Last updated: March 8, 2026
What is the Drug Identified by NDC 55513-0843?
NDC 55513-0843 corresponds to Keytruda (pembrolizumab), a programmed death receptor-1 (PD-1) inhibitor developed by Merck. It is indicated for multiple oncology indications, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma.
Current Market Position
Keytruda holds a dominant position in cancer immunotherapy. As of 2022, it maintains approximately 40% global market share among immune checkpoint inhibitors, outpacing competitors like Opdivo (nivolumab) and Tecentriq (atezolizumab).
The drug generates over $17 billion annually, accounting for Merck’s substantial oncology revenue. Growth is driven by expanding approvals for additional tumor types, including indications in Hodgkin lymphoma and microsatellite instability-high (MSI-H) tumors.
Market Dynamics
Competitive Landscape
- Major competitors: BMS's Opdivo, Roche's Tecentriq
- Patent expiry: Keytruda's US patent protection extends into 2028; patent cliffs influence future pricing.
- Biosimilars: No biosimilar threats currently; patent protections secure market exclusivity.
Demographic Trends
- Rising cancer incidence in aging populations of North America, Europe, Asia
- Growing approval for first- and second-line treatments widens target patient populations
- Expansion into earlier-stage cancers enhances total addressable market (TAM)
Regulatory Environment
- Continuous approval updates in multiple jurisdictions
- Price negotiations and reimbursement policies impact net revenue
Pricing Strategies
- USA: List price approximately $10,000 per infusion, administered every 3 weeks
- International markets: Prices vary widely, generally lower due to local regulations and payers
Price Projections
Short-term (Next 2 Years)
- US Market: List prices expected to remain stable, with discounts and rebates averaging 20-25% based on negotiations.
- Global Markets: Price adjustments due to currency fluctuations and regulatory changes expected to result in 3-5% annual price reduction.
Long-term (Next 5 Years)
- Price erosion due to patent expirations and biosimilar entry in the US projected after 2028 may lead to a 15-20% reduction in list prices.
- With expanding indications and potential combination therapies, revenue might grow despite price pressures.
| Time Frame |
Expected Price Trend |
Impact |
| 2023-2025 |
Stable list prices; 20-25% rebates |
Revenue growth driven by volume |
| 2026-2028 |
Minor price reductions; increased competition |
Marginal profit margins compress |
| Post-2028 |
Potential biosimilar market entry; 15-20% price drop |
Revenue decline without biosimilar uptake |
Revenue Outlook
- Revenue is projected to peak around $20 billion in 2024 driven by expanding approvals and higher patient uptake.
- Post-2028, revenue could decline by 20-30% without new indications, unless biosimilar market share remains limited.
Key Factors Influencing Price and Market Share
- Approval of biosimilars or generics
- Regulatory changes affecting pricing policies
- Adoption rate in combination therapies
- Competitive innovations and pipeline drugs
- Reimbursement negotiations in major markets
Summary
Keytruda (NDC 55513-0843) continues to dominate immunotherapy markets with high revenue and broad indications. Price stability is expected until patent expiration, after which biosimilar entry could reduce prices significantly. Growth is primarily driven by increased indications and market expansion rather than price increases alone.
Key Takeaways
- Keytruda dominates the immuno-oncology segment with over $17 billion in revenue annually.
- US list prices hover around $10,000 per infusion; international prices are lower.
- Short-term prices are stable, with discounts and rebates shaping net revenue.
- Long-term projections suggest a 15-20% price reduction post-2028 due to biosimilar competition.
- Revenue is tied to approval pipeline expansion, not just pricing strategies.
FAQs
Q1: What factors could accelerate biosimilar entry for Keytruda?
Patent expiry in 2028, combined with biosimilar development progress and regulatory approvals, could lead to biosimilar entry.
Q2: How does Keytruda compare price-wise to its competitors?
Keytruda's list price is comparable or slightly higher than Opdivo, but actual net prices may differ due to rebate and negotiation dynamics.
Q3: Are there opportunities for price increases in emerging markets?
Limited; prices in emerging markets tend to follow local reimbursement policies and generally trend downward over time.
Q4: What future indications could expand the market for Keytruda?
Lung, melanoma, head and neck cancers, and potential approvals in colorectal, gastric, and bladder cancers.
Q5: How do regulatory policies impact future pricing?
Reimbursement negotiations and price controls can lead to discounts or set price caps, especially in European and Asian markets.
References
- U.S. Food and Drug Administration. (2022). Keytruda (pembrolizumab) approval history.
- IQVIA. (2022). Global Oncology Market Data.
- Merck & Co. Inc. (2022). Annual Report.
- Evaluate Pharma. (2022). Top Oncology Drugs: Market Sizes and Pricing Dynamics.
- European Medicines Agency. (2022). Keytruda some indications approvals.
