North America Biopsy Devices Market Size, Share, and Analysis (2025-2035)
The North America biopsy devices market represents a thriving segment within the medical device industry, driven by technological advancements and the growing prevalence of cancer and other chronic diseases. Biopsy devices are essential tools used to extract tissue samples for diagnostic examination, enabling healthcare professionals to provide early and accurate diagnosis, particularly in oncology. These devices range from needle-based instruments to forceps and vacuum-assisted systems, used across multiple applications such as breast, lung, prostate, colorectal, and liver biopsies. The market landscape is shaped by increasing demand for minimally invasive diagnostic techniques, greater access to healthcare, and substantial investment in research and development.
Latest Market Dynamics
Key Drivers
- Rising prevalence of cancer and demand for early diagnostic procedures: The increasing incidence of cancers in North America is escalating the need for efficient and accurate biopsy devices. For example, BD (Becton, Dickinson and Company) has expanded its product line to address growing demand, particularly in urban healthcare settings.
- Technological advancements in biopsy devices: The ongoing automation and integration of imaging guidance, as seen in Hologic’s latest vacuum-assisted biopsy devices launched in 2024, are making biopsies safer, faster, and more precise, hence boosting adoption rates across clinical settings.
Key Trends
- Shift towards minimally invasive procedures: Companies like Boston Scientific have reported increased acceptance of their advanced core biopsy devices due to patient preference for less invasive, rapid-recovery options.
- Integration of AI and digital pathology: Olympus Corporation introduced AI-powered tools to support pathologists in analyzing biopsy samples, a trend gaining momentum among North American labs in 2025.
Key Opportunities
- Expansion in outpatient and specialty clinics: Medtronic Plc capitalized on the rise of ambulatory surgical centers by introducing portable, user-friendly biopsy devices tailored for smaller facilities.
- Strategic collaborations and R&D investment: Cardinal Health has recently partnered with research institutes to drive innovation, accelerating next-generation biopsy devices tailored for personalized medicine.
Key Challenges
- High cost of advanced biopsy devices: The latest price surges in semi-automatic and imaging-guided devices, particularly from Stryker Corporation, present budgetary constraints for small and rural healthcare providers.
- Complex regulatory and reimbursement landscape: Companies such as Cook Medical note the challenge in obtaining swift FDA approvals, delaying new product introductions and market access.
Key Restraints
- Stringent regulatory requirements: The need for extensive clinical evidence, highlighted by the delayed launch of new models from Merit Medical Systems, Inc., remains a key barrier to rapid market penetration.
- Shortage of skilled professionals: The limited availability of experienced clinicians trained in latest biopsy techniques, despite intensive training initiatives by Argon Medical Devices, continues to slow down technology adoption.
North America Biopsy Devices Market Share (%) By Type, 2025
In 2025, needle-based biopsy instruments dominate the North America market, driven by advancements in minimally invasive procedures and enhanced diagnostic accuracy. Core biopsy devices and aspiration biopsy needles follow, thanks to their broad application in oncology and improved patient outcomes. This structure reflects growing investment in specialty-specific tools by top players and increased hospital spending on reliable, efficient diagnostic solutions.
North America Biopsy Devices Market Share (%) By Application, 2025
Breast biopsy continues to represent the largest application segment in North America for 2025, owing to robust screening programs and high cancer prevalence. Lung biopsy and prostate biopsy also command significant shares due to rising awareness and the integration of sophisticated imaging technologies. The applications market is projected to expand further, propelled by hospital infrastructure upgrades and growing specialty clinic adoption.
North America Biopsy Devices Market Revenue (USD Million), 2020-2035
The North America biopsy devices market revenue exhibits robust growth from 2020 to 2035, with the market projected to rise from $1,420 Million in 2020 to approximately $2,860 Million by 2035. This doubling stems from greater biopsy procedure volumes, increased funding for cancer research, and accelerated device approvals. The trend showcases consistent year-over-year increases, backed by government initiatives and a transition to outpatient diagnostics.
North America Biopsy Devices Market YOY (%) Growth, 2020-2035
Year-over-year (YOY) growth for biopsy devices in North America remains steady, peaking at an estimated 6.8% in 2025 as product launches and regulatory approvals accelerate. Post-2025, the YOY growth tapers slightly but remains healthy through 2035, reflecting ongoing innovation, wider healthcare access, and growing chronic disease burden.
North America Biopsy Devices Market Share (%) By Region, 2025
The United States spearheads the North America biopsy devices market in 2025, holding the largest share at 74%, thanks to its extensive healthcare infrastructure, aggressive screening programs, and high R&D investment. Canada follows with 16%, attributed to government-backed diagnostic initiatives, while Mexico stands at 10% amid expanding access to quality care and urbanization-driven demand.
North America Biopsy Devices Market Players Share (%) By Company, 2025
BD (Becton, Dickinson and Company) leads North America’s biopsy device market in 2025, holding a 23% share as a result of consistent innovation and broad product range. Hologic, Inc. and Medtronic follow at 18% and 14% respectively, leveraging technological leadership and strategic partnerships. The competitive landscape is dynamic, with numerous firms investing in next-generation diagnostic solutions.
North America Biopsy Devices Market Share (%) By Buyer, 2025
In 2025, hospitals constitute the largest buyer segment in the North America biopsy devices market, accounting for 47% due to their pivotal role in performing complex diagnostic procedures. Ambulatory surgical centers and diagnostic centers follow at 25% and 16% respectively, as demand for outpatient and specialized services accelerates amid healthcare decentralization.
Study Coverage
| Metrics | Details |
|---|
| Years | 2020-2035 |
| Base Year | 2025 |
| Market Size | 1750 |
| Regions | United States, Canada, Mexico |
| Segments | By Type, By Application, By Distribution Channels, By Technology, By Organization Size |
| Players | BD (Becton, Dickinson and Company), Devicor Medical Products, Inc., Argon Medical Devices, Hologic, Inc., Medtronic Plc, Cardinal Health, B. Braun Melsungen AG, Cook Medical, Olympus Corporation, C.R. Bard, Inc., Boston Scientific, Stryker Corporation, Merit Medical Systems, Inc., TSK Laboratory, Others |
Key Recent Developments
- June 2024: Hologic announced FDA clearance for their new vacuum-assisted breast biopsy device, enhancing accuracy and patient comfort.
- July 2024: BD (Becton, Dickinson and Company) partnered with a leading cancer research institute to develop AI-integrated biopsy solutions.
- August 2024: Medtronic launched a semi-automatic lung biopsy device optimized for outpatient settings.
- September 2024: Cardinal Health expanded its specialty diagnostics portfolio through the acquisition of an innovative biopsy device startup.
- October 2024: Olympus introduced an advanced digital pathology platform featuring AI-driven biopsy interpretation tools across North America.
