Introduction

Low disease awareness, poor diagnosis rates, combined with a lack of pharmaceutical industry involvement, has kept celiac disease from the limelight. However, this is changing as evidenced by Shire's recent involvement in the pipeline. Datamonitor believes a drug for celiac disease is up to 5 years away and this untapped gastrointestinal indication has the potential to become a lucrative market.

Scope of this research

• Review of epidemiology, issues with diagnosisboth current techniques and those with future potentialand management of celiac disease, are discussed
• Commercial assessment of celiac disease, including market access scenarios and patient number forecast
• An overview of unmet needs, the celiac disease pipeline and clinical trial design
• Stakeholder opinions based on qualitative interviews with six key opinion leaders in the field of celiac disease

Research and analysis highlights

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. 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's 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 rates5% in the US to 25% in the EUin 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.

Key reasons to purchase this research

• Assess the major diagnostic issues, how these will change and what impact they will have on Datamonitor's celiac disease patient forecast to 2019
• Understand the key factors and unmet needs that makes celiac disease an area with significant opportunities
• Identify the companies and drug candidates in this advancing gastrointestinal area, and realize the approaches that are shaping R&D in celiac disease