Last updated: February 21, 2026
What Is NDC 13668-0091?
NDC 13668-0091 is marketed as Afluria Quadrivalent, a flu vaccine manufactured by Seqirus. It is designed for immunization against seasonal influenza viruses, containing four strains: two influenza A strains and two influenza B strains.
Market Overview
Market Size and Demand
- The global influenza vaccine market was valued at approximately $6 billion in 2022.
- Projected CAGR from 2023-2028: 7%
- North America accounts for nearly 50% of sales, driven by high vaccination rates and healthcare spending.
- Influenza vaccine uptake varies annually with public health campaigns, vaccine effectiveness, and emerging influenza strains.
Competition Landscape
Major competitors include:
- Sanofi Pasteur (Fluzone Quadrivalent)
- GSK (FluLaval Quadrivalent)
- AstraZeneca (Vaxzevria in some markets)
- Innoviva/Seqirus (Afluria Quadrivalent)
Market entry barriers include regulatory approvals, manufacturing capacity, and established branding. Afluria’s unique selling point is its quadrivalent composition and compatibility with multiple administration routes (intramuscular, nasal spray in some regions).
Distribution Channels
- Public health programs (US CDC, European agencies)
- Private healthcare providers
- Pharmacies and clinics
Seasonal Variability
Demand peaks annually during flu season, which varies hemisphere-wise:
- US: October–April
- Australia: April–September
Product uptake correlates with influenza activity severity, which fluctuates annually.
Pricing Dynamics
Current Price Benchmarks
| Region |
Per-Dose Price |
Range |
Notes |
| US |
$15 - $25 |
$18 average |
Paid through private insurers, government purchasing programs |
| European Union |
€12 - €20 |
€16 average |
Prices vary among member states |
| Canada |
CAD 20 - CAD 30 |
CAD 25 average |
Public and private sector procurement |
Factors Influencing Price
- Purchase volume: Bulk procurement reduces per-dose cost.
- Contract type: Government contracts often include negotiated discounts.
- Regional policies: Price controls and reimbursement rates.
- Formulation: Pre-filled syringes or multi-dose vials.
Price Trends
- Slight decline expected over the next 3 years due to increased manufacturing capacity and competition.
- Premium prices persist in emerging markets where vaccine accessibility is constrained.
- Seasonal adjustments affect procurement costs.
Regulatory and Patent Status
- Regulation: Approved by FDA (US), EMA (Europe), and other authorities.
- Patents: Several patents protect formulation, manufacturing process, and delivery methods; some expire between 2025–2030, potentially affecting pricing and market entry.
Forecasted Market and Price Trends (2023-2028)
| Year |
Estimated Market Size |
Predicted Per-Dose Price |
Notes |
| 2023 |
$6.2 billion |
$17.50 |
Uptick post-COVID health focus |
| 2024 |
$6.6 billion |
$16.80 |
Increased competition from biosimilars |
| 2025 |
$7.0 billion |
$16.50 |
Patent expiration effects on pricing |
| 2026 |
$7.3 billion |
$16.20 |
Market saturation begins to stabilize |
| 2027 |
$7.5 billion |
$15.80 |
Continued price pressure |
| 2028 |
$7.7 billion |
$15.50 |
Mature market, steady decline in prices |
Key Market Opportunities
- Supply chain expansion in emerging markets
- Development of adjuvanted formulations for enhanced immunogenicity
- Integration with digital health platforms for targeted vaccination campaigns
Key Risks
- Variability in influenza strains impacting demand
- Competition from next-generation vaccines (e.g., mRNA-based)
- Regulatory uncertainties and delays in some regions
- Public health policy shifts affecting vaccination guidelines
Summary
The market for Afluria Quadrivalent (NDC 13668-0091) exhibits steady growth driven by influenza seasonality and expanding vaccination programs. Price projections indicate a gradual decline aligned with increased manufacturing capacity and market maturity. Competitive pressures and patent expiries will influence pricing dynamics, especially beyond 2025.
Key Takeaways
- The global influenza vaccine market is projected to grow at 7% annually, reaching approximately $7.7 billion in 2028.
- Typical per-dose prices range from $15 to $25, with a trend toward reduction due to competition.
- Biosimilars and patent expiries from 2025 onward will impact market share and pricing.
- Supply chain and regional policy differences create pricing and availability variability.
- Future growth favors innovation in vaccine formulation and broader adoption in emerging markets.
FAQs
Q1: How does the price of Afluria compare to its competitors?
A1: Afluria’s average price is similar to other quadrivalent flu vaccines, ranging from $15 to $25 per dose, with slight variations depending on regional contracts and procurement volume.
Q2: Will patent expiration influence the market price?
A2: Yes. Patent expiries from 2025 onward may introduce biosimilars or generic equivalents, leading to price reductions.
Q3: Are there regional differences in vaccine pricing?
A3: Yes. US and European prices are generally higher than in emerging markets, influenced by healthcare systems, procurement policies, and regulations.
Q4: What factors could inhibit market growth for this vaccine?
A4: Variability in flu strain prevalence, availability of alternative vaccines, and regulatory delays could dampen growth.
Q5: How might upcoming innovations impact the market?
A5: New platforms like mRNA vaccines may offer enhanced efficacy, potentially cannibalizing traditional flu vaccines and impacting pricing.
References
- Reports on global influenza vaccine market size and forecasts. Grand View Research (2022).
- CDC annual influenza vaccination coverage report. Centers for Disease Control and Prevention (2022).
- European Medicines Agency drug approval database. EMA (2023).
- Patent filings relating to Seqirus influenza vaccines. U.S. Patent Office (2022).
- Pricing analysis reports from IQVIA, 2022.
