NASH DIAGNOSIS AND LABS STRATEGIES

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The impact of incoming easy diagnosis of NASH should be analyzed by investors who want to anticipate the futures M&A targets in NASH.

Laboratories known strategies are mainly based on the current landscape of the disease, but incoming NASH diagnosis revolutions will change deeply the look of the future market.

Clearly, GILEAD and ALLERGAN are targeting the NASH induced hepatic fibrosis market and, regarding the current landscape, they are right!

I do not agree with the % given by Gilead for F4 F3 ratio of NASH patients (9% +15%), the ratio I found in literature are smaller for cirrhotic patients (F4) and close to 4%, nevertheless the estimated ratio of diagnosis for cirrhotic patients (decompensated or not) and advanced fibrotic patients is estimate respectively at 70% and 15% (decompensated cirrhotic diagnosis is close to 100% to my opinion) and it is far more than the very low diagnosis rate of the other NASH patients close to 5%.

The treatment rate is also higher in diagnosed cirrhotic patients than advanced or mild fibrotic patients, more, those patients can pay more because their vital prognostic is not very good.

What does it mean?

This means that, currently, the most interesting market segment and the easiest to reach is that of advanced fibrosis and cirrhosis. 

For Gilead and Allergan, a bird in the hand is worth two in the bush.

But things change, the last announcement on the NASH diagnosis front was GENFIT’s one on the last validation process for their based biomarkers NASH diagnosis test and targeting a 90%-95% accuracy, which is better than biopsy.

If the test is validated, the easy diagnosis can modify very quickly the landscape of the market, we can hope to reach a 50% diagnosis rate (based on known T2D patients) for F0, F1, F2 and F3 patients.

One can notice that announcements on NASH diagnosis are increasing OWL, DeMili, Exalens, Superconic Imagine etc , you can find a landscape of diagnosis methods HERE

A first approach of the market segmentation is presented below and is based on a 600 M people population (USA + main Europe).

You can see the physiognomy of the market with and without an easy NASH diagnosis.

 

 

Market size is globaly bigger with easy NASH diagnosis and  more balanced with F1 F2 F3

The NASH induced fibrosis is still a big market but the pure antifibrotics are not the only drug to look at.

For evident reasons, treatment targeting only fibrosis should be combined with a treatment targeting the underlying metabolic causes of the disease. (Have a look on this article)

Moreover last studies shows the high correlation between NASH induced fibrosis improvements and ballooning and hepatocytes inflammation improvements.


It means that treating the metabolic side of the NASH disease could prevent or reduce fibrosis. 

So, for a lot of patients, pure antifibrotics like cenicriviroc or simtuzumab would not be necessaries.


In the next weeks and months, the investors trying to anticipate M&A deals should have a look on Biotech’s targeting the core of NASH instead of fibrotic side.

 

G. Divry



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