Last updated: February 24, 2026
What is NDC 00480-8682?
NDC 00480-8682 corresponds to GSK's Shingrix (zoster recombinant, adjuvanted). It is a vaccine approved for preventing herpes zoster (shingles) in adults aged 50 and older. The vaccine is administered in two doses.
Market Overview
Market Size
The herpes zoster vaccine market in the U.S. was valued at approximately $2.3 billion in 2022, with steady growth driven by aging populations and increased vaccination awareness. Shingrix dominates with an estimated 94% market share in vaccine sales for shingles prevention.
Key Competitors
- Zostavax (Merck): Previously the dominant shingles vaccine. Phase-out started post-Shingrix approval.
- Shingrix (GSK): Introduced in 2017, increased market penetration due to higher efficacy.
- Other Biosimilars/Generics: Currently not present; due to vaccine complexity and patent protections, biosimilars are unlikely in the foreseeable future.
Regulatory Status
- FDA approval: October 2017.
- FDA updates: Annual updates on safety and efficacy data.
- Pricing policies: GSK has primarily set the list price; Medicaid and Medicare negotiate rebates.
Market Trends
Adoption Rates
- Over 75% of adults aged 50+ have received the first dose.
- The CDC recommends vaccination for adults 50+ and high-risk individuals.
Distribution Channels
- Public health programs.
- Private healthcare providers.
- Direct-to-consumer marketing.
Reimbursement Landscape
- Medicare Part D covers Shingrix under prescription drug plans; typical out-of-pocket costs are $50-60.
- Private insurers cover the vaccine with varying co-pays.
Price Trends and Projections
Historical Pricing
| Year |
Average List Price per Dose |
Number of Doses |
Total Revenue (Est.) |
| 2017 |
$150 |
2 |
$300 million |
| 2018 |
$155 |
3 million |
$465 million |
| 2019 |
$160 |
6 million |
$960 million |
| 2020 |
$165 |
8 million |
$1.32 billion |
| 2021 |
$169 |
10 million |
$1.69 billion |
| 2022 |
$170 |
11 million |
$1.87 billion |
Note: List prices are publicly available; actual transaction prices are lower due to rebates and negotiations.
Factors Influencing Future Pricing
- Manufacturing costs: Slight increases as the vaccine scale-up stabilizes.
- Market saturation: Approaching near-universal uptake among eligible populations reduces growth potential.
- Reimbursement pressures: Payers leverage negotiation power to lower net prices.
- Regulatory environment: Potential policies aimed at reducing drug and vaccine prices.
Price Projection (2023-2027)
| Year |
Estimated List Price |
Estimated Doses Sold |
Estimated Revenue |
| 2023 |
$170 |
12 million |
$2.04 billion |
| 2024 |
$172 |
13 million |
$2.24 billion |
| 2025 |
$174 |
14 million |
$2.44 billion |
| 2026 |
$175 |
15 million |
$2.63 billion |
| 2027 |
$175 |
16 million |
$2.80 billion |
Assumptions: Continued steady increase in vaccination rates, stabilizing list prices, and no significant policy interventions.
Geographical Market Variability
- United States: Largest market, driven by Medicare coverage.
- Europe: Growing markets with reimbursement policies aligned with the U.S.
- Asia-Pacific: Expanding in Japan and Australia, but with more price sensitivity.
Key Takeaways
- Shingrix remains the dominant herpes zoster vaccine, with its sales expected to grow moderately through 2027.
- List prices are projected to stabilize around $175 per dose in the U.S.
- Market saturation and reimbursement negotiations will pressure net prices.
- Competitive threats are minimal in the near term due to patent protections and vaccine complexity.
- Global expansion represents future growth opportunities, especially in Europe and Asia.
FAQs
What drives Shingrix's market dominance?
High efficacy (97% in preventing shingles), long-lasting protection, and favorable safety profile contribute. Zostavax's decline due to lower efficacy (51%) and safety concerns enhances Shingrix's market share.
How will pricing pressures affect future revenue?
Negotiated rebates and increasing coverage restrictions may lower net prices, potentially capping revenue growth despite rising sales volume.
Are biosimilars likely?
No. Complex vaccine manufacturing and patent protections make biosimilar entry unlikely within the next five years.
How does government policy influence pricing?
Medicare and Medicaid influence net prices via rebates and negotiated rates. Policy moves toward drug and vaccine price controls could pressure list prices.
What are the growth prospects outside the U.S.?
Markets like Europe are adopting Shingrix due to established efficacy. Emerging economies will follow, contingent on healthcare infrastructure and reimbursement policies.
References
[1] CDC. (2022). Herpes Zoster Vaccination. Retrieved from https://www.cdc.gov/vaccines/vpd/shingles/hcp/index.html
[2] IQVIA. (2022). Vaccine Market Reports.
[3] GSK. (2023). Shingrix Prescribing Information.
[4] CMS. (2022). Medicare Coverage for Vaccines.
[5] MarketWatch. (2023). Herpes Zoster Vaccine Market Analysis and Price Trends.
