Global Biopsy Devices Market Poised for Robust Growth, Expected to Reach USD 10.81 Billion by 2032 | DelveInsight

The global biopsy devices market is on a trajectory of strong growth, projected to increase from USD 5,813.16 million in 2024 to USD 10,812.77 million by 2032, expanding at a CAGR of 8.09% during the forecast period (2025-2032). This growth is being driven by the rising incidence of cancer worldwide, escalating demand for minimally invasive diagnostic procedures, continuous technological advancements, and strong product development pipelines from key market players.

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Rising Cancer Burden Driving Biopsy Devices Market Growth
Cancer remains one of the leading causes of mortality worldwide, creating an urgent demand for reliable and accurate diagnostic technologies. Biopsy procedures remain the gold standard for cancer diagnosis and staging, enabling clinicians to determine tumor type, aggressiveness, and optimal treatment strategies.

According to DelveInsight's 2024 estimates, the global breast cancer incidence reached 2.29 million cases in 2022 and is projected to rise to 3.36 million by 2045. Similarly, cases of prostate, lung, and colorectal cancers are increasing globally, necessitating early detection and accurate diagnostics. Beyond oncology, biopsy devices are also being utilized in diagnosing chronic gastrointestinal, inflammatory, and neurological diseases, further expanding their clinical scope.

Demand for Minimally Invasive Procedures
The shift toward minimally invasive diagnostic methods has significantly influenced the biopsy devices market. Procedures such as core needle biopsy (CNB), fine-needle aspiration (FNA), and vacuum-assisted biopsy (VAB) are gaining widespread adoption because they offer:
• Reduced patient discomfort
• Shorter recovery times
• Fewer complications compared to surgical biopsies
• Enhanced diagnostic accuracy

Image-guided biopsy techniques (ultrasound, CT, MRI-guided) are particularly reshaping clinical practice by ensuring precision and minimizing repeat procedures.

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Technological Advancements Fueling Adoption of Biopsy Devices
The industry is witnessing rapid technological innovation, improving both diagnostic yield and patient safety. Notable advancements include:
• Vacuum-assisted systems enabling larger tissue samples with fewer insertions.
• Robotic-assisted biopsy devices for precise needle navigation.
• AI-integrated digital pathology platforms accelerating interpretation and reducing human error.
• Liquid biopsy technologies complementing traditional tissue biopsies with non-invasive alternatives.

For example, in July 2025, Mendaera received FDA clearance for a handheld robotic needle delivery system designed to enhance precision in fine-needle aspiration biopsies. Similarly, Biobot Surgical's Mona Lisa 2.0 robotic platform, CE-certified in January 2025, allows real-time trajectory adjustments for prostate biopsies, improving accuracy and reducing complications.

Biopsy Devices Market Segmentation Insights
Biopsy Devices Market By Product Type
• Needle-based biopsy instruments are expected to dominate, accounting for nearly 39% of market share in 2024, due to their widespread adoption in oncology diagnostics.
• Biopsy guidance systems, robotic biopsy devices, and accessories represent significant growth segments driven by technological enhancements.

Biopsy Devices Market By Application
• Breast biopsy holds the largest application share (~30% in 2024), supported by growing breast cancer incidence and increased mammography screening programs.
• Lung, colorectal, and prostate biopsies continue to see strong demand, with expanding applications in minimally invasive and image-guided procedures.

Biopsy Devices Market By End-User
• Hospitals dominate as the primary end-user segment, given their role in cancer screening programs, availability of advanced imaging infrastructure, and skilled clinical professionals.
• Diagnostic & imaging centers and ambulatory surgical centers represent growing demand hubs due to patient preference for outpatient settings.

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Biopsy Devices Regional Outlook

North America - Market Leader
North America is projected to dominate the global market with ~41% share in 2024, driven by:
• High prevalence of cancer
• Advanced healthcare infrastructure
• Strong adoption of robotic and AI-assisted technologies
• Favorable reimbursement policies
• Leading presence of device manufacturers

For instance, the U.S. reported over 306,000 new breast cancer cases in 2022, expected to increase by 25% by 2045. Continuous product innovation, such as Roche's FDA-cleared VENTANA DP 600 digital pathology scanner, underscores North America's leadership in adopting AI and digital solutions for oncology diagnostics.

Europe - Strong Growth Through Early Detection Programs
Europe's biopsy devices market is supported by strong healthcare systems, emphasis on early disease detection, and significant cancer research investments. In 2022, Europe recorded over 557,000 new breast cancer cases, projected to exceed 600,000 by 2045. Countries such as Germany, the UK, and France are spearheading adoption of image-guided and minimally invasive biopsy technologies.

Asia-Pacific - Fastest Growing Region
Asia-Pacific is forecasted as the fastest-growing market due to:
• Rising cancer prevalence in China, India, and Japan
• Expanding healthcare infrastructure
• Government-led screening programs
• Increasing healthcare expenditure and awareness
The region's large patient pool and accelerating adoption of advanced diagnostic tools make it a focal point for global manufacturers.

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Biopsy Devices Competitive Landscape
The biopsy devices market is moderately to highly consolidated, with major players driving innovation, regulatory approvals, and global expansion strategies. Leading Biopsy Devices companies include:
• Boston Scientific Corporation
• Cardinal Health
• Medtronic
• BD (Becton Dickinson)
• Cook Medical
• Devicor Medical Products Inc.
• Hologic Inc.
• B. Braun Melsungen AG
• Olympus Corporation
• FUJIFILM Corporation
• ARGON Medical
• INRAD Inc.
• C. R. Bard
• KOELIS
• Owlstone Medical Ltd.

These companies are actively pursuing strategic collaborations, acquisitions, and R&D investments to maintain competitive advantage. For example, Hologic's acquisition of Gynesonics in 2025 strengthened its women's health portfolio.

Recent Developments in Biopsy Devices Market
• July 2025 - Selio Medical earned FDA clearance for its Pre-B. Seal device, the first designed to reduce post-lung biopsy pneumothorax.
• April 2025 - ArteraAI Prostate received FDA authorization to predict long-term cancer outcomes using AI-powered digital pathology.
• February 2025 - Ibex Medical Analytics secured FDA clearance for its Prostate Detect platform, aiding cancer detection in biopsy samples.
• January 2025 - Biobot Surgical's Mona Lisa 2.0 received CE mark approval for robotic prostate biopsy and ablation.

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Biopsy Devices Market Challenges
Despite strong growth prospects, the biopsy devices market faces several hurdles:
• High costs of robotic and image-guided biopsy systems limit access in smaller healthcare settings.
• Regulatory hurdles prolong product launches and increase R&D costs.
• Competition from alternative diagnostics, such as liquid biopsies and advanced imaging, poses long-term substitution risks.
• Shortage of skilled professionals trained in advanced biopsy techniques creates adoption bottlenecks.

Biopsy Devices Strategic Opportunities
• AI and robotics integration offer opportunities for next-generation biopsy solutions.
• Emerging markets in Asia-Pacific and Latin America provide untapped growth potential.
• Partnerships between device manufacturers and cancer research organizations are expected to drive innovation in precision medicine.
• Liquid biopsy integration with tissue biopsy creates a holistic approach to early detection and personalized cancer care.

Analysts Comments on Biopsy Devices Report
The global biopsy devices market is set to experience sustained expansion, propelled by the dual forces of increasing cancer incidence and rapid technological innovation. With a projected CAGR of 8.09% from 2025 to 2032, the industry is witnessing a transformative phase marked by robotics, AI, and precision oncology integration.
As key players continue to launch advanced solutions and expand into high-growth regions, the biopsy devices market will remain at the forefront of cancer diagnostics, driving improved patient outcomes and shaping the future of personalized medicine.

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Ankit Nigam
Manager Marketing
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About DelveInsight
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This release was published on openPR.