The Ascension of Keytruda
Merck's pembrolizumab, marketed under the brand name Keytruda, has firmly established itself as the world's highest selling drug, with sales reaching nearly $29.5 billion in 2024. This cancer immunotherapy, which works by blocking the PD-1 protein on the surface of immune cells to help them recognize and attack cancer cells, has achieved its dominance through a strategy of rapid expansion into numerous indications. With over 40 approved indications, including various forms of lung, gynecological, and head and neck cancers, Keytruda has become a cornerstone of modern cancer treatment.
The strategic expansion of its approved uses, particularly into treating earlier-stage cancers, has been a key driver of its sustained growth. The drug's success highlights a significant shift in the pharmaceutical market toward high-value, specialized biologic therapies. However, its market position faces future threats from potential biosimilar competition, with key patents expiring around 2028, and competition from other immunotherapies.
The Rise of New Contenders
While Keytruda leads, a new class of drugs is experiencing explosive growth and challenging the traditional market leaders. The GLP-1 receptor agonists, primarily used for type 2 diabetes and increasingly for weight loss, are rapidly climbing the sales charts. These include Novo Nordisk's Ozempic (semaglutide) and Eli Lilly's Mounjaro (tirzepatide). Ozempic, for example, saw its sales jump 26% year-on-year to reach approximately $17.5 billion in 2024. This surge is driven by strong demand for its weight-loss benefits, which has made it a household name and placed it among the top performers. Analysts predict these GLP-1 products will continue their upward trend, potentially surpassing some of the current top-selling products in the coming years.
Other notable high-performing medications include:
- Eliquis (apixaban): A blood thinner from Bristol Myers Squibb and Pfizer, which consistently generates billions in revenue, though it faces upcoming patent expirations and price negotiations.
- Dupixent (dupilumab): An immunology drug from Sanofi and Regeneron that addresses conditions like eczema and asthma and has shown significant year-over-year growth.
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide): Gilead's leading HIV treatment, which continues to be a commercial powerhouse in the infectious disease market.
- Skyrizi (risankizumab-rzaa): AbbVie's new immunology drug that is rapidly growing and helping the company offset the revenue loss from its long-time blockbuster, Humira.
The Changing Landscape: From Humira to Keytruda
For nearly a decade, AbbVie's Humira (adalimumab), an anti-inflammatory biologic, reigned supreme as the world's bestselling drug. Its sales peaked in 2022 at over $21 billion before plummeting in 2023 following the loss of patent exclusivity and the entry of biosimilar competition in the U.S. market. This shift created a power vacuum that Keytruda swiftly filled. The fall of Humira serves as a stark reminder of the finite life cycle of blockbuster drugs, a trend exacerbated by factors like patent expiration and government regulations such as the Inflation Reduction Act.
Another significant market shift was seen during the COVID-19 pandemic. In 2021 and 2022, the Pfizer-BioNTech vaccine Comirnaty briefly held the title of the highest-selling pharmaceutical product, generating unprecedented sales due to global demand. However, with the transition to an endemic phase and a decline in vaccine demand, its sales have fallen considerably, highlighting how specific global health crises can temporarily alter the top-selling drug rankings.
Comparison of Recent Top-Selling Drugs (2024 Sales)
| Rank | Drug (Company) | 2024 Sales (approx.) | Main Indication | Patent Expiry (US) |
|---|---|---|---|---|
| 1 | Keytruda (Merck) | $29.5 billion | Oncology | ~2028 |
| 2 | Ozempic (Novo Nordisk) | $17.5 billion | Type 2 Diabetes | Long-term outlook varies |
| 3 | Dupixent (Sanofi/Regeneron) | $15.1 billion | Immunology/Respiratory | ~2031 |
| 4 | Biktarvy (Gilead) | $13.4 billion | HIV | ~2033 |
| 5 | Eliquis (BMS/Pfizer) | $20.7 billion (combined) | Anticoagulant | ~2026 |
Note: Sales figures may vary slightly depending on reporting sources and currency conversions.
Factors Influencing a Drug's Market Dominance
Several key factors determine whether a medication can become a long-term commercial success:
- Unmet Medical Need: High-selling drugs often address prevalent or severe conditions with a lack of effective alternatives. Keytruda's success in treating various cancers and Ozempic's popularity for diabetes and weight loss are prime examples.
- Patent Exclusivity: Strong and long-lasting patent protection allows companies to charge high prices without generic competition, as seen historically with Humira and currently with Biktarvy.
- Expanded Indications: Gaining approval for additional uses significantly increases a drug's market size. Keytruda's extensive list of indications is a testament to this strategy.
- Market Competition: The entry of biosimilars or newer, more effective therapies can rapidly erode a drug's market share, as Humira experienced.
- Pricing and Reimbursement: Government policies and insurance coverage can heavily influence a drug's commercial success. The U.S. market, with its high drug prices, is a major factor in the revenue for many blockbusters.
Conclusion
The pharmaceutical industry's leader in sales is a constantly evolving position, driven by a complex interplay of clinical breakthroughs, market demand, and business strategy. In recent years, Merck's Keytruda has topped the list, capitalizing on the high-value oncology market. However, its reign is not assured, with fast-growing GLP-1 agonists like Ozempic poised to challenge its dominance in the future. The swift fall of former champions like Humira demonstrates the vulnerability of even the most successful products to patent expiration and market forces. Staying informed on these trends is crucial for understanding the dynamic world of medicine and its economic impact. For more information, read the full list of top-selling drugs from BioSpace(https://www.biospace.com/business/10-best-selling-drugs-of-2024-rake-in-billions-amid-exclusivity-threats).
