Last updated: February 17, 2026
What is NDC 33342-0053?
NDC 33342-0053 corresponds to Tezspire (tezepelumab), a monoclonal antibody approved by the FDA in December 2021 for severe asthma in patients aged 12 and older. It is marketed by AstraZeneca.
Current Market Landscape
| Segment |
Data |
| Total asthma market |
Estimated at $13.4 billion globally (2019). Key drivers include inhaled corticosteroids and biologics. |
| Severe asthma segment |
Accounts for roughly 20-25% of total asthma cases. It commands higher medication costs. |
| Biologics penetration |
Biologics like omalizumab, mepolizumab, benralizumab, and now tezepelumab occupy ~50% of the severe asthma treatment market. |
| Competition |
Established biologics: omalizumab (Xolair), mepolizumab (Nucala), benralizumab (Fasenra). Tezspire enters as a broader-eligibility biologic targeting T2 inflammation. |
Market Adoption & Outlook
- Market Penetration: Launched in late 2021, market adoption remains under 10% for severe asthma biologic therapies due to early-stage provider familiarity and formulary coverage.
- Growth Drivers:
- Expanding indications to include broader severe asthma patient subgroups.
- Increasing awareness of biologic efficacy in reducing exacerbations.
- Potential for label expansion in other eosinophilic or inflammatory diseases.
Projection:
| Year |
Projected Global Sales |
Key Assumptions |
| 2023 |
$350 million |
Steady uptake in major markets like US, EU, and Japan. |
| 2025 |
$1.2 billion |
Increased provider adoption, additional approved indications. |
| 2030 |
$3 billion |
Widespread use, competitive pricing strategies, and expanded label. |
Price Overview
| Country/Region |
List Price (Per Dose) |
Dosing |
Annual Cost (Est.) |
| US |
~$3,200 |
210 mg every 4 weeks after initial doses |
~$40,000 |
| EU |
€2,600-€3,000 |
Similar dosing |
€32,000-€36,000 |
| Japan |
¥350,000-¥400,000 |
Similar dosing |
¥4.2 million (~$38,000) |
(Note: Prices do not account for insurance, discounts, or rebates. Actual net prices tend lower.)
Price Trends and Factors
- Pricing Regulation:
- US: List prices primarily set by AstraZeneca, with rebates and discounts affecting actual payer costs.
- EU & Japan: Subject to national reimbursement negotiations, often resulting in price reductions.
- Competitive Pricing:
- Biologics generally range from $25,000 to $45,000 annually.
- Entry of biosimilars, where applicable, may exert downward pressure in the future.
Key Factors Influencing Market and Prices
- Regulatory Approvals: Expanded indications could broaden market size.
- Reimbursement Policies: Variability across regions influences net prices.
- Physician Adoption: Prescriber familiarity with biologics impacts uptake.
- Pricing Strategies: AstraZeneca may employ discounts, patient support programs, and tiered pricing.
Risks and Uncertainties
- Market Penetration Pace: Slow adoption may limit sales growth.
- Competitive Dynamics: New biologics or biosimilars could lower prices and market share.
- Regulatory Changes: Reimbursement adjustments may impact profit margins.
- Patient Access: High costs could restrict treatment adoption despite clinical benefits.
Key Takeaways
- NDC 33342-0053 (Tezspire) entered a biologic-dominated severe asthma market, with promising growth potential.
- Current list prices approximate $3,200 per dose in the US, with annual costs around $40,000; prices are similar internationally, adjusted for regional factors.
- Sales are expected to reach $1.2 billion globally by 2025, driven by increased adoption and expanded indications.
- Pricing strategies impact net revenues; discounts and reimbursement play a crucial role in actual market prices.
- The competitive landscape, regulatory environment, and physician adoption rates will shape future market dynamics.
FAQs
1. What factors could accelerate tezepelumab’s market growth?
Regulatory approval for additional indications, increased physician familiarity, and favorable reimbursement policies.
2. How does tezepelumab compare in price to other biologics?
It is priced similarly to other severe asthma biologics, with list prices typically between $25,000 and $45,000 annually.
3. Are biosimilars likely to impact the price?
Biosimilars are unlikely soon in asthma biologics due to complexity, but competition may increase over time, possibly leading to price reductions.
4. What is the main barrier to market penetration?
Limited physician awareness and formulary restrictions delay rapid adoption.
5. What regions offer the highest growth potential?
The US leads in sales, followed by EU and Japan, where reimbursement negotiations significantly influence pricing and uptake.
Sources:
[1] AstraZeneca FDA Approval Announcement, December 2021
[2] IQVIA Data, Biologic Market Reports, 2022
[3] Evaluate Pharma, 2023 Global Market Forecasts
[4] US Federal Drug Pricing Data, 2023
[5] European Medicines Agency, Reimbursement Policies, 2023
