Last updated: February 15, 2026
What Is NDC 83324-0191?
NDC 83324-0191 refers to a specific drug identified by the National Drug Code, used primarily for the retail or institutional pharmacy setting. Based on available databases, this NDC corresponds to "Durvalumab (Imfinzi)," marketed by AstraZeneca. Durvalumab is an immune checkpoint inhibitor used for treating unresectable stage III non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and certain bladder cancers.
Market Size and Demand Dynamics
Current Market Landscape
- Indications: Primarily approved for NSCLC, SCLC, and bladder cancer. Recently expanded for additional indications, including some metastatic or recurrent tumors.
- Market Penetration: The drug is marketed in the US, with increasing adoption driven by clinical guidelines and expanding indications.
Industry Data
- US Oncology Market: Oncology drugs, particularly immunotherapies like Durvalumab, have grown significantly, contributing to a global value estimated at over $150 billion in 2022.
- Market Share: Durvalumab holds a notable share among PD-L1 inhibitors, ranked behind Pembrolizumab (Keytruda) and Atezolizumab (Tecentriq). Estimated US sales in 2022: approximately $1.2 billion.
Competitive Landscape
| Drug Name |
Manufacturer |
Approved Indications |
US Sales (2022) |
Market Share Impact (%) |
| Pembrolizumab |
Merck |
Multiple cancers |
~$14.4B |
48 |
| Atezolizumab |
Roche/Genentech |
Lung, bladder, others |
~$2.3B |
8 |
| Durvalumab |
AstraZeneca |
NSCLC, SCLC, bladder cancer |
~$1.2B |
4 |
Source: EvaluatePharma[1], ICU Medical Reports
Market Drivers
- Increasing incidence of lung and bladder cancers.
- Growing adoption of immunotherapy as foundation treatment.
- Expanding approvals for new indications.
Price Trends and Projection Models
Current Pricing Overview
- Average Wholesale Price (AWP): Approximately $10,000–$13,000 per treatment dose in the US.
- Average Selling Price (ASP): Slightly lower, around $9,000–$12,000 per dose.
- Cost per Course: Typically involves 4–6 doses, resulting in a total estimate of $36,000–$78,000 per treatment course depending on prescribing pattern.
Historical Price Trends
- Since FDA approval in 2017, prices for Durvalumab have increased gradually, consistent with inflation and market demand.
- No significant discounts or biosimilar competition yet, maintaining original pricing levels.
Industry Projections
Based on market growth forecasts, the overall immunotherapy segment is projected to grow at a CAGR of 11–13% over the next five years[2].
Potential factors influencing price projections:
- Patent expiration or biosimilar entry likely after 2030.
- Uptake in new indications and off-label use.
- Reimbursement changes stemming from policy adjustments.
Price Projection Scenarios (2023–2028)
| Year |
Base Case (Stable Prices) |
High Growth (Price Increase 3% Annually) |
Competitive Entry (5–10% Price Decrease) |
| 2023 |
$11,000 per dose |
$11,330 per dose |
$10,450 per dose |
| 2024 |
$11,000 per dose |
$11,670 per dose |
$9,927 per dose |
| 2025 |
$11,000 per dose |
$12,020 per dose |
$9,430 per dose |
| 2026 |
$11,000 per dose |
$12,380 per dose |
$8,958 per dose |
| 2027 |
$11,000 per dose |
$12,750 per dose |
$8,510 per dose |
| 2028 |
$11,000 per dose |
$13,140 per dose |
$8,085 per dose |
Regulatory and Policy Impacts
- Pricing Regulation: CMS and private payers are scrutinizing immunotherapy costs. Value-based pricing initiatives could pressure list prices downward.
- Patent and Biosimilar Competition: Biosimilars anticipated post-2030, likely reducing prices by 20–40%, similar to trends seen with other biologics.
Key Takeaways
- The drug represented by NDC 83324-0191 (Durvalumab) has a growing market share in immunotherapy for lung and bladder cancers.
- US sales are approximately $1.2 billion in 2022, with ongoing expansion into new indications.
- Prices range around $9,000–$13,000 per dose; the cost per treatment cycle totals between $36,000 and $78,000.
- Market growth forecasts suggest a CAGR of roughly 11–13%, supported by rising cancer incidence and immunotherapy adoption.
- Future pricing will depend on biosimilar entry, clinical guideline updates, and policy reforms.
FAQs
1. What factors influence Durvalumab’s market share?
Clinical guidance updates, indication expansion, and competitor activity influence market share. Adoption rates are higher in academic and high-volume treatment centers.
2. How does Durvalumab compare to other PD-L1 inhibitors?
It has similar efficacy but slightly lower market penetration than Pembrolizumab and Atezolizumab, partly due to earlier approval timing and clinical preference.
3. Will biosimilars significantly impact Durvalumab’s price?
Yes. Biosimilars are projected to enter the market post-2030, potentially reducing prices by 20–40%.
4. How are reimbursement policies affecting prices?
Government and private payer pressure for value-based pricing may limit the price increases and encourage discounts or bundled payments.
5. What is the long-term outlook for Durvalumab?
Stable demand in current indications, with substantial growth potential from new approvals and expanded clinical use. Biosimilar competition will likely influence future pricing strategies.
References
[1] EvaluatePharma, 2023. Oncology Drug Sales Data.
[2] IQVIA, 2022. Immunotherapy Market Forecasts.
