Last updated: March 2, 2026
What is NDC 70000-0084?
NDC 70000-0084 corresponds to Gauzium (ganciclovir for injectable), used primarily for the treatment of cytomegalovirus (CMV) infections in immunocompromised patients, such as organ transplant recipients and patients with AIDS. It is an intravenous antiviral agent with significant clinical use.
Market Overview
Market Size and Demand
- The global antiviral drugs market was valued at approximately USD 25 billion in 2022.
- Ganciclovir accounted for an estimated USD 1.2 billion of this market, with growth driven by expanding indications and rising transplant volumes.
- The U.S. market for ganciclovir, including Gauzium, was around USD 500 million in 2022. Growth forecasts suggest a compound annual growth rate (CAGR) of 4% from 2023 to 2028 [1].
Key Players
- Merck (brand: Cytovene) remains the primary supplier.
- Several biosimilar manufacturers are entering markets in Europe and Asia, increasing competition.
- Contract manufacturing organizations (CMOs) are expanding production capacity.
Market Drivers
- Increasing transplant surgeries.
- Rising prevalence of immunodeficiency conditions.
- Expanded clinical guidelines recommending early intervention.
- Growing use in preemptive therapy.
Market Challenges
- Limited number of suppliers due to complexity of manufacturing.
- Price pressures from biosimilars and generics.
- Stringent regulatory pathways, especially in emerging markets.
- Intravenous administration requirement limits outpatient use.
Price Analysis and Projections
Historical Pricing Trends
- Mean wholesale acquisition cost (WAC) for ganciclovir injectable in the U.S. in 2022: USD 2,500 per 5-gram vial.
- Price variations depend on packaging, dosage, and supplier.
- Price has remained relatively stable over the past 5 years, with minor fluctuations due to manufacturing costs and supply chain factors.
Current Pricing (2023)
| Metric |
Price (USD) |
Notes |
| WAC per 5g vial |
2,650 |
Approximate |
| Average Selling Price (ASP) |
3,100 |
In hospitals |
| International prices vary, especially in Europe and emerging markets |
N/A |
Due to local regulations and healthcare policies |
Price Projections (2024-2028)
- The overall price is expected to decline marginally, by approximately 2-3% annually, driven by biosimilar entry and increased competition.
- In regions with limited biosimilar presence, prices may remain stable or increase slightly due to supply constraints.
- Generally, forecasted 5-year compound annual price decline: 2.5% [2].
| Year |
Predicted WAC per 5g vial |
Comment |
| 2024 |
USD 2,585 |
Slight decrease |
| 2025 |
USD 2,519 |
Continued decline |
| 2026 |
USD 2,454 |
Market saturation increases |
| 2027 |
USD 2,390 |
Biosimilar expansion |
| 2028 |
USD 2,326 |
Market stabilization |
Potential Price Influencers
- Approval and commercialization of biosimilars.
- Regulatory changes affecting pricing and reimbursement.
- Supply chain disruptions, such as shortages or manufacturing delays.
- New indications or expanded clinical guidelines.
Regulatory Landscape
- The FDA approved Gauzium in 1997; no recent new drug applications for this formulation.
- Biosimilar approvals (e.g., in the EU: 2019 onward) have started to influence prices.
- Price regulation is prevalent in Europe, often leading to pricing discounts.
- In the U.S., pricing remains largely market-driven due to lack of direct regulation.
Strategic Implications
- Manufacturers should anticipate pricing declines; focus on cost-effective manufacturing.
- Investment in biosimilars and combination therapies could influence future market share.
- Supply chain robustness remains critical amid potential shortages.
Key Takeaways
- The global ganciclovir injectable market was circa USD 1.2 billion in 2022.
- U.S. market value stood at approximately USD 500 million.
- Current WAC for a 5g vial is around USD 2,650, with downward pricing pressure forecasted at 2.5% annually over five years.
- Market growth driven by increasing clinical demand, with competition from biosimilars expected to intensify.
- Price stability persists in the absence of biosimilar proliferation in certain regions, but overall, prices are set to decline gradually.
FAQs
Q1: What factors most influence the price of Gauzium?
A: Biosimilar entry, manufacturing costs, regulatory policies, and supply chain stability.
Q2: How will biosimilars impact the market?
A: Biosimilars are expected to reduce prices by introducing competition, especially in Europe and Asia.
Q3: Are there significant regional differences in pricing?
A: Yes. The U.S. prices are higher, with less regulation, while European prices tend to be lower due to stricter reimbursement controls.
Q4: What clinical developments could modify market demand?
A: Expanded indications, new therapeutic protocols, and improved transplantation survival rates.
Q5: How can supply constraints affect pricing?
A: Shortages may sustain or increase current prices temporarily until supply stabilizes.
References
[1] Grand View Research. (2023). Antiviral Drugs Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/antiviral-drugs-market
[2] IQVIA. (2023). Market Dynamics of Ganciclovir. Internal report.
