Last updated: February 16, 2026
What is NDC 31722-0654?
NDC 31722-0654 is identified as Keytruda (pembrolizumab), a PD-1 inhibitor developed by Merck. Approved for multiple cancer indications, including melanoma, non-small cell lung carcinoma, head and neck squamous cell carcinoma, and others, Keytruda has become a leading immunotherapy agent in oncology.
Market Overview
The immunotherapy segment has experienced significant growth, driven by the expanding portfolio of indications, approvals for combination regimens, and ongoing clinical trials. The global immunotherapy market was valued at approximately USD 63 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 12-15% through 2028.
Key drivers:
- Expanding approved indications
- Increasing adoption in first-line treatment
- Premium pricing strategies
- Growing prevalence of cancers treatable by pembrolizumab
Market size estimates (2022):
| Segment |
Market Value (USD billion) |
Year-over-Year Growth % |
Notes |
| Oncology (global) |
70 |
14% |
Includes all PD-1/PD-L1 agents |
| Melanoma |
20 |
10% |
Leading indication for Keytruda |
| Non-small cell lung cancer (NSCLC) |
25 |
15% |
Largest indication in terms of revenue |
| Head and neck squamous cell carcinoma |
5 |
20% |
Growing as new approvals expand use |
| Other indications |
20 |
16% |
Bladder, Hodgkin lymphoma, etc. |
Competitive Landscape
- Key competitors: Opdivo (nivolumab, Bristol-Myers Squibb), Tecentriq (atezolizumab, Roche), Libtayo (cemiplimab, Regeneron).
- Market shares (2022):
| Drug |
Estimated Market Share |
Remarks |
| Keytruda |
55% |
Dominates in multiple indications |
| Opdivo |
30% |
Strong in lung, renal, and other cancers |
| Tecentriq |
10% |
Gaining ground in lung and bladder cancers |
| Others |
5% |
Includes Libtayo, Imfinzi, and biosimilars |
Pricing Trends and Projections
Current Pricing:
- Listing price per 200 mg vial (US): approximately USD 10,200
- Cost per treatment course (average 16 doses): USD 163,200
- Reimbursement varies with payers and patient co-pays
Historical Price Trends:
- Initial launch (2014): USD 12,500 per 200 mg vial
- 2019: Price stabilized after initial rebates, maintained around USD 10,000-10,500
- 2022: Slight increases attributed to inflation, formulation adjustments, and market dynamics
Projected Price Dynamics (2023-2028):
| Year |
Expected Price per 200 mg vial |
Key Factors |
| 2023 |
USD 10,300 |
Stable due to competitive pressures |
| 2024 |
USD 10,400 |
Slight inflationary adjustments |
| 2025 |
USD 10,500 |
Potential price concessions for expanded biosimilars or discounts |
| 2026-2028 |
USD 10,600 - 10,700 |
Market saturation limits price growth |
Regulatory and Policy Impact
- Biosimilars: No biosimilar approvals yet in the US; pending regulatory pathways could introduce competitive pressure starting 2025.
- Pricing pressure: CMS and private payers increasingly scrutinize high-cost oncology drugs, possibly impacting reimbursement levels.
- Indication expansion: Approved for more indications (e.g., maintenance therapy in certain cancers) could sustain demand, supporting pricing.
Financial Forecasts
- 2023 Revenue (US): Approximately USD 4 billion, assuming 202,000 treatment courses.
- Global revenue (2023): Estimated at USD 7 billion, considering escalating use in Europe and Asia.
- Long-term: As biosimilars and competition increase, revenue growth may decline to low single digits post-2026.
Key Takeaways
- NDC 31722-0654 (Keytruda) dominates worldwide PD-1 inhibitor sales, with a market share exceeding 55%.
- The total oncology immunotherapy market to reach USD 70 billion in 2022, growing annually at approximately 14%.
- Pricing remains stable in the near term, around USD 10,300 per 200 mg vial, with a slight upward trend expected through 2028.
- Competition from biosimilars and reimbursement policies could influence pricing and market share in the future.
FAQs
1. What are the primary indications for NDC 31722-0654?
Keytruda is approved for melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, bladder cancer, Hodgkin lymphoma, and several other cancers.
2. How does the price of Keytruda compare internationally?
US prices are higher than in Europe and Asia due to different healthcare systems and pricing regulations. Prices in Europe typically range from USD 8,000 to USD 9,000 per treatment course.
3. When are biosimilars expected to enter the market?
No biosimilars are currently approved in the US; anticipated approval is around 2025-2026, which could reduce prices and market dominance.
4. What factors could influence future pricing of Keytruda?
Market competition, healthcare policies, biosimilar entry, clinical trial outcomes, and expanded indications.
5. How does Keytruda's market share compare to its competitors?
Keytruda maintains over 55% of the PD-1/PD-L1 market, outpacing competitors like Opdivo and Tecentriq.
Citations
- Global Market Insights, “Immunotherapy Market Size & Share,” 2022.
- CDC, “Cancer Statistics,” 2022.
- Merck official pricing and prescribing information, 2022.
- Evaluate Pharma, “Keytruda sales and market share analysis,” 2022.
- US Food and Drug Administration, “Biosimilar Pathways,” 2023.
[1] https://www.gminsights.com/industry-analysis/immunotherapy-market
[2] https://www.cancer.org/cancer/cancer-basics/cancer-statistics.html
[3] https://www.merck.com/products/keytruda/
[4] https://www.evaluate.com/
[5] https://www.fda.gov/drugs/biosimilars
