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PharmaPoint: Crohn’s Disease - 5EU Drug Forecast and Market Analysis to 2022

Summary

The Crohn’s disease (CD) market is currently very dynamic, with novel biologic therapies on the horizon. These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If their promising safety and efficacy profiles translate to clinical practice once they enter the market, their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and Humira (adalimumab).The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of biosimilars, such as Hospira’s Inflectra (infliximab) a Remicade biosimilar. Focusing on country dynamics, Canada and the emerging markets of China and India will also play a key role in driving growth in the long term, with each market forecast to post positive Compound Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of Remicade over the forecast period.

In general, US and Canadian gastroenterologists follow the treatment guidelines published by the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA), while physicians in the EU mainly rely on the European Crohn’s and Colitis Organisation (ECCO) guidelines. Outside these regions, Japanese gastroenterologists consult the guidelines published by the MHLW, while their colleagues in China and India adhere to the guidelines published by the ACG and the AGA, in addition to the guidelines issued by local medical authorities.

Scope

- Overview of Crohn’s disease including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the 5 EU countries including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the 5 EU countries from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5 EU Crohn’s disease market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return.
- Stay ahead of the competition by understanding the changing competitive landscape for Crohn’s disease..
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential.
- Make more informed business decisions from insightful and in-depth analysis of drug performance.
- Obtain sales forecast for drugs from 2012-2022 in the 5EU countries.

Table Of Contents

PharmaPoint: Crohn’s Disease - 5EU Drug Forecast and Market Analysis to 2022
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables
9
1.2 List of Figures
11
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 15
3.2 Symptoms 19
3.3 Prognosis 20
3.4 Quality of Life 21
4 Disease Management 22
4.1 Treatment Overview 23
4.2 France 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 28
4.3 Germany 29
4.3.1 Diagnosis 29
4.3.2 Clinical Practice 29
4.4 Italy 31
4.4.1 Diagnosis 31
4.4.2 Clinical Practice 31
4.5 Spain 33
4.5.1 Diagnosis 33
4.5.2 Clinical Practice 33
4.6 UK 35
4.6.1 Diagnosis 35
4.6.2 Clinical Practice 35
5 Competitive Assessment 38
5.1 Overview 38
5.2 Strategic Competitor Assessment 39
5.3 Product Profiles - Major Brands 40
5.3.1 Remicade (infliximab) 40
5.3.2 Humira (adalimumab) 46
5.3.3 Cimzia (certolizumab pegol) 51
5.3.4 Tysabri (natalizumab) 54
5.3.5 Other Marketed Products 59
5.4 Biosimilars 60
5.4.1 Introduction 60
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 61
5.4.3 Biosimilars in the Immunology Community 62
5.4.4 By the Numbers: Biosimilars in Development 62
5.4.5 The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry 64
6 Opportunity and Unmet Need 66
6.1 Overview 66
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 67
6.3 More Therapies for Anti-TNF-Refractory Patients 68
6.4 Unmet Needs Gap Analysis 68
6.5 Targeted Therapies 70
6.6 Predictive Tools for Early Diagnosis and Treatment 71
7 Pipeline Assessment 72
7.1 Overview 72
7.2 Promising Drugs in Clinical Development 72
7.2.1 Entyvio (vedolizumab) 74
7.2.2 Stelara (ustekinumab) 86
7.2.3 Vercirnon (formerly GSK1605786) 92
7.3 Other Late-Stage Pipeline Products 99
7.3.1 Cx601 99
7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 102
8 Market Outlook 107
8.1 Global Markets 107
8.1.1 Drivers and Barriers - Global Issues 107
9 5 EU 112
9.1 France 112
9.1.1 Forecast 112
9.1.2 Key Events 116
9.1.3 Drivers and Barriers 116
9.2 Germany 118
9.2.1 Forecast 118
9.2.2 Key Events 123
9.2.3 Drivers and Barriers 123
9.3 Italy 125
9.3.1 Forecast 125
9.3.2 Key Events 129
9.3.3 Drivers and Barriers 129
9.4 Spain 132
9.4.1 Forecast 132
9.4.2 Key Events 136
9.4.3 Drivers and Barriers 136
9.5 UK 139
9.5.1 Forecast 139
9.5.2 Key Events 143
9.5.3 Drivers and Barriers 143
10 Appendix 147
10.1 Bibliography 147
10.2 Abbreviations 153
10.3 Methodology 156
10.4 Forecasting Methodology 156
10.4.1 Diagnosed CD Patients 156
10.4.2 Percent Drug-Treated Patients 157
10.4.3 Drugs Included in Each Therapeutic Class 157
10.4.4 Launch and Patent Expiry Dates 158
10.4.5 General Pricing Assumptions 158
10.4.6 Individual Drug Assumptions 160
10.4.7 Generic Erosion 162
10.4.8 Pricing of Pipeline agents 163
10.5 Physicians and Specialists Included in This Study 164
10.6 Primary Research - Prescriber Survey 165
10.7 About the Authors 166
10.7.1 Author/Reviewer 166
10.7.2 Global Head of Healthcare 166
10.8 About GlobalData 167
10.9 Disclaimer 167

1.1 List of Tables

Table 1: Symptoms of CD 20
Table 2: Treatment Guidelines for CD 24
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 26
Table 4: Leading Branded Drugs Used to Treat CD 40
Table 5: Product Profile - Remicade 42
Table 6: Remicade SWOT Analysis, 2013 45
Table 7: Product Profile - Humira 47
Table 8: Humira SWOT Analysis, 2013 50
Table 9: Product Profile - Cimzia 52
Table 10: Cimzia SWOT Analysis, 2013 54
Table 11: Product Profile - Tysabri 55
Table 12: Tysabri SWOT Analysis, 2013 59
Table 13: Summary of the Minor Therapeutic Classes in CD, 2013 60
Table 14: Biosimilars Pipeline, 2013 63
Table 15: Overall Unmet Needs in CD - Current Level of Attainment 67
Table 16: Clinical Unmet Needs in CD - Gap Analysis, 2013 70
Table 17: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 73
Table 18: Comparison of Therapeutic Classes in Development for CD, 2013 74
Table 19: Product Profile - Entyvio 76
Table 20: Efficacy of Entyvio in GEMINI II Studies of CD 77
Table 21: Entyvio SWOT Analysis, 2013 85
Table 22: Product Profile - Stelara 87
Table 23: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 89
Table 24: Stelara SWOT Analysis, 2013 92
Table 25: Product Profile - Vercirnon 94
Table 26: Vercirnon SWOT Analysis, 2013 99
Table 27: Product Profile - Cx601 101
Table 28: Cx601 SWOT Analysis, 2013 102
Table 29: Product Profile - RHB-104 104
Table 30: RHB-104 SWOT Analysis, 2013 106
Table 31: Global CD Market - Drivers and Barriers, 2012-2022 107
Table 32: Sales Forecasts ($) for CD in France, 2012-2022 114
Table 33: Key Events Impacting Sales for CD in France, 2012-2022 116
Table 34: CD Market in France - Drivers and Barriers, 2012-2022 116
Table 35: Sales Forecasts ($) for CD in Germany, 2012-2022 121
Table 36: Key Events Impacting Sales for CD in Germany, 2012-2022 123
Table 37: CD Market in Germany - Drivers and Barriers, 2012-2022 123
Table 38: Sales Forecasts ($) for CD in Italy, 2012-2022 127
Table 39: Key Events Impacting Sales for CD in Italy, 2012-2022 129
Table 40: CD Market in Italy - Drivers and Barriers, 2012-2022 129
Table 41: Sales Forecasts ($) for CD in Spain, 2012-2022 134
Table 42: Key Events Impacting Sales for CD in Spain, 2012-2022 136
Table 43: CD Market in Spain - Drivers and Barriers, 2012-2022 136
Table 44: Sales Forecasts ($) for CD in the UK, 2012-2022 141
Table 45: Key Events Impacting Sales for CD in the UK, 2012-2022 143
Table 46: CD Market in the UK - Drivers and Barriers, 2012-2022 143
Table 47: Key Launch Dates 158
Table 48: Key Patent Expiries 158
Table 49: Physicians Surveyed, By Country 165

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 16
Figure 2: Potential Biologic Drug Targets for CD 19
Figure 3: Patient Care Path for CD 25
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 73
Figure 5: Sales for CD in France by Drug Class, 2012-2022 115
Figure 6: Sales for CD in Germany by Drug Class, 2012-2022 122
Figure 7: Sales for CD in Italy by Drug Class, 2012-2022 128
Figure 8: Sales for CD in Spain by Drug Class, 2012-2022 135
Figure 9: Sales for CD in the UK by Drug Class, 2012-2022 142

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