AI in Pathology Market to Surpass $633.69 Million by 2031: A Comprehensive Segment and Geographic Analysis
Dublin, June 30, 2026 (GLOBE NEWSWIRE) -- The "AI In Pathology - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
The Artificial Intelligence (AI) in Pathology market is projected to grow significantly, from USD 145.39 million in 2025 to USD 633.69 million by 2031, driven by a CAGR of 28.16% from 2026 to 2031. This growth is segmented by component types, including software, services, and hardware, as well as by function, use case, end-user, and geographical distribution.
Global AI In Pathology Market Trends and Insights
Clinical Approvals Enabling Adoption (FDA/CE-IVDR Progress) Regulatory advancements between 2025 and 2026 have lowered adoption risks, allowing clinical-grade platforms and computational diagnostics to thrive. In June 2025, PathAI's AISight Dx became the first FDA-cleared system with a Predetermined Change Control Plan, setting a precedent for iterative software improvements within regulated practice. Additionally, the FDA's Breakthrough Device Designation for Roche's VENTANA TROP2 RxDx Device underscores AI's role in therapy selection for non-small cell lung cancer, thus reducing regulatory risk and enabling broader adoption.
Meanwhile, EU IVDR certifications are expanding across digital pathology, signalling mature oversight aligning with innovation cycles. These advancements collectively accelerate enterprise procurement and expand AI integration in pathology.
Oncology Biomarker Surge and Need for Standardized IHC Quantification The need to standardize immunohistochemistry scoring is intensifying as therapy access increasingly relies on precise biomarker thresholds. Efforts to reduce variability across AI methods for HER2 scoring, along with tools like Lunit's PD-L1 scoring suite, aim to enhance accuracy in immuno-oncology workflows. Updates to the American Medical Association's Appendix S taxonomy clarify AI-enabled service categorizations, supporting a move toward standardized, quantitative scoring that improves clinical confidence and accelerates trials and treatment selection in AI pathology.
Unclear Reimbursement and ROI Pathways for AI Pathology Coverage and coding policies significantly impact AI investment justification in hospitals. CMS's payment rules create ambiguity around whether algorithmic pathology services are distinct or bundled, slowing reimbursement processes. Although the AMA's taxonomy aids in classifying AI-enabled services, reimbursement speed remains behind, with providers needing to focus more on productivity and quality improvements. Larger systems and labs, which can afford to treat AI as infrastructure, are currently leading adoption as clear payment pathways develop.
Other drivers and restraints include:
Segment Analysis In 2025, software led the market with a 50.33% share, combining image management and AI modules for clinical tasks. Service growth is predicted at a 29.20% CAGR through 2031, aligning with the requirement for continuous model validation and regulatory compliance. Hardware choices support cloud-enabled workflows, and multi-year collaborative projects enhance deployment success rates.
The reliance on image analysis and pattern recognition for tasks like segmentation and detection accounted for 48.38% market share in 2025. Diagnostic decision support is expected to grow steadily, highlighted by breakthroughs like the VENTANA TROP2 RxDx Device. Validated QC workflows and multi-algorithm orchestration are critical in this transition toward decision support, enhancing clinical reporting across health systems.
Geography Analysis North America leads the market with 50.13% share in 2025, thanks to regulatory clearances and enterprise platform deployments that stabilize AI in healthcare. Europe benefits from IVDR regulations that encourage sustainable clinical use, while Asia-Pacific is poised for the highest CAGR at 31.24% through 2031, driven by demand in high-volume centers and cloud-enabled platforms facilitating market entry.
List of Companies Covered in this Report:
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