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市场调查报告书

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1634220

全球乳房切片设备市场 - 2025 - 2033

Global Breast Biopsy Devices Market - 2025 - 2033

出版日期: 2025年01月13日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2024年，全球乳房切片设备市场规模达22.5亿美元，预计2033年将达到37.7亿美元，2025-2033年预测期间复合年增长率为6.1%。

乳房切片检查是一种医疗程序，包括出于诊断目的取出微小的乳房组织样本。这种治疗对于确定乳房中检测到的问题是恶性还是良性是必要的。专门利用实验室测试来诊断疾病的病理学家会分析组织样本。乳房切片检查被认为是诊断乳癌最明确的方法，因为它们提供了恶性细胞存在的确切证据。

乳房切片技术各不相同，每种技术都使用不同的影像技术来指导手术。空心针切片（CNB）和真空辅助切片（VAB）是两种常见的微创手术。空芯针活检使用空心针从乳房中取出一小部分组织，而抽吸辅助活检则在一次插入中收集多个组织样本。其他手术包括细针抽吸 (FNA)（使用非常细的针去除液体或细胞）和手术活检（需要透过切口去除较大的组织块）。乳房 X 光检查、超音波或 MRI 等影像学检查中发现的异常特征经常影响所使用的活检方法的类型。

市场动态：

驱动程式和限制

对乳房切片设备的需求不断增加

对乳房切片手术的需求不断增长预计将成为全球乳房切片市场成长的重要因素。由于乳癌盛行率不断上升、技术进步、人们对乳癌的认识不断增强以及最近的推出和批准，对乳房活检手术的需求不断增加。

由于乳癌仍然是全世界最常见的癌症之一，因此对准确、及时的诊断程序的需求变得前所未有的迫切。例如，根据国际癌症控制联盟 (UICC) 的数据，乳癌是全球 157 个国家女性中最常被诊断出的癌症，占癌症病例的四分之一。它是男女中第二常见的恶性肿瘤，也是女性癌症死亡的主要原因。预计到 2022 年，乳癌将导致 230 万新病例，几乎占全世界诊断出的两性恶性肿瘤的九分之一。预计到 2022 年，乳癌将导致 669,418 人死亡，其中大部分死亡事件发生在低收入社区。乳癌盛行率的上升正在推动医疗保健系统优先考虑乳房活检等早期检测程序，这对于确认诊断和决定有效的治疗策略至关重要。

由于乳癌仍然是全世界最常见的恶性肿瘤之一，每年诊断出数百万新病例，因此对准确诊断工具的需求从未如此强烈。由于技术进步，乳房切片设备变得更加方便、高效且侵入性较小，促使更多女性接受必要的检查和活检。最近推出和批准的许多产品都使用了新技术和最新的製造技术。例如，2024年5月，BSC（巴塞隆纳超级计算中心）在希伯伦谷大学医院启动了已建立的无辐射乳癌诊断技术的临床验证。这种新颖的策略将现代超音波技术与超级计算相结合，以提高乳癌检测的成像质量，为依赖电离辐射的乳房X光检查等标准程序提供了实质性的替代方案。这项新技术是 QUSTom 计画的一部分，旨在提高诊断准确性，同时让患者在测试过程中保持舒适。

感染的风险

感染风险等因素预计将阻碍全球乳房切片市场。活检技术，包括切口或插入针来收集组织样本，有可能将病原体引入体内。在外科手术和空心针活检等侵入性方法中，当更深的穿透使患者暴露于周围的细菌和其他传染源时，这种危险尤其高。研究表明，术后感染可能会导致问题，包括恢復时间延迟和进一步的医疗治疗，这可能会阻止患者接受这些所需的诊断程序。

对活检后感染的恐惧可能会引起患者的焦虑和不情愿，可能导致乳癌诊断和治疗的延迟。这种延迟尤其令人担忧，因为早期识别对于提高乳癌患者的存活率至关重要。医疗保健从业者越来越意识到这些问题，并正在努力透过引入更严格的灭菌流程和开发最大限度减少侵入性的新型活检技术来提高病患安全。

A breast biopsy is a medical procedure that includes removing a tiny sample of breast tissue for diagnostic purposes. This treatment is necessary to determine whether a concern detected in the breast is malignant or benign. Pathologists, who specialize in using laboratory tests to diagnose diseases, analyze the tissue sample. Breast biopsies are considered the most definitive procedure for diagnosing breast cancer since they provide conclusive evidence of the existence of malignant cells.

Breast biopsy techniques vary, with each using a distinct imaging technology to guide the procedure. Core needle biopsy (CNB) and vacuum-assisted biopsy (VAB) are two common minimally invasive procedures. A hollow needle is used in a core needle biopsy to take a small cylinder of tissue from the breast, whereas a suction-assisted biopsy collects several tissue samples in a single insertion. Other procedures include fine needle aspiration (FNA), which removes fluid or cells using a very thin needle, and surgical biopsies, which require removing bigger pieces of tissue through an incision. The characteristics of the abnormality found during imaging examinations such as mammograms, ultrasounds, or MRIs frequently influence the type of biopsy method used.

Market Dynamics: Drivers & Restraints

Increasing demand for breast biopsy devices

The increasing demand for breast biopsy procedures is expected to be a significant factor in the growth of the global breast biopsy market. The demand for breast biopsy procedures is increasing owing to the rising prevalence of breast cancer, technological advancements, growing awareness regarding breast cancer, and recent launches and approvals.

As breast cancer continues to be one of the most prevalent cancers worldwide, the need for accurate and timely diagnostic procedures has never been more critical. For instance, according to the Union for International Cancer Control (UICC), Breast cancer is the most commonly diagnosed cancer in women worldwide and in 157 countries, accounting for one in every four cancer cases. It is the second most common malignancy in both sexes and the major cause of mortality from cancer in women. Breast cancer is expected to cause 2.3 million new cases in 2022, accounting for nearly one out of every nine malignancies diagnosed in both sexes worldwide. Breast cancer is expected to kill 669,418 people in 2022, with a disproportionate amount of these fatal incidents taking place in low-income communities. The rising prevalence of breast cancer is driving healthcare systems to prioritize early detection procedures like breast biopsies, which are critical for confirming diagnoses and deciding effective treatment strategies.

As breast cancer remains one of the most common malignancies worldwide, with millions of new cases diagnosed each year, the need for accurate diagnostic tools has never been greater. Breast biopsy equipment has become more accessible, efficient, and less intrusive due to technological advancements, promoting more women to receive essential tests and biopsies. There are many recent launches and approvals that use novel technology and the latest manufacturing techniques. For instance, in May 2024, BSC (Barcelona Supercomputing Center) launched clinical validation of an establishing radiation-free breast cancer diagnosis technology at Vall d'Hebron University Hospital. This novel strategy combines modern ultrasound technology with supercomputing to improve imaging quality for breast cancer detection, providing a substantial alternative to standard procedures such as mammograms, which rely on ionizing radiation. The new technology, part of the QUSTom initiative, aims to increase diagnostic accuracy while keeping patients comfortable during the test.

Risk of infections

Factors such as the risk of infections are expected to hamper the global breast biopsy market. Biopsy techniques, which include incisions or needle insertions to collect tissue samples, have the potential to introduce pathogens into the body. This danger is especially high in invasive methods like surgical and core needle biopsies when deeper penetration exposes patients to ambient germs and other infectious agents. Studies have indicated that post-procedure infections can lead to problems, including delayed recovery times and further medical treatments, which may prevent patients from undergoing these required diagnostic procedures.

The fear of post-biopsy infections can cause anxiety and reluctance among patients, potentially leading to delayed breast cancer diagnosis and treatment. This delay is especially concerning because early identification is crucial for boosting survival rates in breast cancer patients. Healthcare practitioners are increasingly aware of these concerns and are working to improve patient safety by introducing stricter sterilizing processes and developing novel biopsy techniques that minimize invasiveness.

Segment Analysis

The global breast biopsy market is segmented based on product, technique type, guidance technology, end-user, and region.

Core needle biopsy segment is expected to dominate the global breast biopsy market share

The core needle biopsy segment is anticipated to dominate the global breast biopsy market owing to its growing importance in the diagnosis of breast cancer, technological advancements, recent launches and approvals, and increase in the number of breast cancer. Core needle biopsies use a stronger, hollow needle to take a cylindrical tissue sample from the breast, providing for a more thorough examination than fine needle aspiration biopsies (FNA) and other traditional methods, which typically obtain smaller samples. This capability not only improves diagnosis accuracy but also provides more detailed architectural information about the tissue, which is critical for assessing the possibility and severity of cancer.

Core needle biopsies are now much more precise due to technological integration with imaging modalities including ultrasonography, mammography, and MRI. Recently launched technologies such as PrecisionCore combine modern imaging technology with real-time guidance, allowing clinicians to precisely target lesions during the biopsy procedure. This breakthrough not only improves diagnostic accuracy but also increases patient safety by decreasing unwanted tissue removal. Moreover, in May 2024, Hologic introduced a new disposable 7-gauge breast biopsy needle as part of its Brevera breast biopsy system in Europe.

This advancement is significant as it allows radiologists to capture larger tissue samples, which can enhance diagnostic accuracy while potentially reducing patient discomfort and the duration of compression during the procedure. The Brevera system is notable for being the world's first vacuum-assisted breast biopsy solution that integrates tissue acquisition, real-time imaging, and post-biopsy handling. The newly launched 7-gauge needle complements the existing 9-gauge options, providing healthcare professionals with more flexibility to choose the most appropriate needle size for specific procedures. This adaptability is crucial for accommodating varying patient needs and enhancing overall procedural efficiency.

Recent advancements in molecular analysis techniques have significantly reinforced the importance of core needle biopsy in customized therapy. Core needle biopsies allow for the analysis of proteins and genetic mutations within tumor tissues, facilitating individualized therapy methods for patients. This skill is essential for monitoring individual responses to medicines and optimizing treatment programs based on specific tumor features.

Geographical Analysis

North America is expected to hold a significant position in the global breast biopsy market share

North America will likely account for a significant share of the global breast biopsy market, owing to its advanced healthcare infrastructure, extensive research capabilities, proactive patient awareness initiatives a high prevalence of breast cancer, technological advancements, and recent launches and approvals. The increasing number of breast cancer cases is a primary driver of the breast biopsy market in North America.

For instance, according to breastcancer.org, approximately 13% (or one out of every eight) of women in the United States will develop invasive breast cancer over their lives. In recent years, incidence rates have grown somewhat, approximately 0.5% each year. Breast cancer is one of the leading causes of cancer-related deaths among women in the United States, trailing only lung cancer. Breast cancer is the most commonly diagnosed cancer in women in the United States, second only to skin cancer. Every year, breast cancer accounts for around 30% of all newly diagnosed cancers in women. In the United States, approximately four million women have been diagnosed with breast cancer. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.

The region has established itself as a pioneer in the use of advanced medical technologies, particularly in oncology. The design and functionality of biopsy equipment have advanced significantly. The discovery of liquid biopsy techniques, which examine circulating tumor cells or cell-free DNA in blood samples, represents a significant advancement. For instance, in June 2023, Labcorp launched liquid biopsy to detect cancer biomarkers. This non-invasive method offers a viable alternative to standard tissue biopsies and is gaining popularity in the North American market due to its potential for early diagnosis and monitoring of breast cancer progression. Patients find these tests appealing because they can be performed with minimal discomfort.

Asia Pacific is growing at the fastest pace in the global breast biopsy market

The Asia Pacific region is emerging as the fastest-growing market for breast biopsy, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of breast cancers. The Asia-Pacific (APAC) region is experiencing strong expansion in the breast biopsy market, owing mostly to the increased incidence of breast cancer. This concerning trend is highlighted by considerable increases in breast cancer cases in different countries, including China, India, and South Korea. According to the World Health Organization, breast cancer is currently the most frequent cancer in the world, affecting millions of women each year. In APAC, the expanding population and aging demographic exacerbate the situation, as older women are more likely to acquire breast cancer. For instance, according to the National Institute of Health, Female breast cancer (BC) is the major cause of cancer incidence and mortality in India, accounting for 13.5% of new cancer cases and 10% of all cancer-related deaths. So, the increasing number of breast cancers increases the demand for cancer diagnostics which increases the demand for breast biopsy devices.

Competitive Landscape

The major global players in the global breast biopsy market include STERYLAB S.r.l., Argon Medical Devices, Danaher Corporation, Cigna, Siemens Healthcare Private Limited, BD, Hologic, Inc., Devicor Medical Products, Inc., F. Hoffmann-La Roche Ltd, Cook among others.

Emerging Players

AOA DX, Kheiron Medical, and Hera-MI among others

Key Developments

In November 2024, Mammotome launched the Mammotome AutoCore, the first-ever single-insertion, spring-loaded core biopsy technology. This novel technology intends to transform ultrasound-guided breast biopsy operations by greatly increasing efficiency and patient satisfaction. The AutoCore's unique design enables clinicians to perform biopsies with a single insertion, decreasing procedural complexity.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global breast biopsy market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product
3.2. Snippet by Technique Type
3.3. Snippet by Guidance Technology
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Increasing Demand for Breast Biopsy Devices
- 4.1.3. Restraints
- 4.1.4. Risk of Infections
- 4.1.5. Opportunity
- 4.1.6. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Product

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 6.1.2. Market Attractiveness Index, By Product
6.2. Biopsy Needles*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Biopsy Tables
6.4. Biopsy Wires
6.5. Guidance Systems
6.6. Others

7. By Technique Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 7.1.2. Market Attractiveness Index, By Technique Type
7.2. Fine Needle Aspiration Biopsy*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Core Needle Biopsy
7.4. Biopsy Markers
7.5. MRI-Guided Core Needle Biopsy
7.6. Surgical Biopsy
7.7. Wire Localization
7.8. Sentinel Node Biopsy

8. By Guidance Technology

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 8.1.2. Market Attractiveness Index, By Guidance Technology
8.2. Fine Ultrasound-Guided*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Mammography-Guided Magnetic Resonance
8.4. CT-Guided Biopsy
8.5. Others

9. By End-User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.1.2. Market Attractiveness Index, By End-User
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Diagnostic Centers
9.4. Other

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique Type
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Guidance Technology
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. STERYLAB S.r.l.*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Argon Medical Devices
12.3. Danaher Corporation
12.4. Cigna
12.5. Siemens Healthcare Private Limited
12.6. BD
12.7. Hologic, Inc.
12.8. Devicor Medical Products, Inc.
12.9. F. Hoffmann-La Roche Ltd
12.10. Cook

LIST NOT EXHAUSTIVE