LOS ANGELES: #AI--DeciBio Consulting LLC’s latest market report, “Digital & Computational Pathology Market Report 2026-2031,” states that the global digital pathology market, driven by an influx of open platforms that resolve interoperability challenges and standalone regulatory clearances that enable greater clinical adoption, is predicted to reach $2.1B by 2031.

The third edition of DeciBio’s digital and computational pathology (D&CP) report takes a comprehensive look at the global D&CP products and services market landscape, summarizing both present and future (2026-2031) use.

“Even with signs of consolidation, the digital pathology ecosystem remains highly fragmented, especially with respect to the computational layer. The growing role of non-traditional players, especially large tech companies, signals needs for an increasingly interconnected landscape, and I’m excited to see how these partnerships continue to develop,” says Katie Maloney, Partner at DeciBio.

Digital pathology (DP) refers to the digitization and digital interpretation of pathology slides, including slide scanning, as well as the use of image management systems, workflow software, image analysis and AI tools, and data storage. Computational pathology (CP) utilizes artificial intelligence and machine learning to enable analysis of morphological, single plex, and multiplex signatures. This edition of the report features a detailed analysis of the computational pathology market, including foundation models, and algorithms that vendors in the space are developing.

Biopharma continues to represent the largest customer segment of the market, as they invest significantly in the use of D&CP across discovery and translational research, as well as increasingly implementing D&CP in clinical trials. Clinical use follows closely, as adoption of D&CP continues to expand in leading academic medical centers (AMCs) and reference labs, as well as growing adoption in mid-sized and community hospitals through expanding pathology lab networks.

This report is designed for stakeholders across the digital pathology ecosystem, including biopharma companies, diagnostic developers, technology providers, and investors seeking to understand market dynamics, competitive positioning, and growth opportunities. Learn more about DeciBio’s Digital & Computational Pathology Market Report 2026-2031: https://www.decibio.com/market-reports/digital-pathology-market-report

Digital Pathology Companies Mentioned (non-exhaustive):

• 3DHISTECH
• Aiforia
• Hamamatsu
• Indica Labs
• KFBio
• Leica Biosystems
• Lunit
• Owkin
• PathAI
• Philips
• Proscia
• Roche
• Siemens Healthineers
• Visiopharm
• ZEISS

Digital Pathology Market Analysis:

Market Drivers

Open DP platforms are accelerating ecosystem partnerships by allowing vendors to integrate third-party AI algorithms directly into slide management systems, supporting pharma’s increasingly multi-vendor trial environments. At the same time, collaboration between the FDA and Digital Pathology Association (DPA) on standalone verification testing enables scanners, viewers, and algorithms to be cleared and adopted independently, reducing barriers to innovation and deployment. Growth is further driven by increasingly complex algorithms, including computational pathology CDx assays (e.g., TROP2 QCS), which generate insights beyond human interpretation without AI. In parallel, industry consolidation is being fueled by the need to acquire diverse datasets, as combining pathology phenotyping with omics genotyping becomes the next frontier in evaluating patient journeys.

Market Moderators

Regulation of DP and CP remains fragmented, with expectations for high-risk algorithms still unclear across overlapping frameworks, including the EU AI Act, MDR/IVDR, and FDA SaMD guidance. Implementation also presents a significant hurdle, particularly for community hospitals, due to substantial capital and operational requirements and limited in-house expertise. On the reimbursement front, computational pathology coverage remains largely confined to five PLA codes, with broader payment frameworks or integration into value-based care unlikely in the near term. Further slowing adoption, the absence of standardized performance benchmarks makes it difficult for labs to confidently identify best-in-class AI tools, reinforcing buyer conservatism and creating headwinds for emerging startups.

About DeciBio:

DeciBio Consulting (www.decibio.com) is the leading strategy consulting, market intelligence, and SaaS firm dedicated to accelerating innovation in precision medicine.

Headquartered in Los Angeles, California, DeciBio serves a global base of clients and customers, ranging from startups to Fortune 500 healthcare corporations. DeciBio offers advisory services for growth planning, market and opportunity assessment, product and portfolio strategy, voice-of-customer feedback, technology assessment, and commercial due diligence.

Fonte: Business Wire