Last updated: February 25, 2026
What is NDC 62484-0015?
NDC 62484-0015 is the biologic drug Nucala (mepolizumab), a monoclonal antibody indicated primarily for eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is marketed by GlaxoSmithKline (GSK). Approved by the FDA in 2015, Nucala was among the first anti-IL-5 therapies targeting eosinophilic conditions.
Market Overview
The global market for mepolizumab and similar biologics has experienced rapid growth due to expanding indications and heightened demand for targeted therapies. The key segments include:
- Asthma (Severe Eosinophilic Form)
- EGPA
- HES
Key competitors include:
| Drug |
Manufacturer |
Indications |
Approval Year |
Approved Market Shares (%) |
| Nucala (mepolizumab) |
GSK |
Asthma, EGPA, HES |
2015, 2017, 2016 |
70% (US) |
| Cinqair (reslizumab) |
Regeneron |
Asthma |
2016 |
~15% |
| Fasenra (benralizumab) |
AstraZeneca |
Asthma, EGPA |
2017 |
~10% |
The drug's revenue reached $1.3 billion in 2022, driven by increasing prevalence of eosinophilic conditions and expanded label indications.
Market Drivers
- Rising Prevalence: Asthma affects approximately 8% of adults globally; severe eosinophilic asthma constitutes a significant subset.
- Label Expansion: FDA approvals for EGPA (2017) and HES (2019) have widened the patient base.
- Biologic Adoption: Physicians favor targeted biologics over corticosteroids due to fewer side effects.
- Pricing and Reimbursement: High reimbursement rates in developed countries sustain premium pricing.
Price and Cost Analysis
Current Market Pricing
In the US, the average wholesale price (AWP) of Nucala is approximately:
| Parameter |
Volume/Cost |
| Cost per dose (100 mg) |
$4,586 |
| Dosing frequency |
100 mg IV or SC every 4 weeks |
| Annual treatment cost |
~$56,600 |
Variability exists based on insurer discounts, patient assistance programs, and specific dosing regimens.
Price Trends (2018–2023)
| Year |
Average Price per Dose |
Notes |
| 2018 |
$4,349 |
Initial market entry price |
| 2020 |
$4,590 |
Slight increase aligned with inflation |
| 2022 |
$4,586 |
Stable, considering market dynamics |
| 2023 |
Estimated $4,560–$4,600 |
Based on inflation and competitive pressures |
Price Drivers & Constraints
- Reimbursement Policies: Favorable in US, limiting discounts.
- Generic/Biosimilar Competition: Currently absent, but biosimilar entry expected beyond 2030.
- Price Regulation: Limited in the US; more control in Europe and emerging markets.
Future Market and Price Projections
Market Growth Outlook (2023–2028)
| Year |
Estimated Market Size |
CAGR |
Notes |
| 2023 |
$1.4 billion |
12% |
Continued expansion driven by new indications and uptake |
| 2025 |
$2.0 billion |
|
Growing awareness and clinician adoption |
| 2028 |
$2.8 billion |
|
Potential entry of biosimilars and price stabilization |
Price projections
| Time Frame |
Expected Price Range (per dose) |
Key Factors |
| 2025 |
$4,500–$4,700 |
Market maturity, inflation, biosimilar threat unlikely yet |
| 2028 |
$4,700–$5,000 |
Biosimilar entry, increased competition, potential regulatory shifts |
Key Influences on Price
- Regulatory Environment: Price controls in Europe may pressure US prices.
- Market Penetration: Broadened indication approval may pressure margins.
- Pricing Pressure from Biosimilars: Entry anticipated post-2030 may lead to substantial discounts.
Regulatory and Policy Considerations
- US FDA approvals secured for multiple indications; no significant barriers.
- EMA (European Medicines Agency) approval recognized; pricing negotiations more intense.
- Potential Price Controls: Emerging markets and European countries consider cost containment measures.
Summary
Nucala (NDC 62484-0015) remains a dominant player with approximately 70% market share in US eosinophilic biologics. Its high-cost profile is maintained through targeted indications and physician preference. Market growth persists, supported by expanding indications and increasing diagnosis rates. Price stability is anticipated until biosimilar competition intensifies beyond 2030, likely leading to significant reductions in US list prices.
Key Takeaways
- Nucala dominates the eosinophilic biologic market with stable high prices, around $4,600 per dose.
- Market size exceeds $1.4 billion in 2023, with expected CAGR of approximately 12% through 2028.
- Expanded indications and high unmet medical need support ongoing revenue growth.
- Biosimilar competition is unlikely before 2030 but will exert downward pressure subsequently.
- Regional pricing policies vary, with more aggressive price regulation expected outside the US.
FAQs
Q1: What factors influence the high price of Nucala?
A1: Its targeted mechanism, orphan disease status, limited competition, and patent protections sustain the high list price.
Q2: How does biosimilar entry impact Nucala's pricing?
A2: Entry post-2030 could reduce prices by 20–50%, depending on market dynamics and regulatory policies.
Q3: Are there significant reimbursement challenges for Nucala?
A3: In the US, reimbursement remains strong due to high insurance coverage; challenges may increase in emerging markets.
Q4: Which indications are most profitable for GSK?
A4: Severe eosinophilic asthma remains the primary revenue driver; expansion into EGPA and HES also contribute.
Q5: How do prices compare internationally?
A5: European prices are often lower due to price negotiations and regulations; US prices remain among the highest worldwide.
References
- GSK. (2022). Nucala (mepolizumab) prescribing information.
- IQVIA. (2022). Global biologic market size and forecasts.
- FDA. (2015–2022). Approvals and label expansions for mepolizumab.
- EvaluatePharma. (2023). Biologic drug market analysis.
- European Medicines Agency (EMA). (2022). Summary of product characteristics for mepolizumab.
