Biopsy Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Biopsy Devices Market is anticipated to expand from a valuation of USD 6.69 Billion in 2025 to USD 9.92 Billion by 2031, reflecting a CAGR of 6.79%. These devices serve as essential medical instruments for extracting tissue samples utilized in pathological analysis and disease surveillance, playing a crucial role in oncology for confirming malignancies via minimally invasive techniques like fine needle aspiration. Market growth is largely underpinned by the escalating global prevalence of cancer and a rising clinical inclination toward diagnostic approaches that minimize patient recovery duration. Data from the American Cancer Society indicates that in 2025, approximately 2,041,910 new cancer cases were projected in the United States, a growing disease burden that necessitates frequent diagnostic procedures and bolsters demand for sophisticated biopsy solutions.

However, the industry faces substantial hurdles stemming from rigorous regulatory frameworks. Manufacturers are required to adhere to intricate compliance standards, which often prolong the commercial release of advanced innovations. Furthermore, the high costs linked to automated biopsy systems hinder their adoption in regions with limited healthcare funding. Together, these regulatory complexities and economic barriers constitute significant challenges that may impede the sustained growth of the global biopsy devices market.

Market Drivers

The rising global incidence of cancer serves as the principal driver for the biopsy devices market, significantly increasing the volume of diagnostic interventions needed for disease confirmation and staging. As malignancy trends evolve and detection rates increase within specific population segments, healthcare providers are compelled to perform more frequent tissue sampling to facilitate timely treatment decisions, a necessity particularly visible in younger demographics where disease burden is unexpectedly rising. According to the American Cancer Society's January 2025 report, cancer incidence rates among women under 50 were found to be 82% higher than in their male counterparts, ensuring a continuous and growing clinical demand for reliable biopsy tools among working-age populations.

Concurrently, the market is being transformed by technological advancements in image-guided and robotic biopsy systems, which offer unmatched precision for accessing challenging lesions. The incorporation of robotics into biopsy procedures reduces patient trauma and enhances diagnostic outcomes, accelerating the transition away from conventional open surgical techniques. Intuitive Surgical reported in January 2025 that Ion procedure volumes surged by approximately 70% in the fourth quarter of 2024 compared to the previous year, highlighting the enthusiastic market adoption of these technologies. Additionally, Merit Medical Systems reported preliminary 2024 revenue of roughly $1.36 billion in January 2025, further evidencing the robust commercial demand for these essential interventional and diagnostic solutions.

Market Challenges

The global biopsy devices market confronts significant obstacles arising from strict regulatory frameworks regarding the approval and commercialization of medical technologies. Manufacturers are required to navigate increasingly intricate compliance standards, necessitating rigorous and extended conformity assessments that force companies to dedicate substantial resources to clinical data generation and safety documentation. This regulatory landscape creates a considerable bottleneck, hampering market growth by creating a delay between product development and clinical accessibility, which effectively slows the introduction of innovative biopsy tools needed for timely disease diagnosis.

The consequences of these delays are both severe and measurable for the industry. In 2025, MedTech Europe reported that the average duration for the Technical Documentation Assessment of medical devices was approximately 22 months. Such prolonged review periods introduce operational uncertainty and disrupt supply chains, especially for legacy devices that require recertification. As a result, these regulatory barriers limit the immediate expansion of the market, preventing healthcare providers from accessing the latest diagnostic technologies required to manage the increasing cancer burden.

Market Trends

The widespread adoption of single-use and disposable biopsy devices is fundamentally transforming procurement strategies as healthcare facilities place greater emphasis on infection control and operational efficiency. Unlike reusable instruments, which demand expensive and time-intensive reprocessing, disposable options mitigate cross-contamination risks and streamline procedural workflows, a shift that is especially notable in endoscopy-based biopsies where sterility is critical. The market's transition toward these sterile solutions is demonstrated by the rapid growth of manufacturers focusing on single-use technologies; for instance, Ambu reported in November 2024 that its Endoscopy Solutions business achieved 19.7% organic revenue growth for the full year, highlighting the accelerating global demand for sterile interventional tools.

In parallel, the integration of 3D tomosynthesis for breast biopsy guidance is setting new benchmarks for diagnostic precision within women's health. This technology offers radiologists superior visualization of tissue layers compared to conventional 2D imaging, significantly enhancing the targeting of complex calcifications and lesions during sampling. The improved accuracy of tomosynthesis-guided systems minimizes the necessity for re-biopsies and aids in the early detection of malignancies in dense breast tissue. This trend is driving significant commercial activity, as evidenced by Hologic’s November 2024 financial results, which showed a 6.4% revenue increase in its Breast Health division, reflecting strong market uptake of its interventional and imaging portfolio.

Key Players Profiled in the Biopsy Devices Market

• 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.

Report Scope

In this report, the Global Biopsy Devices Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biopsy Devices Market.

Available Customization

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• Detailed analysis and profiling of additional market players (up to five).

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