Merck CEO Rob Davis Just Told Investors Keytruda is Getting a New Body
At the January 2025 JP Morgan Healthcare Conference, Merck CEO Rob Davis announced a pivotal shift for the world’s top-selling drug. Keytruda, which generated over USD 25 billion in 2025, is transitioning from a 30-minute intravenous infusion to a subcutaneous (SC) injection deliverable in minutes. With regulatory filings submitted, this move marks a sophisticated lifecycle management strategy ahead of the 2028 patent expiration.
What the Subcutaneous Move Means Competitively
This transition is designed to neutralize the threat from the Keytruda biosimilar pipeline, including developers like Samsung Bioepis. By shifting the clinical standard to a proprietary SC formulation with a separate patent estate extending into the 2030s, Merck creates “clinical inertia.” Oncologists and patients are unlikely to revert to an IV biosimilar for marginal savings once the faster, more efficient SC protocol is established.
“The subcutaneous formulation resets the value proposition of pembrolizumab… it improves healthcare resource utilization and patient experience at a critical strategic moment.” — Senior Oncology Market Analyst.
READ: In February 2025, the FDA granted Priority Review for Keytruda as a perioperative treatment for head and neck squamous cell carcinoma, continuing its expansion into earlier-stage, higher-duration settings.
The Indication Multiplier Effect
Unlike drugs limited to few indications, Keytruda utilizes an indication multiplier model. Every new approval—such as the 30th European Commission approval in October 2024 for endometrial and cervical cancers—expands the eligible patient base and treatment duration.
The structural shift from metastatic relapse to adjuvant and first-line settings is the primary revenue driver. Moving treatment to the post-surgery stage can triple the eligible population and extend therapy from months to years. Valued between USD 27–31 billion in 2025, the market grows as the definition of “eligible patient” consistently broadens.
READ: In May 2024, Merck’s partnership with Tempus AI integrated genomic profiling into its strategy, refining PD-L1 biomarker selection to improve response rates and regulatory outcomes.
The pembrolizumab market is not merely approaching a patent cliff; it is treating it as a redesign opportunity. The molecule that redefined survival for melanoma and lung cancer is being rebuilt for the next decade, ensuring its position as the foundational backbone of global oncology.