Headquarters: Basel, Switzerland
2024 projected sales: $16.3 billion
2024 projected R&D spend: $1.4 billion
2017 sales: $12.3 billion
2017 R&D spend: $1.3 billion
With the worldwide in vitro diagnostics market predicted to reach nearly $80 billion in 2024, Evaluate forecasts that Roche will easily remain on top of the segment, riding the wave from its $2.4 billion acquisition of Foundation Medicine up to eighth place among the largest medtech companies.
Roche’s 17.8% projected IVD market share for that year, while a drop from 2017’s 19.5%, is still expected to generate over $14.1 billion in sales—putting more than $4 billion of daylight between it and its next-closest competitor, Abbott Labs, which is set to nearly double its IVD sales by 2024.
In July, the Basel-based Big Pharma spent $2.4 billion to buy out the rest of Foundation, three years after it invested $1 billion for a 56% stake in the precision medicine company. During that time, Foundation received both FDA approval and Medicare coverage for its pan-cancer FoundationOne companion diagnostic test.
And by choosing to manage Foundation from arm’s length—giving it the autonomy to continue and pursue companion diagnostic development deals with the likes of Merck and Pfizer—Roche is working to further ingrain itself in the growing precision medicine market, while also bolstering its own targeted drug R&D efforts.
Meanwhile, Roche’s cobas line of companion diagnostics continues to rack up FDA approvals, including recently to evaluate EGFR mutation status for AstraZeneca’s Iressa in first-line non-small cell lung cancer. The test was previously approved for NSCLC therapies such as Tarceva, marketed by Roche’s Genentech unit, as well as AZ’s Tagrisso.
In 2017, Roche’s diagnostics division accounted for nearly a quarter of the larger Big Pharma’s worldwide sales, with immunotherapy tests serving as a large growth driver in both centralized and point-of-care settings.
Since announcing the buyout this past summer, Roche and Foundation have launched a new blood test that scans for 70 genes linked to solid tumor growth, as well as a patient’s microsatellite instability status. Roche hopes the non-invasive test will prove useful for patients ineligible for a tissue biopsy, or whose biopsy would be too small to be tested.
Earlier this year, the FDA granted Foundation a breakthrough device designation for a liquid biopsy assay under development for measuring tumor mutational burden, which could incorporate multiple companion diagnostics to guide cancer therapy.