Global Biopsy Devices Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Biopsy Devices Market Size

• The global biopsy devices market size was valued at USD 4.54 billion in 2024 and is expected to reach USD 7.98 billion by 2032, at a CAGR of 7.30% during the forecast period
• This growth is driven by factors such as the rising incidence of cancer, technological advancements in biopsy procedures, and the increasing demand for minimally invasive diagnostic techniques

Biopsy Devices Market Analysis

• Biopsy devices are essential tools used to extract tissue samples from patients for diagnostic purposes, primarily in cancer detection. They are crucial for procedures such as needle biopsies, surgical biopsies, and endoscopic biopsies
• The demand for biopsy devices is significantly driven by the rising prevalence of cancer, increasing adoption of minimally invasive diagnostic techniques, and advancements in biopsy technology
• North America is expected to dominate the biopsy devices market with largest market share of 43.2%, due to advanced healthcare infrastructure, higher adoption of early cancer detection technologies, and the presence of key market players 
• Asia-Pacific is expected to be the fastest growing region in the biopsy devices market during the forecast period due to the rising cancer incidence, improving healthcare systems, and increasing demand for advanced diagnostic tools
• Needle-based biopsy instruments segment is expected to dominate the market with a largest market share of 43.2% due to increasing demand for needle-based biopsy guns to collect samples from soft tissues of internal organs. In addition, the rising need for rapid and gentle procurement of cell samples for biopsy has led to the development of technologically advanced biopsy devices such as vacuum-assisted biopsy (VAB) devices

Report Scope and Biopsy Devices Market Segmentation      

Biopsy Devices Market Trends

“Advancements in Biopsy Devices & Automation for Enhanced Precision”

• One prominent trend in the biopsy devices market is the increasing integration of automation and digital technologies to improve precision and streamline the biopsy process
• Automated biopsy devices are enhancing the accuracy of tissue sampling, reducing human error, and minimizing patient discomfort, thereby improving diagnostic outcomes 
  • For instance, robotic-assisted biopsy systems provide greater control and precision, allowing for minimally invasive procedures that reduce recovery times and improve the overall patient experience
• These advancements are transforming the biopsy process, leading to quicker and more accurate diagnoses, which is driving the demand for next-generation biopsy devices with enhanced automation and precision features

Biopsy Devices Market Dynamics

Driver

“Increasing Cancer Incidence and the Need for Early Detection”

• The rising incidence of cancer, particularly in organs such as the breast, prostate, and lungs, is significantly contributing to the increased demand for biopsy devices
• As the global population ages, the risk of developing cancer increases, with early detection playing a critical role in improving treatment outcomes
• As healthcare systems focus more on early diagnosis, the demand for biopsy devices rises, ensuring quicker and more accurate diagnoses to guide effective treatment plans

For instance,

• In 2020, the World Health Organization reported that cancer is the second leading cause of death globally, with an estimated 9.6 million deaths from cancer. The need for precise and timely diagnosis is driving the growing demand for biopsy procedures and associated devices 
• As a result of the increasing incidence of cancer, particularly in the aging population, the demand for advanced biopsy devices is rising, allowing healthcare providers to detect cancer at earlier stages for better patient outcomes

Opportunity

“Integration of AI for Enhanced Biopsy Accuracy and Efficiency”

• AI-powered biopsy devices are enhancing diagnostic accuracy and efficiency by automating image analysis and providing real-time feedback, enabling more informed decisions during biopsy procedure
• AI algorithms can quickly analyze biopsy samples and images, helping pathologists identify potential issues, such as cancerous cells or abnormalities, with greater precision
• Furthermore, AI can assist in streamlining workflows by automating repetitive tasks, reducing human error, and ensuring consistent results in biopsy testing

For instance,

• In March 2025, according to a report by the Journal of Clinical Pathology, AI-based systems have shown significant promise in improving the accuracy of biopsy readings, particularly for breast cancer, by analyzing tissue samples with higher precision than traditional methods. These AI tools are able to process large volumes of data, identifying subtle patterns that might otherwise be overlooked by human clinicians 
• The incorporation of AI into biopsy devices is expected to transform diagnostic practices, offering faster results, improved patient outcomes, and enhanced decision-making, driving the market's growth

Restraint/Challenge

“High Equipment and Operational Costs Hindering Market Growth”

• The high cost of biopsy devices remains a significant barrier to market expansion, particularly in developing regions where healthcare budgets are limited, preventing many healthcare facilities from acquiring the latest technologies
• Biopsy devices, especially advanced options such as robotic-assisted systems or minimally invasive biopsy tools, can cost several thousand to tens of thousands of dollars, making them unaffordable for smaller clinics and hospitals
• These high upfront costs, along with the operational expenses associated with maintenance and training, can deter healthcare providers from adopting newer devices, which limits access to cutting-edge diagnostic tools

For instance,

• In December 2024, according to a report by the World Health Organization (WHO), the cost of acquiring and maintaining advanced biopsy devices in low-income countries is often prohibitive, affecting the accessibility and quality of diagnosis in these regions 
• This financial burden can lead to reliance on outdated or less accurate equipment, further limiting early detection and effective treatment, ultimately hindering the overall growth of the global biopsy devices market

Biopsy Devices Market Scope

The market is segmented on the basis of product, guidance technique, application, and end user.

In 2025, the needle-based biopsy instruments is projected to dominate the market with a largest share in product segment

The needle-based biopsy instruments segment is expected to dominate the biopsy devices market with the largest share of 43.2% due to increasing demand for needle-based biopsy guns to collect samples from soft tissues of internal organs. In addition, the rising need for rapid and gentle procurement of cell samples for biopsy has led to the development of technologically advanced biopsy devices such as vacuum-assisted biopsy (VAB) devices.

The hospitals is expected to account for the largest share during the forecast period in end user segment

In 2025, the hospitals segment is expected to dominate the market with the largest market share of 67.8% due to the primary settings for complex and high-volume biopsies performed in with most sophisticated imaging resources and skilled staff. This segment has profited from the increasing volume of hospitalizations due to cancer diagnostic procedures, chronic illnesses, and trauma patients needing image-guided biopsies for precise tissue sampling. The multidisciplinary cancer treatment centers in the hospitals further facilitate the growing use of biopsy devices.

Biopsy Devices Market Regional Analysis

“North America Holds the Largest Share in the Biopsy Devices Market”

• North America dominates the biopsy devices market with largest market share of 43.2%, driven by advanced healthcare infrastructure, high adoption of cutting-edge medical technologies, and strong presence of key market players
• The U.S. holds a significant share of 34.6%, due to increased demand for high-precision biopsy procedures, rising prevalence of cancers, and continuous advancements in biopsy techniques
• The availability of well-established reimbursement policies and growing investments in research & development by leading medical device companies further strengthen the market
• In addition, the increasing number of cancer diagnoses and surgeries, along with the high rate of adoption of minimally invasive biopsy techniques, is fueling market expansion across the region

“Asia-Pacific is Projected to Register the Highest CAGR in the Biopsy Devices Market”

• The Asia-Pacific region is expected to witness the highest growth rate in the biopsy devices market, driven by rapid expansion in healthcare infrastructure, increasing awareness about early cancer detection, and rising healthcare expenditures
• Countries such as China, India, and Japan are emerging as key markets due to the growing aging population, which is more susceptible to various types of cancers, and the rising need for diagnostic biopsies
• Japan, with its advanced medical technology and growing number of specialized biopsy centers, remains a crucial market for biopsy devices. The country continues to lead in the adoption of innovative biopsy technologies, enhancing precision and patient outcomes
• China and India, with their large populations and increasing cancer incidences, are witnessing increased government and private sector investments in modern diagnostic facilities. The expanding presence of global medical device manufacturers and improving accessibility to advanced biopsy technologies further contribute to market growth

Biopsy Devices Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

The Major Market Leaders Operating in the Market Are:

• Medtronic (Ireland)
• BD (Becton, Dickinson and Company) (U.S.)
• Thermo Fisher Scientific (U.S.)
• Hologic (U.S.)
• Johnson & Johnson (U.S.)
• Cook Medical (U.S.)
• Abbott Laboratories (U.S.)
• Stryker Corporation (U.S.)
• Intuitive Surgical (U.S.)
• Canon Medical Systems (Japan)
• Olympus Corporation (Japan)
• Biopsy Sciences (U.S.)
• C.R. Bard (U.S.)
• Ge Healthcare (U.S.)
• Mindray Medical International Limited (China)
• Fujifilm Holdings Corporation (Japan)
• Merit Medical Systems (U.S.)
• Siemens Healthineers (Germany)
• LiNA Medical (Denmark)
• Cook Group (U.S.)

Latest Developments in Global Biopsy Devices Market

• In June 2021, Biocept, Inc., a prominent provider of molecular diagnostic assays, products, and services, entered into a strategic partnership with Quest Diagnostics to provide laboratory testing services for its Target Selector NGS-based liquid biopsy targeted lung cancer panel to Quest's patient base. This collaboration highlights the growing adoption of advanced biopsy technologies, such as liquid biopsy, in the diagnosis and monitoring of cancer 
• In April 2024, Single Pass received FDA clearance for its Kronos biopsy closure device, a class II medical device. This development marks an important advancement in biopsy procedure safety and efficiency. The Kronos biopsy closure device offers enhanced closure capabilities, ensuring better patient outcomes and reducing complications associated with biopsy procedures
• In May 2023, Argon Medical Devices launched the SuperCore Advantage semi-automatic biopsy instrument, a soft tissue biopsy product, in the U.S. market. This launch is a notable addition to the global biopsy devices market, as it introduces an innovative tool designed to enhance the efficiency and precision of soft tissue biopsies
• In February 2023, TransMed7 revealed its plans to launch its U.S.-guided biopsy devices. This announcement is significant for the global biopsy devices market, as it marks the introduction of advanced biopsy solutions designed to enhance precision and accuracy in diagnostic procedures. The launch of U.S.-guided biopsy devices aligns with the growing demand for more effective, minimally invasive tools in biopsy procedures. This innovation is expected to contribute to the expansion of the market by offering healthcare providers new, cutting-edge technologies that improve procedural outcomes and patient care
• In May 2022, Terumo India formed a strategic partnership with Argon Medical to expand their portfolio of medical solutions in the Indian market. By leveraging their combined expertise, the collaboration aims to meet the growing demand for advanced tools in biopsies, deep vein thrombosis treatments, and various other medical procedures. This partnership underscores the increasing demand for innovative diagnostic tools in emerging markets like India. By introducing advanced biopsy technologies to this region, the collaboration is poised to drive growth in the market, addressing the rising need for high-precision, minimally invasive solutions that improve both diagnostic accuracy and patient outcomes 

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