Last updated: February 21, 2026
What is NDC 00713-5521?
NDC 00713-5521 corresponds to Keytruda (pembrolizumab), a programmed death-1 (PD-1) immune checkpoint inhibitor. It is used primarily in oncology, approved for multiple cancer types, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and others.
Market Overview
Market Size and Growth
The global oncology drug market for immune checkpoint inhibitors, including pembrolizumab, exceeds USD 30 billion in 2022. Keytruda holds approximately 40-45% of this market share, making it one of the top-selling immunotherapies.
Competitive Landscape
Main competitors include:
- Opdivo (nivolumab) by Bristol-Myers Squibb
- Libtayo (cemiplimab) by Regeneron
- Tecentriq (atezolizumab) by Roche
Keytruda's broad label indications and rapid approval expansion have solidified its market dominance. As of 2022, Keytruda is approved for over 20 indications.
Prescription Trends
The drug’s prescriptions have increased by around 15% annually over the past three years, driven by expanding indications and ongoing clinical trials supporting additional approvals.
Pricing Dynamics
Current Price Point
As of 2023, the average wholesale price (AWP) for a 200 mg dose of pembrolizumab is approximately USD 7,200 per dose, with a typical treatment course involving 200 mg doses every 3 weeks.
Price Trends
Since initial FDA approval in 2014, the price per 200 mg dose has risen from approximately USD 5,500 to USD 7,200, reflecting inflation and market positioning.
Reimbursement and Cost Considerations
Reimbursement rates vary by country and payer but generally favor the drug’s high efficacy profile. The average net price to providers is estimated around USD 6,500, after discounts and rebates.
Future Price Projections
Factors Influencing Pricing
- Market Competition: Introduction of biosimilars could pressure pricing, although no biosimilars for pembrolizumab have been approved yet.
- Regulatory Changes: Policy shifts aiming to lower drug prices in the US and other countries could impact pricing.
- Expansion of Indications: Broader use expands revenue but might not proportionally increase unit prices.
- Manufacturing Costs: Technological advances may reduce production costs over time, allowing for potential price reductions.
Short-Term Projections (Next 2 Years)
- Stability or slight decline: Prices are expected to remain around USD 7,000-7,500 per dose owing to high demand and lack of approved biosimilars.
- Reimbursement pressure: Payers may negotiate discounts, pushing net prices down slightly.
Long-Term Outlook (3-10 Years)
- Potential decline: Introduction of biosimilars could reduce prices by an estimated 20-30%.
- Pricing stabilization: If biosimilars face delays or regulatory hurdles, prices may stabilize or grow modestly, influenced by inflation and expansion of indications.
Investment and R&D Considerations
- The pipeline includes trials for new indications and combination therapies, potentially extending Keytruda’s lifecycle.
- Patent expirations for some formulations are expected around 2028-2030, pressuring future prices.
Summary Table
| Metric |
2023 Data |
Projections 2025-2030 |
| Current average dose price |
USD 7,200 |
USD 7,000-7,500 (2025) |
| Market share |
40-45% of immune checkpoint inhibitors |
Stable or slightly declining |
| Prescriptions (annual growth rate) |
~15% |
Stabilization or slight decrease |
| Future biosimilar impact |
No biosimilars approved yet |
Potential 20-30% price reduction |
Key Takeaways
- Keytruda remains the market leader in immune checkpoint inhibitors, with stable pricing projected over the next two years.
- Price reductions may occur with biosimilar entry, though delays could sustain current pricing.
- Significant revenue growth hinges on expanding indications and clinical trial outcomes.
- Reimbursement policies and competitive pressures are key risks to price stability.
FAQs
-
When are biosimilars for pembrolizumab expected?
No biosimilars have been approved in the US as of 2023. Pending regulatory filings could bring biosimilars to market by 2028-2030.
-
How does Keytruda compare price-wise to its competitors?
Its per-dose price is comparable to Opdivo but tends to have higher overall sales due to broader indications.
-
What are the primary drivers of prescription growth?
Expansion of approved indications, increased clinical trial success, and growing adoption in oncology practices.
-
Could policy changes significantly alter pricing?
Yes. Efforts to implement price caps, biosimilar policies, and value-based reimbursement could reduce prices.
-
What is the outlook for Keytruda’s revenue?
Revenue is projected to grow modestly in the short term, with potential for stabilization or decline if biosimilars and policy shifts impact pricing and market share.
References
- IQVIA. (2022). Oncology market insights.
- FDA. (2022). Approval histories for pembrolizumab.
- EvaluatePharma. (2023). Oncology drugs forecast.
- U.S. Food and Drug Administration. (2023). Biosimilar pathway and approvals.
- Bright, J. (2022). Industry pricing trends for immune checkpoint inhibitors. Pharmaceutical Executive.
