Stargardt Disease Market Predicted to See Upsurge Through 2034, Highlights DelveInsight | Acucela, Astellas Pharma, Alkeus Pharma

The Key Stargardt Disease Companies in teh market include - Ocugen, Kubota Vision Inc, Nanoscope Therapeutics Inc., RBP4 Pty Ltd, Stargazer Pharmaceuticals, Inc., Belite Bio, Inc, Alkeus Pharmaceuticals, Inc., IVERIC bio, Inc., Kubota Vision Inc., Astellas Institute, Nanoscope Therapeutics, Alkeus Pharmaceuticals, and others.

The Stargardt Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Stargardt Disease pipeline products will significantly revolutionize the Stargardt Disease market dynamics.

DelveInsight's "Stargardt Disease Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Stargardt Disease, historical and forecasted epidemiology as well as the Stargardt Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Stargardt Disease market report covers emerging drugs, current treatment practices, market share of the individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

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Some of the key facts of the Stargardt Disease Market Report:

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The Stargardt Disease market size was valued ~USD 27 million in 2024 and is anticipated to grow with a significant CAGR during the study period (2020-2034)

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In March 2025, Barcelona-based genetic medicines company SpliceBio administered the first dose in its Phase 1/2 ASTRA clinical trial (NCT identifier pending), evaluating SB-007, a dual AAV vector-based gene therapy for Stargardt disease. This inherited retinal dystrophy, caused by ABCA4 gene mutations, is a progressive condition with no currently approved treatments.

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In February 2025, Ocugen, Inc. (NASDAQ: OCGN), a biotechnology leader in gene therapies for blindness-related diseases, has secured FDA alignment to proceed with a Phase 2/3 pivotal confirmatory trial for OCU410ST. If successful, the trial could support a biologics license application (BLA) submission.

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In December 2024, The FDA approved SpliceBio's IND application to initiate a clinical trial for SB-007, a protein splicing gene therapy aimed at treating Stargardt disease. As the first therapy to receive this clearance, SB-007 targets the genetic root cause of the disease and has the potential to benefit all patients, regardless of their ABCA4 mutation. SpliceBio plans to launch the Phase I/II ASTRA trial in the first half of next year.

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In September 2024, Nanoscope Therapeutics Inc. announced a successful End-of-Phase II (EOP2) meeting with the FDA, discussing its clinical program for MCO-010 in treating severe vision loss from Stargardt Macular Degeneration (SMD). The meeting supports the advancement of MCO-010 into a Phase III registrational trial.

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In August 2024, Ocugen, Inc. announced the completion of dosing in the third cohort of its Phase I/II GARDian clinical trial for OCU410ST (AAV-hRORA), a modifier gene therapy candidate designed to treat Stargardt disease.

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In July 2024, Alkeus Pharmaceuticals Inc. presented interim findings from its TEASE-3 study, revealing that early-stage Stargardt disease patients treated with gildeuretinol acetate showed no disease progression and remained asymptomatic while receiving treatment for 2 to 6 years.

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In January 2024, Alkeus Pharmaceuticals disclosed encouraging interim findings indicating that gildeuretinol effectively arrested the progression of Stargardt disease for a period of up to six years. Within the ongoing TEASE-3 clinical trial targeting early-stage Stargardt disease, the initial three adolescent participants who received oral gildeuretinol acetate remained symptom-free and did not experience any advancement of the disease throughout their treatment duration, which ranged from two years for one patient to six years for two patients.

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According to information from Orphanet (2023), the prevalence of Stargardt Disease is approximated to vary between 1 in 8,000 to 1 in 10,000 people, with both males and females equally impacted by the condition in Europe.

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According to the NIH (2023), the projected prevalence of Stargardt macular degeneration stands at approximately 1 in 6,500 individuals within the United States.

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In 2023, the United States had the highest number of diagnosed prevalent cases of Stargardt, representing 43.0% of the total diagnosed-incident cases across the 7MM.

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In the EU4 and the UK, Germany reported the highest number of Stargardt disease cases, followed by the UK, while Spain had the fewest prevalent cases.

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Throughout the forecast period (2024-2034), pipeline candidates like ALK-001 (gildeuretinol), Tinlarebant (LSB-008), IZERVAY (avacincaptad pegol), MCO-010 (Sonpiretigene Isteparvovec), and Emixustat are anticipated to contribute to the growth of the Stargardt disease market.

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By 2034, MCO-010 (Sonpiretigene Isteparvovec) is projected to capture the largest market share, with ALK-001 (gildeuretinol) following in the 7MM.

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Key Stargardt Disease Companies: Ocugen, Kubota Vision Inc, Nanoscope Therapeutics Inc., RBP4 Pty Ltd, Stargazer Pharmaceuticals, Inc., Belite Bio, Inc, Alkeus Pharmaceuticals, Inc., IVERIC bio, Inc., Kubota Vision Inc., Astellas Institute, Nanoscope Therapeutics, Alkeus Pharmaceuticals, and others

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Key Stargardt Disease Therapies: OCU410ST, Emixustat, Gene Therapy-vMCO-010, tinlarebant, STG-001, Tinlarebant, ALK-001, Zimura, Emixustat, MA09-hRPE, MCO-010 (Sonpiretigene Isteparvovec), ALK-001 (Gildeuretinol), and others

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The Stargardt Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Stargardt Disease pipeline products will significantly revolutionize the Stargardt Disease market dynamics.

Stargardt Disease Overview

Stargardt disease, also known as Stargardt macular dystrophy or juvenile macular degeneration, is a genetic eye disorder that affects the macula, a small area near the center of the retina responsible for sharp, central vision. It is typically diagnosed in childhood or adolescence. Stargardt disease is characterized by the gradual degeneration of the cells in the macula, leading to progressive central vision loss.

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Stargardt Disease Market

The dynamics of the Stargardt Disease market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecasted period 2020-2034.

"In the near future, there are some positive candidates in the developmental stage by key players such as Acucela Inc (Kubota), Alkeus Pharmaceuticals Inc, Astellas Pharma Inc, Revision Therapeutics and others."

Stargardt Disease 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.

Stargardt Disease Epidemiology Segmentation:

The Stargardt Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Stargardt Disease

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Prevalent Cases of Stargardt Disease by severity

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Gender-specific Prevalence of Stargardt Disease

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Diagnosed Cases of Episodic and Chronic Stargardt Disease

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Stargardt Disease Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Stargardt Disease market or expected to get launched during the study period. The analysis covers Stargardt Disease 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 Stargardt Disease 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 analyses recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Stargardt Disease Therapies and Key Companies

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OCU410ST: Ocugen

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Emixustat: Kubota Vision Inc

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Gene Therapy-vMCO-010: Nanoscope Therapeutics Inc.

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tinlarebant: RBP4 Pty Ltd

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STG-001: Stargazer Pharmaceuticals, Inc.

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Tinlarebant: Belite Bio, Inc

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ALK-001: Alkeus Pharmaceuticals, Inc.

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Zimura: IVERIC bio, Inc.

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Emixustat: Kubota Vision Inc.

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MA09-hRPE: Astellas Institute

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Emixustat : Kubota Pharmaceuticals

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MCO-010 (Sonpiretigene Isteparvovec): Nanoscope Therapeutics

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ALK-001 (Gildeuretinol): Alkeus Pharmaceuticals

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Stargardt Disease Market Strengths

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Stargardt Disease has a well-identified genetic basis, primarily associated with mutations in the ABCA4 gene, allowing for targeted research and potential therapeutic interventions.

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Regulatory agencies, such as the FDA, recognize Stargardt Disease as an orphan disease, providing incentives for the development of orphan drugs and accelerated approval pathways.

Stargardt Disease Market Opportunities

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Ongoing research in gene therapies, pharmacological interventions, and emerging technologies provides opportunities for the development of novel and effective treatments.

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Rapid advancements in genetic technologies, including CRISPR-Cas9, offer potential breakthroughs in gene editing and correction of ABCA4 mutations

Scope of the Stargardt Disease Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Stargardt Disease Companies: Ocugen, Kubota Vision Inc, Nanoscope Therapeutics Inc., RBP4 Pty Ltd, Stargazer Pharmaceuticals, Inc., Belite Bio, Inc, Alkeus Pharmaceuticals, Inc., IVERIC bio, Inc., Kubota Vision Inc., Astellas Institute, Nanoscope Therapeutics, Alkeus Pharmaceuticals, and others

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Key Stargardt Disease Therapies: OCU410ST, Emixustat, Gene Therapy-vMCO-010, tinlarebant, STG-001, Tinlarebant, ALK-001, Zimura, Emixustat, MA09-hRPE, MCO-010 (Sonpiretigene Isteparvovec), ALK-001 (Gildeuretinol), Zimura, and others

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Stargardt Disease Therapeutic Assessment: Stargardt Disease current marketed and Stargardt Disease emerging therapies

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Stargardt Disease Market Dynamics: Stargardt Disease market drivers and Stargardt Disease market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Stargardt Disease Unmet Needs, KOL's views, Analyst's views, Stargardt Disease Market Access and Reimbursement

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Table of Contents

1. Stargardt Disease Market Report Introduction

2. Executive Summary for Stargardt Disease

3. SWOT analysis of Stargardt Disease

4. Stargardt Disease Patient Share (%) Overview at a Glance

5. Stargardt Disease Market Overview at a Glance

6. Stargardt Disease Disease Background and Overview

7. Stargardt Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Stargardt Disease

9. Stargardt Disease Current Treatment and Medical Practices

10. Stargardt Disease Unmet Needs

11. Stargardt Disease Emerging Therapies

12. Stargardt Disease Market Outlook

13. Country-Wise Stargardt Disease Market Analysis (2020-2034)

14. Stargardt Disease Market Access and Reimbursement of Therapies

15. Stargardt Disease Market Drivers

16. Stargardt Disease Market Barriers

17. Stargardt Disease Appendix

18. Stargardt Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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