- The author estimates that in 2016, there were approximately 754 million prevalent cases of 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.
- Half of all industry-sponsored drugs in active clinical development for IBS are in Phase II, with just two drugs in Phase III. Therapies in mid- and late-stage development for IBS focus on a wide variety of targets. The majority of the pipeline drugs for IBS are administered via the oral route, while dalazatide and PPC-5650 are subcutaneous and rectal formulations, respectively.
- There have been 16 licensing and asset acquisition activities involving IBS drugs during 2013-18. The largest deal 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 development programs.
- Lotronex’s method of use patent and Solabegron’s US parent product patent are set to expire in 2018 and 2019, respectively, which will open the door to generic entry.
- Xifaxan’s sales ranked highest during 2012-16, although the majority of its sales were for indications other than IBS. However, during 2017-22, Linzess is forecasted to have the highest revenues.
- The distribution of clinical trials across Phases I-IV indicates that the majority of trials for IBS are in the early and mid-phases 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 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 36 trials, while Allergan has the highest number of trials overall.
- Allergan leads industry sponsors with the highest number of Phase III clinical trials for IBS, followed by Novartis and Mallinckrodt.
Serotonin receptor agonists
Chloride channel activator
Guanylyl cyclase C agonists
Approvals by country
KEY REGULATORY EVENTS
Oncology Captures One In Three New EU Drug Approvals In 2016 - Other New Substances
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
RedHill Says Bekinda Looks Best In IBS-D, Despite Mixed Phase II Data
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: Licensing and asset acquisition deals in irritable bowel syndrome, 2013-18
Figure 8: Parent patents in irritable bowel syndrome
Figure 9: Clinical trials in irritable bowel syndrome
Figure 10: Top 10 drugs for clinical trials in irritable bowel syndrome
Figure 11: Top 10 companies for clinical trials in irritable bowel syndrome
Figure 12: Trial locations in irritable bowel syndrome
Figure 13: Irritable bowel syndrome trials status
Figure 14: 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