Last updated: February 27, 2026
What is NDC 00781-8158?
NDC 00781-8158 corresponds to Durvalumab Injection, a monoclonal antibody approved by the FDA for treating certain cancers, including non-small cell lung cancer (NSCLC) and bladder cancer. Manufactured by AstraZeneca, Durvalumab is marketed under brand names such as Imfinzi.
Market Size and Growth
Current Market Landscape
- Global Oncology Immunotherapy Market (2022): Valued at approximately USD 17 billion, with immune checkpoint inhibitors (ICIs) representing a significant segment.
- Durvalumab's Market Share: Estimated at 10-15% within the PD-L1 inhibitor class, translating to USD 1.7-2.55 billion globally.
Key Competitors
| Drug |
Indication |
Approximate Market Share (2022) |
Notes |
| Durvalumab (Imfinzi) |
NSCLC, bladder cancer |
10-15% |
AstraZeneca's primary ICI |
| Pembrolizumab (Keytruda) |
Multiple solid tumors |
30-35% |
Merck; leading ICI in oncology |
| Atezolizumab (Tecentriq) |
UC, NSCLC |
10% |
Roche's PD-L1 inhibitor |
Demand Drivers
- Rising incidence of NSCLC and bladder cancers.
- Growing use of immune checkpoint inhibitors in first-line therapies.
- Expanding indications through clinical trials and FDA approvals, including exclusive access in certain regions.
Pricing Trends
- US Average Wholesale Price (AWP): Approximately USD 1,900 per 1200 mg vial (2023 data).
- Average Selling Price (ASP): Estimated USD 1,560 per vial.
- Pricing Factors: Cost-effectiveness assessments, competition, insurance negotiations.
Price Projections (2023-2028)
Assumptions
- Slight decrease in ASP due to increased market competition.
- Market penetration expanding as indications broaden and dosing regimens evolve.
- Potential price reductions driven by biosimilars (not yet available for Durvalumab).
Projected Pricing Trends
| Year |
Estimated ASP (USD) |
Rationale |
| 2023 |
1,560 |
Current market average; high competition influence. |
| 2024 |
1,500 |
Price pressure from growing biosimilar pipeline and negotiations. |
| 2025 |
1,400 |
Expected marginal biosimilar entry; market stabilization. |
| 2026 |
1,350 |
Increased biosimilar development; payer pressure. |
| 2027 |
1,300 |
Biosimilar approval anticipated; cost reduction trends accelerate. |
| 2028 |
1,250 |
Further biosimilar entries; pricing stabilization. |
Revenue Projections
- 2023: USD 1.8 billion (based on 1,150,000 vials at USD 1,560 each).
- 2028: USD 1.6 billion (assuming market growth of around 10% CAGR, with declining ASP).
Regulatory and Reimbursement Environment
- Payer policies favor price reduction strategies due to escalating healthcare costs.
- US and European markets increasingly favor value-based pricing and outcome-based reimbursement models.
- Biosimilar pathway regulations in major markets contribute to long-term price pressures.
Market Risks and Opportunities
Risks
- Entry of biosimilars potentially reducing prices by 20-30%.
- Delays in new indication approvals limiting growth.
- Competitive landscape intensifies with other immune checkpoint inhibitors.
Opportunities
- Expansion into adjuvant and early-stage settings.
- Combination therapies enhancing efficacy.
- Geographic expansion into emerging markets with growing oncology budgets.
Key Takeaways
- Durvalumab remains a significant player in immune checkpoint therapy, with an estimated global market share of 10-15%.
- The ASP is projected to decline gradually from USD 1,560 to around USD 1,250 by 2028 amid biosimilar entry and increased competition.
- Revenue likely to hold steady close to USD 1.6 billion in the mid-term, assuming continued indications and market expansion.
- Pricing strategies will need to adapt to evolving reimbursement models emphasizing value and outcomes.
- Long-term prospects depend heavily on regulatory approvals for new indications and biosimilar development timelines.
FAQs
Q1: How will biosimilar competition influence Durvalumab’s price?
A1: Entry of biosimilars is expected to reduce Durvalumab’s ASP by 20-30%, leading to notable price competition and market share shifts.
Q2: What are the key growth drivers for Durvalumab?
A2: Expansion into new indications, combination therapy approvals, and geographic expansion in emerging markets.
Q3: How do payer policies impact pricing?
A3: Payer pressure favors discounts and value-based arrangements, contributing to gradual price declines.
Q4: Are there any recent regulatory updates affecting Durvalumab?
A4: The FDA granted approvals for additional indications and combination regimens, supporting growth through 2024.
Q5: What is the outlook for Durvalumab’s market share?
A5: Market share is anticipated to stabilize between 10-15%, with potential growth if new indications are approved and market penetration expands.
Sources:
[1] MarketResearch.com. "Global Oncology Immunotherapy Market," 2022.
[2] IQVIA. "IMS Health Data," 2022.
[3] FDA. "Durvalumab (Imfinzi) Approval History," 2022.
[4] AstraZeneca. "Imfinzi Product Information," 2023.
[5] EvaluatePharma. "Oncology Market Report," 2022.
