AI-Driven Retinal Screening Device Market - By Technology, By Application, By End Use - Global Forecast, 2025 - 2034

AI-Driven Retinal Screening Device Market Size

The global AI-driven retinal screening device market was estimated at USD 1.9 billion in 2024. The market is expected to grow from USD 2.2 billion in 2025 to USD 6.1 billion in 2034, at a CAGR of 12.3% during the forecast period, according to the latest report published by Global Market Insights Inc. The market is driven by increasing prevalence of diabetes, technological advancements, rising awareness and screening programs, and surging focus on integration of AI-based tools, among other factors.

A growing geriatric population, public health campaigns and funding, and telemedicine integration are among the key factors propelling the industry demand. AEYE Health, DIGITAL DIAGNOSTICS, RetinaLyze, EYENUK, and EyRIS are among the leading players operating in the market. These players mainly focus on product innovation, ease of integration, scalability, and affordability to improve their industry positioning.
 

The market reached USD 1.6 billion in 2023 from USD 1.1 billion in 2021. The global rise in diabetes has led to a surge in diabetic retinopathy cases, a leading cause of preventable blindness. For instance, according to the data reported by the World Health Organization (WHO), the number of patients suffering from diabetes witnessed a significant surge from around 200 million in 1990 to around 830 million people in 2022 globally. AI-driven retinal screening devices offer a scalable solution for early detection, especially in primary care and community health settings. These tools help identify retinal damage before symptoms appear, reducing the burden on ophthalmologists and improving patient outcomes. As diabetes becomes more widespread, especially in low- and middle-income countries, the demand for accessible, automated screening solutions continues to grow.
 

Further, advances in deep learning, image processing, and portable imaging devices have significantly improved the accuracy and usability of AI-driven retinal screening systems. These technologies now offer real-time analysis, multi-disease detection, and integration with electronic health records. Innovations such as handheld fundus cameras and cloud-based AI platforms are making screening more accessible and cost-effective. In addition, as AI models become more advanced with next-generation technologies, they are capable of detecting subtle retinal changes, enabling earlier intervention and personalized treatment strategies.
 

Furthermore, governments, NGOs, and healthcare providers are launching awareness campaigns and screening initiatives to combat preventable blindness. AI-driven devices are central to these efforts, offering rapid, reliable diagnostics in both urban and rural settings. Mobile screening units equipped with AI tools are reaching underserved populations, while public health programs are integrating AI into routine checkups.
 

An AI-driven retinal screening device is a medical diagnostic tool that uses artificial intelligence algorithms to analyze retinal images for signs of eye diseases. It enables fast, accurate, and often autonomous detection of conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration, improving access to early eye care.
 

AI-Driven Retinal Screening Device Market Trends

Integration with telemedicine and mobile health, favorable regulatory support, advancements in imaging and AI algorithms, and a rise in chronic and vision disorders are among the key trends shaping the market growth.
 

• Retinal screenings powered by artificial intelligence (AI) are becoming increasingly embedded in telehealth frameworks and mobile clinics, facilitating remote diagnosis and monitoring in rural and underserved communities. The advantages of portable devices and cloud-based AI analytics allow retinal screening outside traditional clinical settings and expand the reach of the market.
   
• Advancements in imaging technology, such as high-resolution fundus cameras and optical coherence tomography (OCT), and the availability of sophisticated deep learning architecture have improved accuracy. Increasingly, multi-modal AI systems that combine and assess multiple forms of data are becoming more prevalent and offer better insights about retinal health and systemic issues.
   
• Further, retinal screening devices that rely on AI offer a potentially scalable solution to supervised early detection, especially among populations that have limited access to eye care professionals. Such developments continue to promote healthcare systems to adopt fully automated screening devices for preventive medical applications.
   
• Moreover, governments and health systems are supporting promoting AI systems in diagnostics with the goal of reducing preventable blindness. With regulatory approval for the rollout of autonomous AI devices, implementation in clinical settings is expected to improve, resulting in widespread adoption across different facilities.
   

AI-Driven Retinal Screening Device Market Analysis

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In 2021, the market was valued at USD 1.1 billion and grew to USD 1.3 billion in 2022, reaching USD 1.6 billion by 2023. Growing geriatric population, technological advancements in AI and supportive funding to combat preventable blindness are among the key variables contributing to industry growth.
 

Based on technology, the global AI-driven retinal screening device market is segmented into fundus image-based AI, OCT-based AI, and multi-modal AI. The fundus image-based AI segment accounted for a leading share of 56.7% in 2024. Growing focus on early detection of different ophthalmic disorders is anticipated to fuel the industry growth. The segment is expected to exceed USD 3.5 billion by 2034, growing at a CAGR of 12.7% during the forecast period.
 

• Fundus image-based AI systems require the input of 2D images of the retina or back of the eye that were obtained using fundus cameras. These images exhibit specific surface-level characteristics such as microaneurysms, hemorrhages, and abnormalities of the optic disc. Such AI models have been developed and trained to diagnose diabetic retinopathy, glaucoma, and hypertensive retinopathy.
   
• Fundus imaging and image-based applications have widespread implementation due to their cost-effectiveness and portability, helping them to be used in primary care and rural settings. It allows for rapid screening and may be used for large-scale health programs.
   
• The OCT-based AI segment was valued at USD 559.8 million in 2024. Optical Coherence Tomography (OCT)-based image analysis uses cross-sectional imaging, which shows deeper layers of the retina. OCT provides a 3D-like or high-resolution type scan that is beneficial in diagnosing causes of macular degeneration (e.g., diabetic macular edema) and glaucoma.
   
• Furthermore, the algorithms have been successively trained on OCT images, which also show very subtle structural changes that may not be possible to examine through fundus imaging. While the imaging of the OCT technique is more expensive and used in specialized clinics, it is expected to improve diagnostic accuracy and relevant workflow using eye care practitioners trained in multi-modal imaging systems.
   
• Further, the multi-modal AI segment is anticipated to record robust growth with a CAGR of 11.5% through the analysis timeframe. Multi-modal AI integrates data from multiple imaging modalities, such as fundus photography, OCT, and clinical patient records, to provide a complete diagnostic assessment.
   
• It improves accuracy by associating surface-level and structural retinal characteristics with systemic health indicators. Multi-modal systems are particularly useful in identifying complex and co-existing diseases, such as diabetic macular edema and cardiovascular disease.
   

Based on application, the global AI-driven retinal screening device market is segmented into diabetic retinopathy, age-related macular degeneration, glaucoma, cataract, and other applications. The diabetic retinopathy segment accounted for a leading share and was valued at USD 987.8 million in 2024.
 

• Diabetic retinopathy is the leading cause of vision loss among diabetic patients. AI-driven screening devices are highly effective in detecting early signs such as microaneurysms, hemorrhages, and exudates from fundus images. These tools enable rapid, non-invasive diagnosis, often without the need for an ophthalmologist.
   
• Additionally, their use in primary care settings and diabetes clinics has significantly improved screening coverage, especially in underserved regions. Diabetic retinopathy remains the most dominant application due to its high prevalence and preventability.
   
• The age-related macular degeneration segment was valued at USD 435.8 million in 2024. AMD affects the central part of the retina and is a major cause of blindness in older adults. AI systems trained on OCT and fundus images can detect early structural changes in the macula, helping differentiate between dry and wet forms of AMD.
   
• These tools support timely intervention, which is critical for preserving vision. Further, as aging populations grow globally, AI-based AMD screening is gaining importance in geriatric care and routine eye exams.
   
• The glaucoma segment was valued at USD 287.8 million in 2024. Glaucoma is a progressive optic nerve disease often linked to increased intraocular pressure. AI models analyze optic disc cupping and nerve fiber layer thickness using fundus and OCT images to detect early signs.
   
• Since glaucoma progresses silently, AI tools are valuable for routine screening and monitoring. Their integration into ophthalmology clinics and mobile units helps identify at-risk individuals before irreversible damage occurs, making glaucoma a key growth area for AI diagnostics.

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Based on end use, the AI-driven retinal screening device market is segmented into hospitals, ophthalmology clinics, mobile clinics/rural camps, and other end users. The hospitals segment accounted for the leading market share of 47.6% in 2024 as it records high patient footfall and are capable of investing in advanced resources.
 

• Hospitals are the largest adopters of AI-driven retinal screening devices due to their broad patient base and advanced diagnostic infrastructure. Tighter work environments may also integrate AI applications into EHRs, making them user-friendly and expediting their diagnostic decision-making in the workflow. Both fundus and OCT-based AI are frequently used in hospitals and especially for screening in departments where there are higher risk factors, such as in diabetes, neurology, and geriatrics.
   
• Additionally, hospitals have the ability to invest in higher-cost devices and personnel training, as compared to clinics and other settings, and are key adopters for multi-modal AI utilization.
   
• The ophthalmology clinics segment was valued at USD 617.2 million in 2024. Ophthalmology clinics, on the other hand, have rapidly been adopting AI technologies in order to help improve diagnostic accuracy while minimizing patient wait time. Most clinics are focused on the specific area of eye care and therefore expected to be more adaptable and progressive with AI/technologies in OCT-based and fundus image-based AI systems.
   
• Further, AI tools assist with early detection and treatment support for conditions such as glaucoma, AMD, and diabetic retinopathy, as well as monitoring patients and their conditions over time to streamline the process. AI can automate routine screenings and allow ophthalmologists to focus on more complicated cases.

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North America AI-Driven Retinal Screening Device Market
 

North America market accounted for majority share of 47.3% in 2024 in the global market and is anticipated to show notable growth over the forecast period.
 

• The market for AI-driven screening devices for retinal health is driven by innovation and a growing focus on faster disease diagnosis through advanced tools in the region. The region benefits from a well-established healthcare infrastructure, high awareness of preventive eye care, and a strong presence of AI startups and medical device companies.
   
• Diabetes and age-related eye diseases (such as age-related macular degeneration and glaucoma) are prevalent, leading to the uptake of AI tools for early diagnosis. For instance, according to recently published information, over 11 million people in the U.S. are suffering from some form of AMD, and the number is expected to double (22 million) by 2050.
   
• In addition, integrating AI-based screening exams and digital tools with electronic health records and telehealth systems allows for seamless workflows and remote evaluation with diagnosis at the point of care. AI-based screening exams are being used autonomously and opportunistically in pharmacy and community health clinic settings, helping improve access from detection to treatment of eye diseases in at-risk and underserved populations.
   
• Further, government support for digital health initiatives and reimbursement policies are enabling the improved implementation of such tools and systems.
   
• The North American market is anticipated to continue to serve as a key contributor in clinical validation, pilot programs, and commercial opportunities with emerging upgrades of AI technology, specifically in the field of ophthalmology.
   

The U.S. AI-driven retinal screening device market was valued at USD 478.3 million and USD 596.5 million in 2021 and 2022, respectively. In 2024 the market size was valued at USD 851.4 million from USD 729.6 million in 2023. The increasing trend of adopting advanced devices and tools with AI integration for faster disease diagnosis in the country is projected to fuel the market growth.
 

• The U.S. is the largest and most advanced market for AI-driven retinal screening devices. For example, with over 38 million people living with diabetes, the demand for diabetic retinopathy screening is witnessing a notable growth. AI tools are widely deployed in hospitals, primary care clinics, and retail health settings, offering fast, accurate, and cost-effective diagnostics.
   
• Additionally, the U.S. has provided regulatory approvals for autonomous AI systems, such as those capable of diagnosing diabetic retinopathy without clinician oversight. Integration with telehealth platforms and EHRs is common, enabling scalable screening programs.
   
• Reimbursement codes for AI-based diagnostics have encouraged adoption across healthcare networks. Academic institutions and startups collaborate to develop and validate new AI models, while mobile and handheld devices are expanding access in rural and underserved areas.
   
• Moreover, the U.S. also plays a key role in shaping global standards for AI in healthcare, making it a leader in both innovation and implementation.
   

Europe AI-Driven Retinal Screening Device Market
 

Europe accounted for a significant share of the market and was valued at USD 553 million in 2024.
 

• Europe is a steadily growing market for AI-driven retinal screening devices, driven by its aging population and increasing prevalence of chronic eye conditions such as diabetic retinopathy and age-related macular degeneration. Countries across the region are integrating AI tools into national health systems to improve early diagnosis and reduce specialist workload.
   
• In addition, the adoption of CE-certified AI systems is accelerating, particularly in the UK, France, and the Nordic countries. Telemedicine and mobile health initiatives are helping extend screening services to rural areas.
   
• Further, public health campaigns and EU-level digital health strategies are fostering innovation and cross-border collaboration. The region also hosts several AI startups and academic research centers focused on ophthalmic diagnostics, making it a key region for both deployment and development of AI-based retinal screening technologies.
   

Germany held significant share of the European AI-driven retinal screening device market, showcasing strong growth potential.
 

• Germany is emerging as a leader in Europe’s AI-driven retinal screening landscape. With a high prevalence of diabetes and long wait times for ophthalmologists, AI tools are being deployed to improve access and efficiency.
   
• Innovative models such as Skleo Health are placing AI screening stations in pharmacies, optometry shops, and retail clinics, allowing walk-in patients to receive quick diagnostics.
   
• Additionally, Germany’s strong regulatory framework supports CE-certified AI systems, and partnerships between hospitals, universities, and startups are driving clinical validation and adoption of such tools and systems. The country’s emphasis on digital health under its eHealth initiatives is encouraging the integration of AI into routine care.
   
• Germany’s healthcare providers are increasingly recognizing the value of AI in reducing diagnostic bottlenecks and enhancing preventive care, positioning the country as a key growth hub for AI-powered ophthalmic solutions in Europe.
   

Asia Pacific AI-Driven Retinal Screening Device Market
 

The Asia Pacific market accounted for the substantial share in the market and was valued at USD 356 million in 2024.
 

• Asia Pacific is the fastest-growing region in the AI-driven retinal screening device market, fueled by rising diabetes rates, aging populations, and limited access to ophthalmologists in rural areas. Countries such as India, Indonesia, and Thailand are deploying AI tools in mobile health units and primary care centers to address screening gaps.
   
• Additionally, the affordability and portability of fundus image-based AI systems make them a preferred choice for large-scale public health programs. Governments and NGOs are increasingly supporting AI adoption to reduce preventable blindness.
   
• Further, local startups and academic institutions are also contributing to innovation, developing AI models tailored to regional demographics and disease patterns. Telemedicine integration is expanding, allowing remote diagnosis and follow-up care.
   
• Moreover, the region’s digital health momentum and growing awareness of eye health are driving rapid adoption.
   

China AI-driven retinal screening device market is estimated to grow with a robust CAGR in the Asia Pacific market.
 

• China is experiencing rapid growth in the AI-driven retinal screening market, driven by its large diabetic population and government-backed digital health initiatives. For example, the country accounts for around 22 percent of the global diabetic population. This highlights the urgency and need for scalable screening solutions in the country.
   
• AI tools are being deployed in community health centers, pharmacies, and mobile clinics to improve early detection of diabetic retinopathy and glaucoma. Local companies are developing AI models trained on Chinese patient data, enhancing diagnostic accuracy and relevance.
   
• Additionally, the integration of AI with telemedicine platforms is expanding access in rural and underserved regions. China’s regulatory environment is increasingly supportive, with fast-track approvals for AI medical devices.
   
• Further, public-private partnerships and investments in AI infrastructure are accelerating commercialization. The country’s emphasis on healthcare modernization under its Healthy China 2030 strategy positions AI as a key enabler of preventive care.
   

Latin America AI-Driven Retinal Screening Device Market
 

Brazil leads the Latin American market, exhibiting remarkable growth during the analysis period.
 

• Brazil is a growing market for AI-driven retinal screening devices, driven by a high prevalence of diabetes and limited access to specialized eye care in rural and underserved regions. Public health systems are increasingly adopting AI tools to support early detection of diabetic retinopathy and glaucoma.
   
• In addition, mobile health units using fundus image-based AI technologies are helping bridge the gap in ophthalmic services. Local initiatives are integrating AI into primary care workflows, enabling faster referrals and reducing the burden on specialists.
   
• Further, Brazil’s urban centers are also seeing adoption of OCT-based AI systems in private clinics and hospitals.
   
• The country’s growing digital health ecosystem and interest in scalable, cost-effective solutions make it a promising market for AI-powered eye screening technologies, especially those tailored for community-level deployment.
   

Middle East and Africa AI-Driven Retinal Screening Device Market
 

Saudi Arabia market to experience substantial growth in the Middle East and Africa market in 2024.
 

• Saudi Arabia is witnessing a substantial growth in the adoption of AI-driven retinal screening, particularly for diabetic retinopathy. National initiatives such as Eyenai, developed by SDAIA and King Khaled Eye Specialist Hospital, are deploying AI tools in pharmacies, clinics, and retail spaces to enable walk-in diagnostics. These systems offer fast, autonomous screening without requiring specialist interpretation, making them a preferred option for expanding access.
   
• Additionally, the local regulatory agency is actively approving AI-based medical devices, and the government’s Vision 2030 strategy emphasizes digital health transformation. Public-private partnerships are fostering innovation, while hospitals and mobile units are integrating AI into routine care.
   
• Furthermore, Saudi Arabia’s focus on preventive healthcare and modernization of its medical infrastructure positions it as a key player in the regional AI-powered ophthalmology, with strong potential for further expansion across the Middle East.
   

AI-Driven Retinal Screening Device Market Share

The market for AI-enabled screening devices used in retinal screening includes established competitors as well as companies entering the industry from the digital health start-up space. The key players in the market include AEYE Health, Digital Diagnostics, Eyenuk, RetinaLyze, and EyRIS, among other companies.
 

AEYE Health and Digital Diagnostics both build fully autonomous AI devices designed to work independent of clinician oversight and are targeting primary care and retail health settings. Eyenuk is focused on multi-disease detection and expanding their technology into other global markets. RetinaLyze offers a cloud-based platform to affordably deliver rapid retinal screening to pharmacy and optometry chains where access is expected to improve, contributing to regular usage. EyRIS is based in Asia and is strategically implementing partnerships in emerging markets. In addition, the market is also witnessing competition from localized and regional players that have designed and built localized AI models using regional data from identifiable populations.
 

Further, the continued strategic partnership with hospitals and telemedicine platforms and public health programs is key to gaining market share. Lastly, as the regulatory environment continues to evolve and there is a growing demand for preventive care, players that are able to provide scalable, accurate, and totally integrated offerings may have a better sales prospect in the industry.
 

AI-Driven Retinal Screening Device Market Companies

A few of the prominent players operating in the global AI-driven retinal screening device industry include:
 

• AEYE Health
• Airdoc
• DIGITAL DIAGNOSTICS
• evolucare
• EYENUK
• EyRIS
• Forus Health
• HEART EYE
• iCare
• identifeye HEALTH
• MONA.health
• remidio
• RetinaLyze
• Retmarker
• Topcon Healthcare
• Visionix
  
   
• DIGITAL DIAGNOSTICS

Digital Diagnostics leads the market with around 16% share in 2024. Digital Diagnostics focuses on autonomous AI systems that operate without clinician oversight. Their strategy centers on regulatory leadership, as they have launched the first FDA-cleared AI for diabetic retinopathy. They emphasize integration with electronic health records (EHRs) and scalable deployment in primary care settings to reduce specialist bottlenecks and improve early detection.
 

• RetinaLyze

RetinaLyze leverages cloud-based AI for fast, remote retinal analysis. Their strategy emphasizes ease of integration into existing workflows, including optometry chains and pharmacies. They focus on multi-condition detection and real-time reporting, aiming to support non-specialist users and expand across Europe through strategic partnerships and CE-certified solutions.
 

• AEYE Health

AEYE Health targets accessibility and portability by offering handheld, autonomous AI screening devices. Their strategy involves rapid diagnostics, making them a key participant for retail clinics, pharmacies, and rural health centers. AEYE emphasizes affordability, ease of use, and expansion into non-specialist environments to democratize eye care.
 

AI-Driven Retinal Screening Device Industry News:

• In September 2025, Identifeye Health announced the launched of its AI-powered retinal camera to revolutionize eye disease diagnosis. It is a portable device that aims to increase access to vision-saving screenings. This development is expected to improve company's product reach and brand image in the market.
   
• In May 2025, Medibrix, a key provider of innovative digital healthcare solutions, and RetinaLyze System A/S, an AI-based eye screening technology company, announced a strategic cooperation aimed at improving access to efficient eye health screening through the Medibrix platform. Under the collaboration, RetinaLyze’s clinically validated AI technology for detecting signs of DR, AMD, and glaucoma will be integrated directly into Medibrix’s comprehensive digital healthcare ecosystem. This enables healthcare providers to offer rapid and reliable eye screenings to their patients.
   
• In February 2025, Altris AI announced the launch of an advanced glaucoma Optic Disc Analysis module with an aim to aid in the early detection of the disease. The key parameters captured by the module include disc area, cup area, cup volume, minimal cup depth, maximum cup depth, cup/disc area ratio, rim absence angle, and disc-damage likelihood scale. This product launch is expected to improve the company's focus towards providing high-quality glaucoma care.
   

The global AI-driven retinal screening device market research report includes an in-depth coverage of the industry with estimates and forecasts in terms of revenue in (USD Million) from 2021 - 2034 for the following segments:

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Market, By Technology

• Fundus image-based AI
• OCT-based AI
• Multi-modal AI

Market, By Application

• Diabetic retinopathy
• Age-related macular degeneration
• Glaucoma
• Cataract
• Other applications

Market, By End Use

• Hospitals
• Ophthalmology clinics
• Mobile clinics/Rural camps
• Other end use

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• MEA
  • South Africa
  • Saudi Arabia
  • UAE