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PharmaPoint: Crohns Disease-Global Drug Forecast and Market Analysis to 2026

Published By :

GlobalData

Published Date : Sep 2017

Category :

Pharmaceutical

No. of Pages : 226 Pages

PharmaPoint: Crohns Disease - Global Drug Forecast and Market Analysis to 2026

Summary

Crohns disease (CD) is a form of inflammatory bowel disease (IBD), which is comprised of two chronic autoimmune diseases that cause intestinal inflammation: Crohn's disease (CD) and ulcerative colitis (UC). In CD, chronic inflammation may affect any part of the gastrointestinal (GI) tract from the mouth to the anal area; however, CD occurs most commonly in the lower part of the small intestine (ileum) and in the large intestine. The pathophysiology of CD is complex, as the disease is characterized by recurring flares that evolve along with periods of inactivity and remission.

GlobalData estimates the 2016 sales for the COPD market at approximately $9.2 billion across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the CD market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.8% across the 7MM. Each of the 7MM are anticipated to grow, recording CAGRs of 4.9%, 1.3%, and 3.6% across the US, 5EU, and Japan, respectively. At the end of 2026, the US will account for 87.2% of sales across the 7MM, while the 5EU and Japan, will account for around 11.3% and 1.4% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of CD in the region, as well as the high annual cost of therapy (ACOT) of J&Js Stelara and the anticipated ACOT of AbbVies risankizumab in the US market.

Scope

- Overview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline CD market revenue from 2016-2026. ACOT and major pipeline product sales in this forecast period are included.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting CD therapeutics sales in the 7MM.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global CD therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global CD therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CD therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 7
2 Executive Summary 8
2.1 Launch of Non-Anti-TNF Therapies Will Fuel CD Market Growth to 2026 9
2.2 R&D and Corporate Strategies Will Be Focused on the Competitive Biologics Space 11
2.3 A Number of Clinical Unmet Needs Exist in the CD Treatment Realm 12
2.4 Treatments for the Management of Perianal Fistulas Remain Elusive 13
2.5 Novel Biologics and Biosimilars Will Reshape the CD Competitive Landscape 13
2.6 What Do Physicians Think? 14
3 Introduction 17
3.1 Catalyst 17
3.2 Related Reports 18
3.3 Upcoming Related Reports 18
4 Disease Overview 19
4.1 Etiology and Pathophysiology 19
4.2 Biomarkers/Targets of Interest 22
4.3 Symptoms 22
4.4 Prognosis 23
4.5 Quality of Life 24
5 Epidemiology 25
5.1 Disease Background 25
5.2 Risk Factors and Comorbidities 26
5.3 Global and Historical Trends 27
5.4 Forecast Methodology 30
5.5 Epidemiological Forecast for Crohns Disease 43
5.6 Alternate Epidemiological Forecast for Crohns Disease (2016-2026) 49
5.7 Discussion 51
6 Disease Management 54
6.1 Diagnosis Overview 54
6.2 Treatment Overview 54
6.3 US 57
6.4 5EU 59
6.5 Japan 61
7 Competitive Assessment 63
7.1 Overview 63
7.2 Remicade (infliximab) 63
7.3 Humira (adalimumab) 70
7.4 Cimzia (certolizumab pegol) 74
7.5 Entyvio (vedolizumab) 78
7.6 Stelara (ustekinumab) 83
7.7 Inflectra/Remsima (infliximab biosimilar) 88
7.8 Renflexis/Flixabi (infliximab biosimilar) 92
7.9 Amjevita/Amgevita (adalimumab biosimilar) 95
7.10 Biosimilar Assessment 97
7.11 Other Therapeutic Classes 105
8 Unmet Needs and Opportunity Assessment 106
8.1 Overview 106
8.2 Improved Drug Efficacy and Safety in the Maintenance Therapy Setting 107
8.3 Biomarkers to Predict Responsiveness to Therapy and Prognosis 109
8.4 Improve Medical Management of Perianal Fistulas 111
8.5 Patient Adherence to Maintenance Therapy 112
9 Pipeline Assessment 115
9.1 Overview 115
9.2 Clinical Trial Mapping 117
9.3 Promising Drugs in Clinical Development 118
9.4 Etrolizumab 120
9.5 Mongersen 126
9.6 Filgotinib 132
9.7 SHP-647 139
9.8 Risankizumab 143
9.9 Other Drugs in Early-Stage Development 148
9.10 Other Promising Drugs in Development 149
10 Current and Future Players 153
10.1 Overview 153
10.2 Trends in Corporate Strategy 155
10.3 Johnson & Johnson 156
10.4 AbbVie 158
10.5 UCB 160
10.6 Takeda 162
10.7 Roche 163
10.8 Celgene 165
10.9 Galapagos 166
10.10 Shire 167
11 Market Outlook 169
11.1 Global Markets 169
11.2 US 172
11.3 5EU 176
11.4 Japan 180
12 Appendix 184
12.1 Bibliography 184
12.2 Abbreviations 204
12.3 Methodology 207
12.4 Primary Research - KOLs Interviewed for This Report 214
12.5 Primary Research - Prescriber Survey 217
12.6 About the Authors 218
12.7 About GlobalData 220
12.8 Contact Us 221
12.9 Disclaimer 221

1.1 List of Tables
Table 1: Crohns Disease: Key Metrics in the 7MM 13
Table 2: Symptoms of Crohns Disease 28
Table 3: Risk Factors and Comorbidities for Crohns Disease 31
Table 4: 7MM, Diagnosed Incident Cases of CD, All Ages, Both Sexes, Select Years 2016-2026 49
Table 5: 7MM, Diagnosed Prevalent Cases of CD, Men and Women, All Ages, Select Years 2016-2026 50
Table 6: Treatment Guidelines for Crohns Disease 61
Table 7: Most Prescribed Drugs for Crohns Disease by Class in the Global Markets, 2016 61
Table 8: Country Profile - US 63
Table 9: Country Profile - 5EU 65
Table 10: Country Profile - Japan 67
Table 11: Product Profile - Remicade 70
Table 12: Safety Data From the ACCENT II Study Up to Week 54 73
Table 13: Remicade SWOT Analysis, 2017 74
Table 14: Product Profile - Humira 76
Table 15: Humira SWOT Analysis, 2017 78
Table 16: Product Profile - Cimzia 80
Table 17: Cimzia SWOT Analysis, 2017 82
Table 18: Product Profile - Entyvio 84
Table 19: Efficacy Data From the Phase III GEMINI II Maintenance Study 85
Table 20: Safety Data for Entyvio from the GEMINI II Study 86
Table 21: Entyvio SWOT Analysis, 2017 87
Table 22: Product Profile - Stelara 89
Table 23: Efficacy Data From the IM-UNITI Phase III Study 90
Table 24: Safety Data for Stelara from the IM-UNITI Study 91
Table 25: Stelara SWOT Analysis, 2017 92
Table 26: Product Profile - Inflectra/Remsima 94
Table 27: Inflectra/Remsima SWOT Analysis, 2017 96
Table 28: Product Profile - Renflexis/Flixabi 97
Table 29: Renflexis/Flixabi SWOT Analysis, 2017 99
Table 30: Product Profile - Amjevita 101
Table 31: Amjevita SWOT Analysis, 2017 102
Table 32: Marketed and Pipeline Biosimilars for CD, 2017 105
Table 33: Biosimilar Legislation Across the 7MM 109
Table 34: Summary of Minor Therapeutic Classes, 2017 110
Table 35: Comparison of Therapeutic Classes in Development for Crohns Disease, 2016-2026 125
Table 36: Product Profile - Etrolizumab 126
Table 37: Phase II Safety Data for Etrolizumab in UC 128
Table 38: Etrolizumab SWOT Analysis, 2017 130
Table 39: Product Profile - Mongersen 132
Table 40: Phase II Efficacy Data for Mongersen Sodium 133
Table 41: Phase II Safety Data for Mongersen Sodium 134
Table 42: Mongersen Sodium SWOT Analysis, 2017 136
Table 43: Product Profile - Filgotinib 139
Table 44: Phase II Efficacy Data for Filgotinib from the FITZROY Study 140
Table 45: Phase II Safety Data for Filgotinib 140
Table 46: Filgotinib SWOT Analysis, 2017 143
Table 47: Product Profile - SHP-647 145
Table 48: Phase II Efficacy Data for SHP-647 from the OPERA Study 145
Table 49: SHP-647 SWOT Analysis, 2017 147
Table 50: Product Profile - Risankizumab 149
Table 51: Phase II Safety Data for Risankizumab 150
Table 52: Risankizumab SWOT Analysis, 2017 151
Table 53: Drugs in Development for CD, 2017 153
Table 54: Drugs in Development for Crohns Disease, 2017 154
Table 55: Key Companies in the Crohns Disease Market in the 7MM, 2017 158
Table 56: J&Js Disease Portfolio Assessment, 2017 162
Table 57: J&J SWOT Analysis, 2017 163
Table 58: AbbVies Disease Portfolio Assessment, 2017 164
Table 59: AbbVie SWOT Analysis, 2017 165
Table 60: UCBs Disease Portfolio Assessment, 2017 166
Table 61: UCB SWOT Analysis, 2017 166
Table 62: Takedas Disease Portfolio Assessment, 2017 168
Table 63: Takeda SWOT Analysis, 2017 168
Table 64: Roche/Genentechs Disease Portfolio Assessment, 2017 169
Table 65: Roche/Genentech SWOT Analysis, 2017 169
Table 66: Celgenes Disease Portfolio Assessment, 2017 170
Table 67: Celgene SWOT Analysis, 2017 171
Table 68: Galapagos Disease Portfolio Assessment, 2017 172
Table 69: Galapagos SWOT Analysis, 2017 172
Table 70: Shires Disease Portfolio Assessment, 2017 173
Table 71: Shire SWOT Analysis, 2017 173
Table 72: Crohns Disease Market - Global Drivers and Barriers, 2016-2026 177
Table 73: Key Events Impacting Sales for Crohns Disease in the US, 2016-2026 180
Table 74: Crohns Disease Market - Drivers and Barriers in the US, 2016-2026 180
Table 75: Key Events Impacting Sales for Crohns Disease in the 5EU, 2016-2026 184
Table 76: Crohns Disease Market -Drivers and Barriers in the 5EU, 2016-2026 184
Table 77: Key Events Impacting Sales for Crohns Disease in Japan, 2016-2026 188
Table 78: Crohns Disease Market - Global Drivers and Barriers in Japan, 2016-2026 188
Table 79: Key Historical and Projected Launch Dates for Crohns Disease 214
Table 80: Key Historical and Projected Patent Expiry Dates for Crohns Disease 214
Table 81: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 222

1.2 List of Figures
Figure 1: Global (7MM) Sales Forecast by Country for Crohns Disease in 2016 and 2026 15
Figure 2: Analysis of the Company Portfolio Gap in Crohns Disease During the Forecast Period 17
Figure 3: Crohns Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016-2026 19
Figure 4: 7MM, Age-Adjusted Diagnosed Prevalence of CD (%), Men, All Ages, 2006 to 2026 32
Figure 5: 7MM, Age-Adjusted Diagnosed Prevalence (%) of CD, Women, All Ages, 2006-2026 33
Figure 6: Sources Used and Not Used, Diagnosed Incident Cases of CD 36
Figure 7: Sources Used and Not Used, Diagnosed Prevalent Cases of CD 37
Figure 8: Sources Used, Diagnosed Prevalent Cases of CD with Comorbid Autoimmune Diseases 38
Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of CD, Both Sexes, 2016 50
Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of CD, All Ages, 2016 51
Figure 11: 7MM, Diagnosed Prevalent Cases of CD by Severity, Both Sexes, All Ages, 2016 52
Figure 12: 7MM, Diagnosed Prevalent Cases of CD with PsO, Ankylosing Spondylitis, and Pyoderma Gangrenosum, Both Sexes, All Ages, 2016 53
Figure 13: US and 5EU, Alternate Diagnosed Incident Cases of CD, Both Sexes, All Ages, 2016 54
Figure 14: Germany, Spain, Italy, and the UK, Alternate Diagnosed Prevalent Cases of CD, Both Sexes, All Ages, 2016 55
Figure 15: Unmet Need and Opportunity in Crohns Disease, 2017 111
Figure 16: Overview of the Development Pipeline for CD 121
Figure 17: CD Therapeutics - Phase III Commercial Clinical Trials by Class of Therapy, 2017 122
Figure 18: Key Phase II/III Trials for Promising Pipeline Agents for Crohns Disease, 7MM, 2016-2026 123
Figure 19: Crohns Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016-2026 124
Figure 20: Clinical and Commercial Positioning of Etrolizumab 129
Figure 21: Clinical and Commercial Positioning of Mongersen Sodium 136
Figure 22: Clinical and Commercial Positioning of Filgotinib 142
Figure 23: Clinical and Commercial Positioning of SHP-647 146
Figure 24: Clinical and Commercial Positioning of Risankizumab 151
Figure 25: Global Sales of Branded Products for Crohns Disease by Company in 2016 and 2026 159
Figure 26: Analysis of the Company Portfolio Gap in Crohns Disease During the Forecast Period 160
Figure 27: Global (7MM) Sales Forecast by Country for Crohns Disease in 2016 and 2026 176
Figure 28: Sales Forecast by Class for Crohns Disease in the US in 2016 and 2026 179
Figure 29: Sales Forecast by Class for Crohns Disease in the 5EU in 2016 and 2026 183
Figure 30: Sales Forecast by Class for Crohns Disease in Japan in 2016 and 2026 187

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