The KLAS Digital Pathology 2026 Report has highlighted significant growth in the United States digital pathology market, driven by recent FDA clearances and advancements in reimbursement strategies. Despite this, fewer than 15% of US healthcare organizations have implemented a digital pathology vendor, indicating that the adoption curve remains in its early stages.
Leading Vendors in Image Management Systems
In the realm of Image Management Systems (IMS), vendors specializing in pathology—such as Proscia, PathAI, and LUMEA—are currently leading in customer satisfaction compared to traditional radiology providers. Customers commend these companies for their tailored platforms and strategic support, which cater specifically to the needs of pathology.
The report identifies Leica Biosystems as the dominant player in the clinical scanner market within the US. Users consistently praise its ability to deliver high-quality scans, efficient slide loading, and reliability in day-to-day operations. In contrast, customers of Roche have expressed dissatisfaction regarding reliability and throughput, which they find inadequate for high-volume workflows.
AI’s Role in Clinical Applications
Hospitals are increasingly focusing on the integration of artificial intelligence for clinical applications, particularly in relation to breast and prostate cancer algorithms. One of the main requirements for these AI tools is seamless integration into the IMS workflow, eliminating the need for pathologists to navigate separate systems.
The report reveals a divide in the IMS market between established radiology vendors, including Sectra, Philips, and Fujifilm, and newer companies dedicated exclusively to pathology. Currently, the latter group is leading in customer satisfaction metrics. Notably, Proscia has emerged as the most frequently considered IMS vendor, praised for its collaborative and educational approach.
Initial feedback for PathAI indicates a positive reception, with clients highlighting proactive communication and strong executive involvement in implementation. Similarly, LUMEA’s users appreciate the platform’s user-friendly design and the vendor’s strategic commitment to adapting workflows to specific customer needs. In contrast, while traditional imaging vendors like Sectra continue to gain momentum due to existing relationships in radiology PACS, some customers report a lack of proactive engagement post-implementation, particularly regarding AI interoperability.
The report underscores the importance of effective scanning hardware, as software cannot function without high-quality digitized images. Leica Biosystems stands out with its Aperio GT 450 DX scanner, which has become the most widely adopted clinical scanner in the US following its early FDA clearance. Users attribute significant productivity gains to its features, including high-quality scans and efficient slide handling.
Conversely, Roche customers have reported substantial challenges in scaling their scanners for primary diagnosis, citing issues with reliability and throughput that hamper workflow efficiency.
The integration of AI technology into digital pathology systems is gaining traction, with organizations moving beyond research to assess AI for practical clinical use. Breast cancer algorithms that support biomarker assessment—such as Ki-67, HER2, estrogen receptor (ER), and progesterone receptor (PR)—are of particular interest. Key AI developers currently under consideration include Ibex, Visiopharm, Paige.ai, and PathAI. Buyers have made it clear that these AI solutions must integrate directly into IMS workflows, functioning as an integral part of clinical operations rather than as standalone systems.
For further insights and detailed findings from the KLAS Digital Pathology 2026 Report, visit KLAS Research.
