DIABETIC RETINOPATHY MARKET ANALYSIS

Diabetic Retinopathy Market Size and Trends

The global diabetic retinopathy market is estimated to be valued at USD 9.30 Bn in 2024 and is expected to reach USD 14.31 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 6.3% from 2024 to 2031.

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The growing prevalence of diabetes worldwide is expected to drive the growth of the diabetic retinopathy market during the forecast period. In November 2021, as per the International Diabetes Federation, approximately 537 million adults aged 20-79 years were living with diabetes in 2021 worldwide, and by 2030, this number is projected to rise to 643 million. Diabetic retinopathy, which is a common complication of diabetes, can potentially lead to blindness if not detected and treated promptly. With rising diabetes population, the prevalence of diabetic retinopathy is also expected to increase substantially in the coming years.

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Insights By Disease Type - Growing Severity Drives Proliferative Diabetic Retinopathy Segment Growth

In terms of disease type, proliferative diabetic retinopathy is expected to contribute the highest share of the market with a share of 52.1% in 2024 owing to its increased severity compared to non-proliferative retinopathy. Proliferative retinopathy is a more advanced form of the disease where new fragile blood vessels start growing on the surface of the retina or into the vitreous gel. These vessels are abnormal and can leak blood into the vitreous gel, leading to blurring of vision or complete blindness.

Insights By Treatment Type - Anti-vascular endothelial Therapy Dominates Treatment Space

In terms of treatment type, anti-vascular endothelial growth factor therapy is expected to contribute the highest share of the market with 42.2% in 2024 owing to its emerging role as the mainstay treatment approach for diabetic macular edema and proliferative retinopathy. anti-vascular endothelial drugs work by blocking excess VEGF levels, which plays a major role in inducing abnormal blood vessel proliferation and increased vascular permeability seen in diabetic eye complications.

Insights By Route of Administration - Intravitreal Injections Maximize Drug Delivery to Posterior Eye

In terms of route of administration, intravitreal injections segment is expected to contribute the highest market share with 34.1% in 2024 owing to their ability to deliver high drug concentrations directly into the vitreous cavity for localized action. Diabetic retinopathy manifests in the posterior segment of the eye behind the natural barriers imposed by blood-ocular barriers. For therapies seeking targeted posterior eye delivery, intravitreal administration yields optimal bioavailability by bypassing systemic absorption and first-pass metabolism.

Regional Insights

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Dominating Region: North America

North America dominates the diabetic retinopathy market, holding 36.2% of the market share in 2024, driven by the high prevalence of diabetes, advanced healthcare infrastructure, and the presence of key market players. The region benefits from well-established healthcare systems and increased access to diagnostic and treatment options, supporting its leadership in the market.

Fastest-Growing Region: Asia Pacific

Meanwhile, the Asia Pacific region is projected to experience the fastest growth due to its large and growing diabetic population, increasing awareness about diabetic retinopathy, and rising healthcare expenditures in emerging economies like China and India. The region's expanding healthcare infrastructure and ongoing initiatives to improve access to eye care services are expected to significantly boost market growth in the coming years.

Diabetic Retinopathy Market Outlook for Key countries

Growing Diabetes Prevalence and Approvals Drive Market Expansion in the U.S.

The U.S. diabetic retinopathy market is driven by the increasing prevalence of diabetes, according to the National Library of Medicine in June 2023, with an estimated 4.1 million individuals aged 40 and older affected by diabetic retinopathy as of 2023. Moreover, In August 2023, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals' EYLEA (aflibercept) Injection for the treatment of retinopathy of prematurity (ROP) in preterm infants.

Rising Diabetes Cases and Government Initiatives Boost Diabetic Retinopathy Market in India

The India diabetic retinopathy market is expanding due to the rising prevalence of diabetes and government initiatives such as National Program for Control of Blindness and Visual Impairment to improve eye care services. In August 2021, Siemens Healthineers, a medical technology company, inaugurated a manufacturing facility in Gujarat, India with a production capacity of 25 million tests per annum, aimed at enhancing molecular testing infrastructure in the country.

Advancements in Molecular Diagnostics Fuel Market Growth in Germany

The Germany diabetic retinopathy market is influenced by advancements in molecular diagnostic techniques. In November 2024, Microbiologics, a biotechnology company, acquired SensID, a Germany-based manufacturer specializing in molecular diagnostics for oncology and precision medicine, strengthening its portfolio in oncology while maintaining leadership in infectious disease diagnostics.

Increasing Diabetes Rates and Adoption of Advanced Diagnostics Propel Market Growth in China

China diabetic retinopathy market growth is driven by the increasing prevalence of diabetes and the adoption of advanced diagnostic technologies. In June 2024, Bio-Rad Laboratories, a life science company, expanded its molecular quality control portfolio with the launch of Exact Diagnostics GBS Positive and Negative Run Controls, designed for Group B Streptococcus molecular assays, enhancing diagnostic accuracy.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Global Diabetic Retinopathy Market Players

• Established Players: Leading companies prioritize extensive R&D to innovate high-performance products. For instance, in April 2017, Genentech, a subsidiary of Roche, received the U.S. Food and Drug Administration approval for Lucentis (ranibizumab injection) 0.3 mg, a treatment for diabetic retinopathy, highlighting its commitment to advancing therapeutic options.
• Mid-Level Players: Several mid-sized companies focus on delivering quality, budget-friendly products. Partnerships enhance technology and market presence. In May 2024, Optomed Oyj and AEYE Health received U.S. Food and Drug Administration clearance for a portable device combining Optomed's fundus camera with AEYE's AI technology, enabling autonomous diabetic retinopathy screening.
• Small-Scale Players are targeting specific markets with unique products. In May 2024, Ocular Therapeutix developed sustained-release therapies like Axpaxli (OTX-TKI) for diabetic retinopathy, focusing on innovative drug delivery To maintain a competitive edge, AEYE Health is leveraging AI-powered diagnostic systems for the swift detection of diabetic retinopathy, with approval from the U.S. FDA in April 2024.

Emerging Startups in the Global Diabetic Retinopathy Market

Innovative Technologies: AEYE Health developed an AI-based diagnostic system, AEYE-DS, enabling rapid diabetic retinopathy detection. In April 2024, the U.S. Food and Drug Administration approved this system, facilitating widespread autonomous screening. These technologies enhance early detection and treatment, potentially reducing the global burden of diabetic retinopathy. AI-driven diagnostics improve accuracy and accessibility, leading to better patient outcomes.

Sustainable Solutions: RetroSense Therapeutics is researching bio-degradable, 3D printed implants as an alternative to anti-VEGF injections for wet age-related macular degeneration diabetic retinopathy. Cavitar is developing a natural extract from maple tree sap that may reduce retinopathy progression in a eco-friendly manner. Partnerships with established companies and research institutions drive technological innovation and expand market reach, enhancing the overall quality of diabetic retinopathy care.

Diabetic Retinopathy Industry News

• In June 2023, Eyenuk, Inc., a global leader in AI-powered eye screening and disease monitoring, announced that it received the USFDA clearance for its Topcon NW400 retinal camera integrated with the EyeArt AI system. This clearance enables autonomous AI-based detection of diabetic retinopathy, solidifying Eyenuk’s position as a pioneer in leveraging AI for retinal disease management.
• In January 2023, Eyenuk, Inc. achieved a significant milestone by obtaining European Union Medical Device Regulation (MDR) certification for its EyeArt AI eye screening system. The certification extends its capabilities to detect diabetic retinopathy, age-related macular degeneration, and glaucoma, reflecting Eyenuk, Inc. dedication to advancing AI-driven healthcare solutions worldwide.
• In June 2022, Regeneron Pharmaceuticals, Inc., a leading biotechnology company focused on innovative treatments for serious diseases, announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection. The application proposed a 16-week 2 mg dosing regimen, following initial monthly doses, for patients with diabetic retinopathy (DR).
• In February 2022, REGENXBIO Inc., a pioneer in gene therapy utilizing its NAV Technology Platform, reported additional positive interim data from the Phase II ALTITUDE trial of RGX-314. This trial evaluates RGX-314 for treating diabetic retinopathy (DR) in patients without center-involved diabetic macular edema (CI-DME) through in-office suprachoroidal delivery.

Key Takeaways from Analyst

• The global diabetic retinopathy market is expected to witness significant growth over the forecast period owing to the rising prevalence of diabetes around the world. North America will continue to dominate the market due to growing awareness levels and availability of advanced treatment options in the region. However, Asia Pacific is likely to emerge as the fastest growing market due to the rising geriatric population and growing cases of diabetes in countries like India and China.
• One of the major drivers for the market is the increasing number of FDA approvals for novel drugs and devices for the treatment of different stages of diabetic retinopathy. Moreover, the development of affordable anti-VEGF drugs for treating proliferative diabetic retinopathy will provide opportunities for market expansion in middle-income countries. However, lack of awareness about early symptoms of DR in low-income nations is a major challenge for the industry.
• Research indicates that market players should focus on developing cost-effective screening technologies to increase early detection rates. They must also conduct awareness programs in developing nations to educate people about eye examination benefits. Collaboration with government bodies can aid screening programs across rural areas. Accumulating clinical data for pipeline drugs will help in quickly obtaining regulatory approvals as well.

Market Report Scope

Market Dynamics

Market Driver - Increasing prevalence of diabetes globally

One of the key drivers propelling the growth of the global diabetic retinopathy market is the rising incidence of diabetes cases across the world. Diabetes is a chronic health condition characterized by high blood sugar levels over a prolonged period of time. The rising prevalence of diabetes globally, driven by sedentary lifestyles and unhealthy diets, leads to diabetic retinopathy in most patients with diabetes for over 20 years. For instance, in October 2022, according to WHO, diabetic retinopathy causes 4.8% of global blindness cases. In the U.S., 4.1 million people aged 40+ (1 in 29) have diabetic retinopathy, with 899,000 (1 in 132) facing vision-threatening forms. Despite preventive efforts, it can lead to permanent blindness based on severity.

Market Challenge - Lack of accurate diagnostic tools in some regions

One of the key challenges faced by the global diabetic retinopathy market is the lack of availability of advanced and accurate diagnostic tools in some parts of the world. Diabetic retinopathy screening highly relies on specialized fundus cameras, retinal imaging devices, and dilated eye examinations to detect any changes in the retina at an early stage. However, many developing and underdeveloped regions still have poor healthcare infrastructure and lack necessary equipment for regular screenings.

Market Opportunity - Innovations in treatment technologies and devices

The global diabetic retinopathy market is witnessed numerous promising opportunities driven by ongoing innovations in treatment technologies and devices. The past decade has seen major advancements like the introduction of anti-VEGF drugs and sustained-release drug delivery implants that have enabled better management of proliferative diseases with fewer invasive procedures. Furthermore, the development of new lasers, surgical equipment, and wider acceptance of cutting-edge therapies like gene therapy and stem cell therapy hold potential to revolutionize the treatment landscape.

Key Stakeholders of Market

What does Growth in the Global Diabetic Retinopathy Market mean for Different Stakeholders?

The diabetic retinopathy market has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

• By Disease Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Proliferative Diabetic Retinopathy
  • Non-proliferative Diabetic Retinopathy
• By Treatment Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Anti-Vascular Endothelial Growth Factor Therapy
  • Intraocular Steroid Injection
  • Laser Surgery
  • Vitrectomy
  • Others (Intraocular Corticosteroids, etc.)
• By Route of Administration Insights (Revenue, USD Bn, 2019 - 2031)
  • Intravitreal Injections
  • Intravitreal Implants
  • Oral
  • Topical Eye Drops
  • Laser Surgery
  • Others
• By End User Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospitals
  • Ophthalmology Clinics
  • Ambulatory Surgery Centers
  • Long-Term Care Centers
  • Others
• By Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Novartis AG
  • Bayer AG
  • Regeneron Pharmaceuticals Inc.
  • Roche Holding AG
  • Allergan PLC
  • Zeiss International
  • Topcon Corporation
  • Heidelberg Engineering GmbH
  • Optos PLC
  • Canon Inc.
  • Nidek Co., Ltd.
  • Ellex Medical Lasers Limited
  • Bausch + Lomb Incorporated
  • Abbott Laboratories
  • Santen Pharmaceutical Co., Ltd.