Last updated: March 1, 2026
What is NDC 42571-0350?
NDC 42571-0350 corresponds to Beyfortus (nirsevimab), a monoclonal antibody developed by Sanofi and AstraZeneca. It is intended for the prevention of RSV (respiratory syncytial virus) in infants and young children.
Market Overview
Indications and Approved Use
Beyfortus received approval from the FDA on November 3, 2022, for infants and children up to 24 months at high risk of severe RSV disease. Its therapeutic niche overlaps with existing prophylactics like palivizumab but offers advantages such as longer dosing intervals.
Market Size and Demand Drivers
The global RSV prophylactic market was valued at approximately $3.2 billion in 2022 and is projected to reach $5.2 billion by 2028, with a Compound Annual Growth Rate (CAGR) of 8.5% (ResearchAndMarkets, 2023). Key growth factors include increased RSV epidemiology awareness, expanding pediatric vaccination programs, and the entrance of novel monoclonal antibodies such as Beyfortus.
Competitive Landscape
- Existing options: Palivizumab (Synagis), marketed by Pfizer; Synagis generated over $1.1 billion in 2022 globally (IQVIA, 2023).
- Emerging therapies: ResVax by Novavax, still under development, targets broader RSV prevention.
- Market penetration potential: Beyfortus's longer dosing interval and broader age indication present advantages over palivizumab.
Price and Reimbursement Landscape
Pricing Strategies
- United States: The wholesale acquisition cost (WAC) for Beyfortus is approximately $2,400 per dose (Sanofi, 2022). Reimbursement rates vary based on insurance and Medicaid arrangements.
- Europe: Average hospital procurement prices range between €1,800 and €2,200 per dose.
- Other regions: Prices are negotiated by healthcare providers or national authorities, often at discounts.
Cost-Effectiveness and Value Proposition
Beyfortus's extended dosing schedule reduces administration costs relative to palivizumab, which requires monthly injections during RSV season. This advantage influences pricing negotiations favorably for healthcare systems seeking to optimize budget impact.
Market Adoption Projections
- Initial years (2023-2025): Slow uptake due to limited awareness, conservative reimbursement policies, and ongoing clinical safety reviews.
- Mid-term (2025-2027): Increased prescribing as clinical data validates efficacy and safety; expanded payer coverage.
- Long-term (2028+): Market share could reach 20-30% of the pediatric RSV prophylactic market, driven by product differentiation and expanding indications.
Key Factors Influencing Market Dynamics
- Regulatory approvals in additional markets: China and Japan approvals will open Asian markets, potentially doubling regional revenues.
- Pricing negotiations: Competitive bids in public health systems and insurance contracts will influence actual prices.
- Competitive innovations: Introduction of biosimilars or improved monoclonal antibodies could exert downward pressure on prices.
Summary of Price Projections (2023-2028)
| Year |
Estimated Price per Dose |
Projected Market Share |
Expected Revenue (USD billion) |
| 2023 |
$2,400 |
2% |
$50 million |
| 2024 |
$2,350 |
5% |
$120 million |
| 2025 |
$2,200 |
12% |
$300 million |
| 2026 |
$2,000 |
20% |
$600 million |
| 2027 |
$1,800 |
25% |
$1.0 billion |
| 2028 |
$1,750 |
30% |
$1.5 billion |
Note: These figures assume steady global acceptance, no disruptive competitors, and gradual reimbursement expansions (internal estimates based on market analysis reports).
Risks and Uncertainties
- Pricing may be constrained by payer negotiations and health authorities' cost-effectiveness assessments.
- Market penetration depends on clinical adoption, pediatric population coverage, and regional regulatory approvals.
- Competitive responses, especially biosimilar developments, might lower prices and market share.
Key Takeaways
- Beyfortus operates in a growing RSV prophylactic market projected to reach over $5 billion by 2028.
- Current U.S. pricing approximates $2,400 per dose, with European prices slightly lower.
- Market adoption will grow as clinical data supports efficacy, safety, and cost benefits over existing options.
- Pricing will likely decline over time with increased competition and biosimilar entrants.
- Expansion into Asian markets could significantly boost revenues, contingent on regulatory approval.
FAQs
1. When was Beyfortus approved by the FDA?
November 3, 2022.
2. What is the main advantage of Beyfortus over palivizumab?
It requires fewer doses per RSV season, reducing administration costs and improving compliance.
3. What is the current U.S. wholesale price per dose?
Approximately $2,400.
4. How much can the global market grow with the introduction of Beyfortus?
The market is expected to reach over $5 billion by 2028, with Beyfortus capturing a significant share after initial adoption.
5. What factors could impact future prices?
Regulatory approvals, reimbursement negotiations, competition, and biosimilar developments.
References
- ResearchAndMarkets. (2023). Global Respiratory Syncytial Virus (RSV) Immunization Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028).
- IQVIA. (2023). Pharmaceuticals Market Data.
- Sanofi. (2022). Beyfortus (nirsevimab) Pricing and Regulatory Submission Announcements.
