AI in Pathology Market

Market Definition

The market focuses on the development and application of artificial intelligence in analyzing pathology images, automating workflows, and improving diagnostic accuracy. AI-driven solutions assist in detecting abnormalities, quantifying biomarkers, and segmenting tissues in histopathological and cytological examinations. 

These technologies integrate deep learning algorithms with digital pathology platforms to enhance disease identification, prognostic assessments, and treatment planning. AI-powered pathology is widely used in cancer diagnostics, drug discovery, and translational research, streamlining processes for pathologists by reducing workload and minimizing diagnostic variability. 

The market encompasses AI algorithms, software platforms, and imaging solutions designed to optimize pathology workflows and clinical decision-making.

AI in Pathology Market Overview

The global AI in pathology market size was valued at USD 72.4 million in 2023 and is projected to grow from USD 82.2 million in 2024 to USD 223.1 million by 2031, exhibiting a CAGR of 15.33% during the forecast period. 

The market is driven by the increasing adoption of digital pathology and the growing demand for AI-powered diagnostic solutions to enhance accuracy and efficiency. Advancements in ML algorithms are enabling faster analysis of pathology slides, reducing diagnostic errors and improving patient outcomes. 

Additionally, rising investments in AI-driven healthcare technologies are accelerating product innovation and expanding the adoption of AI-powered pathology solutions across laboratories and hospitals.

Major companies operating in the AI in pathology industry are Mindpeak GmbH, Owkin Inc., Aidoc, Deciphex, Veracyte, Inc., Aignostics GmbH, Paige AI, Inc., Ibex Medical Analytics Ltd., Visiopharm A/S, Indica Labs, LLC., Aiforia, Proscia Inc., PathAI, Deep Bio Inc., and HistoIndex Pte. Ltd.

The increasing shift toward digital pathology has accelerated the adoption of AI-powered solutions, transforming traditional diagnostic processes. AI enhances pathology workflows by enabling automated image analysis, reducing turnaround time, and improving diagnostic accuracy. 

Laboratories and healthcare institutions are integrating AI-driven digital pathology platforms to handle large volumes of histopathological data efficiently. The demand for AI-driven diagnostic tools continues to rise as healthcare providers seek solutions that improve operational efficiency. 

Investments in digital pathology infrastructure are expanding, further strengthening the growth of the market by supporting real-time collaboration and remote consultations.

• In March 2024, Ibex Medical Analytics and PathPresenter, a leading global image-sharing platform for pathology, announced a partnership to accelerate the adoption of AI-powered digital pathology. Through this collaboration, the companies will provide an AI-driven digital pathology solution, supporting laboratories, hospitals, and healthcare systems globally.

Key Highlights:

1. The AI in pathology industry size was valued at USD 72.4 million in 2023.
2. The market is projected to grow at a CAGR of 15.33% from 2024 to 2031.
3. North America held a market share of 36.44% in 2023, with a valuation of USD 26.4 million.
4. The convolutional neural networks (CNNs) segment garnered USD 27.0 million in revenue in 2023.
5. The disease diagnosis and prognosis segment is expected to reach USD 88.6 million by 2031.
6. The pharmaceutical and biotechnology companies segment is poised for a robust CAGR of 16.14% through the forecast period.
7. The market in Asia Pacific is anticipated to grow at a CAGR of 16.10% during the forecast period.

Market Driver

"Emergence of Cloud-based AI Pathology Platforms"

Cloud-based AI pathology solutions are enabling remote access to pathology data, facilitating telepathology and second opinions from specialists. AI-driven cloud platforms are improving collaboration among pathologists, enhancing diagnostic accuracy in underserved regions. 

Healthcare providers are adopting cloud-based AI pathology tools to streamline data management and ensure scalability. The ability to access AI-powered pathology solutions through cloud-based platforms is driving adoption across hospitals and laboratories. 

Expanding investments in cloud-based healthcare technologies are supporting the AI in pathology market, improving accessibility to AI-driven diagnostics and enabling real-time pathology insights.

• In May 2024, Aiforia announced that its clinical software solutions for AI-powered pathology image analysis are now accessible on Google Cloud Marketplace. This new sales and marketing channel allows pathology laboratories using Google Cloud to streamline the procurement process for Aiforia’s solutions. The company also plans to expand its offerings on the platform by including its full portfolio, including research solutions.

Market Challenge

"Regulatory and Compliance Barriers Hinder Market Growth"

Stringent regulatory requirements and complex approval processes present a significant challenge to the growth of the AI in pathology market. Variations in regulatory frameworks across regions delay product commercialization and adoption, limiting the widespread integration of AI-powered solutions. 

Thus, companies are actively collaborating with regulatory bodies to streamline approval processes and ensure compliance with evolving standards. Many firms are investing in clinical validation studies and obtaining certifications such as FDA clearance and CE marking to enhance market credibility. 

Additionally, strategic partnerships with healthcare institutions help in generating real-world evidence, facilitating smoother regulatory approvals and market adoption.

Market Trend

"Expansion of AI in Cancer Diagnostics and Personalized Medicine"

The rising prevalence of cancer is driving the demand for AI-powered pathology solutions that support early detection and personalized treatment strategies. AI is enhancing oncology diagnostics by identifying cancerous lesions, grading tumor severity, and predicting disease progression with high accuracy. 

Pathologists and oncologists are leveraging AI-driven pathology tools to improve patient stratification and optimize treatment plans. The growing emphasis on precision medicine is accelerating investments in AI-powered diagnostic solutions. 

Pharmaceutical companies and research institutions are integrating AI in biomarker analysis, further expanding the AI in pathology market and advancing cancer care through data-driven insights.

• In February 2025, Paige announced the expansion of Paige PanCancer Detect, the first AI application designed to identify cancer across various tissue and organ types. Initially introduced in early 2024 to assist pathologists in detecting cancer in over 17 different tissues, its capabilities have now been extended to more than 40 tissue and organ types.

AI in Pathology Market Report Snapshot

Segmentation	Details
By Neural Network	Convolutional Neural Networks (CNNs), Generative Adversarial Networks (GANs), Recurrent Neural Networks (RNNs), Others
By Application	Disease Diagnosis and Prognosis, Drug Discovery, Clinical Workflow, Training and Education
By End User	Hospitals and Reference, Pharmaceutical and Biotechnology Companies, Academic and Research Institutes
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia Pacific
	Middle East & Africa: Turkey, UAE, Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation:

• By Neural Network (Convolutional Neural Networks (CNNs), Generative Adversarial Networks (GANs), Recurrent Neural Networks (RNNs), and Others): The convolutional neural networks (CNNs) segment earned USD 27.0 million in 2023, due to its superior ability to analyze high-resolution pathology images with precision, enabling accurate feature extraction, automated tissue classification, and enhanced diagnostic efficiency in clinical and research applications.
• By Application (Disease Diagnosis and Prognosis, Drug Discovery, Clinical Workflow, and Training and Education): The disease diagnosis and prognosis segment held 37.32% share of the market in 2023, due to the increasing adoption of AI-powered tools for early and precise disease detection, improving diagnostic accuracy, workflow efficiency, and personalized treatment planning in clinical settings.
• By End User (Hospitals and Reference, Pharmaceutical and Biotechnology Companies, and Academic and Research Institutes): The hospitals and reference segment is projected to reach USD 100.0 million by 2031, owing to the high adoption of AI-powered diagnostic solutions for enhanced efficiency, accuracy, and large-scale pathology workflows, driven by the increasing demand for advanced cancer diagnostics and integrated digital pathology systems.

AI in Pathology Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

North America accounted for around 36.44% share of the global AI in pathology market in 2023, with a valuation of USD 26.4 million. North America is registering significant investments in AI-driven healthcare solutions, fueling the adoption of AI in pathology. 

Governments and private organizations are allocating substantial funds to support digital pathology infrastructure and AI-powered diagnostic tools. The presence of well-established healthcare technology companies and research institutions is accelerating advancements in AI-based pathology solutions. 

Increased funding for AI integration in hospitals and laboratories is enhancing diagnostic capabilities and streamlining workflows. These factors are driving the market in North America by strengthening technological adoption and expanding access to AI-driven pathology diagnostics.

• In January 2025, NVIDIA collaborated with Mayo Clinic to accelerate the advancement of next-generation digital pathology by equipping the hospital with its latest AI platforms. Mayo Clinic plans to integrate NVIDIA’s DGX B200 platform, a high-performance computing system with 1.4 terabytes of memory, specifically designed to process large medical image files, including digital pathology slides. Additionally, the hospital will leverage MONAI, NVIDIA’s open-source platform for developing AI-driven medical imaging tools, to enhance pathology research and diagnostics.

Additionally, the growing burden of cancer and chronic diseases in North America is driving the demand for AI-powered pathology solutions that enhance early detection and precision diagnostics. 

Pathologists and healthcare providers are leveraging AI-driven image analysis tools to improve diagnostic accuracy and streamline disease classification. AI-powered pathology solutions are playing a critical role in optimizing cancer detection, biomarker analysis, and treatment planning. 

The increasing need for rapid and reliable diagnostic tools to manage the rising caseload of cancer and chronic illnesses is accelerating the adoption of AI in pathology, fueling the market across the region.

The AI in pathology industry in Asia Pacific is poised for significant growth at a robust CAGR of 16.10% over the forecast period. Governments across Asia Pacific are actively supporting AI adoption in healthcare through funding, policy reforms, and strategic initiatives. 

Countries such as China, Japan, India, and South Korea are implementing AI-driven healthcare programs to enhance diagnostic capabilities and improve patient outcomes. National healthcare strategies promoting AI in pathology are facilitating the deployment of digital pathology solutions in hospitals and research institutions. 

The increasing number of government-backed AI initiatives and investments in healthcare innovation are key factors driving the market in Asia Pacific.

Furthermore, Asia Pacific is attracting significant investments from global and regional AI healthcare companies aiming to expand their presence in the market. Leading AI-driven pathology firms are establishing partnerships with hospitals, research institutions, and healthcare providers to enhance AI adoption. 

Regional startups are also developing innovative AI pathology solutions tailored to local healthcare needs. The increasing flow of investments, coupled with strategic collaborations, is boosting the AI in pathology market in Asia Pacific, fostering rapid advancements in AI-powered diagnostic technologies.

• In July 2024, Indica Labs announced the expansion of its reseller network across Asia Pacific. This strategic move builds on the company’s strong commercial performance in China and Japan, where sales have registered significant growth in recent years. Through new distribution agreements, APAC resellers can now offer HALO AP, a CE-IVDR marked enterprise digital pathology platform, along with HALO Clinical AI Solutions, which integrate seamlessly into HALO AP as Research-Use-Only (RUO) products.

Regulatory Frameworks

• The U.S. Food and Drug Administration (FDA) regulates AI-based medical devices, including those used in pathology. These devices are evaluated through pathways such as Premarket Notification (510(k)), Premarket Approval (PMA), and De Novo classification, depending on their risk level and novelty. The FDA has been actively working on frameworks to address the unique challenges posed by adaptive AI and ML technologies in medical devices.
• The EU's Artificial Intelligence Act (AI Act), which entered into force on August 1, 2024, establishes a comprehensive regulatory framework for AI applications, including those in healthcare and pathology. The Act classifies AI systems based on risk categories—unacceptable, high, and low/minimal risk—and imposes corresponding requirements to ensure safety and compliance. High-risk AI systems, such as certain medical devices, are subject to stringent requirements before they can be marketed.
• China has been proactive in developing AI regulations, focusing on data security and the ethical use of AI in healthcare. The government has implemented policies to oversee AI applications in medicine, including pathology, to ensure that they meet national standards for safety and efficacy. Notably, China announced the creation of over fifty new standards for the AI sector by 2026, reinforcing its regulatory stance on technological innovations.
• Japan's regulatory framework for AI in healthcare emphasizes the integration of AI technologies while ensuring patient safety. The Pharmaceuticals and Medical Devices Agency (PMDA) oversees the approval of AI-based medical devices, including those used in pathology, ensuring that they comply with national standards.

Competitive Landscape

The AI in pathology industry is characterized by several market players that are implementing strategic investments and securing funding to accelerate AI-powered pathology product development, driving the market. 

Companies are actively channeling resources into research and development to enhance AI algorithms, improve diagnostic accuracy, and streamline pathology workflows.

Several firms have secured funding from venture capitalists, government grants, and strategic partnerships to scale their AI-driven solutions. These investments are facilitating technological advancements, regulatory approvals, and commercial deployments in hospitals and laboratories. 

By strengthening AI-powered pathology solutions, market players are enhancing efficiency, reducing diagnostic errors, and expanding their global footprint, ultimately contributing to the sustained growth of the market.

• In September 2024, Mindpeak secured USD 15.3 million in Series A funding to advance the development of its AI-powered histopathological assessment solutions. This investment will enhance its product roadmap, enabling clinical laboratories and biopharma companies globally to leverage AI-driven pathology for improved diagnostic capabilities.

List of Key Companies in AI in Pathology Market:

• Mindpeak GmbH
• Owkin Inc.
• Aidoc
• Deciphex
• Veracyte, Inc.
• Aignostics GmbH
• Paige AI, Inc.
• Ibex Medical Analytics Ltd.
• Visiopharm A/S
• Indica Labs, LLC.
• Aiforia
• Proscia Inc.
• PathAI
• Deep Bio Inc.
• HistoIndex Pte. Ltd.

Recent Developments (Collaboration/Partnerships/Product Launch)

• In September 2024, Mindpeak announced a collaboration with Roche to integrate its advanced AI algorithms into Roche’s Digital Pathology Open Environment. This partnership aims to enhance clinical decision-making, support personalized medicine, and improve patient care through AI-powered pathology solutions.
• In January 2025, Deciphex introduced Diagnexia Analytix, an advanced pathology service that combines AI-powered workflows, analytics, and expert-led diagnostics to enhance study outcomes. Tailored for the drug development industry, Diagnexia Analytix provides critical pathology insights, enabling faster and more precise decision-making throughout translational research and drug development.
• In May 2024, Indica Labs launched a groundbreaking new version of its industry-leading life sciences software. The 4.0 release of HALO, HALO AI, and HALO Link enhances usability and performance, providing researchers and pathologists with expanded capabilities to integrate advanced AI-powered image analysis within an open digital pathology ecosystem.
• In October 2023, Roche partnered with Ibex Medical Analytics and Amazon Web Services to enhance the access of pathology laboratories to AI-powered decision support tools. Through the navify Digital Pathology software platform, this collaboration aims to assist clinicians in diagnosing breast and prostate cancer with greater accuracy and efficiency.
• In June 2023, Mindpeak collaborated with Proscia to expand access to enhanced cancer diagnostics. This partnership establishes a foundation for seamlessly integrated AI-powered workflows, empowering pathologists to deliver more efficient, well-informed, and consistent clinical decisions.