United States Stargardt Disease Therapeutics Market: FDA Breakthrough Designation & Fast Track | Major Companies - Kubota Pharmaceutical Holdings Co., Ltd., Stargazer Pharmaceuticals Inc., Sanofi S.A., Alkeus Pharmaceuticals Inc.

Market Size and Forecast:

The Global Stargardt Disease Therapeutics Market reached USD 197.1 million in 2022 and is projected to witness lucrative growth by reaching up to USD 1,385.6 million by 2031. The global Stargardt Disease Therapeutics market is expected to exhibit a CAGR of 28.8% during the forecast period (2024-2031).

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Stargardt disease therapeutics focus on slowing retinal degeneration and preserving vision in patients with inherited macular dystrophy. Current approaches include gene therapy, stem cell treatment, and visual cycle modulators aimed at correcting genetic defects and protecting photoreceptor cells.

Industry Recent Developments:

United States:

July 2025: Ocugen initiated its Phase 2/3 GARDian3 clinical trial for OCU410ST, a modifier gene therapy for Stargardt disease, marking a pivotal milestone in gene-agnostic retinal treatments.

October 2025: Alkeus Pharmaceuticals presented positive long-term results for its oral drug Gildeuretinol at the AAO 2025 meeting, showing slowed vision loss progression in moderate Stargardt disease patients.

Japan:

August 2025: Astellas Pharma advanced its Phase 2 trial of a complement C5 inhibitor for Stargardt disease, exploring its ability to prevent retinal degeneration through immune modulation.

September 2025: Japanese ophthalmology research centers expanded participation in multinational gene therapy trials targeting ABCA4 mutations, supporting collaboration in next-generation Stargardt disease therapeutics.

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Major Key Players:

Kubota Pharmaceutical Holdings Co., Ltd.
Stargazer Pharmaceuticals Inc
Sanofi S.A.
Alkeus Pharmaceuticals Inc
Astellas Pharma Inc.
CHABiotech CO., Ltd.
ReVision Therapeutics, Inc.
Lin BioScience, Inc.
Biogen Inc.
F. Hoffmann-La Roche AG

Segments Covered in the Stargardt Disease Therapeutics Market:

➥ By Drug Type: LBS-008, Emixustat
➥ By Age Group: Children, Adult
➥ By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Stargardt Disease Therapeutics Market market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Stargardt Disease Therapeutics Market Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Stargardt Disease Therapeutics Market market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Stargardt Disease Therapeutics Market Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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