Last updated: February 13, 2026
Product Details
NDC 59651-0307 corresponds to Sars-CoV-2 monoclonal antibody therapy developed by GSK, used for outpatient treatment of COVID-19 in specific cases. The drug is part of the broader class of monoclonal antibodies targeting SARS-CoV-2 spike proteins.
Market Landscape
Market Size
- The global COVID-19 monoclonal antibody market reached approximately USD 8 billion in 2022.
- Post-pandemic, the segment has contracted but remains significant, valued at roughly USD 3-4 billion in 2023, due to continued use in high-risk populations and evolving variants.
Key Competitors
- Eli Lilly's Bamlanivimab/Etesevimab
- Regeneron’s Casirivimab/Imdevimab
- GSK’s Sotrovimab (NDC 59651-0307)
- Others: AstraZeneca's Evusheld
Regulatory Status
- US FDA Emergency Use Authorization (EUA) issued for treatment.
- The drug has received full or partial approvals in multiple jurisdictions, with ongoing clinical trial data to support broader approval.
Pricing Dynamics
2022-2023 Pricing
- List Price: Approximately USD 2,100 - USD 2,400 per infusion (per dose).
- Reimbursement policies vary; payers often negotiate discounts based on volume and indication.
Factors Influencing Price
- Manufacturing costs: Monoclonal antibodies are expensive to produce, with estimates ranging from USD 600 to USD 1,200 per gram.
- Market competition: Entry of biosimilars could reduce pricing but is limited due to patent protections.
- Supply chain constraints: Increased demand during surges led to price premiums in certain regions.
Price Trends and Projections
Current Trends
- Decline from peak pandemic prices due to reduced demand.
- Negotiated discounts and utilization controls in developed markets.
- Price stabilization expected as demand stabilizes.
Future projections (Next 2-3 years)
| Year |
Estimated Price per Dose |
Factors Influencing Price |
| 2023 |
USD 2,100 – USD 2,400 |
Reduced demand, negotiation, supply chain normalization |
| 2024 |
USD 2,000 – USD 2,200 |
Increased competition with potential biosimilar entry |
| 2025 |
USD 1,800 – USD 2,000 |
Biosimilar market penetration, price erosion |
Market Entry and Competition
- Biosimilar versions could enter the market within 3 to 5 years, pressing prices downward.
- Patent extensions and legal strategies may delay biosimilar entry.
- Use in emerging markets remains limited due to cost and infrastructure constraints.
Regulatory and Policy Impact
- US CDC and FDA continue to update guidelines, affecting usage and reimbursement.
- Governments and healthcare providers prioritize cost-effectiveness, influencing future pricing.
- Internationally, price variation is significant; some countries negotiate heavily, others see higher list prices.
Conclusion
NDC 59651-0307’s market has transitioned from pandemic-driven high demand to a more stabilized, competitive environment. Price projections indicate gradual declines over the next three years due to biosimilar competition and market maturation.
Key Takeaways
- The current average price per dose ranges from USD 2,100 to USD 2,400.
- The market size is estimated at USD 3-4 billion globally in 2023.
- Biosimilars are expected to influence prices starting around 2025.
- Market dynamics are influenced by competition, regulatory policies, and supply constraints.
- Price erosion likely to continue at a moderate pace over the next three years.
FAQs
1. How do biosimilar versions affect the price of NDC 59651-0307?
Biosimilars typically lead to price reductions of 20-40% once they enter the market, assuming patent rights are challenged or expire.
2. What are the key factors determining reimbursement rates for this drug?
Reimbursement depends on regulatory approval, clinical guidelines, payer negotiations, and the drug's inclusion in formularies.
3. How does the drug's efficacy impact its market and pricing?
Higher efficacy, especially against multiple variants, sustains demand and supports higher prices. Reduced efficacy or new variants could suppress demand and lower prices.
4. Are there regional differences in pricing?
Yes. Developed markets like the US and Western Europe tend to have higher list prices and more negotiated discounts. Emerging markets often see lower prices due to negotiations and different reimbursement frameworks.
5. When are biosimilars expected to enter the market?
Potential biosimilar entry is anticipated within 3 to 5 years, depending on patent litigation, regulatory approval, and market incentives.
Sources
[1] World Health Organization. "COVID-19 Therapeutics Market Data," 2023.
[2] IQVIA. "Global Infectious Disease Market Analysis," 2023.
[3] FDA. "Emergency Use Authorization for COVID-19 Therapeutics," 2023.
[4] EvaluatePharma. "Biologic and Biosimilar Pricing Trends," 2023.
[5] MarketWatch. "Monoclonal Antibody COVID-19 Treatment Market," 2023.
