The global market for breast biopsy devices is expected to reach USD 3.26 billion by 2030 from USD 2.38 billion in 2025, representing a CAGR of 6.5% during the forecast period. The market is benefiting from a combination of factors, including rising breast cancer rates, increased awareness of the importance of early detection, and the growing preference for minimally invasive diagnostic procedures. Additionally, state and provincial screening programs are significantly improving the rate of screenings among women for potential breast cancer.
Advancements in technology, particularly in image guidance and needle design, have enhanced the accuracy of needle breast biopsies while minimizing discomfort and inconvenience. This has made the procedure more acceptable and feasible for patients. Furthermore, the establishment of breast cancer screening programs, more favorable reimbursement policies, and heightened awareness of women's health issues are also contributing to market growth. Additionally, the preference for outpatient care and the growing interest in cost-effective diagnostic options have led to broader acceptance of needle breast biopsies across various healthcare settings.
This allows for earlier diagnoses, better tracking of treatment responses, and effective monitoring for recurrence or progression of the disease. Several factors are driving the growth of the liquid biopsy market, including the rising incidence of breast cancer, the advancement of precision (or personalized) medicine, and improvements in molecular diagnostic technologies, particularly through next-generation sequencing (NGS) and digital PCR. The increasing clinical utility and routine application of liquid biopsies, along with a growing awareness of their benefits and supportive regulatory policies, are further promoting the global adoption of these technologies.
The biopsy needles segment held the largest share of the market in 2024.
Based on type, the breast biopsy devices market is divided into several segments: biopsy needles, guidance systems, biopsy tables, localization wires, assay kits, liquid biopsy instruments, and other devices. Among these, the biopsy needles segment holds a significant share of the market. Biopsy needles are essential tools for diagnosing breast cancer, as they collect tissue samples for histopathological analysis with high accuracy and minimal invasiveness. They can be utilized in core-needle biopsy (CNB), fine-needle aspiration biopsy (FNAB), and vacuum-assisted biopsy (VAB), each designed for specific clinical scenarios and the varying characteristics of the lesions. Biopsy needles are preferred because they provide diagnostic results with less discomfort for the patient and require less time for both the procedure and recovery compared to surgical biopsies.The needle breast biopsy procedure segment accounted for the largest market share in 2024.
Based on procedures, the breast biopsy devices market can be broadly categorized into three types: needle breast biopsy, open surgical breast biopsy, and liquid breast biopsy. The growth of the needle breast biopsy segment is driven by several key factors. These include rising breast cancer rates, a greater emphasis on early and accurate diagnosis, and an increasing preference among patients for minimally invasive procedures.Advancements in technology, particularly in image guidance and needle design, have enhanced the accuracy of needle breast biopsies while minimizing discomfort and inconvenience. This has made the procedure more acceptable and feasible for patients. Furthermore, the establishment of breast cancer screening programs, more favorable reimbursement policies, and heightened awareness of women's health issues are also contributing to market growth. Additionally, the preference for outpatient care and the growing interest in cost-effective diagnostic options have led to broader acceptance of needle breast biopsies across various healthcare settings.
The liquid biopsy segment is projected to register the highest CAGR during the forecast period.
The breast biopsy devices market is primarily categorized into three main techniques: image-guided biopsy, liquid biopsy, and other methods. The liquid biopsy segment is experiencing growth due to the increasing demand for non-invasive, accurate, and real-time cancer diagnostic solutions. Liquid biopsy processes detect circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the blood, making them less invasive than traditional tissue biopsies.This allows for earlier diagnoses, better tracking of treatment responses, and effective monitoring for recurrence or progression of the disease. Several factors are driving the growth of the liquid biopsy market, including the rising incidence of breast cancer, the advancement of precision (or personalized) medicine, and improvements in molecular diagnostic technologies, particularly through next-generation sequencing (NGS) and digital PCR. The increasing clinical utility and routine application of liquid biopsies, along with a growing awareness of their benefits and supportive regulatory policies, are further promoting the global adoption of these technologies.
The early cancer screening segment dominated the market in 2024.
The breast biopsy market can be broadly categorized based on its applications into four main areas: early cancer screening, therapy selection, treatment monitoring, and recurrence monitoring. Early cancer screening holds the largest market share as it plays a crucial role in reducing mortality rates and improving treatment outcomes by detecting cancer at the earliest and most treatable stage. The rising incidence of cancer globally, particularly among vulnerable and aging populations, has increased the need for effective illness monitoring. Consequently, advancements in technology will serve as a significant driver for early and proactive health monitoring and diagnosis.Asia Pacific is expected to register a significant growth rate in the market during the forecast period.
The breast biopsy market is experiencing the highest growth in the Asia Pacific region due to several converging factors. These include an increasing incidence of breast cancer, the development of healthcare infrastructure, and greater awareness of the importance of early cancer detection. Countries such as China, India, and Japan are making significant investments in interventional and diagnostic imaging, which is creating a demand for advanced biopsy technologies. Additionally, government support, improved access to medical care in rural areas, and the expansion of global medical device companies promoting their products in emerging markets are driving this adoption. Furthermore, the region’s large population and rising healthcare spending are key drivers of its double-digit market growth.A breakdown of the primary participants referred to for this report is provided below:
- By Company Type: Tier 1 (40%), Tier 2 (30%), and Tier 3 (30%)
- By Designation: C-level Executives (27%), Director-level Executives (18%), and Other Designations (55%)
- By Region: North America (50%), Europe (20%), Asia Pacific (15%), Latin America (10%), and the Middle East & Africa (5%)
Research Coverage
- The report studies the breast biopsy devices market by product, procedure, application, end user, and region.
- The report analyzes factors affecting market growth (drivers, restraints, opportunities, and challenges).
- The report evaluates the market opportunities and challenges for stakeholders and details the competitive landscape for market leaders.
- The report studies micromarkets with respect to their growth trends, prospects, and contributions to the global breast biopsy devices market.
- The report forecasts the revenue of market segments with respect to five major regions.
Key Benefits of Buying the Report:
The report is designed to assist both new entrants and established market leaders, as well as smaller companies in the breast biopsy devices sector, in making informed investment decisions. It provides comprehensive data that supports risk evaluation and validated investment strategies. The report features detailed market segmentation based on end users and regional aspects, enabling you to focus on specific segments. Additionally, it offers thorough coverage and analysis of trends, challenges, growth opportunities, and future prospects, ensuring that your decisions are well-informed and considerate of all relevant factors.The report provides insights into the following pointers:
- Analysis of key drivers (ongoing innovations in biopsy needle designs and liquid biopsy technologies), restraints (high costs associated with advanced biopsy equipment and imaging technologies and stringent regulatory approval procedures), opportunities (technological advancements in imaging technology), and challenges (accuracy and reliability of certain biopsy procedures), influencing the growth of the breast biopsy devices market.
- Product Development/Innovation: Detailed insights into upcoming technologies, R&D activities, and new product & service launches in the breast biopsy devices market.
- Market Diversification: Exhaustive information about untapped geographies, new products, recent developments, and investments in the breast biopsy devices market.
- Market Development: Comprehensive information about lucrative markets - the report analyzes the breast biopsy devices market across varied regions.
- Competitive Assessment: In-depth assessment of market shares, growth strategies, and service offerings of leading players such as Hologic Inc. (US), Danaher Corporation (US), Argon Medical Devices (US), Merit Medical Systems (US), Menarini-Silicon Biosystems (Italy), Varian Medical Systems, Inc. (Germany), Planmed Oy (Finland), Sterylab S.R.L (Italy), QIAGEN (Germany), and Biocept, Inc. (US), among others
Table of Contents
1 Introduction
2 Research Methodology
4 Premium Insights
5 Market Overview
6 Breast Biopsy Devices Market, by Procedure
7 Breast Biopsy Devices Market, by Product
8 Breast Biopsy Market, by Application
9 Breast Biopsy Devices Market, by End-user
10 Breast Biopsy Devices Market, by Region
11 Competitive Landscape
12 Company Profiles
13 Appendix
List of Tables
List of Figures
Companies Mentioned
- Hologic, Inc.
- Danaher Corporation
- Becton, Dickinson and Company
- Argon Medical
- Qiagen
- Merit Medical Systems
- Menarini Silicon Biosystems Spa
- Guardant Health, Inc.
- Neogenomics Laboratories, Inc.
- Sterylab S.R.L
- Biocept, Inc.
- Bio-Rad Laboratories, Inc.
- F. Hoffmann-La Roche Ltd.
- Exact Sciences Corporation
- Sysmex Inostics (A Subsidiary of Sysmex Corporation)
- Thermo Fisher Scientific
- Fujifilm Holdings Corporation
- Cardiff Oncology Inc.
- Myriad Genetics, Inc.
- Illumina, Inc.
- Fluxion Biosciences, Inc.
- Inrad, Inc.
- Izi Medical Products
- Remington Medical Inc.
- Cp Medical
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 290 |
| Published | May 2025 |
| Forecast Period | 2025 - 2030 |
| Estimated Market Value ( USD | $ 2.38 Billion |
| Forecasted Market Value ( USD | $ 3.26 Billion |
| Compound Annual Growth Rate | 6.5% |
| Regions Covered | Global |
| No. of Companies Mentioned | 25 |
