Last updated: March 19, 2026
What is NDC 51672-2129?
NDC 51672-2129 is the National Drug Code for Durvalumab (Imfinzi), a monoclonal antibody produced by AstraZeneca. It is approved for treating certain forms of lung and bladder cancers, primarily as an immunotherapy agent targeting PD-L1 (programmed death-ligand 1).
Market Overview
Regulatory Status and Approvals
Durvalumab has received multiple approvals:
- FDA (2017): For unresectable stage III non-small cell lung cancer (NSCLC).
- EMA (2018): Similar indications in the European Union.
- Additional approvals: For bladder cancer and extensive-stage small cell lung cancer (ESC-LC).
Market Size
The global oncology monoclonal antibody market was valued at approximately USD 44 billion in 2022 with a compound annual growth rate (CAGR) of around 8.4% [1].
Durvalumab accounts for an estimated USD 800 million to USD 1 billion annual sales as of 2022, with growth driven by expanding indications and approval in emerging markets.
Competitive Landscape
Key competitors include:
- Pembrolizumab (Keytruda) by Merck
- Atezolizumab (Tecentriq) by Roche
- Avelumab (Bavencio) by Pfizer and Merck KGaA
Durvalumab's market share remains competitive but is often concentrated in non-small cell lung cancer (NSCLC) and bladder cancer indications.
Adoption & Reimbursement
- Widely reimbursed in the U.S., EU, and Japan.
- Oncologists favor Durvalumab for its efficacy in specific patient subsets and manageable safety profile.
- Market penetration varies based on regional approvals and clinician preferences.
Price Projections
Current Pricing
- Average wholesale price (AWP): Around USD 13,000–USD 15,000 per 1,200 mg dose.
- Cost per treatment cycle (for 4 cycles typical in NSCLC): USD 52,000–USD 60,000.
Price Trends and Drivers
- Patent expiry: No imminent patent loss; exclusivity extends until at least 2030.
- Manufacturing costs: Stable, but subject to biosimilar entry after patent expiration.
- Market competition: Pressure from biosimilars could reduce prices by 20–40% post-2030.
Future Price Projections
| Year |
Estimated Price Range (USD) per 1,200 mg dose) |
Commentary |
| 2023 |
USD 13,000–USD 15,000 |
Current market prices, stable distribution channels |
| 2025 |
USD 12,500–USD 14,000 |
Slight downward pressure from increased competition and biosimilar prep |
| 2030 |
USD 9,000–USD 11,500 (post-patent expiry) |
Potential biosimilar entry, market-driven price adjustments |
| 2035 |
USD 8,000–USD 10,000 (biosimilar market dominance) |
Biosimilar proliferation, regional pricing variances |
Cost-Effectiveness Considerations
- Cost per quality-adjusted life year (QALY): Estimated USD 90,000–USD 150,000, depending on country and indication.
- Reimbursement policies influence final payer costs, with some regions negotiating discounts up to 50%.
Key Market Risks
- Regulatory delays or rejections in new indications.
- Market saturation with existing competitors.
- Biosimilar entry which could sharply reduce pricing.
- Patient access: Limited in low- and middle-income countries due to high pricing and infrastructure barriers.
Strategic Opportunities
- Expand indications—adjuvant or combination therapies.
- Enter emerging markets with tiered pricing.
- Invest in biosimilar development to prepare for patent expiry.
Conclusions
Durvalumab maintains a strong market position, with steady growth driven by new indications. Prices are expected to remain stable until patent expiration, after which biosimilar competition will exert downward pricing pressure. Strategic planning should involve monitoring market entry of biosimilars, regulatory developments, and regional reimbursement policies.
Key Takeaways
- Current market value: USD 800 million–USD 1 billion annually.
- Dominant competition includes Keytruda and Tecentriq.
- Prices hover around USD 13,000–USD 15,000 per 1,200 mg dose.
- Biosimilar entry anticipated post-2030 could cut prices by up to 40%.
- Market growth driven by expanding indications and geographic penetration.
FAQs
Q1: When is biosimilar competition likely to impact Durvalumab pricing?
A: Post-2030, following patent expiry and regulatory approval of biosimilars.
Q2: Which indications generate the highest revenue for Durvalumab?
A: Non-small cell lung cancer and bladder cancer.
Q3: Are there regional differences in Durvalumab pricing?
A: Yes, prices vary significantly based on local reimbursement policies, healthcare infrastructure, and negotiated discounts.
Q4: How does Durvalumab compare to its main competitors?
A: It offers comparable efficacy with a favorable safety profile but faces stiff competition in the oncology immunotherapy space.
Q5: What factors could influence the market growth beyond 2025?
A: New clinical trial results, additional approved indications, regional market penetration, and biosimilar availability.
References
[1] IQVIA (2022). Global Oncology Market Data.
[2] EvaluatePharma (2022). Oncology Drug Sales.
[3] AstraZeneca (2022). Durvalumab Regulatory and Market Access Updates.
[4] MarketsandMarkets (2023). Oncology Monoclonal Antibodies Market.
[5] FDA (2017). Approval of Durvalumab for NSCLC.
