Biopsy Device Market By Product Type (Needle-based Instruments (Aspiration Biopsy Needles, Core Biopsy Devices, and Vacuum-assisted Biopsy Devices), Localization Wires, Procedure Trays, and Others), By Application (Breast Biopsy, Colorectal Biopsy, Lung Biopsy, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The Biopsy Device Market Size is expected to be worth around US$ 4.8 billion by 2034 from US$ 2.4 billion in 2024, growing at a CAGR of 7.1% during the forecast period 2025 to 2034.

Growing demand for early disease detection and minimally invasive diagnostic procedures is driving the expansion of the biopsy device market. The rising prevalence of cancer, including breast, lung, and prostate cancer, is accelerating the need for advanced biopsy technologies that offer precise tissue sampling and reduced patient discomfort.

The increasing adoption of image-guided biopsy techniques, such as ultrasound, MRI, and CT-guided procedures, is enhancing diagnostic accuracy and improving patient outcomes. In August 2022, Mammotome launched a Vacuum-Assisted Breast Biopsy System designed to improve lesion excision procedures. This innovation is expected to contribute to advancements in minimally invasive breast cancer diagnostics, driving growth in the biopsy device market.

The growing preference for liquid biopsies, which enable non-invasive cancer detection through blood samples, is further transforming the industry by offering rapid and repeatable testing options. The demand for disposable biopsy devices is increasing due to their ability to reduce cross-contamination risks and enhance procedural safety. Rising healthcare investments and technological advancements, including robotic-assisted biopsy procedures, are expanding the capabilities of biopsy devices across multiple medical specialties.

The growing incidence of gastrointestinal, kidney, and liver disorders is fueling demand for endoscopic and needle biopsy solutions. Increasing regulatory approvals for innovative biopsy devices are facilitating market entry for new players, fostering competition, and driving technological improvements. The integration of artificial intelligence in biopsy analysis is streamlining pathology workflows and improving diagnostic efficiency.

A shift toward outpatient and ambulatory settings is promoting the adoption of portable and user-friendly biopsy devices. Expanding applications of biopsy technology in dermatology, neurology, and musculoskeletal disorders are further strengthening market growth. Manufacturers are focusing on product innovations, such as automated core needle biopsy systems, to enhance precision and reduce procedure time.

The rising emphasis on personalized medicine is driving demand for molecular and genetic biopsies that enable targeted therapy selection. With continuous advancements in biopsy technologies and increasing adoption of minimally invasive procedures, the market is expected to witness sustained growth in the coming years.

Key Takeaways

• In 2023, the market for Biopsy Device generated a revenue of US$ 2.4 billion, with a CAGR of 7.1%, and is expected to reach US$ 4.8 billion by the year 2033.
• The product type segment is divided into needle-based instruments, localization wires, procedure trays, and others, with needle-based instruments taking the lead in 2023 with a market share of 47.8%.
• Considering application, the market is divided into breast biopsy, colorectal biopsy, lung biopsy, and others. Among these, breast biopsy held a significant share of 42.7%.
• North America led the market by securing a market share of 40.4% in 2023.

Product Type Analysis

The needle-based instruments segment led in 2023, claiming a market share of 47.8% owing to their critical role in minimally invasive diagnostic procedures. These instruments, which include fine needle aspiration (FNA) needles, core needles, and biopsy guns, are crucial for obtaining tissue samples for pathology analysis. The increasing demand for early-stage cancer diagnosis and the rising prevalence of conditions such as cancer and benign tumors are projected to drive the demand for needle-based instruments.

Additionally, technological advancements in needle design, which improve precision, reduce patient discomfort, and enhance sample quality, are likely to support the expansion of this segment. Healthcare providers are anticipated to continue adopting needle-based instruments as part of their standard diagnostic protocols, further accelerating market growth.

Application Analysis

The breast biopsy held a significant share of 42.7% due to the increasing global incidence of breast cancer and the growing focus on early detection and personalized treatment. Technological advancements, including the development of more precise and less invasive biopsy techniques such as vacuum-assisted and stereotactic-guided biopsies, are expected to contribute to the segment’s growth.

With early detection being a critical factor in successful breast cancer treatment, demand for breast biopsy devices is projected to increase as healthcare professionals strive to provide more accurate and less traumatic diagnostic procedures. In addition, government initiatives focused on breast cancer awareness and screening are likely to further propel the growth of this segment, particularly as more women seek early-stage detection and treatment.

Key Market Segments

By Product Type

• Needle-based Instruments
  • Aspiration Biopsy Needles
  • Core Biopsy Devices
  • Vacuum-assisted Biopsy Devices
• Localization Wires
• Procedure Trays
• Others

By Application

• Breast Biopsy
• Colorectal Biopsy
• Lung Biopsy
• Others

Drivers

Rising Prevalence of Cancer Driving the Biopsy Device Market

Increasing cancer incidence is projected to drive demand for biopsy devices as the need for early and accurate diagnosis rises globally. In 2050, the global incidence of cancer is projected to rise significantly, with an estimated 36 million new cases, marking an 80% increase from the 19.8 million cases reported in 2022, according to data from international health organizations.

This sharp rise highlights the growing need for advancements in cancer research, treatment accessibility, and early detection initiatives. As oncologists increasingly rely on minimally invasive diagnostic methods, image-guided biopsy devices are gaining widespread adoption. Liquid biopsy technologies are also emerging as a promising alternative for detecting cancer biomarkers with high precision.

Healthcare providers are emphasizing rapid biopsy procedures to facilitate early treatment interventions, leading to increased demand for advanced biopsy instruments. The rising adoption of robotic-assisted biopsy systems is expected to enhance procedural accuracy and patient outcomes. The integration of artificial intelligence in biopsy analysis is improving diagnostic efficiency and reducing false-negative rates.

Government initiatives aimed at expanding cancer screening programs are anticipated to fuel market growth. Leading medical device manufacturers are focusing on developing cost-effective and user-friendly biopsy technologies to increase accessibility in low-resource settings. The expansion of cancer research facilities and specialty diagnostic centers is further supporting biopsy device adoption. Increasing awareness about routine cancer screening is encouraging individuals to undergo early diagnostic testing.

Restraints

High Cost of Advanced Biopsy Devices

Rising costs associated with biopsy devices are expected to limit market accessibility, particularly in developing regions. Many advanced biopsy instruments, including robotic-assisted and image-guided systems, require significant capital investment, making them unaffordable for smaller healthcare facilities. The high price of disposable biopsy needles and vacuum-assisted biopsy systems adds to procedural costs, creating financial burdens for patients.

Limited reimbursement policies for certain biopsy procedures discourage their widespread adoption. Hospitals and diagnostic centers in low-income countries often face challenges in upgrading to state-of-the-art biopsy technologies. The requirement for skilled professionals to operate specialized biopsy devices further adds to operational expenses. Stringent regulatory approvals and lengthy clinical validation processes contribute to the high costs of introducing new biopsy technologies to the market. Although innovation continues to advance biopsy techniques, cost constraints remain a major challenge for broader market penetration.

Opportunities

Rising R&D Activities Creating Opportunities in the Biopsy Device Market

Growing investments in research and development are expected to create new opportunities for biopsy device innovation and expansion. In 2022, the National Cancer Institute received a record USD 7 billion in research funding, reflecting a 6% increase compared to the previous fiscal year. This boost in financial resources was allocated toward groundbreaking cancer research, innovative treatment development, and expanding access to early detection programs across the country.

Increased funding has led to the development of novel biopsy technologies, including real-time imaging-guided biopsy and AI-powered diagnostic tools. Liquid biopsy research is advancing rapidly, providing non-invasive alternatives for detecting circulating tumor DNA. The growing adoption of nanotechnology in biopsy devices is enhancing sample collection precision and diagnostic accuracy. Biopharmaceutical companies and diagnostic laboratories are collaborating to improve biopsy efficiency for personalized cancer treatment.

The expansion of clinical trials exploring new biopsy methods is accelerating the commercialization of next-generation diagnostic solutions. Academic research institutions are actively working on improving biopsy sensitivity and reducing procedural risks. The integration of smart sensors in biopsy instruments is enabling real-time monitoring and automated data analysis.

Emerging partnerships between medical device manufacturers and research organizations are fostering rapid technological advancements. Governments worldwide are increasing grants and incentives to support biopsy innovation, encouraging market growth. As R&D investments continue to rise, the biopsy device market is likely to experience significant advancements in diagnostic capabilities and accessibility.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors have a significant impact on the biopsy device market. On the positive side, the growing prevalence of cancer, coupled with increased healthcare spending, drives demand for advanced biopsy procedures and technologies. Rising awareness about early cancer detection across global populations fosters the adoption of biopsy devices in both developed and emerging markets.

Additionally, improved healthcare infrastructure in developing economies opens new opportunities for growth in these regions. However, economic downturns, budget constraints in healthcare systems, and high device costs can limit adoption in low-income areas. Geopolitical tensions, trade barriers, and regulatory variations across regions can also disrupt the supply chain and increase production costs.

Despite these challenges, continuous advancements in biopsy technology, such as more precise and less invasive devices, along with growing public health campaigns emphasizing early detection, ensure the long-term growth of the market.

Trends

Surge in Popularity of Robot-Assisted Biopsy Driving the Biopsy Device Market

The rising popularity of robot-assisted biopsy is a recent trend driving the biopsy device market. High demand for more accurate and minimally invasive procedures has led to increased adoption of robotic systems in biopsy procedures. Robotic-assisted devices are expected to provide enhanced precision, reduce human error, and improve patient outcomes, making them particularly attractive in the fields of oncology and neurology.

The use of robotics in biopsy procedures is likely to grow as technology advances, offering more efficient and comfortable options for patients. As the healthcare industry continues to shift toward more automated and technology-driven solutions, the market for robot-assisted biopsy devices is projected to experience significant expansion.

In July 2022, a cutting-edge robotic-assisted biopsy system was launched at a premier medical center in New York, revolutionizing lung disease diagnostics. The new system allows for greater precision in tissue sampling, reducing the risks associated with traditional procedures and offering patients a more comfortable experience. This technological advancement is expected to fuel market growth as more healthcare providers adopt these innovative devices.

Regional Analysis

North America is leading the Biopsy Device Market

North America dominated the market with the highest revenue share of 40.4% owing to technological advancements and increasing cancer screening programs. The introduction of a breakthrough lung biopsy technique in July 2022 at a leading U.S. medical institution provided a minimally invasive alternative for diagnosing pulmonary conditions, improving patient safety and diagnostic accuracy.

The rising incidence of cancer, particularly breast, lung, and prostate cancer, fueled demand for advanced biopsy solutions. Widespread adoption of image-guided biopsy techniques, including ultrasound and MRI-assisted procedures, enhanced precision in tissue sampling. Government initiatives promoting early cancer detection and research funding contributed to increased adoption of biopsy technologies.

The integration of robotic-assisted biopsy systems further improved procedural efficiency and reduced patient discomfort. Additionally, collaborations between medical device companies and healthcare institutions accelerated innovation, leading to the development of next-generation biopsy tools with improved accuracy and faster turnaround times.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to increasing healthcare investments and rising cancer prevalence. Expanding healthcare infrastructure in countries like China, India, and Japan is expected to improve access to advanced diagnostic technologies. Government-led cancer screening programs and awareness campaigns are likely to boost demand for minimally invasive biopsy techniques.

Collaborations between international manufacturers and regional healthcare providers are anticipated to enhance product availability and affordability. The growing adoption of liquid biopsy technology for non-invasive cancer detection is projected to accelerate market expansion. Advancements in AI-powered imaging and robotic-assisted procedures are expected to improve diagnostic accuracy and procedural efficiency.

Increasing healthcare expenditure and rising medical tourism in Asia Pacific are likely to further drive demand for innovative biopsy solutions. Additionally, ongoing research in biomarker-based diagnostics is anticipated to open new opportunities for early disease detection, supporting continued market growth in the region.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

Key players in the biopsy device market focus on developing minimally invasive and precision-driven technologies to enhance diagnostic accuracy and patient comfort. Companies invest in research and development to introduce automated, image-guided, and vacuum-assisted biopsy systems that improve procedural efficiency. Strategic collaborations with healthcare providers and diagnostic centers help expand product adoption and improve accessibility.

Geographic expansion into regions with rising cancer prevalence supports further market growth. Many players also emphasize cost-effective and disposable biopsy instruments to enhance procedural safety and affordability. BD (Becton, Dickinson and Company) is a leading company in this market, offering innovative biopsy solutions such as the BD Vacutainer and BD OncoTect systems.

The company prioritizes technological advancements and strong partnerships with healthcare institutions to improve cancer diagnostics. BD’s commitment to precision, efficiency, and global healthcare solutions solidifies its position as a key player in the industry.

Top Key Players in the Biopsy Device Market

• TransMed7, LLC
• Single Pass
• INRAD, Inc
• Gallini Srl
• DTR Medical
• Devicor Medical Products Inc
• Danaher Corporation
• Argon Medical Devices

Recent Developments

• In April 2024: Single Pass secured FDA clearance for the Kronos biopsy closure device, a Class II medical device designed to enhance procedural efficiency and post-biopsy wound closure, ensuring improved patient outcomes.
• In May 2023: The SuperCore Advantage was launched by Argon Medical Devices in the United States. This semi-automatic biopsy instrument is designed to improve the efficiency and accuracy of soft tissue sampling, offering healthcare providers a more streamlined and precise approach to biopsy procedures.
• In February 2023: TransMed7 announced its upcoming launch of ultrasound-guided biopsy devices, expanding its product portfolio to provide more accurate and efficient tissue sampling solutions for various clinical applications.

Report Scope