This Market Spotlight report covers the Celiac Disease market, comprising key pipeline drugs, clinical trials, upcoming events, probability of success, and a 10-year disease prevalence forecast

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were approximately 121.1 million seropositive prevalent cases of celiac disease and 48.0 million prevalent cases of biopsy-proven celiac disease worldwide.
• Pooled seroprevalence is estimated to be 1.4%, and the pooled prevalence of biopsy-proven disease is estimated to be 0.7% worldwide.
• Half of the industry-sponsored drugs in active clinical development for celiac disease are in Phase II, with only one drug in Phase III.
• Therapies in development for celiac disease focus on targets such as zonulin and zonulin receptor, interleukin-15/interleukin-15 receptor, and gluten. Pipeline drugs for celiac disease are administered via the oral, intravenous, and subcutaneous routes.
• The release of topline Phase III trial results for INN-202 is the only high-impact upcoming event in the celiac disease space. The overall likelihood of approval of a Phase I autoimmune/immunology asset is 11.9%, and the average probability a drug advances from Phase III is 65.9%. Drugs, on average, take 9.4 years from Phase I to approval in the overall autoimmune/immunology space.
• All clinical trials for celiac disease have been in either Phase I or Phase II.
• The US has the highest number of celiac disease clinical trials globally. Clinical trial activity in the celiac disease space is dominated by completed trials. 9 Meters Biopharma has the highest number of completed clinical trials for celiac disease, with six trials.
• 9 Meters Biopharma leads industry sponsors with the highest overall number of clinical trials for celiac disease