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市场调查报告书
商品编码
1776739
2032 年病理学 AI 诊断自动化市场预测:按组件、部署模式、技术、应用、最终用户和地区进行的全球分析AI in Pathology - Diagnostic Automation Market Forecasts to 2032 - Global Analysis by Component (Software, Hardware and Services), Deployment Mode (On-premise, Cloud-based and Hybrid), Technology, Application, End User and Geography |
根据 Stratistics MRC 的数据,全球病理学 AI 诊断自动化市场预计在 2025 年将达到 8,697 亿美元,到 2032 年将达到 3,2,648 亿美元,预测期内的复合年增长率为 20.8%。
病理学中的人工智慧 - 诊断自动化利用人工智慧分析病理影像,从而简化工作流程并支援诊断决策。它可自动执行诸如切片筛检和影像量化等重复性任务,从而提高准确性和效率。将机器学习与数位病理学工具结合,有助于病理学家更快、更准确地检测疾病,最终改善患者预后,并在现代医疗保健中实现更具可扩展性、数据驱动的诊断。
根据《卫报》报道,剑桥大学的一种人工智慧演算法分析了 4,000 多张十二指肠切片检查影像,几乎立即诊断出乳糜泻,而人类病理学家则需要 5-10 分钟才能诊断出来。
扩大数位病理学的应用
医疗保健机构正在增加对全切片成像扫描仪和数位基础设施的投资,以提高诊断准确性和工作流程效率。这种转变将使病理学家能够远端分析组织样本,从而促进跨地域的远距病理咨询和第二意见。此外,数位病理学为人工智慧演算法的部署奠定了重要基础,因为机器学习模型需要数位化病理组织影像进行训练和检验。数位病理学平台与人工智慧的结合将显着缩短诊断审查时间,同时提高病理评估的一致性。
缺乏标准化数据
缺乏标准化的数据通讯协定对人工智慧在诊断病理学中的应用构成了重大挑战。不同实验室的组织准备、染色程序和成像参数各不相同,导致数据不一致,从而影响了人工智慧模型的性能。此外,缺乏统一的病理图像註释标准,阻碍了精确人工智慧演算法所需的强大训练资料集的开发。此外,高品质註释资料集的匮乏也限制了深度学习模型的有效性及其对不同患者群体和疾病类型的适用性。
与多体学资料和精准医疗的整合
人工智慧病理学与多体学数据的融合为个人化医疗提供了前所未有的机会。透过将组织病理学图像分析与基因组学、蛋白质组学和代谢组学资讯相结合,人工智慧系统可以提供全面的疾病表征和治疗方法建议。这种整合能够识别新的生物标记和治疗标靶,这在精准医疗方法日益普及的肿瘤学应用中尤其重要。此外,对个人化医疗的日益重视为能够无缝整合各种数据以支援临床决策流程的人工智慧解决方案创造了巨大的市场机会。
数据偏见和普遍性问题
数据偏差对人工智慧在病理诊断领域的广泛应用构成了重大威胁,因为基于不具代表性的数据集训练的演算法可能会在不同患者群体中产生不可靠的结果。疾病概况在地理、人口和机构方面的差异可能导致人工智慧模型在某些环境中表现良好,但在部署到不同的临床环境中时却会失败。此外,训练资料集缺乏多样性可能会加剧现有的医疗保健差距,并限制人工智慧解决方案的全球适用性。此外,许多人工智慧演算法的「黑箱」特性引发了人们对透明度和可解释性的担忧,使病理学家难以理解和信任人工智慧产生的建议。这种普遍性挑战可能会削弱人们对人工智慧系统的信任,并减缓其在临床实践中的应用。
新冠疫情加速了数位病理学和人工智慧技术的采用,因为医疗保健系统力求在维持诊断服务的同时最大限度地减少身体接触。远距办公的需求促使远距病理学解决方案的引入,使病理学家能够在家中审查病例并与同事进行虚拟协作。此外,疫情凸显了病理学家的严重短缺以及对自动化诊断工具的需求,以有效应对日益增长的工作量。这场危机也刺激了对云端基础的病理学平台和人工智慧诊断系统的投资,以确保即使在封锁和保持社交距离措施期间也能持续提供医疗服务。
预计在预测期内软体部分将成为最大的部分。
人工智慧演算法和分析平台在病理诊断自动化中发挥重要作用,预计软体领域将在预测期内占据最大的市场占有率。软体解决方案包括影像分析演算法、机器学习模型和诊断决策支援系统,这些构成了人工智慧病理工作流程的核心。对自动化影像解读、模式识别和诊断辅助的需求日益增长,推动了软体开发的大量投资。此外,持续的演算法改进和针对各种病理状况的专用应用程式的开发,也巩固了该领域的市场主导地位。
预计在预测期内,云端基础的部分将以最高的复合年增长率成长。
预计在预测期内,云端基础的细分市场将实现最高成长率,这得益于对可扩展、可存取且经济高效的人工智慧病理学解决方案的需求。云端平台使医疗机构无需大量的领先基础设施投资即可存取复杂的人工智慧演算法,即使是规模较小的实验室和资源受限的环境也能使用先进的诊断工具。此外,云端基础的系统促进了病理学家之间的无缝协作,实现了远距会诊,并支援共用训练人工智慧模型所需的大型组织病理学资料集。此外,云端平台支援持续的演算法更新和改进,使用户无需手动安装软体即可享受最新的人工智慧功能。
在预测期内,北美预计将占据最大的市场占有率,这得益于其先进的医疗基础设施、强劲的研发投入以及对人工智慧医疗设备的良好法规环境。该地区受益于强有力的政府倡议,例如ARPA-H等组织的资助计划,这些计划推动了人工智慧在临床诊断中的应用。此外,领先科技公司的出现以及医疗保健提供者与人工智慧开发商之间建立的伙伴关係正在加速市场发展。数位病理系统的高采用率和熟练专业人员的存在进一步巩固了北美市场的地位。
预计亚太地区在预测期内的复合年增长率最高。这得益于医疗保健支出的增加、数位基础设施的扩张以及人们对人工智慧在医疗诊断领域应用的日益关注。中国、日本和印度等国家正在大力投资医疗保健现代化计划,包括人工智慧病理学解决方案,以应对日益加重的疾病负担和病理学家短缺的问题。此外,该地区庞大的患者群体为训练和检验人工智慧模型提供了丰富的数据集,为本地化演算法开发创造了机会。政府对数位健康倡议的支持以及对人工智慧在医疗保健领域应用的优惠政策将推动市场扩张。
According to Stratistics MRC, the Global AI in Pathology - Diagnostic Automation Market is accounted for $869.7 billion in 2025 and is expected to reach $3264.8 billion by 2032 growing at a CAGR of 20.8% during the forecast period. AI in Pathology-Diagnostic Automation uses artificial intelligence to analyze pathology images, streamline workflows, and support diagnostic decisions. It automates repetitive tasks like slide screening and image quantification, improving accuracy and efficiency. By integrating machine learning with digital pathology tools, it helps pathologists detect diseases faster and with greater precision, ultimately enhancing patient outcomes and enabling more scalable, data-driven diagnostics in modern healthcare.
According to The Guardian, a University of Cambridge AI algorithm analysed 4,000+ duodenal biopsy images and diagnosed coeliac disease almost instantly, compared to the 5-10 minutes a human pathologist takes per case.
Increasing adoption of digital pathology
Healthcare institutions are increasingly investing in whole slide imaging scanners and digital infrastructure to enhance diagnostic accuracy and workflow efficiency. This transformation enables pathologists to analyze tissue samples remotely, facilitating telepathology consultations and second opinions across geographical boundaries. Furthermore, digital pathology creates the essential foundation for AI algorithm deployment, as machine learning models require digitized histopathological images for training and validation. The integration of AI with digital pathology platforms significantly reduces diagnostic review time while improving consistency in pathological assessments.
Lack of standardized data
The absence of standardized data protocols poses a significant challenge to AI implementation in pathology diagnostics. Variability in tissue preparation, staining procedures, and imaging parameters across different laboratories creates inconsistencies that can compromise AI model performance. Additionally, the lack of uniform annotation standards for pathological images hinders the development of robust training datasets required for accurate AI algorithms. Moreover, the scarcity of high-quality, annotated datasets limits the effectiveness of deep learning models and their applicability across diverse patient populations and disease types.
Integration with multi-omics data and precision medicine
The convergence of AI pathology with multi-omics data presents unprecedented opportunities for personalized healthcare delivery. By combining histopathological image analysis with genomic, proteomic, and metabolomic information, AI systems can provide comprehensive disease characterization and treatment recommendations. This integration enables the identification of novel biomarkers and therapeutic targets, particularly valuable in oncology applications where precision medicine approaches are increasingly adopted. Furthermore, the growing emphasis on personalized medicine creates substantial market opportunities for AI solutions that can seamlessly integrate diverse data types to support clinical decision-making processes.
Data bias and generalizability issues
Data bias represents a critical threat to the widespread adoption of AI in pathology diagnostics, as algorithms trained on non-representative datasets may produce unreliable results across different patient populations. Geographic, demographic, and institutional variations in disease presentation can lead to AI models that perform well in specific settings but fail when deployed in diverse clinical environments. Additionally, the lack of diversity in training datasets can perpetuate existing healthcare disparities and limit the global applicability of AI solutions. Moreover, the "black box" nature of many AI algorithms raises concerns about transparency and explainability, making it difficult for pathologists to understand and trust AI-generated recommendations. These generalizability challenges can undermine confidence in AI systems and slow their clinical adoption.
The COVID-19 pandemic accelerated the adoption of digital pathology and AI technologies as healthcare systems sought to maintain diagnostic services while minimizing physical contact. Remote work requirements necessitated the implementation of telepathology solutions, enabling pathologists to review cases from home and collaborate virtually with colleagues. Furthermore, the pandemic highlighted the critical shortage of pathologists and the need for automated diagnostic tools to handle increased workloads efficiently. The crisis also drove investments in cloud-based pathology platforms and AI-powered diagnostic systems to ensure continuity of care during lockdowns and social distancing measures.
The software segment is expected to be the largest during the forecast period
The software segment is expected to account for the largest market share during the forecast period due to the fundamental role of AI algorithms and analytical platforms in pathology automation. Software solutions encompass image analysis algorithms, machine learning models, and diagnostic decision support systems that form the core of AI-powered pathology workflows. The increasing demand for automated image interpretation, pattern recognition, and diagnostic assistance drives substantial investment in software development. Additionally, continuous algorithm improvements and the development of specialized applications for various pathological conditions contribute to the segment's dominant market position.
The cloud-based segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the cloud-based segment is predicted to witness the highest growth rate, driven by the need for scalable, accessible, and cost-effective AI pathology solutions. Cloud platforms enable healthcare institutions to access sophisticated AI algorithms without substantial upfront infrastructure investments, making advanced diagnostic tools available to smaller laboratories and resource-constrained settings. Furthermore, cloud-based systems facilitate seamless collaboration between pathologists, enable remote consultations, and support the sharing of large histopathological datasets required for AI model training. Additionally, cloud platforms support continuous algorithm updates and improvements, ensuring that users have access to the latest AI capabilities without manual software installations.
During the forecast period, the North America region is expected to hold the largest market share owing to the region's advanced healthcare infrastructure, substantial research and development investments, and favorable regulatory environment for AI medical devices. The region benefits from strong government initiatives, including funding programs from organizations like ARPA-H that promote AI implementation in clinical diagnostics. Additionally, the presence of leading technology companies and established partnerships between healthcare providers and AI developers accelerate market growth. The high adoption rate of digital pathology systems and the availability of skilled professionals further strengthen North America's market position.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by increasing healthcare expenditure, expanding digital infrastructure, and rising awareness of AI applications in medical diagnostics. Countries like China, Japan, and India are investing heavily in healthcare modernization initiatives that include AI pathology solutions to address growing disease burdens and pathologist shortages. Furthermore, the region's large patient population provides extensive datasets for AI model training and validation, creating opportunities for localized algorithm development. Government support for digital health initiatives and favorable policies for AI adoption in healthcare accelerate market expansion.
Key players in the market
Some of the key players in AI in Pathology - Diagnostic Automation Market include PathAI, Inc., Paige.AI, Inc., Aiforia Technologies Plc, Akoya Biosciences, Inc., Deep Bio, Inc., Ibex Medical Analytics Ltd., Proscia Inc., Indica Labs, Inc., Inspirata, Inc., Mindpeak GmbH, Tribun Health, OptraSCAN, Inc., aetherAI Co., Ltd., DoMore Diagnostics AS, Hologic, Inc., Roche Tissue Diagnostics, Google (Alphabet Inc.) and Microsoft.
In June 2025, PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight(R) Dx*-its digital pathology image management system-for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform's continuous innovation and PathAI's commitment to delivering enhanced capabilities as the product evolves.
In March 2025, Aiforia Technologies, a pioneer in AI-driven diagnostics in pathology, has announced a new partnership with PathPresenter. This collaboration aims to broaden the reach and adoption of Aiforia's AI-powered image analysis solutions by utilizing PathPresenter's comprehensive pathology workflow platform. By combining their distinct expertise in digital pathology, the companies aim to provide pathologists with enhanced diagnostic capabilities and streamlined end-to-end workflow management solutions.
In March 2025, Proscia(R), a software company leading pathology's transition to digital and AI, has secured $50M in funding, bringing its total raised to $130M. This investment follows Proscia's record-breaking growth in 2024. Proscia now counts 16 of the top 20 pharmaceutical companies among its users and is on track for 22,000+ patients to be diagnosed on its Concentriq(R) software platform each day.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.