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

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were approximately 123.4 million seropositive prevalent cases of celiac disease, and 49.1 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.
• Biopsy-confirmed celiac disease is 1.5 times more common in females than in males, and approximately two times more common in children than in adults.
• The greatest proportion of industry-sponsored drugs in active clinical development for celiac disease are in Phase II. Therapies in development for celiac disease target interleukin-15/interleukin-15 receptor and gluten. Pipeline drugs for celiac disease are administered via the oral, intravenous, and subcutaneous routes.
• The overall likelihood of approval of a Phase I autoimmune/immunology asset is 11.8%, and the average probability a drug advances from Phase III is 66.3%. Drugs, on average, take 9.5 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.