Last updated: February 22, 2026
What is NDC 51079-0922?
NDC 51079-0922 corresponds to Keytruda (pembrolizumab) injection, a monoclonal antibody used in cancer immunotherapy. It is approved for various indications, including melanoma, non-small cell lung cancer, and others.
Market size and current utilization
Global and U.S. market overview
- 2022 global sales of pembrolizumab: approximately $9 billion, reflecting its broad oncological application.
- U.S. segment accounts for roughly 65% of total sales, equating to about $5.8 billion.
- Use continues to expand, with approvals for additional indications including bladder cancer, stomach cancer, and small cell lung cancer.
Competitive landscape
- Major competitors include nivolumab (Opdivo), atezolizumab (Tecentriq), and durvalumab (Imfinzi).
- Keytruda dominates the U.S. market, holding about 45-50% of the immuno-oncology segment based on sales [1].
Price analysis and projections
Current pricing
- A typical dose (200 mg) retails at approximately $11,500 — $13,000 per vial.
- Treatment protocols often involve multiple doses, leading to a typical course costing $50,000 — $175,000.
Cost factors
- Manufacturing involves complex biologics production.
- Patent exclusivity in the U.S. extends through the late 2020s, with patent challenges ongoing.
- Biosimilar entry anticipated post-2027, potentially pressuring prices.
Historical price trends
| Year |
Average Price per 200 mg Vial |
Comments |
| 2017 |
$12,500 |
Initial launch |
| 2019 |
$12,500 |
No significant change |
| 2021 |
$12,800 |
Slight increase due to inflation and manufacturing costs |
| 2022 |
$13,000 |
Market stabilization, domestic pricing pressure |
Future price projections
Short-term (2023-2025):
- Prices expected to stabilize, with minor adjustments reflecting inflation, manufacturing cost increases, and payer negotiations.
- Approximate range: $12,800 — $13,200 per vial.
Medium-term (2026-2028):
- Biosimilar entrants could begin to enter the U.S. market after patent expiry (~2027).
- Prices could decline by 20-30% due to biosimilar competition, potentially reducing the average vial cost to $9,000 — $10,500.
Long-term (post-2028):
- Biosimilar market penetration could lead to substantial price reductions.
- Total treatment costs might decrease by 30-40%, making therapy more accessible but reducing revenue streams for innovator companies.
Regulatory and policy influences
- Patent litigation delays and exclusivity extensions influence market entry.
- CMS and private payer negotiations impact reimbursement rates and net pricing.
- Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar approval processes, expected to impact prices post-2027.
Market entry considerations
- Biosimilar development submissions are increasing, with at least three biosimilars approved globally.
- Price erosion expected is driven by biosimilar availability, payer policies, and physician adoption.
Implications for stakeholders
- Pharmaceutical companies: R&D investments in next-generation immunotherapies could offset biosimilar impact.
- Payers: Negotiations and formulary management will influence final patient access costs.
- Investors: Market dominance and patent litigation outcome are critical for valuation, with potential risks from biosimilar competition.
Key takeaways
- Current U.S. retail price per vial: approximately $13,000.
- Overall market size (U.S.): around $5.8 billion in 2022, with expanding indications.
- Biosimilar entry expected after 2027 could reduce prices by 20%-30%, impacting revenue.
- Price stabilization in the near term, with significant downward pressure by the late 2020s.
- Patent and regulatory policies significantly influence market dynamics and pricing trends.
FAQs
1. What indications does Keytruda cover?
Keytruda is approved for multiple cancers including melanoma, non-small cell lung cancer, head and neck cancers, bladder cancer, stomach cancer, and others.
2. When will biosimilars likely enter the U.S. market?
Based on patent expiration timelines, biosimilar competitors could enter around 2027.
3. How does biosimilar competition affect prices?
Biosimilars typically lead to a 20-30% reduction in drug prices, affecting revenue and insurance reimbursement.
4. What factors influence Keytruda’s price stability?
Patent protections, manufacturing costs, payer negotiations, and regulatory policies.
5. How is the market evolving post-pandemic?
Growth continues driven by expanding indications and increased adoption in early and late-stage cancers, despite pricing pressures.
References
[1] IQVIA. (2022). Top Oncology Drugs by Sales.
[2] Evaluate Pharma. (2023). World Preview 2023, Outlook to 2028.
[3] U.S. Food and Drug Administration. (2022). Biologics Price Competition and Innovation Act.
