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

Publisher Name :
Date: 13-Sep-2016
No. of pages: 161

Gastrointestinal disorders are common, and a number of them have a large patient population. Across the seven major markets (the US, the UK, France, Germany, Italy, Spain and Japan), gastro esophageal reflux disease (GERD), irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) have patient populations of 148 Million, 41 Million and 2 Million, respectively. For the purpose of this report, IBD comprises Ulcerative Colitis and Crohn’s disease.

The market size for gastrointestinal therapeutics is expected to grow considerably, from USD35.7 Billion in 2015 to USD48.4 Billion in 2022, at a compound annual growth rate (CAGR) of 4.45%. Over a third of the global gastrointestinal market is accounted for by the US, whose market size is expected to increase from USD14.0 Billion in 2015 to USD17.6 Billion in 2022 at a CAGR of 4.51%.

According to Jennifer Goossens, GBI Research, explains: “Recently approved products include Intercept’s Ocaliva, for the treatment of primary biliary cirrhosis, and Takeda’s Takecab for acid-related diseases such as gastroesophageal reflux disease – which are both forecast to generate annual revenue of over USD1 Billion by 2022 – as well as Entyvio for inflammatory bowel disease (IBD).”

There are 937 gastrointestinal pipeline products in active development, most of which are small molecules and biologics. The gastrointestinal therapy area is highly active and has the seventh-largest pipeline across the pharma industry, having more active pipeline products than therapy areas such as respiratory, ophthalmology and dermatology. Over half of the pipeline products are at early stages of development, with Discovery and Preclinical products accounting for 61%. The leading companies, Takeda and AbbVie, are expected to maintain their strong positions. In 2015, AbbVie was the leading company in revenue generated from the gastrointestinal market, closely followed by Takeda, with market shares of 19.02% and 18.75%, respectively. By the end of the forecast period, Takeda is expected to overtake AbbVie and become the leading company in gastrointestinal products.

The report “Global Gastrointestinal Drug Market to 2022 - Pipeline Characterized by Emerging Biologic Therapies, While TNF Inhibitors and PPIs Continue to Dominate Therapy Landscape” provides an introduction to the gastrointestinal disease cluster, and some detailed background information regarding the key indications GERD, IBS and IBD. Information is also included regarding symptoms, etiology and pathophysiology, comorbidities and epidemiology.

In particular, this report provides the following:

• Provides an overview of the gastrointestinal marketed products landscape, including product profiles of key marketed products, and revenue projections for each of these drugs.

• Analyzes the gastrointestinal pipeline, detailing, among other parameters, drug distribution by stage of development, molecule type and molecular target, plus an analysis of the key indications GERD, IBS and IBD.

• Presents forecast projections to 2022 on a global level, with forecasts provided for the US, plus aggregate revenue forecasts of the top five EU markets (the UK, France, Germany, Italy and Spain) and Japan. Additionally, revenue forecasts for the major product categories and key players are provided.

• Assesses the company landscape for the disease cluster, with an analysis of the key players, the types of company involved, and whether the disease cluster comprises a large proportion of each company’s pipeline portfolio and total revenues.

• Analyses about trends in co-development and licensing deals relating to gastrointestinal products. Some of the most prominent deals are discussed in detail.

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

Table of Contents

1 Tables of Contents 4
1.1 Lists of Tables 6
1.2 Lists 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

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

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

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