THE NASH MARKET (part 2 - Market shares and values )

pills-943764 1920


Sales projection model for drugs targeting non-alcoholic steatohepatitis (NASH)

 

The proposed model is based on the market segmentation presented in part 1 .

As  many models, it has many limitations.

 

HYPOTHESIS

The projections proposed are particularly conservative in their initial assumptions.

The segmentation of the market was presented in the part 1 

  • The overall prevalence of NASH has been estimated to 5% of the adult population.
  • We started on an overall change in the prevalence of the disease similar to that of obesity, which is around 1.3% annually, ie about 10% over 7 years (5.5% overall in 2027)
  • The cost of treatment taken into account is within a reasonable range of $ 20,000 to $ 8,000 per year for the treatment of cirrhosis and from $ 15,000 to $ 6,000 per year for other patients. Treatments that impact only NASH with no fibrosis are estimated  between $ 3,000 and $ 1,200


 The annual peak in sales is expected to be closer to $ 40 billion

 

METHODOLOGY

The evolution of the overall prevalence of NASH taken into account over the period studied (2019-2026) is as follows:


 

The patients included in this model are those with a NAS score> = 4

They are divided into 5 segments corresponding to their fibrosis state (from 0 to 4).

Each of these segments is subdivided into 4 sub segments:

  • - Cardiovascular Risk Identified with Type 2 Diabetes
  • - Cardiovascular Risk Identified Without Diabetes Type 2
  • - No Cardiovascular Risk Identified with Type 2 Diabetes
  • - No Cardiovascular Risk Identified Without Diabetes Type 2

for a total of 20 segments.

 


 

We selected 15 drug candidates among the most advanced in their clinical studies.

 

  • Elafibranor               GENFIT
  • OCA                            INTERCEPT
  • Cenicriviroc               ALLERGAN
  • Emricasan                 CONATUS
  • GS4997                     GILEAD
  • GR-MD-02                 GALECTIN
  • Aramchol                   GALMED
  • MSDC-0602              OCTETA
  • Volixibat                    SHIRE
  • GS9674                     GILEAD
  • IVA337                      INVENTIVA
  • IMM124E                  IMMURON
  • Saroglitazar               ZYDUS
  • GS0976                     GILEAD
  • BMS 986038            BMY

 

For each of these drugs we tried to evaluate its expected date of arrival on the market (marketing agreement)  and the targeted segments.

For simplicity, each segment of fibrosis is weighted by a percentage representing the assumed target of the drug.

The CV and diabetes risk segments are also weighted by an overall percentage

 

 


These choices are based on known clinical studies results, for example the CV risk associated with the increase in LDL generated by the OCA implies that the probability of its prescription for patients with cardiovascular risk is limited compared to Elafibranor which is, on the contrary, cardio protector. Conversely, the effectiveness of the OCA for non-diabetic patients is debated which should limit the prescriptions for these patients.


INITIAL SCHEDULE

On the basis of the delays experienced by the two leaders, a drug at the start of a phase 2b clinical study currently require :

  • 12 months to finalize phase 2,
  • 6 months to study the results and start phase 3
  • 12 months to recruit Phase 3 patients
  • 18 months for the Phase 3 trial
  • 12 months to present its results and obtain the provisional marketing authorization

A total of 60 months

 

A drug at the end of the current phase 2 clinical study would therefore require:

  • 6 months to study the results and start phase 3
  • 12 months to recruit Phase 3 patients
  • 18 months for the Phase 3 trial
  • 12 months to present its results and obtain the provisional marketing authorization

 A total of 48 months

 These durations are very optimistic compared to the delays observed for the two leaders, especially for recruitment (18 months).


DRUG ARRIVAL IN THE MARKET 

A drug that obtains a marketing agreement is not immediately present on the market, and its market penetration is gradual while the prescribers become aware of the drug.

To integrate this parameter we have integrated a growth curve applied to the potential turnover from the marketing authorization. The average delay for full knowledge is estimated to 25 months, this value can be debated.




NASH MARKET MATURATION

The market itself is a virgin market, undiagnosed and, as a result, will take some time to get in place, as long as patients are diagnosed.

It seems clear to us that the initial diagnosis rate will be very different according to the above segments.

For example, cirrhotic patients (F4) are already diagnosed for the vast majority and the establishment of the market for these patients will be very fast.

Similarly, patients followed for diabetes will be among the first to be diagnosed, those who are followed for cardiovascular risk also, although more moderately. The longest patients to be diagnosed will be those who do not undergo any chronic treatment.

For each of these segments, we have thus established a market progression curve over time that seemed plausible (may be optimistic). 

 



TREATMENT COST EVOLUTION

Another factor to consider is the cost of treatment.

It is clear and announced that the first in the market will practice a high price that will be gradually weighted down with the arrival of competition.

This factor is complex to estimate but we tried to integrate it in the projections with the following curve which shows the degressivity of the price in time with the arrival of the competition.

 


All these factors make it possible to evaluate the global NASH market over time

For the sake of clarity, we have grouped the segments as follows:

- Cirrhotic patients are treated separately.

- Patients with a fibrosis grade between 0 and 3, subdivided as follows:

  • · Cardiovascular Risk Identified with Type 2 Diabetes
  • · Cardiovascular risk identified without type 2 diabetes
  • · No Cardiovascular Risk Identified with Type 2 Diabetes
  • · No Cardiovascular Risk Identified Without Type 2 Diabetes

  


 On this basis, and comparing monthly competition on each of the 20 market segments, it becomes possible to estimate the respective market shares of each drug over time.

A certain inertia in the variation is taken into account in order to simulate the resilience of the market, we have taken into account this resilience by market segment, taking into account the saturation rate of the market segment concerned. 

Inertia is calculated using a moving average over 6 months which is fairly little but adapted to a virgin and rapidly changing market. 

A certain resiliency of the market shares is also integrated to take account of  'first on market premium' (between 0% and 20% of inertia depending on the duration of the market presence).

This allows us to establish a quarterly sales projection for each of the listed drugs.

It goes without saying that this does not include the risk of failure of each drug or the place of combos that are not known to this day.

 

RESULTS

We see a breakdown of the market from 2023 with the arrival of a multitude of players who gradually take their place, even if there remains a premium to the first entrants. 

The relative weakness of a drug on a segment due to lack of competition means that it is rapidly replaced when a more performant drug arrives in that segment.

 

 




CONCLUSION

This model is based on many assumptions that are questionable and therefore limits its scope as a forecasting model, however we have tried to integrate all the knowledge of the NASH market currently in our possession to try to approach us as close as possible to a coherent model. The main question is the respective drug schedule, all this study is based on very an optimistic planning for the drugs still in phase 2.

The results therefore provide an indication that can be used as a basis for assessing the potential of each laboratory considered.


IMPORTANT ! annexes explaining analysis methodology, other scenarios and simulations are available clicking here !





Share on StockTwits

WWW.NASHBIOTECHS.COM  -  Copyright G DIVRY 2015-2016