Last updated: February 16, 2026
Overview
NDC 00032-0047 corresponds to Mepolizumab, marketed as Nucala. It is a monoclonal antibody targeting interleukin-5 (IL-5), approved by the FDA in 2015 for severe eosinophilic asthma and other eosinophilic conditions. The drug is administered via subcutaneous injection and is available through specialty pharmacies.
Market Size and Segment
The global severe eosinophilic asthma market is projected to reach approximately $8 billion by 2027. Nucala, as a leading biologic in this space, accounts for an estimated 60-70% market share.
The U.S. asthma biologics market surpasses $3 billion annually, with Nucala generating an estimated $1.8 billion in revenue in 2022, according to IQVIA data.
Key competitors include Benralizumab (Fasenra) and Dupilumab (Dupixent), which are expanding indications and capturing market share.
Market Drivers
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Approval expansion for indications such as eosinophilic granulomatosis with polyangiitis (EGPA).
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Growing diagnosis rates of eosinophilic asthma and related allergies.
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Payer incentives favoring biologics over oral therapies, given better safety profiles.
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Patient adherence driven by less frequent dosing (monthly or quarterly injections).
Pricing and Reimbursement Landscape
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Average wholesale price (AWP): Approximately $3,700 per dose (based on 100 mg vials).
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Average patient cost: After insurance, out-of-pocket payments typically range from $25-$150 per dose.
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Annual treatment cost: About $45,000 to $50,000 per patient, considering dosing schedules (typically 6 doses per year).
Reimbursement constraints and payer policies influence net revenue realization. Contract negotiations and prior authorization are standard.
Price Trends and Projections
| Year |
Estimated Wholesale Price per Dose |
Approximate Annual Cost |
Notes |
| 2022 |
$3,700 |
$22,200 |
Based on 6 doses of 100 mg each, administered over the year |
| 2023 |
$3,750 |
$22,500 |
Slight increase reflecting inflation and manufacturing cost adjustments |
| 2024 |
$3,800 |
$22,800 |
Continued inflation trend |
| 2025 |
$3,850 |
$23,100 |
Anticipated stabilization, with possible discounts or rebates affecting net |
Future price projections suggest minimal per-dose increases, constrained by payer negotiations and competitive pressures. Breakthrough therapies or biosimilars are unlikely to enter the market before 2028–2030.
Market Penetration and Growth
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Penetration into eligible patient pools is approximately 30–40%, limited by diagnosis rates and access.
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Expansion into additional indications (e.g., eosinophilic esophagitis) might expand the market by an estimated 15–20% over the next five years.
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The growth rate of Nucala sales is expected to be 3–5% annually, driven by new approvals and increased awareness.
Regulatory and Policy Impact
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The FDA’s approval of biosimilar variants is unlikely soon, given the complexity of biologic manufacturing and patent protections.
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Payer policies increasingly favor dose-based payment models, influencing net revenue margins.
Competitive Landscape
| Product |
Indications |
Market Share (2022) |
Price (per dose) |
Key Features |
| Nucala (Mepolizumab) |
Severe eosinophilic asthma, EGPA |
60–70% |
~$3,700 |
First-approved biologic targeting IL-5 |
| Fasenra (Benralizumab) |
Severe eosinophilic asthma |
20–25% |
~$3,500 |
IgE-inducing mechanism less prominent |
| Dupixent (Dupilumab) |
Eosinophilic dermatitis, asthma |
10–15% |
~$3,600 |
Broader indications, increasing off-label use |
Key Takeaways
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Nucala remains the dominant biologic for eosinophilic asthma, with stable pricing in the near-term.
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Market growth hinges on expanded indications, accurate diagnosis, and payer acceptance.
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Competitive positioning relies on efficacy, safety profiles, and the ability to navigate reimbursement trajectories.
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Price increases are expected to be modest, constrained by market dynamics and payer negotiations.
FAQs
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What is the current price per dose of Nucala?
It averages approximately $3,700, with minor annual increases.
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How many patients are eligible for Nucala?
Estimated at 300,000-400,000 in the U.S., representing around 10% of severe asthma sufferers.
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Are biosimilars likely for Nucala?
Biologic biosimilars are unlikely before 2028–2030 due to patent protections and manufacturing complexity.
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What factors could influence Nucala’s pricing in the future?
Payer policies, competition, manufacturing costs, and regulatory changes.
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What is the growth outlook for Nucala sales?
Averages 3–5% annual growth, supported by new indications and increased diagnosis.
Sources
[1] IQVIA. Pharmaceutical Market Data.
[2] FDA. Approval History of Mepolizumab.
[3] EvaluatePharma. Biologic Market Reports.
[4] CDC. Asthma Prevalence Data.
