The World Gastrointestinal Disorders Market 2006-2011

1. Executive Summary - Gastrointestinal Treatments Constitute a Large Market

2. Introduction to Gastrointestinal Disorders
2.1 Gastrointestinal Disorders Constitute a Large Market for Pharmacological Treatments
2.1.1 Gastrointestinal Disorders have a Significant Economic Impact on Society
2.1.2 The Market for Gastrointestinal Drugs Generates Large Revenues and is well Represented in the Top 100 Best Selling Prescription Drugs
2.2 Gastroesophageal Reflux Disease
2.2.1 What is Gastroesophageal Reflux Disease (GERD)?
2.2.2 Aetiology of GERD
2.2.3 Symptoms of the Condition
2.2.4 Diagnosis of GERD
2.2.5 Prevalence of GERD
2.2.6 Economic Impact of GERD
2.2.7 Treatment of GERD
2.3 Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
2.3.1 What is Crohn's Disease?
2.3.2 Aetiology of Crohn's Disease
2.3.3 Symptoms of Crohn's Disease
2.3.4 Diagnosis of the Condition
2.3.5 What is Ulcerative Colitis?
2.3.6 Aetiology of Ulcerative Colitis
2.3.7 Symptoms of Ulcerative Colitis
2.3.8 Diagnosis of Ulcerative Colitis
2.3.9 Worldwide Prevalence of Inflammatory Bowel Disease - Crohn's Disease is Becoming Increasingly Prevalent Throughout the World
2.3.10 Economic Burden of Inflammatory Bowel Disease
2.3.11 Treatment of Inflammatory Bowel Disease
2.4 Irritable Bowel Syndrome
2.4.1 Overview of Irritable Bowel Syndrome
2.4.2 Aetiology of Irritable Bowel Syndrome
2.4.3 Symptoms of Irritable Bowel Syndrome
2.4.4 Diagnosis of Irritable Bowel Syndrome
2.4.5 Prevalence of Irritable Bowel Syndrome
2.4.6 The Cost of Irritable Bowel Syndrome
2.4.7 Treatment of Irritable Bowel Syndrome
2.5 Peptic Ulcer Disease
2.5.1 What is Peptic Ulcer Disease?
2.5.2 Aetiology of Peptic Ulcer Disease
2.5.3 Symptoms of the Condition
2.5.4 Diagnosis of Gastric Ulcers
2.5.5 Helicobacter Pylori: often the Putative Causative Agent of Ulcers
2.5.6 Zollinger-Ellison Syndrome - A Rare Disorder that can be Treated by Acid-Suppressing Drugs
2.5.7 Demographic Prevalence of Peptic Ulcers
2.5.8 Economic Impact of Peptic Ulcers
2.6 An Overview of the Gastrointestinal Drug Market
2.7 Histamine H2 Receptor Antagonists for the Treatment of Gastrointestinal Disorders
2.7.1 Histamine H2 Receptor Antagonists: an Older Drug Class that Retains a Market Presence Among the Leading Gastrointestinal Drugs
2.7.2 Modes of Action for Histamine H2 Receptor Antagonists Inhibitors
2.8 Proton Pump Inhibitors for the Treatment of Gastrointestinal Disorders
2.8.1 Proton Pump Inhibitors are a Newer Class of Medication - Currently these Agents Lead the Gastrointestinal Market
2.8.2 The Proton Pump Inhibitors - their Modes of Action
2.9 Other Drugs for Treating Gastrointestinal Disorders
2.9.1 OTC Antacids
2.9.2 Bismuth Subsalicylate
2.9.3 Sucralfate
2.9.4 Prokinetic Agents
2.9.5 Aminosalicylic Acid (5-ASA) Compounds
2.9.6 Mesalamine
2.9.7 Sulfasalazine
2.9.8 Corticosteroids
2.9.9 Remicade (infliximab)
2.9.10 Antibiotics


3. The World Gastrointestinal Market 2004-2011
3.1 Shifting Internal Dynamics Cause a Marked Overall Decline of Revenues in the Prescription Gastrointestinal Market Between 2004-2011
3.2 AstraZeneca to Remain the Leading Company in the 2011 Prescription Gastrointestinal Market
3.2.1 Collaborations in the GI Market
3.3 Proton Pump Inhibitors to Continue their Domination of the Gastrointestinal Market, 2005-2011
3.4 There will Remain Potential for Blockbuster Revenues in the Gastrointestinal Market During 2005-2011
3.5 OTC Switching Creates Good Opportunities for Life Cycle Management - But at what Cost to Prescription Drug Revenues?
3.6 The GI Market is Likely to Remain Strong in Terms of Prescription Numbers and Unit Sales - But Generics will Continue to be a Threat

4. The World Market for Proton Pump Inhibitors, 2005-2011
4.1 The Proton Pump Inhibitors - A Market Under Increasing Threat from Patent Expiry and OTC Switching
4.2 Loss of Patent Protection will have a Significant Effect on Revenue Generation in the PPI Market
4.2.1 OTC Prilosec and Generics will Continue to Play a Decisive Role in the Dynamics of the GI Market
4.3 Market Shares of the Leading GI Drugs - 2005 and 2011 Compared
4.4 Nexium will Face Declining Revenues and Loss of Predominance in the World Gastrointestinal Market
4.4.1 Sales of Nexium Increased Strongly in the First Three Quarters of 2005
4.4.2 Brand Management is Succeeding for AstraZeneca – Will Competitors be able to Emulate this Winning Strategy?
4.4.3 AstraZeneca Commences Litigation Against Ranbaxy Laboratories Regarding Alleged Patent Infringement on Nexium
4.4.4 Recently AstraZeneca Lost an Important Contract to Supply Nexium - Will Nexium Face Other Setbacks like this?
4.4.5 Nexium Receives FDA Approval for Risk Reduction of NSAID-Related Ulcers
4.4.6 Nexium I.V. Approved as a Short-Term Treatment for GERD
4.4.7 The Promotion and Marketing of Nexium Beset by Legal Challenges
4.5 Prevacid - Another Major PPI that Faces Declining Revenues
4.5.1 TAP Pharmaceutical Inc, a Joint Venture Shared Between Abbott and Takeda: Prevacid is its Leading Product
4.5.2 Abbott Admits Increased Competition for Prevacid and Contraction of the PPI Market
4.5.3 TAP Reconsiders Expenditure on DTC Advertising for Prevacid
4.5.4 FDA Extends Approval for Prevacid Delayed Release Orally Disintegrating Tablets
4.5.5 Prevacid Receives Extended Paediatric Approval from FDA
4.5.6 FDA Approves Prevacid I.V. for Erosive Esophagitis in Hospitalised Patients
4.6 Prilosec/Losec - AstraZeneca Uses Product Lifecycle Management Decisively
4.6.1 Prilosec/Losec Revenues Declined Sharply During Q1-Q3 of 2005 - But there was Marked Growth in China and Japan
4.6.2 Generic Substitutes will Increasingly Threaten the Vulnerable Prilosec/Losec Brand
4.6.3 AstraZeneca Facing EU Patent Abuse Charges Concerning Losec
4.7 Protonix is another Leading PPI Facing Patent Expiry later this Decade
4.7.1 Protonix is a Strong Performer with Increasing Revenues from 2002-2005
4.7.2 Protonix Benefited from Early FDA Approval for Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
4.8 Pantozol will Experience Patent Expiry, Leading to a Sharp Decline in Revenue
4.8.1 Wyeth Acts as a Partner for Sales of Pantoprazole in the US
4.8.2 Patent Protection for Pantoprazole Extended to 2010 in the US; Similar Protection in Europe - Altana Optimistic Over Continuing Revenue Growth
4.8.3 Pantozol Continues to Perform Well in 2005
4.8.4 Sales in Germany Declined Slightly Due to Mandatory Discount - Altana Challenges State's Decision
4.9 Takepron will Supplant Nexium to Become the Leading PPI
4.9.1 Takeda Developed Lansoprazole
4.9.2 Revenues for Takepron During Part of 2005 Revealed Disappointing Growth Rate
4.10 Aciphex/Pariet will Continue to Grow Moderately in Revenue
4.10.1 Eisai's Long-Running Commercial Arrangement with Johnson & Johnson for Aciphex/Pariet
4.10.2 Eisai Commences US Legal Actions Over ANDA Filings for Generic Versions of Aciphex/Pariet
4.10.3 Eisai Receives European Marketing Authorization for PARIET for Zollinger-Ellison Syndrome
4.10.4 Eisai Applies For A New Indication for Pariet in Japan for Eradicating H. Pylori
4.10.5 New Production Facilities for Aciphex/Pariet Incorporate Latest Technology to Achieve Cost Savings
4.11 Zoton's Loss of Patent Protection will Cause this Product Difficulties in the Market
4.11.1 Zoton Displayed Increasing Revenues Until 2004 but Faced a Downturn in 2005
4.11.2 Zoton Released in OTC Form - How well will it Compete with Prilosec OTC and Other Preparations?
4.12 Prevacid/Ogastro
4.13 The Market for Proton Pump Inhibitors: Summary and Conclusions


5. The World Market for Histamine H2 Receptor Antagonists and Other Leading Gastrointestinal Drugs, 2004-2011
5.1 Histamine H2 Antagonists - This Older Class will Suffer Declining Revenues from 2005-2011
5.1.1 The H2 Antagonists are Now a Mature Drug Class Characterised by the Loss of Patent Protection and Availability of Generic Substitutes
5.1.2. Both Gaster and Zantac are Available in OTC Formulations
5.2 Gaster - This Older Drug Faces Continuing Decline
5.2.1 Prescription Gaster will Continue to Lose Sales to OTC Formulation (Gaster 10)
5.2.2 Prescription Sales of Gaster in 2005 Show a Decline - Further Decline Predicted
5.3 Zantac - Loss of Patent Protection Accelerates the Decline of this Brand
5.3.1 Zantac is Marketed in Japan by Sankyo Under Licence from GlaxoSmithKline
5.3.2 Sales of Zantac are Declining in All Regions
5.3.3 Zantac EFFER dose Formulation for GERD In Children May Help to Slow Decline
5.4 Other Leading GI Agents will Exhibit Growth in Revenue
5.5 Zelnorm/Zelmac - Will Continue to Perform Strongly
5.5.1 Revenues of Zelnorm/Zelmac will Continue to Increase in 2005
5.5.2 Zelnorm/Zelmac is Currently Being Developed for Other Important GI Indications
5.6 Gasmotin - Steady Growth Leads to Maturity
5.6.1 Dainippon Pharmaceutical is Striving To Maintain Growth of Key Product Gasmotin
5.6.2 Gasmotin Currently Being Developed Further - New Indication Sought
5.7 Nauzelin Will Experience Falling Revenues
5.8 Canasa/Salofalk will Produce Steady Growth for Axcan Pharma
5.8.1 Axcan Pharma is a Specialist Pharmaceutical Company Focused on Gastroenterology
5.9 The Market for H2 Antagonists and Other Leading GI Agents: Summary and Conclusions

6. An Analysis of Factors that Influence the Prescription Gastrointestinal Market
6.1 SWOT Analysis of the Prescription Gastrointestinal Market
6.2 Shifting Dynamics in the Prescription Gastrointestinal Market Create Opportunities, Especially in Product Lifecycle Management and Generics
6.3 GERD Symptoms are Very Common - There are Opportunities for Expanding the Treatment Population
6.4 An Aging Population will Drive the GI Market, Especially in Self Medication
6.5 OTC Switching - Prilosec OTC has Been Influential in the GI Market - This Trend is Set to Continue
6.6 Risk Reduction of NSAID-Associated Stomach Ulcers Constitutes an Opportunity for Proton Pump Inhibitors
6.7 What Unmet Needs Exist in the Gastrointestinal Market? What Potential Solutions Exist?
6.7.1 How Effective are PPIs and H2 Antagonists?
6.7.2 Combination Therapy May Alleviate Acid Breakthrough Problems - Is there Untapped Commercial Potential in this Area?
6.7.3 Agents that May Improve Treatment of IBS, Crohn's Disease and Ulcerative Colitis
6.8 Major Loss of Patent Protection will Constitute the Principal Restraint in the Prescription Gastrointestinal Market
6.9 To What Extent is the Gastrointestinal Market Threatened by Generic Substitutes?
6.9.1 Loss of Patent Protection will Lead to Increasing Generic Competition for Leading Drugs in the GI Market
6.9.2 The Approval of Generic Omeprazole was a Major Coup for Schwarz Pharma - A Case Study in Generic Erosion of Branded Sales
6.9.3 AstraZeneca Recently Lost US Defense Contract for Nexium - A Warning of the Generic Threat to Branded Gastrointestinal Drugs
6.10 Prices of Leading GI Drugs Compared - High Prices of Branded PPIs Encourage Use of Generics and OTC Formulations
6.11 A Backlash Against DTC Advertising of Drugs Affects the Prominent GI Prescription Market - Companies are Reformulating Advertising Strategies
6.11.1 AstraZeneca Recently Encountered Controversy Over its Marketing of Nexium

7. A Geographical Breakdown of the World Gastrointestinal Market
7.1 Patient Populations and Revenues in the Principal Markets for Gastrointestinal Drugs - The US will Lead a High Revenue Global Market in 2011
7.2 The Leading GI Drugs Generate High Revenues and Prescription Numbers in the Large US Market
7.3 The Prevalence of Gastrointestinal Disorders Worldwide - A Serious Global Health Problem with Many Sufferers Currently Untreated or Under-treated
7.4 Conclusions: There is Scope to Expand the Treatment of Gastrointestinal Disorders on a Global Scale

8. Pipeline Drugs for Gastrointestinal Disorders
8.1 The GI Market will Become Increasingly Competitive for New Drugs - Optimising Distribution Channels and Commercial Alliances will Become Increasingly Important
8.2 AstraZeneca has Novel Agents for GERD in Pre-Clinical Development
8.3 Agents in Phase I of Clinical Development
8.4 Agents in Phase II of Clinical Development
8.4.1 The Potassium-Competitive Acid Blockers - Are these the Way Forward?
8.4.2 Acid-Pump Antagonists - Can Reversible Inhibition of Proton Pumps Yield Advantages Such as Faster Onset of Acid Suppression?
8.5 Agents in Phase III of Clinical Development
8.5.1 Axcan's Itax to Treat Functional Dyspepsia - Can this Dual Action Drug be the First To Market for the Treatment of a Common Disorder?
8.6 Agents that have Completed Phase III of Clinical Development
8.7 Agents for which Final Regulatory Approval is Pending
8.8 An Overall Assessment of Pipeline Developments in the Gastrointestinal Market


9. Conclusions: Gastrointestinal Disorders Constitute a Large Drugs Market that is Facing Decisive Commercial Pressures
9.1 Shifting Internal Dynamics will Cause a Marked Decline of Revenues in the Overall Prescription Gastrointestinal Market
9.2 The Pipeline for Gastrointestinal Drugs is Strong
9.3 Continuing Public and Private Sector Investment is Required

List of Tables
Table 1.1, Leading Drugs for Treating Gastrointestinal Disorders, 2005
Table 2.1 Direct and Indirect Costs ($m) of Selected Gastrointestinal Diseases, 2000
Table 2.2, Indications for Leading Gastrointestinal Drugs
Table 2.3, Leading Histamine H2 Receptor Antagonists to Treat Gastrointestinal Disorders, 2004
Table 2.4, Leading Proton-Pump Inhibitors to Treat Gastrointestinal Disorders, 2004
Table 2.5, Other Leading Agents for Treating Gastrointestinal Disorders, 2004
Table 2.6, Summary of Principal Agents for Treating Gastrointestinal Disorders, 2004
Table 3.1, World Revenues ($m) for the Leading Gastrointestinal Drugs, by Class, 2004-2011
Table 3.2, World Market Revenue ($m) and Market Share (%) for Leading Gastrointestinal Drugs by Class, 2011
Table 3.3, Blockbuster Drugs in the World Gastrointestinal Market, 2011
Table 4.1, World Revenues for Proton Pump Inhibitors, 2004-2011
Table 4.2, Patent Expiry for Proton Pump Inhibitors, 2005
Table 4.3, World Market Shares (%) for Proton Pump Inhibitors, 2005 and 2011
Table 5.1, World Revenues for Histamine H2 Receptor Antagonists, 2004-2011
Table 5.2, Patent Expiry for Histamine H2 Receptor Antagonists, 2005
Table 5.3, World Revenues for Other Gastrointestinal Agents, 2004-2011
Table 5.4, Patent Expiry for Other Gastrointestinal Agents, 2005
Table 5.5, World Market Shares (%) for H2 Antagonists, 2005 and 2011
Table 5.6, World Market Shares (%) for Other Gastrointestinal Agents, 2005 and 2011
Table 6.1, Some Leading OTC Drugs for Heartburn Associated With Acid Reflux In Adults
Table 6.2, Leading GI Brands Due to Lose Patent Protection During the Forecast Period 2005-2011
Table 6.3, Generic Substitutes for Leading GI Prescription Drugs, 2005
Table 7.1, Potential Treatment Populations for PPIs and H2 Antagonists (Combined) by Country, 2011
Table 7.2, Forecast Revenues ($m) For PPIs and H2 Antagonists (Combined) by Country, 2011
Table 8.1, GI Agents in Phase I of Clinical Development
Table 8.2, GI Agents in Phase II of Clinical Development
Table 8.3, GI Agents in Phase III of Clinical Development
Table 8.4, GI Agents That Have Completed Phase III of Clinical Development
Table 8.5, GI Agents For Which Final Regulatory Approval Is Pending
Table 9.1, World Market Revenue ($m) and Market Share (%) for Leading Gastrointestinal Drugs by Class, 2011


List of Figures
Figure 3.1, World Revenues ($m) for the Total Gastrointestinal Drugs Combined, 2004-2011
Figure 3.2, World Revenues ($m) for the Classes of Gastrointestinal Drugs, 2004-2011
Figure 3.3, World Market Share (%) for Gastrointestinal Drugs by Class, 2005
Figure 3.4, World Market Share (%) for Gastrointestinal Drugs by Class, 2011
Figure 3.5, Market Share (%) for Gastrointestinal Drugs by Company, 2005
Figure 3.6, Market Share (%) for Gastrointestinal Drugs by Company, 2011
Figure 3.7, Changes ($m) in World Revenue for the Classes of Gastrointestinal Drugs, 2005-2011
Figure 3.8, Changes (%) in World Revenues for the Classes of Gastrointestinal Drug, 2005-2011
Figure 4.1, World Revenue ($m) for All The Proton Pump Inhibitors, 2004-2011
Figure 4.2, World Revenues ($m) for The Proton Pump Inhibitors By Drug, 2004-2011
Figure 4.3, World Market Share (%) for The Proton Pump Inhibitors, 2005
Figure 4.4, World Market Share (%) for The Proton Pump Inhibitors, 2011
Figure 4.5, Revenues ($m) for The Proton Pump Inhibitors, 2005 and 2011 Compared
Figure 4.6, World Nexium Revenues ($m), 2004-2011
Figure 4.7, World Prevacid (TAP) Revenues ($m), 2004-2011
Figure 4.8, World Prilosec/Losec Revenues ($m), 2004-2011
Figure 4.9, World Protonix Revenues ($m), 2004-2011
Figure 4.10, World Pantozol Revenues ($m), 2004-2011
Figure 4.11, World Takepron Revenues ($m), 2004-2011
Figure 4.12, World Aciphex/Pariet Revenues ($m), 2004-2011
Figure 4.13, World Zoton Revenues ($m), 2004-2011
Figure 4.14, World Prevacid/Ogastro (Abbott) Revenues ($m), 2004-2011
Figure 5.1, World Revenue ($m) for Histamine H2 Receptor Antagonists, 2004-2011
Figure 5.2, World Revenues ($m) for Histamine H2 Receptor Antagonists By Drug, 2004-2011
Figure 5.3, World Market Share (%) for Histamine H2 Receptor Antagonists, 2005
Figure 5.4, World Market Share (%) for Histamine H2 Receptor Antagonists, 2011
Figure 5.5, Revenues ($m) for Histamine H2 Receptor Antagonists, 2005 and 2011 Compared
Figure 5.6, World Gaster Revenues ($m), 2004-2011
Figure 5.7, World Zantac Revenues ($m), 2004-2011
Figure 5.8, World Revenue ($m) for Other Gastrointestinal Agents, 2004-2011
Figure 5.9, World Revenues ($m) for Other Gastrointestinal Agents by Drug, 2004-2011
Figure 5.10, World Market Share (%) for Other Gastrointestinal Agents, 2005
Figure 5.11, World Market Share (%) for Other Gastrointestinal Agents, 2011
Figure 5.12, Revenues ($m) for Other Gastrointestinal Agents, 2005 and 2011Compared
Figure 5.13, World Zelnorm/Zelmac Revenues ($m), 2004-2011
Figure 5.14, World Gasmotin Revenues ($m), 2004-2011
Figure 5.15, World Nauzelin Revenues ($m), 2004-2011
Figure 5.16, World Canasa/Salofalk Revenues ($m), 2004-2011
Figure 6.1, A SWOT Chart for the Prescription Gastrointestinal Market, 2005-2011
Figure 6.2, Generic Revenues ($m) for Selected GI Agents in the US, 2004
Figure 6.3, Revenues ($m) of AstraZeneca's Prilosec and KUDCo's Generic Omeprazole, 2002-2004
Figure 6.4,