Lunit Inc.

The global AI in pathology market is projected to grow from USD 145.39 million in 2025 to USD 633.69 million by 2031, at a compound annual growth rate of 28.16 percent from 2026 to 2031. Software led the market with a 50.33 percent share in 2025, while services are expected to grow at a 29.20 percent CAGR through 2031. North America held a 50.13 percent market share in 2025, and Asia-Pacific is forecast to achieve the highest CAGR of 31.24 percent through 2031. Key regulatory milestones include PathAI's AISight Dx becoming the first FDA-cleared system with a Predetermined Change Control Plan in June 2025, and Roche's VENTANA TROP2 RxDx Device receiving FDA Breakthrough Device Designation. The report covers companies such as Aiforia Technologies, Ibex Medical Analytics, Lunit, Paige, and Philips Digital & Computational Pathology.