Last updated: July 28, 2025
Overview of NDC 00078-0512
NDC 00078-0512 corresponds to a specific pharmaceutical product, prominently used in clinical settings—most notably, Remdesivir (Veklury), an antiviral agent developed by Gilead Sciences. Approved by the FDA for treating COVID-19, Remdesivir has become a focal point within the infectious disease therapeutic market. Its authorization and subsequent utilization significantly influence market dynamics and pricing strategies.
Current Market Landscape
1. Product Profile and Therapeutic Use
Remdesivir (NDC 00078-0512) received FDA approval in October 2020 for hospitalized patients with COVID-19, marking it as the first antiviral authorized in the US for this indication. Clinical trials demonstrated its efficacy in reducing hospital stay durations, positioning it as a cornerstone in COVID-19 treatment protocols.
Its relevance extends globally, especially in regions with strained healthcare infrastructures. The drug’s usage patterns are predominantly driven by the ongoing pandemic, mutations, and emerging variants, impacting supply and demand.
2. Competitive Environment
Prior to COVID-19, remdesivir was under development for multiple viral illnesses but gained prominence through its emergency authorization for COVID-19. Its primary competitors include:
- Favipiravir: An antiviral with limited approval outside Japan.
- Molnupiravir: An oral antiviral developed by Merck & Co., gaining approval in 2022.
- Paxlovid: An oral protease inhibitor from Pfizer, also approved for COVID-19.
Remdesivir's market dominance is waning as oral alternatives demonstrate superior ease of administration and comparable efficacy, influencing prescribing patterns and reimbursement landscape.
3. Regulatory and Supply Dynamics
Supply chain constraints, manufacturing scalability, and government procurement agreements globally influence the drug’s market availability. The U.S. government initially secured substantial stockpiles, but as demand stabilizes, procurement strategies are evolving toward commercial channels and third-party suppliers.
Market Size and Demand Forecast
1. Global and U.S. Market Valuation
- Initial market size (2020–2021): Estimated at $2.5 billion, driven primarily by COVID-19 hospitalizations.
- Post-pandemic projections: Anticipate decline in COVID-19-related sales as vaccination coverage and new treatments reduce hospitalizations.
- Long-term outlook: Limited use outside therapeutic niches, predominantly in pandemic scenarios, suggest a decreasing trend.
2. Clinical Adoption and Usage Trends
While initial adoption was robust, the shift toward oral antivirals reduces parenteral remdesivir's market share. Considering the waning severity of COVID-19 and vaccination efforts, forecasted annual growth rates are negative, approximately -15% to -20% over five years, barring unforeseen outbreaks or new indications.
3. Geographic Market Trends
The U.S. remains the largest market, with Europe and Asia-Pacific showing variable adoption based on regulatory approvals and healthcare infrastructure. Countries like India and Brazil exhibit increasing local manufacturing, potentially affecting pricing and market penetration.
Pricing Strategies and Projections
1. Current Pricing Landscape
- List Price: The average wholesale price (AWP) for remdesivir vials was approximately $520 per 100 mg vial (as of 2022).
- Reimbursement: Insurers, including Medicare and Medicaid, negotiated much lower rates; average reimbursement ranges between $300 and $400 per vial.
2. Factors Influencing Pricing
- Supply and Demand: High initial demand, followed by stabilization.
- Manufacturing Costs: As production scales, per-unit costs decline.
- Market Competition: The advent of oral antivirals has commoditized the market, reducing the pricing power for remdesivir.
- Regulatory Environment: Emergency use authorizations (EUAs) and full approvals influence pricing flexibility.
3. Future Price Projections (2023–2028)
Given the declining pandemic-driven demand:
- Short-term (2023–2024): Prices are expected to stabilize around current levels, with minimal increases driven by inflation and supply chain costs.
- Mid-to-long-term (2025–2028): Anticipate a gradual price decline of 10–15% annually, reaching approximately $200–$300 per vial by 2028. This projection aligns with reducing demand, increased competition from oral agents, and potential biosimilar or generic developments.
Note: Price reductions may be amplified by patent expirations or licensing deals, although Gilead's patent protections remain robust in major markets until at least 2030.
Implications for Stakeholders
- Manufacturers: Should focus on cost-efficient scale-up and diversification into new indications to sustain profitability.
- Payers and Providers: Need to negotiate value-based agreements, considering alternative therapies with comparable efficacy.
- Investors: Anticipate a declining revenue horizon, urging strategic diversification or portfolio expansion.
Regulatory and Policy Impact
Government procurement policies, especially in COVID-19 management, significantly influence market size and price stability. Any future emergency declarations or new indications could temporarily boost demand and prices. Conversely, increased competition and biosimilar entry will accelerate price declines.
Key Takeaways
- The market for NDC 00078-0512 (Remdesivir) peaked during the height of the COVID-19 pandemic, with revenues surpassing $2.5 billion globally.
- As the pandemic subsides and oral antivirals gain prominence, demand and prices are expected to decline substantially over the next five years.
- Pricing will be influenced by competition, manufacturing efficiencies, and policy decisions; projections suggest a decrease to approximately $200–$300 per vial by 2028.
- The drug's market remains susceptible to shifts in clinical guidelines, viral variants, and emerging therapies.
- Stakeholders should monitor competitive developments closely to optimize procurement strategies and R&D investments.
FAQs
1. How has COVID-19 impacted remdesivir’s market value?
The pandemic caused a surge in demand, inflating sales and global revenues to over $2.5 billion initially. Demand is expected to decline as vaccination rates rise and alternative treatments become standard, leading to decreased market value.
2. Are there upcoming patent expirations that could affect remdesivir pricing?
Current patents in major markets extend until at least 2030. Future biosimilar or generic entrants could accelerate price reductions, but significant market entry is unlikely before patents expire.
3. How do competing antiviral agents influence remdesivir’s market?
Oral antiviral options like molnupiravir and Paxlovid offer comparable efficacy with easier administration, which limits remdesivir's use outside hospitalized settings, pressuring its market share and pricing.
4. What role do government contracts play in remdesivir’s demand?
Government procurement significantly elevated early demand. As policies shift from emergency responses to targeted use, demand will likely stabilize or decline, impacting pricing strategies.
5. Is remdesivir likely to expand into new indications?
While research continues, current evidence supports limited expansion; primarily, its role remains tied to COVID-19. Any new indications could temporarily boost demand and prices.
References
[1] Gilead Sciences. Veklury (remdesivir) prescribing information. 2022.
[2] IQVIA. Global Pharmaceutical Market Trends. 2022.
[3] U.S. Food and Drug Administration. Remdesivir Emergency Use Authorization and Approval Updates. 2021-2022.
[4] Statista. COVID-19 antiviral and vaccine market insights. 2022.
[5] WHO. COVID-19 Therapeutics and Market Impact. 2022.
