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市场调查报告书
商品编码
1965386

数位乳房断层合成设备市场－全球产业规模、份额、趋势、机会、预测：按产品类型、最终用户、地区和竞争对手划分，2021-2031年

Digital Breast Tomosynthesis Equipment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By End-User, 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

全球数位乳房断层合成设备市场预计将从 2025 年的 35.2 亿美元成长到 2031 年的 63.1 亿美元，复合年增长率为 10.22%。

作为诊断技术，数位乳房断层合成技术能够从不同角度拍摄多张X光片，并重建乳房组织的三维截面影像。市场成长的主要驱动力是乳癌发生率的不断上升，以及临床医生对这种在緻密乳房组织病变检测方面比传统乳房X光摄影更具精准度的技术的强烈偏好。此外，各国政府强制推行定期筛检政策，也持续推动全球医疗机构对这些先进诊断系统的需求。

市场概览
预测期 2027-2031
市场规模：2025年 35.2亿美元
市场规模：2031年 63.1亿美元
复合年增长率：2026-2031年 10.22%
成长最快的细分市场 2D/3D联合乳房X光摄影系统
最大的市场 北美洲

儘管存在这些积极迹象，但断层合成设备高的购买和营运成本仍然是市场扩张的主要障碍。这限制了其在资源匮乏环境中的应用。即使疾病负担日益加重，对先进早期检测能力的需求也日益迫切，但这一经济障碍依然存在。美国癌症协会估计，到2024年，美国女性将新增约310,720例浸润性乳癌病例，凸显了对便利有效的诊断解决方案的迫切需求，也印证了这项需求的严峻性。

市场驱动因素

技术创新和人工智慧 (AI) 的整合正在透过提高诊断准确性和优化临床工作流程，改变全球数位乳房断层合成设备市场。将 AI 引入 3D乳房X光摄影系统，能够有效应对解读容积数据的复杂挑战，降低假阳性率，并减轻放射科医生的疲劳。利用深度学习演算法，可以更精准地辨识緻密组织中那些常被传统方法忽略的细微恶性肿瘤。作为这项进展的佐证，iCAD 公司于 2024 年 11 月报告称，其获得 FDA 批准的 ProFound Detection 4.0 版软体的受试者工作特征曲线下面积(AUC) 提高了 6.3%，凸显了现代 AI 增强型解决方案的显着。

同时，全球乳癌发生率的上升是推动断层合成设备广泛应用的主要动力，也因此亟需建立更完善的全球筛检体系。医疗机构正在加速向三维成像技术转型，以应对不断增长的患者群体，并透过早期检测提高存活率。世界卫生组织（WHO）于2024年2月发布的数据显示，乳癌是全球第二大常见癌症，2022年新增病例约230万例。长期市场趋势也印证了这日益加重的疾病负担。美国癌症协会于2024年10月发布报告称，2012年至2021年间，乳癌发生率年均增长1%，这一趋势凸显了对能够精准应对日益增长的筛检需求的先进诊断设备的持续需求。

市场挑战

实施和维护数位乳房断层合成系统所需的大量资本投入是限制市场成长的主要阻碍因素。许多医疗机构，特别是新兴经济体的区域医院和医疗机构，难以负担这些三维成像系统的费用，因为它们比标准乳房X光摄影设备更昂贵。这种价格差异迫使许多机构放弃投资新技术，转而延长现有设备的使用寿命，从而有效地阻碍了价格敏感型市场对数位乳房断层合成系统的广泛应用。

影像服务报销率持续下调，加剧了这项经济挑战，限制了用于升级资本设备的资金。据美国放射学会称，2024年联邦医疗保险（Medicare）医生报销表中的转换係数同比下降了约1.69%。如此低的报销水准限制了放射科诊所收回断层合成设备高昂的初始成本和营运成本的财务能力，直接阻碍了全球市场的预期扩张。

市场趋势

该领域的一个显着趋势是采用针对高密度乳房组织的个人化筛检通讯协定，这正在显着影响筹资策略。这项转变主要源自于新规的实施，新规强制要求告知乳房密度，迫使医疗机构优先选择数位乳房断层合成（DBT）而非传统的二维乳房X光摄影来检查纤维组织患者。与可能掩盖病灶的标准检查方式不同，断层合成技术能够提供满足这些新的患者照护标准所需的深度解析度。例如，为了说明这项要求的重要性，《私人健康管理》杂誌在2024年10月针对美国食品药物管理局（FDA）的新规指出，近一半40岁以上的女性患有高密度乳房组织，这凸显了庞大的患者群体需要先进的三维成像技术来进行正确诊断。

同时，市场正经历着向高性能3D断层合成系统的强劲转变。这主要是由于医疗机构以更有效率、高通量的技术取代老旧设备所致。随着医疗机构升级到能够产生合成2D影像和进行高速扫描的高阶机架系统，製造商的资本投资销售持续成长。即使在经济压力日益增大的情况下，这些系统仍然是产生收入资产的重点。这种强劲的硬体投资也体现在近期的企业获利中。 2024年7月，Hologic公司公布其乳房健康部门的营收年增6.9%，主要得益于机架销售和业务收益的强劲成长。这些数据表明，医疗服务提供者正在持续投资最先进的系统，以保持其诊断标准的竞争力。

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：全球数位乳房断层合成设备市场展望

  • 市场规模及预测
    • 按金额
  • 市占率及预测
    • 产品类型（2D/3D组合式乳房X光摄影系统、独立式3D乳房X光摄影系统）
    • 依最终使用者（医院、诊断中心和其他最终使用者）划分
    • 按地区
    • 按公司（2025 年）
  • 市场地图

第六章：北美数位乳房断层合成设备市场展望

  • 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：欧洲数位乳房断层合成设备市场展望

  • 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：亚太地区数位乳房断层合成设备市场展望

  • 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：中东和非洲数位乳房断层合成设备市场展望

  • 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：南美洲数位乳房断层合成设备市场展望

  • 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：全球数位乳房断层合成设备市场：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

  • PerkinElmer Inc.
  • Hologic, Inc
  • GE HealthCare Technologies Inc.
  • Fujifilm Holdings Corporation
  • Siemens Healthineers
  • General Medical Merate SpA
  • Varex Imaging Corporation
  • Trivitron Healthcare
  • Metaltronica Spa
  • Analogic Corporation

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: 23908

The Global Digital Breast Tomosynthesis Equipment Market is projected to expand from USD 3.52 Billion in 2025 to USD 6.31 Billion by 2031, reflecting a compound annual growth rate of 10.22%. As a diagnostic modality, digital breast tomosynthesis functions by capturing multiple X-ray images from various angles to reconstruct three-dimensional cross-sectional views of breast tissue. The market's growth is largely driven by the increasing prevalence of breast cancer and a strong clinical preference for technologies that provide superior accuracy in detecting lesions within dense breast tissue compared to conventional mammography. Furthermore, the implementation of government initiatives mandating regular screening programs continues to strengthen the demand for these advanced diagnostic systems in healthcare facilities globally.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 3.52 Billion
Market Size 2031USD 6.31 Billion
CAGR 2026-203110.22%
Fastest Growing Segment2D/3D Combination Mammography Systems
Largest MarketNorth America

Despite these positive indicators, a significant hurdle to broader market growth remains the substantial acquisition and operational costs linked to tomosynthesis equipment, which restricts adoption in resource-limited environments. This financial obstacle persists even as the rising disease burden creates an urgent need for advanced early detection capabilities. Highlighting the severity of this demand, the American Cancer Society estimated that in 2024, approximately 310,720 new cases of invasive breast cancer would be diagnosed among women in the United States, underscoring the critical necessity for accessible and effective diagnostic solutions.

Market Driver

Technological innovations and the integration of artificial intelligence are transforming the Global Digital Breast Tomosynthesis Equipment Market by refining diagnostic precision and optimizing clinical workflows. The incorporation of AI into 3D mammography systems tackles the difficulty of interpreting complex volumetric data, thereby lowering false-positive rates and alleviating radiologist fatigue. By utilizing deep learning algorithms, these systems demonstrate improved proficiency in identifying subtle malignancies within dense tissue that might otherwise be overlooked by traditional methods. As evidence of this advancement, iCAD, Inc. reported in November 2024 that their FDA-cleared ProFound Detection Version 4.0 software achieved a 6.3% improvement in the area under the receiver operating characteristic curve (AUC), highlighting the measurable benefits of modern AI-enhanced solutions.

Simultaneously, the rising global incidence of breast cancer serves as a primary driver for the widespread adoption of tomosynthesis equipment, creating a need for more robust worldwide screening infrastructures. Healthcare providers are increasingly shifting toward 3D modalities to manage expanding patient volumes and secure better survival outcomes through earlier detection. According to the World Health Organization in February 2024, breast cancer was the second most common cancer globally, with roughly 2.3 million new cases diagnosed in 2022. This growing disease burden is further confirmed by long-term market trends; the American Cancer Society noted in October 2024 that breast cancer incidence rates rose by 1% annually from 2012 to 2021, a trajectory that reinforces the continued demand for advanced diagnostic equipment capable of handling higher screening loads with precision.

Market Challenge

The significant capital expenditure necessary to acquire and maintain digital breast tomosynthesis systems acts as a major constraint on market growth. Many healthcare providers, especially community hospitals and facilities in emerging economies, struggle to afford the premium costs of these three-dimensional imaging modalities compared to standard mammography units. This price gap compels many organizations to prolong the lifespan of legacy equipment instead of investing in newer technology, effectively halting widespread adoption in price-sensitive markets.

This economic challenge is further exacerbated by continuous downward pressure on reimbursement rates for imaging services, which restricts funds available for capital equipment upgrades. According to the American College of Radiology, the Medicare Physician Fee Schedule conversion factor decreased by approximately 1.69 percent in 2024 compared to the previous year. Such reductions in reimbursement levels limit the financial capacity of radiology practices to recoup the high acquisition and operational expenses associated with tomosynthesis equipment, thereby directly obstructing the projected expansion of the global market.

Market Trends

A defining trend in the sector is the adoption of personalized screening protocols for dense breast tissue, which is significantly shaping procurement strategies. This shift is largely driven by recently enforced regulations mandating breast density notification, compelling healthcare providers to prioritize Digital Breast Tomosynthesis (DBT) over traditional 2D mammography for patients with fibroglandular tissue. Unlike standard modalities where lesions may be hidden, tomosynthesis provides the depth resolution needed to meet these new patient-care standards. Highlighting the extent of this requirement, Private Health Management noted in October 2024 regarding a new FDA rule that nearly half of women over 40 possesses dense breast tissue, emphasizing the vast population now requiring these advanced 3D imaging capabilities for adequate diagnosis.

In parallel, the market is experiencing a strong shift toward high-performance 3D tomosynthesis systems as facilities replace aging installed bases with more efficient, high-throughput technology. Manufacturers are seeing sustained momentum in capital equipment sales as providers upgrade to premium gantries that offer synthesized 2D imaging and faster scan times, prioritizing these revenue-generating assets despite broader economic pressures. This resilience in hardware investment is reflected in recent corporate results; Hologic, Inc. reported in July 2024 that Breast Health revenue increased by 6.9% year-over-year, a rise primarily driven by robust gantry sales and service revenue. This data signals a continued commitment from healthcare providers to invest in state-of-the-art systems to uphold competitive diagnostic standards.

Key Market Players

  • PerkinElmer Inc.
  • Hologic, Inc
  • GE HealthCare Technologies Inc.
  • Fujifilm Holdings Corporation
  • Siemens Healthineers
  • General Medical Merate SpA
  • Varex Imaging Corporation
  • Trivitron Healthcare
  • Metaltronica Spa
  • Analogic Corporation

Report Scope

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

Digital Breast Tomosynthesis Equipment Market, By Product Type

  • 2D/3D Combination Mammography Systems
  • Standalone 3D Mammography Systems

Digital Breast Tomosynthesis Equipment Market, By End-User

  • Hospitals
  • Diagnostic Centers
  • Other End-Users

Digital Breast Tomosynthesis Equipment 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 Digital Breast Tomosynthesis Equipment Market.

Available Customizations:

Global Digital Breast Tomosynthesis Equipment 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 Digital Breast Tomosynthesis Equipment Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Product Type (2D/3D Combination Mammography Systems, Standalone 3D Mammography Systems)
    • 5.2.2. By End-User (Hospitals, Diagnostic Centers, Other End-Users)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Digital Breast Tomosynthesis Equipment Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Product Type
    • 6.2.2. By End-User
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Digital Breast Tomosynthesis Equipment 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 Product Type
        • 6.3.1.2.2. By End-User
    • 6.3.2. Canada Digital Breast Tomosynthesis Equipment 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 Product Type
        • 6.3.2.2.2. By End-User
    • 6.3.3. Mexico Digital Breast Tomosynthesis Equipment 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 Product Type
        • 6.3.3.2.2. By End-User

7. Europe Digital Breast Tomosynthesis Equipment Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Product Type
    • 7.2.2. By End-User
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Digital Breast Tomosynthesis Equipment 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 Product Type
        • 7.3.1.2.2. By End-User
    • 7.3.2. France Digital Breast Tomosynthesis Equipment 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 Product Type
        • 7.3.2.2.2. By End-User
    • 7.3.3. United Kingdom Digital Breast Tomosynthesis Equipment 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 Product Type
        • 7.3.3.2.2. By End-User
    • 7.3.4. Italy Digital Breast Tomosynthesis Equipment 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 Product Type
        • 7.3.4.2.2. By End-User
    • 7.3.5. Spain Digital Breast Tomosynthesis Equipment 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 Product Type
        • 7.3.5.2.2. By End-User

8. Asia Pacific Digital Breast Tomosynthesis Equipment Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Product Type
    • 8.2.2. By End-User
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Digital Breast Tomosynthesis Equipment 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 Product Type
        • 8.3.1.2.2. By End-User
    • 8.3.2. India Digital Breast Tomosynthesis Equipment 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 Product Type
        • 8.3.2.2.2. By End-User
    • 8.3.3. Japan Digital Breast Tomosynthesis Equipment 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 Product Type
        • 8.3.3.2.2. By End-User
    • 8.3.4. South Korea Digital Breast Tomosynthesis Equipment 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 Product Type
        • 8.3.4.2.2. By End-User
    • 8.3.5. Australia Digital Breast Tomosynthesis Equipment 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 Product Type
        • 8.3.5.2.2. By End-User

9. Middle East & Africa Digital Breast Tomosynthesis Equipment Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Product Type
    • 9.2.2. By End-User
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Digital Breast Tomosynthesis Equipment 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 Product Type
        • 9.3.1.2.2. By End-User
    • 9.3.2. UAE Digital Breast Tomosynthesis Equipment 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 Product Type
        • 9.3.2.2.2. By End-User
    • 9.3.3. South Africa Digital Breast Tomosynthesis Equipment 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 Product Type
        • 9.3.3.2.2. By End-User

10. South America Digital Breast Tomosynthesis Equipment Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Product Type
    • 10.2.2. By End-User
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Digital Breast Tomosynthesis Equipment 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 Product Type
        • 10.3.1.2.2. By End-User
    • 10.3.2. Colombia Digital Breast Tomosynthesis Equipment 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 Product Type
        • 10.3.2.2.2. By End-User
    • 10.3.3. Argentina Digital Breast Tomosynthesis Equipment 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 Product Type
        • 10.3.3.2.2. By End-User

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 Digital Breast Tomosynthesis Equipment 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. PerkinElmer 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. Hologic, Inc
  • 15.3. GE HealthCare Technologies Inc.
  • 15.4. Fujifilm Holdings Corporation
  • 15.5. Siemens Healthineers
  • 15.6. General Medical Merate SpA
  • 15.7. Varex Imaging Corporation
  • 15.8. Trivitron Healthcare
  • 15.9. Metaltronica Spa
  • 15.10. Analogic Corporation

16. Strategic Recommendations

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