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. 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 13.6%, and the average probability a drug advances from Phase III is 68.3%. Drugs, on average, take 9.0 years from Phase I to approval in the overall autoimmune/immunology space.
• There have been seven licensing and asset acquisition deals involving celiac disease drugs during 2014–19. The largest deal during the period was the $800m collaboration and license agreement signed in May 2019 between Parvus and Genentech to develop, manufacture, and commercialize novel Navacim therapeutics for the treatment of inflammatory bowel disease, autoimmune liver diseases, and celiac disease.
• The distribution of clinical trials across Phase I–IV 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 the highest number of celiac disease clinical trials globally. Clinical trial activity in the celiac disease space is dominated by completed trials. Innovate Biopharmaceuticals has the highest number of completed clinical trials for celiac disease, with six trials.
• Innovate Biopharmaceuticals leads industry sponsors with the highest overall number of clinical trials for celiac disease.