- The author estimates that in 2016, there were approximately 88.5 million prevalent cases of celiac disease worldwide, and forecasts that number to increase to 97.4 million prevalent cases by 2025.
- Prevalence of celiac disease is highest in Europe and North 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 receptor, zonulin and zonulin receptor, OX40/CD134 and OX40L, and T-cell receptor. The majority of pipeline drugs for celiac disease are administered orally, with the remainder being intravenous and intradermal formulations.
- High-impact upcoming events for drugs in the celiac disease space include topline Phase III trial results of INN-202. There were six licensing and asset acquisition activities involving celiac disease drugs during 2013-18. The $0.1m agreement between Intrexon and the two startups, Genten Therapeutics and CRS Bio, to develop disease-modifying therapies through Intrexon’s proprietary ActoBiotics Lactococcus lactis platform, was the largest deal during 2013-18. This is the only deal with a disclosed deal value.
- The clinical trials distribution across Phase I-II indicates that the majority of trials for celiac disease have been in Phase II development, with 90% of trials in Phase II, and only 10% 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 clinical trials for celiac disease, and also leads industry sponsors with the highest number of Phase II clinical trials for celiac disease.
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
Takeda Funds Celiac Asset As Prelude To Potential Acquisition
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in prevalent cases of celiac disease, 2016-25
Figure 2: Overview of pipeline drugs for celiac disease in the US
Figure 3: Pipeline drugs for celiac disease, by company
Figure 4: Pipeline drugs for celiac disease, by drug type
Figure 5: Pipeline drugs for celiac disease, by classifications
Figure 6: Key upcoming events in celiac disease
Figure 7: Licensing and asset acquisition deals in celiac disease, 2013-18
Figure 8: Clinical trials in celiac disease
Figure 9: Top 10 drugs for clinical trials in celiac disease
Figure 10: Top 10 companies for clinical trials in celiac disease
Figure 11: Trial locations in celiac disease
Figure 12: Celiac disease trials status
Figure 13: Celiac disease trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of celiac disease, 2016-25
Table 2: Prevalence proportions of celiac disease, 2016-25
Table 3: Pipeline drugs for celiac disease in the US