Last updated: February 28, 2026
What is the drug associated with NDC 80005-0119?
The National Drug Code (NDC) 80005-0119 corresponds to Keytruda (pembrolizumab). It is an anti-PD-1 immunotherapy used primarily in oncology treatments, targeting various cancers including melanoma, non-small cell lung cancer (NSCLC), and urothelial carcinoma. Keytruda is marketed by Merck & Co.
Market Size and Demand Dynamics
Global Oncology Market
The oncology sector is expanding due to higher cancer prevalence and improved diagnostic techniques. The global oncology drug market was valued at approximately USD 125 billion in 2022, with an expected compound annual growth rate (CAGR) of 10% through 2027 [1].
Keytruda’s Market Share
Keytruda has become a leading immunotherapy. In 2022, it accounted for roughly 25% of the global PD-1/PD-L1 inhibitor sales, with estimated revenues exceeding USD 15 billion [2].
Usage and Indications
Currently approved for multiple indications, including:
- Melanoma
- NSCLC
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
The expanding list of indications and approved lineages boosts overall demand.
Competitive Landscape
Primary competitors include:
- Opdivo (nivolumab, Bristol-Myers Squibb)
- Libtayo (cemiplimab, Regeneron)
- Tecentriq (atezolizumab, Roche)
Keytruda's efficacy and company-backed reimbursement strategies give it advantages over rivals.
Price Trends and Projections
Current Pricing
Average wholesale price (AWP) per 100 mg vial: USD 6,000–7,000 [3]. A typical treatment course involves multiple vials, resulting in treatment regimens costing USD 40,000–150,000 depending on the indication and dosage.
Cost Drivers
- Drug manufacturing complexity
- Patent protections and exclusivity periods
- Reimbursement policies and negotiated discounts
- Demand-driven pricing adjustments
Price Projections: 2023–2028
| Year |
Estimated AWP per 100 mg vial |
Notes |
| 2023 |
USD 6,500 |
Stable based on current manufacturing costs |
| 2024 |
USD 6,300 |
Slight reduction expected due to increased competition |
| 2025 |
USD 6,000 |
Price pressures from biosimilars anticipated |
| 2026 |
USD 5,800 |
Biosimilar market entry possible |
| 2027 |
USD 5,500 |
Increased biosimilar availability impacts prices |
| 2028 |
USD 5,200 |
Sustained downward trend as biosimilars expand |
Impact of Biosimilar Competition
Patent expiration is projected around 2028. Biosimilars could reduce prices by 20–35%, leading to significant payer savings and shifts in market share from originator to biosimilar players.
Regulatory and Reimbursement Factors
- FDA approvals continue to expand Keytruda's indications, supporting revenue growth.
- Reimbursement policies favor high-value treatments but are sensitive to price reductions tied to biosimilar competition.
- Pricing negotiations are increasingly focused on value-based models, linking reimbursement levels to clinical outcomes.
Strategic Implications
- Merck likely maintains premium pricing until biosimilar market entry.
- Early indication expansions and combination therapy approvals could sustain sales growth.
- Biosimilar competitors will exert downward pressure post-2028, potentially leading to a 30–50% reduction in price per vial.
Key Takeaways
- Keytruda remains dominant in the immuno-oncology market with global revenues surpassing USD 15 billion.
- Price per vial is around USD 6,500, with treatment costs between USD 40,000 and USD 150,000 per course.
- Biosimilar entry slated for 2028 may lower prices by up to 35%.
- Market expansion depends on new indications, combination therapies, and regulatory approvals.
- Competitive dynamics and reimbursement policies strongly influence future pricing trajectories.
FAQs
-
How does biosimilar entry affect Keytruda’s market share?
Biosimilars could capture 50% or more of the market post-2028, reducing originator revenue and pricing power.
-
What are the main indications driving demand for Keytruda?
Melanoma, NSCLC, and head and neck cancers are primary indications with the highest usage.
-
Are there upcoming patent expirations for Keytruda?
Patent protection is expected to expire around 2028, opening the market to biosimilars.
-
How are reimbursement policies influencing pricing strategies?
Reimbursement is increasingly tied to clinical value, pressuring prices but also enabling value-based agreements.
-
What is the outlook for the global oncology market?
CAGR of 10%, driven by increased cancer prevalence and innovations in immunotherapy.
References
[1] MarketsandMarkets. (2022). Oncology Drugs Market. https://www.marketsandmarkets.com/Market-Reports/oncology-drugs-market-768.html
[2] IQVIA. (2022). Global Oncology Market Report. https://www.iqvia.com
[3] RedBook. (2023). Wholesale Drug Pricing Data. https://www.redbook.com
