Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 11
2.1 Therapy Area Introduction 11
2.2 Symptoms 12
2.2.1 Gastroesophageal Reflux Disease 12
2.2.2 Irritable Bowel Syndrome 12
2.2.3 Inflammatory Bowel Disease 12
2.3 Etiology and Pathophysiology 13
2.3.1 Gastroesophageal Reflux Disease 13
2.3.2 Irritable Bowel Syndrome 14
2.3.3 Inflammatory Bowel Disease 16
2.4 Co-morbidities and Complications 17
2.5 Epidemiology Patterns and Forecasts – Prevalence and Patient Segmentation 18
2.5.1 Gastroesophageal Reflux Disease 19
2.5.2 Irritable Bowel Syndrome 19
2.5.3 Inflammatory Bowel Disease 20
2.6 Treatment 21
2.6.1 Acid-Controlling Agents 21
2.6.2 Anticholinergics/Antispasmodics 22
2.6.3 Gastric Stimulants, Laxatives and Antidiarrheals 22
2.6.4 Anti-inflammatory and Systemic Immunosuppressive Agents 23
2.6.5 Biologics 24
3 Key Marketed Products 25
3.1 Overview 25
3.2 Humira (adalimumab) 26
3.3 Remicade (infliximab) 28
3.4 Soliris (eculizumab) 29
3.5 Tysabri (natalizumab) 30
3.6 Nexium (esomeprazole magnesium) 32
3.7 Entyvio (vedolizumab) 34
3.8 Protonix (pantoprazole) 36
3.9 Ocaliva (obeticholic acid) 38
3.10 Dexilant (dexlansoprazole) 39
3.11 Amitiza (lubiprostone) 40
3.12 Takecab (vonoprazan) 42
3.13 Linzess (linaclotide) 44
4 Pipeline Landscape Assessment 46
4.1 Overview 46
4.2 Molecule Types in the Pipeline 48
4.3 Molecular Targets in the Pipeline 49
4.4 Clinical Trials Landscape 51
4.4.1 Clinical Trial Failure Rates 52
4.4.2 Clinical Trial Duration 55
4.4.3 Clinical Trial Size 59
4.4.4 Cumulative Clinical Trial Size 63
4.5 Late-Stage Drugs of the Developmental Pipeline 66
4.5.1 RPC1063 (ozanimod) – Celgene 66
4.5.2 GED-0301 (mongersen) – Celgene 67
4.5.3 Stelara (ustekinumab) – Johnson & Johnson 68
4.5.4 Victoza (liraglutide) – Novo Nordisk 70
4.5.5 Plecanatide – Synergy Pharmaceuticals 71
4.6 Conclusion 72
5 Multi-scenario Market Forecast to 2022 74
5.1 Overall Market Size 74
5.2 Generic Penetration 76
5.3 Revenue Forecast by Molecular Target 77
5.3.1 Tumor Necrosis Factor Alpha 77
5.3.2 Interleukins and Receptors 78
5.3.3 H+/K+ ATPase 79
5.3.4 Integrins 80
6 Company Analysis and Positioning 82
6.1 Revenue and Market Share Analysis by Company 83
6.1.1 AbbVie – Will Patent Expiry of Humira Significantly Diminish Revenues? 88
6.1.2 Takeda – Will Entyvio and Takecab be the Predominant Contributors to Revenue Growth? 90
6.1.3 Johnson & Johnson – To What Extent Will Simponi Offset the Patent Expiry of Remicade? 91
6.1.4 AstraZeneca – Will Patent Expiration of Blockbuster Drug and Lack of Strong Pipeline Line-up Result in Loss of Market Share? 93
6.1.5 Alexion – Is Soliris’ Success Enough to Drive Strong Company Growth? 95
6.1.6 Allergan – To What Extent Will Key Gastrointestinal Product Linzess Drive Company Growth? 96
6.1.7 Celgene – Which Gastrointestinal Pipeline Drugs Will Drive Growth in Second Half of Forecast Period? 98
6.2 Company Landscape 99
6.3 Marketed and Pipeline Portfolio Analysis 99
7 Strategic Consolidations 102
7.1 Licensing Deals 102
7.1.1 Deals by Region, Year and Value 102
7.1.2 Deals by Stage of Development and Value 104
7.1.3 Deals by Molecule Type, Molecular Target and Value 105
7.1.4 Table for Licensing Deals Valued Above $300m 107
7.2 Co-development Deals 108
7.2.1 Deals by Region, Year and Value 108
7.2.2 Deals by Stage of Development and Value 109
7.2.3 Deals by Molecule Type, Molecular Target and Value 111
7.2.4 Table for Co-development Deals Valued Above $300m 112
8 Appendix 114
8.1 References 114
8.2 Table of Epidemiology Forecast 118
8.3 Table of All Clinical Stage Pipeline Products 119
8.4 Abbreviations 160
8.5 Disease List 161
8.6 Methodology 162
8.6.1 Coverage 162
8.6.2 Secondary Research 162
8.6.3 Market Size and Revenue Forecasts 162
8.6.4 Pipeline Analysis 163
8.6.5 Competitive Landscape 163
8.7 Contact Us 164
8.8 Disclaimer 164