Last updated: February 14, 2026
What Is the Current Market Status of the Drug NDC 65757-0652?
NDC 65757-0652 refers to Tezepelumab, a monoclonal antibody developed by AstraZeneca. It is approved for the treatment of severe asthma, including cases with eosinophilic phenotype. As of 2023, Tezepelumab has gained regulatory approval in the U.S., European Union, and multiple other regions. Its commercialization is active, with supply primarily driven by AstraZeneca's manufacturing and distribution channels.
In circulating markets, Tezepelumab is positioned as a high-cost biologic. The drug’s market penetration varies by region, influenced by insurance reimbursement policies, healthcare provider adoption, and formulary placements. Pricing and reimbursement frameworks significantly impact sales volumes.
How Has the Market for Tezepelumab Evolved?
The biologic asthma segment has experienced increased competition. Key competitors include:
- Mepolizumab (Nucala)
- Benralizumab (Fasenra)
- Dupilumab (Dupixent)
Tezepelumab distinguishes itself through broader efficacy across multiple asthma phenotypes, including eosinophilic and non-eosinophilic asthma.
Sales figures indicate Helium’s initial launch in late 2021 showed rapid uptake among eligible patients. Global revenue estimates for AstraZeneca in 2022 ranged between $400 million and $600 million, with projections reaching approximately $1 billion by 2025, contingent on market expansion, payer coverage, and clinical acceptance.
What Are the Price Projections for Tezepelumab?
Pricing models for biologics such as Tezepelumab typically range from $20,000 to $35,000 per year per patient in the U.S., depending on dosage, administration frequency, and negotiated discounts.
Current List Prices:
| Region |
Approximate Annual Cost |
Notes |
| U.S. |
$27,000 – $30,000 |
List price; actual costs vary by insurer |
| EU |
$22,000 – $28,000 |
Reflects regional pricing strategies |
| Japan |
$25,000 |
Local regulatory and market factors |
Price Trends:
- The price is expected to decrease slightly over the next 2-3 years due to payer negotiations.
- Biosimilar development in the biologic asthma segment is limited but could influence price competitiveness by 2027.
- Price reductions in the U.S. are possible due to policy shifts toward value-based pricing and biosimilar entry, although biosimilars are currently limited in this space due to patent protections.
What Are the Key Factors Influencing Market and Price Trends?
-
Regulatory Approvals and Expanding Indications: Additional approvals for other eosinophilic conditions could broaden market access, impacting revenue and pricing strategies.
-
Competitive Dynamics: Mergers and pipeline developments, including emerging biologics targeting asthma, will influence market share and price positioning.
-
Reimbursement Policies: Payer negotiations, formulary placements, and cost-effectiveness assessments will shape accessible pricing tiers and prescription volumes.
-
Supply Chain Dynamics: Manufacturing capacity, supply chain disruptions, and collaborations will affect availability and pricing stability.
-
Patient Access Programs: AstraZeneca’s patient assistance programs aim to reduce out-of-pocket costs, which indirectly influence market acceptance and utilization.
What Are the Long-Term Market Outlooks?
Forecasts vary based on assumptions but several models project:
- Compound Annual Growth Rate (CAGR) of 10-12% for the biologic asthma market through 2028.
- Tezepelumab’s share could reach 15-20% within the biologic asthma segment in North America and Europe.
- Price erosion may occur as biosimilars enter the market, with potential reductions of 15-25% in list prices over five years.
The market remains sensitive to regulatory changes, payer policies, and clinical innovation. The potential expansion into atopic dermatitis and chronic obstructive pulmonary disease (COPD) may further influence volume and pricing.
Key Takeaways
- Tezepelumab (NDC 65757-0652) is a leading biologic for severe asthma with an active global sales presence.
- Market revenues are projected to approach $1 billion by 2025, driven by broader approvals and increased patient access.
- Current list prices in the U.S. range from $27,000 to $30,000 annually; adjustments are likely due to payer negotiations.
- Competitive pressure from existing biologics and biosimilar development could influence price erosion.
- Market expansion depends on clinical trial outcomes, additional indications, regulatory pathways, and reimbursement strategies.
FAQs
Q1: What determines the pricing strategy for Tezepelumab?
A1: Pricing considers manufacturing costs, clinical efficacy, comparative positioning, payer negotiations, and regional market dynamics.
Q2: How does Tezepelumab compare to competitors in terms of cost?
A2: Its list price is comparable to or slightly higher than older biologics like mepolizumab but offers broader efficacy, which can justify premium pricing.
Q3: Will biosimilars impact Tezepelumab’s price?
A3: Biosimilar development is slow due to patent protections and complexity but could lead to price reductions once available.
Q4: What factors could accelerate market growth?
A4: Regulatory approvals for additional indications, favorable reimbursement policies, and increased clinical adoption.
Q5: How does Tezepelumab’s price in the U.S. compare globally?
A5: Prices are generally higher in the U.S. due to less centralized regulation and more insurance-driven pricing; European and Asian prices tend to be slightly lower.
Sources:
[1] AstraZeneca Annual Reports 2022.
[2] IQVIA Biotech Market Reports 2023.
[3] FDA approval announcements 2021.
[4] European Medicines Agency (EMA) approvals.
[5] Industry pricing studies (Clinical Trials Arena, 2023).
