Last updated: February 20, 2026
What is NDC 82584-0604?
NDC 82584-0604 corresponds to Benralizumab (brand name: Fasenra), a monoclonal antibody developed by AstraZeneca. It is approved for severe eosinophilic asthma and other eosinophil-driven diseases. The drug's mechanism involves targeting the IL-5 receptor to reduce eosinophil levels.
Market Size and Growth Drivers
Current Market Dynamics
- Global asthma therapeutics market was valued at approximately USD 37 billion in 2022.
- The severe asthma segment accounts for roughly 15% of the total asthma market, on which Benralizumab targets.
- Benralizumab sales are expected to reach USD 1.2 billion globally in 2023, with a CAGR of 22% projected until 2028.
- The orphan drug designation and expanded indication filings have increased market penetration.
Key Competitors
| Drug |
Indications |
Market Share (2023 est.) |
Price (per dose) |
| Mepolizumab (Nucala) |
Severe eosinophilic asthma |
30% |
USD 3,800 (excluding administration costs) |
| Reslizumab (Cinqair) |
Severe eosinophilic asthma |
15% |
USD 4,500 |
| Dupilumab (Dupixent) |
Eosinophilic asthma, atopic dermatitis |
20% |
USD 3,600 |
| Benralizumab (Fasenra) |
Severe eosinophilic asthma |
25% |
USD 4,300 |
Regulatory and Market Expansion
- Approved in the US (2017), the EU (2018), and other major markets.
- Recent approvals include pediatric indications (ages 12 and older).
- Pipeline shows promising indications for nasal polyps and hypereosinophilic syndromes.
Price Projections
Pricing Trends
- The average wholesale acquisition cost (WAC) per dose has increased from USD 3,700 in 2019 to USD 4,300 in 2023.
- Price inflation is driven by manufacturing costs, extended indications, and competitive dynamics.
Projected Price Developments (2023-2028)
| Year |
Estimated WAC per Dose |
Pricing Influencers |
| 2023 |
USD 4,300 |
Stable, with annual inflation of 3.5% |
| 2024 |
USD 4,470 |
Potential for slight discounting to expand market share |
| 2025 |
USD 4,640 |
Introduction of biosimilars expected in late 2025 |
| 2026 |
USD 4,750 |
Biosimilar competition reduces average price by ~10% |
| 2027 |
USD 4,400 |
Market consolidation, increased competition from biosimilars |
| 2028 |
USD 4,300 |
Stabilization with normal inflation, biosimilar penetration |
Biosimilar Impact
Traditionally, monoclonal antibody prices decline by 20-30% within 3-5 years of biosimilar entry. Biosimilar entrants are expected from 2025 onward in the US and Europe, exerting price pressure.
Revenue Projections
| Year |
Estimated Global Revenue |
Major Factors |
| 2023 |
USD 1.2 billion |
Market share: 25%, price: USD 4,300 per dose |
| 2024 |
USD 1.4 billion |
Market share growth, price increases |
| 2025 |
USD 1.5 billion |
Biosimilar launches suppress pricing |
| 2026 |
USD 1.3 billion |
Biosimilar competition, market maturation |
| 2027 |
USD 1.2 billion |
Market stabilization, price decline |
| 2028 |
USD 1.1 billion |
Continued biosimilar adoption, market saturation |
Risks and Opportunities
Risks
- Biosimilar entry from 2025 may depress prices and revenue.
- Regulatory delays in expanding indications could limit growth.
- Competition from novel therapeutics targeting eosinophilic asthma.
Opportunities
- Label extension into new indications like nasal polyps, hypereosinophilic syndrome could expand revenue.
- Market expansion in emerging countries with increasing asthma prevalence.
- Partnerships for biosimilar development and market access.
Key Takeaways
- Benralizumab (Fasenra) is a significant player in the severe eosinophilic asthma market, with current sales around USD 1.2 billion globally.
- Prices have increased steadily since launch, with a projected stabilization around USD 4,300 per dose in 2023.
- Biosimilar competition expected from 2025 will likely reduce prices by 20-30%, impacting revenues.
- Market expansion into new indications and geographies offers growth potential.
- Competitive positioning depends on regulatory approvals and biosimilar strategies.
FAQs
Q1: How does Benralizumab compare to other IL-5 inhibitors?
A1: It has a unique mechanism, targeting the IL-5 receptor rather than the cytokine itself, leading to faster eosinophil depletion. Pricing and market share are similar to Mepolizumab, though biosimilar competition may vary.
Q2: What factors influence its price in the coming years?
A2: Biosimilar entry, market competition, indication expansion, and manufacturing costs will drive price changes.
Q3: When are biosimilars expected to enter the market?
A3: Likely from late 2024 to 2025 in the U.S. and Europe.
Q4: What additional indications could boost sales?
A4: Nasal polyps, hypereosinophilic syndromes, and eosinophilic dermatitis.
Q5: What is the primary target market?
A5: Patients with severe eosinophilic asthma inadequately controlled with inhaled therapies in developed markets.
Sources
[1] AstraZeneca. (2023). Fasenra prescribing information.
[2] IQVIA. (2023). Global asthma therapeutics market report.
[3] EvaluatePharma. (2023). Biogenerics and biosimilars analysis.
[4] European Medicines Agency. (2022). Marketing authorization for Fasenra.
[5] U.S. Food and Drug Administration. (2017). Approved drugs.
