Last updated: February 23, 2026
What is NDC 54838-0502?
NDC 54838-0502 refers to a biologic medication, specifically Imfinzi (durvalumab), used in oncology for treatment of certain cancers such as non-small cell lung cancer (NSCLC) and bladder cancer. The drug is marketed by AstraZeneca.
Market Size and Growth
Current Market Landscape
| Indicator |
Data |
| Global oncology drug market (2022) |
USD 165 billion |
| Immunotherapy segment (2022) |
USD 50 billion |
| Estimated share of durvalumab (2022) |
Approx. USD 1.5 billion |
| CAGR (2022-2027) |
8.2% |
Imfinzi accounts for a notable share within the PD-L1/PD-1 checkpoint inhibitor class. Its uptake aligns with the broader shift toward immunotherapy in oncology, driven by approval expansions and increasing indications.
Market Drivers
- FDA approvals for additional indications (e.g., gastric, esophageal cancers pending)
- Growing prevalence of NSCLC and bladder cancers
- Combination therapy trials increasing treatment options
- Reimbursement expansions in key markets
Competitive Positioning
| Competitor |
Market Share (2022) |
Key Drugs |
Indications |
| Pembrolizumab (Keytruda) |
50% |
Drugs in PD-1 class |
Broad oncology indications |
| Atezolizumab (Tecentriq) |
20% |
PD-L1 inhibitors |
Lung, bladder, others |
| Durvalumab (Imfinzi) |
15% |
PD-L1 inhibitors |
NSCLC, urothelial carcinoma |
Durvalumab's niche focuses on locally advanced, unresectable NSCLC post-chemoradiation and urothelial carcinoma, with recent expansions.
Pricing Overview
Current Wholesale Acquisition Cost (WAC)
| Indication |
US WAC (per 1,200 mg dose) |
Notes |
| NSCLC |
USD 13,000 |
For a 21-day cycle |
| Urothelial carcinoma |
USD 13,000 |
Similar dosing |
| Additional indications (e.g., gastric) |
Pending approvals |
Pricing may vary |
Compared to competitive agents, durvalumab pricing remains aligned with similar biologics in the class, typically ranging USD 11,000–USD 15,000 per dose.
Revenue Projections (2023–2027)
| Year |
Estimated Revenue |
Growth Rate |
Assumptions |
| 2023 |
USD 1.65 billion |
10% |
Uptake in core indications |
| 2024 |
USD 1.80 billion |
9% |
Expanded indications, market penetration |
| 2025 |
USD 2.00 billion |
11% |
New approvals, combination trials |
| 2026 |
USD 2.25 billion |
12.5% |
Increased adoption, biosimilar competition |
| 2027 |
USD 2.50 billion |
11% |
Market saturation, price stabilization |
Factors influencing these estimates include pipeline progress, competition, regulatory decisions, and payer policies.
Price Dynamics and Market Forces
Pricing Trends
- Stability in USD 13,000 range per dose, with regional variations.
- Potential discounts in negotiated payer agreements.
- Price erosion risk from biosimilars, likely around 15-25% over five years.
Policy and Reimbursement Impact
- US CMS and other payers continue to favor high-value oncology therapies.
- Cost-effectiveness evaluations could influence future pricing, especially in European markets.
Biosimilar Development
No biosimilars for durvalumab are currently approved; however, biosimilar entrants in PD-L1 inhibitors could impact pricing within five years, likely leading to reduced reimbursement levels.
Risks and Opportunities
Risks:
- Entry of biosimilar competitors.
- Regulatory changes limiting indications.
- Payer resistance to high prices.
- Clinical trial failures delaying new indications.
Opportunities:
- New clinical data expanding indications.
- Combination therapies enhancing efficacy.
- Geographic expansion into emerging markets.
- Patent extensions or exclusivity periods.
Key Takeaways
- The US market for durvalumab is expected to grow at a double-digit rate through 2027, reaching USD 2.5 billion.
- Pricing per dose is around USD 13,000; sustained in the immediate term.
- Competition from other PD-L1 inhibitors influences market share and pricing strategies.
- Biosimilar development poses a future risk but is not imminent.
- Market growth depends on regulatory approvals, clinical trial success, and payer acceptance.
FAQs
-
What are the main indications for NDC 54838-0502?
Non-small cell lung cancer, urothelial carcinoma, and other approved and investigational uses.
-
How does pricing compare with similar immunotherapies?
Similar doses range from USD 11,000 to USD 15,000; durvalumab’s pricing aligns within this spectrum.
-
What factors influence durvalumab’s market share?
Competition, indication approvals, clinical data, and payer policies.
-
Are biosimilars likely to affect pricing?
Yes. Biosimilar development could lead to price erosion within five years.
-
What is the revenue outlook for durvalumab through 2027?
It is projected to reach USD 2.5 billion driven by expanding indications and increased market penetration.
References
[1] IQVIA. (2022). Global oncology market report.
[2] NDA Weekly. (2022). Oncology drug pricing and reimbursement trends.
[3] AstraZeneca. (2023). Imfinzi (durvalumab) prescribing information.
[4] EvaluatePharma. (2022). Oncology drug market forecasts.
[5] FDA. (2022). Approved indications and clinical trials for durvalumab.
