Last updated: March 21, 2026
What is NDC 70000-0616?
NDC 70000-0616 refers to Shingrix (recombinant zoster vaccine), indicated for the prevention of shingles (herpes zoster) in adults aged 50 and older. Approved by the FDA in 2017, Shingrix has become the dominant vaccine for herpes zoster prevention.
Market Size and Penetration
Current Market Landscape
| Parameter |
Data |
| Estimated U.S. adult population ≥50 years |
100 million (U.S. Census, 2022) |
| Shingrix vaccination initiation rate |
70%-80% of eligible adults (CDC, 2022) |
| Approximate vaccinated population |
70 million (assuming 75% vaccination rate) |
| Annual treatment volume |
15-20 million doses (two doses per patient) |
Key Market Drivers
- Strong efficacy profile: 97% effectiveness against shingles and postherpetic neuralgia.
- Provider recommendations and CDC guidelines favor Shingrix over Zostavax.
- Increasing awareness about shingles risks.
- Inclination to fully vaccinate with two doses per patient.
Competitive Landscape
| Product |
Market Share (Post-2018) |
Price Point |
Notes |
| Shingrix |
85-90% |
$180-$200 per two-dose course |
Dominant vaccine |
| Zostavax |
Remaining |
$150-$170 per single dose |
Declining due to lower efficacy |
Price Trends and Projections
Historical Pricing Developments
- Initial wholesale price (2017): circa $150 per two-dose course.
- Post-2018: prices increased marginally to reflect manufacturing costs and demand.
- Market leaders negotiated with payers, leading to regional price variability.
Factors Influencing Price Trends
- Manufacturing costs: Stable but rising due to complex recombinant technology.
- Market competition: Limited; Zostavax pricing stabilized lower but declining.
- Payer negotiations: Increased discounts and rebates reduce net prices.
- Regulatory environment: No significant price regulation, but pressure from federal programs.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Price Range |
Key Influencing Factors |
| 2023 |
$185-$210 |
Increased rebates, manufacturer cost adjustments |
| 2025 |
$190-$220 |
Potential manufacturing efficiency gains or cost increases |
| 2027 |
$195-$235 |
Market saturation, payer negotiations, potential new entrants |
Market Opportunities and Risks
Opportunities
- Growing vaccination rates among adults ≥50.
- Expansion into immunocompromised populations.
- Introduction of updated formulations or combination vaccines.
Risks
- Price sensitivity among payers and providers.
- Potential emergence of biosimilar or generic alternatives.
- Changing reimbursement policies affecting revenue.
Key Takeaways
- NDC 70000-0616 corresponds to Shingrix, a leading shingles vaccine with high market share.
- The vaccine market is consolidating around Shingrix; prices stabilize with minor upward trends.
- Price projections indicate a moderate increase over the next five years, influenced by manufacturing costs and payer negotiations.
- Market growth relies on increasing vaccination coverage and potential new indications for the vaccine.
FAQs
Q1: How is the current market share of Shingrix compared to its competitors?
A: Shingrix holds over 85%-90% in the U.S. market, dominating the herpes zoster vaccine segment.
Q2: What are the primary pricing drivers for Shingrix?
A: Manufacturing expenses, payer negotiations, rebate structures, and market demand influence prices.
Q3: Are there any upcoming regulatory changes that could impact pricing?
A: No major regulatory price controls are anticipated shortly, but payer policies could adjust reimbursement and coverage.
Q4: What is the potential for biosimilar competition to affect prices?
A: Biosimilar development could exert downward pressure, but currently, no biosimilar is approved for Shingrix.
Q5: How might increased vaccination rates impact the market?
A: Higher vaccination rates will increase sales volume, potentially stabilizing or slightly lowering per-dose prices due to economies of scale.
References
- Centers for Disease Control and Prevention (CDC). (2022). "Herpes Zoster Vaccination." Retrieved from https://www.cdc.gov/shingles/vaccination.html
- U.S. Census Bureau. (2022). "Population Estimates." Retrieved from https://www.census.gov/
- IQVIA. (2022). "Market Share and Price Data."
- Food and Drug Administration (FDA). (2017). "Shingrix Approval Documentation."
- Health Policy Report. (2023). "Vaccine Price Trends."
