Roche to invest $550 million in US CGM manufacturing hub

Image courtesy of Roche Diagnostics.

Roche Diagnostics has announced a major investment to expand its U.S. manufacturing capabilities for continuous glucose monitoring (CGM) technology. The company will invest $550 million to expand its Indianapolis facility, where it will produce the Accu-Chek® SmartGuide CGM system—Roche’s first CGM device, launched in select European markets in 2024.

The expansion is expected to create 650 new jobs, according to Roche Diagnostics North America CEO Brad Moore. The company will receive a 10-year property tax abatement from the city of Indianapolis and approximately $20 million in tax credits from the state of Indiana to support the project.

“Our goal is to initiate production within three years, followed by preparing for future generations of that CGM solution,”said Richeal Cline, Head of Global Operations for Roche Diagnostics.

The Indianapolis site serves as Roche Diagnostics’ North American headquarters, supporting research and development, laboratories, production of Accu-Chek diabetes test strips, and global distribution functions. Roche plans to refurbish an existing building for CGM manufacturing and may construct new facilities to meet anticipated demand growth.

About the Accu-Chek SmartGuide CGM

Roche received CE Mark approval for the Accu-Chek SmartGuide in July 2024, and the system is currently available in Germany, Switzerland, and the Netherlands. The sensor is worn for 14 days and includes predictive algorithms to forecast glucose trends up to two hours ahead and flag potential nocturnal hypoglycemia risks—an area of growing concern for insulin-dependent patients.

However, unlike newer CGMs from Dexcom (G7) and Abbott (FreeStyle Libre 2 Plus/3), the SmartGuide requires finger-stick calibration. This feature may limit its appeal among users seeking a more streamlined, no-prick solution.

Strategic Context & Market Positioning

While Roche declined to comment on whether the U.S. expansion is a response to President Trump’s recent tariffs, the company has publicly committed to investing $50 billion in the U.S. over five years. Roche sees this expansion as both a logistical and strategic move.

“The expansion helps expand access to U.S. patients here,”said Cline. “It provides both capacity growth and resilience of our global manufacturing network.”

US Plans

The Accu-Chek SmartGuide is not yet cleared for use in the United States.

In a statement, Roche spokesperson Jen Dial said the company is“diligently navigating the necessary development, manufacturing scale-up, and regulatory processes to bring this product to the US,”but did not provide a timeline for FDA submission or approval.

Roche’s move signals its ambition to gain a stronger foothold in the competitive CGM market, which has been dominated by Dexcom and Abbott.

Roche is a Swiss company, founded in Basel in 1896. It is the world’s largest biotechnology company and has a strong heritage in more than 130 countries globally.