1 Executive Summary
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 20 Best Selling Prescription Drugs
2.2 Gastroesophageal Reflux Diseases
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 Proton Pump Inhibitors Currently Leading the Gastrointestinal Market
3 The World Gastrointestinal Market, 2008-2023
3.1 How Will Shifting Internal Dynamics Affect the World Gastrointestinal Market from 2008 to 2023?
3.2 Biologics Help Steady the Market – A Great Hope for the Future
3.3 Gastrointestinal Drugs among Some of the Most Lucrative in the Market in 2007
3.4 AstraZeneca
3.4.1 AstraZeneca and Prilosec’s Patent Expiry
3.4.2 AstraZeneca Faces Growing Biologics Market in GI Disorders
3.4.3 Collaborations in the Gastrointestinal Market
3.5 Will Biologics Overtake Proton Pump Inhibitors as the Leading Drug Class in the Gastrointestinal Market by 2013?
3.6 How Market for Biologics Therapies will Develop from 2008 to 2023
3.7 OTC Switching Creates Good Opportunities for Life Cycle Management – But at what Cost to Prescription Drug Revenues?
3.7.1 Effects of OTC Switching in GI Market
3.7.2 OTC Switching as a Strategy to Extend Brand Revenues and Profitability
3.8 The GI Market is Likely to Remain Strong in Terms of Prescription Numbers and Unit Sales – But Will Generics Continue to Threaten Significantly?
4 The World Market for Proton Pump Inhibitors, 2008-2023
4.1 The Proton Pump Inhibitors – A Strong Market under Increasing Threat from Patent Expiry and OTC Switching
4.2 Will PPIs Lose Dominance in the GI Market by 2013?
4.3 Loss of Patent Protection and Revenue Generation in the PPI Market
4.3.1 OTC Prilosec and Generics will Play Decisive Roles in the Dynamics of the GI Market
4.3.2 Reference-Based Pricing will Impose Additional Constraints on the PPI Market
4.4 Market Shares of the Leading GI Drugs – 2007 and 2013 Compared
4.5 Nexium will Face Declining Revenues and Loss of Predominance in the World Gastrointestinal Market
4.5.1 Brand Management is Succeeding for AstraZeneca – Will Competitors be able to Emulate this Winning Strategy?
4.5.2 Nexium Dropped from Reimbursement by Leading Health Insurer
4.5.3 AstraZeneca Reaches Deal with Ranbaxy Laboratories, but Continues to Battle Challenges to Nexium’s Patents
4.5.4 AstraZeneca Sets Aggressive Brand Extension for Nexium
4.6 Prevacid – Accelerated Decline Awaits this Major Brand
4.6.1 Prevacid is Attractive to Generic Companies
4.6.2 TAP Joint Venture Comes to an End
4.7 Protonix/Pantazol is Another Leading PPI in Decline – How Will it Fare?
4.7.1 Protonix Sales and Premature Generic Penetration
4.8 Pariet/Aciphex and Competition in the Market
4.8.1 Will Gains in the Asian GI Market be Enough to Offset Sales Maturation and Declines in Other Regions?
4.9 Prilosec/Losec – AstraZeneca Uses Product Lifecycle Management Decisively
4.9.1 Losec Maintains Blockbuster Status despite Expanding Generic Sales
4.9.2 Losec Shows Marked Growth in Japan and China
5 The World Market for Biologics Indicated for Gastrointestinal Disorders, 2008-2023
5.1 Biologics - A Thriving Market with Significant Prospects within the Maturing Gastrointestinal Space
5.2 Biologics’ Growth Will Outpace Other Classes in the Declining Overall Gastrointestinal Market
5.2.1 Biologics Enjoy Key Advantages over Other Drug Classes
5.3 Remicade and Humira Paving the Way for the High Profile of Biologics in the Gastrointestinal Market, With Significant Commercial Gains to be Made
5.4 Will Remicade Continue to Hold its Ground Despite Intense Competition from Second-Generation Therapies?
5.4.1 Remicade is the Current Leading Biologic, but how will it Fare in the Future?
5.5 Humira - High-Paced Growth?
5.5.1 Will Humira Supplant Nexium to Become the Leading Drug in the Gastrointestinal Market?
5.6 Biologics Do Not Face Biogeneric/Biosimilar Competition for the Time Being
5.7 Potential for Biologics is Enormous but Cost Containment Strategies will be an Underlying Restraint
5.7.1 Big and Expensive: Development Costs Limit Growth
5.8 High Profile Safety Cases Increase Regulatory Concerns
6 The World Market for Histamine H2 Receptor Antagonists and Mesalazines, 2008-2023
6.1 Histamine H2 Antagonists – This Older Class Will Suffer Declining Revenues from 2008-2023
6.2 The H2 Antagonists are Now a Mature Drug Class Characterised by the Loss of Patent and Availability of Generic Substitutes
6.2.1 Both Gaster and Zantac are Available in OTC Formulations
6.3 The Histamine H2-Antagonists Market will Remain Fragmented
6.4 Will Gaster Undergo the Least Decline in the H2-Antagnoists Group?
6.4.1 Further Decline Predicted for Gaster
6.5 Zantac Expected to Plunge Further
6.5.1 Zantac has Shown Market Sustainability, but will this Situation Last?
6.6 Mesalazines Have Dominated the Market for Inflammatory Bowel Disease Treatments, but for How Much Longer Can they Lead?
6.6.1 Can Mesalazines Seize Opportunity before Biologics Grow to Full Potential?
6.7 Mesalazine Products Struggling to Remain Competitive in the GI Market
6.8 Will Asacol Remain the Mesalazine of Choice?
6.9 Pentasa – Steady Growth Leads to Maturity
7 Factors that Influence the Prescription Gastrointestinal Market
7.1 SWOT Analysis of the Prescription GI Market
7.2 Shifting Dynamics in the GI Market Create Opportunities, Especially in Product Lifecycle Management and Generics
7.3 GERD Symptoms are Very Common - There are Opportunities for Expanding the Treatment Population
7.4 An Ageing Population will Drive the GI Market, Especially in Self Medication
7.5 Prilosec/Losec OTC has been Influential in the GI Market
7.6 What Unmet Needs Exist in the Gastrointestinal Market? What Potential Solutions?
7.6.1 How Effective are PPIs and H2 Antagonists?
7.6.2 Agents that may Improve Treatment of IBS, Crohn's Disease and Ulcerative Colitis
7.7 Major Loss of Patent Protection will Constitute the Principal Restraint in the GI Market
7.8 Loss of Patent Protection will Lead to Increasing Generic Competition for Leading Drugs in the Market
7.9 Public and Private Health Insurers are Imposing Cost-Containment Strategies to Improve Cost-Effectiveness
7.9.1 Nexium Dropped from Reimbursement from Leading Health Insurer in the US - a Warning to Other Leading Brands
7.9.2 Reference-Based Pricing will Dissuade Uses of Highly-Priced Patented GI Drugs
8 Geographical Breakdown of the World Gastrointestinal Market
8.1 The Gastrointestinal Market in 2007: Geographical Analysis
8.2 Sales Forecast for the Leading Gastrointestinal Disorders Country Market, 2008-2023
8.3 The US Gastrointestinal Disorders Market, 2008-2023
8.4 The Gastrointestinal Disorders Market in Other Leading Developed Countries, 2008-2023
8.4.1 The Japanese Market
8.4.2 The French Market
8.4.3 The German Market
8.4.4 The Italian Market
8.4.5 The Canadian Market
8.4.6 The Spanish Market
8.4.7 The UK Market
8.5 The Gastrointestinal Disorders Market in Emerging Countries, 2008-2023
8.5.1 The Indian Market
8.5.2 The Chinese Market
9 Pipeline Drugs for Gastrointestinal Disorders
9.1 Overview of Emerging Drugs for Gastrointestinal Disorders
9.2 New Classes of Therapies are Being Investigated to Treat the Enigmatic Irritable Bowel Syndrome
9.2.1 Sucampo and Takeda’s Amitiza
9.2.2 AGI Therapeutics’ Rezular
9.2.3 Rottapharm’s Dexloxiglumide
9.2.4 Aryx Therapeutics’ ATI-7505
9.2.5 Dynogen Pharmaceuticals’ Pumosetrag
9.3 Pipeline Biologic Agents Aiming to Emulate and Extend the Initial Success of Existing Brands
9.3.1 UCB’s Cimzia
9.3.2 Elan’s Tysabri
9.3.3 Centocor/Schering-Plough’s Golimumab
9.3.4 Otsuka’s Tetomilast
9.3.5 Isis’ Alicaforsen
9.3.6 Bristol-Myers Squibb’s Orencia
9.3.7 Novartis’ Simulect
9.4 An Overall Assessment of Pipeline Developments in the Gastrointestinal Market
10 Conclusions: Gastrointestinal Disorders Constitute a Large Drugs Market that is Facing Decisive Commercial Pressures
10.1 Shifting Internal Dynamics Affecting the Prescription Gastrointestinal Market between 2008-2023
10.2 Biologics will Drive the Market
10.3 The World Gastrointestinal Market will be Affected by Cost-Containment Measures in Healthcare Budgets
10.4 Thinning Pipeline is a Major Cause of Concern
10.5 Continuing Public and Private Sector Investment is Required
List of Tables
Table 2.1, Leading Gastrointestinal Drugs in 2007
Table 3.1, Leading Gastrointestinal Agents, Sales ($m) and Growth (%), 2007
Table 3.2, World Revenues ($m) for the Total Gastrointestinal Drugs Combined, 2007-2013, 2018, 2023
Table 3.3, Blockbuster Drugs in the World Gastrointestinal Market, 2007
Table 3.4, World Market Share (%) for Gastrointestinal Drugs by Company, 2007
Table 3.5, World Revenues ($m) for the Classes of Gastrointestinal Drugs, 2007-2013, 2018, 2023
Table 3.6, Blockbuster Drugs in the World Gastrointestinal Market, Revenues ($m), 2013
Table 3.7, Possible Future OTC Switching
Table 4.1, World Leading Therapeutic Classes by Sales ($m), 2007
Table 4.2, World Revenues ($m) for Proton Pump Inhibitors, 2007-2013, 2018 and 2023
Table 4.3, Patent Expiry for Proton Pump Inhibitors, 2008
Table 4.4, World Revenues ($m) for Leading Proton Pump Inhibitors, 2007-2013, 2018, 2023
Table 4.5, World Market for Nexium, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 4.6, World Market for Prevacid, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 4.7, World Market for Prevacid, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 4.8, World Market for Pariet, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 4.9, World Market for Losec, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 5.1, World Market for Biologics Indicated for Gastrointestinal Disorders, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023
Table 5.2, World Revenues ($m) for Biologics Indicated for Gastrointestinal Disorders, 2008-2013, 2018, 2023
Table 5.3, World Market for Remicade, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023
Table 5.4, World Market for Humira, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023
Table 6.1, World Revenue ($m) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023
Table 6.2, Patent Expiry for Histamine H2 Receptor Antagonists, 2008
Table 6.3, World Revenues ($m) for Leading Histamine H2-Antagonists, 2007-2013, 2018 and 2023
Table 6.4, World Market for Gaster, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 6.5, World Market for Zantac, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 6.6, World Revenue ($m) for Mesalazines, 2008-2013, 2018 and 2023
Table 6.7, World Revenues ($m) for Leading Mesalazines, 2007-2013, 2018 and 2023
Table 6.8, World Market for Asacol, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 6.9, World Market for Pentasa, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023
Table 7.1, SWOT Chart for the Prescription Gastrointestinal Market, 2008-2023
Table 8.1, Leading Gastrointestinal Disorders Country Market, Sales ($m), 2007
Table 8.2, Gastrointestinal Disorders Sales for Leading Country Markets ($m), 2007-2013, 2018 and 2023
Table 9.1, Emerging Drugs for Gastrointestinal Disorders
List of Figures
Figure 3.1, World Revenues ($m) for the Total Gastrointestinal Drugs Combined, 2007-2013, 2018 and 2023
Figure 3.2, CAGRs (%) of the World Gastrointestinal Market Compared, 2007-2013, 2013-2018 and 2018-2023
Figure 3.3, CAGR (%) in World Revenues for the Classes of Gastrointestinal Drugs, 2007-2013
Figure 3.4, World Market Share (%) for Gastrointestinal Drugs by Company, 2008
Figure 3.5, World Revenues ($m) for the Classes of Gastrointestinal Drugs, 2007-2013, 2018 and 2023
Figure 3.6, World Market Share (%) for Gastrointestinal Drugs by Class, 2007
Figure 3.7, World Market Share (%) for Gastrointestinal Drugs by Class, 2013
Figure 3.8, World Market Share (%) for Gastrointestinal Drugs by Class, 2023
Figure 3.9, Sales of Blockbuster GI Drugs Compared, ($m), 2007-2013, 2018, 2023
Figure 4.1, World Revenues ($m) for Proton Pump Inhibitors, 2008-2023
Figure 4.2, CAGR (%) for the Proton Pump Inhibitors, 2007-2013, 2013-2018 and 2018-2023
Figure 4.3, Market Share (%) for Proton Pump Inhibitors in the World Gastrointestinal Market, 2007-2013, 2018 and 2023
Figure 4.4, World Revenues ($m) for Leading Proton Pump Inhibitors Drug, 2008-2023
Figure 4.5, World Revenues ($m) for the Proton Pump Inhibitors, 2007 and 2013 Compared
Figure 4.6, World Market Share (%) for the Proton Pump Inhibitors, 2007
Figure 4.7, World Market Share (%) for the Proton Pump Inhibitors, 2013
Figure 4.8, World Nexium Revenues ($m), 2008-2023
Figure 4.9, World Prevacid Revenues ($m), 2008-2023
Figure 4.10, World Protonix Revenues ($m), 2008-2023
Figure 4.11, World Pariet Revenues ($m), 2008-2023
Figure 4.12, World Losec Revenues ($m), 2008-2023
Figure 5.1, World Market for Monoclonal Antibodies Indicated for Gastrointestinal Disorders, Sales ($m), 2008-2023
Figure 5.2, CAGRs (%) of the Gastrointestinal Market and the Biologics Drug Class - 2007-2013, 2013-2018, 2018-2023 Compared
Figure 5.3, Market Share (%) of the Biologics Drug Class, 2007-2013, 2018 and 2023
Figure 5.4, World Revenue ($m) for the Classes of Gastrointestinal Drugs Compared, 2007, 2013, 2018 and 2023
Figure 5.5, Market Share of Leading Biologics – 2007, 2013, 2018 and 2013 Compared
Figure 5.6, CAGRs of Leading Biologics – 2007-2013, 2013-2018, and 2018-2023 Compared
Figure 5.7, World Revenues ($m) for Remicade, 2008-2023
Figure 5.8, World Revenues ($m) for Humira, 2008-2023
Figure 6.1, World Revenue ($m) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023
Figure 6.2, CAGR (%) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023
Figure 6.3, Market Share (%) of Histamine H2 Receptor Antagonists in the World Gastrointestinal Market, 2008-2013, 2018 and 2023
Figure 6.4, Market Revenues ($m) of Leading Histamine H2-Antagonists, 2007, 2013, 2018 and 2023
Figure 6.5, World Gaster Revenues ($m), 2008-2023
Figure 6.6, World Zantac Revenues ($m), 2008-2023
Figure 6.7, World Revenue ($m) for Mesalazines, 2008-2013, 2018 and 2023
Figure 6.8, CAGR (%) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023
Figure 6.9, Market Share (%) of Mesalazines in the World Gastrointestinal Market, 2008-2013, 2018 and 2023
Figure 6.10, World Asacol Revenues ($m), 2008-2023
Figure 6.11, World Pentasa Revenues ($m), 2008-2023
Figure 8.1, Gastrointestinal Disorders Market Share by Leading Country (%), 2007
Figure 8.2, The US Gastrointestinal Disorders Market. Sales ($m), 2008-2023
Figure 8.3, The Gastrointestinal Disorders Market in Other Leading Developed Countries, Sales ($m), 2008-2023
Figure 8.4, The Gastrointestinal Disorders Market in India and China, Sales ($m), 2008-2023