Artificial Intelligence (AI) Pathology Quality Control Market Report 2025

The artificial intelligence (AI) pathology quality control market size has grown exponentially in recent years. It will grow from $1.46 billion in 2024 to $1.78 billion in 2025 at a compound annual growth rate (CAGR) of 21.6%. The growth during the historic period is driven by rising prevalence of cancer and chronic diseases, increasing demand for diagnostic accuracy, shortage of skilled pathologists, higher healthcare expenditure, and growth of personalized medicine.

The artificial intelligence (AI) pathology quality control market size is expected to see exponential growth in the next few years. It will grow to $3.84 billion in 2029 at a compound annual growth rate (CAGR) of 21.2%. The projected growth in the forecast period is supported by rising demand for automated quality assurance, increasing investment in healthcare AI startups, adoption of cloud-based pathology solutions, expansion of precision medicine initiatives, and greater focus on early disease detection. Key trends in this period include advancements in deep learning algorithms, innovations in QC automation tools, integration of AI with digital pathology platforms, development of cloud-based pathology systems, and progress in multimodal diagnostic analytics.

The growing demand for personalized medicine is expected to drive the expansion of the artificial intelligence (AI) pathology quality control market. Personalized medicine involves tailoring treatment and prevention strategies to an individual's genetic makeup, lifestyle, and environmental factors. The rise in personalized medicine adoption is largely attributed to advancements in genomics, which enable more precise identification of genetic variations and the development of targeted treatments. AI-powered pathology quality control enhances personalized medicine by offering accurate and consistent diagnostic insights, facilitating the creation of individualized treatment plans. It minimizes diagnostic errors by automating quality checks, improving accuracy and reliability, and advancing patient-specific care. For example, the Personalized Medicine Coalition (PMC), a US-based nonprofit, reported that the U.S. Food and Drug Administration (FDA) approved 26 new personalized medicines in 2023, a significant increase from 12 in 2022. This growing demand for personalized medicine is expected to propel the AI pathology quality control market.

Key players in the artificial intelligence (AI) pathology quality control market are focusing on developing advanced solutions, such as AI-powered technologies, to enhance diagnostic precision, streamline laboratory workflows, and ensure the reliability of pathology data. These next-generation AI solutions perform complex tasks with improved speed, accuracy, and efficiency. For instance, in November 2023, PathAI, a US-based biotechnology company, introduced Artifact Detect 1 on its AISight digital pathology platform. This tool automates the detection and quantification of artifacts in whole slide images (WSI), which are non-relevant features that can reduce diagnostic accuracy. ArtifactDetect helps prevent misdiagnoses and unnecessary rescans by automatically screening slides for quality issues, boosting accuracy, laboratory efficiency, and overall throughput. It enables timely corrective actions, such as re-staining or re-scanning, improving digital workflows and conserving resources for pathologists and technicians.

In November 2024, Molbio Diagnostics Pvt. Ltd., an India-based molecular diagnostics company, acquired a majority stake in OptraSCAN Inc. through a $30 million investment. This acquisition enables Molbio to expand its presence in digital and AI-driven pathology, broaden its diagnostic portfolio beyond molecular testing, enhance its global market reach, and accelerate innovation in pathology quality control and precision diagnostics. OptraSCAN Inc., based in the US, provides AI solutions for pathology quality control as part of its digital pathology offerings.

Major players in the artificial intelligence (AI) pathology quality control market are Roche Diagnostics GmbH, Danaher Corporation, Philips Healthcare, Agilent Technologies Inc., Hologic Inc., Clinisys Group Ltd., Sectra AB, PathAI Inc., OptraSCAN Inc., Paige.AI Inc., Proscia Inc., Quibim S.L., 3DHISTECH Ltd., Visiopharm A/S, Indica Labs Inc., Ibex Medical Analytics Ltd., Aiosyn B.V., DeepBio Inc., Nucleai Ltd., and Gestalt Diagnostics LLC.

North America was the largest region in the artificial intelligence (AI) pathology quality control market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI) pathology quality control report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the artificial intelligence (AI) pathology quality control market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Artificial intelligence (AI) pathology quality control involves using AI algorithms and machine learning models to automatically evaluate and ensure the accuracy, consistency, and reliability of pathology data and slide interpretations. Its primary goal is to identify errors, standardize analyses, and enhance diagnostic precision in histopathology and cytopathology workflows, ultimately improving patient outcomes.

The main components of AI pathology quality control include software, hardware, and services. The software consists of AI-driven platforms and applications for automated analysis, quality assessment, and error detection in pathology workflows. These solutions can be deployed on-premises or via cloud-based systems. Applications include cancer diagnostics, infectious disease detection, digital pathology, research, and related areas, serving hospitals, diagnostic laboratories, research institutes, pharmaceutical and biotechnology companies, and other key end users.

The artificial intelligence (AI) pathology quality control market research report is one of a series of new reports that provides artificial intelligence (AI) pathology quality control market statistics, including the artificial intelligence (AI) pathology quality control industry global market size, regional shares, competitors with the artificial intelligence (AI) pathology quality control market share, detailed artificial intelligence (AI) pathology quality control market segments, market trends, and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) pathology quality control industry. This artificial intelligence (AI) pathology quality control market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The artificial intelligence (AI) pathology quality control market consists of revenues earned by entities by providing services such as automated slide review, error detection in pathology reports, consistency checks in histopathology and cytopathology analyses, digital image analysis, workflow optimization, and validation of diagnostic results using AI-powered tools. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) pathology quality control market also includes sales of artificial intelligence (AI)-powered pathology software, digital pathology platforms, image analysis tools, and quality assurance modules. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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