The market for Digital Pathology & AI Assisted Microscopy includes imaging systems, digital slide scanners, AI analysis software and data management platforms which convert analogue histopathology to digital workflows. Rapid sharing of images, quantitative analysis and AI driven pattern recognition is used to help diagnose disease states such as cancer, infections and chronic inflammatory disorders. Due to the increasing incidence and prevalence of major diseases, such as (globally) ~20 million new cases of cancer each year (and more on the way due to ageing populations), there is a growing demand for efficient diagnostic solutions that will decrease turnaround times and enhance accuracy. Regulatory authorities such as the U.S. FDA and the European Union MDR are currently creating a framework for the safety and effectiveness of AI's integration into clinical practice by establishing standards for their use and performance validation. The WHO is encouraging partners to implement digital health strategies to increase access to quality diagnostics, create consistency in their data and support clinical decision making throughout the region. Digital pathology will become widely accepted as part of the standard of care for complementing traditional microscopy and facilitating remote collaboration between clinicians and laboratories.
Volume of Disease Increasing: The number of people with cancer is growing all around the world. The increased number of people suffering from chronic diseases throughout the world will also contribute to the demand for pathology services, as will the recommendations of health authorities advocating the use of digital pathology and AI microscope applications to increase their ability to diagnose patients faster and more accurately by improving throughput and the speed at which they can identify disease.
Regulatory Agencies Supporting AI in Diagnostics: Government regulatory agencies are establishing guidelines for the future regulatory process for digital pathology and AI technologies. The FDA has implemented the “Digital Pathology Program” to assist with the understanding of validation and use of whole slide imaging and AI algorithms for the diagnosis and monitoring of health conditions. The EU’s Medical Device Regulation (MDR) establishes a framework for the regulation of software and AI as medical devices. This will improve safety for patients and interoperability between devices. Regulatory clarity will lower the barrier to the clinical adoption of digital pathology and AI platforms, which should help promote additional investments.
Patent Activity & New Innovation Incentives: The number of patents filed in the areas of AI based image analysis, automated microscopy workflow processes, and digital slide annotation is continuing to grow, indicating that innovation is continuing in these areas. The patent activity generated from research institutions, health care consortia, and health technology companies reflects a significant R&D investment and encourages the competition and innovation that will provide laboratories with the next generation of products to improve the speed, accuracy, and ease of interpretive analysis used in clinical practice or research.
Increased Operational Efficiency Via Automation: Digital pathology and AI enabled microscopy provide automated solutions for many repetitive tasks performed in laboratories, such as cell counting, biomarker quantification, and pattern recognition, producing faster, more accurate results than traditional methods. Automated solutions also provide laboratories with the means to maintain regulatory compliance. Digital pathology and AI tools are integrated into laboratory information systems and electronic health.
The Digital Pathology and AI assisted microscopy market is currently struggling with regulation, data privacy, and integrating clinically. The vendors developing the fast growing AI algorithms for Digital Pathology must validate their products according to the following, as outlined by US FDA Digital Pathology Program, EU Medical Device Regulation (MDR) and UK MHRA, while also complying with HIPAA and GDPR for HIPAA compliant patient data privacy. Integrating these algorithms into existing laboratory information systems (LIS) and electronic health records (EHR) can be complex and typically requires training for the clinician to use the AI component, both of which add a layer of complexity for the vendor developing the algorithm. Additionally, AI validation and interpretability are vital to gaining the clinician's confidence in the use of the technology. While validating the use of Digital Pathology algorithms for AI assisted microscopy remains a barrier for widespread use among clinicians, the increase in the incidence of disease, especially cancer and other chronic conditions, will only drive the adoption of high throughput Digital Pathology platforms to support diagnosis and treatment. The WHO has initiated government programs that support the safe use of AI in telepathology as a digital health solution. The rapid emergence of patent applications for image analysis and automated quantification technologies is an indicator of the strong potential for innovation and growth in the Digital Pathology market. Telepathology will allow the delivery of remote pathology services for diagnostic purposes and expedite the dissemination of clinical data in support of clinical research and drug development efforts. Competitive intelligence for pharmaceutical companies indicates that the top solutions for Digital Pathology include Philips IntelliSite Pathology Solution, Roche Ventana DP 200, and Leica Aperio AT2. Philips offers AI assisted cancer detection and seamless integration with EHRs, while Roche focuses on workflow automation and high speed scanning, and Leica has superior image resolution and multi staining analysis capabilities. Factors that dictate a company's ability or willingness to adopt an AI assisted microscopy solution include performance, features associated with supercomputing or machine learning/artificial intelligence, and regulatory compliance issues. Therefore, it will be vital for each company to segregate itself from the other vendors in order to achieve market leadership.
March 2025: Philips Healthcare announced the expansion of its IntelliSite Pathology Solution (PIPS) in collaboration with Ibex Medical Analytics, introducing new AI powered capabilities designed to enhance diagnostic workflows and address growing pathology workloads. The updated platform supports improved interoperability between digital pathology scanners and advanced AI applications for cancer diagnostics, including case prioritization and automated image analysis. PIPS 6.0 also delivers streamlined workflows for pathology teams, making digital and AI assisted diagnosis more efficient and scalable in clinical laboratories. This development reflects the company’s broader strategy to accelerate the adoption of AI tools in routine pathology practice worldwide and improve diagnostic confidence and turnaround times.
The market is segmented by component, deployment mode, application and geography.
AI enhanced microscopy is where optical microscopy utilises AI algorithms/technology, thus enabling high throughput analysis and helping to reduce manual errors, as well as providing real time diagnostic assistance for the analysis of cancer and infectious disease processes. Hospitals and research laboratories can use these types of microscopes to improve how quickly they can process histological slides, to optimise workflow by enhancing reproducibility, and to create standardised analytical methodologies across different individuals.
Cancer diagnostic processes are where AI assisted digital pathology systems are used extensively in the grading of tumor, determining the grade of tumors and identifying, characterizing disease processes. Artificial intelligence can be integrated into the analysis of whole slide images/numerous images and identify areas of malignancy, provide automated quantitative information on the number of tumour cells within the total number of tumour cells present on the slide, and can recognise sub microscopic changes relative to standard histologic features that are otherwise not readily recognised through a microscopic review of the slide.
Diagnostic laboratories utilise AI enabled digital pathology systems and AI assisted microscopy technologies for the digital scanning, storing, and reviewing of histologic slides. AI enhanced digital pathology systems provide a laboratory with automated image analysis capabilities, data performance capabilities, and easily integrate into the laboratory information system (LIS), improving laboratory efficiency and turnaround time while providing higher quality control of their overall testing process. AI based software programs provide additional capabilities for growing laboratory caseloads and provide support for remote consultations regarding patient outcomes with healthcare practitioners and/or hospitals beyond the laboratory's point of test performance.
North America is currently the leader in digital pathology and AI microscopy adoption due to large numbers of people being diagnosed with cancer and having a good healthcare system. The United States (U.S) Food and Drug Administration (FDA) provides guidance on how to validate AI for use in clinical practice as well as guidance on how to implement digital pathology workflows within hospitals and laboratories. Digital pathology in Canada is also supported by a national regulatory system based on the European Union's (EU) directives on digital diagnostics. By utilizing AI for pathology diagnosis, healthcare providers will be able to increase the number of specimens they can process and provide more accurate pathology diagnoses, as well as integrate pathology data into electronic health records (EHR), thus supporting telepathology and remote pathology consultations. North America has made significant investments from both the public and private sectors in research & development (R&D), which has created significant levels of patent activity and will support North America in continuing to be one of the largest markets for AI based diagnostic tools.
South America is emerging as a growth region, with increasing investment in digital pathology to support hospitals, research centres, and telemedicine initiatives. Countries like Brazil, Argentina, and Chile are piloting AI assisted microscopy systems for oncology and infectious disease diagnosis. Regulatory frameworks are evolving to align with MDR and WHO digital health guidelines, ensuring safe and effective clinical deployment. AI tools improve workflow efficiency, enable remote slide analysis, and reduce diagnostic delays. Partnerships with international technology providers, government support for healthcare digitalisation, and rising disease incidence drive adoption, creating opportunities for scalable AI enabled pathology platforms across the continent.
Europe is also making significant progress with respect to the adoption of digital pathology being driven by EU Medical Device Regulation and National Digital Health Strategies from the UK, Germany, and France. Currently, there are multiple large scale digital pathology systems being developed through the National Pathology Imaging Cooperative in the UK that will allow the development of interoperable digital pathology systems within hospitals using AI assisted diagnostic capabilities. Regulatory frameworks established throughout Europe are primarily focused on safety, performance, and transparency and are driving the use of AI in the diagnosis of cancer and the delivery of cancer research. By developing telepathology and remote diagnosis capabilities, Europe is working to eliminate the disparity in access to highly qualified pathologists. The significant level of innovation in infrastructure and AI training, combined with strong collaborative relationships between laboratories, will ultimately help advance Europe’s role as a leader in digital pathology through improvements in both clinical efficiency and increased accuracy of pathology diagnoses.
The Middle East and Africa are slowly adopting digital pathology, due to limitations in both infrastructure and trained professionals, through the support of government led and region wide health initiatives. Countries like the UAE, Saudi Arabia, and South Africa are investing in AI assisted pathology solutions to improve the accuracy of cancer diagnostics and the efficiency of cancer related research. Telepathology provides remote access to expert pathologists, addressing the low density of pathologists in the Middle East and Africa. Governments in the Middle East and Africa are actively promoting the use of regulations to protect the security of patient data and comply with internationally accepted standards. There is cooperation between governments and the private sector, both at the regional level and through international partnerships, to support technology transfer, training, and infrastructure development, leading to more opportunities for AI assisted diagnostics and the implementation of digital pathology in the delivery of health care in Middle Eastern and African countries.
The Asia Pacific region is quickly adopting AI assisted pathology solutions, as seen in a number of countries such as Japan, Australia, Singapore, and South Korea, where governments have implemented national strategies to promote digital health and AI. An increase in the incidence of various diseases (notably cancer and other chronic diseases) has created demand for improved accuracy of diagnostic results and efficiency of the diagnostic process through the use of AI assisted pathology solutions. Furthermore, there are initiatives by governments and regional authorities to safely implement and train healthcare professionals to utilise digital pathology in their practices. Telepathology and cloud based digital pathology platforms provide access to experts in pathology in remote areas of the Asia Pacific region. The investment of resources into the development of AI solutions and research partnerships that will facilitate predictive analysis, quantification of images, and standardisation of diagnostic results has extended clinical and research uses in hospitals and laboratories of every country in the Asia Pacific.
Philips Healthcare
Leica Biosystems
Hamamatsu Photonics
3DHISTECH
PerkinElmer
Indica Labs
PathAI
Paige.AI
Sectra
Roche Diagnostics
The industry is in the process of consolidation as players target the provision of " Digital Pathology and AI Assisted Microscopy Market" toolchains.
Philips Healthcare is a leading global provider of imaging and digital pathology products. IntelliSite Pathology Solution is used for whole slide imaging, managing images, and providing clinical workflow support within hospitals & labs. Throughout all of this, Philips uses AI technology to automatically perform measurements, identify tumors, and rank the importance of different workflow steps. Each platform is evaluated against current regulatory requirements (including the FDA guidance document regarding use of digital pathology) as well as able to interact with electronic health record (EHR) systems. In addition, Philips collaborates with academic/research institutions to validate AI models for use in diagnosing cancer.
Manufacturers produce digital pathology scanners, slide imaging systems, and software to scan and create high definition images of histologic specimens. Leica Biosystems’?Aperio AT2 and VueScan systems enable fast scanning of complete glass Slides and allow integration with Artificial Intelligence (AI) analysis tools. The Leica scanner has been used extensively in both clinical and research environments to improve the accuracy of diagnosis and reduce turnaround time. Leica has made a commitment to providing high quality products while optimising workflow and maintaining compliance with global regulations. Collaborating with software developers to create AI assisted tools for the detection of disease and quantification has expanded the breadth of AI capabilities that can assist in making a diagnosis.