Estimated 2026 sales: $35.26 billion
2019 sales: $29.76 billion (estimate)
2019-26 CAGR: 2.45%
Takeda's $59 billion Shire buyout vaulted it into the world’s top 10 pharma companies in 2019. However, as Bristol Myers Squibb folds in Celgene and AstraZeneca grows at unparalleled rates, the Japanese drugmaker will be squeezed off the elite roster by 2026, according to EvaluatePharma.
But slipping off the top rank of absolute sales isn’t necessarily a bad thing for Takeda. The company is now refocusing on five main areas: gastroenterology, rare diseases, oncology, neuroscience and plasma-derived therapies. It’s doing that by shedding some non-core assets potentially worth $10 billion, which will cut into its top line.
For the near future, the top-selling drug and major growth engine at Takeda is inflammatory bowel disease med Entyvio. In the 12 months ended in March 2020, Entyvio sales hit JPY 347.2 billion ($3.23 billion), up 29% year-over-year.
Takeda’s been expanding the drug to more countries, while also seeking approvals for a more convenient subcutaneous formulation.
In March, after being put on China's first list of “urgently needed” drugs, Entyvio snagged an approval in the country to treat patients with moderate to severe ulcerative colitis or Crohn’s disease who had an inadequate response to or were unsuitable for conventional therapies, including TNF-alpha inhibitors. In May, the subcutaneous version won an EU nod, even though it hit an FDA snag at the end of 2019.
The largest product Takeda inherited from Shire is ADHD and binge eating disorder treatment Vyvanse, whose fiscal year 2019 haul of JPY 274.1 billion ($2.55 billion) marked 13.7% underlying growth.
Vyvanse’s patent protection is expected to expire in 2023, though, and Entyvio will start to lose exclusivity in the EU in 2024 and in the U.S. and Japan in 2026. Not to mention that Takeda's hemophilia franchise, led by recombinant factor Advate, is also suffering from a sharp double-digit decline as new products such as Roche’s Hemlibra steal away market share.
So, Takeda needs its newer products to drive future growth. These include myeloma drug Ninlaro, ALK-positive non-small cell lung cancer therapy Alunbrig, and Shire’s new hereditary angioedema med Takhzyro, to name a few.
Over the years, Takeda has penned multiple early R&D deals. For example, it just inked a potentially $900 million deal with startup Carmine Therapeutics to develop rare-disease gene therapies based on the biotech’s red blood cell extracellular vesicles platform.
Some late-stage pipeline assets are also on the horizon. Takeda lately has been touting 12 new molecules it hopes to bring to market by 2024.
The nearest one could be CoVIg-19, formerly known as TAK-888, an unbranded polyclonal hyperimmune globulin Takeda and collaborators are developing against the novel coronavirus. The plasma-based treatment is made by concentrating antibodies from recovered patients or immunized individuals.
Potentially looking at a 2021 approval is TAK-788, an inhibitor of EGFR and HER2 that Takeda is testing in non-small cell lung cancer patients with EGFR exon 20 insertion, whom existing TKIs, such as AstraZeneca’s Tagrisso, don't help. Dengue vaccine TAK-003 is also eyeing a green light around that timeframe.
All told, Takeda management believes these 12 Wave 1 pipeline drugs can generate combined peak sales of $10 billion.