Celiac Disease Drug Therapy - $8 Billion Market by 2019

A new study about the market for Celiac Disease Drug Therapy was recently released by a company called DataMonitor. The UK-based Datamonitor Group is an independent, premium business information and market analysis company that assists clients with operational and strategic decision-making.

Some interesting tidbits from the study...

A drug launch in Celiac Disease is up to 5 years away. Datamonitor estimates that under optimal conditions drug sales could reach $8 billion by 2019 in the seven major markets (US, UK, Germany, France, Japan, Spain & Italy). Two market access strategies are available to companies, which are dictated by the targeted Celiac Disease subpopulation and drug price point.

The pipeline is small, and not advanced past Phase II, but candidates show various approaches to potentially treating Celiac Disease. Small, venture-backed biopharmaceutical companies power R&D, but Shire Pharmaceuticals recent in-licensing of the lead pipeline candidate AT-1001 (Alba Therapeutics) shows the promise of future Big Pharma involvement.

Low disease awareness among primary care physicians is a major factor behind low diagnosis rates (5% in the US to 25% in the EU) in Celiac Disease. Continued efforts to increase awareness, especially once a drug comes to market, will drive Celiac Disease diagnosis rates up to 50%-60% by 2019, which will expand the overall patient population.

Some other interesting points...

• Datamonitor estimates there are between 4 million and 7.5 million Celiac Disease sufferers in the seven major markets in 2009.
• Potential worldwide Celiac Disease population could be upwards of 25 million.
• Over three million Celiac Disease sufferers in the US. Celiac Disease is extremely rare in Japan and few epidemiology studies exist. France lacks population-based studies for Celiac Disease. Lower Celiac Disease prevalence in Germany than in the UK. There is an abundance of robust epidemiology studies for Celiac Disease originating from Italy. Spain has the smallest Celiac Disease population in the seven major markets. UK prevalence of Celiac Disease is the highest of the major EU regions outside the seven major markets.
• Pharmacological treatment will not replace the gluten-free diet.
• Small, privately held, biopharmaceutical companies are the power houses in the field of Celiac Disease research and development.
• Key opinion leaders believe that enzymatic degradation of gluten holds the most promise for Celiac Disease.
• Alba Therapeutics (in Phase II trials) estimates AT-1001 could launch for Celiac Disease in the US by 2011 and would have a value of $500 million.
  
• GlaxoSmithKline could exercise its option to commercialize CCX-282 (Traficet-EN; ChemoCentryx - also in Phase II trials) with proof-of-concept data.
• ALV-003 (Alvine Pharmaceuticals) is an oral, two-enzyme cocktail designed to degrade dietary gluten. Alvine Pharmaceuticals initiated a Phase I proof-of-concept study in human volunteers and Celiac Disease patients.
• Celiac Disease vaccine currently under development by Nexpep in Australia. Celiac Disease is well suited to a therapeutic peptide-based vaccine. Nexpep aims to put a peptide-based vaccine into Phase I trials in H1 2009.
  

The 150 page report can be purchased here for only a mere $3800.