A prominent therapeutic area of focus for our team is an advanced form of fatty liver disease called NASH or nonalcoholic Steatohepatitis.
As the name implies, it's an inflammatory form of fatty liver disease that is not driven by excessive alcohol use. Based on epidemiology studies, about a quarter of Americans have fatty liver disease and about a quarter of those have NASH.
If not managed properly, these patients could develop fibrosis, leading to scarring of the liver called cirrhosis, which requires a transplant and leads to significantly higher chance of developing the most common form of liver cancer called hepatocellular carcinoma. Alarmingly, hepatocellular carcinoma is typically associated with chronic infections, such as by hepatitis B or hepatitis C.
If the current trend continues, NASH could overtake hepatitis as a leading cause of that cancer along with liver transplant. Based on our analysis, the total addressable market for NASH could reach $30 to $40 billion globally.
Beyond the therapeutics field, we continue to observe a steady progress on noninvasive diagnosis. This is because the gold standard for diagnosis remains histological examination from tissue acquired through liver biopsy. The procedure is costly, it’s invasive, and the interpretation suffers from human reader variability.
While non-invasive tests require large clinical studies to validate their utility, the aspiration here is that this could lead to a more streamlined process for diagnosis, getting patients proper treatment and potentially reimbursement. I also see a trend in increased incorporation of artificial intelligence or machine learning techniques in helping pathologists to interpret and score liver biopsies.
As NASH remains a nascent therapeutic market, voices from various stakeholders such as physicians, patients, caretakers, and payers allow investors to better understand the commercial market dynamics.
In the next six to 12 months. We could potentially have the first NASH drug on the market, and this is very exciting medical advancement, given that most of us were unaware of NASH a decade ago.
It is encouraging that pharmaceutical and biotech companies have a renewed interest in testing drugs in large primary care markets.
This is a reversal from roughly a decade ago when the strategy was to gravitate towards specialty drugs almost exclusively. Drugs that address large markets such as NASH or type two diabetes will likely have the most impact from a public health perspective, and millions of patients across the globe stand to benefit from improved quality of life and potentially extended longevity.