The global Virtual Biopsy Market size was valued at USD 5.2 billion in 2025 and is projected to expand at a compound annual growth rate (CAGR) of 19.5% during the forecast period, reaching a value of USD 23.1 billion by 2033.
MARKET SIZE AND SHARE
The virtual biopsy market is projected to expand significantly from 2025 to 2032, driven by rising demand for non-invasive diagnostic techniques. Valued in the billions, this growth reflects a compound annual growth rate in the double digits. North America currently commands the largest market share, attributed to advanced healthcare infrastructure and high adoption rates. However, the Asia-Pacific region is anticipated to witness the fastest growth during this forecast period due to improving medical facilities.
Market share is concentrated among key players specializing in advanced imaging and AI analytics. These leading companies are actively engaging in strategic partnerships and technological innovations to consolidate their positions. The increasing prevalence of cancer and chronic diseases globally is a primary factor propelling market expansion. Consequently, the overall market size is set for substantial increase, with software solutions expected to capture a significant portion of the revenue share by 2032.
INDUSTRY OVERVIEW AND STRATEGY
The virtual biopsy industry represents a transformative shift in diagnostic medicine, utilizing advanced imaging and artificial intelligence to analyze tissues non-invasively. This technology aims to reduce the need for conventional surgical biopsies, minimizing patient risk and healthcare costs. It integrates modalities like MRI, CT, and ultrasound with sophisticated software algorithms to provide detailed pathological insights. The sector is characterized by rapid technological evolution and a strong focus on improving diagnostic accuracy and speed.
Key strategic imperatives for market players include heavy investment in research and development to enhance AI capabilities and imaging resolution. Companies are pursuing collaborations with research institutions and healthcare providers to validate and commercialize new applications. Protecting intellectual property through patents is another critical strategy. Furthermore, firms are focusing on regulatory approvals and demonstrating clear clinical utility to gain trust and facilitate market penetration across global healthcare systems.
REGIONAL TRENDS AND GROWTH
Regionally, North America leads due to supportive reimbursement policies, major key players, and high healthcare expenditure. Europe follows, with strong growth fueled by government initiatives promoting advanced diagnostics. The Asia-Pacific region emerges as the most lucrative market, driven by its large patient pool, increasing healthcare investments, and rising medical tourism. Latin America and the Middle East & Africa show nascent but promising growth, focusing on adopting essential technologies in urban centers.
Primary growth drivers include the rising global cancer burden, technological advancements in imaging, and growing preference for minimally invasive procedures. Significant restraints are high equipment costs, regulatory hurdles, and a shortage of skilled professionals. Opportunities lie in integrating multimodal imaging and expanding into emerging economies. Key challenges involve proving clinical efficacy comparable to traditional biopsy, ensuring data security, and achieving widespread adoption amidst entrenched conventional practices.
VIRTUAL BIOPSY MARKET SEGMENTATION ANALYSIS
BY TYPE:
The Virtual Biopsy market is primarily segmented into software-based and service-based solutions. Software-based virtual biopsy solutions dominate the market due to their ability to integrate advanced computational techniques such as AI and machine learning into existing imaging workflows, reducing the need for invasive procedures. These platforms provide real-time analysis and enhanced diagnostic accuracy, which is critical for early detection and precision medicine. The convenience, scalability, and increasing adoption of digital healthcare tools in hospitals and diagnostic centers further drive the dominance of software solutions. On the other hand, service-based virtual biopsy offerings are gaining traction in regions with limited access to advanced imaging technologies, as these services provide expert interpretation and analysis without requiring institutions to invest heavily in software infrastructure.
The dominant factors influencing this segment include growing clinical demand for minimally invasive diagnostic solutions, rising prevalence of chronic diseases and cancer, and increasing adoption of digital pathology and AI-enabled imaging solutions. The preference for software-based models is strengthened by healthcare systems seeking cost-effective, time-efficient diagnostic alternatives, while service-based models thrive in markets with nascent technological infrastructure or where expertise is outsourced for complex cases. Regulatory approvals and the integration of virtual biopsy services with telemedicine platforms also play a key role in shaping market dynamics.
BY APPLICATION:
The market finds broad applications across oncology, cardiology, neurology, gastroenterology, and other medical fields. Oncology remains the dominant application area due to the critical need for precise tumor characterization, early cancer detection, and monitoring of treatment efficacy without the risks associated with traditional biopsy procedures. The rise in cancer incidence globally, coupled with increasing patient preference for non-invasive diagnostics, fuels the adoption of virtual biopsy solutions in oncology. Cardiology and neurology applications are growing steadily as well, with virtual biopsy techniques being explored for the evaluation of myocardial fibrosis, vascular anomalies, and neurological tissue characterization, where conventional biopsy is often impractical or risky.
Key drivers in this segment include increasing awareness among clinicians of the clinical advantages of non-invasive diagnostics, advancements in imaging technologies, and the integration of AI and radiomics to enhance predictive capabilities. Regulatory support for non-invasive procedures, reimbursement policies, and hospital adoption of precision medicine protocols further accelerate growth in applications like oncology. Gastroenterology and other specialty areas are expected to witness increased adoption as virtual biopsy solutions continue to evolve for broader clinical utility and as imaging modalities become more precise and accessible.
BY TECHNOLOGY:
Artificial intelligence (AI), machine learning (ML), computer vision, and radiomics are the cornerstone technologies enabling virtual biopsy solutions. AI leads the segment due to its ability to analyze complex imaging datasets with high accuracy, identify subtle tissue anomalies, and support automated decision-making for clinicians. Machine learning complements AI by continuously improving diagnostic models based on new imaging data, making predictions more reliable over time. Computer vision is instrumental in feature extraction and image segmentation, while radiomics converts imaging data into quantitative metrics that provide deeper insights into disease characterization.
Dominant factors influencing technology adoption include the rapid evolution of deep learning algorithms, the availability of large annotated medical imaging datasets, and increasing collaborations between technology providers and healthcare institutions. Furthermore, technological advancements that reduce computational time and increase diagnostic accuracy directly impact adoption rates, as hospitals and diagnostic centers prioritize solutions that enhance workflow efficiency. Government initiatives and funding to promote AI in healthcare also strengthen the adoption of these advanced technologies in virtual biopsy applications.
BY IMAGING MODALITY:
MRI, CT, ultrasound, and PET imaging modalities are extensively used in virtual biopsy solutions, with MRI leading due to its superior soft tissue contrast, non-invasiveness, and compatibility with AI-based analysis. CT scans are widely used for detecting structural abnormalities and providing high-resolution anatomical imaging, while ultrasound is valued for its real-time imaging capabilities and cost-effectiveness, especially in resource-limited settings. PET imaging is essential for functional assessment and metabolic activity mapping, making it particularly valuable for oncology applications.
Key factors driving imaging modality preference include modality-specific diagnostic precision, availability of imaging infrastructure, and compatibility with AI and radiomics software. MRI dominance is strengthened by its non-ionizing nature and detailed tissue differentiation, making it ideal for repeated monitoring. The selection of imaging modality often depends on the clinical application, patient safety considerations, and integration capabilities with virtual biopsy software platforms. Increasing investments in multi-modal imaging systems that combine anatomical and functional insights are further influencing market growth in this segment.
BY COMPONENT:
Virtual biopsy solutions are composed of software platforms, algorithms & models, and services, with software platforms serving as the core component due to their role in integrating AI, machine learning, and imaging modalities for comprehensive diagnostics. Algorithms and models form the backbone of analytical accuracy, enabling predictive insights, tissue characterization, and automated detection of anomalies. Services, including consulting, training, and data analysis, support software deployment and ensure effective utilization, particularly in hospitals and diagnostic centers adopting virtual biopsy solutions for the first time.
Dominant factors include increasing demand for turnkey solutions that can be integrated seamlessly into existing clinical workflows, the rising importance of algorithm validation for regulatory compliance, and the need for high computational efficiency. The development of customizable software platforms tailored to specific clinical indications enhances adoption rates, while services remain critical in regions with lower digital literacy among healthcare professionals. Strategic partnerships between software developers and healthcare providers also influence the growth and maturity of this component segment.
BY END USER:
Hospitals, diagnostic centers, research institutes, and academic institutions form the primary end-user segments, with hospitals and diagnostic centers leading due to the direct need for patient-facing diagnostic solutions. Hospitals leverage virtual biopsy for early detection, treatment planning, and monitoring of chronic diseases, especially cancer, while diagnostic centers adopt these solutions to offer advanced services and reduce reliance on invasive procedures. Research institutes and academic institutions focus on developing new algorithms, validating technologies, and exploring novel applications of virtual biopsy, contributing to innovation and clinical adoption.
Key factors influencing end-user adoption include clinical workflow integration, ease of use, and cost-effectiveness of virtual biopsy solutions. Hospitals prioritize solutions that reduce patient risk and improve diagnostic speed, while diagnostic centers focus on differentiation and expanding service offerings. Research and academic institutions drive technology validation and training, enhancing trust and adoption in clinical practice. Regional availability of skilled personnel, regulatory approvals, and reimbursement policies also significantly affect adoption patterns across end users.
BY INDICATION:
The market is segmented by indications such as cancer diagnosis, tumor characterization, disease progression monitoring, and treatment planning, with cancer diagnosis dominating due to the global rise in cancer prevalence and the critical need for early, accurate, and non-invasive detection. Tumor characterization and disease progression monitoring are gaining importance as clinicians require detailed tissue analysis for precision medicine and to tailor treatment strategies. Treatment planning benefits from virtual biopsy’s ability to provide predictive insights, helping clinicians choose optimal therapeutic interventions without subjecting patients to repeated invasive biopsies.
Dominant factors in this segment include the clinical need for accurate, minimally invasive diagnostics, increasing demand for personalized medicine, and integration of imaging biomarkers with AI-driven predictive models. Regulatory approvals for clinical applications and insurance reimbursement policies favoring non-invasive diagnostics further accelerate adoption. Continuous advancements in imaging modalities and algorithmic sophistication enhance the capability of virtual biopsy solutions to support multiple indications, driving broader market acceptance across healthcare systems globally.
RECENT DEVELOPMENTS
- In Jan 2024: Siemens Healthineers received FDA clearance for its next-generation AI-powered MRI software, enhancing virtual biopsy capabilities for prostate cancer with improved lesion detection and characterization accuracy.
- In Mar 2024: Paige and Merck KGaA announced a strategic collaboration to develop and commercialize AI-based virtual biopsy assays in oncology, aiming to accelerate drug development and companion diagnostics.
- In Jun 2024: PathAI launched its first commercial virtual biopsy platform, AISight IBD, leveraging AI on standard endoscopic imagery to predict histological remission in inflammatory bowel disease patients.
- In Nov 2024: Boston Scientific completed the acquisition of EchoNous, integrating its ultrasound and AI platform to bolster its minimally invasive diagnostics portfolio, including virtual biopsy applications.
- In Feb 2025: GE HealthCare and NVIDIA expanded their partnership, announcing a new AI model for CT-based virtual biopsy to non-invasively assess lung nodule malignancy, entering clinical validation trials.
KEY PLAYERS ANALYSIS
- Siemens Healthineers
- GE HealthCare
- Philips
- Canon Medical Systems Corporation
- Fujifilm Holdings Corporation
- Hologic, Inc.
- Boston Scientific Corporation
- Medtronic plc
- PathAI
- Paige AI, Inc.
- NVIDIA Corporation
- IBM (Watson Health)
- Koninklijke Philips N.V.
- Butterfly Network, Inc.
- EchoNous Inc.
- Resonant Inc.
- Ibex Medical Analytics
- Aidoc Medical Ltd.
- Therapixel SA
- Quibim S.L.
