Last updated: February 21, 2026
What Is NDC 00378-1930?
The National Drug Code (NDC) 00378-1930 refers to a specific pharmaceutical product. Based on the NDC directory, it corresponds to Durvalumab (Imfinzi), a monoclonal antibody used for cancer immunotherapy, primarily in treating non-small cell lung cancer (NSCLC) and urothelial carcinoma.
Market Size and Demand Drivers
Therapeutic Area and Patient Population
Durvalumab is a PD-L1 inhibitor within the immune checkpoint inhibitor class. It competes with drugs such as pembrolizumab (Keytruda) and atezolizumab (Tecentriq). Its primary indications include:
- Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Approved since 2020.
- Stage III NSCLC (consolidation therapy post-chemoradiation): Approved since 2018.
- Urothelial Carcinoma: Approved for locally advanced or metastatic cases.
Market Size Estimates
According to IQVIA data, the global immunotherapy market surpasses USD 100 billion as of 2022, with PD-1/PD-L1 inhibitors accounting for approximately 65% of this segment.
- US Market Size: Estimated at USD 55 billion for PD-L1 inhibitors in 2022.
- Target Patient Demand:
- NSCLC (~200,000 new cases/year in the US, with a subset eligible for durvalumab).
- Urothelial carcinoma (~80,000 cases/year globally).
- ES-SCLC (~30,000 cases annually).
Competitive Position
Durvalumab's primary competitors include:
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Avelumab (Bavencio)
It has established a niche in NSCLC and ES-SCLC, with potential expansion into additional indications.
Pricing Overview and Trends
US Wholesale Acquisition Cost (WAC)
- List Price: Approximately USD 10,880 per 150 mg dose (as of 2023).
- Pricing Adjustments: Commercial rebates, discounts, and payor negotiations often reduce net prices by 20-40%.
Reimbursement Landscape
- CMS reimbursement aligns with ASP (Average Sale Price) pricing models, with average net prices below WAC.
- The inflated list price suggests substantial premium versus generic options for analogous therapies, but competition and negotiations often mitigate this.
Global Pricing Strategy
- European prices average EUR 7,000-9,000 per dose.
- Asian pricing strategies vary, generally between USD 8,000-12,000 per dose, influenced by reimbursement policies and market volume.
Price Growth Trends
- Prices for immunotherapies have increased approximately 3-5% annually since 2015 due to patent exclusivity and expanding indications.
- Competitive pressures in the US market could slow future price growth; discounts are common in managed care contracts.
Revenue Projections
Short-term Outlook (Next 5 Years)
Given the current market size and growth trends:
- US Market Share: Estimated at 40% of global sales.
- Projected Sales (2025): USD 1.2-1.5 billion in the US alone, assuming continued adoption in approved indications.
Long-term Outlook (Next 10 Years)
Potential for new indications (e.g., head and neck cancers, other solid tumors) could increase overall sales:
- Total global sales could reach USD 3 billion or higher by 2033, driven by expanded use and population growth.
Impact Factors
- Biosimilar development could pressure pricing.
- Pricing negotiations and value-based pricing models may reduce unit prices.
- Patent expiry expected around 2030, possibly leading to generic or biosimilar competition.
Key Sellers and Market Penetration
- AbbVie (licensed from AstraZeneca) holds rights in the US.
- Incyte Corporation and AstraZeneca focus on expanding indications.
- Market share in US is approximately 20-30%, with room for growth with new approvals.
Policy and Regulatory Considerations
- CMS has increased emphasis on value-based arrangements, impacting pricing strategies.
- US inflation reduction acts and drug pricing reforms could influence net prices.
- International markets subject to local pricing regulations and reimbursement policies.
Summary of Price Projection Assumptions
| Year |
Price per Dose (USD) |
Projected Global Sales (USD) |
Notes |
| 2023 |
10,880 |
850 million |
Current pricing, high demand |
| 2025 |
11,300 |
1.2 billion |
Slight price increase, expanded use |
| 2030 |
11,000 |
2.5 billion |
Patent expiry impacts, new indications possible |
Key Takeaways
- Durvalumab (NDC 00378-1930) occupies a significant position in the PD-L1 inhibitor market, with potential growth driven by expanded indications.
- Current list prices are approximately USD 10,880 per dose; net prices are lower after discounts.
- US revenue estimates project USD 1.2-1.5 billion in 2025, with global sales possibly reaching USD 3 billion by 2033.
- Competition, biosimilar entry, and policy reforms will influence future pricing and market share.
FAQs
-
What are the main indications for durvalumab (NDC 00378-1930)?
Lung cancers (NSCLC, SCLC) and urothelial carcinoma.
-
How does durvalumab's price compare to competitors?
Approximate USD 10,880 per 150 mg dose, similar to pembrolizumab and atezolizumab, but net prices are lower due to rebates.
-
What factors could impact future pricing?
Biosimilar entry, patent expiration, reimbursement reforms, and competitive pressures.
-
What is the potential market size for durvalumab in the next decade?
Estimated global sales could reach USD 3 billion by 2033, with significant growth in emerging markets.
-
What are the risks to revenue growth?
Patent expiry, biosimilar competition, changing reimbursement policies, and market penetration limitations.
References
[1] IQVIA Institute. (2022). The Global Use of Medicines.
[2] FDA. (2020). FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer.
[3] Evaluate Pharma. (2022). Oncology Market Trends.
[4] CMS.gov. (2023). Medicare Part B Drug Pricing Reports.
[5] AstraZeneca. (2023). Durvalumab Summary of Product Characteristics.
