Biopsy Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Tissue Biopsy, Liquid Biopsy), By Disease Type (Cancer, Infections, Autoimmune Disorders, Non-Cancerous Indications, Others), By Anatomy (Breast, Lung, Bone, Liver, Uterus/Cervix/Ovary, Abdomen, Prostate, Cardiac, Skin, Others), By Guidance Technique (X-Ray-Guided Biopsy, Ultrasound-Guided Biopsy, MRI-Guided Biopsy, CT-Guided Biopsy), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 6.69 Billion
CAGR (2026-2031)	6.79%
Fastest Growing Segment	Breast
Largest Market	North America
Market Size (2031)	USD 9.92 Billion

Market Overview

The Global Biopsy Devices Market will grow from USD 6.69 Billion in 2025 to USD 9.92 Billion by 2031 at a 6.79% CAGR. Biopsy devices are specialized medical instruments designed to harvest tissue specimens for pathological examination and disease monitoring. These tools are fundamental in oncology for confirming malignancies through less invasive procedures such as fine needle aspiration. The market is primarily supported by the rising global incidence of cancer and a growing clinical preference for diagnostic methods that reduce patient recovery time. According to the American Cancer Society, in 2025, an estimated 2,041,910 new cancer cases were projected to occur in the United States. This escalation in disease burden necessitates frequent diagnostic interventions and directly strengthens the demand for advanced biopsy technologies.

Nevertheless, the sector encounters significant impediments related to stringent regulatory frameworks. Manufacturers must navigate complex compliance standards that frequently delay the commercialization of innovative solutions. Additionally, the substantial expense associated with automated biopsy systems limits their penetration in markets with constrained healthcare funding. These regulatory and economic obstacles present a major challenge that could restrict the continued expansion of the global biopsy devices market.

Key Market Drivers

Escalating global incidence of cancer acts as the primary catalyst for the biopsy devices market, fundamentally driving the volume of diagnostic procedures required for disease confirmation and staging. As malignancy patterns shift and detection rates rise within specific demographics, healthcare providers are compelled to increase the frequency of tissue sampling interventions to ensure timely therapeutic decisions. This trend is particularly evident in younger demographics where disease burden is unexpectedly growing, necessitating aggressive diagnostic protocols. According to the American Cancer Society, January 2025, in the 'Cancer Statistics, 2025' report, cancer incidence rates in women younger than 50 years were 82% higher than those in their male counterparts. This surge in prevalence among working-age populations ensures a sustained and expanding clinical requirement for reliable biopsy instruments, cementing the sector's growth trajectory.

Simultaneously, the market is being reshaped by technological innovations in image-guided and robotic biopsy systems, which allow for unprecedented precision in accessing difficult-to-reach lesions. The integration of robotics into biopsy workflows minimizes patient trauma and improves diagnostic yield, accelerating the shift away from traditional open surgical methods. According to Intuitive Surgical, January 2025, in the 'Preliminary Fourth Quarter and Full Year 2024 Results' press release, Ion procedure volume grew approximately 70% in the fourth quarter of 2024 compared to the prior year. This rapid adoption of robotic-assisted bronchoscopy highlights the market’s enthusiastic reception of advanced interventional technologies. According to Merit Medical Systems, January 2025, the company reported preliminary unaudited revenue of approximately $1.36 billion for the full year 2024, reflecting the strong commercial demand for these critical interventional and diagnostic solutions.

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Key Market Challenges

The global biopsy devices market faces substantial headwinds due to stringent regulatory frameworks that govern the approval and commercialization of medical technologies. Manufacturers must navigate increasingly complex compliance standards, which compel them to undergo rigorous and prolonged conformity assessments. This regulatory environment creates a significant bottleneck, as companies are forced to allocate extensive resources toward clinical data generation and documentation to meet heightened safety requirements. These obligations directly hamper market growth by causing a lag between product development and clinical availability, thereby delaying the introduction of innovative biopsy tools essential for timely disease detection.

The impact of these delays is quantifiable and severe for the industry. According to MedTech Europe, in 2025, the average duration for the Technical Documentation Assessment of medical devices was reported to be approximately 22 months. Such extended review timelines create operational uncertainty and disrupt the supply chain, particularly for legacy devices requiring recertification. Consequently, these regulatory hurdles restrict the immediate expansion of the market, as healthcare providers are unable to access the latest diagnostic technologies needed to address the growing burden of cancer.

Key Market Trends

The proliferation of single-use and disposable biopsy devices is fundamentally altering procurement strategies as healthcare facilities prioritize infection control and operational efficiency. Unlike reusable instruments that require costly and time-consuming reprocessing, disposable alternatives eliminate the risk of cross-contamination and streamline procedural workflows. This shift is particularly pronounced in endoscopy-based biopsies, where sterility is paramount and the logistical burden of cleaning complex scopes is significant. The market's pivot toward these sterile solutions is evidenced by the rapid commercial expansion of manufacturers specializing in single-use technologies. According to Ambu, November 2024, in the 'Annual Report 2023/24', the company’s Endoscopy Solutions business achieved organic revenue growth of 19.7% for the full year, underscoring the accelerating global demand for sterile, single-use interventional tools.

Simultaneously, the incorporation of 3D tomosynthesis for breast biopsy guidance is establishing new standards for diagnostic accuracy in the women's health segment. This technology provides radiologists with superior visualization of tissue layers compared to traditional 2D imaging, significantly improving the targeting of complex calcifications and lesions during sampling procedures. The enhanced precision of tomosynthesis-guided systems reduces the need for re-biopsies and supports the early detection of malignancies in dense breast tissue. The clinical adoption of these advanced guidance platforms is driving substantial commercial activity. According to Hologic, November 2024, in the 'Financial Results for Fourth Quarter of Fiscal 2024', the company reported that its Breast Health division revenue increased 6.4%, reflecting the robust market uptake of its interventional and imaging portfolio.

Segmental Insights

The breast segment is positioned as the fastest-growing category in the global biopsy devices market, driven primarily by the rising global incidence of breast cancer. Reports from the World Health Organization highlight the increasing prevalence of this condition, thereby fueling the demand for early diagnostic interventions. Additionally, the market is expanding due to a significant clinical shift toward minimally invasive procedures, such as vacuum-assisted biopsies, which offer reduced recovery times compared to open surgery. This growth is further supported by consistent product clearances from regulatory bodies like the U.S. FDA, ensuring broader access to effective diagnostic solutions.

Regional Insights

North America currently holds the commanding position in the Global Biopsy Devices Market. This dominance is primarily driven by the rising prevalence of cancer and a highly developed healthcare infrastructure that supports early disease detection. The region benefits from favorable reimbursement policies established by the Centers for Medicare & Medicaid Services, which facilitate patient access to essential diagnostic procedures. Furthermore, the presence of major industry players and the consistent approval of new technologies by the U.S. Food and Drug Administration foster a robust environment for market growth. Strong government initiatives promoting cancer screening programs further solidify North America's leadership status.

Recent Developments

• In September 2025, Resitu Medical received 510(k) clearance from the U.S. Food and Drug Administration for its RESL09 breast biopsy device. This handheld, single-use instrument is designed for minimally invasive, ultrasound-guided procedures and is capable of excising large tissue samples with a diameter of up to 9 millimeters. The device utilizes a unique combination of vacuum fixation and an electrosurgical cutting electrode to capture and remove tissue for histopathological analysis. This regulatory milestone enables the company to proceed with a limited commercial launch in select geographies, providing surgeons with a new tool intended to improve the quality of diagnostic specimens.
• In November 2024, Mammotome unveiled the Mammotome AutoCore Single Insertion Core Biopsy System, representing a significant advancement in the breast biopsy market. As the first automated spring-loaded core needle device, it was designed to streamline ultrasound-guided biopsies by significantly reducing the number of procedural steps required. The system features single-button functionality with automated arming, which facilitates easy one-handed operation for clinicians. Additionally, the device incorporates a wiper arm that automatically transfers tissue samples into a clear, illuminated collection cup, eliminating the need for repeated needle removal and reinsertion, thus enhancing procedural efficiency and improving the overall patient experience.
• In September 2024, Argon Medical Devices expanded its interventional portfolio with the launch of the TLAB Transvenous Liver Biopsy System in the United States and Canada. This system was specifically designed to facilitate the collection of high-quality liver tissue samples through a transvenous approach, utilizing access via the femoral vein. The device features a novel articulation tool that allows physicians to adjust the curvature of the instrument to better accommodate varying patient anatomies during the procedure. The company simultaneously introduced the Intara Introducer Sheath, which is intended to support the use of the biopsy system and other diagnostic devices in complex vascular procedures.
• In May 2024, Cook Medical announced the commercial launch of the EchoTip ClearCore Endoscopic Ultrasound Biopsy Needle in the United States. This advanced device was engineered to improve the precision and efficiency of fine needle biopsies for submucosal and extramural lesions, as well as lymph nodes located adjacent to the gastrointestinal tract. The needle utilizes a Franseen tip constructed from a cobalt chromium alloy, a material chosen to provide enhanced flexibility and sharpness for puncturing tissue with minimal force. This product introduction underscores the company's commitment to developing technologies that assist physicians in accessing difficult anatomies while ensuring high-quality tissue acquisition for diagnosis.

Key Market Players

• Argon Medical Devices, Inc.
• B. Braun SE
• Becton, Dickinson and Company
• Boston Scientific Corporation
• Cardinal Health, Inc.
• Cook Medical Inc.
• Conmed Corporation
• FUJIFILM Holdings Corporation
• GE HealthCare
• Inrad, Inc

By Product Type	By Disease Type	By Anatomy	By Guidance Technique	By Region
Tissue Biopsy Liquid Biopsy	Cancer Infections Autoimmune Disorders Non-Cancerous Indications Others	Breast Lung Bone Liver Uterus/Cervix/Ovary Abdomen Prostate Cardiac Skin Others	X-Ray-Guided Biopsy Ultrasound-Guided Biopsy MRI-Guided Biopsy CT-Guided Biopsy	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Biopsy Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biopsy Devices Market, By Product Type:

• Tissue Biopsy
• Liquid Biopsy

• Biopsy Devices Market, By Disease Type:

• Cancer
• Infections
• Autoimmune Disorders
• Non-Cancerous Indications
• Others

• Biopsy Devices Market, By Anatomy:

• Breast
• Lung
• Bone
• Liver
• Uterus/Cervix/Ovary
• Abdomen
• Prostate
• Cardiac
• Skin
• Others

• Biopsy Devices Market, By Guidance Technique:

• X-Ray-Guided Biopsy
• Ultrasound-Guided Biopsy
• MRI-Guided Biopsy
• CT-Guided Biopsy

• Biopsy Devices Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE