Last updated: February 15, 2026
Market Analysis and Price Projections for NDC 50991-0977
Overview of the Drug
NDC 50991-0977 corresponds to Durvalumab (Imfinzi), a monoclonal antibody approved for the treatment of multiple cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and urothelial carcinoma. It is developed by AstraZeneca and has received multiple regulatory approvals globally.
Market Landscape
Market Size and Trends:
The global oncology immunotherapy market was valued at approximately USD 60 billion in 2022 and is projected to reach USD 130 billion by 2028, at a compound annual growth rate (CAGR) of 14-15%. Durvalumab accounts for a significant share within this sector, with an estimated market value of USD 4 billion in 2022.
Key Competitors:
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Roche)
- Nivolumab (Opdivo, BMS)
Durvalumab's competitiveness hinges on its approval breadth, combination therapy efficacy, and clinical outcomes.
Regulatory Status:
- Approved in the United States for unresectable Stage III NSCLC post chemoradiation (since 2018).
- Approved for urothelial carcinoma in multiple regions, including the EU and Japan.
Pricing and Reimbursement:
Pricing varies by indication and region. In the U.S., list prices are roughly USD 13,500 to USD 15,000 per infusion, with an average of 5-6 infusions per treatment cycle, resulting in total treatment costs around USD 70,000 to USD 90,000 per course.
Usage Penetration:
Use is growing due to expanded approvals and combination therapies. The uptake is faster in high-income countries with established payer coverage.
Price Projections (2023-2028)
| Year |
Estimated Annual Cost per Patient |
Market Penetration |
Estimated Global Revenue (USD billions) |
| 2023 |
USD 75,000 |
35% of eligible patients |
USD 2.2 billion |
| 2024 |
USD 75,000 |
45% |
USD 2.8 billion |
| 2025 |
USD 75,000 |
55% |
USD 3.4 billion |
| 2026 |
USD 75,000 |
65% |
USD 4.1 billion |
| 2027 |
USD 75,000 |
75% |
USD 4.7 billion |
| 2028 |
USD 75,000 |
85% |
USD 5.4 billion |
Assumptions:
- Price per treatment remains stable due to patent protections and limited competition in stage-specific indications.
- Market penetration grows as clinical data solidifies Durvalumab's efficacy.
- Reimbursement policies favor use in approved indications.
Pricing Dynamics:
List prices are expected to stay stable through 2028, with potential discounts or rebates in certain regions. Biosimilar entry is unlikely before 2030 due to the complexity of antibody manufacturing and patent protections.
Regulatory and Commercial Risks
- Patent Expirations: Patents in key markets expire between 2027-2030, risking biosimilar competition.
- Clinical Trial Outcomes: Ongoing trials could expand or restrict approved indications, impacting revenue.
- Pricing pressures: Payers' cost containment efforts may temper price realizations.
Strategic Outlook
AstraZeneca's commercialization strategy emphasizes combination regimens, such as durvalumab with chemotherapy, which enhances market share growth. Expanding into earlier stages of disease and new indications could elevate revenue streams.
Key Takeaways
- Durvalumab remains crucial in the immuno-oncology landscape, with projected revenues reaching USD 5.4 billion globally by 2028.
- Pricing is stable around USD 75,000 per treatment course, supported by high clinical value and limited biosimilar competition before 2030.
- Market growth depends on approval extensions, clinical outcomes, and payer acceptance, particularly in emerging regions.
- Patent protections sustain current pricing and market dominance, but biosimilar entry post-2027 could reduce prices and market shares.
- The drug's success hinges on clinical trial results, regulatory approvals, and competitive positioning among immunotherapy agents.
FAQs
1. How does Durvalumab compare to competitors like Keytruda or Tecentriq?
It offers similar efficacy in approved indications but may differ in combination regimens and specific indications, influencing market share.
2. What are the main factors influencing Durvalumab's price stability?
Patent protections, clinical value, and manufacturing complexity prevent biosimilar competition before 2030.
3. How are reimbursement policies affecting its market growth?
High reimbursement levels in developed countries facilitate uptake, although payers are increasingly scrutinizing costs.
4. What is the potential impact of biosimilar entrants?
Biosimilar competition post-2027 could reduce prices significantly and erode market share.
5. Are there new indications or formulations in development?
Yes, AstraZeneca is evaluating Durvalumab in combination therapies and earlier-stage cancers, which could expand its revenue base.
References
[1] Market data and projections sourced from Grand View Research and GlobalData reports (2022-2023).
[2] FDA and EMA drug approval documentation (2018-2022).
[3] AstraZeneca annual reports and pipeline information (2022).
