2020 sales: $4.0 billion
Key patent expirations: 2025 to 2026
Competing in the Crohn’s disease/ulcerative colitis market against the likes of AbbVie’s Humira and Johnson & Johnson’s Stelara isn't easy.
But Takeda's Entyvio has made major gains by winning approvals around the globe, especially in Asia, where demand for drugs in those fields is rising rapidly. Takeda also has drawn users to Entyvio by adding a subcutaneous formulation and demonstrating benefits as a maintenance treatment.
A game-changer for Entyvio in ulcerative colitis came in 2019 when it revealed results of a head-to-head trial with Humira where Takeda's drug showed superior efficacy and safety. The transformational trial prompted GobalData analyst Patrick Aiyes to say that "Entyvio will most likely be the dominant drug in the UC landscape."
Given its upward trajectory, with a 29% growth in sales from 2019 to 2020, Takeda figures to take full advantage of Entyvio's final years of exclusivity. The drug is set to lose U.S. exclusivity around the middle of the decade, Moody's analysts said.
While the outlook is positive, things can change quickly in the ulcerative colitis market where next-generation biologics are taking a more targeted approach to the disease, according to Spherix Global Insights, which points to IL-23 inhibitors such as Johnson & Johnson's Tremfya, among others.
Entyvio is Takeda’s biggest moneymaker, but the company isn’t overly dependent upon the blockbuster. In the last fiscal year, Takeda boasted five other treatments that made more than $1 billion. One of those, blood cancer stalwart Velcade, went off patent in 2019. Another, binge eating disorder drug Vyvanse, loses its exclusivity in 2023. When Entyvio follows with its own patent expiration, the company could be feeling the pinch, especially since it doesn't have any pipeline products in phase 2/3 development for ulcerative colitis.
But Takeda CEO Christophe Weber didn’t sound concerned at the J.P. Morgan virtual healthcare conference in January. He predicted that the company's annual revenues will reach $47 billion by 2030, citing 40 clinical-stage new molecular assets in the pipeline.
Takeda made its global growth playback in 2018 when it scooped up rare disease drugmaker Shire in a $62 billion deal. With that deal, the company vaulted into the top 10 rankings of pharma companies worldwide. It ranked 10th by global drug sales last year.