Disease and disorders involving the gastrointestinal system are among the most common conditions encountered worldwide, and many of them can have a significant impact on quality of life. The direct and indirect socio-economic burden associated with gastrointestinal disorders is profound. The direct costs of medical consultations and treatments in the US for gastroesophageal reflux disease alone are estimated to amount to $9.3 billion, while the indirect costs due to absenteeism and impairment in work performance total $75 billion (Chait, 2010).
Despite the significant global socio-economic burden, many gastrointestinal disorders are still poorly understood, and there is a significant unmet need for novel, safe and effective therapies, as treatment options are often lacking, causing many patients to be dissatisfied with their treatment. The unmet need and demand for better treatments and the high prevalence of digestive conditions make the gastrointestinal market an attractive candidate for therapeutic development.
This report covers all gastrointestinal disorders, but there is a particular focus on three key diseases: gastroesophageal reflux disease, irritable bowel syndrome and inflammatory bowel disease. The global gastrointestinal market was valued at $35.7 billion in 2015 and is projected to grow at a compound annual growth rate (CAGR) of 4.45%, reaching $48.4 billion in 2022. Proton pump inhibitors (PPIs) and tumor necrosis factor (TNF)-α inhibitors generate the largest revenues and continue to retain commercial prominence. Key drivers of market growth will be the uptake of recently approved premium products, rising prevalence, and promising late-stage products, including a number of biologic therapies that are expected to be highly valuable.
The gastrointestinal market landscape is expected to change substantially with the advent of promising novel pipeline products.
There are 937 gastrointestinal pipeline products in active development, of which small molecules and biologics account for 53% and 38%, respectively.
- Which molecular targets are most prominent within the pipeline?
- How do the key indications differ in terms of molecule type?
- How does the composition of the pipeline compare with that of the existing market?
- What mechanisms of action are most common for pipeline drugs?
Global revenue for the gastrointestinal market is forecast to grow at a CAGR of 4.45%, from $35.7 billion in 2015 to $48.4 billion in 2022.
- Which products will be the biggest drivers for market growth?
- Will the current market leaders retain their dominance over the forecast period, and how is their revenue share of the gastrointestinal market set to change?
- What CAGR will these companies register in the forecast period?
Reasons to buy
This report will allow you to -
- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis and the treatment options available at each stage of diagnosis.
- Visualize the composition of the gastrointestinal market across each indication, in terms of dominant molecule types and targets, highlighting the key commercial assets and players.
- Analyze the gastrointestinal pipeline, stratifying it by stage of development, molecule type and molecular target and providing a granular breakdown across key indications.
- Understand the growth in patient epidemiology and market revenue for the gastrointestinal market globally and across the key players and product types.
- Stratify the market in terms of the split between generic and premium products and assess the role of these product types in the treatment of the various gastrointestinal conditions.
- Identify commercial opportunities in the gastrointestinal deals landscape by analyzing trends in licensing and co-development deals.
Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 9
2.1 Therapy Area Introduction 9
2.2 Symptoms 10
2.2.1 Gastroesophageal Reflux Disease 10
2.2.2 Irritable Bowel Syndrome 10
2.2.3 Inflammatory Bowel Disease 10
2.3 Etiology and Pathophysiology 11
2.3.1 Gastroesophageal Reflux Disease 11
2.3.2 Irritable Bowel Syndrome 12
2.3.3 Inflammatory Bowel Disease 14
2.4 Co-morbidities and Complications 15
2.5 Epidemiology Patterns and Forecasts – Prevalence and Patient Segmentation 16
2.5.1 Gastroesophageal Reflux Disease 17
2.5.2 Irritable Bowel Syndrome 17
2.5.3 Inflammatory Bowel Disease 18
2.6 Treatment 19
2.6.1 Acid-Controlling Agents 19
2.6.2 Anticholinergics/Antispasmodics 20
2.6.3 Gastric Stimulants, Laxatives and Antidiarrheals 20
2.6.4 Anti-inflammatory and Systemic Immunosuppressive Agents 21
2.6.5 Biologics 22
3 Key Marketed Products 23
3.1 Overview 23
3.2 Humira (adalimumab) 24
3.3 Remicade (infliximab) 26
3.4 Soliris (eculizumab) 28
3.5 Tysabri (natalizumab) 29
3.6 Nexium (esomeprazole magnesium) 31
3.7 Entyvio (vedolizumab) 33
3.8 Protonix (pantoprazole) 35
3.9 Ocaliva (obeticholic acid) 37
3.10 Dexilant (dexlansoprazole) 38
3.11 Amitiza (lubiprostone) 40
3.12 Takecab (vonoprazan) 41
3.13 Linzess (linaclotide) 43
4 Pipeline Landscape Assessment 45
4.1 Overview 45
4.2 Molecule Types in the Pipeline 47
4.3 Molecular Targets in the Pipeline 48
4.4 Clinical Trials Landscape 50
4.4.1 Clinical Trial Failure Rates 51
4.4.2 Clinical Trial Duration 54
4.4.3 Clinical Trial Size 58
4.4.4 Cumulative Clinical Trial Size 61
4.5 Late-Stage Drugs of the Developmental Pipeline 64
4.5.1 RPC1063 (ozanimod) – Celgene 64
4.5.2 GED-0301 (mongersen) – Celgene 65
4.5.3 Stelara (ustekinumab) – Johnson & Johnson 66
4.5.4 Victoza (liraglutide) – Novo Nordisk 68
4.5.5 Plecanatide – Synergy Pharmaceuticals 69
4.6 Conclusion 70
5 Multi-scenario Market Forecast to 2022 72
5.1 Overall Market Size 72
5.2 Generic Penetration 74
5.3 Revenue Forecast by Molecular Target 75
5.3.1 Tumor Necrosis Factor Alpha 75
5.3.2 Interleukins and Receptors 76
5.3.3 H+/K+ ATPase 77
5.3.4 Integrins 78
6 Company Analysis and Positioning 80
6.1 Revenue and Market Share Analysis by Company 81
6.1.1 AbbVie – Will Patent Expiry of Humira Significantly Diminish Revenues? 85
6.1.2 Takeda – Will Entyvio and Takecab be the Predominant Contributors to Revenue Growth? 87
6.1.3 Johnson & Johnson – To What Extent Will Simponi Offset the Patent Expiry of Remicade? 88
6.1.4 AstraZeneca – Will Patent Expiration of Blockbuster Drug and Lack of Strong Pipeline Line-up Result in Loss of Market Share? 90
6.1.5 Alexion – Is Soliris’ Success Enough to Drive Strong Company Growth? 92
6.1.6 Allergan – To What Extent Will Key Gastrointestinal Product Linzess Drive Company Growth? 93
6.1.7 Celgene – Which Gastrointestinal Pipeline Drugs Will Drive Growth in Second Half of Forecast Period? 95
6.2 Company Landscape 96
6.3 Marketed and Pipeline Portfolio Analysis 96
7 Strategic Consolidations 99
7.1 Licensing Deals 99
7.1.1 Deals by Region, Year and Value 99
7.1.2 Deals by Stage of Development and Value 101
7.1.3 Deals by Molecule Type, Molecular Target and Value 102
7.1.4 Table for Licensing Deals Valued Above $300m 104
7.2 Co-development Deals 105
7.2.1 Deals by Region, Year and Value 105
7.2.2 Deals by Stage of Development and Value 106
7.2.3 Deals by Molecule Type, Molecular Target and Value 108
7.2.4 Table for Co-development Deals Valued Above $300m 109
8 Appendix 111
8.1 References 111
8.2 Table of Epidemiology Forecast 115
8.3 Table of All Clinical Stage Pipeline Products 116
8.4 Abbreviations 157
8.5 Disease List 158
8.6 Methodology 159
8.6.1 Coverage 159
8.6.2 Secondary Research 159
8.6.3 Market Size and Revenue Forecasts 159
8.6.4 Pipeline Analysis 160
8.6.5 Competitive Landscape 160
8.7 Contact Us 161
8.8 Disclaimer 161
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