Market Spotlight: Irritable Bowel Syndrome (IBS)
Market Spotlight: Irritable Bowel Syndrome (IBS)
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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.
- Half of the 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 21 licensing and asset acquisition deals involving IBS drugs during 2013–18. 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
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Subtypes
9 TREATMENT
9 Laxatives
9 Antidiarrheal drugs
9 Antispasmodics
9 Antidepressants
9 Serotonin receptor agonists
10 Chloride channel activators
10 Guanylyl cyclase C agonists
10 Antibiotics
10 Opioid receptors
10 Probiotics
12 EPIDEMIOLOGY
18 MARKETED DRUGS
21 Approvals by country
24 PIPELINE DRUGS
30 RECENT EVENTS AND ANALYST OPINION
30 Zelnorm for IBS (October 17, 2018)
31 Zelnorm for IBS (October 15, 2018)
32 Bekinda for IBS (October 3, 2017)
34 Tenapanor for IBS (May 12, 2017)
37 KEY UPCOMING EVENTS
38 KEY REGULATORY EVENTS
38 The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety
38 US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)
38 Oncology Captures One In Three New EU Drug Approvals In 2016 – Other New Substances
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 Luoxin Gets Trulance Rights In China From Synergy
40 Sinovant Builds Pipeline With Greater China Rights To Renexxion’s Naronapride
41 Knight Gets Exclusive Canadian Rights To Ardelyx’s Tenapanor
41 Cipher Gets Canadian Rights To Synergy’s GI Drug Trulance
41 Deal Watch: Boehringer’s Busy End Of Year Includes Deals With Roche, Autifony
42 PARENT PATENTS
43 REVENUE OPPORTUNITY
44 CLINICAL TRIAL LANDSCAPE
45 Sponsors by status
46 Sponsors by phase
47 Recent events
49 BIBLIOGRAPHY
50 Prescription information
51 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of IBS, 2017–26
17 Figure 2: Prevalent cases of IBS, by age group, 2017
24 Figure 3: Overview of pipeline drugs for IBS in the US
25 Figure 4: Pipeline drugs for IBS, by company
25 Figure 5: Pipeline drugs for IBS, by drug type
26 Figure 6: Pipeline drugs for IBS, by classification
32 Figure 7: Zelnorm for IBS (October 15, 2018): Regulatory – FDA Advisory Panel Brief
34 Figure 8: Bekinda for IBS (October 3, 2017): Phase II – 02 (IBS-D)
36 Figure 9: Tenapanor for IBS (May 12, 2017): Phase III – T3MPO-1 (12-Week Study)
37 Figure 10: Key upcoming events in IBS
39 Figure 11: Probability of success in the IBS pipeline
40 Figure 12: Licensing and asset acquisition deals in IBS, 2013–18
42 Figure 13: Parent patents in IBS
44 Figure 14: Clinical trials in IBS
44 Figure 15: Top 10 drugs for clinical trials in IBS
45 Figure 16: Top 10 companies for clinical trials in IBS
45 Figure 17: Trial locations in IBS
46 Figure 18: IBS trials status
47 Figure 19: IBS trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of IBS, 2017–26
15 Table 2: Prevalent cases of IBS, by gender, 2017
16 Table 3: Prevalence of IBS, by gender, 2017
19 Table 4: Marketed drugs for IBS
22 Table 5: Approvals by country for IBS
27 Table 6: Pipeline drugs for IBS in the US
30 Table 7: Zelnorm for IBS (October 17, 2018)
31 Table 8: Zelnorm for IBS (October 15, 2018)
33 Table 9: Bekinda for IBS (October 3, 2017)
34 Table 10: Tenapanor for IBS (May 12, 2017)
43 Table 11: Historical global sales, by drug ($m), 2013–17
43 Table 12: Forecasted global sales, by drug ($m), 2018–22
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