GENFIT Eyes $1.5B MASH Diagnostics Opportunity by 2033

Event summary

IQVIA estimates U.S. peak sales of GENFIT's NISTM Technology could exceed $1.5B by 2033.
Medicare reimbursement for Labcorp's NASHnext® test (based on GENFIT's NISTM Technology) became effective in August 2026.
GENFIT's NISTM Technology is incorporated into over 20 large-scale clinical studies by leading pharmaceutical companies.
GENFIT and the Global Liver Institute are establishing a coalition to advance MASH awareness and patient identification.

The big picture

GENFIT's NISTM Technology is positioned to capitalize on the growing need for non-invasive, blood-based testing in the MASH diagnostics market. With the FDA approval of two MASH treatments in 2025 and additional late-stage programs in development, the focus is shifting from treatment availability to patient identification and disease management. The company's technology is gaining recognition for its ability to assess both disease activity and fibrosis, making it a key player in the evolving landscape of MASH diagnostics.

What we're watching

Reimbursement Expansion: Whether broader reimbursement coverage across geographies and private payers will accelerate adoption of GENFIT's technology.
Clinical Guidelines: The pace at which GENFIT's NISTM Technology will be incorporated into additional clinical practice guidelines from major hepatology, gastroenterology, and diabetology societies.
Therapeutic Market Growth: How the expansion of the MASH therapeutic market will drive physician education, patient identification, and disease-monitoring needs, further supporting diagnostics use.