Last updated: September 5, 2025
Introduction
NDC 68791-0101 corresponds to Remdesivir (Veklury), an antiviral medication developed by Gilead Sciences primarily authorized for the treatment of COVID-19. Since its emergency use approval and subsequent full FDA approval, remdesivir remains a critical component in the therapeutic arsenal against COVID-19, particularly for hospitalized patients. This analysis assesses current market dynamics, competitive landscape, pricing trends, regulatory trajectories, and future price projections for remdesivir, offering vital insights for stakeholders.
Market Landscape Overview
Global and U.S. Market Scope
Remdesivir’s initial market penetration was driven by the COVID-19 pandemic's urgent treatment needs. The drug gained widespread use in early 2020, especially following emergency authorization, with subsequent FDA approval in October 2020. Its market in the United States remains prominent, with additional growth observed in Europe, Asia-Pacific, and emerging markets as supply constraints ease and access expands.
The drug is primarily supplied to hospitals and government procurement channels, limiting broad retail distribution. According to IQVIA data, remdesivir's U.S. sales recorded approximately $2.4 billion in 2022, reflecting stabilized demand following the peak pandemic years.
Market Drivers and Constraints
-
Evolving Treatment Guidelines: While remdesivir became a standard care component initially, recent studies suggest its marginal benefit in certain patient groups, prompting adjustments in clinical recommendations (e.g., NIH guidelines) and influencing demand.
-
COVID-19 Variants and Pandemic Dynamics: Fluctuations in infection rates, emergence of critical variants, and vaccination coverage modulate overall demand. Nonetheless, remdesivir remains integral for severe cases requiring hospitalization.
-
Supply Chain and Manufacturing: Gilead scaled manufacturing rapidly during the pandemic, but current capacity constraints and the push toward generic production in some regions could influence pricing and availability.
-
Regulatory Developments: Approval extensions and potential inclusion in combination therapies may alter market size, depending on clinical trial outcomes and global health policies.
Competitive Landscape
Key Competitors and Alternatives
Remdesivir's primary competitors include other antiviral agents such as:
- Molnupiravir (Lagevrio): Oral antiviral developed by Merck, approved for outpatient COVID-19 management.
- Nirmatrelvir/Ritonavir (Paxlovid): Oral combo from Pfizer, with strong early-stage efficacy.
- Favipiravir: Used in some markets but with inconsistent regulatory approval.
Current treatment guidelines increasingly favor oral agents for early-stage infections, relegating remdesivir mainly to hospitalized patients, which constrains its market share growth.
Patent and Regulatory Status
- Gilead holds patents protecting remdesivir, though patent expiry is anticipated around 2028-2030.
- The drug's patent protection and exclusive manufacturing rights currently support high pricing.
Pricing Trends and Market Value
Historical Pricing Dynamics
Initially, remdesivir was priced at approximately $3,120 per treatment course in the U.S. during 2020. The high price reflected R&D costs, emergency authorization status, and limited competition.
The subsequent FDA approval and manufacturing scaling led to price negotiations, discounts for government procurement, and tiered pricing in international markets.
Current Pricing Environment
-
U.S. Market: Gilead offers remdesivir through government contracts at negotiated prices, generally around $390 to $520 per vial[1], translating to roughly $1,200 to $1,560 per treatment course (6 vials per course).
-
International Markets: Prices vary, with lower costs in low- and middle-income countries due to voluntary licensing agreements, generic production, and donor subsidies.
Market Projection
Given stabilization in demand, ongoing negotiations, and potential competition, the price trajectory for remdesivir is expected to:
- Plateau in the short term: Prices could stabilize within the current range, especially in government contracts and hospital procurement channels.
- Gradually decline: With patent expiration and increased generic competition, international and institutional prices are likely to decrease by 2025-2028.
Supply and Demand Shock Scenarios
- Pandemic resurgence: Could sustain or temporarily increase demand and prices.
- Shift toward oral antivirals: Efficiency gains from oral agents might diminish remdesivir's market share and exert downward pricing pressure.
Regulatory and Policy Impact
Potential Regulatory Developments
- Extended approvals and expanded indications could maintain or slightly increase market demand.
- Global health policies favoring multipurpose antivirals could lead to price negotiations aimed at affordability, especially outside high-income countries.
Government and Payer Strategies
- Pricing negotiations with Gilead aim to balance cost containment and access.
- Voluntary licensing agreements bolster generic competition, putting downward pressure on prices in certain regions.
Future Price Projections
| Timeframe |
Price Expectation |
Key Influencing Factors |
| 2023-2024 |
Stabilization (~$390–$520/vial) |
Existing contracts, steady demand, regulatory status |
| 2025-2026 |
Slight decline (10–20%) |
Patent protection nearing expiry, increased generic production |
| 2027-2030 |
Significant decrease (30–50%) |
Patent lapse, global licensing expansion, international market penetration |
Key Challenges and Opportunities
Challenges:
- Competition from oral antivirals diminishing hospital-based demand.
- Variability in COVID-19 dynamics affecting utilization.
- Regulatory pressures to reduce drug prices globally.
Opportunities:
- Repurposing or combination therapies expanding indications.
- International licensing enabling broader access and revenue diversification.
- Ongoing clinical trials to improve efficacy, potentially revamping demand.
Key Takeaways
- Market Position: Remdesivir remains a vital COVID-19 therapeutic for hospitalized patients despite emerging competition.
- Pricing Stability: Current prices are largely stabilized due to existing contracts and high demand, but downward pressure is imminent as patents expire.
- Future Trends: Anticipate notable price reductions post-patent expiry, especially in international markets leveraging generics.
- Strategic Focus: Stakeholders should monitor patent timelines, licensing agreements, and emerging clinical data to adapt market forecasts.
- Regulatory and policy environment will significantly shape pricing trajectories, especially with global emphasis on equitable access.
FAQs
1. Will the price of remdesivir decrease significantly after patent expiry?
Yes. Patent expiration allows for generic manufacturing, which historically reduces prices by 30-50% or more, especially in jurisdictions with active licensing agreements.
2. How does the emergence of alternative oral antivirals impact remdesivir’s market and pricing?
Oral agents like Paxlovid and molnupiravir are used earlier in disease progression, reducing reliance on remdesivir, which targets hospitalized cases. This shift could diminish demand and support price reductions for remdesivir over time.
3. Are there ongoing clinical trials that could influence remdesivir’s future market value?
Yes. Trials exploring combination therapies, extended indications, or improved formulations may enhance remdesivir’s application but could also lead to competitive pricing adjustments based on efficacy data.
4. What role do international licensing agreements play in the global pricing of remdesivir?
Voluntary licensing enables generic manufacturers in developing countries, substantially lowering costs and increasing access, which exerts downward pressure on pricing globally.
5. What future regulatory actions could influence remdesivir’s market?
Regulatory bodies may approve extended indications, new formulations, or safety profiles, affecting demand and pricing dynamics. Policy shifts promoting drug affordability could also accelerate price declines.
References
[1] Gilead Sciences. (2022). Remdesivir (Veklury) Price. Official Price List.
[2] IQVIA. (2022). US Infectious Disease Market Insights.
[3] NIH COVID-19 Treatment Guidelines. (2022). Remdesivir.
[4] World Health Organization. (2022). COVID-19 Therapeutics Landscape.
[5] Bloomberg Intelligence. (2022). Market Outlook for COVID-19 Therapeutics.
This comprehensive market analysis equips stakeholders with strategic insights enabling informed decision-making concerning NDC 68791-0101, ensuring preparedness for upcoming market shifts and regulatory developments.
