Biopsy Devices Market by Product, Technique, Application, End User

List of Tables

[183 Pages Report] The Biopsy Devices Market size was estimated at USD 9.47 billion in 2023 and expected to reach USD 10.46 billion in 2024, at a CAGR 10.82% to reach USD 19.46 billion by 2030.

The biopsy devices are used explicitly in diagnostic procedures that involve the extraction of sample cells and tissues for examination aimed at identifying the existence and extent of a disease. These devices range from needle biopsy devices, biopsy guidance systems to biopsy forceps. Biopsy devices have a crucial role in several medical applications pertaining to disease detection and monitoring, including breast biopsy, gastrointestinal biopsy, prostate biopsy, liver biopsy, and lung biopsy. An increasing prevalence of cancer worldwide and a growing preference for minimally invasive surgeries are pivotal factors driving the market growth. In contrast, high equipment costs, risks associated with biopsy procedures, and the stringent regulatory hurdles by health authorities hinder the market growth. However, several vendors are focusing on R&D to overcome these issues. Furthermore, advancements in the manufacturing process of biopsy devices, extending the usage of biopsy devices in research and tissue banking, improved healthcare infrastructures, and investments in emerging economies contribute to market expansion.

KEY MARKET STATISTICS
Base Year [2023]	USD 9.47 billion
Estimated Year [2024]	USD 10.46 billion
Forecast Year [2030]	USD 19.46 billion
CAGR (%)	10.82%

Product: Growing preference for needle-based biopsy instruments as it provide minimal risk of complications

Biopsy forceps are sophisticated, hand-held devices used during minimally invasive procedures, designed with a two-leaf structure; they are adept at extracting tissue samples from targeted areas with sheer precision and minimal patient discomfort. Localization wires act as a guide in identifying the correct area for biopsy, particularly in breast biopsy procedures. They are used preoperatively to seperate non-palpable lesions detected during mammography or ultrasound, ensuring precision and aiding radiologists in obtaining tissue samples. Needle-based biopsy instruments are preferred for deep-seated lesions; common types include fine-needle aspiration and core-needle biopsies. These devices reduce procedural complications and are known for their efficiency in obtaining high-quality samples, helping in precise diagnoses. Needle-based biopsy instruments include aspiration needles, core biopsy devices, and vacuum-assisted biopsy devices. Aspiration needles play a crucial role in fine-needle aspiration biopsy procedures, often used to investigate lumps or masses. Core biopsy devices remove a small tissue section for pathological examination, usually used in breast, liver, or bone biopsies. Vacuum-assisted biopsy devices are remarkably efficient tools for minimally invasive biopsy procedures. Employing a vacuum mechanism, these devices allow for a continuous tissue sample to be acquired without reinserting the needle. Procedure trays are a compact, systematic solution encompassing all necessary biopsy tools for a specific procedure. They optimize the workflow, promote efficient resource use, and enhance the sterility of the procedure.

Technique: Significant role of MRI-guided biopsy in biopsy device for high diagnosis accuracy

Image-guided biopsy is a noteworthy innovation in the realm of biopsy devices, harnessing the precision of modern imaging technologies. This advanced technique enables doctors to extract samples from difficult-to-access areas, leading to a more accurate and less invasive procedure. Image-guided biopsy includes MRI-guided biopsy, stereotactic-guided biopsies, and ultrasound-guided biopsy. MRI-guided biopsy has become a preferred technique for diagnosing abnormalities located in difficult-to-reach areas or those of more intricate structures such as the brain and the breast. Stereotactic-guided biopsies are more applicable for relatively superficial abnormalities, including those in the breast and lesions close to the skin. This technique is a boon for patients to avoid the discomfort of invasive procedures while still ensuring a highly accurate diagnosis. Ultrasound-guided biopsy primarily leverages its advantage in real-time image provision, making it the go-to option for neck, chest, and abdomen biopsies. Furthermore, it is a cost-effective and faster way of performing biopsies and is preferred in situations where cost and time are primary considerations. In comparison, MRI-guided biopsy stands at the forefront of advanced cases, stereotactic biopsy rings are necessary for superficial cases, and ultrasound-guided offerings are proven beneficial in real-time requirements and cost-effective scenarios. Non-image guided biopsy includes techniques where palpation or anatomical landmarks are used to determine the biopsy site without the assistance of live-image guidance. The choice between image-guided and non-image-guided biopsies largely depends on the location and nature of the lesion, the patient's health status, and the resources available. Image-guided biopsy methods are leading in the context of precision and safety, particularly for non-palpable and deep-seated lesions. However, non-image-guided procedures remain a fast and cost-effective option for superficial masses.

Application: Growing need for breast and prostate biopsy devices due to increasing instances of cancer in both areas

The upsurge in breast cancer cases worldwide has subsequently triggered the need for breast biopsy devices. Devices such as vacuum-assisted biopsy (VAB) systems attain favor for their minimally invasive nature, confident diagnosis, and high-speed, painless process. Flexible sigmoidoscopes are preferred for colorectal biopsy due to their ability to detect abnormalities in the rectum and sigmoid colon. The rising incidence of lung conditions, including cancer, triggers the need for lung biopsy devices, where transthoracic needle biopsy (TTNB) devices are commonly used. Prostate biopsy procedures largely use transrectal ultrasound (TRUS) guided prostate biopsy devices, as per need-based preference. Biopsy devices for breast and prostate biopsies are undergoing significant technological advancement owing to rising cancer rates. Simultaneously, devices for lung and colorectal biopsies address a range of illnesses, cancer included. Biopsy devices remain paramount in medical diagnosis, reflecting continuous progress and ensuring patient health.

End User: Rising utilization of biopsy devices that promote lesser recovery time in the hospitals

Academic and research institutes pursue innovative solutions for improving the accuracy and efficiency of biopsy procedures, with a particular emphasis on non-invasive techniques. These institutions seek sophisticated and advanced biopsy devices that allow them to explore new frontiers of medical research. Diagnostic and imaging centers focus primarily on timely and accurate diagnosis. They require biopsy devices that facilitate rapid sample collection with minimal patient discomfort. Biopsy devices that allow for shorter recovery times, fewer complications, and lower costs are ideally preferred by primary healthcare providers and hospitals as they mainly focus on patient safety, comfort, and cost-effectiveness. The shared objective across these user groups is to enhance biopsy procedure accuracy and efficiency. The varied sector needs to drive market evolution, promising more subtle innovations and improved global health outcomes.

Regional Insights

The Americas region has witnessed a rising trend in the utilization of biopsy devices due to the increase in various cancer cases. According to the American Cancer Society, in 2023, there are estimated to be 1,958,310 new cancer cases. This directly contributes to the need for biopsy devices. State-of-the-art technology and medical advancements, alongside favorable reimbursement policies in this region, contribute to the market growth. Also, growing awareness about early detection of cancer, reinforced by strong healthcare marketing, paves the path for increased use of biopsy devices in the region. Furthermore, the EMEA region, characterized by rapidly aging populations and a high incidence of cancer, has a strong need for biopsy devices. The market inflow is also credited to the adoption of technologically advanced healthcare equipment and infrastructure. National healthcare systems in this region promote timely and accurate cancer diagnosis, enabling increased biopsy device utilization. The awareness campaigns by the World Health Organization (WHO) and the European Institute of Oncology stimulate the need for biopsy devices in the region. Moreover, the APAC region is experiencing a rapid increase in lifestyle-related diseases, including cancers. The aging population, environmental pollution, and unhealthy lifestyle habits are fueling the incidences of cancer, thereby increasing the need for biopsy devices. In addition, improving healthcare systems, increasing healthcare spending, and raising awareness about early cancer detection are other factors fostering the adoption of biopsy devices.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Biopsy Devices Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biopsy Devices Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Biopsy Devices Market, highlighting leading vendors and their innovative profiles. These include Advin Health Care, Argon Medical Devices, Inc., Axlab Limited, B. Braun SE, Becton, Dickinson and Company, Boston Scientific Corporation, Cardinal Health, Inc., CONMED Corporation, Cook Group Incorporated, Danaher Corporation, F. Hoffmann-La Roche Ltd., Ferrosan Medical Devices A/S, Fujifilm Holdings Corporation, Guardant Health, Inc., Hologic, Inc., Innovia Medical, INRAD, Inc., Integra LifeSciences Holdings Corporation, IZI Medical Products, LLC by Halma PLC, JEB Technologies Limited, Limaca-Medical, MediTech Devices Pvt Ltd., Medtronic PLC, Merit Medical Systems, Inc., Mermaid Medical, Olympus Corporation, PAJUNK GmbH Medizintechnologie, Remington Medical, Spectra Medical Devices, LLC, Stryker Corporation, Suretech Medical Inc., Trajan Scientific and Medical Pty Ltd., TransMed7, LLC, TSK Laboratory, UVision360, Volkmann MedizinTechnik GmbH, weLLgo Medical Products GmbH, and Zamar Care.

Market Segmentation & Coverage

This research report categorizes the Biopsy Devices Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Biopsy Forceps
- Localization Wires
- Needle-Based Biopsy Instruments
  - Aspiration Needles
  - Core Biopsy Devices
  - Vacuum-Assisted Biopsy Devices

Procedure Trays

Technique
- Image Guided Biopsy
  - MRI-Guided Biopsy
  - Stereotactic-Guided Biopsy
  - Ultrasound-Guided Biopsy

Non-Image Guided Biopsy

Application
- Bone Marrow Biopsy
- Breast Biopsy
- Kidney Biopsy
- Lung Biopsy
- Prostate Biopsy

End User
- Academic & Research Institutes
- Diagnostic & Imaging Centers
- Hospitals

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Biopsy Devices Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopsy Devices Market?

3. What are the technology trends and regulatory frameworks in the Biopsy Devices Market?

4. What is the market share of the leading vendors in the Biopsy Devices Market?

5. Which modes and strategic moves are suitable for entering the Biopsy Devices Market?

Product Code: MRR-4103B31E073F

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Growing incidences of cancer and gastrointestinal diseases
  - 5.1.1.2. Rise in adoption of minimally-invasive techniques
  - 5.1.1.3. Increasing awareness of the importance of early detection and screening of diseases
- 5.1.2. Restraints
  - 5.1.2.1. High cost associated with the production of biopsy devices
- 5.1.3. Opportunities
  - 5.1.3.1. Continuous technological advancements in biopsy devices
  - 5.1.3.2. Growing inclination towards liquid biopsy devices
- 5.1.4. Challenges
  - 5.1.4.1. Problems associated with stringent regulations by health authorities
5.2. Market Segmentation Analysis
- 5.2.1. Product: Growing preference for needle-based biopsy instruments as it provide minimal risk of complications
- 5.2.2. Technique: Significant role of MRI-guided biopsy in biopsy device for high diagnosis accuracy
- 5.2.3. Application: Growing need for breast and prostate biopsy devices due to increasing instances of cancer in both areas
- 5.2.4. End User: Rising utilization of biopsy devices that promote lesser recovery time in the hospitals
5.3. Market Trend Analysis
- 5.3.1. Growing research activities in developing novel biopsy devices coupled with robust presence of major companies in the Americas region
- 5.3.2. Increasing product approvals from regional regulatory bodies coupled with growing research and development activities to expand the application of biopsy devices in the APAC region
- 5.3.3. Advanced healthcare facilities and cancer detection and prevention program in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Biopsy Devices Market, by Product

6.1. Introduction
6.2. Biopsy Forceps
6.3. Localization Wires
6.4. Needle-Based Biopsy Instruments
6.5. Procedure Trays

7. Biopsy Devices Market, by Technique

7.1. Introduction
7.2. Image Guided Biopsy
7.3. Non-Image Guided Biopsy

8. Biopsy Devices Market, by Application

8.1. Introduction
8.2. Bone Marrow Biopsy
8.3. Breast Biopsy
8.4. Kidney Biopsy
8.5. Lung Biopsy
8.6. Prostate Biopsy

9. Biopsy Devices Market, by End User

9.1. Introduction
9.2. Academic & Research Institutes
9.3. Diagnostic & Imaging Centers
9.4. Hospitals

10. Americas Biopsy Devices Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Biopsy Devices Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Biopsy Devices Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. LUMINELLE Announces China National Intellectual Property Administration's Decision to Grant Issuance of Patent for LUMINELLE Bx (Biopsy) System, Expanding Global Footprint
- 13.3.2. Limaca Medical Receives FDA 510(k) Clearance for its Breakthrough Precision GI Endoscopic Biopsy Device
- 13.3.3. Stryker Announces Commercial Launch of Q Guidance System with Cranial Guidance Software
- 13.3.4. Merit Medical Acquires AngioDynamics' Catheter Portfolio and Biopsy System
- 13.3.5. Argon's SuperCore Advantage Biopsy Instrument Launched in United States
- 13.3.6. Quest Diagnostics to Acquire Haystack Oncology, Adding Sensitive Liquid Biopsy Technology for Improving Personalized Cancer Care to Oncology Portfolio
- 13.3.7. Innovia Medical Launches the Oral Rotating Biopsy Punch at BACO International 2023
- 13.3.8. Guardant360 CDx Gets FDA Approval as Companion Diagnostic for ORSERDU
- 13.3.9. TransMed7, LLC Announces First Clinical Use of SpeedBird Breast Biopsy Devices for Commercial Launch
- 13.3.10. Terumo India Partners with Argon Medical to Expand Portfolio

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio