16649740_lThe Market – Disease Management

Huge unmet need in the celiac community

Celiac disease (CD) is significantly under-diagnosed: a little over one million patients have been identified in the US and the EU, which is barely 12% of the estimated total number of patients, but is growing rapidly. Using the commonly accepted CD affliction rate of 0.71% and approximate diagnosed cases for the US, Europe, and the rest of the world (ROTW) of 15%, 25%, 2%, one can estimate the genetically afflicted and diagnosed populations as follows:

CALCULATED POPULATIONS for CELIAC DISEASE
POPULATION GROUP
US EUROPE ROTW TOTAL
Total population 314,000,000 740,000,000 6,069,000,000 7,123,000,000
Celiac disease 2,229,400 5,254,000 43,089,900 50,573,300
Diagnosed CD
334,410 1,313,500 861,798 2,509,708

It is clear that the CD market is huge, growing rapidly, yet is barely tapped.

There is currently no treatment to CD except for the practice of a lifelong, strict, gluten-free diet (GFD). Unfortunately a high proportion of patients, even after being asymptomatic over several years of GFD, still display enteropathy. Persistently active disease can lead to serious complications and co-morbidities. It is therefore essential to be able to monitor the intestinal health and inflammation that may occur in patients with CD on treatment. Most though not all centers only undertake follow-up biopsies if symptoms or serologic tests are abnormal, which has been shown to greatly underestimate the likelihood of damage.

ImmunogenX’ competitive advantage and approach

ImmunogenX is developing the leading candidate for non-invasive monitoring of intestinal villi atrophy in recovering celiac patients as demonstrated in an initial Phase I clinical study. Based on revenue of just a few hundred dollars a year for diagnostic testing of recovering patients the projected potential current market is nearly $1 billion and growing rapidly. ImmunogenX will develop the CypCel diagnostic test kit and then perform the serum analysis at central laboratories in the US, Europe and eventually other localities around the world.

An additional impetus to the diagnostic test market is the development of therapeutic drugs such as latiglutenase for CD, a market predicted to reach $8 billion. This will naturally also propel the submarket for non-invasive tests assessing drug efficacy and compliance. It is ImmunogenX’ ambition to strategically position itself in this large emerging market by partnering with pharmaceutical companies active in CD treatment.