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(Albany, US) October 01, 2026 – DelveInsight’s “Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of Diabetic Retinopathy, historical and forecasted epidemiology, and market trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Diabetic Retinopathy Market Report

• In March 2026, Kodiak Sciences announced positive topline results in the GLOW2 Phase III superiority study of ZENKUDA for the treatment of patients with Diabetic Retinopathy. ZENKUDA is an anti-VEGF intravitreal biologic built on Kodiak’s proprietary antibody biopolymer conjugate platform.

• According to REGENXBIO’s Q4 2025 financial results and operational update, the company plans to report topline data, in collaboration with AbbVie, from the pivotal ATMOSPHERE and ASCENT trials evaluating sura-vec via subretinal delivery in Q4 2026, with global regulatory submissions anticipated in 2027.

• The Diabetic Retinopathy Market Report provides current treatment practices, emerging drugs, revenue and market share dynamics, peak patient share and therapy uptake analysis, and current and forecasted market size from 2022 to 2036 across the 7MM, along with epidemiology trends, treatment algorithms, and unmet medical needs.

• According to secondary analysis, at any given point, 15–30% of the diabetic population suffers from some form of Diabetic Retinopathy, and approximately half of patients are unaware of their condition due to a lack of symptoms and mild non-proliferative disease that might go undetected.

• Anti-VEGF therapy remains the primary pharmacological approach, preventing abnormal blood vessel growth and leakage, while AVASTIN, often used off-label, is a widely reimbursed option.

• The pipeline includes tarcocimab tedromer (KSI-301) by Kodiak Sciences and ABBV-RGX-314 by Regenxbio and AbbVie, alongside emerging neuroprotective agents, gene therapies, and novel drug delivery systems.

Diabetic Retinopathy Market Overview

Diabetic Retinopathy is a diabetic complication that affects the eyes, caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). It is a diabetes-related microvascular disorder resulting from chronic hyperglycemia and can lead to vision impairment and blindness if left untreated. It is one of the most common causes of severe vision loss among working-age adults, particularly in developed regions.

The disease progresses from non-proliferative diabetic retinopathy (NPDR), an early stage marked by leaky, damaged vessels causing retinal swelling, macular edema, and blurred vision, to proliferative diabetic retinopathy (PDR), an advanced stage characterized by abnormal new vessel growth, bleeding, scar formation, and a high risk of severe vision loss or retinal detachment. The risk and progression of the disease are strongly associated with poor glycemic control, hypertension, dyslipidemia, nephropathy, obesity, and other systemic factors.

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Diabetic Retinopathy Market Key Growth Drivers

• Rising Prevalence of Diabetic Retinopathy: The prevalence is steadily increasing, driven by the global rise in diabetes, improved screening programs, and greater disease awareness. This expanding patient pool is expected to significantly drive market growth over the coming years.

• Growing Opportunities in Targeted Therapies: The landscape is evolving with increasing adoption of anti-VEGF biologics and the emergence of novel therapies, including longer-acting agents, gene therapies, and pathway-targeted treatments. These innovations aim to improve durability, reduce treatment burden, and deliver better visual outcomes.

• Advancing Late-Stage Pipeline: Positive Phase III topline results for ZENKUDA from Kodiak Sciences and upcoming pivotal data for sura-vec from REGENXBIO and AbbVie reflect growing momentum in differentiated therapies addressing persistent unmet needs in durability of response and clinical outcomes.

• Emphasis on Screening and Early Detection: Telemedicine, routine eye screenings, and patient education are enhancing early detection and monitoring, supporting timely intervention and better visual outcomes.

Diabetic Retinopathy Epidemiology

The epidemiology chapter provides historical and forecasted data from 2022 to 2036 across the 7MM, segmented by:

• Total Prevalent Cases of Diabetic Retinopathy

• Gender-specific Prevalent Cases of Diabetic Retinopathy

• Type-specific Prevalent Cases of Diabetic Retinopathy

• Age-specific Prevalent Cases of Diabetic Retinopathy

• Total-treated Cases of Diabetic Retinopathy

Key epidemiology findings:

• According to CDC data, the prevalence of Diabetic Retinopathy in the US rises with age, affecting 13% of individuals under 25 and increasing to 28.4% among those aged 65–79.

• Among US adults aged 40 and above, approximately 8.94 million are affected by Diabetic Retinopathy, with 1.71 million experiencing vision-threatening complications.

• Diabetic Retinopathy affects approximately 3%–4.1% of the European population, with prevalence in those over age 60 highest in France, followed by Germany.

• Non-proliferative Diabetic Retinopathy is notably prevalent across Europe, with the UK exhibiting the highest rate at 48%, followed by Spain at 38.9%, while Germany reports a significantly lower prevalence of 10%.

• In Japan, Diabetic Retinopathy affects around 3 million individuals, ranking as the third leading cause of visual impairment.

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Diabetic Retinopathy Diagnosis and Treatment

Diabetic Retinopathy is assessed through clinical history, ocular examination, and imaging. Patients may present with decreased or fluctuating vision, floaters, or visual field defects. Fundus examination typically reveals microaneurysms, hemorrhages, hard exudates, cotton-wool spots, macular edema, and, in advanced stages, neovascularization. The disease is classified into nonproliferative (mild to severe) and proliferative stages, the latter associated with a higher risk of vision loss. Diagnostic tools include a dilated eye exam, fluorescein angiography to detect vascular leakage and ischemia, and optical coherence tomography (OCT) to evaluate retinal thickness and macular edema. HbA1c remains an essential marker for monitoring glycemic control and disease progression.

Treatment depends on disease stage and severity, with the primary goal of slowing progression and preventing vision loss. In early nonproliferative stages, active treatment may not be required, and management focuses on strict glycemic and blood pressure control with regular monitoring. In advanced stages, particularly PDR or when diabetic macular edema is present, intervention includes intravitreal anti-VEGF injections such as ranibizumab, aflibercept, faricimab, and off-label bevacizumab. Additional options include laser photocoagulation and vitrectomy surgery for complications like vitreous hemorrhage or retinal detachment. Although these treatments can effectively stabilize or slow disease progression, they are not curative, and ongoing monitoring remains essential.

Diabetic Retinopathy Marketed Drugs

• LUCENTIS (ranibizumab): Genentech

LUCENTIS is a vascular endothelial growth factor (VEGF) inhibitor that blocks VEGF from inside the eye. It is administered by intravitreal injection once a month, typically every 28 days. In April 2017, Genentech announced that the US FDA approved LUCENTIS (ranibizumab injection) at a 0.3 mg dose for monthly administration to treat all forms of Diabetic Retinopathy.

• EYLEA (aflibercept): Ionis Pharmaceuticals and AstraZeneca

EYLEA was approved by the FDA for the treatment of Diabetic Retinopathy in 2019, marking the first time a VEGF inhibitor was approved for all stages of the disease, including DME, to reduce the risk of blindness. It is the only VEGF inhibitor approved with two dosing options for DR. The recommended dose is 2 mg administered by intravitreal injection every 4 weeks for the first 5 injections, followed by once every 8 weeks thereafter.

Diabetic Retinopathy Emerging Drugs

• Tarcocimab tedromer (KSI-301): Kodiak Sciences

Tarcocimab tedromer is a novel anti-VEGF biologic built on a proprietary antibody biopolymer conjugate platform, administered via intravitreal injection and expected to inhibit VEGF for up to 6 months continuously. It is intended to provide long-term control of DME, improve visual results, and reduce the burden of frequent anti-VEGF injections. The Phase III GLOW2 study is a multi-center, prospective, randomized, double-masked trial assessing its effectiveness and safety in patients with Diabetic Retinopathy who have not previously undergone treatment.

• ABBV-RGX-314: Regenxbio/AbbVie

ABBV-RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding a monoclonal antibody fragment. The expressed protein is designed to neutralize VEGF activity, modifying the pathway for the formation of new leaky blood vessels and retinal fluid accumulation. It is currently in Phase II development for Diabetic Retinopathy, with the ALTITUDE (NCT04567550) trial using suprachoroidal delivery.

Diabetic Retinopathy Market Outlook

Current treatments for Diabetic Retinopathy are predominantly focused on addressing macular edema, a common complication. Traditional therapies like vitrectomy, photocoagulation, and corticosteroids lack the potential for vision enhancement and are associated with significant complication rates. In recent years, anti-VEGF drugs have emerged as a promising advancement in managing DME, though they may not be effective for all cases, particularly in patients who have undergone multiple treatments.

Corticosteroids like dexamethasone, fluocinolone acetonide, and triamcinolone acetonide reduce inflammation and macular swelling but may cause side effects like increased intraocular pressure and cataracts. Emerging therapies, including neuroprotective agents, gene therapy, and novel drug delivery systems, aim to improve outcomes, while personalized medicine and ongoing research focus on optimizing long-term treatment efficacy and accessibility. Persistent unmet needs include limited disease-modifying therapies, high treatment burden and poor adherence, suboptimal response in a subset of patients, and delayed diagnosis and screening gaps.

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Scope of the Diabetic Retinopathy Market Report

• Study Period: 2022–2036

• Historical Year: 2022–2025

• Forecast Period: 2026–2036

• Base Year: 2026

• Geographies Covered: US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan

• Key Companies: Regenxbio, AbbVie, Kodiak Sciences, Genentech, Ionis Pharmaceuticals, AstraZeneca, and others

• Key Therapies: LUCENTIS (ranibizumab), KSI-301, ABBV-RGX-314, and others

• Analysis: KOL Views, SWOT Analysis, Reimbursement, Conjoint Analysis, Unmet Need, Market Drivers and Barriers

Table of Content

1. Key Insights

2. Report Introduction

3. Executive Summary of Diabetic Retinopathy

4. Key Events

5. Diabetic Retinopathy Market Overview at a Glance

6. Epidemiology and Market Forecast Methodology of Diabetic Retinopathy

7. Disease Background and Overview of Diabetic Retinopathy

8. Epidemiology and Patient Population of Diabetic Retinopathy

9. Patient Journey of Diabetic Retinopathy

10. Marketed Therapies

11. Emerging Therapies

12. Diabetic Retinopathy: Seven Major Market Analysis

13. KOL Views of Diabetic Retinopathy

14. SWOT Analysis of Diabetic Retinopathy

15. Unmet Needs of Diabetic Retinopathy

16. Market Access and Reimbursement of Diabetic Retinopathy

17. Appendix

18. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

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