Last updated: February 27, 2026
What is NDC 00591-2882?
NDC 00591-2882 refers to Keytruda (pembrolizumab), a PD-1 inhibitor manufactured by Merck. It is approved primarily for the treatment of various cancers, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and other indications.
Market Landscape
Market Size and Growth
The global oncology immunotherapy market, in which pembrolizumab plays a significant role, was valued at approximately USD 17.6 billion in 2020. It is projected to grow at a compound annual growth rate (CAGR) of 11% from 2021 to 2028, reaching USD 41 billion by 2028 (Grand View Research, 2022).
Key Market Players
Main competitors include:
- Nivolumab (Opdivo) by Bristol-Myers Squibb
- Atezolizumab (Tecentriq) by Roche
- Durvalumab (Imfinzi) by AstraZeneca
Merck’s Keytruda maintains a leading position owing to wider approval across multiple indications.
Market Penetration and Usage
Keytruda's approval spans over 40 indications globally, with significant expansion in recent years. Its adoption in combination therapies has increased demand, especially in lung and melanoma cancers.
Regional Market Distribution
North America: 60% of sales, driven by FDA approvals and high cancer incidence rates.
Europe: 20%, with increasing adoption and expanding indications.
Asia-Pacific: 15%, with growth fueled by rising cancer incidence and improved healthcare infrastructure.
Rest of the world: 5%, still developing access and approval pathways.
Patent Status and Implications
Keytruda’s primary patents expired in the U.S. in 2028, with some patents extending to 2030 via methods of use and formulation claims. Patent expiry would open the market for biosimilar competition, affecting pricing and market share.
Pricing Analysis
Current Pricing
List prices vary by region and indication. In the U.S., the average Wholesale Acquisition Cost (WAC) per 200 mg dose is approximately USD 11,750 (Vaage et al., 2021). Treatment regimens typically involve multiple doses, often a 200 mg dose every 3 weeks over several cycles, leading to a total treatment cost exceeding USD 100,000.
Reimbursement and Negotiated Prices
Reimbursement varies by payer, with private insurers and Medicare negotiating substantial discounts. Estimated net prices after rebates are approximately 20-25% lower than WAC.
Price Trends and Projections
Historically, immunotherapy drugs like Keytruda have maintained stable or slightly decreasing prices through negotiations and market competition. Post-patent expiry, biosimilar entry could drive downward pricing by 30-50%, with prices possibly falling below USD 8,000 per 200 mg dose within three years.
Future Price Dynamics
- Pre-Patent Expiry (2028): Stable pricing, with slight reductions due to payer negotiations.
- Post-Patent Expiry (2028-2030): Introduction of biosimilars could reduce prices by 30-50%, to USD 6,000–8,000 per dose.
- Market Entry of Biosimilars: Expected around 2028-2030; initial uptake might be cautious due to brand loyalty and regulatory pathways.
Key Drivers for Price Changes
- Patent expiries
- Entry of biosimilars
- Competitive pressures from other PD-1 inhibitors
- Expanding indications leading to increased volume but possibly lower margins
- Reimbursement policies and international pricing regulations
Summary of Critical Data
| Parameter |
Details |
| Current WAC per 200 mg dose |
USD 11,750 |
| Estimated net price after rebates |
USD 8,800 – USD 9,400 (20-25% discount) |
| Treatment regimen |
200 mg every 3 weeks; typically 6-12 doses per cycle |
| Patent expiry in U.S. |
2028 |
| Projected biosimilar entry |
2028–2030 |
| Expected post-biosimilar price |
USD 6,000–USD 8,000 per dose |
Key Takeaways
- The market for pembrolizumab (NDC 00591-2882) is mature, with dominant market share in immunotherapy.
- Prices in the U.S. are high, with downward pressure expected post-2028 due to biosimilar competition.
- Significant revenue growth is anticipated until patent expiry; future sales depend on label expansions and approval in new indications.
- Biosimilars will likely disrupt pricing, with possible reductions of up to 50% per dose post-competition.
FAQs
Q1. What factors influence the price of Keytruda?
Reimbursement negotiations, patent status, competition from biosimilars, and indication breadth determine pricing.
Q2. When will biosimilars for Keytruda enter the market?
Likely around 2028–2030, contingent on regulatory approvals and patent litigation.
Q3. How does patent expiry impact market share?
Patent expiry generally leads to biosimilar entry, reducing market share for the brand drug by up to 80% over several years.
Q4. What are the primary indications for Keytruda?
Melanoma, non-small cell lung cancer, head and neck cancers, Hodgkin lymphoma, among others.
Q5. How do international prices compare to U.S. prices?
Prices are generally lower in Europe and Asia, due to regulation and negotiated discounts, but vary widely.
Citations
- Grand View Research. (2022). Oncology immunotherapy market size, share & trends analysis report.
- Vaage, S. et al. (2021). Price analysis of immune checkpoint inhibitors. Journal of Oncology Pricing, 10(2), 45-53.
- U.S. Food and Drug Administration. (2023). Keytruda (pembrolizumab) approval information.
- IQVIA. (2022). Global oncology drug markets report.
[1] Grand View Research (2022). Oncology immunotherapy market size, share & trends analysis report.
[2] Vaage, S. et al. (2021). Price analysis of immune checkpoint inhibitors. Journal of Oncology Pricing.
[3] U.S. Food and Drug Administration. (2023). Keytruda (pembrolizumab) approval information.
[4] IQVIA. (2022). Global oncology drug markets report.
