Last updated: March 2, 2026
What is NDC 70000-0474?
NDC 70000-0474 is the National Drug Code for Keytruda (pembrolizumab), a monoclonal antibody developed by Merck (MSD). Approved by the FDA in 2014, it is used in oncology for multiple indications, including melanoma, non-small cell lung cancer, bladder cancer, and head and neck cancers.
Market Size and Growth Dynamics
Global Oncology Market
The global oncology drug market was valued at approximately $157 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030, reaching over $330 billion by 2030 (Frost & Sullivan).
Keytruda's Market Penetration
- As of 2022, Keytruda held a leading position with a 46% share of the worldwide immuno-oncology market.
- Revenue for Merck's oncology segment in 2022 reached $22.2 billion, with Keytruda accounting for approximately 78% of this segment.
- The drug is indicated for over ten cancer types, with ongoing trials expanding its use.
Geographical Breakdown
| Region |
2022 Revenue (USD billions) |
Market Share |
Growth Rate (YoY) |
| United States |
15.8 |
72% |
11% |
| Europe |
4.0 |
20% |
9% |
| Rest of World |
2.4 |
8% |
12% |
Competitive Landscape
- Key competitors include Bristol-Myers Squibb's Opdivo (nivolumab), Roche's Tecentriq (atezolizumab), and AstraZeneca's Imfinzi (durvalumab).
- Keytruda's efficacy, broad indication portfolio, and strong reimbursement coverage sustain its market dominance.
Pricing Trends and Projections
Historic Pricing
- The average selling price (ASP) of Keytruda was approximately $10,000 per 100 mg dose in 2022.
- Dosing varies by indication but generally ranges between 200-400 mg every 3 weeks.
Price Factors Affecting Future Projections
- Patent expiry: Merck's key patents are protected until 2028 in the US; biosimilar entrants are expected after 2028.
- Pricing policies: Global price adjustments reflect healthcare reforms and negotiated rebate strategies.
- Reimbursement landscape: Insurance coverage and government reimbursement policies influence net prices.
Projected Price Trends (2023–2030)
| Year |
Estimated Price per 100 mg (USD) |
Key Factors |
| 2023 |
10,000 |
Stable; patent protection; high demand |
| 2024 |
9,800 |
Beginning price competitiveness adjustments |
| 2025 |
9,600 |
Competitive pressures intensify |
| 2026 |
9,400 |
Developing biosimilar approvals |
| 2027 |
9,200 |
Market negotiation strategies increase |
| 2028 |
8,750 |
Biosimilar entry expected |
| 2029+ |
7,500–8,000 |
Biosimilar expansion and price competition |
Biosimilar Impact
Post-2028 biosimilars are projected to reduce prices by 30–50%, depending on scale and market acceptance. Initiatives in Europe suggest biosimilar prices will be 40–50% lower than originator biologics.
Revenue Projections (2023–2030)
| Year |
Total Global Revenue (USD billions) |
Notes |
| 2023 |
18.5 |
Continued growth, high demand |
| 2024 |
19.2 |
Slight increase due to new indications |
| 2025 |
20.0 |
Expanding indications, price adjustments |
| 2026 |
21.0 |
Biosimilar entry begins, volume growth |
| 2027 |
21.5 |
Market saturation, price competition |
| 2028 |
22.0 |
Revenue peaks, patent expiry impact begins |
| 2029 |
17.0 |
Biosimilar proliferation impacts revenue |
| 2030 |
15.0 |
Continued biosimilar competition reduces revenue |
Conclusion
Keytruda remains a dominant immuno-oncology agent with sustained revenue streams through 2025. The upcoming patent cliff around 2028 is expected to halve its price, leading to an approximate 20–25% reduction in global revenues by 2030. Price declines will accelerate with biosimilar entrants and competitive pressures, yet volume expansion and indication expansion will partially offset pricing reductions.
Key Takeaways
- Keytruda holds a leading position in the immuno-oncology market, with a sizable share of revenue.
- Price per 100 mg doses is projected to decline from around $10,000 in 2022 to approximately $7,500–$8,000 by 2030 due to biosimilar competition.
- Revenues will peak in 2028, then decline as biosimilars capture market share.
- Market expansion into additional cancer types and geographic regions supports revenue growth despite pricing pressures.
- Post-2028 biosimilar entry represents a major price and revenue risk but offers opportunity for market maturation and lower-cost options.
FAQs
What is the primary market driver for Keytruda's growth?
Expansion into new cancer indications and geographic markets, alongside its efficacy profile, drives growth.
When are biosimilars for Keytruda expected to enter the market?
Likely around 2028, following patent expiration in key markets.
How will biosimilar entry affect prices?
Prices for biosimilars are anticipated to be 40–50% lower than the originator, leading to significant price reductions.
What are the main competitive threats?
Other PD-1/PD-L1 inhibitors such as Opdivo and Tecentriq, along with potential new entrants and biosimilars.
How does pricing differ across regions?
Prices are higher in the US (~$10,000 per 100 mg) and lower in Europe and Asia due to negotiated reimbursements and healthcare policies.
References
- Frost & Sullivan. (2023). Global Oncology Market Report.
- Merck & Co. Inc. (2022). Annual Report.
- IQVIA. (2022). Biopharmaceutical Market Data.
- FDA. (2014). Approval for Keytruda (pembrolizumab).
- EvaluatePharma. (2023). Oncology Market Trends.
