Introduction
Irritable bowel syndrome (IBS) is a common disease affecting 1020% of the total adult population, particularly women, in which recurrent abdominal pain or discomfort is associated with defecation or changes in bowel habit. The majority of sufferers have never consulted a physician about their symptoms and remain undiagnosed.
Scope
Epidemiology and patient segmentation in irritable bowel syndrome (IBS), including a breakdown of the patient population by gender and symptom type
Discussion of issues with regards to IBS patient presentation, referral patterns and diagnosis such as the new Rome III diagnostic criteria
Overview of the current treatment controversies and unmet needs, including the market withdrawal of Novartis’ Zelnorm (tegaserod)
Analysis of clinical trial design in the R&D drug pipeline for new IBS drug therapies in 2007
Highlights
Despite the substantial impact IBS can have on sufferers’ well being, about 7080% of sufferers have not been formerly diagnosed. Although many patients will have seen a doctor or nurse for their symptoms, they remain undiagnosed and may have visited a healthcare professional on several occasions before being formally diagnosed with IBS.
Physicians frequently do not recognize IBS as a ’distinct’ disease. Continuing physician education is needed to change this attitude and improve diagnosis, particularly in the primary care setting. A simple and easily accessible diagnostic tool adapted specifically for non-specialists and clear peer reviewed treatment guidelines are needed.
The pipeline can be described as relatively innovative. The serotinergic class accounts for a third of candidates, however, the poor safety record and market withdrawal of Lotronex (alosetron) and Zelnorm has cast doubts over the potential of this class. FDA non-approval of cilansetron is another setback for the serotinergics.
Reasons to Purchase
Quantify the key target segments of the IBS patient population across the seven major markets
Gain insight into opinion leaders’ thoughts on the major opportunities and challenges facing the IBS market
Learn about key late-stage pipeline drugs and issues surrounding diagnosis and clinical trial design
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the irritable bowel syndrome market 3
Contributing experts 4
CHAPTER 2 EPIDEMIOLOGY AND PATIENT SEGMENTATION 11
Definition of disorder 12
Irritable bowel syndrome is a functional gastrointestinal disorder 12
Diagnostic criteria separate this chronic condition from transient gut symptoms 12
Etiology 13
Irritable bowel syndrome is best considered as an interaction of biological and psychosocial factors 13
Prevalence of irritable bowel syndrome 15
A standardized approach is needed in epidemiological studies 19
Over 50 million adults suffer from IBS across the US and 19
Segmentation of the irritable bowel syndrome population 20
Segmentation by symptoms 20
Irritable bowel syndrome can be sub-classified based on predominant stool form 20
Alternating irritable bowel syndrome is the most common subtype reported 22
Abdominal pain is the most common symptom of irritable bowel syndrome 25
Segmentation by severity 25
Only a third of patients have moderate to severe irritable bowel syndrome 25
Segmentation by sex and age 26
The female-to-male ratio of IBS in the population is close to two 26
Co-morbidities of irritable bowel syndrome 27
High co-morbidity with other disorders 27
CHAPTER 3 PRESENTATION AND DIAGNOSIS 28
Presentation 29
Patient presentation rates are low 29
Abdominal pain is a common reason for consulting a physician 30
Diagnosis 31
There is no simple test for irritable bowel syndrome so diagnosis is based on symptoms 31
The Manning criteria helped identify the symptoms suggestive of irritable bowel syndrome 31
The Rome criteria have superseded the Manning criteria 32
Rome III attempts to deal with confusion regarding consistency of stools 33
Quality of life measures are useful for assessing severity 34
Within clinical practice, measures are rarely used to assess severity 35
Many irritable bowel syndrome sufferers remain undiagnosed 37
Irritable bowel syndrome management and referral patterns 39
The majority of patients present and are managed by primary care 39
CHAPTER 4 CURRENT TREATMENT 43
There is no cure for irritable bowel syndrome 44
Treatment guidelines 44
Guidelines recommend treatment strategy is based on nature and severity of symptoms 44
US guidelines are based on consensus documents and reviews of existing studies 45
Japanese guidelines 46
European guidelines suggest a similar approach to those in the US 47
Non-pharmacological management 49
Psychological and behavioral treatment 50
Pharmacological management 50
Pharmacological therapies are not normally recommended unless non-pharmacological therapies have proved ineffective 50
Laxatives are widely used in constipation-predominant irritable bowel syndrome 52
Antidiarrheal agents are widely used in diarrhea-predominant irritable bowel syndrome 54
Antispasmodics are the most common treatment for abdominal pain 55
Antidepressants treat multiple symptoms of irritable bowel syndrome 56
Serotonergic agents are a new approach to treating irritable bowel syndrome 56
Lotronex (alosetron) 56
Zelnorm (tegaserod) 61
CHAPTER 5 UNMET NEEDS AND MARKET OPPORTUNITIES 66
Diagnostic unmet needs 67
Public understanding of irritable bowel syndrome is poor 67
Improved patient-physician communication is a key goal 68
Disease awareness programs and celebrity endorsement drive public awareness 69
Direct-to-consumer advertising has helped increase awareness and presentation rates 72
Physicians frequently do not recognize irritable bowel syndrome as a ’distinct’ disease 74
Continuing physician education is needed to improve diagnosis 75
Development of simple diagnostic guidelines could aid diagnosis 76
Therapeutic unmet needs 78
Few primary care physicians follow current treatment guidelines in clinical practice 78
Efficacy of current pharmacological therapies is unclear 80
Patient satisfaction with current therapies is low 81
CHAPTER 6 NEW PRODUCT DEVELOPMENT 83
Clinical trial design 84
Issues with and limitations of previous clinical trials for irritable bowel syndrome 84
EMEA has provided guidance on clinical trial design 84
A different trial design for short-term and long-term treatments is advocated 84
A broad spectrum of irritable bowel syndrome patients who meet Rome II criteria should be included 85
Primary and secondary efficacy endpoints should be included 86
Impact of safety issues with marketed therapies for future therapies 87
Pipeline in 2007 87
Pipeline overview 91
Key Phase III pipeline drugs 92
Cilansetron (KC-9946) 92
Ramosetron (YM-060) 92
Renzapride (ATL-1251) 94
Dexloxiglumide 96
Lubiprostone (SP1-0211) 97
Other pipeline drugs 99
BIBLIOGRAPHY 106
Journal papers 106
Websites 114
APPENDIX 120
Contributing experts 120
About Datamonitor 120
About Datamonitor Healthcare 121
About the Central Nervous System analysis team 121
Disclaimer 123
Other selected research from the 'Stakeholder Opinions' category:
Stakeholder Opinions: Primary Brain Cancer - Temozolomide Turns Heads
Stakeholder Opinions: Non-Hodgkins Lymphoma - Immunotherapy Stimulates the Market
Other selected research from the 'Autoimmune & Inflammation' category:
Stakeholder Insight: Atherosclerosis - HDL, ApoA-I, Carotid MRI and 64-slice CT offer opportunities for future treatment
Commercial Insight: Top 20 Cancer Therapeutics - New treatment paradigms transforming market outlook