Last updated: January 15, 2026
Executive Summary
NDC 13668-0527 corresponds to Imfinzi (durvalumab), a PD-L1 immunotherapy developed by AstraZeneca for the treatment of various cancers, notably non-small cell lung cancer (NSCLC) and bladder cancer. This analysis evaluates current market dynamics, competitive landscape, regulatory considerations, pricing strategies, and future price projections. Given the growing role of immunotherapies, demand for durvalumab is expected to expand, impacting pricing and market share within oncology.
Introduction
Durvalumab (NDC 13668-0527) entered the market in 2017 and is part of the burgeoning class of immune checkpoint inhibitors. Its approval in multiple indications, including unresectable stage III NSCLC post-chemoradiation and extensive-stage small cell lung cancer (SCLC), has positioned it as a prominent contender in oncology.
This report details:
- Market size and segmentation
- Competitive landscape
- Regulatory events impacting pricing
- Current pricing strategies
- Future price projections (next 5 years)
- Key factors influencing evolution
Market Landscape: Current Status
1. Market Size & Growth Dynamics
| Indicator |
2022 Figures |
Sources & Remarks |
| Global Oncology Immunotherapy Market |
~$60 billion |
MarketResearch.com[1] |
| Durvalumab’s Approved Indications |
NSCLC, SCLC, urothelial carcinoma |
FDA & EMA approvals |
| Estimated Annual US Sales (2022) |
~$2.1 billion |
IQVIA[2] |
| Global Reach (2023) |
~$2.9 billion |
Company reports |
Note: The market cap for durvalumab is expected to grow owing to approved new indications and expanded payer coverage.
2. Key Competitors and Market Share
| Competitor |
Key Drugs |
Market Share (2022) |
Notes |
| Pembrolizumab (Keytruda) |
Pembrolizumab (Merk), nivolumab |
~45% |
Dominates PD-1 class; aggressive market expansion |
| Atezolizumab (Tecentriq) |
Atezolizumab (Roche), durvalumab |
~20% |
Direct competitor in NSCLC and urothelial carcinoma |
| Avelumab (Bavencio) |
Avelumab (Pfizer/Biovent) |
~10% |
Used mainly in urothelial carcinoma |
| Others |
Cemiplimab, agent-based therapies |
~25% |
Smaller market segments and emerging therapies |
Observation: Durvalumab’s share increases notably in specific indications, especially in unresectable stage III NSCLC.
3. Regulatory Milestones Impacting Market Penetration
- 2017: FDA approval for urothelial carcinoma
- 2018: Expanded indication for stage III NSCLC post-chemoradiation
- 2021: Approval for extensive-stage SCLC
- 2022 & Beyond: Ongoing trials, potential approvals in hepatocellular carcinoma and other solid tumors
These milestones catalyze market expansion and influence pricing strategies.
Current Pricing Strategy
1. Pricing Overview
| Region |
Approximate Cost per Dose |
Dosing Regimen |
Annual Cost Estimate (per patient) |
| United States |
~$12,500 |
10 mg/kg every 2 weeks (standard dosing) |
~$180,000 |
| European Union |
€11,000-€12,500 |
Similar to US; varies by country |
€160,000–€180,000 |
| China |
~$10,000 |
Adjusted for local market policies |
~$150,000 |
Note: Pricing is influenced by reimbursement negotiations and negotiated discounts, with list prices often reduced in practice.
2. Pricing Factors
- Cost per vial: Approximately $3,000 to $4,000
- Dosing variability: Based on patient weight; average dose ~20-25 mg/kg
- Reimbursement and discounts: DMOs and PBMs often negotiate rebates, impacting actual net prices
3. Pricing Policies
- AstraZeneca employs value-based pricing in certain markets
- Early market access programs and patient assistance plans mitigate initial cost barriers
- Price increases are generally aligned with inflation and regulatory approvals
Future Price Projections (2023–2028)
1. Assumptions and Methodology
- Market expansion: Anticipated FDA approvals for additional indications (e.g., hepatocellular carcinoma, head & neck cancers)
- Competitive pressures: Pricing adjustments due to biosimilars or competitors like pembrolizumab
- Regulatory influences: Price controls potentially implemented in certain regions (e.g., EU, Asia)
- Cost inflation: Expected to increase drug prices by roughly 2-3% annually
2. Projection Table: Estimated Average Selling Price (ASP)
| Year |
Expected ASP per Dose |
Changes from Prior Year |
Market Penetration Impact |
Notes |
| 2023 |
~$13,200 |
+5% |
15% increase |
Launch of new indications boosts sales |
| 2024 |
~$13,800 |
+4.5% |
20% growth in patient base |
Continued market expansion |
| 2025 |
~$14,500 |
+5% |
Additional indications approved |
Price adjustments due to inflation and negotiations |
| 2026 |
~$15,200 |
+5% |
Stable demand, potential biosimilar competition |
Increased payer scrutiny |
| 2027 |
~$15,900 |
+4.5% |
Market saturation limit reached |
Biosower impact may press prices downward |
| 2028 |
~$16,600 |
+4.5% |
Slight decline expected with biosimilar entry |
Price stabilization |
Note: These projections are conservative, assuming no major price regulation shocks.
3. Impact of Biosimilars and Market Competition
- Bios repars will likely emerge by late 2025, exerting downward pressure (~10-15%) on prices.
- AstraZeneca’s strategic discounts and patient programs may mitigate some pricing erosion.
- Price differentials between regions will persist due to regulatory and economic disparities.
Factors Influencing Future Market and Pricing
| Factor |
Impact |
Details |
| Regulatory approvals |
Significant |
New indications often lead to price hikes; delays can stall revenue growth |
| Competitive dynamics |
High |
Entry of biosimilars and new immunotherapies may reduce prices |
| Patent expirations |
Critical |
Patent expiry around 2027 could lead to generic biosimilar introduction |
| Payer policies |
Highly Influential |
Cost containment efforts, value-based agreements, and reimbursement models impact net prices |
| Technological advances |
Moderate |
Improvements in manufacturing or delivery could reduce costs |
Comparative Analysis: Durvalumab vs. Key Competitors
| Attribute |
Durvalumab (Imfinzi) |
Pembrolizumab (Keytruda) |
Atezolizumab (Tecentriq) |
Avelumab (Bavencio) |
| Launch Year |
2017 |
2014 |
2016 |
2017 |
| Major Indications |
NSCLC, SCLC, urothelial |
Multiple, including melanoma |
NSCLC, urothelial |
Urothelial, Merkel cell carcinoma |
| Avg. Price per Dose |
~$12,500 |
~$13,500 |
~$12,000 |
~$11,500 |
| Peak Market Share |
20–25% |
~45% |
~20% |
10–15% |
| Patent Status |
Active until ~2027 |
Active until ~2027 |
Active until ~2027 |
Active until ~2027 |
Note: The price differences are marginal and often influenced by regional negotiations.
Regulatory and Policy Environment Impact
- US: CMS and private payers push for value-based arrangements, influencing net prices.
- EU: Price caps and clinical value assessments are prevalent, potentially restraining price increases.
- Asia: Market growth driven by emerging economies with cost-sensitive pricing models; local manufacturing efforts may reduce costs.
Key Takeaways
- Durvalumab remains a significant player in the immunotherapy segment, with expanding indications driving growth.
- Current pricing approximates $12,500 per dose, with regional variations influenced by regulatory and reimbursement policies.
- Market competitions, especially biosimilars, are expected to exert downward pressure beginning around 2027.
- Future prices are projected to increase modestly (~4-5% annually) until biosimilar entry, after which significant price erosion is likely.
- Strategic positioning—such as early indication approval, value-based pricing, and patient access programs—will influence profit margins.
FAQs
Q1: What are the main considerations influencing durvalumab’s future pricing?
A1: Key factors include regulatory approval of new indications, biosimilar competition, regional pricing policies, patent expirations, and payer negotiations.
Q2: How does durvalumab compare cost-wise with its main competitors?
A2: Its price per dose (~$12,500) is comparable to pembrolizumab (~$13,500) and atezolizumab (~$12,000), with slight regional variations driven by market strategies.
Q3: When are biosimilars expected for durvalumab, and what impact will they have?
A3: Biosimilars are expected around 2027, stemming from patent expiry. They will likely reduce net prices by 10-15%, impacting revenue margins.
Q4: Which regions are most likely to see pricing pressures?
A4: Europe and Asia are where price controls and reimbursement negotiations are most aggressive, potentially constraining price increases.
Q5: What growth areas could influence price projections most significantly?
A5: Approval of new indications, improved patient access programs, and technological manufacturing innovations are pivotal future drivers.
References
- MarketResearch.com, 2022. Global Oncology Immunotherapy Market Analysis.
- IQVIA, 2022. Hospital and Prescription Data.
- AstraZeneca Annual Reports, 2022. Financial Insights and Pipeline Updates.
- FDA & EMA Regulatory Approvals, 2017–2022.
- Industry Expert Publications, 2023.
Disclaimer: Market and pricing projections are estimates based on current data and may vary due to unforeseen regulatory, competitive, or economic factors.
