What you should know
- The adoption curve: KLAS Digital Pathology Report 2026 reveals that the US digital pathology market is growing rapidly due to recent FDA clearances and progress towards targeted reimbursements. However, adoption is still in the early stages: less than 15% of U.S. healthcare organizations have selected a digital pathology provider.
- The IMS Leaders: When it comes to image management systems (IMS), pathology-specific vendors like Proscia, PathAI, and LUMEA are currently outperforming traditional radiology vendors in early customer satisfaction. Customers praise its purpose-built platforms and strategic guidance.
- The heavyweight of hardware: Leica Biosystems is the undisputed market leader in clinical scanners in the US. Customers consistently highlight its high-quality scans, efficient slide loading, and high reliability on a day-to-day basis. In contrast, Roche scanner customers report significant dissatisfaction due to reliability issues and poor performance.
- The AI Approach: Hospitals are primarily evaluating AI for clinical use, particularly for breast and prostate cancer algorithms. An important requirement for these AI tools is that they must be integrated directly into the IMS workflow rather than functioning as a separate system.
The IMS battle: specialists versus generalists
The image management system (IMS) is the backbone of digital pathology software. KLAS data reveals a clear divide in this market between two types of vendors: early ones that expanded into pathology from a broader radiology background (such as Sectra, Philips, and Fujifilm) and newer vendors built specifically for pathology.
Right now, specialists are winning the battle of satisfaction.
- proscia is the most frequently considered IMS provider. Clients cite their highly collaborative, education-focused approach as a key differentiator.
- RouteAI is receiving positive initial feedback focused on proactive communication, hands-on integration efforts, and visible executive engagement.
- LUMEA Customers praise the solution’s ease of use and the vendor’s strategic and practical commitment to tailoring workflows to specific customer needs.
While traditional imaging providers like Sectra continue to grow rapidly thanks to their established relationships with radiology PACS, some customers report that post-go-live engagement feels limited. As organizations mature, they demand more proactive guidance, especially around AI interoperability.
The reality of hardware: scanning at scale
The software is useless without a digitized image. Leica Biosystems dominates the scanner hardware market. As one of the first to receive FDA clearance, its Aperio GT 450 DX scanner is the most widely adopted for clinical use in the U.S. Customers consistently highlight the scanner’s high-quality scans, efficient slide loading, high throughput, and everyday reliability as huge productivity drivers.
At the other end of the spectrum, Roche customers express significant discontent. Echoing global research trends, US respondents report significant challenges in scaling up Roche scanners for primary diagnostics, citing reliability issues and poor performance that disrupt high-volume workflows.
The Imperative of AI Integration
The ultimate promise of digital pathology is not simply viewing a slide on a monitor; is unleashing Artificial Intelligence in pixels. Early indicators point to strong and growing interest in AI. Organizations no longer focus solely on research; They are evaluating AI for direct clinical use. Breast and prostate cancer algorithms have become the most common areas of focus. Specifically, interest is greatest in breast cancer applications that support the assessment of biomarkers, such as Ki-67, HER2, estrogen receptor (ER), and progesterone receptor (PR).
Top AI developers currently being considered include Ibex, Visiopharm, Paige.ai, and PathAI. However, there is a strict operational mandate from buyers: integration is non-negotiable. Respondents consistently emphasize that AI should be integrated directly into the IMS workflow. Hospitals expect AI to function as a seamless part of routine clinical operations, rather than forcing pathologists to log into a separate, disconnected system.
For more information about this report, visit https://klasresearch.com/report/digital-pathology-2026-early-adoption-and-technology-performance-in-an-emerging-us-market/3711
