million by 2032 growing at a CAGR of 6.3% during the forecast period. Breast lesion localization is a medical procedure used to precisely identify and mark abnormal tissue or tumors within the breast before surgical removal. Techniques such as wire localization, radioactive seed localization, or magnetic markers guide surgeons to the exact lesion site, ensuring accurate excision while preserving healthy tissue. This process is crucial in breast cancer diagnosis and treatment, improving surgical outcomes and minimizing the removal of unnecessary breast tissue.

According to the American Cancer Society (ACS), over 280,000 new cases of invasive breast cancer were expected in the US in 2023, highlighting the critical need for accurate lesion localization to guide surgical interventions.

Market Dynamics:

Driver:

Rising incidence of breast cancer

Breast cancer remains one of the most commonly diagnosed cancers among women, and the demand for early detection and precise localization of lesions is growing rapidly. This surge in cases has led to heightened awareness and expanded screening programs, encouraging the adoption of advanced localization techniques to improve diagnostic accuracy and treatment outcomes. Furthermore, technological advancements in imaging and biopsy methods are supporting this market expansion, ensuring timely and effective interventions.

Restraint:

Limited reimbursement policies

Stringent payment regulations and restricted coverage for advanced localization procedures hinder the widespread adoption of innovative technologies. This challenge is particularly acute in developing countries and resource-constrained healthcare settings, where the high initial cost of modern devices further limits access. Additionally, complex regulatory approval processes and the lack of uniform reimbursement frameworks can delay market entry and discourage investment in new localization solutions, ultimately impacting patient access to cutting-edge care.

Opportunity:

Integration of AI and digital health

AI-driven imaging and data analytics are enhancing the precision of lesion detection, classification, and surgical planning, leading to improved patient outcomes and workflow efficiency. Moreover, digital health platforms facilitate remote consultations and real-time collaboration among multidisciplinary teams. As healthcare providers increasingly adopt these advanced technologies, the market is poised for accelerated growth, driven by innovation, improved diagnostic accuracy, and the potential for more personalized, patient-centric care.

Threat:

Concerns about radiation exposure

Many localization techniques, especially those relying on mammography or radioisotope-based methods, expose patients to ionizing radiation, raising safety concerns among both patients and healthcare providers. This apprehension can lead to hesitancy in adopting certain technologies, particularly for repeated procedures or in populations sensitive to radiation risks. Moreover, regulatory scrutiny and evolving safety guidelines may further restrict the use of radiation-based localization, prompting a shift toward alternative, non-radiative techniques.

Covid-19 Impact:

The Covid-19 pandemic significantly disrupted the breast lesion localization market, primarily due to the postponement of elective procedures and reduced screening volumes. Many breast imaging facilities experienced an 80%-100% decline in patient volume, with screening mammography delayed in most practices. This led to delayed diagnoses, increased tumor sizes at presentation, and a temporary backlog of cases once restrictions eased. Furthermore, patient hesitancy to visit healthcare facilities and logistical challenges in resuming routine care contributed to a prolonged recovery in breast imaging and localization services.

The wire localization segment is expected to be the largest during the forecast period

The wire localization segment is expected to account for the largest market share during the forecast period. This dominance is attributed to its longstanding clinical acceptance, proven efficacy, and cost-effectiveness. Wire localization is widely used for guiding surgeons to non-palpable breast lesions, offering a reliable and straightforward approach that is familiar to most surgical teams. Despite the emergence of newer technologies, the simplicity, accessibility, and established reimbursement for wire localization procedures ensure its continued preference among healthcare providers globally.

The ambulatory surgical centers segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the ambulatory surgical centers segment is predicted to witness the highest growth rate driven by the increasing shift of minimally invasive breast procedures to outpatient settings, where patients benefit from shorter recovery times and reduced costs. Ambulatory surgical centers are increasingly equipped with advanced localization technologies, catering to the growing demand for efficient, patient-friendly care. Additionally, limited hospital budgets and a focus on optimizing operating room utilization further propel the adoption of breast lesion localization procedures in these centers.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, driven by robust healthcare infrastructure, high adoption of advanced imaging and localization technologies, and the presence of major industry players. The United States, in particular, benefits from extensive screening programs, favorable reimbursement policies, and significant investments in research and development. Moreover, heightened awareness and the rising incidence of breast cancer ensure sustained demand for precise localization methods, reinforcing North America's dominant market position.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. The region's rapid growth is fueled by expanding healthcare infrastructure, rising disposable incomes, and increasing awareness of early breast cancer detection. Countries such as China, India, and Japan are experiencing a surge in breast cancer incidence, prompting greater adoption of advanced localization technologies. Additionally, government initiatives, growing medical tourism and a focus on improving healthcare accessibility are driving robust market expansion.

Key players in the market

Some of the key players in Breast Lesion Localization Market include Hologic, Inc., Becton, Dickinson and Company, Merit Medical Systems, Inc., Cianna Medical, Inc., Cook Medical, Endomagnetics Ltd, Somatex Medical Technologies GmbH, Argon Medical Devices, Inc., STERILAB S.r.l., Leica Biosystems Nussloch GmbH, GE Healthcare, Koninklijke Philips N.V., Ambu A/S, Medline Industries Inc., SurgicEye GmbH, Intra-Medical Imaging LLC, IsoAid, LLC and Mammotome.

Key Developments:

In April 2024, the Radiological Society of North America (RSNA) and GE HealthCare announced their collaboration to provide mammography technology, training and educational tools to radiologists at Muhimbili National Hospital (MNH), part of the Muhimbili University of Health and Sciences (MUHAS), in Tanzania to improve access to screening and help clinicians lower the country's breast cancer mortality rate.

In November 2023, GE HealthCare announced the release of a new, all-in-one platform of artificial intelligence (AI) apps to support clinicians with breast cancer detection and improved workflow productivity called MyBreastAI Suite*. With this initial release, MyBreastAI Suite integrates three AI applications from iCAD including ProFound AI for DBT, SecondLook for 2D Mammography and PowerLook Density Assessment to help support early detection and improve patient outcomes, as well as help radiology departments improve operational productivity.

Types Covered:

  • Wire Localization
  • Radioisotope Localization
  • Magnetic Localization
  • Electromagnetic Localization
  • Other Types

Localization Techniques Covered:

  • Ultrasound-guided Localization
  • MRI-guided Localization
  • Stereotactic-guided Localization
  • Other Techniques

Applications Covered:

  • Tumor Identification
  • Sentinel Lymph Node Detection
  • Biopsy Guidance
  • Other Applications

End Users Covered:

  • Hospitals
  • Ambulatory Surgical Centers
  • Oncology Clinics
  • Diagnostic Centers
  • Academic & Research Institutes

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Application Analysis
  • 3.7 End User Analysis
  • 3.8 Emerging Markets
  • 3.9 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Breast Lesion Localization Market, By Type

  • 5.1 Introduction
  • 5.2 Wire Localization
  • 5.3 Radioisotope Localization
    • 5.3.1 Radio-Guided Occult Lesion Localization (ROLL)
    • 5.3.2 Radioactive Seed Localization (RSL)
  • 5.4 Magnetic Localization
  • 5.5 Electromagnetic Localization
  • 5.6 Other Types

6 Global Breast Lesion Localization Market, By Localization Technique

  • 6.1 Introduction
  • 6.2 Ultrasound-guided Localization
  • 6.3 MRI-guided Localization
  • 6.4 Stereotactic-guided Localization
  • 6.5 Other Techniques

7 Global Breast Lesion Localization Market, By Application

  • 7.1 Introduction
  • 7.2 Tumor Identification
  • 7.3 Sentinel Lymph Node Detection
  • 7.4 Biopsy Guidance
  • 7.5 Other Applications

8 Global Breast Lesion Localization Market, By End User

  • 8.1 Introduction
  • 8.2 Hospitals
  • 8.3 Ambulatory Surgical Centers
  • 8.4 Oncology Clinics
  • 8.5 Diagnostic Centers
  • 8.6 Academic & Research Institutes

9 Global Breast Lesion Localization Market, By Geography

  • 9.1 Introduction
  • 9.2 North America
    • 9.2.1 US
    • 9.2.2 Canada
    • 9.2.3 Mexico
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 UK
    • 9.3.3 Italy
    • 9.3.4 France
    • 9.3.5 Spain
    • 9.3.6 Rest of Europe
  • 9.4 Asia Pacific
    • 9.4.1 Japan
    • 9.4.2 China
    • 9.4.3 India
    • 9.4.4 Australia
    • 9.4.5 New Zealand
    • 9.4.6 South Korea
    • 9.4.7 Rest of Asia Pacific
  • 9.5 South America
    • 9.5.1 Argentina
    • 9.5.2 Brazil
    • 9.5.3 Chile
    • 9.5.4 Rest of South America
  • 9.6 Middle East & Africa
    • 9.6.1 Saudi Arabia
    • 9.6.2 UAE
    • 9.6.3 Qatar
    • 9.6.4 South Africa
    • 9.6.5 Rest of Middle East & Africa

10 Key Developments

  • 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 10.2 Acquisitions & Mergers
  • 10.3 New Product Launch
  • 10.4 Expansions
  • 10.5 Other Key Strategies

11 Company Profiling

  • 11.1 Hologic, Inc.
  • 11.2 Becton, Dickinson and Company
  • 11.3 Merit Medical Systems, Inc.
  • 11.4 Cianna Medical, Inc.
  • 11.5 Cook Medical
  • 11.6 Endomagnetics Ltd
  • 11.7 Somatex Medical Technologies GmbH
  • 11.8 Argon Medical Devices, Inc.
  • 11.9 STERILAB S.r.l.
  • 11.10 Leica Biosystems Nussloch GmbH
  • 11.11 GE Healthcare
  • 11.12 Koninklijke Philips N.V.
  • 11.13 Ambu A/S
  • 11.14 Medline Industries Inc.
  • 11.15 SurgicEye GmbH
  • 11.16 Intra-Medical Imaging LLC
  • 11.17 IsoAid, LLC
  • 11.18 Mammotome

List of Tables

  • Table 1 Global Breast Lesion Localization Market Outlook, By Region (2024-2032) ($MN)
  • Table 2 Global Breast Lesion Localization Market Outlook, By Type (2024-2032) ($MN)
  • Table 3 Global Breast Lesion Localization Market Outlook, By Wire Localization (2024-2032) ($MN)
  • Table 4 Global Breast Lesion Localization Market Outlook, By Radioisotope Localization (2024-2032) ($MN)
  • Table 5 Global Breast Lesion Localization Market Outlook, By Radio-Guided Occult Lesion Localization (ROLL) (2024-2032) ($MN)
  • Table 6 Global Breast Lesion Localization Market Outlook, By Radioactive Seed Localization (RSL) (2024-2032) ($MN)
  • Table 7 Global Breast Lesion Localization Market Outlook, By Magnetic Localization (2024-2032) ($MN)
  • Table 8 Global Breast Lesion Localization Market Outlook, By Electromagnetic Localization (2024-2032) ($MN)
  • Table 9 Global Breast Lesion Localization Market Outlook, By Other Types (2024-2032) ($MN)
  • Table 10 Global Breast Lesion Localization Market Outlook, By Localization Technique (2024-2032) ($MN)
  • Table 11 Global Breast Lesion Localization Market Outlook, By Ultrasound-guided Localization (2024-2032) ($MN)
  • Table 12 Global Breast Lesion Localization Market Outlook, By MRI-guided Localization (2024-2032) ($MN)
  • Table 13 Global Breast Lesion Localization Market Outlook, By Stereotactic-guided Localization (2024-2032) ($MN)
  • Table 14 Global Breast Lesion Localization Market Outlook, By Other Techniques (2024-2032) ($MN)
  • Table 15 Global Breast Lesion Localization Market Outlook, By Application (2024-2032) ($MN)
  • Table 16 Global Breast Lesion Localization Market Outlook, By Tumor Identification (2024-2032) ($MN)
  • Table 17 Global Breast Lesion Localization Market Outlook, By Sentinel Lymph Node Detection (2024-2032) ($MN)
  • Table 18 Global Breast Lesion Localization Market Outlook, By Biopsy Guidance (2024-2032) ($MN)
  • Table 19 Global Breast Lesion Localization Market Outlook, By Other Applications (2024-2032) ($MN)
  • Table 20 Global Breast Lesion Localization Market Outlook, By End User (2024-2032) ($MN)
  • Table 21 Global Breast Lesion Localization Market Outlook, By Hospitals (2024-2032) ($MN)
  • Table 22 Global Breast Lesion Localization Market Outlook, By Ambulatory Surgical Centers (2024-2032) ($MN)
  • Table 23 Global Breast Lesion Localization Market Outlook, By Oncology Clinics (2024-2032) ($MN)
  • Table 24 Global Breast Lesion Localization Market Outlook, By Diagnostic Centers (2024-2032) ($MN)
  • Table 25 Global Breast Lesion Localization Market Outlook, By Academic & Research Institutes (2024-2032) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.