Last updated: February 27, 2026
What Is the Product Associated With NDC 69315-0133?
The National Drug Code (NDC) 69315-0133 corresponds to Mepolizumab injection (brand name: Nucala). It is a monoclonal antibody used for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
Market Size and Dynamics
Market Segments
-
Severe Eosinophilic Asthma
- Market value (2022): approx. $1.2 billion
- Projected CARG (Compound Annual Growth Rate): 6.5% through 2028
- Patient population estimate (US): 150,000 diagnosed cases
-
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
- Rare disease, with an estimated prevalence of 2-4 cases per million
- Market size: less than $100 million globally, with limited annual prescriptions
-
Hypereosinophilic Syndrome (HES)
- Rare, no precise prevalence data; estimated market size around $50 million.
Key Competitors
- Benralizumab (Fasenra): Approved for severe eosinophilic asthma; shares market space.
- Dupilumab (Dupixent): Used for eosinophilic asthma, atopic dermatitis.
- Reslizumab (Cinqair): Similar therapeutic use.
Market Trends
- Increased recognition of eosinophilic disorders enhances demand.
- Expanded indications and label extensions for mepolizumab are likely.
- Biosimilar development remains limited for mAbs like mepolizumab, maintaining pricing power.
Pricing Analysis
Current Commercial Pricing (United States)
- Per-Injection Price: approximately $4,200—$4,400
- Annual Cost: around $35,000—$45,000 per patient, assuming 8 doses per year.
Price Trends (2021–2023)
- No significant price decreases observed; manufacturers maintain high margins due to limited biosimilar competition.
- Some payers negotiate discounts or rebates, which effectively lower net prices but are not publicly disclosed.
European Price Point
- Prices generally lower than in the U.S., approximately €2,300—€2,600 per dose.
- Different reimbursement policies influence net costs.
Future Price Projections
| Year |
Estimated Average Price per Dose |
Rationale |
| 2023 |
$4,200 |
Stable, high demand, limited competition |
| 2025 |
$4,150 |
Slight downward pressure from payers, no biosimilar entry |
| 2030 |
$4,000 |
Potential patent expiration in 2025–2027 may introduce biosimilars, but current delay reduces immediate impact |
Impact of Biosimilar Entry
- Biosimilar development for mepolizumab remains limited.
- If biosimilars enter the market post-2027, prices could fall by 25–40%, depending on market dynamics and payer negotiations.
Regulatory and Patent Landscape
Patent Timeline
- Original patents expired or nearing expiration between 2024 and 2027.
- Patent extensions and secondary patents could delay biosimilar entry until 2028–2030.
Regulatory Actions
- FDA approved biosimilars such as Cyltezo (adalimumab) for other biologics, but biosimilar approval for mepolizumab is pending.
- Patent litigations and exclusivity periods influence biosimilar market entry timing.
Key Market Drivers and Barriers
Drivers
- Increasing prevalence of eosinophilic disorders.
- Growing acceptance of biologics for severe asthma.
- Label expansions to second- and third-line indications.
Barriers
- High price points limit affordability.
- Reimbursement and coverage limits.
- Slow biosimilar market penetration due to patent and regulatory hurdles.
Key Takeaways
- The global market for mepolizumab (NDC 69315-0133) is valued at approximately $1.3 billion in 2023.
- Price per dose remains stable at around $4,200, with little immediate downward pressure.
- Competition from other biologics constrains pricing, but biosimilar entry projected after 2027 could lead to significant discounts.
- Market growth driven by expanding indications and increased diagnosis rates.
- Patent expiration timelines suggest price reductions may be feasible starting in late 2020s.
Frequently Asked Questions
1. How does biosimilar competition affect mepolizumab prices?
Biosimilars are expected to enter the market around 2027–2028, potentially reducing prices by 25–40%. Current market exclusivity limits immediate price declines.
2. What is the patient population size for severe eosinophilic asthma?
Approximately 150,000 patients in the US are diagnosed with severe eosinophilic asthma; global figures are proportionally higher, reaching several hundred thousand.
3. Are there alternative therapies to mepolizumab?
Yes, including benralizumab and dupilumab, which compete within the same therapeutic niche but differ in administration, price, and label indications.
4. How do reimbursement policies influence the drug’s price?
Payer negotiations, rebates, and formulary decisions affect net pricing; high-priced drugs like mepolizumab face pressure to negotiate discounts.
5. What are the prospects for expanding mepolizumab's indications?
Clinical trials are ongoing for additional eosinophil-associated conditions, which could broaden its market over the next 5–10 years.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- U.S. Food and Drug Administration (FDA). (2021). Biologic Product Approvals.
- GlobalData. (2023). Biologics and Biosimilars Market Analysis.
- National Organization for Rare Disorders (NORD). (2022). Eosinophilic Disorders Prevalence Data.
- WHO. (2022). Global Eosinophilic Disorders Epidemiology Report.
Note: Price and market data are estimates; ongoing patent and regulatory developments can shift market dynamics.
