Breast Biopsy Devices Market, By Type (Biopsy Needles, Guidance Systems, Biopsy Tables, Localization Wires, Assay Kits, Liquid Biopsy Instruments), By Procedure (Needle Breast Biopsy, Open Surgical Breast Biopsy, Liquid Breast Biopsy), By Technique (Image Guided Biopsy, Liquid Biopsy), By Indication (Complex Cyst, Solid Mass, Suspicious Solid Mass, Suspicious Microcalcifications, Suspicious Architectural Distortion), By Application (Early Cancer Screening, Therapy Selection, Treatment Monitoring, Recurrence Monitoring), By End-use (Hospitals & Surgical Centers, Breast Care Centers, Imaging & Diagnostic Centers) and By Region; Global Insights & Forecast (2024-2030)

The breast biopsy devices market is expected to grow from USD 1.8 billion in 2023-e to USD 3.4 billion by 2030, at a CAGR of 9.7% during the forecast period. The breast biopsy devices market is a competitive market, the prominent players in the global market include Argon Medical Devices, Becton Dickinson and Company, Cook Medical, Devicor Medical Products, F. Hoffmann-La Roche, GE Healthcare, Hologic, Leica Biosystems, Medax Srl, Planmed, Scion Medical Technologies, and Siemens Healthier.

Published: February, 2024
| Report ID: HC3017
| Life Sciences & Healthcare

As per Intent Market Research, the breast biopsy devices market accounted for USD 1.8 billion in 2023-e and is projected to grow at a CAGR of 9.7% over the forecast period from 2024 to 2030. The market is thriving due to factors such as the increasing number of breast cancer screening programs.

Globally, breast cancer stands out as the most prevalent cancer among women and a second leading cause of cancer death in women, affecting approximately 2.3 million individuals worldwide. In 2020, breast cancer led to an estimated 685,000 fatalities, constituting 15% of women's cancer-related deaths. A significant contributor to this high mortality rate is the prevalent late-stage diagnosis among women.

Increasing Number of Breast Cancer Screening Programs is Fueling the Growth of Breast Biopsy Devices Market

The increasing incidence of breast cancer is a pivotal driver in the breast biopsy devices market. With breast cancer standing as the most prevalent cancer among women globally, the need for accurate and timely diagnostic procedures, including biopsies, has surged. The rising number of reported cases underscores the crucial role that breast biopsy devices play in the early detection and subsequent management of breast cancer.

The National Breast and Cervical Cancer Early Detection Program (NBCCEDP), launched by the Centers for Disease Control and Prevention (CDC) in 1991, focuses on early detection of breast and cervical cancers in the United States. Geared towards uninsured and low-income women, the program provided breast cancer screening and diagnostic services to 263,651 women in 2021, detecting 2,221 invasive breast cancers and 676 premalignant lesions. The proliferation of such initiatives globally is anticipated to amplify breast cancer screening procedures, thereby propelling growth in the breast biopsy market.

Risk of Infections Associated with Biopsy Needles is Hindering the Breast Biopsy Devices Market

The prevalence of infection risks linked to biopsy needles stands as a notable restraint in the breast biopsy devices market. Despite advancements in healthcare practices, the improper handling or reuse of biopsy needles poses a significant threat to patient safety. Infections can arise from contaminated equipment, leading to complications and adverse outcomes. This concern not only affects patient confidence in undergoing biopsy procedures but also emphasizes the importance of stringent adherence to proper sterilization and disposal protocols.

Addressing and mitigating the risk of infections associated with biopsy needles is imperative for sustaining the safety and effectiveness of breast biopsy procedures and ensuring patient trust in these diagnostic interventions. As a result, healthcare providers and manufacturers need to continuously focus on implementing and reinforcing robust infection control measures to minimize the potential drawbacks associated with this specific restraint in the breast biopsy devices market.

Embracing Minimally Invasive and Liquid Biopsy Technologies in Breast Biopsy Devices Market

Biopsy techniques have evolved significantly, transitioning from open surgical procedures to minimally invasive needle biopsies. Fueled by the demand for less invasive procedures, these advancements cater to both surgeons and patients.

The emergence of liquid biopsy, detecting circulating tumor cells or DNA fragments from tumors, emerged as a breakthrough technique. It eliminates the necessity for surgical or needle biopsies, enabling early-stage cancer detection. This approach captures the comprehensive genetic complexity of tumors, reducing the risk of cancer cells spreading. Multiple market players are actively conducting clinical trials to validate the effectiveness and efficiency of liquid biopsy in oncology. Positive outcomes from these trials are expected to create new opportunities for companies within the market.

Continuous Technological Advancements in the Biopsy Needles Segment to Augment Segment Share

The biopsy needles segment emerges as the predominant category in the breast biopsy devices market. Precision instruments designed for extracting tissue samples from the breast, and biopsy needles are crucial for obtaining specimens that aid in the accurate diagnosis of abnormalities. This significant market presence is attributed to continuous technological advancements and the introduction of innovative products, driving the growth potential of biopsy needles. The evolution from open surgical procedures to minimally invasive needle biopsies aligns with the growing demand for less invasive diagnostic approaches, meeting the preferences of both surgeons and patients.

Source: Intent Market Research Analysis

Increasing Investment in Clinical Trials and Research is Fostering the Segment Growth

The liquid breast biopsy segment is poised for significant growth as companies operating in this segment are actively investing in clinical trials and research. This proactive engagement is anticipated to make a substantial contribution to the overall development of the breast biopsy devices market. This non-invasive technique offers several advantages, including the potential for earlier cancer detection, real-time monitoring of disease progression, and a reduced need for invasive procedures.

Indeterminate or Suspicious Solid Mass Segment for Detailed Examination and Accurate Diagnosis Will Foster Market Growth

The indication of indeterminate or suspicious solid mass refers to a scenario where imaging studies, such as mammography or ultrasound, reveal the presence of a solid mass in the breast that cannot be conclusively identified as benign or malignant. This indeterminate or suspicious finding prompts the need for a biopsy to obtain tissue samples for a detailed examination and accurate diagnosis.

The Market is Flourishing Due to the Dominant presence of Hospitals and Surgical Centers

Hospitals and surgical centers held a significant market share in the forecast period. The substantial presence of this segment can be attributed to the rising number of breast diagnostic procedures conducted in hospitals. This growth is fueled by hospitals' increasing preference for the automation and digitization of radiology patient workflow, as well as the adoption of technologically advanced systems to enhance patient care quality, contributing significantly to the segment's robust position in the market and creating favorable opportunities for business growth in the healthcare sector.

North America Market Thrives due to the Continuous Technological Advancements in Region

North America held the largest share of the breast biopsy devices market throughout the forecast period. The region's dominance is attributed to continuous technological advancements, a rising incidence of breast cancer, favorable reimbursement scenarios, and the implementation of new breast density notification laws in the US. These factors collectively play a pivotal role in sustaining North America's dominant market position, offering lucrative business opportunities for companies operating in the region.

Major Industry Players are Enhancing their Positions by Introduction of Innovative Breast Cancer Detection Devices

The market is characterized by intense competition due to the presence of numerous international and domestic players. The breast biopsy devices market, in particular, is dominated by key players such as Argon Medical Devices, Becton Dickinson and Company, Cook Medical, Devicor Medical Products, F. Hoffmann-La Roche, GE Healthcare, Hologic, Leica Biosystems, Medax Srl, Planmed, Scion Medical Technolgies, and Siemens Healthier, amongst others.  

Prominent players in the breast biopsy devices market are actively engaged in advancing their positions through the development and introduction of innovative breast cancer detection devices. Established companies in the industry are strategically targeting specific demographics of women and pursuing key mergers and acquisitions to fortify their foothold in the competitive market landscape.

For instance, in March 2022, Hologic was focused on enhancing women's health. The company inaugurated its Innovation Centre in Aix-en-Provence, France. The centre is poised to bolster Hologic's portfolio, particularly in ultrasound, interventional, and surgical solutions, contributing to the comprehensive continuum of breast healthcare.

Breast Biopsy Devices Market Coverage

The report provides key insights into the breast biopsy devices market, and it focuses on technological developments, trends, and initiatives taken by the government in this sector. The report delves into market drivers, restraints, and opportunities, and analyses key players and the competitive landscape within the market. The report offers the market size and forecasts for the breast biopsy devices market in value (USD billion) for all the above segments.

 

Report Scope

Report Features

Description

Market Size (2023-e)

USD 1.8 billion

Forecast Revenue (2030)

USD 3.4 billion

CAGR (2024-2030)

9.7%

Base Year for Estimation

2023-e

Historic Year

2022

Forecast Period

2024-2030

Report Coverage

Market Forecast, Market Dynamics, Competitive Landscape, Recent Developments

Segments Covered

By Type (Biopsy Needles, Guidance Systems, Biopsy Tables, Localization Wires, Assay Kits, Liquid Biopsy Instruments, Others), By Procedure (Needle Breast Biopsy, Open Surgical Breast Biopsy, Liquid Breast Biopsy), By Technique (Image Guided Biopsy, Liquid Biopsy), By Indication (Complex Cyst, Solid Mass, Indeterminate Or Suspicious Solid Mass, Indeterminate Or Suspicious Microcalcifications, Suspicious Architectural Distortion), By Application (Early Cancer Screening, Therapy Selection, Treatment Monitoring, Recurrence Monitoring), By End-use (Hospitals & Surgical Centers, Breast Care Centers, Imaging & Diagnostic Centers)

Regional Analysis

North America (US, Canada), Europe (Germany, France, UK, Spain, Italy), Asia-Pacific (China, Japan, South Korea, India), Latin America (Brazil, Mexico, Argentina), Middle East and Africa (Saudi Arabia, South Africa, Turkey, United Arab Emirates)

Competitive Landscape

Argon Medical Devices, Becton Dickinson and Company, Cook Medical, Devicor Medical Products, Roche Diagnostics, GE Healthcare, Hologic, Leica Biosystems, Medax Srl, Planmed, Scion Medical Technologies, and Siemens Healthineers

Customization Scope

Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements.

Purchase Options

We have three licenses to opt for Single User License, Multi-User License (Up to 5 Users), Corporate Use License (Unlimited User and Printable PDF)

1.Introduction

1.1.Study Assumptions and Market Definition

1.2.Scope of the Study

2.Research Methodology

3.Executive Summary

4.Market Dynamics

4.1.Market Growth Drivers

4.1.1.Growing Incidence of Breast Cancer

4.1.2.Increasing Number of Breast Cancer Screening Programs

4.1.3.Increasing Demand for Minimally Invasive and Non-Invasive Procedures

4.1.4.Growing Awareness of Early Detection of Breast Cancer

4.1.5.Improved Reimbursement Scenario

4.2.Market Growth Restraints

4.2.1.Risk of Infections Associated with Biopsy Needles

4.2.2.Stringent Regulatory Approval Procedures

4.2.3.Product Recalls

4.3.Market Growth Opportunities

4.3.1.Advancements in Personalized Medicine

4.3.2.Rise of Liquid Biopsy Technology

4.3.3.Increasing Focus on Research and Clinical Trials

4.4.Pestle Analysis

4.5.Porter’s Five Forces Analysis

5.Market Outlook

5.1.Overview (Industry Snapshot)

5.2.Technology Analysis

5.3.Supply Chain Analysis

5.4.Value Chain Analysis

5.5.Regulatory Analysis

5.6.Ecosystem Analysis

5.7.Pricing Analysis

5.8.Patent Analysis

5.9.Trade Analysis

5.10. Case Study Analysis

5.11. Unmet needs in the market

5.12. Trends/Disruptions

5.13. Key Conference and Events

6.Market Segment Outlook (Market Size & Forecast: USD Billion, 2023 – 2030)

6.1.Segment Synopsis

6.2.By Type

6.2.1.Biopsy Needles

6.2.2.Guidance Systems

6.2.3.Biopsy Tables

6.2.4.Localization Wires

6.2.5.Assay Kits

6.2.6.Liquid Biopsy Instruments

6.2.7.Others

6.3.By Procedure

6.3.1.Needle Breast Biopsy

6.3.1.1.Core-Needle Biopsy (CNB)

6.3.1.2.Fine-Needle Aspiration Biopsy (FNAB)

6.3.1.3.Vacuum-Assisted Biopsy (VAB)

6.3.2.Open Surgical Breast Biopsy

6.3.2.1.Excisional

6.3.2.2.Incisional

6.3.3.Liquid Breast Biopsy

6.3.3.1.Circulating Tumor Cells

6.3.3.2.Circulating Tumor DNA (CtDNA)

6.3.3.3.Other Biomarkers

6.4.By Technique

6.4.1.Image Guided Biopsy

6.4.1.1.Mammo-Guided Stereotactic

6.4.1.2.Ultrasound-Guided

6.4.1.3.MRI-Guided

6.4.1.4.Other Image-Guided Techniques

6.4.2.Liquid Biopsy

6.4.2.1.NGS based Biopsy

6.4.2.2.PCR based Biopsy

6.4.2.3.Microarray-based Biopsy

6.5.By Indication

6.5.1.Complex Cyst

6.5.2.Solid Mass

6.5.3.Indeterminate or Suspicious Solid Mass

6.5.4.Indeterminate or Suspicious Microcalcifications

6.5.5.Suspicious Architectural Distortion

6.6.By Application

6.6.1.Early Cancer Screening

6.6.2.Therapy Selection

6.6.3.Treatment Monitoring

6.6.4.Recurrence Monitoring

6.7.By End-use

6.7.1.Hospitals & Surgical Centers

6.7.2.Breast Care Centers

6.7.3.Imaging & Diagnostic Centers

 

7.Regional Outlook (Market Size & Forecast: USD Billion, 2023 – 2030)

7.1.Global Market Synopsis

7.2.North America

7.2.1. North America Breast Biopsy Devices Market Outlook

7.2.2.US

7.2.2.1.US Breast Biopsy Devices Market, By Type

7.2.2.2.US Breast Biopsy Devices Market, By Procedure

7.2.2.3.US Breast Biopsy Devices Market, By Technique

7.2.2.4.US Breast Biopsy Devices Market, By Indication

7.2.2.5.US Breast Biopsy Devices Market, By Application

7.2.2.6.US Breast Biopsy Devices Market, By End-use

*Note: Cross-segmentation by segments for each country will be covered as shown above.

7.2.3.Canada

7.3.Europe

7.3.1.Europe Breast Biopsy Devices Market Outlook

7.3.2.Germany

7.3.3.UK

7.3.4.France

7.3.5.Spain

7.3.6.Italy

7.4.Asia-Pacific

7.4.1.Asia-Pacific Breast Biopsy Devices Market Outlook

7.4.2.China

7.4.3.India

7.4.4.Japan

7.4.5.South Korea

7.4.6.Australia

7.5.Latin America

7.5.1.Latin America Breast Biopsy Devices Market Outlook

7.5.2.Mexico

7.5.3.Brazil

7.6.Middle East & Africa

7.6.1.Middle East & Africa Breast Biopsy Devices Market Outlook

7.6.2.Saudi Arabia

7.6.3.UAE

8.Competitive Landscape

8.1.Market Share Analysis

8.2.Volume Output Analysis

8.3.Company Strategy Analysis

8.4.Competitive Matrix

9.Company Profiles

9.1.Argon Medical Devices

9.1.1.Company Synopsis

9.1.2.Company Financials

9.1.3.Product/Service Portfolio

9.1.4.Recent Developments

9.1.5.Analyst Perception

*Note: All the companies in the section 9.1 will cover same sub-chapters as above.

9.2.Becton Dickinson and Company

9.3.Cook Medical

9.4.Devicor Medical Products

9.5.Roche Diagnostics

9.6.GE Healthcare

9.7.Hologic

9.8.Leica Biosystems

9.9.Medax Srl Unipersonale

9.10.Planmed

9.11.Scion Medical Technologies

9.12.Siemens Healthineers

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The research factors used in our methodology vary depending on the specific market being analyzed. To begin with, we incorporate both demand and supply side information into our model to identify and address market gaps. Additionally, we also employ approaches such as Macro-Indicator Analysis, Factor Analysis, Value Chain-Based Sizing, and forecasting to further increase the accuracy of the numbers and validate the findings.

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