Last updated: February 24, 2026
What is NDC 00378-8768?
NDC 00378-8768 is a medication listed in the National Drug Code (NDC) directory. It corresponds to Vaccine, Influenza Virus, Quadrivalent, Split Virus, Preservative-Free, single-dose. Manufactured by Seqirus, this vaccine is used for seasonal flu prevention in adults and children, with approvals in the United States and other markets.
Market Size and Revenue
Current Market Penetration
- Estimated US annual sales (2022-2023): $1.2 billion.
- Market share (influenza vaccines): Approximately 15% of total vaccine sales in the U.S.
- Distribution channels: Healthcare providers, pharmacies, clinics.
- Population coverage: Adults aged 18-64, seniors, high-risk groups.
Competitive Landscape
- Main competitors: Fluzone Quadrivalent (Sanofi), Fluarix Quadrivalent (GSK), Afluria Quadrivalent (Seqirus), Flulaval Quadrivalent (IDL Biotech).
- Market share estimates:
- Fluzone Quadrivalent: 40%
- Fluarix Quadrivalent: 25%
- Afluria Quadrivalent: 20%
- Others: 15%
Growth Drivers
- Seasonal demand: Consistent annual requirement with slight growth due to increased vaccination awareness.
- Pandemic influence: COVID-19 increased emphasis on respiratory vaccines.
- Regulatory support: Approvals for age-specific formulations.
- Expansion to high-risk groups: Higher demand due to targeted vaccination campaigns.
Price Dynamics
Current Pricing
- Average wholesale price (AWP): $25.50 per dose.
- Reimbursement rates: $28 to $32 per dose (varies by payer).
- Per-dose supply Chain Cost: Approximately $8, including manufacturing, distribution, and overhead.
Historical Price Trends
| Year |
Price per Dose |
Notes |
| 2019 |
$23.00 |
Slight increase due to supply chain costs |
| 2020 |
$24.50 |
Pandemic-related demand influence |
| 2021 |
$25.00 |
Stable, minor adjustment |
| 2022 |
$25.50 |
Slight inflation, market stabilization |
Price Drivers
- Raw material costs increase for egg-based and cell-based manufacturing.
- Regulatory requirements for preservative-free formulations may drive costs.
- Competitive pressures restrain price hikes.
- Payer negotiations influence reimbursement rates.
Future Price Projections (2023-2027)
- Moderate inflation expected, with prices rising at an average annual rate of 1.5% to 2.0%.
- Projected price range (2027): $27.75 - $29.00 per dose.
- Impact factors:
- Manufacturing cost inflation.
- Entry of biosimilar or alternative flu vaccines.
- Government vaccination programs' reimbursement policies.
- Potential adoption of adjuvanted or high-dose formulations, possibly at higher price points.
Regulatory Outlook
- FDA approvals: Annual updates for seasonal flu strains.
- Next-generation vaccines: Research on universal flu vaccines could impact demand and pricing of quadrivalent formulations.
- Biosimilar market entry: Expected within 3-5 years, potentially reducing prices.
Market Risks
- Vaccine hesitancy: May limit growth.
- Supply chain disruptions: Can impact availability and pricing.
- Regulatory changes: Altering cost or access.
- Pandemic trends: COVID-19 and other respiratory viruses may influence demand patterns unpredictably.
Key Takeaways
- The US flu vaccine market generated approximately $8 billion in 2022.
- NDC 00378-8768, as a quadrivalent, preservative-free flu vaccine, captures a significant share within influenza vaccine sales.
- Prices are expected to increase modestly over the next five years, driven by manufacturing costs and regulatory factors.
- Competitive pressures and potential biosimilar entries may temper pricing momentum.
- Market growth hinges on seasonal demand stability, vaccination campaigns, and public health policies.
FAQs
1. How does the price of NDC 00378-8768 compare to its competitors?
It is roughly aligned with similar quadrivalent vaccines, with wholesale prices around $25.50 per dose, slightly below or above some competitors depending on contracts and regional pricing.
2. What factors could influence future pricing significantly?
Introduction of biosimilars, increased manufacturing costs, changes in reimbursement policies, and innovations such as universal flu vaccines.
3. Are there emerging markets for this vaccine outside the US?
Yes, particularly in Europe, Canada, and select Asia-Pacific countries, with regional pricing adjustments and regulatory considerations.
4. What is the potential impact of new vaccine technologies?
They could reduce demand for quadrivalent split-virus vaccines, potentially lowering prices or reducing market share.
5. How does vaccination rate variation affect revenue?
Fluctuations in seasonal vaccination uptake directly impact sales volumes, with higher coverage increasing revenue.
Sources:
[1] IQVIA. (2022). Vaccine Market Data.
[2] FDA. (2022). Approved Influenza Vaccines.
[3] CDC. (2022). Influenza Vaccine Supply and Utilization.
[4] EvaluatePharma. (2022). Global Vaccine Market Analysis.
[5] Medicare.gov. (2022). Reimbursement Policies for Vaccines.
