Market Spotlight: Irritable Bowel Syndrome (IBS) (2020)

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

• The publisher estimates that in 2017, there were approximately 766 million prevalent cases of irritable bowel syndrome (IBS) in people 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, sodium-hydrogen exchanger 3, serotonin 5- HT3 receptor, guanylyl cyclase c receptor, opioid receptors, gram-negative bacteria, RNA polymerase, and serotonin 5-HT4 receptor. These drugs are administered via the oral route.
• The majority of industry-sponsored drugs in active clinical development for IBS are in Phase II.
• Therapies in development for IBS focus on a wide variety of targets. All of the pipeline drugs are administered via the oral route. High-impact upcoming events for drugs in the IBS space comprise topline Phase II trial results for MD-7246 and ORP-101, and an expected PDUFA date for Linzess.
• The overall likelihood of approval of a Phase I gastroenterology (non inflammatory bowel disease)-other asset is 21%, and the average probability a drug advances from Phase III is 66.7%. Drugs, on average, take 9.8 years from Phase I to approval, compared to 9.7 years in the overall gastroenterology (non inflammatory bowel disease) space.
• There have been 18 licensing and asset acquisition deals involving IBS drugs during 2015–20. 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 65% of trials in Phase I–II, and only 35% in Phase III–IV.
• The US has a substantial lead in the number of IBS clinical trials globally. The UK leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the IBS space is dominated by completed trials. Allergan has the highest number of completed clinical trials for IBS, with 39 trials. Allergan leads industry sponsors with the highest overall number of clinical trials for IBS, followed by GlaxoSmithKline.