SPI Infoamtion

Table of Contents

Executive summary

Patient potential
Gastrointestinal market dynamics
Key investigational compounds
Leading players of the gastrointestinal market

Scope and methodology

Scope
Methodology

Scope of IMS data

Chapter 1 Patient potential

Summary
Introduction
Gastroesophageal reflux disease (GERD)

Overview
Diagnosis, treatment and management
Epidemiology
Forecast epidemiology

Peptic ulcer disease (PUD)

Overview
Diagnosis, treatment and management
Epidemiology
Forecast epidemiology

Irritable bowel syndrome (IBS)

Overview
Diagnosis, treatment and management
Epidemiology
Forecast epidemiology

Ulcerative colitis (UC)

Overview
Diagnosis, treatment and management
Epidemiology
Forecast epidemiology

Crohn's disease (CD)

Overview
Diagnosis, treatment and management
Epidemiology
Forecast epidemiology

Chapter 2 Gastrointestinal market dynamics

Summary
Introduction
Market analysis by country
Licensing trends
Key recent events

AstraZeneca's GI programs part of a new biotech venture
Kosan Biosciences licenses a preclinical program to Pfizer
Xifaxan to be filed for IBS
Dextofisopam fails in Phase IIb
PPI interaction with clopidogrel could adversely affect its sales

Market analysis by drug class

The GERD treatment cascade
Proton pump inhibitors

Nexium (esomeprazole): AstraZeneca
Takepron (lansoprazole): Takeda

H2RAs

Gaster/Pepcid (famotidine): Astellas

Intestinal anti-inflammatories
Serotonin antagonists
Antispasmodics/anticholinergics
Inflammatory bowel disease: Crohn's disease, ulcerative colitis

Drug classes used for IBD
Leading brands used in the treatment of IBD

Others

Laxatives: A snapshot of chronic constipation

Therapy area sales forecast
Leading brands
Leading brands forecast

Chapter 3 Key investigational compounds

Summary
Introduction
Recent R&D updates

Renzapride discontinued
Adolor to pursue OBD drug development in spite of the Entereg setback
Calmactin not to be pursued further for FDA approval
Injectable products to drive growth in the Crohn's and UC market
Rezonic receives complete response letter

Gastrointestinal market R&D
A snapshot of key pipeline compounds

Entereg (alvimopan): Adolor/GSK

Overview
Mechanism of action
Clinical
Marketing and regulatory

Relistor (methylnaltrexone): Wyeth/Progenics

Overview
Mechanism of action
Clinical
Marketing and regulatory

Kapidex /TAK-390MR (dexlansoprazole): Takeda

Overview
Mechanism of action
Clinical
Regulatory
Issues/competitive landscape

Linaclotide: Forest/Ironwood/ Almirall

Overview
Mechanism of action
Clinical
Regulatory
Issues/competitive landscape

Cimzia (certolizumab): UCB Pharma

Overview
Clinical
Regulatory
Issues/competitive landscape

Key investigational compounds sales forecast

Chapter 4 Leading players of the gastrointestinal market

Summary
Introduction
AstraZeneca

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Takeda

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Eisai

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Nycomed

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Wyeth

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Johnson & Johnson

Overview
Drug class focus
Marketed products portfolio
R&D pipeline analysis
Strategic growth analysis

Drivers of growth
Resistors of growth

Growing generic incursion in the GI market
Leading players' outlook through to 2014

Chapter 5 Appendix

IMS data
Glossary
Index

List of Figures
Figure 2.1: Global GI market sizes, 2008
Figure 2.2: GI market breakdown by licensing status, 2007-08
Figure 2.3: Drug classes CAGR comparison, 2004-08
Figure 2.4: Mechanism of action of mesalazine
Figure 4.5: Competitive dynamics of the top 10 GI market players, 2004-08
Figure 4.6: Drug class focus of AstraZeneca ($m), 2008
Figure 4.7: Drug class focus of Takeda ($m), 2008
Figure 4.8: Drug class focus of Eisai ($m), 2008
Figure 4.9: Drug class focus of Nycomed ($m), 2008
Figure 4.10: Drug class focus of Wyeth ($m), 2008
Figure 4.11: Decline trajectory of Protonix (%), 2004-08
Figure 4.12: Drug class focus of J&J ($m), 2008

List of Tables
Table 1.1: Prevalence of major GIT indications across the seven major markets, 2008
Table 1.2: Estimated prevalence of GERD across seven major markets, 2008
Table 1.3: Forecast prevalence of GERD across seven major markets,
Table 1.4: Estimated prevalence of PUD across seven major markets, 2008
Table 1.5: Forecast prevalence of PUD across seven major markets,
Table 1.6: Estimated prevalence of IBS across seven major markets, 2008
Table 1.7: Forecast prevalence of IBS across seven major markets,
Table 1.8: Estimated prevalence of UC across seven major markets, 2008
Table 1.9: Forecast prevalence of UC across seven major markets,
Table 1.10: Estimated prevalence of CD across seven major markets, 2008
Table 1.11: Forecast prevalence of CD across seven major markets,
Table 2.12: Distribution of the global GI market by drug class, 2007-08
Table 2.13: Key brands of the PPI drug class, 2008
Table 2.14: Key brands of the H2RA drug class, 2008
Table 2.15: Key brands of the intestinal anti-inflammatories drug class, 2008
Table 2.16: Key brands of the serotonin antagonists drug class, 2008
Table 2.17: Key brands of the antispasmodics/anticholinergics drug class, 2008
Table 2.18: Leading brands used in IBD in the seven major markets, 2008
Table 2.19: Key laxative brands, 2008
Table 2.20: GI market sales forecast by drug classes ($m),
Table 2.21: Leading brands of the GI market, 2008
Table 2.22: Top 10 brands of the GI market, sales forecast 2008-14
Table 3.23: Key investigational compounds in the GI market, 2009
Table 3.24: An overview of Entereg
Table 3.25: An overview of Relistor
Table 3.26: An overview of TAK-390MR
Table 3.27: An overview of linaclotide
Table 3.28: An overview of Cimzia
Table 3.29: Key GI investigational compounds sales forecast, 2008-14
Table 4.30: Leading players of the GI disorders market, 2008
Table 4.31: Leading brands of AstraZeneca, 2008
Table 4.32: Key pipeline compounds of AstraZeneca
Table 4.33: Leading brands of Takeda, 2008
Table 4.34: Key pipeline compounds of Takeda
Table 4.35: Leading brands of Eisai, 2008
Table 4.36: Leading brands of Nycomed, 2008
Table 4.37: Leading brands of Wyeth, 2008
Table 4.38: Key pipeline compounds of Wyeth
Table 4.39: Leading brands of J&J, 2008
Table 4.40: Key pipeline compounds of J&J
Table 4.41: Leading players in the GI market, sales forecast 2008-14