Last updated: July 28, 2025
Overview of NDC 16714-0119
NDC 16714-0119 corresponds to Keytruda (pembrolizumab), a PD-1 inhibitor used in oncology treatment, primarily for non-small cell lung cancer (NSCLC), melanoma, and other solid tumors. Since its FDA approval in 2014, Keytruda has emerged as a leading immunotherapy agent, experiencing widespread adoption due to its proven efficacy and convenient administration.
Market Dynamics and Competitive Landscape
Market Size and Growth Trajectory
The global oncology immunotherapy market, with Keytruda as a cornerstone, has demonstrated exponential growth over the past decade. According to IQVIA, the global oncology market was valued at approximately $153 billion in 2021, with immunotherapies accounting for over 40% of this figure[1].
In the United States alone, Keytruda's sales surged from around $7 billion in 2019 to nearly $12 billion in 2022, reflecting its broad label expansion—covering multiple tumor types and line-of-treatment settings[2].
Regulatory and Label Expansion
Keytruda’s approvals span dozens of indications, including head and neck cancers, classical Hodgkin lymphoma, and colorectal cancers. Continued clinical trial successes prompt frequent label extensions, further enlarging its market footprint. The drug’s predominant position is reinforced by its favorable profile in combination therapies, with ongoing trials increasingly positioning it at the forefront of immuno-oncology.
Competitive Environment
Keytruda faces competition from other PD-1/PD-L1 inhibitors such as Opdivo (nivolumab), Tecentriq (atezolizumab), and Libtayo (cemiplimab). While Opdivo initially held a significant market share, Keytruda has maintained dominance due to its broader approved indications and robust efficacy data[3].
Innovations in biomarker-driven patient selection and combination strategies continue to shape competitive dynamics, although Keytruda’s extensive label expansion and strong manufacturer support (Merck & Co.) provide a competitive edge.
Price Trends and Revenue Considerations
Historical Pricing Data
The average wholesale price (AWP) for a 200 mg dose of Keytruda has remained relatively stable, generally ranging from $10,000 to $15,000 per dose, depending on indication, dosing schedule, and payer negotiations. However, the actual net price to payers is often lower due to rebates and discounts.
Pricing Strategy and Reimbursement Landscape
Merck's pricing strategy reflects the high value associated with durable response rates and survival benefits. Payer acceptance panels tend to favor the drug due to its demonstrated clinical benefits, which supports premium pricing models.
Reimbursement remains pivotal; payers increasingly favor value-based arrangements, including outcomes-based contracts, especially as new comparator data and real-world evidence emerge.
Projected Market Trends and Price Movements (2023-2028)
Market Penetration and Usage Growth
With an expanding label and increasing adoption in combination regimens, the overall patient base is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% globally over the next five years. The U.S. market is expected to maintain its leadership due to higher healthcare expenditure and rapid adoption curves.
Price Projections
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Per-Patient Pricing:
Given stable manufacturing costs and high demand, per-dose prices are projected to remain around $10,000 - $15,000 in the near term. Small incremental increases (~2-3%) annually could occur due to inflation, market access negotiations, and potential label expansions.
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Total Revenue:
As usage expands, revenue from Keytruda could surpass $15 billion globally by 2027, assuming sustained market penetration and additional approvals.
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Price Adjustment Factors:
Pricing may experience upward pressure from increased use in combination therapies and expanded indications; however, healthcare payers' efforts to contain costs could impose downward pressure via formulary restrictions and rebate negotiations.
Impact of Biosimilars and Market Competition
Currently, biosimilar competition for pembrolizumab is not imminent; no biosimilars have received regulatory approval yet, partly due to patent protections and high barriers for biosimilar development. This is expected to mitigate significant downward pressure on pricing over the next 3-5 years.
Key Influencers and Risks
- Regulatory approvals and label expansions will continue to drive growth.
- Market access policies and reimbursement negotiations will impact effective pricing.
- Introduction of biosimilars or novel competitors could exert downward pricing pressure in the medium term.
- Real-world evidence demonstrating improved patient outcomes may justify premium pricing strategies.
- Manufacturing and supply chain challenges could influence pricing and availability.
Conclusion
NDC 16714-0119, representing Keytruda, remains a dominant force in oncology therapeutics. The market is positioned for sustained growth, driven by broadening indications and ongoing clinical development. While per-dose prices are likely to stay stable in the near term, total revenue will benefit from increased adoption and expansion into new treatment settings. Payer negotiations and competitive dynamics will be pivotal in shaping future pricing landscape.
Key Takeaways
- Market dominance: Keytruda holds over 40% share in the immuno-oncology sector, with extensive FDA-approved indications.
- Growth prospects: The global market is expected to grow at CAGR of 7-9%, reaching over $15 billion in revenue by 2027.
- Pricing stability: Per-dose prices are projected to stay between $10,000 and $15,000, with modest annual increases.
- Competitive landscape: Limited biosimilar competition currently mitigates downward price pressure; but future biosimilar entries could influence this.
- Strategic considerations: Market expansion, clinical trial progress, and payer negotiations will influence profitability and pricing strategies moving forward.
FAQs
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What factors influence the price of Keytruda (NDC 16714-0119)?
- Market demand, indication expansion, payer negotiations, manufacturing costs, and competitive landscape.
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How does the competition from other PD-1/PD-L1 inhibitors affect Keytruda's pricing?
- Competition can exert downward pressure, but Keytruda's broader approval base and clinical data help maintain premium pricing.
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Are biosimilars a concern for future pricing of pembrolizumab?
- Currently, biosimilars are not yet approved, but their eventual entry could lead to price reductions.
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What are the main drivers of Keytruda’s revenue growth?
- Increasing approved indications, expanding patient access, combination therapies, and global market penetration.
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How might regulatory changes impact pricing strategies?
- Stricter cost containment policies and value-based reimbursement models might incentivize pricing adjustments.
References
[1] IQVIA, "Global Oncology Market Report," 2022.
[2] Merck & Co., Annual Reports and Quarterly Earnings, 2019-2022.
[3] FDA Approvals Database, 2023.
