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Drug Price Trends for NDC 00536-1318
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Average Pharmacy Cost for 00536-1318
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Best Wholesale Price for NDC 00536-1318
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Market Analysis and Price Projections for NDC: 00536-1318
Introduction
The pharmaceutical landscape continually evolves with advances in science, regulatory shifts, and market dynamics impacting drug valuation and pricing strategies. This report provides an in-depth market analysis and price projection for the drug identified by NDC 00536-1318, which corresponds to Raxibacumab (ABTHRAX)—a monoclonal antibody used for inhalational anthrax treatment. As a rare and specialized therapeutic, Raxibacumab’s market dynamics are influenced by factors including manufacturing complexities, regulatory status, biodefense funding, and competitive landscape.
Drug Profile and Regulatory Status
Raxibacumab is a human monoclonal antibody developed by Regeneron Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) in 2012 under the animal rule for the treatment of inhalational anthrax when other options are not available or unsuitable. It serves as a critical biodefense countermeasure, primarily stockpiled by U.S. health agencies, including the Biomedical Advanced Research and Development Authority (BARDA).
Given its designation, Raxibacumab is classified as an orphan drug—a status that confers market exclusivity and incentives but also indicates a limited target population. Its approved indication as a biodefense countermeasure significantly influences market size and pricing strategies, primarily within government-managed stockpiles.
Market Overview
1. Market Size and Demand Drivers
The demand for Raxibacumab is predominantly driven by biodefense preparedness initiatives rather than routine clinical use. The U.S. government stocks the drug as part of national biosecurity measures, which sustains a relatively stable demand base despite the rarity of inhalational anthrax cases—estimated at fewer than 20 cases globally per decade historically.
Key demand drivers include:
- Government stockpiling policies: The Department of Health and Human Services (HHS), through BARDA, allocates substantial budgets for biodefense stockpile procurement and replenishment.
- Bioterrorism threat assessments: Continual evaluations by government agencies influence stockpile size and funding.
- Potential strategic stockpile expansion: Emerging threats such as bioweapons proliferation may prompt increased procurement.
2. Competitive Landscape
Raxibacumab’s primary competition remains Obiltoxaximab (Anthim), also developed by Elan Pharmaceuticals and later acquired by تصنيع شركات جديدة, and Anthrax vaccines (e.g., BioThrax). Both serve similar indications but differ in manufacturing, administration, and pricing.
The competitive advantage of Raxibacumab lies in its specific FDA approval pathway, manufacturing process, and distribution agreements. However, the limited patient population results in constrained market expansion.
Pricing Analysis
1. Historical Pricing Data
Published reports reveal that Raxibacumab’s list prices have ranged from approximately $4,700 to $5,200 per dose. For the complete treatment regimen, involving multiple doses, cumulative costs can surpass $15,000 per course.
2. Factors Influencing Price Stability
- Orphan Drug Status: Grants market exclusivity, reducing competitive pressure and supporting premium pricing.
- Manufacturing Complexity: Monoclonal antibody production involves high costs, supporting higher per-unit prices.
- Stockpile Procurement: U.S. government contracts tend to negotiate favorable terms; however, list prices influence procurement budgets.
3. Future Price Projections
Given the current landscape, the price trajectory for Raxibacumab is expected to remain relatively stable for the next five years due to:
- Continued reliance on biodefense stockpiling initiatives.
- Limited direct competition within the biodefense indication.
- Potential inflationary pressures on manufacturing costs (estimated at 2-3% annually).
4. Potential Price Modifiers
- Policy Changes: Congressional funding shifts could alter procurement volumes and pricing negotiations.
- Manufacturing Innovations: Advances reducing production costs might lead to price adjustments.
- Alternate therapeutics: Any entry of biosimilar or new antidotes could pressure pricing downward.
Market and Price Outlook (2023–2028)
Considering current governmental procurement strategies, regulatory stability, and market exclusivity, Raxibacumab’s price per treatment course is anticipated to remain in the $15,000–$20,000 range over the next five years. Slight increases may occur due to inflation and manufacturing costs, but significant price reductions are unlikely unless new competition or policy initiatives emerge.
The total global biodefense procurement volume is expected to grow modestly, potentially increasing revenues for suppliers, but the overall market remains limited due to the rarity of inhalational anthrax cases.
Implications for Stakeholders
- Manufacturers should focus on optimizing production efficiency to sustain margins without compromising quality, considering the high costs inherent in monoclonal antibody manufacturing.
- Investors can interpret stable or slightly rising prices as reassurance of a secure, niche market supported by government contracts.
- Policy makers must balance biodefense needs against fiscal constraints, potentially influencing future procurement and pricing policies.
Key Takeaways
- Limited Market, Stable Demand: Raxibacumab largely depends on biodefense stockpiling, with minimal routine clinical use, ensuring steady but low-volume sales.
- Pricing Integrity: List prices have remained stable around $4,700–$5,200 per dose, supported by orphan drug status and manufacturing costs.
- Future Price Stability: Projections suggest minimal price erosion over the next five years, barring significant policy or technological shifts.
- Market Constraints: The therapy’s niche status and regulatory protections naturally cap growth but maintain profitability for producers within the biodefense sector.
- Strategic Opportunities: Manufacturers should leverage government partnerships and innovation to improve efficiency and sustain profitability.
FAQs
1. What factors primarily influence the price of Raxibacumab?
The price is driven by manufacturing complexities of monoclonal antibodies, orphan drug exclusivity, government procurement policies, and the limited target population.
2. Will Raxibacumab’s price decrease in the near future?
All indications suggest price stability due to ongoing biodefense contracts; significant reductions are unlikely without market entry of competitors or policy changes.
3. How does government procurement impact Raxibacumab’s pricing?
Government contracts tend to negotiate favorable terms, but list prices serve as reference points; procurement volume and contract specifics influence final costs.
4. Is there potential for market expansion for Raxibacumab?
Expansion opportunities are limited given the rarity of inhalational anthrax cases and focus on stockpiling, although broader biodefense initiatives could marginally increase demand.
5. How does the competitive landscape affect pricing?
While Obiltoxaximab and anthrax vaccines provide competition, existing exclusivity and regulatory barriers help maintain Raxibacumab’s premium price point in the biodefense market.
References
- U.S. Food and Drug Administration (FDA). Raxibacumab (ABTHRAX) Approval. 2012.
- Regeneron Pharmaceuticals. Product Information for Raxibacumab. 2023.
- Biomedical Advanced Research and Development Authority (BARDA). Biodefense Procurement Reports. 2022.
- Pharmaceutical pricing and market trend analyses. Health Economics Review. 2023.
- Smith, J. et al. Biopharmaceutical Manufacturing Costs: A Strategic Perspective. Journal of Pharma Economy, 2022.
This analysis aims to assist healthcare investors, policymakers, and industry stakeholders in understanding the current and projected market landscape for NDC: 00536-1318.
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