In its most significant structural overhaul since the 2021 Organon spin-off, MSD (known as Merck & Co. in the U.S. and Canada) has announced the division of its Human Health business into two standalone units: an Oncology Business Unit and a Specialty, Pharma & Infectious Diseases Business Unit.
The move, effective March 2, 2026, is a strategic “ringfencing” of the company’s massive oncology franchise as it prepares for the 2028 patent expiration of its blockbuster immunotherapy, Keytruda.
Strategy: Precision in Execution
While oncology has been the company’s primary engine, accounting for nearly half of its $65 billion revenue in 2025 the new structure aims to decouple the high-risk “patent cliff” years from the rest of the portfolio. By operating separately, each unit can prioritise its own capital allocation:
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Oncology Unit: Tasked with defending the Keytruda franchise and accelerating the transition to the subcutaneous version, Keytruda Qlex (approved Sept. 2025), which could extend market exclusivity into the 2030s.
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Specialty & Pharma Unit: Focused on scaling non-oncology “growth drivers,” including the blockbuster cardiovascular launch Winrevair (pulmonary arterial hypertension) and the market-leading HPV vaccine Gardasil.
“We are sharpening our focus on delivering innovative medicines and creating long-term value,” said CEO Robert M. Davis. “This structure ensures strong commercial execution as we advance 80 Phase 3 studies and prepare for more than 20 potential blockbuster launches.”
New Leadership Appointments
MSD has tapped seasoned veterans to lead the transition, ensuring a blend of internal continuity and external “specialty” expertise.
| Executive | Role | Strategic Mandate |
| Jannie Oosthuizen | EVP & President, Oncology | Defend the $30B+ Keytruda franchise and integrate the Daiichi Sankyo ADC alliance. |
| Brian Foard | EVP & President, Specialty | Drive expansion into Immunology and Rare Disease, leveraging his experience from Sanofi (Dupixent). |
The 2030 Pivot: Revenue Projection Shift
The primary goal of this reorganisation is to manage the revenue bridge between the peak of the Keytruda era and a diversified 2030 portfolio. Current analyst models suggest a dramatic shift in how MSD will generate its billions:
| Product/Franchise | 2025 Revenue (Actual/Est) | 2030 Revenue Projection | Key Growth Driver |
| Keytruda Family | ~$31.7 Billion | ~$24.2 Billion | Transition to Keytruda Qlex (SC) |
| Winrevair | ~$1.4 Billion | ~$5.5+ Billion | Expansion into Group 2/3 PAH |
| Gardasil/Vaccines | ~$8.6 Billion | ~$11.0 Billion | CAPVAXIVE & Gardasil China demand |
| Immunology (New) | <$1.0 Billion | ~$5.0+ Billion | Tulisokibart (MK-7240) launch |
Key 2026 Pipeline Catalysts
The split comes as MSD enters a “data-rich” period intended to de-risk approximately $35 billion of its 2030 revenue goals.
1. Oncology: Beyond PD-1
While defending Keytruda, the Oncology unit is looking toward its next-gen assets:
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ADC Expansion: 2026 will see pivotal updates on sac-TMT (a TROP2-directed ADC) across various tumor types following the multibillion-dollar collaboration with Kelun-Biotech.
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Earlier Stage Cancers: Continued readouts from the LITESPARK-022 trial (Welireg in adjuvant RCC) aim to solidify MSD’s dominance in renal cell carcinoma.
2. Specialty & Infectious Disease: Diversifying the Base
The Specialty unit faces immediate milestones that will define its independence:
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HIV (April 2026): The FDA has set a target action date of April 28, 2026, for the once-daily doravirine/islatravir regimen. Concurrently, Phase 3 results for the once-weekly islatravir/lenacapavir (partnered with Gilead) are highly anticipated.
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Immunology (August 2026): Phase 3 results for tulisokibart (MK-7240) in ulcerative colitis will determine MSD’s ROI on its $10.8 billion acquisition of Prometheus Biosciences.
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Ophthalmology (Late 2026): Initial readouts from the BRUNELLO study for MK-3000 (a trispecific Wnt agonist) in diabetic macular edema will test MSD’s success in the vision care space following its EyeBio acquisition.
The 2028 “Patent Cliff” vs. The “Hill”
The primary catalyst for this split is the looming December 2028 loss of exclusivity for Keytruda in the U.S. Analysts have long feared a revenue vacuum, but MSD management remains bullish, projecting that their “widest pipeline in history” will help the company reach $70 billion in annual sales by the mid-2030s.
The reorganisation is designed to minimise “internal competition” for resources. Previously, vaccines or cardiometabolic drugs often competed for budget against the all-consuming requirements of the oncology pipeline. Now, the Specialty unit will have its own dedicated P&L to drive the 20+ identified growth drivers.
