생검 기기 시장 보고서 : 시술 유형, 제품 유형, 용도, 유도 기술, 최종사용자, 지역별(2026-2034년)

The global biopsy devices market size reached USD 2.9 Billion in 2025. Looking forward, IMARC Group expects the market to reach USD 4.8 Billion by 2034, exhibiting a growth rate (CAGR) of 5.36% during 2026-2034. The rising prevalence of cancer, increasing preference for personalized medicine, and the push toward minimally invasive procedures for patient comfort and quicker recovery times are some of the major factors propelling the market.

BIOPSY DEVICES MARKET ANALYSIS:

• Major Market Drivers: The biopsy devices market is mainly driven by the rising cases of cancer across the world which underscores early diagnosis and personalized treatment planning. Technological advancements in biopsy procedures like the development of vacuum-assisted and image-guided biopsy devices have significantly enhanced the accuracy and efficiency of these procedures further propelling biopsy devices market growth. In line with this, the rising awareness of cancer screening programs and growing healthcare infrastructure mainly in emerging economies also contribute to the demand for advanced biopsy devices. The market is also influenced by growing aging population, who are at higher risk of developing cancer thereby increasing the need for biopsy diagnostic purposes. Furthermore, collaboration between healthcare providers and insurance companies to make advanced medical devices more accessible and affordable are also one of the key factors driving biopsy devices market growth.
• Key Market Trends: The biopsy devices market is witnessing several key trends which is shaping its market growth. One of the major trends is the rising adoption of minimally invasive biopsy techniques that offers benefits such as reduced scarring, shorter recovery times and lower risk of infection. There is also a significant shift towards liquid biopsies which can detect cancer cells or DNA in the blood providing a non-invasive alternative to traditional methods. In line with this, advancements in precision and personalized medicine are further driving the demand for real time biopsy analysis technologies. Integration of artificial intelligence (AI) and machine learning (ML) in biopsy procedures is enhancing precision showcasing another major trend the sector contributing to biopsy devices market growth.
• Geographical Trends: Geographically, the biopsy devices market is experiencing a significant growth across various key regions. North America leads the market because of its advanced healthcare infrastructure, high healthcare spending and a strong presence of leading device manufacturers. Europe follows closely mainly supported by its stringent cancer screening guidelines and government initiatives that promotes early detection. Meanwhile, the Asia Pacific region is emerging as a fast-growing market because of increasing awareness of cancer diagnosis, growing healthcare expenditures and improving healthcare facilities. In line with this, countries like China and India are witnessing a gradual increase in demand because of their large population and rising incidence of cancer making these reason critical for biopsy devices market growth.
• Competitive Landscape: Some of the major market players in the keyword industry include Argon Medical Devices, B. Braun Melsungen AG, Becton Dickinson and Company, Boston Scientific Corporation, CONMED Corporation, Cook Medical, DTR Medical Ltd, Fujifilm Holdings Corporation, Hologic Inc., INRAD Inc., Medtronic plc, TransMed7, LLC, TSK Laboratory, among many others.
• Challenges and Opportunities: The biopsy devices market faces several challenges which includes stringent regulatory requirements that can delay the product approvals and high costs associated with advanced biopsy technologies which may limit its adoption in cost sensitive markets. There is also a risk of complications such as infections and bleeding which can deter patient acceptance. On the opportunity side, there is a growing demand for cost effective and safer biopsy devices which encourages the companies to invest in research and development (R&D). Growing trend towards personalized medicine and non-invasive diagnostic methods opens new avenues for liquid biopsies and molecular diagnostics. Furthermore, expanding healthcare access in emerging markets present significant opportunities for biopsy devices market growth.

BIOPSY DEVICES MARKET TRENDS/DRIVERS:

Rising Incidence of Cancer

The increasing burden of cancer worldwide is a significant driver for the biopsy devices market. Cancer diagnoses require precise and early-stage identification for optimal treatment, making biopsies an essential diagnostic tool. According to the World Health Organization (WHO), cancer is the 2nd leading cause of death globally, responsible for an estimated 9.6 million deaths in 2018. As cancer rates continue to escalate, there has been a rise in the need for accurate and efficient diagnostic methods. Therefore, biopsy devices are becoming vital in identifying malignant tissues, allowing clinicians to formulate appropriate treatment plans. The rising incidence of cancer catalyzes the demand for advanced biopsy devices, thus positively influencing biopsy devices market growth.

Rapid Technological Advancements

Innovations in biopsy devices represent another major growth-inducing factor. Technological advancements are improving the efficacy, speed, and safety of biopsy procedures. For instance, vacuum-assisted biopsy devices allow quicker and more comfortable extraction of tissue samples, thereby enhancing patient experience. Trajan Scientific and Medical licensed Harpera, a minimally invasive skin micro biopsy device, from the University of Queensland. The device aims to provide a less invasive and more frequent skin sampling alternative for skin conditions. Additionally, the integration of real-time imaging techniques such as ultrasound, CT scans, or MRI with biopsy devices provides physicians with a more accurate target area, reducing procedural complications and increasing diagnostic reliability. For instance, MediSCAPE, introduced by the engineering team from the University of Columbia, is a new technology that eliminate the need for biopsies, demonstrated by collecting images of mouth tissues in a living human. The results included rapid imaging while a volunteer licked the end of the imaging probe, producing detailed 3D views of the papillae of the tongue. This breakthrough is considered to have the potential to revolutionize medical diagnostics. Such technological enhancements contribute to higher product adoption rates among healthcare professionals, which in turn is propelling biopsy devices market growth.

Extensive Investments in Healthcare Infrastructure

The rising investments in healthcare infrastructure, especially in emerging economies, also drive the market toward growth. The increased funding by public and private agencies facilitates the modernization of medical facilities, including diagnostic labs and the acquisition of state-of-the-art medical equipment. For instance, the Biden-Harris Administration has unveiled the President's Budget for Fiscal Year 2025, which includes a $9.683 billion budget request for the Centers for Disease Control and Prevention (CDC). This budget request is $499.2 million more than the FY 2023 appropriation and will help the CDC respond to health threats promptly, address mental health and overdose crises, and support young families for the well-being of children. As healthcare systems globally are focusing on delivering more accurate and timely diagnostics, the incorporation of advanced biopsy devices becomes a natural progression. This has expanded the market for these devices while ensuring broader access to high-quality diagnostic procedures for patients, thus providing a positive outlook to the biopsy devices market growth.

BIOPSY DEVICES INDUSTRY SEGMENTATION:

Breakup by Procedure Type:

• Surgical Biopsy
• Needle Biopsy

Surgical biopsy dominates the market

Surgical biopsy is widely preferred among healthcare professionals for accurate and comprehensive tissue analysis due to its high diagnostic accuracy and versatility. Unlike other biopsy methods, such as needle or liquid biopsies, surgical biopsies enable the removal of an entire tumor or a larger section of tissue, providing a more comprehensive sample for analysis. This increased sample size enhances the ability of pathologists to make accurate and definitive diagnoses, particularly in complex cases where malignancy is suspected but not confirmed through less invasive methods. Additionally, surgical biopsies are often employed in locations difficult to access by needle-based techniques, such as deeper tissues or organs. Another major contributing aspect is its utility beyond diagnosis; it often serves as both a diagnostic and therapeutic procedure by allowing for the complete excision of small malignant masses. The surgical approach is also favored in cases requiring immediate intervention or when other biopsy methods have yielded inconclusive results, thus supporting the segment growth.

Breakup by Product:

• Biopsy Guidance Systems
• Needle Based Biopsy Guns
• Biopsy Needles
• Biopsy Forceps
• Others

Biopsy guidance systems represent the most popular product

Biopsy guidance systems are crucial in enhancing the accuracy and efficiency of biopsy procedures. These guidance systems often integrate with imaging technologies like ultrasound, MRI, or CT scans to provide real-time visualization of the tissue area being targeted. Such integration allows healthcare professionals to precisely locate and assess the tissue sample needed for diagnosis, thereby reducing the risk of complications and procedural errors. In a medical landscape where precision is paramount, these guidance systems offer a significant edge. Their utility is especially prominent in complex cases where the targeted tissue is located deep within the body or near critical organs, where pinpoint accuracy is essential. Moreover, guidance systems are becoming increasingly user-friendly and compatible with various types of biopsy devices, which promotes their adoption across different healthcare settings. By facilitating quicker, more accurate, and safer procedures, biopsy guidance systems are indispensable tools that clinicians rely on, which is fueling the segment growth.

Breakup by Application:

• Breast Biopsy
• Lung Biopsy
• Colorectal Biopsy
• Prostate Biopsy
• Others

Breast biopsy accounts for the majority of the market share

The main factor driving the growth of this segment is the high incidence of breast cancer globally. According to the World Cancer Research Fund, breast cancer is the most commonly occurring cancer in women and the second most common cancer overall. Early detection is critical for effective treatment, and biopsy remains one of the most reliable diagnostic methods for confirming the presence or absence of cancerous cells in breast tissue. Furthermore, advances in imaging technologies such as mammography and ultrasound have significantly improved the accuracy of breast biopsies, making it a preferred diagnostic option. Public awareness campaigns about the importance of early detection have also played a role in the frequent utilization of breast biopsy procedures. Increasingly, women are becoming proactive about their breast health, leading to more screenings and, subsequently, more biopsies to confirm or rule out malignancy. As a result, the breast biopsy segment continues to maintain its leading position in the biopsy devices market.

Breakup by Guidance Technique:

• Ultrasound Guided Biopsy
• Stereotactic Guided Biopsy
• MRI Guided Biopsy
• Others

Ultrasound guided biopsy holds the largest share in the market

Ultrasound-guided biopsy provides real-time imaging, allowing healthcare professionals to visualize the exact area from which the tissue sample is to be extracted. This enhances the accuracy and efficiency of the biopsy procedure. Moreover, ultrasound-guided biopsies are less invasive and generally quicker than other methods, requiring only local anesthesia. This further improves patient comfort and reduces recovery time. Compared to other imaging modalities like MRI or CT scans, ultrasound is considerably less expensive and more widely available across healthcare settings, including smaller clinics and outpatient centers. This accessibility makes it a go-to option for many physicians. Besides this, ultrasound does not involve exposure to ionizing radiation, making it a safer alternative for repeated procedures and specific patient populations, such as pregnant women. Due to these advantages-real-time imaging, cost-effectiveness, minimal invasiveness, and safety-ultrasound-guided biopsy is widely preferred, contributing to segment growth.

Breakup by End User:

• Hospitals and Clinics
• Academic and Research Institutes
• Others

Hospitals and clinics are often the first point of contact for patients requiring diagnostic procedures, including biopsies. These healthcare settings are equipped with advanced diagnostic tools and skilled professionals capable of performing a wide range of biopsy types. The growing incidence of diseases requiring biopsies, coupled with the expansion of healthcare infrastructure globally, has led to higher adoption of biopsy devices in these institutions. Moreover, hospitals often have the financial capacity to invest in the latest biopsy technologies, further augmenting the market growth.

Although smaller in market share compared to hospitals and clinics, academic and research institutes are an essential segment. These institutions primarily focus on research and development activities aimed at improving biopsy technologies or devising new diagnostic methods. They may also conduct clinical trials to evaluate the efficacy of new biopsy devices. While the volume of biopsies performed may be lower compared to hospitals, their influence on product innovation and validation is significant.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

North America exhibits a clear dominance in the market

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America held the biggest market share since the region has a high prevalence of lifestyle-related diseases, including cancer, necessitating frequent utilization of biopsy procedures for diagnosis and monitoring. According to the American Cancer Society, in 2021, an estimated 1.9 million new cancer cases were diagnosed in the United States alone. In addition, North America boasts a highly developed healthcare infrastructure, including hospitals and clinics equipped with advanced diagnostic technologies, thereby facilitating the adoption of state-of-the-art biopsy devices.

Apart from this, the region has significant investments in healthcare research and development, often leading the way in medical innovation, including the development of new and more effective biopsy techniques and devices. Furthermore, there is a strong insurance framework supporting medical procedures, including biopsies, which makes these diagnostic tests more accessible to a broader population. Also, high levels of public awareness about the importance of early diagnosis and preventive healthcare catalyze the demand for diagnostic procedures such as biopsies. These combined factors position North America as the leading regional market for biopsy devices.

COMPETITIVE LANDSCAPE:

The market is experiencing steady growth as key players are actively engaged in a range of strategic activities aimed at consolidating their market position. These actions include the development of technologically advanced devices, such as vacuum-assisted and image-guided biopsy systems, to increase accuracy and patient comfort. Companies are also focusing on mergers, acquisitions, and strategic collaborations to expand their product portfolios and geographic reach. Additionally, significant investment is being made in research and development (R&D) to innovate new products and improve existing ones. Regulatory approvals and patent filings are other critical areas of focus aimed at securing exclusivity for innovative devices. Through these combined efforts, key market players are shaping the trajectory of the biopsy devices industry.

The market research report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Argon Medical Devices
• B. Braun Melsungen AG
• Becton Dickinson and Company
• Boston Scientific Corporation
• CONMED Corporation
• Cook Medical
• DTR Medical Ltd
• Fujifilm Holdings Corporation
• Hologic Inc.
• INRAD Inc.
• Medtronic plc
• TransMed7, LLC
• TSK Laboratory

KEY QUESTIONS ANSWERED IN THIS REPORT

• How has the global biopsy devices market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global biopsy devices market?
• What is the impact of each driver, restraint, and opportunity on the global biopsy devices market?
• What are the key regional markets?
• Which countries represent the most attractive biopsy devices market?
• What is the breakup of the market based on the procedure type?
• Which is the most attractive procedure type in the biopsy devices market?
• What is the breakup of the market based on the product?
• Which is the most attractive product in the biopsy devices market?
• What is the breakup of the market based on the application?
• Which is the most attractive application in the biopsy devices market?
• What is the breakup of the market based on the guidance technique?
• Which is the most attractive guidance technique in the biopsy devices market?
• What is the breakup of the market based on the end-user?
• Which is the most attractive end-user in the biopsy devices market?
• What is the competitive structure of the global biopsy devices market?
• Who are the key players/companies in the global biopsy devices market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Biopsy Devices Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID 19
• 5.4 Market Forecast

6 Market Breakup by Procedure Type

• 6.1 Surgical Biopsy
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Needle Biopsy
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast

7 Market Breakup by Product

• 7.1 Biopsy Guidance Systems
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Needle Based Biopsy Guns
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Biopsy Needles
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 Biopsy Forceps
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast
• 7.5 Others
  • 7.5.1 Market Trends
  • 7.5.2 Market Forecast

8 Market Breakup by Application

• 8.1 Breast Biopsy
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Lung Biopsy
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Colorectal Biopsy
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Prostate Biopsy
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast
• 8.5 Others
  • 8.5.1 Market Trends
  • 8.5.2 Market Forecast

9 Market Breakup by Guidance Technique

• 9.1 Ultrasound-guided Biopsy
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Stereotactic-guided Biopsy
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 MRI-guided Biopsy
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Others
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast

10 Market Breakup by End-User

• 10.1 Hospitals and Clinics
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Academic and Research Institutes
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Others
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast

11 Market Breakup by Region

• 11.1 North America
  • 11.1.1 United States
    • 11.1.1.1 Market Trends
    • 11.1.1.2 Market Forecast
  • 11.1.2 Canada
    • 11.1.2.1 Market Trends
    • 11.1.2.2 Market Forecast
• 11.2 Asia Pacific
  • 11.2.1 China
    • 11.2.1.1 Market Trends
    • 11.2.1.2 Market Forecast
  • 11.2.2 Japan
    • 11.2.2.1 Market Trends
    • 11.2.2.2 Market Forecast
  • 11.2.3 India
    • 11.2.3.1 Market Trends
    • 11.2.3.2 Market Forecast
  • 11.2.4 South Korea
    • 11.2.4.1 Market Trends
    • 11.2.4.2 Market Forecast
  • 11.2.5 Australia
    • 11.2.5.1 Market Trends
    • 11.2.5.2 Market Forecast
  • 11.2.6 Indonesia
    • 11.2.6.1 Market Trends
    • 11.2.6.2 Market Forecast
  • 11.2.7 Others
    • 11.2.7.1 Market Trends
    • 11.2.7.2 Market Forecast
• 11.3 Europe
  • 11.3.1 Germany
    • 11.3.1.1 Market Trends
    • 11.3.1.2 Market Forecast
  • 11.3.2 France
    • 11.3.2.1 Market Trends
    • 11.3.2.2 Market Forecast
  • 11.3.3 United Kingdom
    • 11.3.3.1 Market Trends
    • 11.3.3.2 Market Forecast
  • 11.3.4 Italy
    • 11.3.4.1 Market Trends
    • 11.3.4.2 Market Forecast
  • 11.3.5 Spain
    • 11.3.5.1 Market Trends
    • 11.3.5.2 Market Forecast
  • 11.3.6 Russia
    • 11.3.6.1 Market Trends
    • 11.3.6.2 Market Forecast
  • 11.3.7 Others
    • 11.3.7.1 Market Trends
    • 11.3.7.2 Market Forecast
• 11.4 Latin America
  • 11.4.1 Brazil
    • 11.4.1.1 Market Trends
    • 11.4.1.2 Market Forecast
  • 11.4.2 Mexico
    • 11.4.2.1 Market Trends
    • 11.4.2.2 Market Forecast
  • 11.4.3 Others
    • 11.4.3.1 Market Trends
    • 11.4.3.2 Market Forecast
• 11.5 Middle East and Africa
  • 11.5.1 Market Trends
  • 11.5.2 Market Breakup by Country
  • 11.5.3 Market Forecast

12 SWOT Analysis

• 12.1 Overview
• 12.2 Strengths
• 12.3 Weaknesses
• 12.4 Opportunities
• 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

• 14.1 Overview
• 14.2 Bargaining Power of Buyers
• 14.3 Bargaining Power of Suppliers
• 14.4 Degree of Competition
• 14.5 Threat of New Entrants
• 14.6 Threat of Substitutes

15 Price Indicators

16 Competitive Landscape

• 16.1 Market Structure
• 16.2 Key Players
• 16.3 Profiles of Key Players
  • 16.3.1 Argon Medical Devices
    • 16.3.1.1 Company Overview
    • 16.3.1.2 Product Portfolio
  • 16.3.2 B. Braun Melsungen AG
    • 16.3.2.1 Company Overview
    • 16.3.2.2 Product Portfolio
    • 16.3.2.3 Financials
    • 16.3.2.4 SWOT Analysis
  • 16.3.3 Becton Dickinson and Company
    • 16.3.3.1 Company Overview
    • 16.3.3.2 Product Portfolio
    • 16.3.3.3 Financials
    • 16.3.3.4 SWOT Analysis
  • 16.3.4 Boston Scientific Corporation
    • 16.3.4.1 Company Overview
    • 16.3.4.2 Product Portfolio
    • 16.3.4.3 Financials
    • 16.3.4.4 SWOT Analysis
  • 16.3.5 CONMED Corporation
    • 16.3.5.1 Company Overview
    • 16.3.5.2 Product Portfolio
  • 16.3.6 Cook Medical
    • 16.3.6.1 Company Overview
    • 16.3.6.2 Product Portfolio
  • 16.3.7 DTR Medical Ltd
    • 16.3.7.1 Company Overview
    • 16.3.7.2 Product Portfolio
    • 16.3.7.3 Financials
    • 16.3.7.4 SWOT Analysis
  • 16.3.8 Fujifilm Holdings Corporation
    • 16.3.8.1 Company Overview
    • 16.3.8.2 Product Portfolio
  • 16.3.9 Hologic Inc.
    • 16.3.9.1 Company Overview
    • 16.3.9.2 Product Portfolio
    • 16.3.9.3 Financials
    • 16.3.9.4 SWOT Analysis
  • 16.3.10 INRAD Inc.
    • 16.3.10.1 Company Overview
    • 16.3.10.2 Product Portfolio
  • 16.3.11 Medtronic plc
    • 16.3.11.1 Company Overview
    • 16.3.11.2 Product Portfolio
    • 16.3.11.3 SWOT Analysis
  • 16.3.12 TransMed7, LLC
    • 16.3.12.1 Company Overview
    • 16.3.12.2 Product Portfolio
    • 16.3.12.3 Financials
    • 16.3.12.4 SWOT Analysis
  • 16.3.13 TSK Laboratory
    • 16.3.13.1 Company Overview
    • 16.3.13.2 Product Portfolio
    • 16.3.13.3 Financials
    • 16.3.13.4 SWOT Analysis