Last updated: February 22, 2026
What is NDC 61958-2002?
NDC 61958-2002 corresponds to a formulation of Benralizumab (brand name Fasenra), a monoclonal antibody indicated for severe eosinophilic asthma and other eosinophil-driven diseases. Approved by the FDA in 2017, it targets the IL-5 receptor alpha to reduce eosinophil levels, improving symptoms in targeted patient populations.
Market Size and Competitive Landscape
Current Market Size
- The global asthma therapeutics market surpassed $20 billion in 2022.
- Within this, biologic agents like Benralizumab account for approximately 25-30% of asthma treatment sales, positioning at roughly $5-6 billion.
- The U.S. accounts for 40-45% of the global biologic asthma drug sales, meaning roughly $2-2.7 billion attributed to similar treatments, including Benralizumab.
Key Competitors
| Drug Name |
Approval Year |
Indications |
Annual US Sales (2022) |
Market Share (Asthma Biologics) |
| Mepolizumab (Nucala) |
2015 |
Eosinophilic asthma, hypereosinophilic syndrome |
$2.3 billion |
45% |
| Reslizumab (Cinquair) |
2016 |
Eosinophilic asthma |
$300 million |
6% |
| Dupilumab (Dupixent) |
2017 |
Asthma, atopic dermatitis, nasal polyps |
$5 billion (total for all indications) |
44% for asthma biologics |
Benralizumab's market share has grown as coverage expands and patient access improves.
Growth Drivers
- Rising prevalence of severe asthma.
- Increasing approval for additional indications like eosinophilic chronic obstructive pulmonary disease (COPD).
- Expansion into international markets, especially Europe and Asia, signaling higher revenue potential.
Market Barriers
- High drug acquisition cost.
- Restricted reimbursement policies in certain regions.
- Competition from emerging biosimilars and next-generation biologics.
Price Projections
Current List Price
- The average wholesale price (AWP) for Benralizumab in the U.S. stands at approximately $32,000 to $35,000 per annual dose per patient.
- This equates to roughly $10,000 to $12,000 per month depending on dosing frequency.
Cost Trends
- The pricing model is based on a fixed-dose schedule: typically 30 mg administered every 4 weeks for the first three doses, then every 8 weeks.
- Price adjustments depend on negotiations, rebate structures, and payer policies.
Future Price Predictions (Next 3-5 Years)
| Year |
Projection Features |
Estimated List Price Per Year |
| 2023 |
Stable pricing, slight discounts through payers |
$35,000 |
| 2024 |
Slight reductions in list price due to increased competition |
$33,000 |
| 2025 |
Potential adoption of value-based pricing models |
$31,000 |
| 2026 |
Introduction of biosimilar competitors or innovative delivery systems |
$28,000 |
Price Erosion Factors
- Biosimilar entry, expected around 2028-2030, could reduce prices by 20-30%.
- Policy-driven price caps and value-based reimbursement models may further lower effective pricing.
Revenue Projections
Assuming market penetration continues and prices trend downward moderately:
- 2023: $2.75 billion globally.
- 2024: $2.4 billion, accounting for global expansion and pricing adjustments.
- 2025: Slight growth to $2.5 billion as new indications and markets open.
- 2026: Revenue stabilizes around $2.4 billion with biosimilar entry looming.
Regulatory and Market Access Outlook
- Priority review status for additional indications in eosinophil-related conditions.
- Increasing insurance coverage and patient access programs.
- Potential pricing pressures driven by new biosimilars and cost containment strategies.
Strategic Recommendations
- Focus on global expansion, especially in Europe and Asia.
- Prepare for biosimilar competition by investing in real-world effectiveness data and value-based pricing negotiations.
- Develop value propositions for payers emphasizing long-term cost savings through reduced hospitalization and improved disease control.
Key Takeaways
- NDC 61958-2002 (Benralizumab) is a leading biologic for eosinophilic asthma, with an estimated global market of $5-6 billion.
- The drug's US sales in 2022 approached $2.3 billion, with market share growing due to expanding indications.
- Price projections suggest stabilization around ( $31,000-$35,000 ) annually, with potential declines driven by biosimilar entry.
- Market growth depends on penetration into new indications and geographies; competition remains a significant factor.
- Cost containment policies and biosimilar availability will influence long-term pricing and revenue.
FAQs
1. When will biosimilars for Benralizumab become available?
Biosimilars are generally authorized 8-12 years after the original biologic's patent date. Benralizumab was approved in 2017, so biosimilar competition could emerge around 2025-2029, subject to patent litigation and regulatory approval.
2. How are reimbursement trends affecting Benralizumab?
Reimbursement is shifting towards value-based models, emphasizing clinical outcomes and long-term cost savings. Payers are negotiating rebates and discounts, which may lower net prices but improve patient access.
3. What are the main markets for Benralizumab outside the US?
Europe represents the largest international market, with growing presence in Asia-Pacific. Market acceptance varies based on disease prevalence, regulatory approval, and healthcare infrastructure.
4. How does Benralizumab compare price-wise with other biologics?
It is priced similarly to Mepolizumab, generally around $32,000–$35,000 annually in the US. Dupilumab, with multiple indications, can be higher, but pricing varies by indication and patient volume.
5. What factors could accelerate or hinder market growth?
Market growth accelerates with expanded indications and international approval. Regulatory delays, pricing restrictions, or biosimilar entry could hinder growth projections.
[1] Food and Drug Administration. (2017). Fasenra (benralizumab) prescribing information.
[2] IQVIA. (2022). Biologic asthma therapy sales report.
[3] Evaluate Pharma. (2023). Global biologics market insights.
[4] BioPharm Insight. (2023). Biosimilar landscape updates.
