Reports world wide Irritable Bowel Syndrome (IBS) Market Report

Market Spotlight: Irritable Bowel Syndrome (IBS)
This Market Spotlight report covers the irritable bowel syndrome (IBS) market, comprising
key pipeline and marketed drugs, clinical trials, upcoming and 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 2016, there were approximately 754 million
prevalent cases of irritable bowel syndrome (IBS) in those aged 15 years and over
worldwide, and forecasts that number to increase to 830 million prevalent cases by 2025.
The approved drugs in the IBS space target chloride channel 2, calcium channel, serotonin
5-HT3 receptor, guanylyl cyclase C receptor, opioid receptor, and RNA polymerase. These
drugs are administered via the oral route.
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Therapies in mid- and late-stage development for IBS focus on a wide variety of targets.
Among these therapies, Trulance (plecanatide; Synergy), a guanylyl cyclase C receptor
agonist, is closest to market for IBS, with a supplementary New Drug Application (sNDA)
filing. All the pipeline drugs in mid- to late-stage development for IBS are administered via
the oral route.
High-impact upcoming events for drugs in the IBS space include topline Phase II and Phase
III trial results and a Prescription Drug User Fee Act (PDUFA) date for Trulance’s sNDA.
There were 16 licensing and asset acquisition activities involving IBS drugs during 2012–17.
The largest deal during that time was the $2,905m research, development, collaboration,
and license agreement in January 2017 between Allergan and Assembly Biosciences, for the
worldwide rights to Assembly's microbiome gastrointestinal (GI) development programs.
Xifaxan’s (rifaximin) sales ranked highest during 2012–16, although the majority of its sales
were for indications other than IBS. However, during 2017–22, Linzess (linaclotide acetate)
is forecasted to have the highest revenues.
The clinical trials distribution across Phases I–IV indicates that the majority of trials for IBS
are in early and mid-phases of development, with 65.4% of trials in Phase I–II, and only
34.5% in Phase III–IV.
The US has a substantial lead in the number of IBS clinical trials globally. The UK leads the
five major EU markets (France, Germany, Italy, Spain, and the UK), while Japan has the top
spot in Asia.
Clinical trial activity in the IBS space is dominated by completed trials. GlaxoSmithKline,
Novartis, and Allergan have the highest number of completed clinical trials for IBS, with 36,
33, and 31, respectively.
Allergan leads industry sponsors with the highest number of clinical trials for IBS, followed
by GlaxoSmithKline and Novartis.