Last updated: March 13, 2026
What Is the Therapeutic Use and Regulatory Status of NDC 76385-0106?
NDC 76385-0106 corresponds to Vaxneuvance (Prevnar 13, 13-valent pneumococcal conjugate vaccine). Manufactured by Merck & Co., Inc., it is indicated for active immunization to prevent pneumococcal disease caused by 13 serotypes in adults aged 50 years and older.
Key Facts:
- Approval date: August 17, 2021 (FDA)
- Label: Pediatric and adult indications
- Packaging options: Vials and prefilled syringes
- Administration: Intramuscular injection
Market Size and Demand Drivers
Pediatric and Adult Pneumococcal Vaccination Market Trends
- The global pneumococcal conjugate vaccine market was valued at USD 6.2 billion in 2022[1].
- Expected CAGR: 8.3% from 2023 to 2030[1].
- The U.S. accounts for approximately 40% of global market demand.
Key Factors Influencing Demand
- Aging Population: Rising vaccination rates among adults aged 50+ due to increased pneumonia risk.
- Childhood Immunization: Established booster schedule; new vaccines supplement existing offerings.
- COVID-19 Impact: Increased vaccination awareness may boost pneumococcal vaccine uptake.
Competitive Landscape
- Existing vaccines: Prevnar 13 (Pfizer), Pneumovax 23 (Merck), Synflorix (GSK)
- Vaxneuvance’s differentiator: Approved for adults 50+ and specific geographic coverage, potentially expanding market penetration.
Pricing Analysis
Current Pricing Landscape
| Product |
Price per Dose (USD) |
Market Share |
Notes |
| Prevnar 13 (Pfizer) |
$170–$190 |
60% |
Market leader, established patent rights |
| Pneumovax 23 (Merck) |
$65–$75 |
30% |
Polysaccharide vaccine, older technology |
| Synflorix (GSK) |
$150–$165 |
7% |
Mainly pediatric, limited adult use |
| Vaxneuvance (Merck) |
Approx. $150–$170* |
Emerging |
New entrant, recent approval in 2021 |
*Estimated based on market analysis and comparator pricing.
Projected Price Trends
- First Year Post-Market: Price likely close to $150–$170, aligning with Prevnar 13 due to similar formulation.
- Long-Term Adjustment: Competition with Prevnar 13 and potential biosimilar entry could drive prices down by 5–10% annually within five years.
- Reimbursement Dynamics: Insurance coverage, CDC recommendations, and purchasing agreements influence net pricing.
Patent and Pricing Policy Implications
- Merck’s patent on Prevnar 13 expired in 2021, but Vaxneuvance holds exclusivity until at least 2026[2], enabling premium pricing.
- Programs like GAVI and PAHO may negotiate lower prices for developing markets; prices there could be 50% of U.S. levels.
Market Entry Barriers and Opportunities
Barriers
- Existing dominance of Prevnar 13.
- High clinical and regulatory standards.
- Established reimbursement pathways.
Opportunities
- Expanded indication for adults 50+ could increase market share.
- Potential for combination vaccines.
- Growing acceptance of adult pneumococcal vaccination programs.
Conclusion
Vaxneuvance is positioned as an innovative adult pneumococcal vaccine with a near-term price similar to Prevnar 13. Its success depends on market penetration, reimbursement policies, and competition from existing vaccines. Price projections suggest a stable initial price with potential gradual decreases due to market competition and patent expiration.
Key Takeaways
- Current market price: USD 150–170 per dose.
- Competitors: Prevnar 13 (Pfizer), Pneumovax 23 (Merck).
- Demand driven by aging population and immunization policies.
- Price stability expected initially, with eventual declines.
- Patent exclusivity until 2026 enables pricing power.
FAQs
What is the primary target population for Vaxneuvance?
Adults aged 50 and older seeking protection against pneumococcal disease.
How does Vaxneuvance compare to Prevnar 13?
It is similar in formulation and pricing but is approved for a broader adult age group, offering potential market expansion.
Will prices for Vaxneuvance decrease as patents expire?
Likely, with biosimilars or competitive pressure reducing the price by 5–10% per year over five years.
What factors could influence the uptake of Vaxneuvance?
Regulatory approvals, CDC recommendations, provider preferences, reimbursement policies, and marketing efforts.
Are there regulatory or policy changes expected that could affect pricing?
Yes, changes in government vaccination subsidies and international procurement policies may impact net prices, especially outside the U.S.
References
- Markets and Markets. (2022). Pneumococcal Vaccine Market - Global Forecast to 2030.
- U.S. Food and Drug Administration. (2021). Vaxneuvance label.
