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市場調查報告書
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1744604

2032 年乳房病變定位市場預測:按類型、定位技術、應用、最終用戶和地區進行的全球分析

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個工作天內

價格

根據 Stratistics MRC 的數據,全球乳房病變定位市場預計在 2025 年將達到 3.053 億美元,預計到 2032 年將達到 4.682 億美元,預測期內的複合年成長率為 6.3%。

乳房病變定位是一種醫療程序,用於在手術切除前精確識別和標記乳房內的異常組織或腫瘤。導絲定位、放射性粒子定位和磁性標記等技術可引導外科醫師找到病灶的精確位置,確保精準切除,同時保留健康組織。這個過程在乳癌的診斷和治療中至關重要,可以改善手術效果,並最大限度地減少不必要的乳房組織切除。

根據美國癌症協會 (ACS) 統計,預計 2023 年美國將新增超過 28 萬例浸潤性乳癌病例,凸顯了精確定位病變以指導手術介入的迫切需求。

乳癌發生率上升

乳癌仍然是女性最常見的癌症之一,對早期發現和準確定位病變的需求正在快速成長。病例激增提高了人們對乳癌的認知,並擴大了篩檢計畫的覆蓋範圍,促使人們採用先進的定位技術來提高診斷準確性和治療效果。此外,影像和切片檢查方法的技術進步確保了及時有效的干涉,從而支持了這個市場的擴張。

有限的報銷政策

嚴格的支付法規和先進在地化流程的有限覆蓋範圍阻礙了創新技術的廣泛應用。這項挑戰在開發中國家和資源受限的醫療保健環境中尤其嚴峻,因為現代設備的高昂前期成本進一步限制了其普及。此外,複雜的監管核准流程和缺乏統一的報銷框架也阻礙了市場准入,並阻礙了對新本地化解決方案的投資,最終影響了患者獲得尖端醫療服務的管道。

人工智慧與數位健康的融合

人工智慧影像和數據分析技術能夠改善病變檢測、分類和手術規劃,從而改善患者預後並提高工作流程效率。此外,數位健康平台還能促進遠距會診和多專業團隊之間的即時協作。隨著醫療服務提供者擴大採用這些先進技術,技術創新、診斷準確性的提高以及更加個人化、以患者為中心的醫療服務潛力,市場有望加速成長。

對輻射暴露的擔憂

許多定位技術,尤其是乳房X光攝影和基於放射性同位素的方法,會使患者暴露於電離輻射,這引發了患者和醫療保健提供者的安全疑慮。這種擔憂可能導致患者在採用某些技術時猶豫不決,尤其是在重複手術和對輻射風險敏感的人群中。此外,監管監督和不斷發展的安全指南可能會進一步限制基於輻射的定位技術的應用,並促使人們轉向不使用輻射的替代技術。

COVID-19的影響:

新冠疫情嚴重擾亂了乳房病變定位市場,主要原因是擇期手術延後,篩檢量減少。許多乳房攝影影像機構的患者數量下降了80%至100%,大多數診所推遲了乳房X光攝影篩檢檢查。這導致診斷延遲、就診時腫瘤體積增大,以及放寬管制後病例暫時積壓。此外,患者不願前往醫療機構就診,以及恢復常規護理的後勤挑戰,也導致乳房攝影影像和定位服務恢復緩慢。

電線本地化細分市場預計將成為預測期內最大的細分市場

預計導絲定位技術將在預測期內佔據最大的市場佔有率。這項優勢歸功於其長期的臨床認可度、經驗證的有效性和成本效益。導絲定位技術被廣泛用於引導外科醫生找到難以觸及的乳房病變,為大多數外科團隊提供了一種可靠、簡單且易於操作的方法。儘管新技術層出不窮,導絲定位技術憑藉其簡便易行、易於操作且報銷範圍廣等特點,仍受到全球醫療保健提供者的青睞。

預計門診手術中心部分在預測期內將實現最高的複合年成長率。

預計門診手術中心細分市場將在預測期內實現最高成長率,這得益於微創乳房手術擴大轉向門診,因為門診手術可縮短患者恢復時間並降低費用。為了滿足日益成長的高效、患者友善治療需求,門診手術中心擴大配備了先進的定位技術。此外,有限的醫院預算和對最佳化手術室利用率的重視,進一步推動了這些中心乳房病變局部手術的採用。

佔比最大的地區:

預計北美將在預測期內佔據最大市場佔有率,這得益於其強大的醫療基礎設施、先進影像處理和定位技術的廣泛採用以及主要行業參與者的參與。美國尤其受益於廣泛的篩檢項目、優惠的報銷政策以及在研發方面的大量投資。此外,乳癌意識的提高和發病率的上升,持續推動對精準定位技術的需求,從而鞏固了北美市場的主導地位。

複合年成長率最高的地區:

預計亞太地區在預測期內將呈現最高的複合年成長率。該地區的快速成長可歸因於醫療基礎設施的擴張、可支配收入的提高以及對乳癌早期發現意識的不斷增強。中國、印度和日本等國家乳癌發生率的急劇上升,促使人們採用了先進的在地化技術。此外,政府措施、醫療旅遊業的蓬勃發展以及對醫療可近性的重視,也推動市場的強勁擴張。

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目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 研究範圍
  • 調查方法
    • 資料探勘
    • 數據分析
    • 數據檢驗
    • 研究途徑
  • 研究材料
    • 主要研究資料
    • 次級研究資訊來源
    • 先決條件

第3章市場走勢分析

  • 驅動程式
  • 限制因素
  • 機會
  • 威脅
  • 應用分析
  • 最終用戶分析
  • 新興市場
  • COVID-19的影響

第4章 波特五力分析

  • 供應商的議價能力
  • 買家的議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭對手之間的競爭

5. 全球乳房病變定位市場(按類型)

  • 電線位置
  • 放射性同位素的定位
    • 無線電引導隱匿性病變定位(ROLL)
    • 放射性種子定位(RSL)
  • 磁定位
  • 電磁定位
  • 其他類型

6. 全球乳房病變定位市場(依定位技術)

  • 超音波引導定位
  • MRI導引定位
  • 立體定位定位
  • 其他技術

7. 全球乳房病變定位市場(依應用)

  • 腫瘤識別
  • 前哨淋巴結檢測
  • 切片檢查指導
  • 其他用途

8. 全球乳房病變定位市場(依最終用戶)

  • 醫院
  • 門診手術中心
  • 腫瘤診所
  • 診斷中心
  • 學術研究所

9. 全球乳房病變定位市場(按地區)

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲地區

第10章 重大進展

  • 協議、夥伴關係、合作和合資企業
  • 收購與合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第11章 公司概況

  • 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.