Last updated: February 12, 2026
What is NDC 00955-1042?
NDC 00955-1042 refers to Benralizumab, marketed under the brand name Fasenra. It is an injectable monoclonal antibody used for severe eosinophilic asthma and other eosinophil-driven diseases. Approved by the FDA in late 2017, Fasenra targets IL-5 receptor alpha to reduce eosinophil levels.
Market Overview
Current Market Landscape
- Indications: Severe eosinophilic asthma, chronic obstructive pulmonary disease (COPD) with eosinophilia, and other eosinophilic conditions.
- Market size: The global severe asthma market was valued at approximately $8.3 billion in 2021, with biologics including Benralizumab contributing a substantial share.
- Key competitors:
- Mepolizumab (Nucala): $2.1 billion in 2021 sales.
- Reslizumab (Cinqair): $512 million.
- Omalizumab (Xolair): $1.9 billion.
- Dupilumab (Dupixent): $9.3 billion, broader indication set.
Market Drivers
- Increased diagnosis of eosinophilic asthma.
- Growing preference for biologics over corticosteroids due to safety profiles.
- Expanded approved indications, including other eosinophil-driven diseases.
Market Challenges
- High therapy costs.
- Competition from established biologics.
- Reimbursement hurdles.
Price and Sales Projections
Historical Pricing
- Per-Use Cost: Approximate wholesale acquisition cost (WAC) in 2022 ranged from $4,000 to $5,000 per injection.
- Average Treatment Cost: Estimated at $30,000—$40,000 annually per patient, considering dosing frequency (every 4 weeks).
Market Penetration and Revenue Estimates
| Year |
Estimated Patients (Worldwide) |
Annual Revenue (USD, billions) |
Assumptions |
| 2022 |
45,000 |
1.4 |
Based on approximately 0.5% of asthma population and conservative adoption |
| 2023 |
55,000 |
1.6 |
Adoption increase, expanding indications |
| 2024 |
65,000 |
2.0 |
Broader access, payor reimbursement improvements |
| 2025 |
75,000 |
2.4 |
Further market expansion |
Growth is driven by increased diagnosis, expanded indications, and global market penetration.
Price Projections
- Price per injection: Expected to stabilize around $4,500 in the short term, possibly decreasing due to competition and biosimilar entry.
- Long-term trends: Slight price reductions may occur with biosimilar or biosimilar-like competition expected around 2030.
Impact of Biosimilars and Generics
- Biosimilars for monoclonal antibodies typically emerge 8-12 years post-approval.
- For Benralizumab, biosimilar competition could arrive between 2025 and 2030, potentially reducing prices by 20-40%.
Policy and Market Dynamics
- Pricing policies: US pricing remains high due to limited price regulation, but rebates and negotiated discounts can reduce actual payer expenditure.
- Reimbursement landscape: Insurers favor cost-effective treatments, increasing formulary access for competitive products.
- Regulatory environment: Continued approvals for additional indications could support sustained demand.
Strategic Considerations
- Investors and pharma companies should monitor biosimilar development timelines.
- The lifecycle of Benralizumab depends on patent protections, which expire around 2032.
- Market entry of competitive biologics or biosimilars could pressure pricing.
Key Takeaways
- NDC 00955-1042 (Fasenra) operates in a growing biologic segment for severe eosinophilic asthma.
- The drug's revenue may reach approximately $2.4 billion annually by 2025 if current trends persist.
- Pricing is expected to be stable short-term but could decline with biosimilar emergence after 2025.
- Market expansion hinges on broader indications and global access.
- Biosimilar competition and reimbursement policies remain key influences.
FAQs
Q1: When are biosimilars for Benralizumab expected?
A1: Biosimilars may enter the market between 2025 and 2030, depending on regulatory and development timelines.
Q2: How does Benralizumab pricing compare to competitors?
A2: It generally costs around $4,000–$5,000 per injection, similar to other monoclonal antibody therapies for asthma.
Q3: What factors are most likely to influence future sales?
A3: Indication expansion, pricing strategies, biosimilar competition, payer reimbursement policies.
Q4: Are there emerging therapies that threaten Benralizumab's market share?
A4: Yes, newer biologics with broader or more convenient administration options could impact market share.
Q5: What is the long-term value outlook for Benralizumab?
A5: Value depends on sustained demand, patent protection, and competition; the drug's lifecycle may extend beyond patent expiration if new indications or formulations emerge.
References
- Global Biologic Market for Severe Asthma, 2022, MarketWatch.
- FDA Approvals and Indications for Benralizumab (Fasenra), FDA.
- Biologics Market Share and Competitor Analysis, 2021, EvaluatePharma.
- Biosimilar Development Timelines and Impact, Scrip Intelligence.
Note: All data are indicative based on current market trends and publicly available sources as of early 2023.
