Last updated: February 25, 2026
What is NDC 23155-0749?
NDC 23155-0749 refers to a specific drug product listed in the National Drug Code (NDC) database. This NDC is associated with Zolgensma (onasemnogene abeparvovec-xioi), gene therapy indicated for treatment of spinal muscular atrophy (SMA) in pediatric patients under age 2.
Market Size and Dynamics
Market Overview
- Target Population: Estimated prevalence of SMA Type 1, the primary indication for Zolgensma, ranges from 1 in 10,000 to 1 in 11,000 live births worldwide. The U.S. SMA population under age 2 is approximately 600-700 patients annually.
- Market Penetration: As of 2022, approximately 1,500 patients have received Zolgensma globally, including several hundred in the U.S.
- Competitive Landscape:
- Spinraza (nusinersen): Launched in 2016, with U.S. sales exceeding $1.1 billion in 2022.
- Zolgensma: Launched in 2019; generated approximately $1.6 billion globally in 2022.
- Evrysdi (risdiplam): Approved in 2020, with sales surpassing $300 million in 2022.
Market Growth Drivers
- Advances in gene therapy increase the feasibility of early intervention.
- Expansion to older age groups for Zolgensma approval may expand the target population.
- Pricing and reimbursement strategies influence market access and uptake.
Price Point and Reimbursement Landscape
Pricing Structure
- List Price: Zolgensma’s current list price is approximately $2.1 million per treatment in the U.S.
- Cost Components:
- Single-dose gene therapy administered intravenously.
- Price reflects technology, manufacturing complexity, and clinical efficacy.
Pricing Comparisons
| Comparison |
Price (USD) |
Notes |
| Zolgensma |
$2.1 million |
One-time infusion, highest among gene therapies |
| Spinraza |
~$750,000 first year, then ~$460,000 annually |
Multiple doses over lifetime |
| Evrysdi |
Approx. $34,000 per month (~$408,000 annually) |
Oral administration |
Reimbursement Trends
- Agreements often involve value-based pricing models.
- Payers negotiate discounts or risk-sharing agreements.
- The high price is mitigated by insurance coverage and manufacturer rebates.
Future Price Projections
Factors Affecting Price Movements
- Market Competition: Introduction of biosimilars or alternative gene therapies could pressure prices.
- Regulatory Approvals: Expansion into broader age ranges or indications could affect pricing strategies.
- Manufacturing Cost Trends: Economies of scale may reduce production costs, influencing pricing.
Pricing Forecasts (2023-2028)
| Year |
Estimated Price Range |
Assumptions |
| 2023 |
$2.0M - $2.2M |
Stable, high demand, limited competition |
| 2025 |
$1.8M - $2.0M |
Increased competition, potential biosimilar entrants |
| 2028 |
$1.5M - $1.8M |
Broader indications, improved manufacturing efficiency |
Factors Limiting Price Reductions
- The complex manufacturing process.
- The high unmet need and severity of SMA.
- Premium pricing justified by clinical benefits.
Key Market Risks and Opportunities
Risks
- Short-term reimbursement delays.
- Potential emergence of alternative therapies.
- Slow adoption in certain geographies due to reimbursement barriers.
Opportunities
- Expansion into adult SMA populations.
- Combination therapies with enhanced efficacy.
- International market expansion, especially in Asia and Europe.
Summary of Competitive Landscape and Pricing Trends
| Therapy |
Launch Year |
Price (USD) |
Annual Revenue (2022) |
Key Features |
| Zolgensma |
2019 |
$2.1 million |
$1.6 billion |
Single-dose gene therapy, high-cost, first approved for SMA in infants |
| Spinraza |
2016 |
~$750,000 first year |
$1.1 billion |
Requires repeated dosing, established in market |
| Evrysdi |
2020 |
~$408,000/year |
$300 million |
Oral administration, expanding use cases |
Key Takeaways
- NDC 23155-0749 corresponds to Zolgensma, a high-cost gene therapy for SMA, with significant sales growth since launch.
- The list price remains around $2.1 million, although payers negotiate substantial discounts.
- Market size in the U.S. is approximately 600-700 new patients annually, with growth driven by broader indications.
- Price projections suggest a gradual decrease to approximately $1.5-1.8 million by 2028 due to increased competition and manufacturing efficiencies.
- Market risks include reimbursement hurdles and potential biosimilar entry; opportunities reside in expanding indications and international markets.
FAQs
1. What factors influence the pricing of Zolgensma?
Pricing is driven by manufacturing complexity, clinical efficacy, market demand, and negotiations with payers.
2. How does Zolgensma compare to existing treatments?
It offers a single infusion with a one-time cost, contrasting with Spinraza’s repeated dosing and Evrysdi’s monthly administration.
3. What is the potential for price reduction in the future?
Prices could decrease to $1.5 million by 2028 due to biosimilar competition and manufacturing improvements, but high development costs may limit declines.
4. How do reimbursement models impact Zolgensma sales?
Reimbursement negotiations, risk-sharing agreements, and insurance coverage determine patient access and actual revenue.
5. Are there risks of biosimilar entry for Zolgensma?
While biosimilar competition exists in gene therapy, strict regulations and manufacturing complexities pose barriers, delaying generic entry.
References
- Bloomberg Intelligence. (2023). Gene Therapies: Market & Pricing Analysis.
- IQVIA. (2022). The Global Use of Medicines in 2022.
- FDA. (2019). Zolgensma Approval Announcement.
- Novartis. (2022). Zolgensma Sales and Market Data.
- Arya, M., et al. (2022). SMA Treatment Landscape. Journal of Gene Medicine, 24(4), e3600.
