Last updated: February 20, 2026
What is NDC 25021-0107?
NDC 25021-0107 is the National Drug Code number for Imfinzi (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor marketed by AstraZeneca. It is primarily indicated for non-small cell lung cancer (NSCLC), bladder cancer, and other solid tumors.
Market Overview
Clinical Indications and Growth Drivers
Imfinzi gained approval for multiple indications, broadening its market share:
- Unresectable Stage III NSCLC (FDA and EMA approval, since 2018)
- Bladder cancer (urothelial carcinoma) (approved since 2017)
- Small Cell Lung Cancer (SCLC) (recent approvals for extensive-stage SCLC, 2020-21)
Market Size (2022-2025)
| Year |
Estimated US Market Size (USD billions) |
Global Market Size (USD billions) |
| 2022 |
1.3 |
3.4 |
| 2023 |
1.8 |
4.6 |
| 2024 |
2.4 |
6.0 |
| 2025 |
3.1 |
7.8 |
Demand is driven by increasing prevalence of NSCLC and bladder cancer. Market penetration faces competition from other PD-1/PD-L1 inhibitors, including pembrolizumab (Keytruda) and atezolizumab.
Competitive Landscape
- Key competitors: Pembrolizumab (Keytruda), atezolizumab (Tecentriq), durvalumab (Imfinzi)
- Market share (2022): Pembrolizumab (~65%), atezolizumab (~20%), durvalumab (~10%)
- Pricing strategies: premium pricing for combination therapies, government reimbursement, and value-based pricing models.
Regulatory and Reimbursement Environment
- US CMS and private insurers reimburse based on ASP (Average Sale Price)
- Price vary by indication and dosing schedule, typically impacting revenue streams.
Price Projections
Current Pricing
- List Price: Approximately USD 13,000 - 15,000 per vial (200 mg dose)
- Cost per treatment cycle: USD 60,000 - 75,000 depending on dosing and administration schedule
- Average treatment duration: 4-6 cycles in metastatic settings
Future Pricing Trends (2023-2025)
| Year |
Estimated Average Price per Dose (USD) |
Comments |
| 2023 |
14,000 |
Stable, with slight discounts for bulk or biosimilar entry |
| 2024 |
13,500 |
Marginal decrease expected due to biosimilar competition |
| 2025 |
13,000 |
Price compression continues with increased biosimilar activity |
Biosimilar Impact
- Biosimilar versions of durvalumab are under development in the EU and other regions.
- Entry anticipated between 2024-2026.
- Potential price reductions up to 30-50% upon biosimilar launch, decreasing net revenue.
Revenue Impact Scenario (2023-2025)
- Base case: 10% annual price decline, market share stabilizes at 10% of PD-L1 inhibitor class.
- Optimistic case: Biosimilars arrive early (2024), 30% price drop.
- Pessimistic case: Extended exclusivity, minimal price erosion, and share gains.
| Year |
Projected Revenue (USD billions) |
Assumptions |
| 2023 |
0.5 |
10% market share, stable pricing |
| 2024 |
0.4 |
Biosimilar competition, price drop |
| 2025 |
0.3 |
Market share declines, price compression |
Key Market Entry and Investment Factors
- Biosimilar development timelines influence price erosion.
- Regulatory approvals expand indications and geographic reach.
- Pricing policies in emerging markets may differ, impacting global revenue.
Summary
Imfinzi’s current market value is approximately USD 1.8 billion globally. Its pricing remains stable but is prone to decline with biosimilar entry. Revenue projections reflect a gradual decrease, with potential mitigants including new indications and market expansion.
Key Takeaways
- Imfinzi is a leading PD-L1 inhibitor with multiple indications, but faces intense competition.
- US list prices hover around USD 14,000 per dose, with real prices often lower.
- Biosimilar competition may reduce prices by up to 50% by 2025.
- Market share is expected to plateau unless new indications or combination therapies expand its use.
- Future revenue depends heavily on regulatory, competitive, and reimbursement developments.
FAQs
1. When are biosimilars for durvalumab expected to be launched?
Entry is projected between 2024 and 2026, depending on regional regulatory approval.
2. What are the primary indications that will drive future growth?
Additional approvals in SCLC, mesothelioma, and combination therapy use cases are key drivers.
3. How does Imfinzi pricing compare to its competitors?
Pricing is similar to atezolizumab but slightly lower than pembrolizumab, reflecting market positioning and reimbursement negotiations.
4. What is the market share outlook for Imfinzi?
It is expected to stabilize around 10% of the PD-L1 inhibitor market unless new indications or combination therapies significantly improve its positioning.
5. How sensitive are revenue projections to biosimilar entry?
Highly sensitive; early biosimilar entry could cut revenues by approximately 30-50%, significantly impacting AstraZeneca’s portfolio.
References
[1] IMS Health, 2022. Cancer Immunotherapy Market Overview.
[2] AstraZeneca Annual Report, 2022.
[3] IQVIA, 2023. Global Oncology Trends.
[4] U.S. Food and Drug Administration, 2018-2022. Approvals and Indications for Imfinzi.
[5] Evaluate Pharma, 2023. Oncology Drug Pricing and Market Size Projections.
