Nonmydriatic Handheld Fundus Cameras Market

Nonmydriatic Handheld Fundus Cameras Market Outlook (2025 to 2035)

The nonmydriatic handheld fundus cameras market is valued at USD 170 million in 2025. As per Fact.MR’s analysis, the nonmydriatic handheld fundus cameras industry will grow at a CAGR of 8% and reach USD 367 million by 2035.

During 2024, the nonmydriatic handheld fundus cameras sector maintained a consistent growth pattern, overcoming the disruption in operations created by the COVID-19 pandemic. Growing concern regarding early diagnosis practices, especially for chronic diseases of the eyes such as diabetic retinopathy and macular degeneration, led to increased use of handheld diagnostic equipment within clinical and outpatient environments. The healthcare industry's growing trend toward portable and convenient ophthalmic devices further sped up the demand.

Looking toward 2025, the future is on track for long-term growth based on continued progress in imaging technology, increased implementation of AI-aided diagnostic support, and broadening teleophthalmology efforts. Public and private systems are investing in expandable diagnostic technology, setting up handheld fundus cameras as crucial instruments in the delivery of affordable and preventive eye care.

Metric	Value
Industry Value (2025E)	USD 170 million
Industry Value (2035F)	USD 367 million
CAGR (2025 to 2035)	8%

Market Analysis

The industry for handheld fundus cameras that do not use mydriatics is robust and growing, driven by increasing worldwide interest in the early identification of chronic eye conditions and demand for portable, high-accuracy diagnostic instruments.

Teleophthalmology services expansion and technological advances are driving adoption in both developed and developing healthcare systems. Health providers and producers of affordable, AI-based imaging solutions still have a long way of progress, whereas traditional diagnostic equipment producers risk becoming obsolete.

Top 3 Strategic Imperatives for Stakeholders

Accelerate AI-Supported Product Development

Invest in AI-fueled imaging and diagnostic capabilities to improve precision, automate initial screening, and differentiate from traditional handheld devices. Fast-paced innovation will be key to addressing changing clinical expectations and worldwide screening needs.

Align Products with Teleophthalmology Growth

Align product design and software integration to meet remote diagnostic workflows and digital health environments. This alignment guarantees relevance as healthcare delivery is moving toward decentralized, technology-enabled models.

Build Global Distribution and OEM Partnerships

Strive for strategic partnerships with regional distributors, OEMs, and healthcare networks to expand penetration into underserved regions. Increasing manufacturing capacity and obtaining cross-border regulatory clearances will put stakeholders in the best position for continued global expansion.

Top 3 Risks Stakeholders Should Monitor

Risk	Probability - Impact
Regulatory holdups in device approvals in critical regions - Slow and cumbersome certification procedures in areas such as the EU and Asia can delay product release and revenue schedules.	Medium - High
Slower uptake in resource-constrained settings due to cost and training challenges - Poor healthcare budgets and shortages of qualified personnel in developing countries can restrict the universal use of the device.	High - Medium
Supply chain interruptions in component supply - Reliance on specialist optical and electronic components exposes the supply chain to geopolitical issues and logistical hold-ups.	Medium - High

1-Year Executive Watch-List

Priority	Immediate Action
Advance AI-Driven Diagnostic Capabilities	Perform an extensive feasibility study on incorporating real-time, cloud-based AI analytics in handheld fundus imaging devices to improve diagnostic accuracy and automate workflow.
Enhance Global Regulatory Preparedness	Initiate a multi-region regulatory preparedness program, comprising pre-submission audits and dossier standardization, to streamline approvals across the USA FDA, EU MDR, and target APAC regions.
Scale International Market Penetration	Set up region-specific distribution pilots with qualified partners in Southeast Asia, Latin America, and the Middle East, backed by localized training and after-sales service models.

For the Boardroom

To stay ahead, companies need to re-strategise their product, regulatory, and go-to-sector approaches to leverage the convergence of AI, handheld diagnostics, and decentralized delivery of care.

This intelligence foretells a transformative turn toward portable ophthalmic devices as front-line instruments in preventive care and teleophthalmology. Businesses need to accelerate AI-facilitated product development, give top priority to global compliance agility, and forge deep-rooted distribution systems in high-growth sectors. Board-level attention should be on developing scalable, tech-savvy platforms that satisfy the needs of value-based care systems while getting ahead of legacy equipment vendors.

Segment-Wise Analysis

By Type:

Non-mydriatic fundus cameras will be the most profitable segment from 2025 to 2035, expected to grow at a CAGR of 9.1%, surpassing both mydriatic and hybrid options.

This segment's leadership is fostered by its non-invasive imaging method, which obviates the requirement for pupil dilation-a significant benefit in high-throughput environments such as primary care and teleophthalmology.

Non-mydriatic devices provide increased user convenience, increased patient throughput, and enhanced comfort, making them especially useful in large-scale diabetic retinopathy and age-related macular degeneration screening programs. Moreover, their compatibility with AI-driven image analysis and remote diagnosis places them at the forefront of the decentralized delivery of eye care.

By End-User:

Ophthalmic & optometrist practices are anticipated to be the most profitable end-user segment during 2025 to 2035, growing at an estimated CAGR of 9.4%.

This segment is growing at a high rate with the decentralization of eye care services and the rising demand for outpatient diagnosis and management of retinal conditions. Nonmydriatic handheld fundus cameras provide portability, simplicity, and high diagnostic accuracy-ideally suited to the operational requirements of independent practices and retail optometry chains.

Further adding strength to this segment's leadership path are increasing patient volumes and rising demand for preventive vision screening at the point of care.

Country-Wise Analysis

United States

The United States is experiencing a sharp increase in demand for nonmydriatic handheld fundus cameras, fueled by the growing incidence of diabetic retinopathy and glaucoma, particularly among the elderly and diabetic populations. Reimbursement by Medicare and private payers is spurring adoption in outpatient facilities and primary care practices. The

USA also dominates AI-driven diagnostic integrations, underpinned by a robust ecosystem of health tech startups and regulatory tailwinds from the FDA for digital diagnostics. Broad teleophthalmology rollout through rural and veterans' health programs also hastens the adoption of portable eye screening devices.

Clinical preferences are quickly moving toward non-invasive, simple-to-use diagnostic equipment, especially in community health networks and multispecialty clinics. FactT.MR opines that the CAGR of the United States will be 8.6% from 2025 to 2035.

India

India is becoming a quick-rising customer base for handheld nonmydriatic fundus cameras driven by exploding diabetes and hypertension numbers and the harsh shortage of eye specialists in rural and tier-2 areas. National schemes like Ayushman Bharat are empowering increased utilization of portable diagnostic products in vision examination camps and government hospitals. Homegrown startups also launched cost-beneficial smartphone-integrated designs, enhancing ease of use.

Training programs conducted by non-governmental organizations are improving usage skills in community health workers. As vision becomes an integral part of universal healthcare planning, demand for portable imaging devices is on the rise on both public and private health channels. Fact.MR forecasts that India's CAGR will be 9.5% from 2025 to 2035.

China

China's ophthalmic diagnostic environment is in the process of fast modernization, driven by national health system reforms, urban population aging, and rising funding in AI-powered medical devices. Provincial health agencies are heavily investing in early screening facilities for chronic eye diseases.

Local players are fighting hard with international brands using price-competitive and software-integrated handheld fundus cameras. Installation is moving beyond the hospital to optical retail chains and mobile clinics. Integration with national e-health records and teleconsultation platforms is building scalable use cases for remote diagnosis. Fact.MR is of the opinion that the CAGR of China will be 8.9% from 2025 to 2035.

United Kingdom

In the United Kingdom, the move to decentralized NHS ophthalmic care is promoting the adoption of nonmydriatic handheld fundus cameras in diagnostic hubs and community optometry clinics. Increasing priority on early detection of age-related macular degeneration and diabetic eye disease is fueling demand for affordable, non-invasive imaging solutions. Public-private partnerships are providing the funding for AI-driven enhancements within handheld devices

UKCA regulation alignment is supporting quicker roll-outs of devices by European and indigenous manufacturers. Screening for vision by school programs and old age care homes is becoming popular too. Fact.MR opines that the CAGR of the United Kingdom will be 8.3% from 2025 to 2035.

Germany

Germany’s structured eye care ecosystem, high coverage by insurance, and robust outpatient infrastructure place it at the forefront of the adoption of nonmydriatic hand-held fundus cameras. German producers are leading the advancement in image clarity and auto-focus functions that make more accurate diagnostics possible in general practice and diabetes clinics.

Interoperability with the nation's electronic health record (EHR) system is augmenting point-of-care imaging usefulness. Increased government investment in digital health by means of policies such as Krankenhauszukunftsgesetz (KHZG) is also supporting swift technology adoption. Fact.MR projects that the CAGR of Germany will be 8.1% from 2025 to 2035.

South Korea

South Korea is unique in that it boasts a highly developed digital infrastructure and rapid uptake of medical imaging technologies, particularly suiting nonmydriatic handheld fundus cameras. It has an aging population and high levels of digital literacy among healthcare workers, so portable diagnosis is now the core of delivering eye care in outpatient clinics.

Pilot programs supported by the government are incorporating the cameras into mobile health vans as well as telehealth platforms targeting rural and older populations. Local technology companies are actively working with hospitals to trial AI-based retinal imaging devices. South Korea's interoperability standards for health IT are also speeding up seamless data sharing and diagnosis. Fact.MR forecasts that South Korea's CAGR will be 8.7% from 2025 to 2035.

Japan

Japan's transition to a super-aged society has rendered vision care a matter of national importance, and rapid, in-clinic eye diagnosis is in very high demand. Handheld fundus cameras are increasingly being used in geriatric care facilities and home healthcare services, particularly in urbanized prefectures. Japanese companies are leaders in miniaturized, ergonomic cameras with auto-alignment and real-time transmission functions.

Close alignment with government telehealth policy and preventive screening requirements is strengthening the need for portable retinal imaging. Institutional purchasers value products that provide smooth integration with health record systems and AI modules for triaging retinal abnormalities. Fact.MR opines that the CAGR of Japan will be 8.4% from 2025 to 2035.

France

France's universal healthcare system and growing number of ophthalmology specialists are building a positive environment for nonmydriatic handheld fundus camera uptake. The Plan Santé 2022 initiative, promoted by the French government, has funded tele-expertise platforms in which these devices are increasingly employed for distant second opinions and initial eye screening.

Pharmacies and opticians are also coming forward as new end users, utilizing portable imaging for first-line vision examination. Advances in camera-light modulation and image stabilization are also fueling interest among clinicians. National reimbursement models continue to mature, incentivizing wider adoption across public and private healthcare providers. Fact.MR projects that the CAGR of France will be 8.2% during the forecast period

Italy

Italy's uptake of nonmydriatic handheld fundus cameras is increasing steadily because of growing emphasis on early detection of diabetic and hypertensive retinopathy in its aging population. Regional health authorities in Lombardy, Emilia-Romagna, and Veneto are encouraging outpatient diagnostics to alleviate tertiary hospital loads. Mobile screening units with handheld imaging equipment are being used for outreach in remote villages.

Italian medtech startups and innovators are entering the space with small, AI-ready devices specifically designed for general practitioners. Country-level telemedicine guidelines are also promoting cross-specialty collaboration, further expanding the clinical applications of portable retinal imaging. Fact.MR forecasts that the CAGR of Italy will be 8.3% from 2035 to 2035.

Australia and New Zealand

Australia and New Zealand are utilizing nonmydriatic handheld fundus cameras to close gaps in healthcare access in remote and indigenous populations. National telehealth programs, like Australia's Rural Health Outreach Fund, are integrating the technology into mobile screening services. District health boards in New Zealand are joining forces with optometrists to roll out fundus imaging into primary care centers.

The area is also investing in cloud-based storage of retinal images to enable cross-site diagnosis and long-term monitoring. Clarity of regulation and stable funding mechanisms are making the ANZ region a desirable place for global and local manufacturers. Fact.MR opines that the CAGR of both countries will be 8.5%.

Fact.MR Survey Results: Nonmydriatic Handheld Fundus Cameras Industry Dynamics Based on Stakeholder Perspectives

(Surveyed Q4 2024, n=450 stakeholder participants evenly distributed across device manufacturers, hospital procurement heads, ophthalmologists, and retail diagnostic clinics in the USA, Western Europe, Japan, and South Korea)

Key Priorities of Stakeholders

• Point-of-Care Accessibility: 79% of the respondents highlighted the necessity of small, portable screening tools for use at community clinics and rural outreach efforts.
• Diagnostic Speed: 73% considered rapid image capture and autofocusing capabilities as essentials to enhance patient throughput.

Regional Variance:

• USA: 64% highlighted EHR integration and imaging sharing features to facilitate multi-provider collaboration.
• Western Europe: 81% focused on diagnostic compliance features like GDPR-compliant cloud storage and audit trails.
• Japan/South Korea: 67% favored ultra-lightweight models to improve usability during bedside examinations, particularly for geriatric patients.

Adopting Advanced Technologies

High Variance

• USA: 56% of hospital procurement directors had invested in AI-powered screening models for diabetic retinopathy detection.
• Western Europe: 48% emphasized DICOM-compatible systems to harmonize diagnostics across public healthcare systems.
• Japan: A mere 23% adopted advanced tech, citing limited infrastructure in smaller clinics and cost issues.
• South Korea: 39% indicated strong use of cloud-based diagnostic dashboards, particularly among private chain hospitals.

ROI Perspectives

• 69% of worldwide stakeholders consider integration with teleophthalmology platforms to be worth investing in.
• However, just 33% of Japanese solo-practice ophthalmologists favored cloud-based models, citing perceived concerns over data privacy.

Device Build Preferences

Consensus:

• 68% favored handheld, rugged designs with drop resistance and heat-resistant materials for mobile screening settings.

Regional Variance:

• Western Europe: 51% chose antimicrobial casings to minimize cross-contamination in multi-patient settings.
• Japan/South Korea: 43% preferred foldable grip and touchscreen for one-handed use.
• USA: 72% preferred devices with removable batteries and modular lenses for field serviceability.

Price Sensitivity

Shared Challenges:

• 84% named increasing semiconductor and optical lens prices as significant cost constraints.

Regional Differences:

• USA/Western Europe: 59% were prepared to pay a 10-15% premium for FDA/CE-certified versions with AI capabilities.
• Japan/South Korea: 75% desired price points below USD 7,000 and supported bulk orders by public health agencies.
• South Korea: 41% of clinics were interested in subscription-based models combined with diagnostics software and training.

Pain Points in the Value Chain

Manufacturers:

• USA: 52% of them were experiencing microchip shortages in image sensor assembly.
• Western Europe: 47% of them were experiencing delays because of stringent RoHS and MDR compliance.
• Japan: 58% of them reported sluggish domestic sales because of high device lifespans that prevented repeat purchases.

Distributors:

• USA: 65% of them were experiencing slow procurement cycles from Medicaid-participating clinics.
• Western Europe: 54% of them reported intense price competition from refurbished device suppliers.
• Japan/South Korea: 61% grappled with customization orders (e.g., language interface, image format) holding up bulk orders.

End-Users:

• USA: 42% griped about complicated training for AI-powered models.
• Western Europe: 38% were beset by Wi-Fi connection issues in mobile clinics, affecting data sync.
• Japan: 55% were not satisfied with technical support and post-sale service coverage.

Future Investment Priorities

Alignment:

• 71% of world manufacturers intend to invest in software-defined updates and cloud analytics for real-time flagging of disease.

Divergence:

• USA: 60% on interoperability with telehealth platforms and third-party EMR systems.
• Western Europe: 59% to develop eco-friendly packaging and energy-efficient device certification.
• Japan/South Korea: 50% intend to localize hardware and UI for elderly populations with visual impairment.

Regulatory Impact

• USA: 66% cited strict FDA Class II regulatory barriers slowing down new product releases, especially those that incorporate AI.
• Western Europe: 80% viewed CE-MDR compliance as an enabler to sector, with reimbursement-tied certifications encouraging innovation.
• Japan/South Korea: A mere 29% felt regulation played a critical role in procurement, with hospital group preferences and budget cycles being mentioned as more influential.

Conclusion: Consensus vs. Variance

• High Consensus: Portability, real-time diagnostics, and pricing flexibility are sought after by everyone in all regions.

Key Variances:

• USA: AI-first development vs. Japan/South Korea: Conservative upgrades with tight budget limits.
• Western Europe: Healthcare-alignment public vs. Asia: Small-practice usability tailorization.

Strategic Insight:

• To thrive across the globe, OEMs need to create modular platforms with regional compliance, support, and price flexibility, achieving advanced analytics without sacrificing form factor simplicity.

Government Regulations

Country	Policy & Regulatory Impact
United States	FDA classifies these as Class II medical devices with 510(k) clearance requirements; AI versions could need extra premarket review. HIPAA also regulates the transmission/storage of data.
India	Regulated under the Medical Device Rules, 2017, non-invasive ophthalmic devices are classified as Class B or C. Importers have to register with CDSCO and get an import license.
China	Must be certified by the National Medical Products Administration (NMPA) Class II. Devices with AI require independent cybersecurity and algorithm transparency approvals.
UK	Needs UKCA marking after Brexit. AI-based models fall under MHRA guidance on software as a medical device (SaMD).
Germany	Complies with EU MDR, with CE Marking necessary for sector access. Further reimbursement approval required from public health insurers (GKV) for widespread use.
South Korea	Governing by the Ministry of Food and Drug Safety (MFDS). AI-driven diagnostic products need further Software Medical Device (SaMD) clearance.
Japan	Needs PMDA approval according to the Pharmaceutical and Medical Device Act (PMD Act). Teleophthalmology devices need to adhere to Japan's stringent data localization and privacy regulations.
France	Imposes CE-MDR certification with additional national requirements for reimbursement listing in the Social Security Code (LPP).
Italy	Needs CE marking under EU MDR, with further clinical documentation to be included in regional health procurement frameworks.
Australia-New Zealand	Devices need to be registered with the Therapeutic Goods Administration (TGA) or Medsafe. AI models also need to meet software-specific safety guidelines.

Competitive Landscape

The global nonmydriatic handheld fundus camera industry is fairly concentrated, with several key players riding on innovation, AI integration, and focused growth strategies.

Leading firms compete on price flexibility, AI-enabled imaging R&D spending, and strategic alliances with healthcare providers and public health agencies to enhance worldwide reach and diagnostic performance.

Topcon Healthcare hired Lance Patton as Chief Commercial Officer in July 2024 to spearhead the company's transition to a direct sales and service model. This reorganization is intended to provide tailored ophthalmic imaging solutions in North America and around the world.

NIDEK Co., Ltd. together with Orbis International contributed in 2024 by donating sophisticated nonmydriatic fundus cameras to support diabetic retinopathy screening programs in Vietnam for regional eye care accessibility.

In October 2024, Siloam Vision, Inc. received a USD 770,000 grant from NIH to create ultrawide-field, portable, nonmydriatic retinal imaging devices aimed at pediatric diagnosis. The technology is focused on underserved children in community clinicS.

Market Share Analysis

Optomed (25-30%)

A Finnish medical technology firm and a major player in portable retinal imaging. With its Optomed Aurora, the company focuses on AI-driven, easy-to-use handheld fundus cameras for point-of-care diagnostics, and thus is a top choice for telemedicine and primary screenings.

Canon Medical Systems (20-25%)

Global leader in medical imaging with high-performance handheld fundus cameras such as the CR-2 AF. Merging advanced optics and mobility, Canon's equipment is used extensively across ophthalmology clinics and large-scale screening programs by virtue of the company's robust distribution network.

Topcon Corporation (15-20%)

A Japanese multinational company, best known for its Topcon NW400 handheld fundus camera. Topcon emphasizes precision imaging, ease of use, and integration with diagnostic systems, serving both clinical and remote health care environments with its reliable ophthalmic solutions.

NIDEK (10-15%)

Focuses on innovative ophthalmic devices, including the Mirante handheld fundus camera. The company focuses on high-resolution imaging and seamless software integration, making its products highly popular among eye care professionals for precise and effective retinal diagnostics.

Carl Zeiss Meditec (8-12%)

A German medical technology leader provides Visuscout 100, a portable fundus camera that has sophisticated imaging and AI analysis. Renowned for its high-performance products, Zeiss aims for both clinical and mobile screening settings, capitalizing on its commanding position in precision optics.

Volk (5-10%)

An American company offering inexpensive and compact handheld fundus cameras such as the Pictor Plus. Its products are well represented in primary care and distant readings, emphasizing simplicity and access, especially in low-income and decentralized healthcare environments.

Other Key Players

• Remidio
• Eyenuk
• Forus Health
• CenterVue (a subsidiary of Heidelberg Engineering)
• VersaCam (by Clarity Medical Systems)
• Ocusight
• Rheon Medical
• OcuSciences
• MicroClear Medical
• Ophthalmic Instruments (OII)

Segmentation

Segmentation by Type:

• Non-mydriatic Fundus Cameras
• Mydriatic Fundus Cameras
• Hybrid Fundus Cameras

Segmentation by End User:

• Hospitals
• Ophthalmology Clinics
• Ophthalmic & Optometrist Offices
• Others

Segmentation by Region:

• North America
• Latin America
• Europe
• East Asia
• South Asia
• Oceania
• Middle East and Africa (MEA)