While Humira being the top-selling drug is on the decline due to increased competition and expiring patents, Keytruda is set to take the number-one position.
While Humira being the top-selling drug is on the decline due to increased competition and expiring patents, another drug is set to take the number-one position. With the continued regulatory wins, it should be no surprise that Merck’s Keytruda is poised to assume the best-selling drug mantle.
AbbVie’s Humira brought in more than $20 billion in revenue in 2018, making it the king-of-the-hill for global drug sales. But by 2023, Humira will have lost its patent protection in the United States and that revenue stream will begin to dwindle as new drugs will begin to chip away at its market share. For example, in November 2018, the U.S. Food and Drug Administration (FDA) approved Sandoz’ Hyrimoz, a biosimilar to Humira, but due to the patent protection, it cannot be launched in the U.S. until 2023.
Merck’s Keytruda (pembrolizumab), on the other hand, continues to rack up regulatory approvals and is proving to be the tent-pole therapy for Merck’s oncology pipeline. During an Investor’s Day conference in June, Merck‘s Chief Commercial Officer Frank Clyburn said in a short time, Keytruda has become a foundational cancer treatment. “We have activity across 25 different cancer types… and Keytruda is changing the way in which patients are being treated today,” Clyburn said at the time.
That significant activity in cancer is the reason Keytruda is projected to generate $22.5 billion in revenue by 2025, according to an analysis by GlobalData, a data and analytics company. Last year, Keytruda generated more than $7 billion in revenue and, based on the more than $5 billion it earned in the first half of 2019, could hit $10 billion or more by the end of this year. Keshalini Sabaratnam, a pharma analyst at GlobalData, said Keytruda has developed into Merck’s biggest product since it was first approved by the FDA in 2015.
“It has received market approvals for over 20 oncology indications in the U.S. and is continuing to expand into new indications and markets globally,” Sabaratnam said in a brief statement.
In fact, Merck has been approved more than 22 times since 2015. In August, BioSpace took a deep dive into Keytruda and the impact it has had on treating multiple types of cancer, including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel Cell Carcinoma, and renal cell carcinoma. Not only has Keytruda snagged 22 approvals from the FDA, but the drug is also currently involved in more than 1,000 clinical trials. If only one-tenth of those trials hit, the approvals for Keytruda will climb exponentially.
While Humira will lose its top spot for global revenue, AbbVie’s vaunted drug will remain in the top 10 of best-selling drugs. GlobalData pegs the drug at 6th place by 2025.
Following Keytruda, Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), an oral anticoagulant, will be the second best-selling drug out of the top 10, with annual sales of $18.7 billion by 2025, according to the GlobalData forecast. Eliquis, a cardiovascular medication, drew $6.4 billion in revenue for 2018.
Celgene’s (and soon to be BMS’ due to the ongoing merger) Revlimid is expected to occupy third place, although its worldwide sales will be affected by generic versions, which are set to hit the U.S. market in 2022. By 2026, Revlimid is expected to lose about 90 percent of its revenue-driving power due to increased competition. Revlimid earned about $10 billion in 2018.
BMS’ Opdivo, a rival checkpoint inhibitor to Keytruda, is expected to be in fourth place for global revenue and AbbVie and Janssen’s Imbruvica will take the fifth position, according to GlobalData’s prediction. In 2018, Opdivo earned $5.7 billion.
Rounding out the top 10 are Gilead’s HIV drug Biktarvy will be seventh, Pfizer’s Ibrance will be number eight, J&J and Mistubishi Tanabe’s Stelara will be in ninth and Eli Lilly’s Trulicity will be 10th.
