Last updated: August 21, 2025
Introduction
NDC 00115-1725 pertains to Durvalumab (Imfinzi), a monoclonal antibody developed by AstraZeneca. Approved initially for treating extensive-stage small cell lung cancer (ES-SCLC) and urothelial carcinoma among others, Durvalumab is a frontrunner in the immune checkpoint inhibitor class, targeting PD-L1. The drug's market dynamics are influenced by factors such as clinical efficacy, competition, regulatory landscape, and pricing strategies. This report provides a comprehensive analysis of its market environment and projects future pricing trends.
Pharmacological Profile and Therapeutic Indications
Durvalumab is a PD-L1 inhibitor that enhances the immune system's ability to recognize and destroy tumor cells. Its primary approved indications include:
- Extensive-stage small cell lung cancer (ES-SCLC)
- Urothelial carcinoma (bladder cancer)
- Non-small cell lung cancer (NSCLC) (pending regulatory updates)
- Other solid tumors under investigation
These indications place Durvalumab squarely in the oncology sector, contributing to its growth potential.
Market Landscape and Competitive Position
Current Market Share and Sales Performance
Since its U.S. approval in 2017, Durvalumab has experienced steady sales growth, driven by its approved indications and inclusion in combination regimens. According to IQVIA data, AstraZeneca's oncology portfolio generated approximately $4.9 billion globally in 2022, with Durvalumab contributing a significant share, especially in North America's rapidly expanding immunotherapy market.
Key Competitors
Durvalumab faces competition from several PD-1/PD-L1 inhibitors:
- Pembrolizumab (Keytruda, Merck)
- Nivolumab (Opdivo, Bristol-Myers Squibb)
- Atezolizumab (Tecentriq, Genentech)
- Avelumab (Bavencio, Pfizer)
While each competitor has distinct regulatory approvals, Durvalumab's differentiation hinges on its efficacy in specific clinical protocols and combination regimens.
Regulatory and Reimbursement Trends
The landscape is evolving with approvals expanding into additional indications and combination therapies, notably in non-small cell lung cancer and bladder cancer settings. Reimbursement policies favor immune checkpoint inhibitors owing to their survival benefits, but cost containment pressures influence pricing strategies across different regions.
Pricing Analysis
Current Price Points
In the United States, the wholesale acquisition cost (WAC) for Durvalumab vials (roughly 1200 mg/20 mL) is approximately $6,300 per 600 mg dose, translating to roughly $10,500 per 1,200 mg dose, depending on dosing schedules. Reimbursement prices through insurers tend to be marginally lower due to negotiations and discounts.
Pricing Compared to Competitors
Compared to Pembrolizumab and Nivolumab, Durvalumab's pricing is comparatively aligned, but slight variations depend on:
- Dosing frequency
- Combination therapy protocols
- Regional price regulations
For example, Pembrolizumab's average wholesale price (AWP) is around $13,000 for a 200 mg dose, whereas Durvalumab's per-dose cost for similar efficacy indications often hovers below.
Impact of Patent and Exclusivity
AstraZeneca's patents on Durvalumab are expected to extend into the early 2030s, providing pricing power and market exclusivity in key territories. Patent challenges or biosimilar developments could pressure prices post-expiry.
Future Price Projections
Factors Influencing Price Trends
- Regulatory expansion: Approval for new indications, especially in broader cancer types, will influence demand and pricing strategies.
- Market competition: Entry of biosimilars post-patent expiry could significantly reduce prices.
- Healthcare policy shifts: Emphasis on value-based care and cost-effectiveness analyses may lead to price adjustments.
- Manufacturing efficiencies: Advances in biomanufacturing could lower production costs, enabling potential price reductions.
Projected Price Trajectory (2023-2030)
Given current dynamics, the following projections are made:
| Year |
Estimated Average Price per Dose |
Notes |
| 2023 |
~$10,500 |
Steady state with stable demand |
| 2025 |
~$9,800 |
Anticipated competition and expanded indications |
| 2027 |
~$9,000 |
Entry of biosimilars post-patent expiry |
| 2030 |
~$8,500 |
Cost containment policies being implemented |
These estimates assume continued growth in indications and adherence to value-based pricing models. Biosimilar market entry, expected around 2030, could accelerate price reductions.
Regional Price Variations
Prices will vary regionally due to regulatory controls:
- U.S. and Western Europe: Higher prices driven by established reimbursement systems.
- Emerging Markets: Significantly lower prices due to affordability constraints and different procurement mechanisms.
- Asia-Pacific: Prices are expected to follow regional negotiations but may lag behind Western markets.
Market Penetration and Access Strategies
AstraZeneca’s market approach emphasizes strategic collaborations, patient access programs, and clinical trial expansion to reinforce Durvalumab’s market position. Cost containment initiatives, such as value-based agreements, are likely to shape future pricing and reimbursement frameworks.
Conclusion
Durvalumab (NDC 00115-1725) is positioned as a leading PD-L1 inhibitor within oncology, with a stable market outlook driven by approved indications, clinical efficacy, and regnant competition. Pricing strategies are expected to remain competitive, with gradual declines projected over the next decade as biosimilars potentially enter the field and healthcare systems prioritize cost-effectiveness.
Key Takeaways
- Durvalumab's market is robust and growing, driven by its expanding indications and combination therapies.
- Current U.S. dosing prices hover around $10,500 per dose, with regional variations.
- Competitive landscape and patent protections enable AstraZeneca price stability until the early 2030s.
- Biosimilar entry anticipated around 2030 is likely to reduce prices significantly.
- Ongoing healthcare policy shifts toward value-based care will influence future pricing and access strategies.
FAQs
1. What are the primary indications for Durvalumab (NDC 00115-1725)?
Durvalumab is approved for extensive-stage small cell lung cancer, urothelial carcinoma, and is under investigation for other solid tumors.
2. How does Durvalumab compare in price to other checkpoint inhibitors?
In the U.S., Durvalumab's per-dose costs are somewhat lower than Pembrolizumab and Nivolumab but similar to Atezolizumab, reflecting market positioning and dosing regimens.
3. When are biosimilars expected to enter the market, and what impact will they have?
Biosimilars for Durvalumab could emerge around 2030, likely leading to significant price reductions and increased access.
4. What factors could influence the future pricing of Durvalumab?
Regulatory approvals, competition, biosimilar development, healthcare policies, and manufacturing costs are key factors.
5. Is there regional variation in the drug’s pricing?
Yes, U.S. and Western Europe maintain higher prices due to reimbursement structures, whereas emerging markets often see lower prices driven by affordability and procurement policies.
Sources
[1] IQVIA. "2022 Global Oncology Market Data."
[2] AstraZeneca. "Durvalumab Product Information and Pricing."
[3] FDA. "Durvalumab (Imfinzi) Approved Indications."
[4] EvaluatePharma. "Biologic Drug Price Trends and Biosimilar Impact."
