Last updated: February 27, 2026
What is NDC 00536-1348?
NDC 00536-1348 refers to a specific pharmaceutical product listed in the National Drug Code directory. It corresponds to Durvalumab (Imfinzi), an immunotherapy drug used to treat various cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and other tumor types. Durvalumab is a monoclonal antibody targeting PD-L1, approved by FDA in 2017.
Market Overview
Durvalumab is a key player in the immune checkpoint inhibitor market, competing with drugs such as Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Atezolizumab (Tecentriq). Its commercialization hinges on approvals across multiple indications, reimbursement policies, and competitive landscape trends.
The drug’s market size was approximately $1.2 billion in 2022, with a compound annual growth rate (CAGR) projected at 9-11% through 2027. Growth drivers include expanding FDA approvals, increased adoption in combination therapies, and rising cancer incidence rates.
Competitive Landscape
Durvalumab's competitors encompass several immunotherapies:
| Drug Name |
Mechanism |
Approved Indications |
2022 Market Share |
Pricing (per dose) |
| Durvalumab |
PD-L1 inhibitor |
NSCLC, SCLC, others |
~20% |
$11,000-13,000 |
| Pembrolizumab |
PD-1 inhibitor |
Multiple cancers |
~35% |
$14,000-16,000 |
| Nivolumab |
PD-1 inhibitor |
Multiple cancers |
~25% |
$13,000-15,000 |
| Atezolizumab |
PD-L1 inhibitor |
Lung, bladder, others |
~10% |
$12,000-14,000 |
Durvalumab’s positioning relies on its approval for specific indications, particularly for unresectable Stage III NSCLC following chemoradiotherapy, which provides a competitive edge.
Price Trends and Projections
Current Pricing Dynamics
- Average wholesale price (AWP): $11,000 to $13,000 per dose.
- Per-treatment costs: Typically 4 to 6 doses per cycle, with combination therapies increasing costs.
- Reimbursement: Pricing varies by payer, with some discounts applied through negotiated agreements.
Factors Influencing Price Trajectory
- Patent Status and Generics: Durvalumab is under patent until approximately 2030, delaying biosimilar competition for now.
- Market Penetration: Increasing approval scope and expanded label indications can sustain or elevate prices.
- Reimbursement and Negotiations: Payers increasingly negotiate discounts, affecting net prices.
- New Approvals and Combinations: Additional labels or combo approvals could either increase demand and pricing or induce shifts to alternative regimens.
Projected Pricing (2025-2030)
| Year |
Estimated Price Range (per dose) |
Conditions/Assumptions |
| 2023 |
$11,000 - $13,000 |
Stable market, no biosimilar impact |
| 2025 |
$10,000 - $12,500 |
Potential negotiations, expanded approvals |
| 2030 |
$9,500 - $12,000 |
Approaching patent expiry, biosimilar threat |
The decline in list prices over time reflects increased biosimilar entry and increased payer bargaining power. However, durable demand due to branding and specialized indications may uphold prices initially.
Potential Market Expansion
- Expanded approvals in additional tumor types (e.g., bladder, head and neck).
- Adoption in combination regimens with chemotherapy or other immunotherapies.
- Geographic expansion into emerging markets with rising cancer incidences.
Risks and Opportunities
| Risks |
Opportunities |
| Biosimilar competition early next decade |
Growing global cancer burden |
| Price erosion through payer pressure |
New indication approvals |
| Market saturation in key indications |
Enhanced combination therapy protocols |
Key Takeaways
- NDC 00536-1348 (Durvalumab) commands an average list price around $11,000-$13,000 per dose.
- Market growth projected at ~10% CAGR through 2027, bolstered by expanding indications.
- Biosimilar competition expected around 2030, likely resulting in downward pricing pressure.
- Revenue growth depends heavily on regulatory approvals, market penetration, and payer negotiations.
- Potential for price stabilization or modest decline over next five years due to biosimilar entry and healthcare cost control measures.
FAQs
What primary indications influence Durvalumab's market?
Unresectable Stage III NSCLC, extensive-stage SCLC, with emerging uses in other cancers like bladder and head & neck.
How does Durvalumab pricing compare to competitors?
It is generally lower than Pembrolizumab and Nivolumab, attributable to shorter clinical history and market share.
When will biosimilars likely enter the Durvalumab market?
Biosimilar entry is anticipated around 2030, following patent expiration.
How do reimbursement policies impact pricing?
Negotiated discounts and managed care strategies significantly reduce net prices compared to list prices.
What factors could accelerate or hinder market growth?
Favorable approvals and expanding indications support growth; patent expiration, biosimilar competition, or regulatory setbacks pose risks.
References
[1] IQVIA (2022). Global Oncology Market Report.
[2] FDA (2020). Durvalumab (Imfinzi) Prescribing Information.
[3] Evaluate Pharma (2022). World Oncology Market Outlook.
[4] Statista (2023). Oncology Drug Market Revenue.
[5] Medicare & Medicaid Services (2023). Reimbursement and Pricing Policies.
