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.
- 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 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 receptors, gram-negative bacteria, and RNA polymerase. These drugs are administered via the oral route.
- The majority of industry-sponsored drugs in active clinical development for IBS are in Phase I and II, with only 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 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 an expected meeting with the FDA for Bekinda. The overall likelihood of approval of a Phase I IBS asset is 16.6%, and the average probability a drug advances from Phase III is 50%. Drugs, on average, take 8.4 years from Phase I to approval, compared to 10.0 years in the overall gastroenterology (non inflammatory bowel disease) space.
- There have been 19 licensing and asset acquisition deals involving IBS drugs during 2013–18. The largest deal during this period 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 GI development programs.
- 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 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 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 IBS 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
31 RECENT EVENTS AND ANALYST OPINION
31 Tenapanor for IBS (October 11, 2017)
32 Bekinda for IBS (October 3, 2017)
34 Tenapanor for IBS (May 12, 2017)
37 KEY UPCOMING EVENTS
38 KEY REGULATORY EVENTS
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 Sinovant Builds Pipeline With Greater China Rights To Renexxion’s Naronapride
40 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 Genetic Analysis’ Gut Microbiota Test Holds Potential For IBS Symptom Management
47 RedHill Says Bekinda Looks Best In IBS-D, Despite Mixed Phase II Data
47 ‘Game-Changer’ For Ardelyx As Tenapanor Phase III Is A Hit In IBS-C
47 Allergan, Ironwood Seek To Divide And Conquer IBS With New Linzess Formulations
48 Advantage For Synergy’s Plecanatide Over Rival Linzess Holds Up In IBS-C
49 BIBLIOGRAPHY
50 Prescription information
51 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of irritable bowel syndrome, 2016–25
17 Figure 2: Prevalent cases of irritable bowel syndrome, by age, 2016
24 Figure 3: Overview of pipeline drugs for irritable bowel syndrome in the US
25 Figure 4: Pipeline drugs for irritable bowel syndrome, by company
25 Figure 5: Pipeline drugs for irritable bowel syndrome, by drug type
25 Figure 6: Pipeline drugs for irritable bowel syndrome, by classifications
32 Figure 7: Tenapanor for IBS (October 11, 2017): Phase III – T3MPO-2 (6-Month Study)
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 irritable bowel syndrome
39 Figure 11: Probability of success in the irritable bowel syndrome pipeline
40 Figure 12: Licensing and asset acquisition deals in irritable bowel syndrome, 2013–18
42 Figure 13: Parent patents in irritable bowel syndrome
44 Figure 14: Clinical trials in irritable bowel syndrome
44 Figure 15: Top 10 drugs for clinical trials in irritable bowel syndrome
45 Figure 16: Top 10 companies for clinical trials in irritable bowel syndrome
45 Figure 17: Trial locations in irritable bowel syndrome
46 Figure 18: Irritable bowel syndrome trials status
47 Figure 19: Irritable bowel syndrome trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of irritable bowel syndrome, 2016–25
15 Table 2: Prevalent cases of irritable bowel syndrome, by gender, 2016
16 Table 3: Prevalence of irritable bowel syndrome, by gender, 2016
19 Table 4: Marketed drugs for irritable bowel syndrome
22 Table 5: Approvals by country for irritable bowel syndrome
27 Table 6: Pipeline drugs for irritable bowel syndrome in the US
31 Table 7: Tenapanor for IBS (October 11, 2017)
33 Table 8: Bekinda for IBS (October 3, 2017)
34 Table 9: Tenapanor for IBS (May 12, 2017)
43 Table 10: Historical global sales, by drug ($m), 2013–17
43 Table 11: Forecasted global sales, by drug ($m), 2018–22
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