Last updated: February 24, 2026
What is NDC 51167-0400?
NDC 51167-0400 is the National Drug Code for Mepolizumab (brand name: Nucala). It is a monoclonal antibody used to treat severe eosinophilic asthma, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis.
Market Size and Trends
Current Market Size
The global mepolizumab market was valued at approximately USD 1.5 billion in 2022. The U.S. accounts for around 65%, suggesting a domestic market size near USD 975 million. The key drivers include increasing prevalence of eosinophilic asthma, especially among adult populations, and rising diagnosis rates due to enhanced awareness.
Patient Population
- Severe eosinophilic asthma prevalence: Estimated at 0.8-1.2% of adults in the U.S.
- Total U.S. adult asthma patients: ~25 million.
- Eosinophilic subset: Approx. 20-30%, or 5-7.5 million.
- Eligible patients for mepolizumab: Roughly 800,000-1 million based on severe phenotype and treatment guidelines.
Market Growth Rate
The compound annual growth rate (CAGR) for mepolizumab over 2022-2027 is forecasted at 8-10%, driven by:
- Expanded indication approvals.
- Growing awareness.
- Improved healthcare access.
Competition Landscape
Key competitors include:
- Benralizumab (Fasenra) by AstraZeneca: Similar mechanism.
- Dupilumab (Dupixent) by Sanofi/Regeneron: Broader indication, including asthma with atopic dermatitis.
- Omalizumab (Xolair) by Genentech: Earlier approved, with a broader asthma market.
Market share distribution (2022 estimate):
| Drug |
Market Share |
Indications |
Price Range (per injection) |
| Mepolizumab |
35% |
Severe eosinophilic asthma |
USD 3,200 per dose |
| Benralizumab |
30% |
Severe eosinophilic asthma |
USD 3,000 per dose |
| Dupilumab |
25% |
Broader asthma indications |
USD 3,600 per dose |
| Omalizumab |
10% |
Allergic asthma, other |
USD 1,200–USD 4,200 per dose |
Price Projections
Current Pricing
- The average wholesale price (AWP) for mepolizumab is approximately USD 3,200 per dose.
- Patients typically receive 1-2 doses per month.
Short-Term Projections (Next 2 Years)
- Stable pricing expected due to benchmark competition.
- Pricing pressure may arise from payer negotiations and biosimilar developments, but biosimilars for monoclonal antibodies are limited.
Long-Term Projections (3-5 Years)
-
Potential price reduction of 10-15% driven by:
- Increased bargaining power of insurers.
- Entry of biosimilar or generic options.
- Policy shifts toward cost containment in biologics.
-
Prices could decline to USD 2,700–USD 2,900 per dose in the U.S.
Impact of Biosimilars and Policy Changes
- Biosimilar development is ongoing; however, no biosimilar for mepolizumab currently available.
- Payer initiatives may incentivize volume discounts.
- Value-based pricing models could influence future costs.
Regulatory and Policy Environment
- Approved by FDA in 2015.
- Reimbursement is primarily through Medicare, Medicaid, and commercial insurers.
- CMS has increased emphasis on value-based care for biologics, affecting pricing strategies.
Key Factors Affecting Pricing and Market Dynamics
- Indication expansion increases eligible patient pool.
- Patent exclusivity lasts until around 2027-2028.
- Pricing and reimbursement negotiations will continue to shape access.
- Pipeline developments, including biosimilars or alternative treatments, could influence pricing downward.
Summary
| Aspect |
Data |
| Market size (2022) |
USD 1.5 billion (global); USD 975 million (U.S.) |
| Projected CAGR (2022-2027) |
8-10% |
| Estimated patient eligible |
800,000–1 million in the U.S. |
| Current price per dose |
USD 3,200 |
| Short-term price outlook |
Stable, with potential minor reductions |
| Long-term price outlook |
Declines to USD 2,700–USD 2,900 per dose (by 2027–2028) |
Key Takeaways
- The mepolizumab market is growing steadily, driven by increasing diagnoses and expanded indications.
- Pricing is expected to remain relatively stable over the next 2 years, with potential declines in the 3-5 year window.
- The absence of biosimilars now could change with patent expirations or biosimilar approvals.
- Market share distribution favors mepolizumab and benralizumab for severe eosinophilic asthma.
- Payer negotiations and policy reforms will influence future pricing and reimbursement landscapes.
FAQs
- What are the main competitors of mepolizumab in the asthma biologic market?
- How does the FDA approval timeline impact market entry and pricing?
- What factors could accelerate biosimilar development for mepolizumab?
- How does insurance coverage influence patient access and market share?
- What are potential new indications that could expand the market for mepolizumab?
References
[1] MarketWatch. (2023). Global Mepolizumab (Nucala) Market Size, Share & Trends Analysis.
[2] IQVIA. (2022). US Biologics Market Report.
[3] FDA. (2015). Approval Details for Mepolizumab.
[4] EvaluatePharma. (2022). Biologic Drugs Market Forecast.
[5] CMS. (2022). Reimbursement Policies for Biologics.
