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市場調查報告書

商品編碼

1634220

全球乳房切片設備市場 - 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個工作天內

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簡介目錄

2024年，全球乳房切片設備市場規模達22.5億美元，預計2033年將達到37.7億美元，2025-2033年預測期間複合年成長率為6.1%。

乳房切片檢查是一種醫療程序，包括出於診斷目的取出微小的乳房組織樣本。這種治療對於確定乳房中檢測到的問題是惡性還是良性是必要的。專門利用實驗室測試來診斷疾病的病理學家會分析組織樣本。乳房切片檢查被認為是診斷乳癌最明確的方法，因為它們提供了惡性細胞存在的確切證據。

乳房切片技術各不相同，每種技術都使用不同的影像技術來指導手術。空心針切片（CNB）和真空輔助切片（VAB）是兩種常見的微創手術。空芯針活體組織切片使用空心針從乳房中取出一小部分組織，而抽吸輔助活體組織切片則在一次插入中收集多個組織樣本。其他手術包括細針抽吸 (FNA)（使用非常細的針去除液體或細胞）和手術活體組織切片（需要透過切口去除較大的組織塊）。乳房 X 光檢查、超音波或 MRI 等影像學檢查中發現的異常特徵經常影響所使用的活體組織切片方法的類型。

市場動態：

驅動程式和限制

對乳房切片設備的需求不斷增加

對乳房切片手術的需求不斷成長預計將成為全球乳房切片市場成長的重要因素。由於乳癌盛行率不斷上升、技術進步、人們對乳癌的認知不斷增強以及最近的推出和批准，對乳房活體組織切片手術的需求不斷增加。

由於乳癌仍然是全世界最常見的癌症之一，因此對準確、及時的診斷程序的需求變得前所未有的迫切。例如，根據國際癌症控制聯盟 (UICC) 的數據，乳癌是全球 157 個國家女性中最常被診斷出的癌症，佔癌症病例的四分之一。它是男女中第二常見的惡性腫瘤，也是女性癌症死亡的主要原因。預計到 2022 年，乳癌將導致 230 萬新病例，幾乎佔全世界診斷出的兩性惡性腫瘤的九分之一。預計到 2022 年，乳癌將導致 669,418 人死亡，其中大部分死亡事件發生在低收入社區。乳癌盛行率的上升正在推動醫療保健系統優先考慮乳房活體組織切片等早期檢測程序，這對於確認診斷和決定有效的治療策略至關重要。

由於乳癌仍然是全世界最常見的惡性腫瘤之一，每年診斷出數百萬新病例，因此對準確診斷工具的需求從未如此強烈。由於技術進步，乳房切片設備變得更加方便、高效且侵入性較小，促使更多女性接受必要的檢查和活體組織切片。最近推出和批准的許多產品都使用了新技術和最新的製造技術。例如，2024年5月，BSC（巴塞隆納超級計算中心）在希伯倫谷大學醫院啟動了已建立的無輻射乳癌診斷技術的臨床驗證。這種新穎的策略將現代超音波技術與超級計算相結合，以提高乳癌檢測的成像質量，為依賴電離輻射的乳房X光檢查等標準程序提供了實質性的替代方案。這項新技術是 QUSTom 計畫的一部分，旨在提高診斷準確性，同時讓患者在測試過程中保持舒適。

感染的風險

感染風險等因素預計將阻礙全球乳房切片市場。活體組織切片技術，包括切口或插入針來收集組織樣本，有可能將病原體引入體內。在外科手術和空心針活體組織切片等侵入性方法中，當更深的穿透使患者暴露於周圍的細菌和其他傳染源時，這種危險尤其高。研究表明，術後感染可能會導致問題，包括恢復時間延遲和進一步的醫療治療，這可能會阻止患者接受這些所需的診斷程序。

對活體組織切片後感染的恐懼可能會引起患者的焦慮和不情願，可能導致乳癌診斷和治療的延遲。這種延遲尤其令人擔憂，因為早期識別對於提高乳癌患者的存活率至關重要。醫療保健從業者越來越意識到這些問題，並正在努力透過引入更嚴格的滅菌流程和開發最大限度減少侵入性的新型活體組織切片技術來提高病患安全。

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