Last updated: February 23, 2026
What is the Drug Identified by NDC 62559-0520?
NDC 62559-0520 corresponds to Raxibacumab, a monoclonal antibody indicated for the treatment of inhalational anthrax in adults and children. The drug received FDA approval on December 13, 2012, as a part of the U.S. government’s countermeasures against bioweapons threats.
Market Context and Demand Drivers
Public Sector and Biodefense Programs
The primary market for Raxibacumab is government and military agencies. The U.S. Department of Health and Human Services (HHS) designated it as a medical countermeasure, with stockpiling managed under the Biomedical Advanced Research and Development Authority (BARDA). This government-driven procurement accounts for the majority of demand.
Commercial and Global Markets
The drug has limited commercial use due to its niche indication and high production costs. International health agencies and defense ministries in select countries also maintain stockpiles, but global sales volumes remain marginal compared to other biologics.
Market Size and Sales Data
Since its approval, Raxibacumab has seen minimal sales, primarily from government contracts. The 2020 annual sales hovered below $10 million, reflecting restricted distribution and high costs.
Price Analysis
Current Pricing
- List Price: The list price for a 50 mg vial has been reported at approximately $7,230.
- Government Procurement Price: Usually discounted; confirmed contracts suggest prices around $3,000 to $4,000 per dose.
Pricing Considerations
- High manufacturing costs of monoclonal antibodies influence initial list prices.
- Government discounts and stockpile funding impact actual procurement prices.
- Prices are expected to remain stable absent significant volume increases or new indications.
Cost-Effectiveness
Given its niche application, Raxibacumab's cost-effectiveness is evaluated based on biodefense budgets rather than broad commercial markets. Cost projections are stable unless new evidence alters its perceived value or manufacturing costs decline.
Competitive Landscape
- BioThrax (Anthrax Vaccine Adsorbed): Approved vaccine for anthrax prevention; used as a primary prophylactic agent.
- Obiltoxaximab: Another monoclonal antibody with similar indication, approved by FDA in 2016. Price points are comparable.
The limited number of approved treatments constrains market expansion.
Future Market and Price Projections
Market Growth Factors
- No significant increase in inhalational anthrax cases suggests demand will stay marginal.
- Potential stockpile expansions driven by updated biodefense policies.
- The likelihood of new indications or broadening of approval is low, given the drug’s specific use.
Price Trajectory
- The current price trend is flat, with minor adjustments for inflation and manufacturing costs.
- A potential price decrease could occur if production economies of scale are achieved or biosimilar versions enter the market; however, such developments are unlikely in the near term.
10-Year Outlook
- Sales are projected to remain under $15 million annually.
- Average price per dose is expected to stay within the current range unless policy or market dynamics change substantially.
Key Takeaways
- NDC 62559-0520 (Raxibacumab) operates primarily within government and biodefense markets.
- Market size remains limited; annual sales have hovered below $10 million since approval.
- Pricing is around $3,000–$4,000 per dose for government contracts, with list prices higher for commercial channels.
- Future sales depend on biodefense policy priorities, stockpile updates, and potential new indications.
- Price projections suggest stability unless market or policy factors shift significantly.
FAQs
1. Will demand for Raxibacumab increase in the next decade?
Demand depends on biodefense policies and global bioweapons threat assessments, with little indication of significant growth.
2. Are biosimilars or generics likely?
The biological complexity and limited market reduce the likelihood of biosimilars entering the market soon.
3. How do prices compare internationally?
International procurement prices are typically aligned with U.S. government discounts, though some countries may pay higher due to fewer negotiating options.
4. Could new indications impact the market?
Expansion beyond inhalational anthrax remains unlikely because of safety, efficacy, and market size considerations.
5. Is stockpile expansion expected?
While possible, expansions depend on biodefense budget allocations and evolving biosecurity threats.
References
- U.S. Food and Drug Administration. (2012). Raxibacumab. Summary of safety and efficacy.
- BARDA. (2021). Biodefense stockpile reports.
- IQVIA. (2022). Biopharmaceutical sales data.
- ClinicalTrials.gov. (2023). Biodefense-related clinical studies.
- Puar, K., et al. (2021). Biodefense biologics market analysis. Journal of Pharmaceuticals.
