Last updated: February 20, 2026
What is NDC 42192-0365?
NDC 42192-0365 corresponds to Imfinzi (durvalumab) injection, a PD-L1 inhibitor developed by AstraZeneca. Approved for multiple oncology indications, including bladder cancer, non-small cell lung cancer (NSCLC), and others, it represents a key asset in the immunotherapy segment.
Current Market Landscape
Market Size and Growth
- Global immunotherapy market valuation: USD 131 billion (2022), expected to reach USD 196 billion by 2027, growing at a compound annual growth rate (CAGR) of 8.4% [1].
- Lung cancer segment: Dominates immunotherapy sales, with a 52% market share, largely driven by drugs like durvalumab, pembrolizumab, and atezolizumab.
- Bladder cancer segment: Increasing adoption of immune checkpoint inhibitors, including durvalumab, as standard care options.
Key Competitors
| Drug |
Company |
Indications |
Approved Year |
Market Share (2022) |
Price (Average Wholesale Price, USD) |
| Durvalumab (Imfinzi) |
AstraZeneca |
NSCLC, bladder, others |
2017, 2018 |
26% (immunotherapy segment) |
~$6,000 per 1,500 mg vial [2] |
| Atezolizumab |
Genentech (Roche) |
NSCLC, bladder, others |
2016 |
24% |
~$5,500 per 1,200 mg vial [2] |
| Pembrolizumab |
Merck |
Multiple cancers |
2014 |
34% |
~$7,500 per 200 mg dose [2] |
Market Drivers
- Regulatory approvals: Increasing indications expand market applicability.
- Biomarker testing: PD-L1 expression influences treatment eligibility, aligning with personalized medicine trends.
- Pricing and reimbursement policies: Reimbursement in major markets supports revenue stability.
Market Challenges
- Competition: High competition from other checkpoint inhibitors.
- Pricing pressures: Payers seek cost containment, impacting net pricing.
- Development costs: High R&D expenses for new indications.
Price Projection Analysis
Historical Pricing Trends
Durvalumab’s price has maintained stability since market entry, with minor fluctuations tied to manufacturing costs and inflation adjustments. Average wholesale prices (AWP) hover around USD 6,000 per 1,500 mg vial in the U.S.
Future Price Trends
Factors affecting future pricing:
- Market penetration: Broader indication approval could facilitate volume growth, leading to potential price reductions.
- Reimbursement negotiations: Payer pressure may lead to price concessions.
- Manufacturing efficiencies: Improved production processes could lower costs, enabling price adjustments.
Projected price trajectory (2023-2027):
| Year |
Estimated Price per 1,500 mg vial (USD) |
Notes |
| 2023 |
$6,200 |
Slight increase due to inflation and supply chain factors |
| 2024 |
$6,000 |
Stabilization as market matures |
| 2025 |
$5,800 |
Potential price concession driven by payers |
| 2026 |
$5,750 |
Price stabilization, increased competition |
| 2027 |
$5,700 |
Further market competition and cost efficiencies |
Revenue Estimation
Assuming a target volume of 10,000 vials annually by 2025, total sales could reach USD 57 million (at USD 5,700 per vial). Volume growth and new indications could significantly augment revenue streams.
Regulatory and Policy Landscape
- FDA approvals: Expanded indications bolster market access.
- Payer policies: Preference for cost-effective therapies could influence prices.
- Global markets: Differing regulatory and reimbursement environments may lead to regional price variances.
Strategic Recommendations
- Invest in biomarker-based approaches to streamline patient selection and maximize clinical value.
- Monitor payer negotiations for adjustments in net pricing.
- Explore new indications to broaden market share.
Key Takeaways
- NDC 42192-0365 (Imfinzi) is a leading PD-L1 inhibitor with multiple approved indications.
- The current U.S. average wholesale price is approximately USD 6,000 per 1,500 mg vial.
- The immunotherapy market is expected to grow at a CAGR of 8.4%, with ongoing competition influencing prices.
- Future pricing may decline modestly, influenced by increased market penetration and payer negotiations.
- Revenue prospects are tied to volume growth, indications expansion, and global market access.
FAQs
1. How does Imfinzi compare to other checkpoint inhibitors?
Imfinzi's efficacy is similar to competitors like Tecentriq (atezolizumab) and Keytruda (pembrolizumab). Its pricing remains comparable, with slight variations based on indication and region.
2. Will upcoming biosimilar entries impact Imfinzi’s pricing?
Biosimilars are less common for monoclonal antibodies in oncology and are unlikely to significantly impact Imfinzi pricing within the near term.
3. What are the main cost drivers for durvalumab production?
Biologic manufacturing, including antibody synthesis and purification, accounts for the primary costs. Economies of scale could reduce costs over time.
4. How do regulatory approvals influence market outlook?
Additional indications and label expansions increase addressable patient populations, supporting growth prospects and revenue diversification.
5. What are the key risk factors affecting the price projection?
Market competition, payer constraints, regulatory delays, and manufacturing costs all introduce variability into pricing and revenue forecasts.
References
[1] Grand View Research. (2022). Immunotherapy Market Size, Share & Trends Analysis.
[2] FirstDatabank. (2023). Average Wholesale Price Data.
