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 2017, there were approximately 89.9 million prevalent cases of celiac disease worldwide, and forecasts that number to increase to 98.8 million prevalent cases by 2026.
• Prevalence of celiac disease is highest in Europe and Northern America, and lowest in Africa and Oceania.
• All industry-sponsored drugs in active clinical development for celiac disease are in Phase I or Phase II. Therapies in development for celiac disease focus on targets such as gluten, interleukin-15, interleukin-15 receptor, zonulin and zonulin receptor, immune system, and T-cell receptor. Pipeline drugs for celiac disease are administered orally, as well as via the subcutaneous, intradermal, and intravenous routes.
• High-impact upcoming events for drugs in the celiac disease space comprise topline Phase III trial results for INN-202. The overall likelihood of approval of a Phase I autoimmune/immunology asset is 14.5%, and the average probability a drug advances from Phase III is 68%. Drugs, on average, take 8.7 years from Phase I to approval in the overall autoimmune/immunology space
• There have been five licensing and asset acquisition deals involving celiac disease drugs during 2014–19. The largest deal during the period was the $170m licensing and co-development agreement signed in 2018 between Amgen and Provention Bio, for the development of anti-IL-15 antibody AMG 714 for the treatment of gluten-free diet non-responsive celiac disease.
• The distribution of clinical trials across Phase I–III indicates that the vast majority of trials for celiac disease have been in the mid and late phases of development, with 91% of trials in Phase II–III, and only 9% in Phase I.
• The US has a substantial lead in the number of celiac disease clinical trials globally. Innovate Biopharmaceuticals has the highest number of completed trials for celiac disease, with six trials, and also leads industry sponsors with the highest number of clinical trials for celiac disease overall.