This Market Spotlight report covers the irritable bowel syndrome (IBS) market, comprising key pipeline and marketed drugs, clinical trials, upcoming regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were approximately 766 million prevalent cases of irritable bowel syndrome (IBS) in those aged 15 years and over worldwide, and forecasts that number to increase to 843 million prevalent cases by 2026.
• The approved drugs in the IBS space target chloride channel 2, calcium channel, serotonin 5-HT3 receptor, guanylyl cyclase c receptor, opioid receptors, gram-negative bacteria, and RNA polymerase. These drugs are administered via the oral route.
• The majority of industry-sponsored drugs in active clinical development for IBS are in Phase II, with only one drug in the NDA/BLA phase.
• Therapies in mid- and late-stage development for IBS focus on a wide variety of targets. The majority of the pipeline drugs are administered via the oral route, with only one drug being tested in a rectal formulation.
• High-impact upcoming events for drugs in the IBS space comprise topline Phase III trial results for Linzess, and expected PDUFA dates for Zelnorm and Tenapanor.
• The overall likelihood of approval of a Phase I gastroenterology (non inflammatory bowel disease)-other asset is 22.5%, and the average probability a drug advances from Phase III is 66.7%. Drugs, on average, take 10.1 years from Phase I to approval, compared to 9.9 years in the overall gastroenterology (non inflammatory bowel disease) space.
• There have been 18 licensing and asset acquisition deals involving IBS drugs during 2014–19. The $2,905m research, development, collaboration, and license agreement signed in 2017 between Allergan and Assembly Biosciences for the worldwide rights to Assembly’s microbiome GI development programs was the largest deal.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for IBS have been in the early and midphases of development, with 66% of trials in Phase I–II, and only 34% in Phase III–IV.
• • The US has a substantial lead in the number of IBS clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
• Clinical trial activity in the IBS space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for IBS, with 37 trials.
• Allergan leads industry sponsors with the highest number of clinical trials for IBS, followed by GlaxoSmithKline and Novartis