PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2026

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Published: September 30, 2017 Report Code: GDHC160PIDR-ST

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Crohn’s 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&J’s Stelara and the anticipated ACOT of AbbVie’s 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.

Table of Contents

1 Table of Contents 2

1.1 List of Tables 10

1.2 List of Figures 12

2 Executive Summary 13

2.1 Launch of Non-Anti-TNF Therapies Will Fuel CD Market Growth to 2026 14

2.2 R&D and Corporate Strategies Will Be Focused on the Competitive Biologics Space 16

2.3 A Number of Clinical Unmet Needs Exist in the CD Treatment Realm 17

2.4 Treatments for the Management of Perianal Fistulas Remain Elusive 18

2.5 Novel Biologics and Biosimilars Will Reshape the CD Competitive Landscape 18

2.6 What Do Physicians Think? 19

3 Introduction 22

3.1 Catalyst 22

3.2 Related Reports 23

3.3 Upcoming Related Reports 23

4 Disease Overview 24

4.1 Etiology and Pathophysiology 24

4.1.1 Etiology 24

4.1.2 Pathophysiology 24

4.2 Biomarkers/Targets of Interest 27

4.3 Symptoms 27

4.4 Prognosis 28

4.5 Quality of Life 29

5 Epidemiology 30

5.1 Disease Background 30

5.2 Risk Factors and Comorbidities 31

5.3 Global and Historical Trends 32

5.3.1 US 33

5.3.2 5EU 34

5.3.3 Japan 34

5.4 Forecast Methodology 35

5.4.1 Sources 36

5.4.2 Forecast Assumptions and Methods 38

5.5 Epidemiological Forecast for Crohn’s Disease 48

5.5.1 Diagnosed Incident Cases of Crohn’s Disease 48

5.5.2 Diagnosed Prevalent Cases of Crohn’s Disease 49

5.5.3 Age-Specific Diagnosed Prevalent Cases of Crohn’s Disease 50

5.5.4 Sex-Specific Diagnosed Prevalent Cases of Crohn’s Disease 51

5.5.5 Diagnosed Prevalent Cases of Crohn’s Disease by Severity 52

5.5.6 Diagnosed Prevalent Cases of Crohn’s Disease with Comorbid Autoimmune Diseases 53

5.6 Alternate Epidemiological Forecast for Crohn’s Disease (2016–2026) 54

5.6.1 Diagnosed Incident Cases of Crohn’s Disease 54

5.6.2 Diagnosed Prevalent Cases of Crohn’s Disease 55

5.7 Discussion 56

5.7.1 Epidemiological Forecast Insight 56

5.7.2 Limitations of Analysis 57

5.7.3 Strengths of Analysis 58

6 Disease Management 59

6.1 Diagnosis Overview 59

6.2 Treatment Overview 59

6.2.1 Treatment Guidelines and Leading Prescribed Drugs 60

6.2.2 Clinical Practice 62

6.3 US 62

6.4 5EU 64

6.5 Japan 66

7 Competitive Assessment 68

7.1 Overview 68

7.2 Remicade (infliximab) 68

7.2.1 Overview 68

7.2.2 Efficacy 71

7.2.3 Safety 72

7.2.4 SWOT Analysis 74

7.2.5 Forecast 75

7.3 Humira (adalimumab) 75

7.3.1 Overview 75

7.3.2 Efficacy 77

7.3.3 Safety 77

7.3.4 SWOT Analysis 78

7.3.5 Forecast 79

7.4 Cimzia (certolizumab pegol) 79

7.4.1 Overview 79

7.4.2 Efficacy 81

7.4.3 Safety 81

7.4.4 SWOT Analysis 82

7.4.5 Forecast 82

7.5 Entyvio (vedolizumab) 83

7.5.1 Overview 83

7.5.2 Efficacy 85

7.5.3 Safety 86

7.5.4 SWOT Analysis 87

7.5.5 Forecast 87

7.6 Stelara (ustekinumab) 88

7.6.1 Overview 88

7.6.2 Efficacy 89

7.6.3 Safety 91

7.6.4 SWOT Analysis 92

7.6.5 Forecast 92

7.7 Inflectra/Remsima (infliximab biosimilar) 93

7.7.1 Overview 93

7.7.2 Efficacy 94

7.7.3 Safety 95

7.7.4 SWOT Analysis 96

7.7.5 Forecast 96

7.8 Renflexis/Flixabi (infliximab biosimilar) 96

7.8.1 Overview 96

7.8.2 Efficacy 98

7.8.3 Safety 98

7.8.4 SWOT Analysis 99

7.8.5 Forecast 100

7.9 Amjevita/Amgevita (adalimumab biosimilar) 100

7.9.1 Overview 100

7.9.2 Efficacy 101

7.9.3 Safety 101

7.9.4 SWOT Analysis 102

7.9.5 Forecast 102

7.10 Biosimilar Assessment 102

7.10.1 Introduction 102

7.10.2 Biosimilars in the Immunology Community 104

7.10.3 By the Numbers: Biosimilars in Development 104

7.10.4 The Impact of Biosimilars Is Being Felt Through the Pharmaceutical Industry 107

7.10.5 Uptake of Biosimilars for CD Is Expected to Vary by Market 108

7.11 Other Therapeutic Classes 110

8 Unmet Needs and Opportunity Assessment 111

8.1 Overview 111

8.2 Improved Drug Efficacy and Safety in the Maintenance Therapy Setting 112

8.2.1 Unmet Need 112

8.2.2 Gap Analysis 113

8.2.3 Opportunity 113

8.3 Biomarkers to Predict Responsiveness to Therapy and Prognosis 114

8.3.1 Unmet Need 114

8.3.2 Gap Analysis 115

8.3.3 Opportunity 115

8.4 Improve Medical Management of Perianal Fistulas 116

8.4.1 Unmet Need 116

8.4.2 Gap Analysis 116

8.4.3 Opportunity 117

8.5 Patient Adherence to Maintenance Therapy 117

8.5.1 Unmet Need 117

8.5.2 Gap Analysis 118

8.5.3 Opportunity 119

9 Pipeline Assessment 120

9.1 Overview 120

9.2 Clinical Trial Mapping 122

9.2.1 Clinical Trials by Class 122

9.3 Promising Drugs in Clinical Development 123

9.4 Etrolizumab 125

9.4.1 Overview 125

9.4.2 Efficacy 126

9.4.3 Safety 127

9.4.4 Dosing and Formulation 128

9.4.5 Potential Clinical and Commercial Positioning 128

9.4.6 SWOT Analysis 130

9.4.7 Forecast 130

9.5 Mongersen 131

9.5.1 Overview 131

9.5.2 Efficacy 132

9.5.3 Safety 134

9.5.4 Dosing and Formulation 134

9.5.5 Potential Clinical and Commercial Positioning 134

9.5.6 SWOT Analysis 136

9.5.7 Forecast 137

9.6 Filgotinib 137

9.6.1 Overview 137

9.6.2 Efficacy 139

9.6.3 Safety 140

9.6.4 Dosing and Formulation 141

9.6.5 Potential Clinical and Commercial Positioning 141

9.6.6 SWOT Analysis 143

9.6.7 Forecast 143

9.7 SHP-647 144

9.7.1 Overview 144

9.7.2 Efficacy 145

9.7.3 Safety 146

9.7.4 Dosing and Formulation 146

9.7.5 Potential Clinical and Commercial Positioning 146

9.7.6 SWOT Analysis 147

9.7.7 Forecast 147

9.8 Risankizumab 148

9.8.1 Overview 148

9.8.2 Efficacy 149

9.8.3 Safety 150

9.8.4 Dosing and Formulation 150

9.8.5 Potential Clinical and Commercial Positioning 150

9.8.6 SWOT Analysis 151

9.8.7 Forecast 152

9.9 Other Drugs in Early-Stage Development 153

9.10 Other Promising Drugs in Development 154

9.10.1 Overview 154

9.10.2 Cx-601 154

9.10.3 RHB-104 154

9.10.4 Alequel 155

9.10.5 Rifaximin Delayed Release 156

9.10.6 Vercirnon Sodium 157

10 Current and Future Players 158

10.1 Overview 158

10.2 Trends in Corporate Strategy 160

10.3 Johnson & Johnson 161

10.3.1 Overview 161

10.3.2 Portfolio Assessment 162

10.3.3 SWOT Analysis 163

10.4 AbbVie 163

10.4.1 Overview 163

10.4.2 Portfolio Assessment 164

10.4.3 SWOT Analysis 165

10.5 UCB 165

10.5.1 Overview 165

10.5.2 Portfolio Assessment 165

10.5.3 SWOT Analysis 166

10.6 Takeda 167

10.6.1 Overview 167

10.6.2 Portfolio Assessment 167

10.6.3 SWOT Analysis 168

10.7 Roche 168

10.7.1 Overview 168

10.7.2 Portfolio Assessment 169

10.7.3 SWOT Analysis 169

10.8 Celgene 170

10.8.1 Overview 170

10.8.2 Portfolio Assessment 170

10.8.3 SWOT Analysis 171

10.9 Galapagos 171

10.9.1 Overview 171

10.9.2 Portfolio Assessment 172

10.9.3 SWOT Analysis 172

10.10 Shire 172

10.10.1 Overview 172

10.10.2 Portfolio Assessment 173

10.10.3 SWOT Analysis 173

11 Market Outlook 174

11.1 Global Markets 174

11.1.1 Forecast 174

11.1.2 Drivers and Barriers – Global Issues 177

11.2 US 177

11.2.1 Forecast 177

11.2.2 Key Events 180

11.2.3 Drivers and Barriers 180

11.3 5EU 181

11.3.1 Forecast 181

11.3.2 Key Events 184

11.3.3 Drivers and Barriers 184

11.4 Japan 185

11.4.1 Forecast 185

11.4.2 Key Events 188

11.4.3 Drivers and Barriers 188

12 Appendix 189

12.1 Bibliography 189

12.2 Abbreviations 209

12.3 Methodology 212

12.3.1 Forecasting Methodology 212

12.3.2 Diagnosed Prevalent Patients 212

12.3.3 Patient Segmentation 213

12.3.4 Percent Drug-Treated Patients 213

12.3.5 Drugs Included in Each Therapeutic Class 213

12.3.6 Launch and Patent Expiry Dates 214

12.3.7 General Pricing Assumptions 214

12.3.8 Individual Drug Assumptions 215

12.3.9 Generic Erosion 218

12.3.10 Pricing of Pipeline Agents 218

12.4 Primary Research – KOLs Interviewed for This Report 219

12.5 Primary Research – Prescriber Survey 222

12.6 About the Authors 223

12.6.1 Analyst 223

12.6.2 Therapy Area Director 223

12.6.3 Epidemiologist 223

12.6.4 Managing Epidemiologist 224

12.6.5 Global Director of Therapy Analysis and Epidemiology 224

12.6.6 Global Head and EVP of Healthcare Operations and Strategy 225

12.7 About GlobalData 225

12.8 Contact Us 226

12.9 Disclaimer 226

Table

Table 1: Crohn’s Disease: Key Metrics in the 7MM

Table 2: Symptoms of Crohn’s Disease

Table 3: Risk Factors and Comorbidities for Crohn’s Disease

Table 4: 7MM, Diagnosed Incident Cases of CD, All Ages, Both Sexes, Select Years 2016–2026

Table 5: 7MM, Diagnosed Prevalent Cases of CD, Men and Women, All Ages, Select Years 2016–2026

Table 6: Treatment Guidelines for Crohn’s Disease

Table 7: Most Prescribed Drugs for Crohn’s Disease by Class in the Global Markets, 2016

Table 8: Country Profile – US

Table 9: Country Profile – 5EU

Table 10: Country Profile – Japan

Table 11: Product Profile – Remicade

Table 12: Safety Data From the ACCENT II Study Up to Week 54

Table 13: Remicade SWOT Analysis, 2017

Table 14: Product Profile – Humira

Table 15: Humira SWOT Analysis, 2017

Table 16: Product Profile – Cimzia

Table 17: Cimzia SWOT Analysis, 2017

Table 18: Product Profile – Entyvio

Table 19: Efficacy Data From the Phase III GEMINI II Maintenance Study

Table 20: Safety Data for Entyvio from the GEMINI II Study

Table 21: Entyvio SWOT Analysis, 2017

Table 22: Product Profile – Stelara

Table 23: Efficacy Data From the IM-UNITI Phase III Study

Table 24: Safety Data for Stelara from the IM-UNITI Study

Table 25: Stelara SWOT Analysis, 2017

Table 26: Product Profile – Inflectra/Remsima

Table 27: Inflectra/Remsima SWOT Analysis, 2017

Table 28: Product Profile – Renflexis/Flixabi

Table 29: Renflexis/Flixabi SWOT Analysis, 2017

Table 30: Product Profile – Amjevita

Table 31: Amjevita SWOT Analysis, 2017

Table 32: Marketed and Pipeline Biosimilars for CD, 2017

Table 33: Biosimilar Legislation Across the 7MM

Table 34: Summary of Minor Therapeutic Classes, 2017

Table 35: Comparison of Therapeutic Classes in Development for Crohn’s Disease, 2016–2026

Table 36: Product Profile – Etrolizumab

Table 37: Phase II Safety Data for Etrolizumab in UC

Table 38: Etrolizumab SWOT Analysis, 2017

Table 39: Product Profile – Mongersen

Table 40: Phase II Efficacy Data for Mongersen Sodium

Table 41: Phase II Safety Data for Mongersen Sodium

Table 42: Mongersen Sodium SWOT Analysis, 2017

Table 43: Product Profile – Filgotinib

Table 44: Phase II Efficacy Data for Filgotinib from the FITZROY Study

Table 45: Phase II Safety Data for Filgotinib

Table 46: Filgotinib SWOT Analysis, 2017

Table 47: Product Profile – SHP-647

Table 48: Phase II Efficacy Data for SHP-647 from the OPERA Study

Table 49: SHP-647 SWOT Analysis, 2017

Table 50: Product Profile – Risankizumab

Table 51: Phase II Safety Data for Risankizumab

Table 52: Risankizumab SWOT Analysis, 2017

Table 53: Drugs in Development for CD, 2017

Table 54: Drugs in Development for Crohn’s Disease, 2017

Table 55: Key Companies in the Crohn’s Disease Market in the 7MM, 2017

Table 56: J&J’s Disease Portfolio Assessment, 2017

Table 57: J&J SWOT Analysis, 2017

Table 58: AbbVie’s Disease Portfolio Assessment, 2017

Table 59: AbbVie SWOT Analysis, 2017

Table 60: UCB’s Disease Portfolio Assessment, 2017

Table 61: UCB SWOT Analysis, 2017

Table 62: Takeda’s Disease Portfolio Assessment, 2017

Table 63: Takeda SWOT Analysis, 2017

Table 64: Roche/Genentech’s Disease Portfolio Assessment, 2017

Table 65: Roche/Genentech SWOT Analysis, 2017

Table 66: Celgene’s Disease Portfolio Assessment, 2017

Table 67: Celgene SWOT Analysis, 2017

Table 68: Galapagos’ Disease Portfolio Assessment, 2017

Table 69: Galapagos SWOT Analysis, 2017

Table 70: Shire’s Disease Portfolio Assessment, 2017

Table 71: Shire SWOT Analysis, 2017

Table 72: Crohn’s Disease Market – Global Drivers and Barriers, 2016–2026

Table 73: Key Events Impacting Sales for Crohn’s Disease in the US, 2016–2026

Table 74: Crohn’s Disease Market – Drivers and Barriers in the US, 2016–2026

Table 75: Key Events Impacting Sales for Crohn’s Disease in the 5EU, 2016–2026

Table 76: Crohn’s Disease Market –Drivers and Barriers in the 5EU, 2016–2026

Table 77: Key Events Impacting Sales for Crohn’s Disease in Japan, 2016–2026

Table 78: Crohn’s Disease Market – Global Drivers and Barriers in Japan, 2016–2026

Table 79: Key Historical and Projected Launch Dates for Crohn’s Disease

Table 80: Key Historical and Projected Patent Expiry Dates for Crohn’s Disease

Table 81: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global (7MM) Sales Forecast by Country for Crohn’s Disease in 2016 and 2026

Figure 2: Analysis of the Company Portfolio Gap in Crohn’s Disease During the Forecast Period

Figure 3: Crohn’s Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016–2026

Figure 4: 7MM, Age-Adjusted Diagnosed Prevalence of CD (%), Men, All Ages, 2006 to 2026

Figure 5: 7MM, Age-Adjusted Diagnosed Prevalence (%) of CD, Women, All Ages, 2006–2026

Figure 6: Sources Used and Not Used, Diagnosed Incident Cases of CD

Figure 7: Sources Used and Not Used, Diagnosed Prevalent Cases of CD

Figure 8: Sources Used, Diagnosed Prevalent Cases of CD with Comorbid Autoimmune Diseases

Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of CD, Both Sexes, 2016

Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of CD, All Ages, 2016

Figure 11: 7MM, Diagnosed Prevalent Cases of CD by Severity, Both Sexes, All Ages, 2016

Figure 12: 7MM, Diagnosed Prevalent Cases of CD with PsO, Ankylosing Spondylitis, and Pyoderma Gangrenosum, Both Sexes, All Ages, 2016

Figure 13: US and 5EU, Alternate Diagnosed Incident Cases of CD, Both Sexes, All Ages, 2016

Figure 14: Germany, Spain, Italy, and the UK, Alternate Diagnosed Prevalent Cases of CD, Both Sexes, All Ages, 2016

Figure 15: Unmet Need and Opportunity in Crohn’s Disease, 2017

Figure 16: Overview of the Development Pipeline for CD

Figure 17: CD Therapeutics – Phase III Commercial Clinical Trials by Class of Therapy, 2017

Figure 18: Key Phase II/III Trials for Promising Pipeline Agents for Crohn’s Disease, 7MM, 2016–2026

Figure 19: Crohn’s Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016–2026

Figure 20: Clinical and Commercial Positioning of Etrolizumab

Figure 21: Clinical and Commercial Positioning of Mongersen Sodium

Figure 22: Clinical and Commercial Positioning of Filgotinib

Figure 23: Clinical and Commercial Positioning of SHP-647

Figure 24: Clinical and Commercial Positioning of Risankizumab

Figure 25: Global Sales of Branded Products for Crohn’s Disease by Company in 2016 and 2026

Figure 26: Analysis of the Company Portfolio Gap in Crohn’s Disease During the Forecast Period

Figure 27: Global (7MM) Sales Forecast by Country for Crohn’s Disease in 2016 and 2026

Figure 28: Sales Forecast by Class for Crohn’s Disease in the US in 2016 and 2026

Figure 29: Sales Forecast by Class for Crohn’s Disease in the 5EU in 2016 and 2026

Figure 30: Sales Forecast by Class for Crohn’s Disease in Japan in 2016 and 2026

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