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Analysis of the Expanding U.S. Market for Gastrointestinal Disorders Prescription Pharmaceuticals Disorders Prescription Pharmaceuticals
Bowel Disorders Market is Buoyant and Poised for Growth
NBB6-52November 2012
Contents
Section Slide Numbers
Executive Summary 14
Market Overview 20
• Definitions 21
• Overview of Inflammatory Bowel Disease 23
o Incidence and Prevalence of Inflammatory Bowel Disease 24
o Diagnosis of Inflammatory Bowel Disease 25
o Clinical Severity of Inflammatory Bowel Disease 27
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o Assessment of Disease Activity in IBD Clinical Trials 29
o Anatomic Extent of Ulcerative Colitis 31
o Clinical Guidelines 33
• Overview of Irritable Bowel Syndrome 38
o Diagnosis of IBS 39
o Assessment of Disease Activity in IBS Clinical Trials 40
o Clinical Trial Design Guidance—IBS 41
o Clinical Guidelines—IBS 43
• Personalized Medicine in Bowel Disorders 44
• Key Questions This Study Will Answer 45
• Market Overview—Segmentation 46
Contents (continued)
Section Slide Numbers
External Challenges: Drivers and Restraints 57
Forecasts and Trends 69
Demand Analysis 84
Market Share and Competitive Analysis 87
Inflammatory Bowel Disease Prescription Pharmaceuticals Segment 123
•5-ASA Subsegment Breakdown 127
•Corticosteroid Subsegment Breakdown 138
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•TNF Inhibitor Subsegment Breakdown 149
•Non-TNF Biologicals Subsegment Breakdown 160
•Novel Orals Subsegment Breakdown 169
Irritable Bowel Syndrome Prescription Pharmaceuticals Segment 177
The Last Word (Conclusions and Implications) 188
Game-changing Strategies 193
Appendix 195
Research Team
Jennifer BriceGlobal Program ManagerLife Sciences
Deborah ToscanoSenior Industry AnalystLife Sciences
Lead Analyst Contributing Analyst
Research Director Strategic Review Committee Leader
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Research Director
Daniel Ruppar Research DirectorHealthcare
Strategic Review Committee Leader
Greg Caressi Sr. Vice PresidentHealthcare
Executive Summary—CEO’s Perspective
2Convenience, efficacy, safety, and tolerability are paramount to the success of new therapies.
1Growth opportunity in the IBD market lies in introduction of improved products, whereas the IBS market is largely untapped.
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3More drug therapies must be developed for IBD patients who fail first line therapies.
4Gastrointestinal bowel disorders affect a large population across a wide demographic.
5Strategies to optimize patient adherence to therapy could greatly improve overall clinical outcomes and product success.
Source: Frost & Sullivan analysis.
Total Bowel Disorders Prescription Pharmaceuticals Market
Total Bowel Disorders Prescription Pharmaceuticals Market: Market Segmentation, U.S., 2011
Market Overview—Segmentation
IBS IBD
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CD* UC*
Source: Frost & Sullivan analysis.
Oral or Injectable Treatments Topical Treatments**
*Considered collectively in forecasts
** Not evaluated in this research
IBS-C IBS-D
CD
Inflammatory Bowel Disease Prescription Pharmaceuticals Market
Total Bowel Disorders Prescription Pharmaceuticals Market: IBD Market Segmentation, U.S., 2011
UC
Market Overview—Segmentation (continued)
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Source: Frost & Sullivan analysis.
Oral or Injectable Treatments
CorticosteroidASA
Topical Treatments*
Antimetabolite* BiologicalsAntibiotics* Corticosteroid
•Not covered in this research service
** Investigational; none yet approved for IBD
5-ASA Novel Orals**
TNFs
Non-TNF
Biologicals
Non-TNF
Biologicals
IBS-D
Irritable Bowel Syndrome Prescription Pharmaceuticals Market
Total Bowel Disorders Prescription Pharmaceuticals Market: IBS Market Segmentation, U.S., 2011
IBS-C
Market Overview—Segmentation (continued)
5-HT3 (serotonin)
IBS-M*
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Source: Frost & Sullivan analysis.
5-HT3 (serotonin)
antagonist
Guanylate cyclase type-
C receptor agonist
Chloride channel (ClC-2)
activator (laxative)
*Not covered in this research service due to lack of approved therapies
Note: Subsegmentation of the IBS market segment is not provided due to low level of commercial activity
Market Overview—Segmentation (continued)
Corticosteroids, 8.6%
IBS-C Drugs, 5.5% IBS-D Drugs, 1.1%
Total Bowel Disorders Prescription Pharmaceuticals Market: Percent Sales Breakdown by Drug Class, U.S., 2011
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5-ASA, 35.3%
TNF inhibitors, 48.7%
Non-TNF biologicals, 0.8%
Biologicals, 49.5%
Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis.
Drivers and Restraints
1–2 Years 3–4 Years 5–6 Years
Substantial patient population with unmet need
despite availability of numerous therapies
Demand for more effective and convenient
therapies is driving innovation
Commercial advantage of potential for lifelong
therapy, particularly if surgery is delayed or
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Total Bowel Disorders Prescription Pharmaceuticals Market: Key Market Drivers and Restraints, U.S., 2012–2017
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Accurate estimation of market size is difficult
Poor adherence to therapy impedes optimal uptake
High risk of failure late in the development process
Lack of solid understanding of disease pathology
therapy, particularly if surgery is delayed or
prevented
Highly symptomatic diseases for which patients
are motivated to seek treatment
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Impact: High Medium Low
Source: Frost & Sullivan analysis.
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Restr
ain
ts
Market Engineering Methodology
One of Frost & Sullivan’s core deliverables
is its Market Engineering studies. They
are based on our proprietary Market
Engineering Methodology. This approach,
developed across the 50 years of
experience assessing global markets,
applies engineering rigor to the often
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nebulous art of market forecasting and
interpretation.
A detailed description of the methodology
can be found here.
Source: Frost & Sullivan research.
