Merck Splits Oncology Business Unit as Keytruda Patent Expiry Nears

Merck Splits Oncology Business Unit as Keytruda Patent Expiry Nears

On February 23, 2026, Merck announced a reorganization of its Human Health structure into two business units: an Oncology Business Unit and a Specialty, Pharma & Infectious Diseases Business Unit.

Leadership changes disclosed with the reorg

Merck appointed Jannie Oosthuizen as executive vice president and president, Oncology and MSD International.

Jannie Oosthuizen/Merck

Jannie Oosthuizen/Merck

Brian Foard was named as executive vice president and president, Specialty, Pharma & Infectious Diseases, effective March 2, 2026; the company noted Foard most recently led a specialty care unit at Sanofi.

Merck Splits Oncology Business Unit as Keytruda Patent Expiry Nears

Brian Foard/Sanofi

The concentration problem: Keytruda is a large share of Merck’s revenue base

Merck reported full-year 2025 sales of $65.0 billion, and separately disclosed KEYTRUDA/KEYTRUDA QLEX sales of $31.7 billion for 2025. The company previously reported full-year 2024 KEYTRUDA sales of $29.5 billion, underscoring the size of the franchise heading into the exclusivity window. It has been reported that Keytruda generated more than $30 billion in 2025 and represented close to half of Merck’s total revenue, framing the organizational change as partially driven by the scale of potential downside when competition arrives.

What “the patent cliff” concretely means for timing

In Merck’s risk disclosures filed with the U.S. Securities and Exchange Commission, the company has stated it expects U.S. sales of Keytruda to decline beginning in January 2028 with IRA-related government pricing, and to further decline upon loss of market exclusivity following expiration of the U.S. compound patent in December 2028; Merck also stated it expects to lose Keytruda market exclusivity in Europe in 2031 following compound patent expiration.

Why is this significant?

Operationally, a standalone oncology unit can tighten accountability around launch sequencing, indication-expansion prioritization, contracting strategy, and field execution at a time when PD-1 competition and pricing pressure are expected to intensify. Strategically, Merck’s structure change is a signal that the company is treating the 2028–2029 window as a franchise transition period rather than a routine lifecycle event. Particularly given its own disclosures that Keytruda decline is expected to begin in 2028 from multiple forces (pricing mechanisms first, followed by loss of exclusivity).

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