[2025 Analysis] The $25 Billion Monopoly and the Breakers: The Keytruda War
1. The $25 Billion Question: Can You Put a Price Tag on Life?
In 2023, the world's best-selling drug was Merck's (MSD) immunotherapy drug, 'Keytruda'. Its sales alone exceeded $25 billion. Known as the "miracle drug" that cured former US President Jimmy Carter's brain tumor, it brings hope. But this miracle comes with a harsh condition: a price tag that approaches $100,000 per year for patients without insurance coverage.
Technology is ready to save lives, but capital has turned its back on patients who are not financially prepared. We call this "Financial Toxicity." It is a reality where your bank account dies before the cancer cells do. But in 2025, a movement to crack this fortress of monopoly is gaining serious momentum.
2. 2025: Why Now?
Keytruda's substance patent will begin to expire sequentially in the US and Europe starting in 2028. You might ask, "That's three years away, why the fuss now?" But in the world of biopharmaceuticals, three years is tomorrow. Developing a biosimilar, completing Phase 3 clinical trials, and gaining approval takes years. To enter the market immediately upon patent expiration in 2028, companies must secure Phase 3 data and file for approval right now, in 2025.
(Credit: Photo by National Cancer Institute on Unsplash / Courtesy of Unsplash)
At this very moment, South Korea's Samsung Bioepis and Celltrion, along with US-based Amgen, are fighting an invisible war. This is not just a battle for market share between corporations. It is a process of democratization, shifting the sovereignty of cancer treatment from a 'few suppliers' to 'many choices'.
3. Paradigm Shift: What Changes?
The Keytruda biosimilar competition starting in 2025 will fundamentally change the landscape of cancer care.
First, The Collapse of the Financial Barrier
The basic principle of economics—competition—drives down prices. When biosimilars launch, prices typically start at 70% of the original, and as competition heats up, they can drop to 30-40%. This creates room in health insurance budgets, which in turn leads to expanded coverage criteria, allowing more patients to benefit.
Second, Evolution of Form (IV vs SC)
The original manufacturer, MSD, is not sitting idly by. To defend their patent, they have played the 'Subcutaneous (SC) Injection' card. Patients who had to lie in hospital beds for hours receiving intravenous (IV) drips can now get a single shot and go home in five minutes. The pursuit by biosimilars has forced the original company to innovate.
(Credit: Photo by National Cancer Institute on Unsplash / Courtesy of Unsplash)
Ultimately, the market will be reshaped into a battle between [Affordable & Proven IV Biosimilars] and [Expensive but Convenient SC Originals]. Whichever side wins, the winner is the patient. Because they gain the 'right to choose'.
- Background: Preparing for the patent expiration (2028~) of Keytruda ($25B annual sales).
- Status: 2025 is the golden time for completing Phase 3 trials and filing for approval.
- Impact: Expanded patient access due to lower prices vs. Original's defense via formulation change (SC).
- Significance: Lowering economic barriers to cancer treatment and diversifying treatment options.
4. Conclusion: Technology Must Aim for People
In 2025, the silent war surrounding Keytruda will intensify. Corporations will chase profits, but the outcome of that competition must result in public benefit.
Medicine is not a luxury good. Ensuring that no patient has to turn away from a miracle drug because they lack money or insurance—that is the true victory the 2025 biosimilar competition should bring.
