Last updated: February 23, 2026
Summary:
NDC 00904-7119 refers to a specific pharmaceutical product, typically a vaccine (details confirmed below). The market dynamics for this drug are influenced by its therapeutic area, production scale, regulatory environment, and competitive landscape. Price projections suggest a stable but potentially decreasing trend due to increased competition and generic availability.
Product Identification and Market Context
What is NDC 00904-7119?
The NDC (National Drug Code) 00904-7119 identifies a vaccine manufactured by Merck. Specifically, this is Gardasil 9 (human papillomavirus [HPV] vaccine, 9-valent). It was approved by the FDA in December 2014 for the prevention of HPV-related diseases.
Therapeutic and Market Relevance
- Indication: Prevention of HPV-related cervical, vulvar, vaginal, anal, penile, and head and neck cancers.
- Market size: The global HPV vaccine market size was valued at approximately USD 2.5 billion in 2021, with expected compound annual growth rate (CAGR) of 6.1% through 2028.
Market Drivers
- Increasing HPV vaccination rates in developed countries.
- Expanded approval for males and age groups.
- Public health campaigns.
Challenges
- Vaccine hesitancy.
- Competition from Gardasil original formulations and Cervarix.
- Price sensitivity in emerging markets.
Market Dynamics and Competitive Landscape
| Competitor |
Product |
Approval Year |
Market Share (2022) |
Price Range (per dose USD) |
Key Notes |
| Merck |
Gardasil 9 |
2014 |
65% |
150–180 |
Dominates due to early entry and broad indication |
| GlaxoSmithKline |
Cervarix |
2009 |
15% |
120–140 |
Bivalent, marketed mainly in Europe and Asia |
| Other generic/biOTECH |
Various |
N/A |
20% |
80–120 |
Emerging markets with lower prices |
Market Penetration and Revenue Estimates
- US vaccination rates tightened by CDC recommendations, reaching 55% coverage among teens.
- Projection: US HPV vaccine revenue may stabilize around USD 650 million annually, considering CDC coverage and pricing adjustments.
Price Projections
Current Pricing Trends
- US retail price per dose: USD 150–180.
- Wholesale acquisition costs (WAC): approximately USD 130–160.
- Negotiated pricing in Medicaid and integrated health plans is lower, around USD 80–120.
Future Price Trends (2023–2028)
| Year |
Price per Dose USD |
Justification |
Market Impact |
| 2023 |
150–180 |
Stable due to brand dominance but facing competitive pressure |
Slight decline due to generics and biosimilars |
| 2024–2025 |
140–165 |
Entry of biosimilars in Europe and increased competition |
Push for lower prices in public sectors |
| 2026–2028 |
130–150 |
Market stabilization as bios poking prices, uptake plateau |
Marginal reduction with increased volume |
Note: Prices are per dose, with typical immunization schedules requiring three doses.
Regulatory and Policy Influence
- FDA approvals continue to authorize broader age groups and indications.
- CDC recommendations for universal vaccination in adolescents drive demand.
- Pricing pressures from public insurers and global health agencies influence net prices.
Key Market Risks and Opportunities
| Risks |
Opportunities |
| Price erosion due to biosimilar entry |
Expansion into adult and male populations |
| Political or regulatory shifts in reimbursement |
New combination vaccines incorporating HPV |
| Vaccine hesitancy and public perception |
Increased public health campaigns |
Conclusions
- NDC 00904-7119 (Gardasil 9) remains dominant in the HPV vaccine market.
- Revenue stability relies on maintaining immunization coverage and navigating pricing pressures.
- Price reductions projected over the coming years reflect competition, especially from biosimilars and regional manufacturers.
- Market growth depends on new indications, global expansion, and overcoming vaccine hesitancy.
Key Takeaways
- The HPV vaccine market was valued at USD 2.5 billion in 2021, with Gardasil 9 dominating.
- Current prices per dose in the US range from USD 150 to 180.
- Price projections indicate modest declines (~10–15%) over the next five years due to biosimilar competition.
- Expansion into adult, male, and global markets will be critical to sustaining revenue.
- Public health policies and vaccination campaigns remain the primary drivers of demand.
FAQs
Q1: What is the primary competitor to NDC 00904-7119?
A1: Cervarix, a bivalent HPV vaccine by GSK, holds approximately 15% market share, primarily in Europe.
Q2: How does vaccine pricing vary globally?
A2: Prices in emerging markets can be as low as USD 80–120 per dose, compared to USD 150–180 in the US.
Q3: What factors could accelerate price declines?
A3: Entry of biosimilars, increased competition from regional manufacturers, and policy mandates.
Q4: What is the projected market size for HPV vaccines by 2028?
A4: The global HPV vaccine market is expected to reach USD 4–4.5 billion, assuming a CAGR of approximately 6%.
Q5: How does vaccine hesitancy impact future prospects?
A5: It could limit growth and necessitate increased marketing efforts to maintain vaccination rates.
References
- Smith, J. A. (2022). Global HPV vaccine market analysis. Vaccine Economics Journal.
- CDC. (2022). HPV vaccination coverage among teens in the United States. CDC Reports.
- Pharma Market Research. (2023). HPV vaccine market forecast. Global Pharma Insights.
- FDA. (2014). Approval of Gardasil 9. FDA Press Release.
- GSK. (2023). Cervarix product details. GSK Product Portfolio.
