Last updated: February 16, 2026
Overview
NDC 31722-0960 is marketed as Fasenra (benralizumab), a monoclonal antibody developed by AstraZeneca. It targets interleukin-5 receptor alpha, primarily approved for severe asthma and eosinophilic conditions. The drug's market dynamics are driven by clinical demand, competitive landscape, regulatory environment, and reimbursement policies.
Market Landscape
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Indications and Patient Population
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Approved for severe asthma with eosinophilic phenotype.
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The prevalence in the U.S. is approximately 2.5 million patients with severe eosinophilic asthma (CDC, 2021).
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Additional indications include eosinophilic chronic rhinosinusitis and rare eosinophilic conditions; approval status varies by region.
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Market Penetration and Sales Performance
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Launched in mid-2019, Fasenra achieved rapid adoption in specialist settings.
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U.S. sales reached approximately $800 million in 2022 (EvaluatePharma, 2022).
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European sales are estimated at $300 million for 2022.
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Key competitors include Nucala (mepolizumab), Cinqair (reslizumab), and Dupixent (dupilumab).
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Competitive Positioning
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Fasenra is administered subcutaneously, with dosing at 30 mg every 4 weeks initially, then every 8 weeks.
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It distinguishes itself with a targeted mechanism of action and potentially improved safety profile.
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Market share within biologic treatments for severe asthma is approximately 25-30%.
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Market Drivers & Challenges
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Growing prevalence of severe asthma cases.
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Increasing adoption following updated guidelines recommending biologic therapies.
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Reimbursement policies favor biologics with demonstrated cost-effectiveness.
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Patent exclusivity until 2030, with biosimilar competition expected thereafter.
Pricing Analysis
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Current List Price
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The wholesale acquisition cost (WAC) in the U.S. for Fasenra is approximately $5,600 per 30 mg dose.
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Considering typical dosing: 30 mg every 8 weeks results in 6 doses per year, translating to an annual cost of roughly $33,600 per patient.
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Cost Trends and Pricing Strategies
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Prices for biologics generally increase at an annual rate of 3-5%, though competitive pressures and payer negotiations influence actual pricing.
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AstraZeneca has maintained a relatively stable pricing policy, focusing on maximizing market coverage through rebates and patient assistance programs.
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Insurance and Reimbursement Impact
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Payers negotiate discounts, with actual reimbursement often 15-25% below WAC.
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Biosimilar entry post-2030 could induce price reductions of 20-30% over five years.
Price Projections (Next 5 Years)
| Year |
Expected Average Patient Cost |
Rationale |
| 2023 |
$33,600 |
Current pricing, stable, with minor rebates |
| 2024 |
$34,800 |
3.5% increase |
| 2025 |
$36,000 |
Continued moderate growth |
| 2026 |
$37,200 |
Slight market adjustments |
| 2027 |
$38,600 |
Increasing biosimilar competition |
| 2028 |
$40,000 |
Biosimilar impact begins, possible discounts |
Key Factors Influencing Future Prices
- Patent Cliff: Patents expire around 2030, opening the market for biosimilars that will likely reduce prices.
- Regulatory Approvals: Expanded indications could increase volume but may pressure prices downward.
- Market Competition: Introduction of biosimilars and new biologics elevates competitive pressures.
- Reimbursement Policies: Shifts toward value-based models could influence pricing structures.
Conclusion
Market size and sales growth for NDC 31722-0960 are expected to plateau post-2025, with potential declines in per-unit price driven by biosimilar competition and market saturation. The U.S. remains the dominant market, with Europe showing steady growth. AstraZeneca’s strategic positioning and patent protections support current pricing, but upcoming biosimilar entries are likely to pressure prices downward over the next five years.
Key Takeaways
- Fasenra’s current annual treatment cost hovers around $33,600 per patient.
- Market share is stable but could be challenged by biosimilar competition post-2030.
- Price projections suggest moderate increases until biosimilar entry, followed by declines of 20-30%.
- Competitive products and reimbursement strategies heavily influence pricing.
- The primary driver for future pricing is patent expiration, enabling biosimilar entry and market penetration.
FAQs
1. When will biosimilars for Fasenra likely enter the market?
Patent expiration is expected around 2030, after which biosimilars are anticipated to gain approval and market share.
2. How does Fasenra's cost compare to its competitors?
Fasenra’s annual treatment cost is similar to Nucala and Cinqair, typically ranging from $30,000 to $36,000, depending on dosing and discounts.
3. What factors could accelerate price reductions?
Introduction of biosimilars, volume-based reimbursement models, and regulatory pressures favoring cost containment.
4. Are there regional variations in pricing?
Yes. U.S. prices are higher due to less price regulation, while European countries often negotiate lower prices through health authorities.
5. How does the market outlook affect investment in biologics like Fasenra?
Steady demand supports ongoing R&D; however, impending biosimilar competition suggests a need for innovation and strategic positioning.
Citations
[1] CDC. (2021). Prevalence of Severe Asthma.
[2] EvaluatePharma. (2022). Global Biosimilar and Biologic Sales Data.
