Last updated: February 25, 2026
What is NDC 52536-0401?
NDC 52536-0401 is a drug marketed as Benralizumab (brand name: Fasenra). It is a monoclonal antibody used for severe eosinophilic asthma. Approved by the FDA in 2017, it belongs to the class of biologics targeting IL-5 receptor alpha, intended to reduce asthma exacerbations in adults.
Market Size and Growth
Current Market Landscape
- Global Asthma Therapy Market (2022): Estimated at USD 16 billion (Source: Grand View Research).
- Biologics Segment: Accounts for approximately 35% of the global asthma treatment market, valued at USD 5.6 billion.
- Benralizumab Contribution: Estimated at USD 200 million—USD 300 million in 2022, based on sales reports and industry estimates.
Market Drivers
- Increasing prevalence of asthma globally.
- Growing approval and adoption of biologics.
- Real-world evidence supporting efficacy and safety.
- Expanded indications, including its potential use for other eosinophilic disorders.
Competition and Market Share
- Key competitors: Mepolizumab (Nucala), Reslizumab (Cinqair), and Dupilumab (Dupixent).
- Mepolizumab leads with an estimated USD 1.3 billion in sales (2022).
- Benralizumab holds approximately 15-20% of the biologic asthma market share in the U.S.
Geographic Markets
- U.S.: Largest market for biologics, representing 60% of sales.
- Europe: Growing adoption.
- Emerging markets: Adoption slower but expected to increase due to approval and pricing adjustments.
Pricing Analysis
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately USD 29,000 - USD 33,000 per autoinjector (single dose).
- Per-Year Cost: Roughly USD 86,000 - USD 120,000 per patient, considering two doses every 4 weeks.
Pricing Factors
- Administration: Administered via subcutaneous injection in clinics, influencing patient and payer costs.
- Reimbursement: Covered largely by commercial insurance, Medicaid, and Medicare Part B.
- Pricing Trends: Slight increase observed, correlating with inflation and manufacturing costs.
Factors Affecting Price Projections
- Patent expiration timelines.
- Entry of biosimilars.
- Manufacturing advancements reducing costs.
- Negotiation power of payers.
Future Price Projections (2024-2028)
| Year |
Estimated Wholesale Price |
Notes |
| 2024 |
USD 28,500 – USD 32,500 |
Stable with minor adjustments |
| 2025 |
USD 28,000 – USD 31,500 |
Possible negotiation discounts for payers |
| 2026 |
USD 27,500 – USD 30,500 |
Biosimilar entry anticipated |
| 2027 |
USD 26,000 – USD 29,000 |
Increased biosimilar competition |
| 2028 |
USD 25,000 – USD 28,000 |
Further price reductions expected |
Impact of Biosimilars
- Biosimilars for Benralizumab are not yet approved; expected entry could reduce prices by 20-30%.
- Patent expiration likely around 2032, facilitating biosimilar development.
Regulatory and Policy Influences
- CMS and private insurer negotiations influence net prices.
- Value-based pricing models could induce discounts.
- Expanded indications may stabilize or increase demand, buffering price drops.
Investment and R&D Outlook
- Biotech firms are exploring next-generation IL-5 inhibitors.
- Reduced manufacturing costs and biosimilar development are critical to future competitiveness.
- Ongoing clinical trials for additional indications could expand market size.
Summary of Key Data
- Market size (~2022): USD 200-300 million for Benralizumab.
- Growth rate: 10-12% annually based on asthma prevalence increases.
- Current price per dose: USD 14,500 - USD 16,500.
- Expected price decline (2026 onwards): 10-15% linked to biosimilar competition.
Key Takeaways
- NDC 52536-0401 (Fasenra) is a mid-tier biologic in a rapidly expanding asthma market.
- Current pricing remains high with marginal increases; future price declines anticipated with biosimilar entry.
- Market share and revenue projections depend heavily on regulatory decisions, biosimilar development, and payer negotiations.
- The overall market is driven by rising asthma prevalence and biologic therapy adoption, supporting durable demand.
FAQs
1. When could biosimilars for Benralizumab enter the market?
Potential regulatory approval could occur around 2030, with biosimilar entry expected by 2032, following patent expiration.
2. How does the pricing of Benralizumab compare to competitors?
It is slightly more expensive than Mepolizumab (~USD 29,000 vs. USD 27,000). Reslizumab and Dupilumab have similar or higher prices depending on dosage and indication.
3. What factors could increase the market size for Benralizumab?
Expanded indications, increased asthma prevalence, and successful clinical trials for other eosinophilic disorders.
4. Are there any current regulatory or patent challenges?
Patent protections are expected to last until approximately 2032. No significant regulatory hurdles have been announced for biosimilars yet.
5. What is the outlook for price reductions in the next five years?
Expect a 10-15% decline starting from 2026, primarily due to biosimilar competition and negotiated discounts.
References
- Grand View Research. (2022). Asthma Treatment Market Size, Share & Trends Analysis.
- U.S. Food and Drug Administration. (2017). FDA approves new drug Fasenra to treat severe eosinophilic asthma.
- IQVIA. (2022). Biologics Market Data.
- Centers for Medicare & Medicaid Services. (2023). Drug Pricing and Reimbursement Policies.
- ClinicalTrials.gov. (2023). Ongoing trials for IL-5 inhibitors and biosimilars.
