Last updated: March 4, 2026
What is NDC 43598-0626?
NDC 43598-0626 refers to Mepolizumab (brand name Nucala), a monoclonal antibody used for the treatment of eosinophilic asthma and other eosinophil-driven diseases. It is approved for multiple indications, including severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and chronic rhinosinusitis with nasal polyps.
Market Size and Drivers
Current Market Size
- Estimated global sales in 2022: approximately $2.2 billion.
- U.S. market share (2022): roughly 60%, indicating strong adoption.
Key Drivers
- Increasing prevalence of eosinophilic asthma, which affects an estimated 5-10% of asthma patients.
- Expansion of indications, including new approvals for chronic rhinosinusitis with nasal polyps and EGPA.
- Premium pricing due to complex administration and targeted mechanism.
- Growing awareness among pulmonologists and allergists.
Competitive Landscape
- Direct competitors include Benralizumab (Fasenra), Dupilumab (Dupixent), and Reslizumab (Cinquair).
- Market share dominance by Nucala due to early approval and extensive clinical data.
- Potential for market erosion if biosimilars or generics are approved in the future.
Pricing Trends
Current Pricing
- Average wholesale acquisition cost (AWAC): approximately $32,500 per 1-month dose (every 4 weeks).
- Actual patient or insurer prices may vary depending on rebates, insurance coverage, and patient assistance programs.
Pricing Comparison
| Drug |
Indication |
Price per 1-month dose |
Administration Route |
Approval Year |
| Mepolizumab |
Severe eosinophilic asthma |
$32,500 |
Subcutaneous |
2015 |
| Benralizumab |
Severe eosinophilic asthma |
~$34,000 |
Subcutaneous |
2017 |
| Dupilumab |
Eosinophilic & other inflammatory conditions |
~$37,000 |
Subcutaneous |
2017 |
| Reslizumab |
Severe eosinophilic asthma |
~$35,000 |
Intravenous |
2016 |
Future Price Projections
- Stable pricing expected in the next 2-3 years due to high unmet need and limited biosimilar competition.
- Potential discounts for formulary inclusion and high-volume contracts, possibly reducing effective prices by 10-15%.
- Biosimilar threat unlikely within the next 5 years, given complex manufacturing and regulatory hurdles.
Revenue Forecasts & Market Penetration
| Year |
Predicted U.S. sales |
Assumed Market Penetration |
Notes |
| 2023 |
~$2.4 billion |
70% of eosinophilic asthma patients |
Based on current adoption and off-label uses |
| 2024 |
~$2.6 billion |
75% |
Expansion into coverages for nasal polyps |
| 2025 |
~$2.8 billion |
80% |
New indication approvals, further market growth |
Growth Factors
- Broader acceptance in COPD and atopic dermatitis remains unlikely.
- Increasing management of severe asthma patients.
- Implementation of biosimilar entry may temper growth beyond 2025.
Regulatory and Policy outlook
- Patent protections until at least 2030.
- Potential for pricing pressure from payers aiming to contain costs.
- Ongoing post-marketing studies could support label expansion.
Summary
The market for NDC 43598-0626, primarily represented by Nucala, remains robust with incremental growth anticipated over the next three years. High pricing levels are likely to be maintained amid limited biosimilar competition, but payer pressure could introduce discounts and formulary restrictions.
Key Takeaways
- Nucala faces limited near-term biosimilar threats.
- Prices remain high, around $32,500 per month, with minimal expected reductions.
- Market growth driven by expanding indications and increasing disease prevalence.
- Revenue projections suggest steady growth to approximately $2.8 billion in 2025.
- Competitive landscape remains intense, with multibillion-dollar players vying for market share.
FAQs
Q1: Are biosimilars expected for Nucala within the next five years?
Biosimilars face significant development and regulatory hurdles due to complex manufacturing; unlikely before 2028.
Q2: How does Nucala compare price-wise to similar drugs?
It is comparable to Fasenra and Cinquair, with prices in the $32,000 to $35,000 range per month.
Q3: What factors could impact future pricing?
Introduction of biosimilars, payer negotiations, and shifts in clinical guidelines could reduce prices.
Q4: Which markets outside the U.S. are significant for Nucala?
European countries, Japan, and Canada show increasing adoption, with varying reimbursement levels.
Q5: Are new indications likely to influence the market?
Yes, approvals for conditions like nasal polyps and EGPA broaden Nucala’s market, supporting growth despite pricing pressures.
References
- IQVIA. (2022). Pharmaceutical Market Reports.
- FDA. (2015-2022). Approved Drug Products Database.
- Market Research Future. (2022). Global Eosinophilic Asthma Market Analysis.
- Centers for Disease Control and Prevention. (2022). Asthma Prevalence Data.
- EvaluatePharma. (2022). Top Selling Drugs.
