스타가르트병 : 세계 시장 전망, 역학, 경쟁 구도 시장 예측 리포트(주요 32 시장) - 2025-2035년

Global Stargardt Disease Market Outlook

Thelansis's "Global Stargardt Disease Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report (Top 32 Markets) - 2025 To 2035" covers disease overview, epidemiology, kidney biopsy cases, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Stargardt Disease treatment modalities options for the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America).

Stargardt Disease Overview

Stargardt disease is a rare, inherited macular dystrophy that leads to progressive central vision loss, typically beginning in childhood or adolescence, and is most commonly caused by mutations in the ABCA4 gene. This genetic defect disrupts the normal transport of vitamin A derivatives in photoreceptor cells, resulting in the accumulation of toxic lipofuscin within the retinal pigment epithelium, which damages the macula-the part of the retina responsible for sharp, detailed vision. Patients often report blurred vision, difficulty reading, and increased sensitivity to light, while peripheral vision usually remains preserved. The condition follows an autosomal recessive inheritance pattern and is diagnosed through fundus imaging, optical coherence tomography (OCT), electroretinography, and genetic testing.

Key Highlights

• The incident Stargardt disease population is relatively small but steadily increasing, from 582 cases in 2025 to 622 cases by 2035, reflecting gradual improvements in diagnosis and genetic screening.
• The prevalent population is estimated at 27,426 cases in 2025, increasing to 29,343 by 2035, highlighting the chronic and progressive nature of the disease.
• The treated patient population remains high (89% treatment rate), increasing from 24,409 patients in 2025 to 26,116 by 2035, largely driven by supportive care and emerging therapy access.
• A female predominance (62%) is observed compared to males (38%), consistent across the forecast period.
• Disease burden spans across age groups but shows higher prevalence in middle-aged and older cohorts (40-70 years), reflecting cumulative disease progression over time.
• Despite treatment availability, there remains a significant unmet need, as current therapies do not address the underlying genetic cause or halt disease progression.

Market Overview

• The Stargardt disease market is currently small and largely supportive-care driven, with total market size estimated at $46.7M in 2025, projected to decline slightly in legacy segments but expand overall with pipeline entry.
• Supportive therapies dominate early years, contributing $46-47M annually (2025-2028), but decline to $25M by 2035 as novel therapies gain share.
• Pipeline therapies collectively generate substantial revenue post-2030, with:
• AAVB-039 emerging as a dominant contributor (~$1.5Bn by 2035)
• OCU410ST reaching $320M by 2035
• ALK-001 and Emixustat also showing steady uptake
• The total market transitions from a low-value, fragmented landscape to a high-growth, innovation-driven market, with gene and cell therapies driving exponential value expansion.

Market Definition:

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

Companies Mentioned

• Sanofi
• Alkeus Pharmaceuticals, Inc.
• AAVantgarde Bio Srl
• Ray Therapeutics, Inc.
• Ocugen
• Splice Bio
• Heronova Pharmaceuticals
• Belite Bio, Inc
• Ascidian Therapeutics, Inc
• VeonGen Therapeutics GmbH
• Astellas Pharma Global Development, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)