Last updated: February 24, 2026
What is NDC 00641-6053?
NDC 00641-6053 corresponds to a specific drug product. As of the latest available data, this NDC pertains to Mepolizumab (brand name: Nucala). It is a monoclonal antibody used in the treatment of eosinophilic asthma, hypereosinophilic syndrome, and other eosinophil-related conditions.
Market Size and Demand Drivers
1. Current Market Size
- The global market for biologics targeting eosinophilic diseases exceeds $4 billion in 2022 (MarketWatch, 2022).
- U.S. sales for mepolizumab in 2022 reached approximately $1.7 billion, growing at a compound annual growth rate (CAGR) of 12% since 2019 (IQVIA, 2022).
2. Growth Drivers
- Increasing prevalence of eosinophilic asthma and related conditions.
- Expanding approval for additional indications—such as chronic rhinosinusitis with nasal polyps (CRSwNP).
- Pipeline developments and potential label expansions promise further market growth.
- Pricing and reimbursement strategies by manufacturers influence accessibility.
3. Competitive Landscape
| Product |
Year FDA Approved |
Annual US Sales (2022) |
Market Share (2022) |
Price per Dose (2023) |
| Nucala (mepolizumab) |
2015 |
$1.7 billion |
65% |
$32,000 |
| Fasenra (benralizumab) |
2017 |
$1.2 billion |
25% |
$28,000 |
| Cinqair (reslizumab) |
2016 |
$150 million |
10% |
$24,000 |
Note: Prices are listed per single dose, varying slightly by healthcare setting and payer agreements.
Price Projection Analysis
1. Historical Pricing Trends
- Average wholesale acquisition cost (WAC) per dose increased around 4% annually from 2019 to 2022.
- Price adjustments are driven by inflation, manufacturing costs, and payer negotiations.
2. Projected Pricing Trends (2023-2028)
| Year |
Estimated Price per Dose |
Comment |
| 2023 |
$32,200 |
Slight price increase due to inflation and market dynamics. |
| 2024 |
$33,000 |
Expected minor increase for coverage expansion. |
| 2025 |
$33,850 |
Potential for price stabilization or slight decrease with biosimilar entry. |
| 2026 |
$34,700 |
Anticipated growth limited by biosimilar competition and tough payer negotiation. |
| 2027 |
$35,200 |
Slight increase driven by manufacturing and R&D costs. |
| 2028 |
$36,000 |
Cap on price hikes, assuming increased biosimilar competition. |
3. Factors Impacting Price Trend
- Biosimilar Entry: Expected entry of biosimilars by 2026 could pressure prices downward by 10-20%.
- Regulatory Changes: Potential policy shifts could alter pricing strategies, especially with new healthcare reforms targeting drug costs.
- Market Penetration: Broader use for new indications may sustain or elevate prices temporarily.
- Reimbursement Policies: Changes in payer coverage influence the final net price.
Future Market Opportunities
- Expanded indications, such as eosinophilic granulomatosis with polyangiitis (EGPA), may increase demand.
- Development of combination therapies could impact demand and pricing.
- Emerging biosimilars could lead to competitive pricing, decreasing average costs.
Summary of Key Data
| Item |
Data Point |
| Current market size |
$4 billion (globally, 2022) |
| U.S. sales (2022) |
$1.7 billion |
| Price per dose (2023) |
$32,000 |
| CAGR (2019-2022) |
12% in U.S. biologics for eosinophilic conditions |
| Estimated price increase 2023-2028 |
6-12% cumulatively, with downward pressure from biosimilars |
Conclusion
Nucala (NDC 00641-6053) remains a dominant biologic for eosinophilic conditions with stable demand in the U.S. Market growth is driven by increasing prevalence and expanding approved indications. Price projections suggest modest increases through 2028, with biosimilar entry potentially reducing prices thereafter.
Key Takeaways
- The market for mepolizumab remains substantial, with U.S. sales exceeding $1.7 billion in 2022.
- Prices per dose are likely to grow gradually, reaching approximately $36,000 by 2028.
- Biosimilar competition beginning around 2026 is expected to exert downward pressure on prices.
- Market expansion into new indications can sustain or increase demand, influencing pricing strategies.
- Policy and reimbursement changes are significant determinants of future price dynamics.
FAQs
Q1: When is biosimilar competition expected for mepolizumab?
A1: Biosimilar entry is anticipated around 2026, based on typical regulatory approval timelines and patent expirations.
Q2: What are the main competitors to Nucala?
A2: Fasenra (benralizumab) and Cinqair (reslizumab) are primary competitors, both FDA-approved for eosinophilic asthma.
Q3: How do pricing strategies vary across payers?
A3: Actual transaction prices are negotiated, often lower than list prices, influenced by formulary placements and rebate agreements.
Q4: Are there any upcoming indications that could impact demand?
A4: Yes, label expansions for conditions like CRSwNP and EGPA could drive demand growth globally.
Q5: How do regulatory policies influence future pricing?
A5: Policy shifts favoring cost containment and biosimilar adoption could slow price increases or lead to reductions.
References
[1] MarketWatch. (2022). "Biologics Market Size Analysis."
[2] IQVIA. (2022). "U.S. Biologic Sales Data."
