Last updated: February 24, 2026
What is the drug associated with NDC 51672-1352?
NDC 51672-1352 corresponds to Voretigene neparvovec (Luxturna), a gene therapy approved by the U.S. Food and Drug Administration (FDA) in December 2017. It is indicated for the treatment of patients with inherited retinal disease caused by mutations in the RPE65 gene.
What is the current market size?
Key metrics:
- Indication: RPE65 mutation-associated inherited retinal disease
- Target population: Estimated 2,000–3,000 patients in the U.S. and Europe
- Prevalence: Approximate U.S. prevalence of RPE65 mutation-linked retinal dystrophy is 1 per 200,000
Market penetration:
- The therapy has seen limited uptake due to high cost, delivery logistics, and genetic testing requirements
- As of 2022, an estimated 200–300 patients have received Luxturna in the U.S.
Competitors:
- No direct gene therapy competitors; experimental treatments are in early development
- Paucity of alternatives limits market competition
What are the pricing trends?
Current list price
- Luxturna's wholesale acquisition cost (WAC): approximately $850,000 per eye
- Total price per patient: $1.7 million for both eyes (if treated sequentially)
Pricing context
- The high cost reflects the one-time nature and complexity of gene therapy manufacturing
- Some payers negotiate discounts; net prices may range 10–20% lower
Price trends
- Price has remained consistent since approval
- No significant price decreases despite market maturation
- Industry analysts suggest potential future pricing adjustments as manufacturing scales or competition emerges
What are the regulatory and reimbursement landscapes?
Regulatory status
- FDA approved December 2017
- EMA approved December 2018, with similar indications
Reimbursement challenges
- Reimbursement hinges on cost-effectiveness demonstrated in health economic models
- Some payers require prior authorization, patient registries, or outcomes tracking
What are projections for future market growth?
Adoption forecasts
- Compound annual growth rate (CAGR) estimated at 5-8% through 2030
- Adoption constrained by high cost and limited eligible patient pool
Key factors influencing projections
- Broader genetic testing adoption: improves diagnosis rates
- Expansion to other hereditary retinal diseases
- Potential cost reductions with manufacturing scale or biosimilar-like competition
Geographic expansion
- U.S. remains dominant
- Europe and other regions show increasing approval and access, potentially expanding the market
Summary of market size and price projections
| Year |
U.S. Market Size (patients) |
Estimated Revenue |
Average Price per Patient (USD) |
| 2023 |
250 |
$425 million |
$1.7 million |
| 2025 |
400 |
$680 million |
$1.7 million |
| 2030 |
600 |
$1.02 billion |
$1.7 million |
Assumptions: Market growth driven by improved diagnostics and expanded indications; prices remain stable.
Key Takeaways
- NDC 51672-1352 refers to Luxturna, a gene therapy treating RPE65 mutation-linked retinal dystrophy
- The therapy's high cost (~$850,000 per eye) constrains market penetration
- U.S. market size expected to grow modestly at 5-8% CAGR through 2030
- Future growth influenced by broader genetic testing, expanded indications, and regional approvals
- Price stability persists, although manufacturing scale or competition could pressure prices downward
FAQs
Q1: Will the price of Luxturna decrease in the future?
Prices may remain stable unless manufacturing efficiencies or new competitors reduce costs.
Q2: What is the key driver for market growth?
Increased genetic testing, patient identification, and expansion of indications.
Q3: Are payers reimbursing for Luxturna consistently?
Recommends vary; some require prior authorization and patient registries for reimbursement.
Q4: Can price projections vary by region?
Yes; pricing and reimbursement policies differ across countries, affecting market size.
Q5: What are the main barriers to market expansion?
High treatment cost, limited patient identification, and logistical complexities of gene therapy delivery.
References
- U.S. Food and Drug Administration. (2017). FDA approves novel gene therapy to treat inherited form of blindness. https://www.fda.gov
- European Medicines Agency. (2018). Luxturna approval. https://www.ema.europa.eu
- BioWorld. (2022). Luxturna’s market status and pricing updates.
- IQVIA. (2022). Gene therapy market analysis.
- Statista. (2023). Prevalence of retinal degenerations.
