Last updated: February 26, 2026
What is the drug associated with NDC 46122-0165?
NDC 46122-0165 corresponds to Vaxneuvance (Prevnar 13) for injection, developed by Merck & Co. It is an approved pneumococcal conjugate vaccine designed for immunization against pneumococcal disease caused by Streptococcus pneumoniae serotypes included in its formulation.
What is the current market size?
The global pneumococcal vaccine market was valued at approximately USD 5.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 7% from 2023 to 2030, reaching USD 10 billion by 2030.
Market segmentation:
| Segment |
2022 Value (USD billion) |
Percentage of Total |
| Pediatric vaccines |
3.1 |
53% |
| Adult vaccines |
2.7 |
47% |
Vaxneuvance primarily targets pediatric and adult markets, with the pediatric segment dominating due to routine immunization programs.
Pricing trends and competitive landscape
Current Pricing
- Vaccine Price (per dose): Reported average prices range from USD 150 to USD 200 per dose in the U.S.
- Market Penetration: Mainly used in high-income countries; expansion into emerging markets remains limited by price and distribution hurdles.
Competitive Landscape
| Vaccine |
Manufacturer |
Coverage |
Year Approved |
Price Range (USD/dose) |
| Prevnar 13 |
Merck |
13 serotypes |
2010 |
USD 150 - 200 |
| Synflorix |
GlaxoSmithKline |
10 serotypes |
2013 |
USD 100 - 150 |
| Pneumovax 23 |
Merck |
23 serotypes |
1979 |
USD 65 - 85 |
Vaxneuvance competes primarily with Prevnar 13, which currently holds approximately 60% of the U.S. pneumococcal vaccine market.
Regulatory and reimbursement environment
- FDA Approval: Vaxneuvance approved in May 2021 for adults aged 50 and older and in infants and children aged 6 weeks to 17 years.
- Reimbursement: Covered under Medicare Part D and private insurance in the U.S., with average reimbursement rates aligned with list prices.
Emerging reimbursement policies in Europe and Asia could influence pricing and market access.
Price projections and future trends
Short-term (2023-2025)
- Stable pricing: No significant price drops expected, driven by limited competition and high demand.
- Pricing pressure: Slight discounts or value-based pricing schemes may emerge as new formulations or biosimilars appear.
Mid- to long-term (2026-2030)
- Potential price decrease: Entry of biosimilars or generics could reduce prices by 20-30%.
- Market expansion: Growth in emerging markets, driven by GAVI and WHO immunization programs, could lead to volume increases but at lower price points (USD 20-50/dose).
- Innovation impact: New formulations offering broader serotype coverage or longer-lasting immunity could command premium pricing.
Key variables influencing prices
- Regulatory approvals in additional markets
- Competitive entries and biosimilar development
- Changes in reimbursement policies
- Manufacturing costs and supply chain stability
Summary
| Aspect |
Details |
| Current market size |
USD 5.8 billion (2022) |
| Projected market size (2030) |
USD 10 billion |
| Current price (U.S.) |
USD 150-200 per dose |
| Long-term price trend |
Mild decrease expected due to biosimilar competition and market expansion |
| Growth drivers |
Increasing adult vaccination, expanding immunization programs in emerging markets, new formulations |
Key Takeaways
- The vaccine is part of a competitive landscape dominated by Prevnar 13.
- Pricing remains stable in high-income markets; discounts are expected with biosimilar entry.
- Market growth fluctuates with global vaccination policies, especially in low- and middle-income regions.
- Pricing strategies and reimbursement policies heavily influence future price trajectories.
- Product innovation can sustain premium pricing or expand market share.
FAQs
-
What regions are most likely to see price reductions for Vaxneuvance?
Emerging markets, where price sensitivity is higher and biosimilars or lower-cost alternatives become available.
-
How does Vaxneuvance compare to Prevnar 13?
It covers similar serotypes with comparable efficacy; however, Prevnar 13 currently holds a larger market share due to earlier market entry and established distribution.
-
Are biosimilars or generics expected for Vaxneuvance?
As a conjugate vaccine, biosimilar development is challenging but possible as patents expire or formulations are adopted by other manufacturers.
-
What impact could new formulations have on pricing?
Formulations offering broader serotype coverage, longer immunity, or fewer doses could command premium prices but may also affect overall market volumes.
-
What factors could influence global adoption?
Regulatory approvals, reimbursement policies, manufacturing capacity, and public health initiatives are key determinants.
References
[1] MarketResearch.com. (2023). Global pneumococcal vaccine market report.
[2] IQVIA. (2023). Vaccine pricing and reimbursement trends.
[3] FDA. (2021). Vaxneuvance approval documentation.
[4] Gavi, the Vaccine Alliance. (2022). Global immunization funding and access report.
