United States Ophthalmic Diagnostic Equipment Market Expands Rapidly at 5.4% CAGR - $2.6 Billion Milestone by 2031, Led by ZEISS Group and Topcon Corporation as Top Competitors | DataM Intelligence

Leander, Texas and TOKYO, Japan - Dec. 12, 2025. According to DataM Intelligence, the United States Ophthalmic Diagnostic Equipment Market Size is growing from USD 1.8 billion in 2023 to USD 2.6 billion by 2031, registering a robust CAGR of 5.4% during 2024-2031. The surging demand for advanced eye care technologies, the expansion of preventive vision screening programs, and advancements in AI-integrated imaging systems are fueling the need for enhanced ophthalmic diagnostic equipment that maximizes precision and non-invasiveness without compromising patient comfort. Ophthalmic diagnostic equipment, the sophisticated tools including OCT scanners and tonometers, revolutionises eye health by integrating seamlessly into clinical workflows, hospitals, and ambulatory centers, detecting conditions like glaucoma and macular degeneration early while ensuring compliance with FDA clearance and ISO medical device standards. By combining high-resolution optics, AI-driven analytics, and portable designs, this market provides accurate, efficient solutions for cataract assessment, retinal imaging, and intraocular pressure monitoring throughout the United States and beyond.

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Recent Developments

1. Advancing Eyecare acquired Eyefficient, an Ohio-based supplier of ophthalmic instruments, in September 2025, expanding U.S. distribution of diagnostic tools by 25% and targeting ambulatory centers, as noted by healthcare analyst Dr. Robert Kline from the American Academy of Ophthalmology, who highlighted the deal's boost to regional access amid rising glaucoma cases.

2. Alcon announced the acquisition of LENSAR for USD 356 million in March 2025, integrating the ALLY Robotic Cataract Laser system into its U.S. portfolio for enhanced diagnostic integration, praised by ophthalmology expert Prof. Laura Gonzalez from Johns Hopkins Wilmer Eye Institute for accelerating precision in refractive procedures.

3. Bausch + Lomb launched SeeNa, an AI-powered ophthalmic diagnostic system for refractive cataract practices, in the U.S. in May 2024, featuring Eyetelligence software for real-time planning and reducing diagnostic errors by 18%, per validation from vision tech consultant Dr. Emily Chen at the Association for Research in Vision and Ophthalmology.

4. Topcon Corporation invested in Pangaea Data in May 2025 to advance AI-driven eye care analytics, focusing on early detection of diabetic retinopathy in U.S. clinics with 92% accuracy in pilots, endorsed by data scientist Dr. Javier Morales from the National Eye Institute for bridging gaps in underserved communities.

5. Carl Zeiss Meditec introduced a next-gen OCT system with AI lesion tracking in October 2024, FDA-cleared for U.S. use in AMD and glaucoma diagnostics, cutting scan times by 30% and lauded by retinal specialist Dr. Sarah Jenkins from the American Society of Retina Specialists for improving patient throughput.

Competitive Landscape

The market is highly competitive among global medtech leaders, imaging innovators, and clinic suppliers.

1️⃣ZEISS Group expanded its U.S. OCT production in California with a $80 million upgrade in mid-2025, operational since rollout, enhancing supply for hospitals with 22% faster imaging and capturing 30% of the retinal segment through AI-enhanced models.

2️⃣Topcon Corporation acquired a Midwest diagnostic software firm in July 2024, strengthening its East Coast presence and reporting a 20% revenue increase in glaucoma tools via integrated perimetry advancements and FDA approvals.

3️⃣Nidek Co., Ltd. partnered with three U.S. academic centers to launch fundus camera upgrades, achieving 95% sensitivity in diabetic screening and securing 28% of ambulatory contracts with portable innovations.

4️⃣Haag-Streit Group debuted slit lamp variants with digital connectivity in early 2025, aligning with HIPAA standards and driving 19% domestic growth through collaborations with optometry chains for routine exams.

5️⃣Coburn Technologies rolled out tonometer systems optimized for teleophthalmology, reducing calibration needs by 35% and teaming with rural health networks for customized deployment.

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Growth Drivers

✦ The global eye care market surpassed USD 100 billion in 2024, with diagnostic equipment accounting for 4.5% of spends, underscoring the drive for non-invasive tools amid rising visual impairments.

✦ US ophthalmic procedures exceeded 10 million in 2024, driving over 5 million diagnostic sessions annually and accelerating equipment adoption for early intervention in aging demographics.

✦ Healthcare regulations spurred USD 350 billion in medtech investments by 2025, prioritising AI-integrated devices that meet FDA clearances and provider demands for interoperability.

✦ North American retinal disorder revenues climbed 15% recently, utilising more than 8 million OCT scans yearly as preventive screening fuels adoption in clinics and hospitals.

✦ Imaging innovations trimmed operational costs by 20%, forecasting USD 220 million in yearly efficiencies for US providers by 2030 through portable and automated systems.

🌍Regional Insights

United States (North America): The U.S. ophthalmic diagnostic equipment market was valued at USD 1.8 billion in 2023, projected to reach USD 2.6 billion by 2031 at a 5.4% CAGR. It holds nearly 40% of the global market share, driven by advanced infrastructure and high procedure volumes. Key players like ZEISS Group and Topcon Corporation lead through innovation, AI integrations, and expanded U.S. facilities. Adoption of OCT and multichannel distribution from manufacturers to clinics strengthens its dominance. Recent launches and acquisitions keep the U.S. as the global market leader.

Canada (North America): Canada's market size was USD 250 million in 2023, expected to grow to USD 360 million by 2031 at a 5.2% CAGR, holding roughly 5% of the global market share. Growth is fueled by federal health grants and regulatory support that boost premium diagnostic demand. Leading U.S. brands are investing in Canadian networks and trials, accelerating market maturity. Provider preference for portable, tech-advanced tools continues to mount. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 25% of the global ophthalmic diagnostic equipment market and is rapidly growing due to expanding NHS initiatives and rising eye health awareness. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through glaucoma screening mandates and diversified imaging launches. Market growth is supported by established medtech demand and the increased entry of North American firms. Europe's evolving frameworks and expanding patient base make it a crucial growth region.

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Market Segmentation Analysis

By Product Type: Optical Coherence Tomography dominates with a 35% market share, valued at USD 630 million in 2023 and projected to grow to USD 910 million by 2031 at a 5.5% CAGR. Tonometers hold 20% of the market, valued at USD 360 million in 2023 and expected to reach USD 520 million by 2031 at a 5.3% CAGR. The OCT segment's growth is driven by increasing demand for retinal imaging compliant with FDA standards, while tonometers sustain demand through cost-effective glaucoma screening in clinics.

By Application: Glaucoma constitutes the largest segment with 30% market share, valued at USD 540 million in 2023 and expected to expand to USD 780 million by 2031, powered by early detection research and prevalence trends. Cataract holds 25% share, valued at USD 450 million in 2023 and projected to reach USD 650 million by 2031, fueled by surgical planning applications. Age-related Macular Degeneration and Diabetic Macular Edema each account for 20% of the market, reflecting growing awareness of chronic condition management and targeted diagnostics.

By End-User: Hospitals lead with a commanding 50% market share, valued at USD 900 million in 2023 and forecasted to reach USD 1.3 billion by 2031, favoured for their high-volume procedures and integrated systems. Ophthalmic Clinics hold a 30% share, worth USD 540 million in 2023 and projected to grow to USD 780 million by 2031, attracting providers seeking portable efficiency. The remaining 20% comprises ambulatory surgical centers and others, growing fastest at 5.6% CAGR to USD 520 million by 2031, catering to niche needs for outpatient imaging and rapid throughput.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in advanced imaging technologies, such as AI-assisted OCT and portable fundus cameras, to improve resolution, reduce diagnostic costs by an estimated 20%, and comply with regulatory expectations. Provider growth is driven by expanding awareness of early vision threats, integration into telehealth routines, and education on non-invasive, high-accuracy tools. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by clinical trials, strategic alliances, and validated precision diagnostics.

Market Outlook and Opportunities: The Global ophthalmic diagnostic equipment market is at a tipping point, driven by preventive health mandates and every ounce of technological evolution in eye care. Valued at USD 4.5 billion in 2023, it is projected to reach USD 6.4 billion by 2031 at a steady 5.4% CAGR. North America, capturing nearly 40% of the global share, spearheads expansion powered by infrastructure demand, while Asia Pacific benefits from demographic shifts. Progress in AI analytics and portable designs align with FDA innovation aims, although hurdles like reimbursement variability, training gaps, and device costs remain. Post-pandemic focus on remote screening and rising embrace of digital workflows and personalized ophthalmology unlock vast potential for disease management and accessibility enhancement in hospitals, clinics, and surgical sectors.

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