US MASH's commercial pool is not the 86.3 million with fatty liver; it is the 6.7 million with F2-F3 fibrosis, and most are unstaged.

MASH is the progressive, inflammatory form of fatty liver disease in which fat accumulation drives liver injury and fibrosis, renamed from NASH under the 2023 multi-society consensus. It sits inside a wide funnel: 86.3 million US adults have fatty liver disease, 14.9 million have MASH, and 6.7 million have MASH with clinically significant fibrosis, the FDA label-eligible pool, projected to rise to 11.7 million by 2050. Fibrosis stage, not the amount of fat in the liver, is what tracks with liver-related outcomes, so the treatable population is defined by staging rather than by the underlying disease's full size.

Fibrosis is graded from F0 to F4, and the treatable band sits at F2, significant, to F3, advanced but not yet cirrhosis; compensated cirrhosis is excluded from both approved agents and is what the next wave of pipeline drugs is chasing. The real constraint, though, is diagnosis, not disease size: most of the 6.7 million eligible patients are undiagnosed or unstaged in primary care. The standard pathway uses a blood test called FIB-4 to sort patients, then refers anyone in the indeterminate range to an elastography scan. Where that referral does not happen, eligible patients never reach a labeled therapy at all.

Diagnosis, not drug efficacy, is the real bottleneck in the US MASH market.

Five questions this report answers:

Q1 - How large is the US F2-F3 label-eligible MASH pool today?

Q2 - How is at-risk MASH staged without a liver biopsy in practice?

Q3 - Which MASH patients fall outside the label boundary entirely?

Q4 - How many US adults are actually eligible for MASH drug treatment?

Q5 - What FIB-4 and elastography thresholds gate a MASH diagnosis?

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#MASH #FattyLiverDisease #Hepatology #Rezdiffra #USHealthcare #DiseaseLandscape

Live report page:  https://axlrx.ai/mash/disease-landscape/

Thanks & Regards,

Mike || Global Pharma Commercial Marketing Head

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