Virtual Biopsy Market

How big is Virtual Biopsy Market in 2026?

USD 0.8 billion in 2026 and USD 2.4 billion by 2036 at an 11.5% CAGR.

Demand for virtual biopsy solutions is projected to expand at 11.5% CAGR between 2026 and 2036, increasing valuation from USD 0.8 billion in 2026 to USD 2.4 billion by 2036. Regulatory readiness shapes hospital purchasing through medical-device pathways requiring documented lifecycle controls for evolving software. In January 2025 the FDA reported authorizing more than 1,000 AI-enabled devices through established premarket pathways. The authorization volume makes update planning and performance monitoring necessary for medical imaging software across clinical networks.

Virtual biopsy combines radiomics with quantitative imaging and AI-assisted analysis to characterize tissue across complete lesions. Hospital teams assess scanner compatibility and clinical decision support evidence for biopsy targeting or treatment-response decisions.

Key Takeaways

• Whole-lesion characterization supports biopsy targeting and treatment-response review through measurements drawn from complete medical images.
• Oncological disorders are projected to represent 52.0% of target therapeutic area demand in 2026 through tumor-focused imaging workflows.
• Magnetic resonance imaging is estimated to account for 38.0% of imaging technology demand in 2026 through multiparametric tissue assessment.
• Cancer diagnosis is forecast to capture 46.0% of application demand in 2026 through tumor detection and characterization requirements.
• Scanner variation and inconsistent acquisition protocols restrain adoption by weakening confidence in image features across clinical sites.
• Siemens Healthineers, GE HealthCare, Philips, Canon Medical, Fujifilm, Samsung Medison, Perspectum, and QUIBIM compete through imaging platforms and quantitative biomarkers.

Analyst Perspective

"Virtual biopsy earns clinical value through measurements that reflect disease instead of scanner protocol differences. Hospitals should connect each result to one decision and reject tools that fail reproducibility during follow-up."

- Anurag Sharma, Principal Consultant, Future Market Insights

How is the virtual biopsy market segmented?

The virtual biopsy industry is segmented by target therapeutic area, cancer targeted, imaging technology, end user, application and region.

Target therapeutic area covers oncological, neurological, cardiovascular, and gastrointestinal disorders across organ-specific diagnosis and monitoring pathways. Cancer targeted includes solid malignancies plus breast, lung, and prostate cancer while imaging technology covers MRI, CT, ultrasound, and X-ray. End users include hospitals and clinics, research institutes and diagnostic centers, and other end users while applications cover cancer diagnosis, disease monitoring, personalized medicine, and early disease detection.

Why do oncological disorders lead the target therapeutic area category?

Oncology requires whole-lesion assessment as one tissue sample represents a limited location within a heterogeneous tumor during diagnosis and response monitoring. Precision cancer imaging compares spatial variation across repeated examinations without adding an invasive procedure for every clinical review.

• The target therapeutic area category is forecast to be led by oncological disorders at 52.0% share in 2026 due to tumor-focused diagnosis and monitoring across specialist services.
• Cancer centers expand use once multi-site validation confirms stable output across scanner models and representative patient groups. Clinical teams need explicit rules that connect quantitative results with cancer diagnosis or treatment planning.

Why do solid malignancies lead the cancer targeted category?

Solid tumors show measurable variation in morphology and perfusion within one mass or across several lesions. In November 2025 QUIBIM launched an oncology platform that connected prostate image acquisition with lesion review and follow-up reporting. The integrated workflow gives oncology teams a route for preserving lesion context across repeated examinations.

• Solid malignancies are set to lead the cancer targeted category with 31.0% share in 2026 due to whole-tumor characterization across imaging pathways.
• Oncology departments select oncology imaging software that preserves measurements across follow-up studies and routine reporting. Unstable reconstruction or segmentation can weaken comparisons between treatment reviews and reduce confidence in targeted sampling decisions.

Why does MRI lead the imaging technology category?

Magnetic resonance imaging combines structural and functional sequences for detailed soft-tissue assessment without ionizing radiation during repeated examinations. Multiparametric protocols measure diffusion and related tissue properties while preserving anatomical context for specialist interpretation.

• By imaging technology, MRI is forecast to represent 38.0% in 2026 driven by multiparametric and diffusion-weighted workflows across hospital oncology applications.
• Radiology teams test quantitative models through algorithm validation platforms during deployment planning across mixed scanner fleets. In February 2026 Siemens Healthineers and Mayo Clinic expanded collaboration on AI-enabled MRI protocols intended to minimize prostate biopsies. The collaboration links protocol development with a defined clinical decision instead of a stand-alone image score.

Why do hospitals and clinics lead the end user category?

Hospitals control scanner access and specialist interpretation alongside multidisciplinary review and treatment decisions throughout the clinical pathway. Their deployment process also covers cybersecurity ownership with integration and post-market monitoring across departments and clinical sites.

• Hospitals and clinics are projected to hold 51.0% share in 2026 owing to tertiary-care capacity and specialist imaging infrastructure across regional clinical pathways.
• Deployment advances once virtual biopsy output enters radiology information systems without duplicate data entry or separate review queues. Financial approval remains difficult unless clinical teams demonstrate a named decision change or reduced procedure burden during routine purchasing reviews.

What are the drivers, restraints and opportunities in the virtual biopsy market?

Driver: Whole-lesion analysis supports diagnosis without sampling every disease site. Restraint: Scanner hardware and inconsistent protocols can destabilize quantitative features across hospitals. Opportunity: Harmonized acquisition and automated checks can support longitudinal biomarkers across clinical networks.

• Driver: Radiologists compare image-derived phenotypes across repeated examinations to decide whether another tissue sample would change patient management.
• Restraint: Reconstruction differences and inconsistent segmentation can change model output across scanners serving the same clinical pathway.
• Opportunity: Standardized acquisition protocols can support comparable longitudinal biomarkers across hospital networks and multi-site clinical research.

Radiologists compare image-derived phenotypes with digital pathology during validation programs that test the value of repeated tissue sampling. Demand strengthens once a measurement answers a defined diagnostic or treatment-response question across serial examinations.

Scanner hardware and reconstruction choices can alter radiomic features within the same disease pathway across clinical sites. Developers need representative validation data and controlled update plans for every hospital software deployment environment.

Harmonized MRI and computed tomography protocols give hospital networks comparable longitudinal measurements across repeated examinations. Automated acquisition checks and consistent segmentation reduce unusable studies while protecting confidence in each reported biomarker.

Which country CAGRs are profiled in the virtual biopsy market?

Country	CAGR
South Korea	12.4%
Japan	11.7%
Australia	11.5%
United Kingdom	11.3%
United States	11.2%

How do country-level CAGRs compare in the virtual biopsy market?

The displayed CAGRs span 1.2 percentage points across countries facing similar software-validation pressures and different commercial conditions.

CAGR variation describes expected expansion without representing current market size or installed adoption in each country.

• South Korea differs through joint clinical-trial principles that provide a defined evidence route for machine-learning medical devices.
• Japan and Australia form a close group although consultation systems and sponsor obligations create different implementation requirements.
• The United Kingdom connects regulatory sandbox learning with NHS pathway assessment across hospital trusts and specialist services.
• The United States supports broad multi-site evaluation although health systems apply separate cybersecurity and integration reviews.

Comparable CAGRs can produce different market entry conditions across regulatory systems and hospital purchasing environments. The full report provides country-level CAGR analysis across North America, Latin America, Europe, East Asia, South Asia and Pacific, and the Middle East and Africa.

Country-wise Analysis

• South Korean developers work through a defined medical-device pathway that supports local clinical study planning for machine-learning diagnostic software and structured evidence submission. In December 2024 MFDS and Singapore’s HSA published joint principles for clinical trials involving machine-learning medical devices across regulated diagnostic studies and participating institutions. South Korea is estimated to post 12.4% CAGR over the forecast period, supported by domestic engineering capacity and clearer expectations for clinical-study design. Major academic hospitals provide specialist training and integration support although Korean patient validation and mixed scanner fleets complicate dependable maintenance coverage across regional care networks outside Seoul and other major centers.
• Japanese imaging developers use a consultation system that supports software classification and approval planning across local deployment programs that require clinical performance documentation and accountable sponsor support. PMDA released updated SaMD seminar materials on March 17, 2025 covering consultation routes and approval review for developers and manufacturers. Adoption of virtual biopsy in Japan is estimated to expand at 11.7% CAGR through 2036, reinforced by established imaging manufacturers and hospital engineering networks. Established engineering networks support equipment servicing and specialist training although Japanese-language workflows and domestic protocol evidence remain necessary across installed scanner generations and regional hospital systems during routine service planning.
• Australian sponsors need national registration for regulated medical-device software supplied to public and private hospital imaging networks under a stated intended purpose and accountable local sponsorship. The TGA clarified manufacturer and sponsor responsibilities for AI-enabled medical-device software in updated guidance dated February 5, 2026. The Australian virtual biopsy sector is projected to record 11.5% CAGR during the assessment period, shaped by concentrated metropolitan imaging networks and specialist trial capacity. Public hospital groups support multi-site evaluation although long service distances require dependable maintenance training and cybersecurity support for regional facilities beyond major coastal centers with smaller engineering teams and specialist staffing.
• United Kingdom developers can combine regulatory engagement with NHS pathway evaluation during the introduction of AI-enabled imaging software across hospital trusts and specialist diagnostic services and local commissioning decisions. The MHRA published its second AI Airlock report on June 9, 2026 with seven case studies from real-world medical-device scenarios that identified regulatory and technical lessons. Virtual biopsy sales in the United Kingdom are forecast to expand at 11.3% CAGR by 2036, aided by coordinated imaging networks and national clinical evaluation programs. National evaluation programs support evidence development although separate trust-level data governance and integration reviews can extend purchasing timelines across existing hospital infrastructure.
• United States health systems provide large multi-site imaging networks that support external validation across diverse scanners and patient populations across academic and community facilities ahead of scaled purchasing. In August 2025 the FDA finalized recommendations for predetermined change control plans covering planned updates to AI-enabled device software functions. Virtual biopsy demand in the United States is forecast to rise at 11.2% CAGR over the forecast period, driven by academic evaluation capacity and specialist training. Independent hospital groups offer broad clinical datasets although separate cybersecurity reviews and integration requirements can delay deployment across regional networks and specialty centers with different purchasing systems.

Who are the notable companies in the virtual biopsy market?

Siemens Healthineers AG, GE HealthCare Technologies Inc., Koninklijke Philips N.V., Canon Medical Systems Corporation, Fujifilm Holdings Corporation, Samsung Medison Co., Ltd., Perspectum Ltd. and QUIBIM S.L. are the notable companies serving this market.

The market is concentrated among global imaging groups at the acquisition-platform level and more fragmented among organ-specific biomarker developers. Entry requires regulated software evidence plus multi-site reproducibility and hospital integration across existing radiology systems, limiting participation by general-purpose analytics companies.

• Siemens Healthineers AG, GE HealthCare Technologies Inc. and Koninklijke Philips N.V. compete through broad MRI and CT platforms with enterprise service coverage.
• Canon Medical Systems Corporation, Fujifilm Holdings Corporation and Samsung Medison Co., Ltd. compete through imaging hardware, workflow software and modality-specific clinical support.
• Perspectum Ltd. and QUIBIM S.L. compete through quantitative biomarkers and disease-specific software linked to liver or prostate imaging decisions.

Competitive Benchmarking: Virtual Biopsy Market

Company	Imaging Platform Breadth	Quantitative Biomarker Capability	Clinical Validation and Workflow Support	Geographic Reach
Siemens Healthineers AG	High	High	High	Global
GE HealthCare Technologies Inc.	High	High	Medium	Global
Koninklijke Philips N.V.	High	High	Medium	Global
Canon Medical Systems Corporation	High	Medium	Medium	Global
Fujifilm Holdings Corporation	High	Medium	Medium	Global
Samsung Medison Co., Ltd.	Medium	Medium	Medium	Global
Perspectum Ltd.	Low	High	High	North America and Europe
QUIBIM S.L.	Low	High	High	Global

Scoring basis: Imaging Platform Breadth is High for several commercial imaging modalities, Medium for one major modality and Low for software without an acquisition platform. Quantitative Biomarker Capability is High for several marketed measurement functions, Medium for one focused function and Low for limited quantitative evidence. Clinical Validation and Workflow Support is High for multi-site evidence plus deployment support, Medium for narrower evidence or integration coverage and Low for an adjacent capability without direct clinical workflow support. Geographic Reach records verified operating regions and does not convert missing evidence into a score.

Key Developments in the Virtual Biopsy Market

• In April 2026, Koninklijke Philips N.V. received USA FDA 510(k) clearance for Verida spectral CT, which provides conventional and spectral results from one acquisition for tissue characterization.
• In March 2026, GE HealthCare Technologies Inc. received USA FDA 510(k) clearance for Photonova Spectra photon-counting CT, supporting energy-resolved tissue analysis and spectral biomarker research.
• In February 2026, Siemens Healthineers AG expanded its Mayo Clinic collaboration to study AI-enabled MRI pathways intended to reduce unnecessary prostate biopsies and improve patient monitoring.

Virtual Biopsy Market - Report Scope

Coverage field	Report scope
Market breakdown	By target therapeutic area, cancer targeted, imaging technology, end user, application and region.
Quantitative Units	USD billion.
Market Definition	Virtual biopsy software uses quantitative imaging and AI-assisted analysis to characterize tissue across clinical workflows.
Regions Covered	North America, Latin America, Europe, East Asia, South Asia and Pacific and Middle East and Africa.
Countries Covered	South Korea, Japan, Australia, United Kingdom and United States.
Key Companies Profiled	Siemens Healthineers AG, GE HealthCare Technologies Inc., Koninklijke Philips N.V., Canon Medical Systems Corporation, Fujifilm Holdings Corporation, Samsung Medison Co., Ltd., Perspectum Ltd. and QUIBIM S.L.
Forecast Period	2026 to 2036.
Approach	Primary and secondary research with market triangulation.

Virtual Biopsy Market - Research Methodology

Method	Approach
Primary Research	FMI analysts gathered input from manufacturers, service providers, technology developers, distributors, end users, procurement teams, and subject-matter experts. Interviews examined purchasing decisions, product or service evaluation, adoption barriers, approval requirements, pricing considerations, and expectations for technical or commercial support. Respondents were also asked what evidence is required before a trial, pilot, or initial order develops into regular purchasing.
Desk Research	Desk research covered government statistics, regulatory publications, trade data, industry associations, technical literature, standards, company filings, product information, and official corporate announcements. Sources were reviewed for relevance, publication date, geographic coverage, and consistency with the defined market scope. Claims relating to performance, applications, approvals, capacity, investment, and commercial activity were retained only when supported by credible public evidence.
Market Sizing and Forecasting	The market model combined the baseline value with historical performance, segment structure, pricing and volume indicators, adoption levels, company participation, and country-level demand conditions. Forecast assumptions considered economic activity, investment trends, regulatory developments, technology adoption, purchasing cycles, supply availability, and barriers to wider market use. Segment and regional estimates were reconciled before the final market total was calculated.
Data Validation	Estimates were checked against multiple independent indicators, including public data, company activity, trade patterns, industry developments, and findings from primary interviews. Validation also tested whether products, services, applications, and company revenues fell within the defined market boundaries. Adjacent categories, unsupported claims, overlapping revenues, and activities without direct market relevance were excluded to reduce double counting and maintain consistency across segments and countries.

Virtual Biopsy Market by Segments

Virtual Biopsy Market segmented by Target Therapeutic Area:

• Oncological Disorders
  • Breast Cancer
  • Lung Cancer
• Neurological Disorders
  • Brain Tumors
  • Neurodegenerative Disorders
• Cardiovascular Disorders
  • Cardiac Disease
  • Vascular Disorders
• Gastrointestinal Disorders
  • Liver Disease
  • Gastrointestinal Tumors

Virtual Biopsy Market segmented by Cancer Targeted:

• Solid Malignancies
  • Tumor Characterization
  • Tumor Heterogeneity Analysis
• Breast Cancer
  • Breast Tumor Detection
  • Breast Lesion Characterization
• Lung Cancer
  • Lung Nodule Analysis
  • Lung Tumor Characterization
• Prostate Cancer
  • Prostate Tumor Detection
  • Prostate Tissue Characterization

Virtual Biopsy Market segmented by Imaging Technology:

• Magnetic Resonance Imaging (MRI)
  • Multiparametric MRI
  • Diffusion-Weighted MRI
• Computed Tomography (CT)
  • High-Resolution CT
  • Contrast-Enhanced CT
• Ultrasound
  • Contrast-Enhanced Ultrasound
  • Elastography
• X-Ray
  • Digital X-Ray
  • Advanced X-Ray Imaging

Virtual Biopsy Market segmented by End User:

• Hospitals & Clinics
  • Tertiary Care Hospitals
  • Specialty Clinics
• Research Institutes & Diagnostic Centers
  • Research Institutes
  • Diagnostic Imaging Centers
• Other End Users
  • Academic Institutions
  • Specialized Medical Centers

Virtual Biopsy Market segmented by Application:

• Cancer Diagnosis
  • Tumor Detection
  • Tumor Characterization
• Disease Monitoring
  • Treatment Response Monitoring
  • Disease Progression Assessment
• Personalized Medicine
  • Patient Stratification
  • Therapy Selection
• Early Disease Detection
  • Screening
  • Risk Assessment

Virtual Biopsy Market by Region:

• North America
  • United States
  • Canada
• Latin America
  • Brazil
  • Chile
  • Mexico
  • Rest of Latin America
• Western Europe
  • Germany
  • United Kingdom
  • Italy
  • Spain
  • France
  • Nordics
  • Benelux
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • Hungary
  • Balkan and Baltic States
  • Rest of Eastern Europe
• East Asia
  • China
  • Japan
  • South Korea
• South Asia and Pacific
  • India
  • ASEAN
  • Australia and New Zealand
  • Rest of South Asia and Pacific
• Middle East and Africa
  • Kingdom of Saudi Arabia
  • Other GCC Countries
  • Türkiye
  • South Africa
  • Other African Union Countries
  • Rest of Middle East and Africa

Research Sources and Bibliography

• USA Food and Drug Administration. (2025, January 6). FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices.
• QUIBIM S.L. (2025, November 21). Quibim Unveils Next-Generation Oncology Ecosystem Platform at RSNA 2025.
• Siemens Healthineers AG. (2026, February 12). Siemens Healthineers and Mayo Clinic Expand Strategic Collaboration to Enhance Patient Care Through Advanced Technology.
• Ministry of Food and Drug Safety. (2024, December 11). Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs.
• Pharmaceuticals and Medical Devices Agency. (2025, March 17). Software as a Medical Device (SaMD).
• Therapeutic Goods Administration. (2026, February 5). Artificial intelligence (AI) and medical device software regulation.
• Medicines and Healthcare products Regulatory Agency. (2026, June 9). AI Airlock Sandbox Phase 2 Programme Report.
• USA Food and Drug Administration. (2025, August). Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
• GE HealthCare Technologies Inc. (2026, March 23). GE HealthCare’s Photonova Spectra photon-counting CT receives FDA clearance.
• Koninklijke Philips N.V. (2026, April 16). Philips receives FDA 510(k) clearance for Verida, the world’s first AI-powered detector-based spectral CT*, advancing diagnostic precision across clinical applications.
• Canon Medical Systems Corporation. (2026, April 9).
• FUJIFILM Healthcare Americas Corporation. (2025, May 12). Fujifilm Strengthens Partnership with the National Rural Health Association to Improve Access to Medical Imaging in Rural Communities.
• Samsung Electronics Co., Ltd. (2025, December 1). Samsung Introduces R20 Ultrasound System, Elevating Imaging Performance and Precision at RSNA 2025.
• Perspectum Ltd. (2025, March 18). New Multinational Study Shows MRI is Cost-Effective in the Diagnosis and Management of Steatotic Liver Disease.
• QUIBIM S.L. (2025, June 26). Quibim Enhances Flagship QP Prostate® Product with The Launch of AI-QUAL™: Industry-First AI Tool for Automated Prostate MRI Image Quality Assessment Based on PI-QUAL.

This bibliography is provided for reader reference and is not exhaustive. The full report contains the complete reference list and detailed citations.

This Report Answers

• How large is the virtual biopsy market in 2026 and 2036?
• Which clinical mechanisms support non-invasive tissue characterization across virtual biopsy workflows?
• Which target therapeutic area accounts for the significant share during 2026?
• How does imaging technology shape virtual biopsy deployment across hospital networks?
• Which operating conditions limit reproducibility across scanners and clinical sites?
• How do profiled country growth rates differ through the 2036 forecast?
• Which companies support quantitative imaging and non-invasive biomarker workflows?
• What evidence requirements shape regulated virtual biopsy adoption across hospitals?