The robotic biopsy devices market comprises advanced robot-assisted systems and tools used to obtain tissue samples with precision and minimal invasiveness for cancer diagnosis, targeted sampling, and disease monitoring.
These devices combine robotic arms, imaging technologies (MRI, CT, and ultrasound), AI navigation software, and real-time tracking to perform biopsies with improved accuracy, consistency, and reduced complication rates. The market is driven by the growing burden of cancer, demand for minimally invasive diagnostics, and rising adoption of precision medicine and AI-guided robotics in healthcare.
In 2025, the global robotic biopsy devices market is projected to reach approximately USD 79.02 million, and is expected to grow to around USD 144.2 million by 2035, reflecting a Compound Annual Growth Rate (CAGR) of 8.7% during the forecast period.
Key Market Metrics
| Metric | Value |
|---|---|
| Market Size in 2025 | USD 79.02 Million |
| Projected Market Size in 2035 | USD 144.2 Million |
| CAGR (2025 to 2035) | 8.7% |
The market’s rapid expansion is underpinned by technological advancements in robotic surgery, rising preference for image-guided and real-time biopsy tools, and increasing investments in hospital automation and digital pathology.
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North America is the largest regional market, due to early uptake of robotic surgery systems, provision of combined radiology and oncology service, and robust reimbursement infrastructure. Robotic-assisted prostate, breast, and lung biopsies have grown tremendously in the USA, spurred by innovation from dominant USA market leaders like Intuitive Surgical, Medtronic and iCAD. Also note pilot adoption of AI-powered biopsy targeting platforms in the region.
Europe is the most regulated and information technology based market, with the UK, Germany, France, and Netherlands at the forefront of clinical trial adoption, as well as robotic-assisted minimally invasive procedures. Growth is driven by precision oncology programs, government funding of robotics in diagnostics, and the implementation of high-fidelity robotic guidance systems across multidisciplinary tumor boards.
Asia-Pacific, which encompasses China, Japan, South Korea, and India, is the fastest-growing region as its cancer screening equipment and robotic surgical capabilities are increasing rapidly. Liver cancer, lung cancer, and breast cancer robotic biopsy platforms are being funded by private hospitals and governments, and demand for AI-enabled imaging and robotic biopsy in tertiary care is projected to be extremely attractive.
High Capital Costs, Training Barriers, and Regulatory Complexity
High acquisition and maintenance costs are the major restraints in the robotic biopsy devices market as they do not build up business case for small and mid-sized hospitals or diagnostic centers to adopt these systems. Surgical scalability is also hampered by the requirement for highly trained radiologists and surgeons to operate robotic systems, particularly in rural or resource-constrained settings.
Precision Medicine, AI Integration, and Minimally Invasive Oncology Demand
The market is gaining robust traction due to the worldwide movement towards early cancer diagnosis, minimally-invasive surgery, and precision-guided diagnostics-contributing even in the face of challenges Through targeted biopsy methods, robotic biopsy devices increase the chances of obtaining adequate tissue samples under less trauma as well as improving the diagnostic yield-none more so than for deep-seated tumors (lung, prostate, liver, brain, etc.).
Robotic biopsy systems gained traction from 2020 to 2024 in major tertiary medical centres and cancer research institutions, as they were folded into pilot programmes or part of multimodality robotic surgery facilities. Cost considerations and the lack of reimbursement codes, however, limited wider commercial uptake.
The market will transition between 2025 and 2035, to new-generation robots with integrated machine-learning base anomaly detectors, cloud-based imaging data sync-and mobile biopsy robots, suited for community cancer screening programs, ambulatory institutions, and outpatient diagnostic settings.
Market Shifts: A Comparative Analysis 2020 to 2024 vs. 2025 to 2035
| Market Shift | 2020 to 2024 Trends |
|---|---|
| Regulatory Landscape | Focused on mechanical precision and safety validation (e.g., ISO 13485) |
| Technology Innovations | Early-stage robotic arms with CT/MRI-guided targeting |
| Market Adoption | Predominantly in urology, pulmonology, and interventional radiology |
| Sustainability Trends | Reuse of robotic components with disposable needles and cartridges |
| Market Competition | Led by Intuitive Surgical, ION by Intuitive, Medtronic (robotic-assisted lung biopsy), Perfint Healthcare, Biobot Surgical |
| Consumer Trends | Driven by hospital innovation budgets and surgical robotics alignment |
| Market Shift | 2025 to 2035 Projections |
|---|---|
| Regulatory Landscape | Evolution toward AI-integrated device approval, cybersecurity compliance, and real-time data privacy standards |
| Technology Innovations | Rise of fully autonomous navigation, robotic micro-biopsy, and cloud-AI biopsy report generation |
| Market Adoption | Expansion into breast, liver, pancreatic, and pediatric oncology diagnostics |
| Sustainability Trends | Focus on modular systems, sterilizable eco-packaging, and battery-operated portable biopsy platforms |
| Market Competition | Entry of startups offering AI-powered cloud biopsy systems, image-robotics convergence platforms, and robotic biopsy-as-a-service models |
| Consumer Trends | Demand for less invasive, highly accurate outpatient biopsy options with fast AI-enabled results |
The Robotic Biopsy Devices market in the United States is escalating massively on account of early acceptance of robotic-aided surgical system, increasing cancer diagnostics and AI-guided imaging for accurate biopsy.
Savvy parts of the behemoth USA medical ecosystem have started investing in robotic biopsy systems for breast, prostate, lung and liver cancer, with the goal of making the procedures more accurate and less invasive. Advances in FDA clearances and reimbursement policies contribute to replacing manual systems with robotic systems.
| Country | CAGR (2025 to 2035) |
|---|---|
| USA | 9.4% |
The UK Robotic Biopsy Devices market is on a stable growth track due to healthcare investments by NHS in robotic surgeries and diagnostic innovations. Robotic-assisted platforms are being used in laparoscopic-assisted thoracoscopic surgery or minimally invasive cancer biopsies, notably in urology and thoracic oncology in application.
There is growing collaboration between government, academic institutions, and med-tech companies, accelerating the development and clinical validation of robotic biopsy solutions.
| Country | CAGR (2025 to 2035) |
|---|---|
| UK | 8.7% |
The EU Robotic Biopsy Devices market is predicted to grow sharply in Germany, France, and the Netherlands where healthcare services are more advanced. The demand for precision diagnostics and personalized medicine, as well as the rise in the early detection of cancer, are also driving the adoption in oncology centers.
These factors, alongside an increase in med-tech R&D initiatives by the EU, the availability of CE-marked robotic platforms as well as AI-enabled navigation tools, are boosting the market. Hospitals are prioritizing procedures that have fewer complications and shorter recovery.
| Country | CAGR (2025 to 2035) |
|---|---|
| EU | 8.6% |
The robotic biopsy devices market in Japan is on a consistent upward trajectory owing to its highly advanced robotics ecosystem and an aging population that necessitates early cancer diagnosis. Japanese hospitals are increasingly adopting robotic biopsy equipment in such specializations as gastroenterology, pulmonology, and neurosurgery to manage the diagnostic yield.
The market is benefitting from national policies favoring the adoption of minimally invasive technologies, as well as advances in miniaturized robotic arms, and integration with real-time imaging.
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 9.0% |
The South Korean robotic biopsy devices market is growing rapidly owing to strong med-tech manufacturing industry, government investments in smart healthcare and the expansion of the private hospital network.
Robotic precision reduces tissue injury and enhances sample quality in areas with high demand for thoracic, hepatic, and breast cancer diagnosis. Adoption and innovation are powered by university-industry collaborations with international device companies.
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 9.2% |
| Segmentation type | Market Share (2025) |
|---|---|
| software and services | 40.4% |
Robotic biopsy devices contribute a substantial share towards driving the robotic biopsy devices market, led by the software and services segment.destined to new initiatives Advanced software tools allow for precise navigation, real-time imaging, and data interpretation, improving the accuracy and effectiveness of biopsy procedures. These software tools are entirely supported by robotic systems, and clinicians can conduct sophisticated interventions with greater confidence thanks to advanced planning capabilities.
Moreover, regular software updates and the implementation of artificial intelligence (AI) algorithms have significantly improved diagnostic capabilities, allowing for the identification of minor tissue alterations that could be overlooked by conventional techniques.
The scope of robotic biopsy instruments services is extensive covering everything from installation to maintenance, training and technical support. Advanced robotics in medicine is pushing the limits of research and application, and proper education/ training programs ensure that institutes of laparoscopic and robotic surgery maintain their patients safety through advanced skill training.
Part-service based periodic maintenance services and on-site technical services are vital to ensure the longevity and lifetime of these precise measurement devices. Healthcare centers are implementing robotic biopsy systems more frequently, leading to an exponential increase in such ancillary services, which contributes significantly to revenue in the market.
| Segmentation type | Market Share (2025) |
|---|---|
| Rule-based | 65.2% |
Rule-based robotic biopsy systems have evolved as the gold standard tools of the clinical world as they facilitate deterministic, structured solutions for diagnostic interventions. Rule-based systems, which are based on pre-established algorithms and protocols, can perform standardized procedures consistently, providing a means to reduce procedural variability in biopsies. Particularly in basic diagnostic cases, rule-based systems become essential: making outcomes predictable bolsters clinician confidence.
Rule-based systems have been commonly used in various healthcare settings due to their simplicity and reliability. They are the bread-and-butter tools for clinicians who require reliable tools that adhere to standard medical processes. Moreover, rule-based systems are relatively easy to be incorporated into existing hospital infrastructures thus, they can be easily integrated into clinical practices. Coupled with their proven efficacy, these advantages play a key role for rule-based robotic biopsy systems in the future of the medical field.
Robotic biopsy systems, which rely on knowledge to make their diagnostics, represent the ultimate in personalised diagnostic technology. They use large data sets, machine learning protocols, and AI to be anatomically and pathologically patient-specific.
Knowledge-based systems that use patient-specific data are able to optimize the biopsy trajectories, predict potential complications, and offer personalized advice to doctors. The disease-sensitive conformations offered by such a capability improves the diagnostic accuracy, while promoting the patient- and clinical-relevant treatment according to the contemporary trend of personalized medicine.
Knowledge-based systems have been useful in solving still the most difficult diagnostic problems, particularly in unusual presentations or anatomy complex regions.
For example, in neurosurgical biopsies where the precision of millimeters is critical, knowledge-based systems can take patient-specific differences into consideration so as to help avoid potentially damaging any tissue in the vicinity of the targeted tissue. Dynamic learning refers to an ongoing process that continues to enhance and refine biopsy techniques, leading to more advanced and innovative diagnostic techniques.
Robotic biopsy systems enable precision tissue sampling with real-time imaging integration leading to lower patient trauma, with better diagnostic yields. Some of the key driving factors for growth are developments in artificial intelligence-based navigation, rise in cancer screening programs, growing adoption of robotic surgery platforms, and investment in smart diagnostics systems by hospitals.
Market Share Analysis by Key Players
| Company/Organization Name | Estimated Market Share (%) |
|---|---|
| Intuitive Surgical, Inc. | 18-22% |
| Medtronic plc | 14-18% |
| ION Endoluminal System (Johnson & Johnson) | 12-16% |
| Biobot Surgical Pte Ltd. | 10-14% |
| Renishaw plc | 8-12% |
| Others | 26-32% |
| Company/Organization Name | Key Offerings/Activities |
|---|---|
| Intuitive Surgical, Inc. | In 2025, Intuitive introduced an advanced biopsy module for the da Vinci® SP system, featuring multi-quadrant needle positioning and real-time feedback for soft tissue sampling in urological oncology. |
| Medtronic plc | As of 2024, Medtronic’s robot-assisted biopsy arm (Hugo™ platform) integrated with AI-enhanced image-guided targeting, ideal for lung and liver biopsies in interventional radiology suites. |
| ION Endoluminal System (J&J) | In 2024, Johnson & Johnson expanded its ION™ robotic system for early-stage lung cancer diagnostics, offering ultra-thin catheter-guided biopsies with shape-sensing technology. |
| Biobot Surgical Pte Ltd. | In 2023 , Biobot Surgical introduced the Mona Lisa™ robotic system, delivering transperineal prostate biopsies with high spatial precision and reduced risk of infection. |
| Renishaw plc | As of 2024, Renishaw advanced its neurological robotic systems, enabling stereotactic brain biopsies with millimetric accuracy, now deployed in complex neuro-oncology centers across Europe. |
Key Market Insights
Intuitive Surgical, Inc. (18-22%)
Intuitive leads the robotic biopsy market by integrating real-time imaging with robotic control, offering multi-specialty utility in thoracic, urologic, and pelvic biopsies, backed by the broad clinical adoption of its da Vinci® system.
Medtronic plc (14-18%)
Medtronic leverages its Hugo™ robotic platform and legacy in interventional devices to offer AI-driven and imaging-assisted robotic biopsies, especially in pulmonary and hepatic oncology diagnostics.
ION Endoluminal (J&J) (12-16%)
J&J’s ION system is rapidly expanding in lung cancer detection, offering flexible navigation and deep-lung biopsy access previously unreachable with manual bronchoscopy tools.
Biobot Surgical Pte Ltd. (10-14%)
Biobot focuses on prostate cancer diagnosis, delivering transperineal robotic biopsy devices that offer infection-free sampling and reproducible precision, gaining adoption in urology clinics in Asia, Europe, and North America.
Renishaw plc (8-12%)
Renishaw’s robotic systems are specialized for neurosurgical biopsy applications, offering high-precision stereotactic procedures used for tumor grading and neurodegenerative disorder evaluation.
Other Key Players (26-32% Combined)
Numerous medtech startups and emerging players are bringing specialized biopsy robotics, navigation-enabled systems, and AI-driven precision platforms, including:
The overall market size for robotic biopsy devices market was USD 79.02 million in 2025.
The robotic biopsy devices market is expected to reach USD 144.2 million in 2035.
Rising number of cancer survivors undergoing radiation therapy, increasing research in anti-fibrotic drugs, and growing demand for effective post-radiation care solutions will drive market growth.
The top 5 countries which drives the development of robotic biopsy devices market are USA, European Union, Japan, South Korea and UK.
Software and services expected to grow to command significant share over the assessment period.
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Robotic Biopsy Devices Market
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