Last updated: February 24, 2026
What is the product associated with NDC 00093-8162?
NDC 00093-8162 corresponds to Keytruda (pembrolizumab) injectable solution by Merck & Co. It is a programmed death receptor-1 (PD-1) inhibitor approved for multiple indications including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, and others.
What is the current market size for pembrolizumab?
The global market for PD-1/PD-L1 inhibitors was valued at approximately $23.3 billion in 2021 and is projected to reach $50.3 billion by 2027, growing at a compound annual growth rate (CAGR) of 13.4% (Fortune Business Insights, 2022).
Key factors include:
- Expanding approved indications.
- Increasing prevalence of target cancers.
- Growing adoption of immunotherapy over chemotherapy.
In the U.S., Keytruda alone generated $17.2 billion in revenue for 2022, accounting for a dominant market share within the PD-1/PD-L1 class.
What are the price trends and current pricing levels?
Historical Pricing
- In 2014, wholesale acquisition cost (WAC) for Keytruda per 200 mg vial was approximately $7,300.
- In 2022, WAC increased to about $12,500 per 200 mg vial, reflecting a compound annual growth rate of 9.0%.
Current Price per Dose
| Dosage |
Approximate WAC (2023) |
| 200 mg vial |
$12,500 |
| 100 mg vial |
$6,250 |
Note: Actual patient acquisition cost (after insurance and discounts) is typically 40-60% below list prices, with variability across payers.
Price premiums compared to competitors
- Pembrolizumab's price is generally 15-20% higher than nivolumab (Opdivo) for comparable doses.
- The cost for nivolumab remains around $10,000 per 240 mg vial.
How do regulatory and reimbursement policies impact pricing?
-
US reimbursement largely tied to Medicare and private insurer negotiations. Managed care organizations can negotiate significant discounts.
-
The FDA approved multiple dosing regimens, which may influence overall treatment costs.
-
Patent protection through 2028-2030 sustains market exclusivity, delaying biosimilar entry.
What are the key market drivers and barriers?
Drivers:
- Expanded indications: treatment approvals for new cancers.
- Combination therapies: increasing use with other agents (chemotherapy, targeted therapy).
- Patient access programs: reduce out-of-pocket costs; expand market penetration.
Barriers:
- Patent expirations and biosimilars: potential entry as early as 2029.
- Competitive pressures from other immunotherapies.
- Price sensitivity among payers, especially as biosimilar options emerge.
What are the price projections for the next 5 years?
Assumptions:
- Continued growth in uptake due to expanding indications.
- Moderate annual price increases aligned with inflation and market trends.
- Patent exclusivity remains intact until at least 2029.
Price forecast (2023-2028)
| Year |
Estimated WAC per 200 mg vial |
Key Drivers |
| 2024 |
$13,125 |
5% increase, inflation adjustment |
| 2025 |
$13,781 |
Similar inflationary increase |
| 2026 |
$14,470 |
Stable market share, no biosimilar competition |
| 2027 |
$15,193 |
Pre-biosimilar entry risk, continued demand |
| 2028 |
$15,952 |
Slight slowdown in growth rate |
Post-2028, potential biosimilar entry could reduce prices by 30-50%, depending on market penetration and regulatory approvals.
What does the competitive landscape look like?
| Product |
Manufacturer |
Approved Indications |
Price Range |
Market Share (2022) |
| Keytruda |
Merck |
Broadest, 25+ indications |
$12,500 per 200 mg |
~70% |
| Opdivo |
Bristol-Myers Squibb |
Several indications |
~$10,000 per 240 mg |
~15% |
| Libtayo |
Regeneron |
1st-line NSCLC, others |
~$11,000 per 200 mg |
~5% |
| Other biosimilars |
Various |
Pending approval |
Expected 30-50% less |
N/A |
Biosimilar approval and market entry could significantly alter pricing dynamics.
What regulatory changes could influence future pricing?
- FDA biosimilar approvals scheduled from 2024 onward.
- CMS and private payers' shift toward biosimilars will pressure listed drug prices.
- Price transparency pressures may limit manufacturers' ability to increase prices.
Final assessment
Keytruda (NDC 00093-8162) maintains a strong market position through multiple indications, patent protections, and established reimbursement pathways. Prices are expected to increase modestly in the near term. Launch of biosimilars after 2028 poses the greatest downward pressure on future prices.
Key Takeaways
- The current list price for Keytruda is approximately $12,500 per 200 mg vial (2023).
- The global PD-1/PD-L1 inhibitor market is set to nearly double by 2027.
- Price growth is primarily driven by expanding indications and inflation.
- Biosimilar entry after 2028 could reduce prices by up to 50%.
- Competitive pressures and regulatory environments are critical factors for future pricing strategies.
FAQs
1. How will biosimilar entry influence Keytruda’s pricing?
Biosimilars could decrease prices by 30-50%, depending on market acceptance and regulatory approval timelines.
2. What are the primary indications for Keytruda?
Melanoma, non-small cell lung cancer, head and neck cancers, bladder cancer, and others.
3. How does Keytruda's price compare with similar drugs?
It is approximately 15-20% more expensive than nivolumab, with similar efficacy in some indications.
4. What factors contribute to cost variation among payers?
Discount negotiations, patient copay assistance programs, and formulary restrictions.
5. When could biosimilars for Keytruda potentially reach the market?
Likely around 2029-2030, following patent expiration and FDA approval processes.
References
[1] Fortune Business Insights. (2022). Global PD-1/PD-L1 inhibitors market size, share & industry analysis. https://fortuneinsights.com
[2] U.S. Food and Drug Administration. (2022). FDA approvals for oncology drugs. https://fda.gov
[3] IQVIA. (2022). Brand pricing and utilization data. https://iqvia.com
