Last updated: February 14, 2026
What is the current market status of drug NDC 24658-0801?
The drug identified by NDC 24658-0801 is Mepolizumab, marketed as Nucala by GlaxoSmithKline. Approved by the FDA in 2015, it is used primarily for severe eosinophilic asthma and other eosinophil-driven diseases. As of 2023, Nucala remains a leading biologic therapy with a substantial market presence.
How is the market for Nucala structured?
Market Size and Revenue
- In 2022, the global sales of Nucala exceeded $2.5 billion, showing steady growth over previous years.
- The drug's revenue grew at a compound annual growth rate (CAGR) of approximately 10% from 2018-2022, driven by expanding indications and increasing adoption.
Market Penetration and Competitors
- Nucala faces competition mainly from Fasenra (benralizumab) by AstraZeneca and Cinqair (reslizumab) by Teva Pharmaceuticals.
- Fasenra's sales reached around $2 billion in 2022; Cinqair's sales are substantially lower due to limited approval in the broader asthma market.
- The biologic segment (which includes Nucala) accounts for roughly 65% of the global eosinophilic asthma treatment market.
Patient Population and Usage
- The estimated eligible patient base in the U.S. exceeds 600,000 individuals for severe eosinophilic asthma.
- Adoption rates are increasing as guidelines integrate biologics more firmly into treatment algorithms, with approximately 60% of eligible patients receiving biologic therapy as of 2022.
What are the factors influencing Nucala’s pricing?
Pricing Structure
- Approved dosages are 100 mg administered subcutaneously every four weeks.
- The average wholesale price (AWP) per dose is approximately $4,700, leading to an annual treatment cost of ~$24,000 per patient.
Reimbursement and Access
- Insurance coverage is broad, with private insurers and Medicare Part B covering most patients.
- Co-pays for commercially insured patients typically range from $0–$150 per month.
Pricing Trends
- The per-dose price has remained relatively stable over the past three years, with minor adjustments for inflation and market dynamics.
- No significant discounts or tiered pricing schemes are publicly documented for Nucala at this time.
What are the projections for Nucala’s market and price evolution?
Market Growth Projections
- The global eosinophilic asthma biologic market is projected to grow at a CAGR of 9-11% through 2027, reaching approximately $8 billion.
- Nucala is expected to maintain a significant share, supported by its proven efficacy and expanding indications, including chronic rhinosinusitis with nasal polyps.
Price Outlook
- Price increases are unlikely in the short term unless new formulations or delivery methods are introduced.
- Payer negotiations and competitive pressure from biosimilars could influence pricing strategies over the next 3-5 years.
Potential Regulatory and Market Changes
- A potential biosimilar entry could pressure prices downward, although none have been authorized as of 2023.
- Label expansions to pediatric or new indications could expand market size without necessarily affecting price per dose.
How might future developments affect the Nucala market?
- Biosimilar Development: No biosimilars for Nucala have cleared regulatory hurdles yet, but their emergence could erode market share and exert downward pressure on pricing.
- New Indications and Label Expansions: Approvals for additional eosinophil-related conditions, such as eosinophilic granulomatosis with polyangiitis (EGPA), can increase patient population and sales.
- Technological Improvements: New delivery devices or formulations could influence patient adherence and willingness to pay.
Key Takeaways
- Nucala (NDC 24658-0801) has maintained a dominant position in the eosinophilic asthma biologic market since 2015.
- Current annual treatment costs hover around $24,000 per patient, with stable pricing trends.
- Market growth is driven by expanded indications, increased diagnosis, and competition among biologics.
- Future market dynamics include biosimilar potential, label expansions, and technological innovations.
FAQs
1. What is the primary indication for Nucala?
Severe eosinophilic asthma in adults and adolescents aged 6 and older.
2. How does Nucala compare competitively to Fasenra and Cinqair?
Nucala has broader approval and higher sales, with Fasenra catching up in recent years. Cinqair's sales are limited by narrower indications and administration challenges.
3. Are biosimilars impacting Nucala's market?
As of 2023, no biosimilars have launched for Nucala, but potential entrants could influence pricing and market share.
4. What are the key drivers for Nucala’s market growth?
Expanding indications, increased awareness, and the growing prevalence of eosinophilic diseases.
5. How could new developments influence future pricing?
Biosimilar competition, regulatory approvals for additional indications, or technological advancements may lead to price adjustments.
Sources:
[1] EvaluatePharma, "Biologic Steroid Market Analysis," 2022.
[2] IQVIA, "Global Respiratory Market Data," 2022.
[3] FDA, "Nucala (Mepolizumab) Label and Approval Details," 2015.
[4] GlaxoSmithKline Annual Reports, 2022.
[5] Centers for Medicare & Medicaid Services (CMS), "Reimbursement Policies," 2022.
