Irritable Bowel Syndrome - A potentially profitable market with limited competition
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the irritable bowel syndrome market - page 3
- Contributing experts - page 4
- CHAPTER 2 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 7
- Definition of disorder - page 8
- Irritable bowel syndrome is a functional gastrointestinal disorder - page 8
- Diagnostic criteria separate this chronic condition from transient gut symptoms - page 8
- Etiology - page 9
- Irritable bowel syndrome is best considered as an interaction of biological and psychosocial factors - page 9
- Prevalence of irritable bowel syndrome - page 11
- A standardized approach is needed in epidemiological studies - page 15
- Over 50 million adults suffer from IBS across the US and - page 15
- Segmentation of the irritable bowel syndrome population - page 16
- Segmentation by symptoms - page 16
- Irritable bowel syndrome can be sub-classified based on predominant stool form - page 16
- Alternating irritable bowel syndrome is the most common subtype reported - page 18
- Abdominal pain is the most common symptom of irritable bowel syndrome - page 21
- Segmentation by severity - page 21
- Only a third of patients have moderate to severe irritable bowel syndrome - page 21
- Segmentation by sex and age - page 22
- The female-to-male ratio of IBS in the population is close to two - page 22
- Segmentation by symptoms - page 16
- Co-morbidities of irritable bowel syndrome - page 23
- High co-morbidity with other disorders - page 23
- Definition of disorder - page 8
- CHAPTER 3 PRESENTATION AND DIAGNOSIS - page 24
- Presentation - page 25
- Patient presentation rates are low - page 25
- Abdominal pain is a common reason for consulting a physician - page 26
- Diagnosis - page 27
- There is no simple test for irritable bowel syndrome so diagnosis is based on symptoms - page 27
- The Manning criteria helped identify the symptoms suggestive of irritable bowel syndrome - page 27
- The Rome criteria have superseded the Manning criteria - page 28
- Rome III attempts to deal with confusion regarding consistency of stools - page 29
- Quality of life measures are useful for assessing severity - page 30
- Within clinical practice, measures are rarely used to assess severity - page 31
- Many irritable bowel syndrome sufferers remain undiagnosed - page 33
- There is no simple test for irritable bowel syndrome so diagnosis is based on symptoms - page 27
- Irritable bowel syndrome management and referral patterns - page 35
- The majority of patients present and are managed by primary care - page 35
- Presentation - page 25
- CHAPTER 4 CURRENT TREATMENT - page 39
- There is no cure for irritable bowel syndrome - page 40
- Treatment guidelines - page 40
- Guidelines recommend treatment strategy is based on nature and severity of symptoms - page 40
- US guidelines are based on consensus documents and reviews of existing studies - page 41
- Japanese guidelines - page 42
- European guidelines suggest a similar approach to those in the US - page 43
- Non-pharmacological management - page 45
- Psychological and behavioral treatment - page 46
- Pharmacological management - page 46
- Pharmacological therapies are not normally recommended unless non-pharmacological therapies have proved ineffective - page 46
- Laxatives are widely used in constipation-predominant irritable bowel syndrome - page 48
- Antidiarrheal agents are widely used in diarrhea-predominant irritable bowel syndrome - page 50
- Antispasmodics are the most common treatment for abdominal pain - page 51
- Antidepressants treat multiple symptoms of irritable bowel syndrome - page 52
- Serotonergic agents are a new approach to treating irritable bowel syndrome - page 52
- Lotronex (alosetron) - page 52
- Zelnorm (tegaserod) - page 57
- CHAPTER 5 UNMET NEEDS AND MARKET OPPORTUNITIES - page 62
- Diagnostic unmet needs - page 63
- Public understanding of irritable bowel syndrome is poor - page 63
- Improved patient-physician communication is a key goal - page 64
- Disease awareness programs and celebrity endorsement drive public awareness - page 65
- Direct-to-consumer advertising has helped increase awareness and presentation rates - page 67
- Physicians frequently do not recognize irritable bowel syndrome as a 'distinct' disease - page 69
- Continuing physician education is needed to improve diagnosis - page 70
- Development of simple diagnostic guidelines could aid diagnosis - page 71
- Public understanding of irritable bowel syndrome is poor - page 63
- Therapeutic unmet needs - page 73
- Few primary care physicians follow current treatment guidelines in clinical practice - page 73
- Efficacy of current pharmacological therapies is unclear - page 75
- Patient satisfaction with current therapies is low - page 76
- Diagnostic unmet needs - page 63
- CHAPTER 6 NEW PRODUCT DEVELOPMENT - page 78
- Clinical trial design - page 79
- Issues with and limitations of previous clinical trials for irritable bowel syndrome - page 79
- EMEA has provided guidance on clinical trial design - page 79
- A different trial design for short-term and long-term treatments is advocated - page 79
- A broad spectrum of irritable bowel syndrome patients who meet Rome II criteria should be included - page 80
- Primary and secondary efficacy endpoints should be included - page 81
- Impact of safety issues with marketed therapies for future therapies - page 82
- Pipeline in 2007 - page 82
- Pipeline overview - page 86
- Key Phase III pipeline drugs - page 87
- Cilansetron (KC-9946) - page 87
- Ramosetron (YM-060) - page 87
- Renzapride (ATL-1251) - page 89
- Dexloxiglumide - page 91
- Lubiprostone (SP1-0211) - page 92
- Other pipeline drugs - page 94
- Clinical trial design - page 79
- BIBLIOGRAPHY - page 101
- Journal papers - page 101
- Websites - page 109
- APPENDIX - page 115
- Contributing experts - page 115
- About Datamonitor - page 115
- About Datamonitor Healthcare - page 116
- About the Central Nervous System analysis team - page 116
- Disclaimer - page 118
- List of Tables
- Table 1: Diagnostic criteria* for irritable bowel syndrome (Rome III criteria, C1) - page 8
- Table 2: Summary of IBS epidemiology study design and results across the seven major markets, 2001-06 - page 13
- Table 3: Summary of IBS epidemiology study design and results for selected countries outside US, Japan and 5EU, 2004-06 - page 14
- Table 4: Prevalence of IBS in the US and 5EU markets, 2007 - page 16
- Table 5: Subtyping irritable bowel syndrome by predominant stool pattern - page 17
- Table 6: The Bristol Stool Form Scale - page 17
- Table 7: Proportion of sufferers with subtypes - page 19
- Table 8: Subtyping of irritable bowel syndrome: current sufferers with no formal diagnosis - page 20
- Table 9: The Manning criteria - page 28
- Table 10: Features used to subclassify irritable bowel syndrome - page 28
- Table 11: Type of healthcare professional seen for irritable bowel syndrome at any stage: percentage of subjects with current symptoms - page 36
- Table 12: Components of the treatment strategy: US medical position statement for irritable bowel syndrome - page 41
- Table 13: British Society of Gastroenterology guidelines for treatment of irritable bowel syndrome - page 43
- Table 14: Pharmacological therapies used for the management of irritable bowel syndrome - page 48
- Table 15: R&D pipeline in irritable bowel syndrome, 2007 - page 83
- List of Figures
- Figure 1: Interaction between the brain, bowel and environment - page 10
- Figure 2: Two-dimensional display of the four possible irritable bowel subtypes according to bowel form at a particular point in time - page 18
- Figure 3: Novartis patient information website on irritable bowel syndrome - page 66
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