Product Code: DMKC0181355
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.
- 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.
- 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.
TABLE OF CONTENTS
- Antidiarrheal drugs
- Serotonin receptor agonists
- Chloride channel activator
- Guanylyl cyclase C agonists
- Opioid receptors
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Oncology Captures One In Three New EU Drug Approvals In 2016
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Prescription information:
LIST OF FIGURES
- Figure 1: Trends in prevalent cases of irritable bowel syndrome, 2016-25
- Figure 2: Prevalent cases of irritable bowel syndrome, by age, 2016
- Figure 3: Overview of pipeline drugs for irritable bowel syndrome in the US
- Figure 4: Pipeline drugs for irritable bowel syndrome, by company
- Figure 5: Pipeline drugs for irritable bowel syndrome, by drug type
- Figure 6: Pipeline drugs for irritable bowel syndrome, by classifications
- Figure 7: Key upcoming events in irritable bowel syndrome
- Figure 8: Licensing and asset acquisition deals in irritable bowel syndrome, 2012-17
- Figure 9: Parent patents in irritable bowel syndrome
- Figure 10: Clinical trials in irritable bowel syndrome
- Figure 11: Top 10 drugs for clinical trials in irritable bowel syndrome
- Figure 12: Top 10 companies for clinical trials in irritable bowel syndrome
- Figure 13: Trial locations in irritable bowel syndrome
- Figure 14: Irritable bowel syndrome trials status
- Figure 15: Irritable bowel syndrome trials sponsors, by phase
LIST OF TABLES
- Table 1: Prevalent cases of irritable bowel syndrome, 2016-25
- Table 2: Prevalent cases of irritable bowel syndrome, by gender, 2016
- Table 3: Prevalence of irritable bowel syndrome, by gender, 2016
- Table 4: Marketed drugs for irritable bowel syndrome
- Table 5: Approvals by country for irritable bowel syndrome
- Table 6: Pipeline drugs for irritable bowel syndrome in the US
- Table 7: Historical global sales, by drug ($m), 2012-16
- Table 8: Forecasted global sales, by drug ($m), 2017-22