Gastrointestinal Disorders Market Intelligence to 2012

Table of Contents

Executive Summary: Gastrointestinal Treatments Constitute A Considerable Increase in the Market

Chapter 2: Introduction to Gastrointestinal Disorders

• 2.1 Gl Conditions are Widespread
  • 2.1.1 Gl Disorders have a Considerable Impact on Society
  • 2.1.2 GI Drugs 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 Causes of GERD
  • 2.2.3 Symptoms of the Condition
  • 2.2.4 Identifying The GERD
  • 2.2.5 Incidence of GERD
  • 2.2.6 Economic Impact of GERD
• 2.3 Inflammatory Bowel Disease (Crohn' s Disease and Ulcerative Colitis)
  • 2.3.1 What is Crohn' s Disease?
  • 2.3.2 Causes of Crohn' s Disease
  • 2.3.3 Symptoms of Crohn' s Disease
  • 2.3.4 Identifying the Condition
  • 2.3.5 What is Ulcerative Colitis?
  • 2.3.6 Causes of Ulcerative Colitis
  • 2.3.7 Symptoms of Ulcerative Colitis
  • 2.3.8 Identifying Ulcerative Colitis
  • 2.3.9 Worldwide Occurrence of IBD - Crohn' s Disease Is Increasing Throughout the World
  • 2.3.10 Economic Burden of IBD
• 2.4 Irritable Bowel Syndrome
  • 2.4.1 Synopsis of Irritable Bowel Syndrome
  • 2.4.2 Causes of Irritable Bowel Syndrome
  • 2.4.3 Symptoms of Irritable Bowel Syndrome
  • 2.4.4 Identifying Irritable Bowel Syndrome
  • 2.4.5 Prevalence of Irritable Bowel Syndrome
  • 2.4.6 The Cost of Irritable Bowel Syndrome
• 2.5 Peptic Ulcer Disease
  • 2.5.1 What is Peptic Ulcer Disease?
  • 2.5.2 Causes of Peptic Ulcer Disease
  • 2.5.3 Symptoms of the Condition
  • 2.5.4 Diagnosis of Gastric Ulcers
  • 2.5.5 Helicobacter Pylori is often the Presumed Causative Agent of Ulcers
  • 2.5.6 Demographic Prevalence of Peptic Ulcers
  • 2.5.7 Economic Impact of the Condition
• 2.6 A Summary of the Gl Drug Market
• 2.7 Histamine H2 Receptor Antagonists for the Treatment of Gl Disorders
  • 2.7.1 Histamine H2 Receptor Antagonists Continues to Maintain a Market Presence Among Leading GI Drugs
  • 2.7.2 Forms of Action for Histamine H2 Receptor Antagonists Inhibitors
• 2.8 Proton Pump Inhibitors for the Treatment of Gl Disorders
  • 2.8.1 PPIs are a Newer Class of Medication ? Which Lead the GI Market
  • 2.8.2 PPIs Modes of Action
• 2.9 Other Agents for Treating Gl Disorders
  • 2.9.1 OTC Antacids
  • 2.9.2 Sucralfate
  • 2.9.3 Bismuth Subsalicylate
  • 2.9.4 Aminosalicylic Acid (5-ASA) Compounds
  • 2.9.5 Prokinetic Agents
  • 2.9.6 Corticosteroids
  • 2.9.7 Mesalamine
  • 2.9.8 Sulfasalazine
  • 2.9.9 Infliximab
  • 2.9.10 Antibiotics

Chapter 3: The World Gastrointestinal Market, 2007-2012

• 3.1 Altering Dynamics will Cause an Overall Decline in Revenues in the GI Market Between 2007-2012
• 3.2 In 2010 AstraZeneca will Remain the Leading Company in the GI Market
• 3.3 Shire' s Focused Strategy
  • 3.3.1 Lialda (mesalamine) with MMX Technology
• 3.4 Given Imaging Announces 500,000th Pill Cam SB Capsule Milestone
• 3.5 Salix in a $55 Million Deal With Merck
• 3.6 Sutent Allowed in Great Britain as Gastrointestinal Cancer Drug
• 3.7 New Crohn' s disease treatment Humira Promises to Reduce Symptoms
• 3.8 PPIs Will Continue Their Domination of the Gl Market
• 3.9 Blockbuster Revenues Can Still be Accomplished During 2007-2012
• 3.10 OTC GI Products to Account for Increased Market Share
• 3.11 Generics Offer Threat to Branded Market Share

Chapter 4: The World Market for Proton Pump Inhibitors, 2007-2012

• 4.1 PPIs -Under Pressure Due to Increasing Competitive Forces
  • 4.1.1 Patent Expirations Will Influence the Size of the Overall Market
  • 4.1.2 OTC Prevacid and Generics Will Continue to Play a Part in the GI Market
• 4.2 Nexium Will Continue to Decline in Revenues, Which will Affect the Overall GI Market
  • 4.2.1 AstraZeneca Realise Increasing Competition in GI market
  • 4.2.2 AstraZeneca' s Conversion Strategy Even More Crucial Than Before
  • 4.2.3 AstraZeneca Litigated Against Ranbaxy Laboratories Regarding Patent Infringement on Nexium
  • 4.2.4 AstraZeneca' s Blockbuster Drugs Coming Under Severe Pressure
    • 4.2.4.1 Dr Reddy' s Submitted ANDA to the FDA for Nexium
    • 4.2.4.2 IVAX Pharmaceuticals Submitted ANDA for Nexium
    • 4.2.4.3 Dexcel Pharma Submitted ANDA for Prilosec
  • 4.2.5 AstraZeneca Lost an Important Contract to Supply Nexium
  • 4.2.6 The Promotion and Marketing of Nexium Plagued by Legal Challenges
    • 4.2.6.1 Examples of Action Against AstraZeneca
  • 4.2.7 Nexium I.V. Approved as a Short-Term Treatment for GERD
• 4.3 Prevacid - Another PPI That Faces Deteriorating Revenues
  • 4.3.1 TAP Pharmaceutical: A Joint Venture Between Abbott and Takeda
  • 4.3.2 Abbott Admits Increased Competition for Prevacid
  • 4.3.3 TAP Licenses Prevacid Intellectual Property Rights to Novartis
  • 4.3.4 TAP Reassess Expenditure on DTC Advertising for Prevacid
  • 4.3.5 FDA Extended Approval for Prevacid Delayed Release Orally Disintegrating Tablets
  • 4.3.6 Prevacid Receives Extended Paediatric Approval from FDA
  • 4.3.7 The FDA Approved Prevacid I.V. For Erosive Oesophagitis in Hospitalised Patients
• 4.4 Prilosec/Losec - AstraZeneca' s Strategy Spot On
  • 4.4.1 Generics Will Continue to Increasingly Threaten Prilosec/Losec
  • 4.4.2 AstraZeneca Faced EU Patent Abuse Charges Concerning Losec
• 4.5 Protonix Facing Patent Expiry Later This Decade
  • 4.5.1 Protonix will Decline in Revenues After Patent Expiration
  • 4.5.2 Protonix Benefited from Early Approval for Pathological Hypersecretory Conditions
  • 4.5.3 Teva Pharmaceuticals Received Tentative Approval for Generic Protonix
• 4.6 Pantozol will Follow the Same Suite as Protonix
  • 4.6.1 Wyeth Acts as a Partner for Sales of Pantoprazole in the US
  • 4.6.2 Patent Protection for Pantoprazole Extended
  • 4.6.3 Altana Challenged State' s Decision on Price Reference
• 4.7 Takepron will Experience Similar Decline in Revenue
  • 4.7.1 Takeda Developed Lansoprazole
  • 4.7.2 Lansoprazole (Takepron) for Nonerosive Oesophagitis in Japan
  • 4.7.3 Takeda Announced Launch of Takepron I.V. in Japan
• 4.8 Aciphex/Pariet will Go Against the PPI Trend and Continue to Grow in Revenue
  • 4.8.1 Eisai' s Commercial Arrangement with Johnson & Johnson for Aciphex/Pariet
  • 4.8.2 Mylan: FDA Gives Tentative OK to Generic Aciphex
  • 4.8.3 Dr Reddy' s Expects Verdict on Aciphex Very Soon
  • 4.8.4 Eisai Applies for New Indication of Non-Erosive Gastro-Oesophageal Reflux Disease for Pariet in Japan
  • 4.8.5 Eisai Receives Approval for a New Indication for Pariet in Japan for Eradicating H. Pylori
  • 4.8.6 Eisai Receives Decisions of Summary Judgment Motion in US Legal Action Over Aciphex ANDA Filing
  • 4.8.7 New Production Facilities for Aciphex/Pariet Incorporate Latest Technology to Achieve Cost Savings
• 4.9 Zoton' s Loss of Patent Protection will Hurt its Revenues
  • 4.9.1 Zoton Capsules Discontinued in the UK
• 4.10 The Market for PPIs: Summary and Conclusions

Chapter 5: The World Market for Histamine H2 Receptor Antagonists and Other Leading Gastrointestinal Drugs, 2007-2012

• 5.1 H2 Antagonists will Suffer Declining Revenues From 2007-2012
  • 5.1.1 H2 Antagonists are a Mature Drug Class
  • 5.1.2 Gaster and Zantac are Available in OTC Formulations
• 5.2 Gaster 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 to Show a Further Decline in Revenues
• 5.3 Zantac Brand in Decline
  • 5.3.1 Sales of Zantac Are Declining in All Regions
  • 5.3.2 Par Pharmaceuticals Signs Supply, Distribution Agreement with GSK for Generic Zantac Syrup
  • 5.3.3 Boehringer Ingelheim Pharmaceuticals Announced Agreement to Acquire Zantac from Johnson & Johnson and the Pfizer Consumer Healthcare Business
• 5.4 Other Leading GI Agents will Show Growth in Revenue
• 5.5 Zelnorm/Zelman
  • 5.5.1 Novartis Halts Zelnrom Sales
  • 5.5.2 Zelnorm Sales Plunge - What Next?
  • 5.5.3 Vioxx - A Similar Case
  • 5.5.4 Zelnorm/Zelmac is Currently Being Developed for Other Important GI Indications - will they be Effected?
• 5.6 Gasmotin - Steady Growth
  • 5.6.1 Dianippon Pharmaceuticals are Striving to Maintain Growth of Gasmotin
  • 5.6.2 Dainippon Pharma and Eisai Sign Licensing Agreement for Gasmotin
  • 5.6.3 Gasmotin Discontinued for New Indication
• 5.7 Nauzelin will Experience Falling Revenues
• 5.8 Canasa/Salofalk will Also Produce Steady Growth
  • 5.8.1 Axcan Pharma Specialises in Gastroenterology
• 5.9 Entocort will Generate Stable Growth
  • 5.9.1 AstraZeneca' s Entocort a Specialised Drug
  • 5.9.2 AstraZeneca' s Agreement With Prometheus Laboratories Key
    • 5.9.2.1 Entocort' s Net Sales Increase Almost Three-Fold in the US
• 5.10 The Market for H2 antagonists and Other Leading GI Agents: Summary and Conclusions

Chapter 6: An Examination of Factors That Influence the Gastrointestinal Market

• 6.1 SWOT Analysis of the Prescription Gl Market
• 6.2 Changes in the Prescription Gl Market Create Opportunities
• 6.3 GERD Symptoms are Increasingly Common - Opportunities Lie for Expanding the Treatment Population
• 6.4 An Ageing Population will Asist the GI
• 6.5 Risk Reduction of NSAID-Associated Stomach Ulcers Illustrate an Opportunity for PPIs
• 6.6 What Unmet Needs and Potential Solutions Exist in the Gl Market?
  • 6.6.1 How Effective are PPIs and H2 Antagonists?
  • 6.6.2 Combination Therapy May have Commercial Potential
  • 6.6.3 5HT3 and 5HT4 Agents May Improve Certain Treatments
• 6.7 Losses of Patent Protection will be the Main Barrier in the Prescription Gl Market
• 6.8 To What Extent is the Gl Market Threatened by Generic Substitutes?
  • 6.8.1 Increasing Generic Competition for Leading GI Drugs
  • 6.8.2 Generic Omeprazole - A Case Study In Generic Erosion of Branded Sales
  • 6.8.3 A Warning of the Generic Threat to Branded Gl Drugs
• 6.9 High Prices of Branded PPIs Encourage Use of Generics and OTC Formulations
• 6.10 Prilosec OTC will Continue to be Influential in the GI Market
• 6.11 DTC Advertising has Affected the GI Market - Companies are Modifying Advertising Strategies
  • 6.11.1 AstraZeneca' s Problems Over its Marketing of Nexium

Chapter 7: Geographical Breakdown of the World Gastrointestinal Market

• 7.1 The US will Lead the Global Market in 2012
• 7.2 The US Market Generates High Revenues and Prescription Numbers
• 7.3 A Serious Global Health Problem - With Many Sufferers Currently Untreated or Under-treated
• 7.4 Conclusions: There is Scope To Expand the Treatment of Gl Disorders Globally

Chapter 8: Pipeline Drugs for Gastrointestinal Conditions

• 8.1 The GI Market will Become Increasingly Competitive For New Drugs - More Onus on Distribution Channels and Commercial Alliances
• 8.2 Agents 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
  • 8.4.2 Acid-Pump Antagonists
• 8.5 Agents in Phase III of Clinical Development
  • 8.5.1 Axcan' s Itax to Treat Functional Dyspepsia -a Mere Disappointment
• 8.6 Agents for Which Final Regulatory Approval is Pending
• 8.7 An Evaluation of Pipeline Developments in the Gl Market

Chapter 9: Conclusions: Gastrointestinal Disorders Constitute a Large Drugs Market That Is Facing Increasing Pressures

• 9.1 Changing Dynamics will Cause Overall Decline of Revenues in the Prescription Gl Market
• 9.2 Zelnorm' s Halt will have Adverse Effects
• 9.3 The Pipeline for Gl Drugs Looks Promising
• 9.4 Continuing Investment is Required
• 9.5 GI Strategy Needs to be Revised

List of Figures

• Figure 1.1 World Revenues ($m) for the Classes of Leading Gl Drugs, 2007-2012
• Figure 1.2 World Revenues ($m) for the Leading Gl Drugs Combined, 2007-2012
• Figure 1.3 Forecast Revenues ($m) for Proton Pump Inhibitors and H2 Antagonists (Combined) by Country, 2012
• Figure 2.1 Prevalence Rates of IBD Worldwide in 2007
• Figure 3.1 World Revenues ($m) for the Leading GI Drugs (Combined), 2007-2012
• Figure 3.2 World Revenues ($m) for the Classes of Leading Gl Drugs, 2007-2012
• Figure 3.3 World Market Share (%) for Gl Drugs by Class, 2007
• Figure 3.4 World Market Share (%) for Gl Drugs by Class, 2012
• Figure 3.5 Changes ($m) in World Revenue for the Classes of Gl Drugs, 2007-2012
• Figure 3.6 Changes (%) in World Revenues for the Classes of Gl Drug, 2007-2012
• Figure 4.1 World Revenue ($m) for All PPIs, 2007-2012
• Figure 4.2 World Revenues ($m) for PPIs By Drug, 2007- 2012
• Figure 4.3 World Market Share (%) for PPIs, 2007
• Figure 4.4 World Market Share (%) for PPIs, 2012
• Figure 4.5 Revenues ($m) for PPIs, Comparing 2007 and 2012
• Figure 4.6 World Nexium Revenues ($bn), 2007-2012
• Figure 4.7 World Prevacid (TAP) Revenues ($m), 2007- 2012
• Figure 4.8 World Prilosec/Losec Revenues ($bn), 2007- 2012
• Figure 4.9 World Protonix Revenues ($bn), 2007-2012
• Figure 4.10 World Pantozol Revenues ($bn), 2007-2012
• Figure 4.11 World Takepron Revenues ($bn), 2007-2012
• Figure 4.12 World Aciphex/Pariet Revenues ($bn), 2007- 2012
• Figure 4.13 World Zoton Revenues ($m), 2007-2012
• Figure 5.1 World Revenue ($m) for Histamine H2 Receptor Antagonists, 2007-2012
• Figure 5.2 World Revenues ($m) for Histamine H2 Receptor Antagonists by Drug, 2007-2012
• Figure 5.3 World Market Share (%) for Histamine H2 Receptor Antagonists, 2007
• Figure 5.4 World Market Share (%) for Histamine H2 Receptor Antagonists, 2012
• Figure 5.5 Revenues ($m) for Histamine H2 Receptor Antagonists, 2007 and 2012 Compared
• Figure 5.6 World Gaster Revenues ($m), 2007-2012
• Figure 5.7 World Zantac Revenues ($m), 2007-2012
• Figure 5.8 World Revenue ($m) for Other Gl Agents, 2007- 2012
• Figure 5.9 World Revenues ($m) for Other Gl Agents by Drug, 2007-2012
• Figure 5.10 World Market Share (%) for Other Gl Agents, 2007
• Figure 5.11 World Market Share (%) for Other Gl Agents, 2012
• Figure 5.12 Revenues ($m) for Other Gl Agents, Comparing 2007 and 2012
• Figure 5.13 World Zelnorm/Zelmac Revenues ($m), 2007- 2012
• Figure 5.14 World Gasmotin Revenues ($m), 2007-2012
• Figure 5.15 World Nauzelin Revenues ($m), 2007-2012
• Figure 5.16 World Canasa Revenues ($m), 2007-2012
• Figure 5.17 World Salofalk Revenue ($m), 2007-2012
• Figure 5.18 World Entocort Revenues ($m), 2007-2012
• Figure 5.19 US Entocort Net Sales $m
• Figure 6.1 Generic Revenues ($ thousands) for Selected GI Agents in the US, 2006
• Figure 6.2 Revenues ($m) of AstraZeneca' s Prilosec and KUDCo' s Generic Omeprazole, 2003-2005
• Figure 6.3 Average Monthly Costs ($) of Using PPIs (20 mg) in the US, 2006
• Figure 7.1 Potential Treatment Populations for PPIs and H2 Antagonists (Combined) by Country, 2012
• Figure 7.2 Forecast Revenues ($m) For PPIs and H2 Antagonists (Combined) by Country, 2012
• Figure 7.3 US Revenues for Leading Prescription GI Drugs ($m), 2005

List of Tables

• Table 1.1 World Revenues ($m) for the Leading Gastrointestinal Drugs, by Class, 2007-2012
• Table 2.1 Cost of GI Conditions to US Healthcare
• Table 2.2 Prevalence of IBD Worldwide in 2007
• Table 2.3 Indications for Leading Gastrointestinal Drugs
• Table 2.4 Leading Histamine H2 Receptor Antagonists to Treat Gl Disorders
• Table 2.5 Leading Proton-Pump Inhibitors to Treat Gastrointestinal Disorders
• Table 2.6 Other Leading Agents for Treating Gastrointestinal Disorders
• Table 3.1 Blockbuster Drugs in the World Gastrointestinal Market
• Table 3.2 World Revenues ($m) for the Leading Gl Drugs, by Class, 2007-2012
• Table 3.3 World Market Revenue ($m) and Market Share (%) for Leading GI Drugs by Class, 2012
• Table 3.4 Blockbuster Drugs in the World Gl Market, 2012
• Table 4.1 World Revenues for PPI Market $m, 2007-2012
• Table 4.2 Patent Expiry for PPIs, 2007
• Table 4.3 World Market Shares (%) for Proton Pump Inhibitors, 2007 and 2012
• Table 5.1 World Revenues for Histamine H2 Receptor Antagonists, 2007-2012
• Table 5.2 Patent Expiry for Histamine H2 Receptor Antagonists, 2007
• Table 5.3 World Revenues for Other Gl Agents $m, 2007- 2012
• Table 5.4 World Market Shares (%) for Histamine H2 Receptor Antagonists, 2007 and 2012
• Table 5.5 World Market Shares (%) for Other Gastrointestinal Agents, 2007 and 2012
• Table 6.1 A SWOT Analysis of GI Market, 2007-2012
• Table 6.2 Leading GI Brands Due to Lose Patent Protection During the Forecast Period 2007- 2012
• Table 6.3 Generic Substitutes for Leading GI Prescription Drugs, 2007
• Table 6.4 The PPI Cost Comparison in the US
• Table 6.5 Some Leading OTC Drugs for Heartburn Associated With Acid Reflux In Adults
• Table 7.1 Potential Treatment Populations for PPIs and H2 Antagonists (Combined) by Country, 2012
• Table 7.2 Forecast Revenues ($m) For PPIs and H2 Antagonists (Combined) by Country, 2012
• Table 9.1 Drivers and Restraints for the GI market
• Table 9.2 World Market Revenue ($m) and Market Share (%) for Leading Gastrointestinal Drugs by Class, 2012

Organisations Listed

• Abbott Laboratories
• Altana
• Apotex Corporation
• ARigen
• Astellas Pharma
• AstraZeneca
• Axcan Pharma
• Bentley Pharmaceuticals
• Berlex Inc
• Boehringer Ingelheim Pharmaceuticals
• Dainippon Pharmaceutical
• Dainippon Sumitomo Pharma Co
• Dexcel Pharma Technologies
• Dr Reddy' s Laboratories
• Eisai
• Eon Labs Manufacturing
• Gedeon Richter
• Genzyme Corp
• Given Imaging
• GlaxoSmithKline
• Impax Laboratories
• Ivax Pharmaceuticals
• Janssen Pharmaceutica
• Johnson & Johnson
• Kissei
• KUDCo
• Kyowa Hakko Kogyo
• Lek Pharmaceutical and Chemical Company
• Lek Services USA
• Merck & Co
• Merck KGaA
• Mylan Pharmaceuticals
• Napo Pharmaceutical
• New River Pharmaceuticals
• Novartis
• NPS Pharmaceuticals
• Otsuka America Pharmaceutical
• Pain Therapeutics
• Par Pharma
• Pfizer
• Prudential
• Proctor & Gamble
• Progenics Pharmaceuticals
• Prometheus Laboratories
• Ranbaxy Laboratories
• Ratiopharm
• Salix Pharmaceuticals
• Sandoz
• Santarus
• Sankyo
• Schering AG
• Schwarz Pharma
• Shire US Inc
• Solvay Pharmaceuticals
• Stada Servier
• Sucampo Pharmaceuticals
• Sumitomo Pharmaceuticals Co
• Takeda Chemical Industries
• Takeda Pharmaceutical
• TAP Pharmaceutical Products
• Teva Pharmaceuticals
• Teva USA
• UCB Pharma
• Western Pharma
• Wyeth