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, 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, with only one drug in the NDA/BLA phase.
- 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 an expected PDUFA date for Tenapanor.
- The overall likelihood of approval of a Phase I gastroenterology (non inflammatory bowel disease)-other asset is 21.9%, 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 19 licensing and asset acquisition deals involving IBS drugs during 2014–19. 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 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 Zelnorm for IBS (July 8, 2019)
28 Multiple Drugs for IBS (June 25, 2019)
28 Linzess for IBS (June 18, 2019)
30 Zelnorm for IBS (October 17, 2018)
31 Zelnorm for IBS (October 15, 2018)
34 KEY UPCOMING EVENTS
35 KEY REGULATORY EVENTS
35 FDA Approves The First Device To Treat Pain Caused By IBS
35 Poland Switches from Rx-To-OTC Mylan’s Duspatalin For IBS, Plus Orion’s ED Treatment
35 Zelnorm Returning To US Market With Broad IBS-C Indication
35 The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety
35 US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Alfasigma Acquires Sloan’s Zelnorm
38 Deals Shaping The Medical Industry, January 2019
39 Luoxin Gets Trulance Rights In China From Synergy
40 PARENT PATENTS
41 REVENUE OPPORTUNITY
42 CLINICAL TRIAL LANDSCAPE
43 Sponsors by status
44 Sponsors by phase
46 BIBLIOGRAPHY
47 Prescription information
48 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
21 Figure 3: Overview of pipeline drugs for IBS in the US
22 Figure 4: Pipeline drugs for IBS, by company
22 Figure 5: Pipeline drugs for IBS, by drug type
22 Figure 6: Pipeline drugs for IBS, by classification
30 Figure 7: Linzess for IBS (June 18, 2019): Phase IIIb – IBS-C Abdominal Symptoms
33 Figure 8: Zelnorm for IBS (October 15, 2018): Regulatory – FDA Advisory Panel Brief
34 Figure 9: Key upcoming events in IBS
37 Figure 10: Probability of success in the IBS pipeline
38 Figure 11: Licensing and asset acquisition deals in IBS, 2014–19
40 Figure 12: Parent patents in IBS
42 Figure 13: Clinical trials in IBS
42 Figure 14: Top 10 drugs for clinical trials in IBS
43 Figure 15: Top 10 companies for clinical trials in IBS
43 Figure 16: Trial locations in IBS
44 Figure 17: IBS trials status
45 Figure 18: 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
24 Table 5: Pipeline drugs for IBS in the US
27 Table 6: Zelnorm for IBS (July 8, 2019)
28 Table 7: Multiple Drugs for IBS (June 25, 2019)
29 Table 8: Linzess for IBS (June 18, 2019)
30 Table 9: Zelnorm for IBS (October 17, 2018)
31 Table 10: Zelnorm for IBS (October 15, 2018)
41 Table 11: Historical global sales, by drug ($m), 2014–18
41 Table 12: Forecasted global sales, by drug ($m), 2019–23
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