Diabetic Macular Edema Market: Strong Pharma Growth Forecast Through 2034 - DelveInsight

DelveInsight's "Diabetic Macular Edema Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Diabetic Macular Edema, historical and forecasted epidemiology as well as the Diabetic Macular Edema market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

The latest healthcare forecast report provides an in-depth analysis of Diabetic Macular Edema, offering comprehensive insights into the Diabetic Macular Edema revenue trends, prevalence, and treatment landscape. The report delves into key Diabetic Macular Edema statistics, highlighting the current and projected market size, while examining the efficacy and development of emerging Diabetic Macular Edema therapies. Additionally, we cover the landscape of Diabetic Macular Edema clinical trials, providing an overview of ongoing and upcoming studies that are poised to shape the future of Diabetic Macular Edema treatment. This report is an essential resource for understanding the market dynamics and the evolving therapeutic options within the Diabetic Macular Edema space.

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Some of the key facts of the Diabetic Macular Edema Market Report:
• The Diabetic Macular Edema market size was valued ~USD 2.9 billion in 2022 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
• In January 2026, Bio Usawa Biotechnology Ltd. (Bio Usawa, Inc.) announced that the Ghana Food and Drugs Authority (Ghana FDA) has approved BioUcentaTM, a biosimilar of Lucentis® (ranibizumab), for the treatment of diabetic macular edema, age-related macular degeneration, and diabetic retinopathy. This approval follows recent authorization by the Rwanda FDA, highlighting the increasing regulatory support for biosimilars across Africa and facilitating wider regional access to essential biologic therapies. BioUcentaTM is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG.
• In October 2025, Eydenzelt has received FDA approval for four retinal conditions, including wet age-related macular degeneration and diabetic macular edema. According to a Celltrion press release, Eydenzelt, a biosimilar of Eylea, is approved for treating wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
• In July 2025, Boehringer Ingelheim has announced the initiation of the Phase II THULITE clinical trial, which will assess the efficacy, safety, and tolerability of BI 1815368, an oral treatment for diabetic macular edema (DME).
• In July 2025, ANI Pharmaceuticals, Inc. reported results from the NEW DAY clinical trial evaluating ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg, for the treatment of patients with diabetic macular edema (DME).
• In May 2025, Innovent Biologics has administered the first dose to a patient in its Phase II clinical trial evaluating efdamrofusp alfa for treating diabetic macular edema (DME).
• In March 2025, Unity Biotechnology reported topline results from its Phase 2b ASPIRE clinical trial evaluating intravitreal UBX1325 in patients with diabetic macular edema (DME) who continued to experience poor vision despite prior anti-VEGF therapy. The trial data includes outcomes for all participants through 24 weeks and most through 36 weeks. ASPIRE (NCT06011798) is a multi-center, randomized, double-masked, active-controlled Phase 2b study. A total of 52 patients were enrolled and randomly assigned in a 1:1 ratio to receive either 10 μg of UBX1325 or 2 mg of aflibercept every 8 weeks for six months following randomization.
• In March 2025, Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness-related conditions, announced that the Data and Safety Monitoring Board (DSMB) has reviewed safety data from the first cohort in the dose-escalation phase of its Phase 1 OCU200 clinical trial. Based on this evaluation, the DSMB has given the green light to begin dosing the second cohort. OCU200 is an innovative fusion protein combining tumstatin and transferrin, being developed as a potential therapy for diabetic macular edema (DME).
• In February 2025, EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), focused on developing innovative therapies for serious retinal diseases, has shared promising six-month data from its ongoing Phase 2 VERONA trial of DURAVYUTM (vorolanib intravitreal insert). This investigational, sustained-release treatment utilizes the company's proprietary bioerodible Durasert ETM platform to deliver the selective tyrosine kinase inhibitor, vorolanib. The study successfully met its primary endpoint by significantly delaying the need for supplemental injections compared to the aflibercept control group in both DURAVYU dosage arms. Notably, patients experienced sustained visual improvement and anatomical stability, with no serious ocular or systemic adverse events related to DURAVYU. At week 24, the 2.7mg dose group achieved a +7.1 letter improvement in best corrected visual acuity (BCVA) and a 76-micron decrease in central subfield thickness (CST), with 73% of patients avoiding supplemental injections versus 50% in the aflibercept group. These results highlight DURAVYU's strong therapeutic promise for treating severe retinal conditions.
• In January 2025, Ocugen, Inc. (NASDAQ: OCGN), a biotechnology firm focused on developing cutting-edge gene and cell therapies, biologics, and vaccines, has announced that the first patient has been successfully dosed in its Phase 1 clinical trial of OCU200, a potential treatment for diabetic macular edema (DME).
• The United States represents the largest share of the Diabetic Macular Edema (DME) market, accounting for roughly 60%, compared with the EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
• Due to its larger patient population and higher treatment costs, estimates indicate that the United States accounted for the largest share of the DME market in 2023, representing approximately 60% of the total market size across the 7MM, followed by Germany and Japan.
• Key Diabetic Macular Edema Companies: Surrozen, AskGene Pharma, Inc., Therini Bio Pty Ltd, Innovent Biologics Technology Limited, Kodiak sciences, Oculis, Eluminex BioSciences, Ocugen, Innovent biologics, Curacle, GlaxoSmithKline, Exonate Limited, Ocuphire Pharma, Unity Biotechnology, Allgenesis Biotherapeutics Inc., Mylan, Kodiak Sciences, Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Graybug Vision, Oxurion, Novartis, YD Life Science, Allegro, Opthalmics/Bausch Health, Clearside Biomedical, KalVista Pharmaceuticals, and others
• Key Diabetic Macular Edema Therapies: SZN 8143, EB-105, ASKG712, THN391, IBI302, Tarcocimab tedromer, OCS-01, EB-102, OCU200, IBI324, CU06-1004, GSK-2798745, EXN407, APX3330, UBX1325, AG-73305, MYL-1701P, KSI-301, BEOVU (RTH258; brolucizumab), VABYSMO (faricimab), KSI-301, ADVM-022, GB-102, THR-149, LKA651, YD-312, Luminate (ALG-1001, Risuteganib), Xipere (CLS-TA), KVD001, and others
• The Diabetic Macular Edema market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Diabetic Macular Edema pipeline products will significantly revolutionize the Diabetic Macular Edema market dynamics.
• The United States accounted for the highest number of total prevalent diabetic macular edema cases among the 7MM.
• Among the EU4 and the UK, Germany accounted for the largest share of diabetic macular edema cases, representing approximately 30%.
• In 2023, gender-based prevalence data from the United States indicated that about 57% of cases occurred in males, compared with roughly 40% in females.

Diabetic Macular Edema Overview
Diabetic Macular Edema (DME) is a complication of diabetes that affects the retina, specifically the macula, which is responsible for sharp, central vision. DME occurs when high blood sugar levels damage the blood vessels in the retina, causing them to leak fluid and leading to swelling in the macula. This swelling disrupts vision and can result in blurred or distorted central vision. DME is a leading cause of vision loss in people with diabetes. Early detection and treatment, such as anti-VEGF injections or laser therapy, can help manage the condition and prevent further vision loss.

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Diabetic Macular Edema Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Diabetic Macular Edema Epidemiology Segmentation:
The Diabetic Macular Edema market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalent Cases of DME in the 7MM
• Total Diagnosed Prevalent Cases of DME in the 7MM
• Gender-specific Diagnosed Prevalent Cases of DME in the 7MM
• Age-Specific Diagnosed Prevalent Cases of DME in the 7MM
• Subgroup-specific Diagnosed Prevalent Cases of DME in the 7MM
• Treated cases of DME in the 7MM

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Diabetic Macular Edema Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Diabetic Macular Edema market or expected to get launched during the study period. The analysis covers Diabetic Macular Edema market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Diabetic Macular Edema Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Diabetic Macular Edema Therapies and Key Companies
• SZN 8143: Surrozen
• ASKG712: AskGene Pharma, Inc.
• THN391: Therini Bio Pty Ltd
• IBI302: Innovent Biologics Technology Limited
• Tarcocimab tedromer: Kodiak sciences
• OCS-01: Oculis
• EB-102: Eluminex BioSciences
• OCU200: Ocugen
• IBI324: Innovent biologics
• CU06-1004: Curacle
• GSK-2798745: GlaxoSmithKline
• EXN407: Exonate Limited
• APX3330: Ocuphire Pharma
• UBX1325: Unity Biotechnology
• AG-73305: Allgenesis Biotherapeutics Inc.
• MYL-1701P: Mylan
• KSI-301: Kodiak Sciences
• BEOVU (RTH258; brolucizumab): Novartis
• VABYSMO (faricimab): Roche
• KSI-301: Kodiak Sciences
• ADVM-022: Adverum Biotechnologies
• GB-102: Graybug Vision
• THR-149: Oxurion
• LKA651: Novartis
• YD-312: YD Life Science
• Luminate (ALG-1001, Risuteganib): Allegro Opthalmics/Bausch Health
• Xipere (CLS-TA): Clearside Biomedical
• KVD001: KalVista Pharmaceuticals

Discover more about therapies set to grab major Diabetic Macular Edema market share @ Diabetic Macular Edema Treatment Landscape
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Diabetic Macular Edema Market Drivers
• Rising global prevalence of diabetes is significantly increasing the patient pool for diabetic macular edema (DME).
• Greater awareness and improved screening programs are enabling earlier diagnosis and treatment initiation.
• Strong adoption of anti-VEGF therapies and corticosteroid implants is driving market growth.
• Ongoing innovation, including long-acting formulations and novel delivery systems, is expanding treatment options.

Diabetic Macular Edema Market Barriers
• High treatment costs and frequent injection requirements can limit patient adherence.
• Limited access to advanced ophthalmic care in low- and middle-income regions restricts market expansion.
• Potential safety concerns and variable patient response to existing therapies pose clinical challenges.
• Reimbursement constraints and pricing pressure may hinder uptake of newer therapies

Scope of the Diabetic Macular Edema Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Diabetic Macular Edema Companies: Surrozen, AskGene Pharma, Inc., Therini Bio Pty Ltd, Innovent Biologics Technology Limited, Kodiak sciences, Oculis, Eluminex BioSciences, Ocugen, Innovent biologics, Curacle, GlaxoSmithKline, Exonate Limited, Ocuphire Pharma, Unity Biotechnology, Allgenesis Biotherapeutics Inc., Mylan, Kodiak Sciences, Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Graybug Vision, Oxurion, Novartis, YD Life Science, Allegro, Opthalmics/Bausch Health, Clearside Biomedical, KalVista Pharmaceuticals, and others
• Key Diabetic Macular Edema Therapies: SZN 8143, EB-105, ASKG712, THN391, IBI302, Tarcocimab tedromer, OCS-01, EB-102, OCU200, IBI324, CU06-1004, GSK-2798745, EXN407, APX3330, UBX1325, AG-73305, MYL-1701P, KSI-301, BEOVU (RTH258; brolucizumab), VABYSMO (faricimab), KSI-301, ADVM-022, GB-102, THR-149, LKA651, YD-312, Luminate (ALG-1001, Risuteganib), Xipere (CLS-TA), KVD001, and others
• Diabetic Macular Edema Therapeutic Assessment: Diabetic Macular Edema current marketed and Diabetic Macular Edema emerging therapies
• Diabetic Macular Edema Market Dynamics: Diabetic Macular Edema market drivers and Diabetic Macular Edema market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Diabetic Macular Edema Unmet Needs, KOL's views, Analyst's views, Diabetic Macular Edema Market Access and Reimbursement

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