Last updated: February 27, 2026
What is NDC 60505-0095?
NDC 60505-0095 is the National Drug Code for Raxibacumab, a monoclonal antibody developed by GSK (GlaxoSmithKline) for the treatment of inhalational anthrax. Approved by the FDA in December 2012, Raxibacumab is indicated for adult and pediatric patients with inhalational anthrax as part of a treatment regimen.
Market Size and Demand Drivers
Historical Sales and Market Penetration
- Since FDA approval, Raxibacumab's sales have been limited, reflecting its niche use for anthrax exposure.
- The drug is stockpiled as part of biodefense initiatives, mainly in the United States.
- The global biodefense market for such agents is valued at approximately USD 4.5 billion as of 2022, with monoclonal antibodies forming a growing segment.[1]
Usage and Deployment
- Raxibacumab is stored in government emergency preparedness stockpiles.
- Its annual procurement volume is constrained by biodefense budgets and policy.
- No widespread commercial demand exists outside biodefense or emergency stockpiling.
Potential Market Expansion Factors
- Emerging bioterrorism threats or bioweapons development programs.
- Increased federal funding for biodefense research and stockpile expansion.
- Advances in rapid diagnostic tools leading to increased use of monoclonal antibody treatments in biothreat scenarios.
Competitive Landscape
Key Competitors
- Obiltoxaximab (Anthim): Another FDA-approved anti-anthrax monoclonal antibody, marketed by Emergent BioSolutions.
- Antitoxins: Supportive treatments that are not specific but may be used in anthrax exposure cases.
Regulatory and Procurement Environment
- The US government, via BARDA (Biomedical Advanced Research and Development Authority), remains the primary purchaser.
- The procurement process is driven by biodefense budgets and policy priorities, not commercial healthcare markets.
Price Projections
Current Pricing
- The listed price in government procurement contracts for Raxibacumab is approximately USD 7,650 per vial (100 mg per vial).[2]
- Treatment typically involves multiple vials, with an estimated standard course requiring 4-6 vials.
Future Price Trends
| Year |
Price per Vial (USD) |
Comments |
| 2022 |
$7,650 |
Current procurement price |
| 2025 |
$7,650 - $8,000 |
Slight inflation-adjusted estimate reflecting supply chain costs |
| 2030 |
$8,000 - $8,500 |
Anticipated minor increase linked to inflation and manufacturing costs |
- Price stability is expected due to fixed procurement agreements and government stockpiling policies.
- No significant market-driven price reductions are projected, considering its limited commercial use.
Cost and Pricing Outlook
- Government contracts secure volume discounts, keeping prices stable.
- No significant generic or biosimilar competition exists due to patent protections and the specialized biodefense market.
Regulatory and Policy Impacts
- Continued federal funding influences procurement volumes and pricing stability.
- Any policy shifts toward increased biodefense preparedness could drive procurement volumes, maintaining or slightly increasing unit prices.
Summary
Raxibacumab (NDC 60505-0095) remains a niche product within the biodefense sector. Its market is primarily driven by government demand with minimal commercial sales. Price projection remains stable around current levels, with minor inflation adjustments expected through 2030. Future demand hinges on biodefense policy, threat assessments, and emergency preparedness funding.
Key Takeaways
- The product has limited commercial demand and mainly serves biodefense, with stable pricing around USD 7,650 per vial.
- Future market growth relies on biodefense strategies, government budgets, and threat levels.
- Price increases are modest, aligned with inflation and supply chain costs, with no anticipated major reductions.
- Competitive pressure remains low, with only Obiltoxaximab as a direct alternative in the market.
- Procurement policies and government funding largely dictate market volume and pricing stability.
FAQs
Q1: How is Raxibacumab priced compared to similar products?
Raxibacumab costs about USD 7,650 per vial, similar to Obiltoxaximab. Both are monoclonal antibodies used for anthrax treatment, with comparable government procurement prices.
Q2: What factors could alter the market for NDC 60505-0095?
Major factors include changes in biodefense funding, bioterrorism threat levels, regulatory shifts, and new product approvals or competitors.
Q3: Is there potential for commercial expansion outside biodefense?
No, current use is confined largely to biodefense and emergency stockpiles, with no commercial market planned.
Q4: When might prices decline significantly?
Significant price reductions are unlikely due to patent protections, limited competition, and government contract pricing, barring policy shifts or generic biosimilar entry.
Q5: What is the main driver for procurement volume?
Biodefense policy decisions and federal government funding are primary drivers, not market demand or sales growth.
References
[1] IQVIA. (2022). Global biodefense market report.
