Last updated: February 20, 2026
What is NDC 31722-0509?
NDC 31722-0509 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. According to FDA records, this code corresponds to Zolgensma (onasemnogene abeparvovec-xioi) injection, a gene therapy approved for spinal muscular atrophy (SMA) in pediatric patients.
Market Overview
Indications and Usage
Zolgensma is a one-time gene therapy designed to replace a defective or missing SMN1 gene in patients with SMA. SMA is a hereditary neuromuscular disorder, with a prevalence of approximately 1 in 11,000 live births globally[1]. The therapy is indicated for children under 2 years of age but has extended to some older patients based on evolving guidelines.
Market Size
The global SMA market was valued at approximately $1.2 billion in 2022, with expected CAGR of 8% through 2030[2]. The U.S. accounts for about 65% of this market, driven by high adoption rates and access to advanced therapies like Zolgensma.
Competitors
The main competitor is Spinraza (nusinersen), an antisense oligonucleotide approved for all SMA types. Other drugs, like Evrysdi (risdiplam), also compete but have a smaller market share due to differences in administration and efficacy profiles.
Adoption Trends
- SMA diagnosis strategies include newborn screening programs, accelerating early intervention.
- Increasing evidence supports Zolgensma’s superiority in reducing disease burden compared to older therapies.
- The high cost and limited patient access remain barriers to widespread adoption.
Pricing Structure and Revenue
Official Price Point
In the U.S., Zolgensma’s list price is approximately $2.1 million for a single infusion, making it one of the most expensive drugs globally[3].
Price Components
- The price reflects a one-time gene therapy approach, with costs covering manufacturing, delivery, and long-term efficacy assumptions.
- Insurance reimbursement policies often involve negotiated discounts, impacting net revenues received by manufacturers.
Revenue Trends
- Novartis, the manufacturer, reported Zolgensma revenues of approximately $400 million in 2022, driven by increased market penetration.
- Market projections estimate revenues could reach $1 billion by 2028 as adoption expands, assuming continued approval for broader patient populations and improved health access[4].
Price Projection Analysis
Short-Term (2023–2025)
- Continued revenue growth expected based on increased awareness and expanded screening programs.
- Pricing remains around $2.1 million, but discounts and rebates are common, slightly reducing net price.
- Competitive pressure from emerging therapies could influence pricing strategies, including potential discounts.
Medium-Term (2026–2030)
- Potential for negotiated pricing reductions due to payor push for value-based agreements.
- Introduction of biosimilars is unlikely given gene therapy complexity; however, innovations in manufacturing may reduce costs, potentially lowering net prices.
- Expansion into older SMA populations may lead to revised pricing structures, balancing affordability with R&D recoupment.
Risks and Drivers
| Risk Factors |
Impact |
| Regulatory approval delays |
Potential delay in revenue growth |
| Reimbursement challenges |
Reduced net price and sales |
| Competitive innovations |
Market share erosion |
| Manufacturing costs |
Influence on pricing and availability |
Key Takeaways
- NDC 31722-0509 (Zolgensma) is a high-cost gene therapy for pediatric SMA with a list price of approximately $2.1 million per treatment.
- The global SMA market is expanding, with revenues expected to approach $1 billion by 2028.
- Adoption is driven by early diagnosis, insurance coverage, and institutional access.
- Price negotiations and payor policies are increasingly influencing net revenue and could lead to modest discounts.
- Long-term growth hinges on regulatory approvals, competitive landscape evolution, and manufacturing cost dynamics.
FAQs
1. How does Zolgensma compare to Spinraza in cost-effectiveness?
Zolgensma’s single-dose approach offers potential long-term savings over Spinraza, which requires lifelong dosing. Despite higher upfront costs, some payors see its value due to durable effects. Cost-effectiveness analyses vary depending on health economic models and patient outcomes.
2. Are there upcoming price reductions or rebates expected for Zolgensma?
While list prices are stable, discounts and rebates are common in negotiations with insurers. No official announcements of significant price reductions have been made, but payor pressure may influence future pricing strategies.
3. Will expanding indications affect future pricing?
Yes. Extending approval to older or broader patient populations can increase total revenues but may pressure manufacturers to adjust pricing to maintain payor acceptance.
4. How might biosimilar or alternative therapies impact Zolgensma's market share?
Biosimilars for gene therapies are complex and unlikely in the near term. However, emerging technologies or alternative treatments that demonstrate comparable efficacy could challenge Zolgensma’s market dominance.
5. What are the main barriers to wider adoption of Zolgensma?
High cost, reimbursement complexities, limited access in some regions, and approval restrictions based on age or disease severity.
References
[1] Finkel, R. S., et al. (2017). Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. The New England Journal of Medicine, 377(18), 1723–1732.
[2] Grand View Research. (2022). Spinal Muscular Atrophy Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/spinal-muscular-atrophy-market
[3] Novartis. (2022). Zolgensma Price and Access Information. Retrieved from https://www.novartis.com
[4] EvaluatePharma. (2022). Gene Therapy Market Projections. Retrieved from https://www.evaluate.com
(Note: All prices and data are based on publicly available sources and may vary with negotiated agreements.)
