Global Gastrointestinal Drug Market to 2022 - Pipeline Characterized by Emerging Biologic Therapies, While TNF Inhibitors and PPIs Continue to Dominate Therapy Landscape

Global Gastrointestinal Drug Market to 2022 - Pipeline Characterized by Emerging Biologic Therapies, While TNF Inhibitors and PPIs Continue to Dominate Therapy Landscape


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Executive Summary

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)-? 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.

Scope

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.



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1 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

1.2 List of Figures

Figure 1: Epidemiology Patterns for Gastroesophageal Reflux Disease (million), 2015-2022 17

Figure 2: Epidemiology Patterns for Irritable Bowel Syndrome (million), 2015-2022 18

Figure 3: Epidemiology Patterns for Inflammatory Bowel Disease (million), 2015-2022 18

Figure 4: Gastrointestinal Disorders, Global, Key Marketed Products and Approved Indications, 2016 24

Figure 5: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Humira ($bn), 2006-2022 26

Figure 6: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Remicade ($bn), 2006-2022 27

Figure 7: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Soliris ($bn), 2006-2022 29

Figure 8: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Tysabri ($bn), 2010-2022 31

Figure 9: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Nexium ($bn), 2006-2022 33

Figure 10: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Entyvio ($bn), 2014-2022 35

Figure 11: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Protonix ($bn), 2006-2022 36

Figure 12: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Ocaliva ($bn), 2016-2022 38

Figure 13: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Dexilant ($bn), 2008-2022 39

Figure 14: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Amitiza ($bn), 2006-2022 41

Figure 15: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Takecab ($bn), 2014-2022 43

Figure 16: Gastrointestinal Therapeutics Market, Global, Annual Revenue for Linzess ($bn), 2012-2022 44

Figure 17: Gastrointestinal Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016 45

Figure 18: Gastrointestinal Therapeutics Market, Global, Gastrointestinal Pipeline by Stage of Development and Molecule Type, 2016 46

Figure 19: Gastrointestinal Therapeutics Market, Global, Pipeline for Key Gastrointestinal Indications by Stage of Development, 2016 47

Figure 20: Gastrointestinal Therapeutics Market, Global, Pipeline for Key Gastrointestinal Indications by Molecule Type, 2016 48

Figure 21: Gastrointestinal Therapeutics Market, Global, Gastrointestinal Pipeline by Molecular Target, 2016 49

Figure 22: Gastrointestinal Therapeutics Market, Global, Pipeline for Key Gastrointestinal Indications by Molecular Target, 2016 50

Figure 23: Gastrointestinal Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2016 51

Figure 24: Gastrointestinal Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2016 52

Figure 25: Gastrointestinal Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2016 53

Figure 26: Gastrointestinal Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2016 54

Figure 27: Gastrointestinal Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2016 55

Figure 28: Gastrointestinal Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2016 56

Figure 29: Gastrointestinal Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 57

Figure 30: Gastrointestinal Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 58

Figure 31: Gastrointestinal Therapeutics Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2016 59

Figure 32: Gastrointestinal Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2016 59

Figure 33: Gastrointestinal Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2016 60

Figure 34: Gastrointestinal Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2016 61

Figure 35: Gastrointestinal Therapeutics Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2016 62

Figure 36: Gastrointestinal Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2016 63

Figure 37: Gastrointestinal Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2016 63

Figure 38: Gastrointestinal Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2016 64

Figure 39: Gastrointestinal Therapeutics Market, Global, Revenue Forecast for RPC1063 ($m), 2018-2022 65

Figure 40: Gastrointestinal Therapeutics Market, Global, Revenue Forecast for GED-0301 ($m), 2018-2022 66

Figure 41: Gastrointestinal Therapeutics Market, Global, Revenue Forecast for Stelara ($m), 2018-2022 67

Figure 42: Gastrointestinal Therapeutics Market, Global, Revenue Forecast for Victoza ($m), 2018-2022 69

Figure 43: Gastrointestinal Therapeutics Market, Global, Revenue Forecast for Plecanatide ($m), 2017-2022 70

Figure 44: Gastrointestinal Therapeutics Market, Global, Market Size ($bn), 2015-2022 72

Figure 45: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for Premium and Generic Products ($bn), 2015-2022 74

Figure 46: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for Tumor Necrosis Factor Alpha Inhibitors ($bn), 2015-2022 76

Figure 47: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for Interleukin Inhibitors ($bn), 2018-2022 77

Figure 48: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for H+/K+ ATPase Inhibitors ($bn), 2015-2022 78

Figure 49: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for Integrin Inhibitors ($bn), 2015-2022 79

Figure 50: Gastrointestinal Therapeutics Market, Global, Cluster by Growth and Market Share, 2015-2022 80

Figure 51: Gastrointestinal Therapeutics Market, Global, Forecast Market Share by Company (%), 2015-2022 83

Figure 52: Gastrointestinal Therapeutics Market, Global, Companies by Compound Annual Growth Rate (%), 2015-2022 84

Figure 53: Gastrointestinal Therapeutics Market, Global, Revenues by Product Type, 2015-2022 85

Figure 54: Gastrointestinal Therapeutics Market, Global, AbbVie Annual Revenue Forecast ($bn), 2015-2022 86

Figure 55: Gastrointestinal Therapeutics Market, Global, Takeda Annual Revenue Forecast ($bn), 2015-2022 88

Figure 56: Gastrointestinal Therapeutics Market, Global, Johnson & Johnson Annual Revenue Forecast ($bn), 2015-2022 89

Figure 57: Gastrointestinal Therapeutics Market, Global, AstraZeneca Annual Revenue Forecast ($bn), 2015-2022 91

Figure 58: Gastrointestinal Therapeutics Market, Global, Alexion Annual Revenue Forecast ($bn), 2015-2022 92

Figure 59: Gastrointestinal Therapeutics Market, Global, Allergan Annual Revenue Forecast ($bn), 2015-2022 94

Figure 60: Gastrointestinal Therapeutics Market, Global, Celgene Annual Revenue Forecast ($bn), 2015-2022 95

Figure 61: Gastrointestinal Therapeutics Market, Global, Companies by Type, 2016 96

Figure 62: Gastrointestinal Therapeutics Market, Global, Pipeline, High-Activity and Late-Stage Developers by Level of Gastrointestinal Specialization, 2016 97

Figure 63: Gastrointestinal Therapeutics Market, Global, Proportion of Total Company Revenue Attributed to Gastrointestinal, 2015-2022 98

Figure 64: Gastrointestinal Therapeutics Market, Global, Licensing Deals by Region, Year and Value, 2006-2015 100

Figure 65: Gastrointestinal Therapeutics Market, Global, Licensing Deals by Indication, 2006-2016 101

Figure 66: Gastrointestinal Therapeutics Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 102

Figure 67: Gastrointestinal Therapeutics Market, Global, Licensing Deals by Molecule Type and Molecular Target, 2006-2016 103

Figure 68: Gastrointestinal Therapeutics Market, Global, Co-development Deals by Region, Year and Value, 2006-2016 105

Figure 69: Gastrointestinal Therapeutics Market, Global, Co-development Deals by Indication, 2006-2016 106

Figure 70: Gastrointestinal Therapeutics Market, Global, Co-development Deals by Stage of Development and Value, 2006-2016 107

Figure 71: Gastrointestinal Therapeutics Market, Global, Co-development Deals by Molecule Type and Molecular Target, 2006-2016 108

1.1 List of Tables

Table 1: Gastrointestinal Disorders, EU5 and US, Epidemiology of Gastrointestinal Disorders, 2015 16

Table 2: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Humira, 2016 24

Table 3: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Remicade, 2016 26

Table 4: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Soliris, 2016 28

Table 5: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Tysabri, 2016 29

Table 6: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Nexium, 2016 32

Table 7: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Entyvio, 2016 33

Table 8: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Protonix, 2016 35

Table 9: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Ocaliva, 2016 37

Table 10: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Dexilant, 2016 38

Table 11: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Amitiza, 2016 40

Table 12: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Takecab, 2016 42

Table 13: Gastrointestinal Therapeutics Market, Global, Approved Gastrointestinal Indications for Linzess, 2016 43

Table 14: Gastrointestinal Therapeutics Market, Global, Annual Revenue Forecast for Key Products ($bn), 2015-2022 73

Table 15: Gastrointestinal Therapeutics Market, Global, Usage of Generics Across Key Indications, 2016 75

Table 16: Gastrointestinal Therapeutics Market, Global, Forecast Revenue by Company, 2015-2022 82

Table 17: Gastrointestinal Therapeutics Market, Global, Licensing Deals, 2006-2016 104

Table 18: Gastrointestinal Therapeutics Market Therapeutics Market, Global, Co-development Deals, 2006-2016 109

Table 19: Epidemiology Patterns for Gastroesophageal Reflux Disease, 2015-2022 115

Table 20: Epidemiology Patterns for Inflammatory Bowel Disease, 2015-2022 115

Table 21: Epidemiology Patterns for Inflammatory Bowel Disease, 2015-2022 115

Table 22: Gastrointestinal, Global, Table of all Clinical Stage Pipeline Products, 2016 116

Table 23: Abbreviations 157

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