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