This Market Spotlight report covers the Celiac Disease market, comprising key pipeline drugs, clinical trials, upcoming events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals.

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.
• The pooled seroprevalence was 1.4%, and the pooled prevalence of biopsy-proven disease was 0.7% worldwide. Biopsy-confirmed celiac disease is 1.5 times more common in females than in males, and approximately twice as common in children compared to adults.
• The majority of 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 and intravenous 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 13.5%, and the average probability a drug advances from Phase III is 67.5%. Drugs, on average, take 9.0 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