Artificial Intelligence in Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Artificial Intelligence in Diagnostics Market Report Segments the Industry Into by Type (In Vitro Diagnostics, Diagnostic Imaging, Other Types), by Application (Cardiology, Oncology, Neurology, Obstetrics/ Gynecology, Other Applications), by End-User (Hospitals, Diagnostic Imaging Centers, Diagnostic Laboratories, Other End-Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America).

Global Artificial Intelligence In Diagnostics Market Size and Share

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Global Artificial Intelligence In Diagnostics Market Analysis by Mordor Intelligence

The AI in diagnostic imaging market is valued at USD 1.77 billion in 2025 and is projected to reach USD 7.41 billion by 2030, advancing at a robust 33.14% CAGR. Expansion rests on three intertwined factors: maturing regulation, the arrival of dedicated reimbursement codes, and accelerating algorithmic performance gains. In January 2025 the FDA issued comprehensive draft guidance for AI-enabled medical devices, clarifying clinical study design and post-market monitoring expectations. At nearly the same time, the Centers for Medicare & Medicaid Services (CMS) finalized the first permanent payment codes for stand-alone AI algorithms used in radiology, transforming once-pilot deployments into billable clinical services. Venture funding floods the field; a sample of 2024–2025 deals shows Imagen Technologies, AZmed and ThinkSono raising a combined USD 50 million for expansion and regulatory submissions. Meanwhile, technology leaders such as GE HealthCare and Siemens Healthineers are embedding NVIDIA’s MONAI Deploy toolkit in their scanners, shortening the path between model development and bedside deployment. Hospitals adopt these tools to counter rising imaging volumes and radiologist shortages, while diagnostic laboratories deploy AI to scale high-throughput screening and remote interpretation.

Key Report Takeaways

  • By diagnostic modality, imaging accounted for 58.12% of the AI in diagnostic imaging market share in 2024; in vitro diagnostics is forecast to expand at a 33.75% CAGR through 2030. 
  • By application, neurology led with a 25.85% revenue share in 2024, while oncology is tracking a 34.16% CAGR to 2030. 
  • By end-user, hospitals held 58.45% of the AI in diagnostic imaging market share in 2024; diagnostic laboratories post the fastest 33.78% CAGR through 2030.

Segment Analysis

By Diagnostic Modality: Imaging Dominates Despite IVD Acceleration

Diagnostic imaging captured 58.12% of the AI in diagnostic imaging market share in 2024, leveraging decades of archived DICOM files that enable supervised deep-learning at scale. Foundation models, pre-trained on millions of X-ray, CT and MRI slices, now deliver organ-agnostic workflows that read multiple pathologies in one pass. Vendors such as GE HealthCare pair these algorithms with edge processors embedded directly in detectors, cutting latency and reducing data-center fees. The AI in diagnostic imaging market size for imaging is projected to expand steadily as autonomous acquisition protocols reduce retakes and standardize quality, making AI indispensable in resource-tight departments.

In vitro diagnostics (IVD) is the fastest-growing modality, set to scale at a 33.75% CAGR through 2030. Pattern-recognition networks classify genomic variants, metabolomic spectra and microbial signatures with higher specificity than rule-based analyzers. The AI in diagnostic imaging market size for IVD will benefit from turnkey cloud APIs that deliver assay interpretation to small labs without dedicated data scientists. Digital pathology sits at the intersection of imaging and IVD; slide scanners feed whole-slide images into convolutional nets that mark tumor margins and grade inflammation, allowing pathologists to focus on complex differential diagnoses.

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Note: Segment shares of all individual segments available upon report purchase

By Application: Oncology Disrupts Neurology’s Leadership

Neurology held 25.85% of AI in diagnostic imaging market share in 2024, underpinned by stroke, epilepsy and dementia workloads that demand rapid intervention. Real-time CT perfusion mapping shortens door-to-thrombolysis times, while 3D volumetry quantifies multiple sclerosis lesion load with sub-millimeter precision. Yet oncology is advancing at a 34.16% CAGR to 2030, propelled by tools such as Clairity BREAST, the first device authorized to predict five-year breast-cancer risk from a single mammogram. Multimodal fusion of radiology, pathology and genomic data further elevates accuracy, shifting oncology from image-centric detection to holistic prognostication.

Cardiology continues steady adoption as HeartFlow’s AI-derived plaque analysis gains Medicare coverage, validating reimbursement-driven uptake. Infectious-disease algorithms classify pathogen species directly from chest X-rays or broad-spectrum sequencing, a priority in antimicrobial-resistance stewardship. Meanwhile, obstetric AI tracks fetal growth curves in motion-compensated 3D ultrasound, expanding prenatal care access in low-resource regions.

By End-User: Laboratories Challenge Hospital Dominance

Hospitals commanded 58.45% of the AI in diagnostic imaging market share in 2024 thanks to large scanner fleets, enterprise PACS and in-house IT teams capable of supporting GPU clusters. Integrated AI raises scanner utilization, creating headroom without capital expansion. The AI in diagnostic imaging market size attributable to hospitals will keep growing as reimbursement stabilizes and bundled-payment models reward diagnostic accuracy.

Diagnostic laboratories post the fastest 33.78% CAGR by leveraging AI to automate high-volume studies ranging from full-body CT screenings to multiplex PCR interpretation. The AI in diagnostic imaging market size for laboratories is lifted by remote-read services that route images through secure clouds to subspecialists thousands of miles away. Partnerships such as Integral Diagnostics’ expansion of Aidoc workflows across Australia and New Zealand show how independent chains level the playing field against tertiary hospitals. Ambulatory centers and tele-imaging platforms round out the user base, exploiting software-as-a-service models that eliminate on-site GPU ownership.

Market Share
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Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America remains the epicenter, accounting for 54.12% of global revenue in 2024. Early FDA clearances—129 radiology AI devices since 2015—established a precedent that de-risked pilot budgets, while new CMS codes ensure monetization for stroke detection, cardiac CTA analysis and breast-cancer triage. Strategic collaborations are a hallmark: GE HealthCare and NVIDIA co-develop autonomous imaging suites to offset staff shortages, and Siemens Healthineers inks decade-long “value partnerships” bundling scanners, AI software and managed service agreements.

Europe follows closely. The EU AI Act mandates risk-based classification, model transparency and bias testing but also provides common technical documentation templates, accelerating cross-border market entry. Vendors like ThinkSono obtained CE marking for point-of-care ultrasound AI that guides novice operators through DVT scans, broadening the sonographer pool. National health systems in Germany, France and the Nordics run reimbursement pilots that tie AI performance to outcome-based bonuses.

Asia-Pacific is the fastest-growing territory. Government-backed electronic medical-record rollouts in India, Japan and South Korea generate structured image archives ideal for machine-learning. The National Health Authority of India and IIT Kanpur launched open-access datasets under IndiaAI to spur domestic algorithm development. Regional leaders like Qure.ai deployed tuberculosis triage across more than 90 districts, reporting 15 million cumulative patient scans. In China, hospital groups bundle AI lung-nodule detection with annual physicals, illustrating consumer-direct monetization outside insurance frameworks. 

Artificial Intelligence In Diagnostics Market
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Competitive Landscape

Moderate fragmentation defines the AI in diagnostic imaging market. Incumbent equipment makers—GE HealthCare, Siemens Healthineers and Philips—integrate proprietary algorithms at the firmware layer, selling scanners as analytics platforms rather than hardware appliances. GE HealthCare has more than 40 FDA-cleared AI applications embedded in its Revolution CT line, while Siemens Healthineers holds over 450 active imaging-AI patents. Pure-play vendors such as Aidoc, Viz.ai and RapidAI compete on triage speed and breadth of FDA-cleared indications; Aidoc alone covers 13 acute findings across the neuro and chest domains.

Strategic alliances blur boundaries. GE HealthCare’s 2025 tie-up with NVIDIA grants access to accelerated inference libraries and MONAI DevKit, halving development cycles for autonomous X-ray positioning. Cleerly and HeartFlow specialize in cardiovascular imaging, while Nanox pairs low-dose digital X-ray hardware with cloud AI that screens for bone fragility at population scale. Standards bodies such as IHE release workflow profiles that govern how AI results populate radiology reports, enhancing vendor interoperability and customer lock-in.

M&A pressures rise as start-ups confront elongating sales cycles and higher validation costs. RadNet’s USD 103 million purchase of iCAD in April 2025 bolsters its breast-imaging AI stack and demonstrates provider appetite for captive algorithm teams. Health-system venture funds increasingly trade minority stakes for exclusive deployment rights, signaling a pivot from vendor-centric to buyer-centric bargaining power. Overall, competitive intensity centers on pipeline breadth, regulatory agility and proof of economic value delivered.

Global Artificial Intelligence In Diagnostics Industry Leaders

  1. Nanox Imaging LTD (Zebra Medical Vision, Inc.)

  2. Riverain Technologies

  3. Aidoc

  4. Siemens Healthineers

  5. Vuno, Inc.

  6. *Disclaimer: Major Players sorted in no particular order
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Recent Industry Developments

  • June 2025: FDA authorized Clairity BREAST as the first AI platform to predict five-year breast-cancer risk from standard mammograms alone.
  • April 2025: RadNet announced acquisition of iCAD for USD 103 million to expand DeepHealth’s breast-imaging AI capabilities.
  • March 2025: GE HealthCare and NVIDIA unveiled collaboration to build autonomous X-ray and ultrasound systems using the Isaac for Healthcare platform.

Table of Contents for Global Artificial Intelligence In Diagnostics Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing demand for AI tools in medical imaging & workload reduction
    • 4.2.2 Government incentives accelerating AI adoption
    • 4.2.3 Surge in venture & strategic funding for AI-diagnostics start-ups
    • 4.2.4 FDA fast-track 510(k) clearances for AI diagnostic devices (post-2024)
    • 4.2.5 Foundation-model integration enabling multimodal diagnostics
    • 4.2.6 Emergence of CMS reimbursement codes for AI algorithms
  • 4.3 Market Restraints
    • 4.3.1 Reluctance among medical practitioners to adopt AI
    • 4.3.2 High procurement & lifecycle-maintenance costs
    • 4.3.3 Algorithmic bias triggering regulatory scrutiny
    • 4.3.4 Fragmented data-interoperability standards
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces Analysis
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Diagnostic Modality
    • 5.1.1 In Vitro Diagnostics
    • 5.1.1.1 Molecular Diagnostics
    • 5.1.1.2 Immunoassays & Clinical Chemistry
    • 5.1.1.3 Point-of-Care Tests
    • 5.1.2 Diagnostic Imaging
    • 5.1.2.1 MRI
    • 5.1.2.2 CT
    • 5.1.2.3 X-ray
    • 5.1.2.4 Ultrasound
    • 5.1.2.5 PET/SPECT & Others
    • 5.1.3 Digital Pathology
    • 5.1.4 Other Modalities
  • 5.2 By Application
    • 5.2.1 Oncology
    • 5.2.2 Cardiology
    • 5.2.3 Neurology
    • 5.2.4 Infectious Disease
    • 5.2.5 Obstetrics & Gynecology
    • 5.2.6 Respiratory & Pulmonology
    • 5.2.7 Other Applications
  • 5.3 By End-User
    • 5.3.1 Hospitals
    • 5.3.2 Diagnostic Laboratories
    • 5.3.3 Ambulatory Surgical Centers
    • 5.3.4 Other End-Users
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Siemens Healthineers
    • 6.3.2 GE HealthCare
    • 6.3.3 Philips Healthcare
    • 6.3.4 Aidoc
    • 6.3.5 Nanox (Imaging/Zebra Medical)
    • 6.3.6 Riverain Technologies
    • 6.3.7 VUNO Inc.
    • 6.3.8 Digital Diagnostics
    • 6.3.9 AliveCor
    • 6.3.10 Enlitic
    • 6.3.11 InformAI
    • 6.3.12 IBM Watson Health
    • 6.3.13 Lunit
    • 6.3.14 Arterys
    • 6.3.15 Qure.ai
    • 6.3.16 Paige AI
    • 6.3.17 Viz.ai
    • 6.3.18 HeartFlow
    • 6.3.19 RapidAI
    • 6.3.20 Tempus
    • 6.3.21 DeepMind Health
    • 6.3.22 Oxipit

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Artificial Intelligence In Diagnostics Market Report Scope

Artificial intelligence (AI) in medicine uses algorithms and software to approximate human cognition in analyzing complex medical data. Specifically, AI in diagnostics assists healthcare providers in making appropriate treatment decisions for their patients. Artificial Intelligence in Diagnostics Market is segmented By Type (In Vitro Diagnostics, Diagnostic Imaging, and Other Types), Application (Cardiology, Oncology, Neurology, Obstetrics/ Gynecology, and Other Applications), End-User (Hospitals, Diagnostic Imaging Centers, Diagnostic Laboratories, and Other End-Users), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the market size and forecasts in value (USD million) for the above segments.

By Diagnostic Modality In Vitro Diagnostics Molecular Diagnostics
Immunoassays & Clinical Chemistry
Point-of-Care Tests
Diagnostic Imaging MRI
CT
X-ray
Ultrasound
PET/SPECT & Others
Digital Pathology
Other Modalities
By Application Oncology
Cardiology
Neurology
Infectious Disease
Obstetrics & Gynecology
Respiratory & Pulmonology
Other Applications
By End-User Hospitals
Diagnostic Laboratories
Ambulatory Surgical Centers
Other End-Users
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
By Diagnostic Modality
In Vitro Diagnostics Molecular Diagnostics
Immunoassays & Clinical Chemistry
Point-of-Care Tests
Diagnostic Imaging MRI
CT
X-ray
Ultrasound
PET/SPECT & Others
Digital Pathology
Other Modalities
By Application
Oncology
Cardiology
Neurology
Infectious Disease
Obstetrics & Gynecology
Respiratory & Pulmonology
Other Applications
By End-User
Hospitals
Diagnostic Laboratories
Ambulatory Surgical Centers
Other End-Users
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

How big is the Global Artificial Intelligence in Diagnostics Market?

The Global Artificial Intelligence in Diagnostics Market size is expected to reach USD 1.77 billion in 2025 and grow at a CAGR of 33.14% to reach USD 7.41 billion by 2030.

What is the current Global Artificial Intelligence in Diagnostics Market size?

Imaging modalities hold 58.12% share, supported by vast DICOM-based datasets and embedded GPU workflows.

Who are the key players in Global Artificial Intelligence in Diagnostics Market?

Nanox Imaging LTD (Zebra Medical Vision, Inc.), Riverain Technologies, Aidoc, Siemens Healthineers and Vuno, Inc. are the major companies operating in the Global Artificial Intelligence in Diagnostics Market.

Which is the fastest growing region in Global Artificial Intelligence in Diagnostics Market?

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Why is North America ahead in adoption?

Streamlined FDA clearances, CMS reimbursement codes and strong venture funding give North America 54.12% revenue share.

Global Artificial Intelligence In Diagnostics Market Report Snapshots