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PharmaPoint: Crohn’s Disease - Canada 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.

Based on GlobalData’s primary research survey, the majority of Canadian gastroenterologists follow the AGA guidelines for the management of their CD patients. Over 65% of referrals for CD patients to a gastroenterologist come from PCPs or colorectal surgeons. The peak age for the diagnosis of CD in over 65% of cases in Canada is 17–40 years, and the diagnosis is typically confirmed by clinical evaluation and a combination of hematological, endoscopic, histological, or imaging-based investigations following the initial presenting symptoms of abdominal pain, diarrhea, and weight loss, or the more common systemic symptoms of malaise, anorexia, and fever.

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 Canada including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Canada from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Canada 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 Canada.

Table Of Contents

PharmaPoint: Crohn’s Disease - Canada Drug Forecast and Market Analysis to 2022
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables
8
1.2 List of Figures
10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 14
3.2 Symptoms 18
3.3 Prognosis 19
3.4 Quality of Life 19
4 Disease Management 20
4.1 Treatment Overview 21
4.2 Canada 26
4.2.1 Diagnosis 26
4.2.2 Clinical Practice 26
5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29
5.3 Product Profiles - Major Brands 30
5.3.1 Remicade (infliximab) 30
5.3.2 Humira (adalimumab) 36
5.3.3 Cimzia (certolizumab pegol) 40
5.3.4 Other Marketed Products 44
5.4 Biosimilars 45
5.4.1 Introduction 45
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 46
5.4.3 Biosimilars in the Immunology Community 47
5.4.4 By the Numbers: Biosimilars in Development 47
5.4.5 The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry 49
6 Opportunity and Unmet Need 51
6.1 Overview 51
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 52
6.3 More Therapies for Anti-TNF-Refractory Patients 53
6.4 Unmet Needs Gap Analysis 54
6.5 Targeted Therapies 55
6.6 Predictive Tools for Early Diagnosis and Treatment 56
7 Pipeline Assessment 57
7.1 Overview 57
7.2 Promising Drugs in Clinical Development 57
7.2.1 Entyvio (vedolizumab) 59
7.2.2 Stelara (ustekinumab) 71
7.2.3 Vercirnon (formerly GSK1605786) 77
7.2.4 Prochymal (Remestemcel-L) 84
7.3 Other Late-Stage Pipeline Products 90
7.3.1 Cx601 90
7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 92
8 Market Outlook 97
8.1 Global Markets 97
8.1.1 Drivers and Barriers - Global Issues 97
9 Canada 102
9.1 Forecast 102
9.2 Key Events 106
9.3 Drivers and Barriers 106
9.3.1 Driver: New product launches in 2015 of non-anti-TNF biologics will challenge the current anti-TNF market leaders 106
9.3.2 Driver: The pathway for biosimilar approval is already in place 107
9.3.3 Driver: Continued uptake of TNF inhibitors, particularly Remicade 107
9.3.4 Driver: Health Canada's complete coverage of all drugs administered in the hospital improves patient access to IV drugs such as Remicade 107
9.3.5 Barrier: Government initiatives to the cut prices of generics will increase the rate of genericization 108
10 Appendix 109
10.1 Bibliography 109
10.2 Abbreviations 114
10.3 Methodology 117
10.4 Forecasting Methodology 117
10.4.1 Diagnosed CD Patients 118
10.4.2 Percent Drug-Treated Patients 118
10.4.3 Drugs Included in Each Therapeutic Class 118
10.4.4 Launch and Patent Expiry Dates 119
10.4.5 General Pricing Assumptions 119
10.4.6 Individual Drug Assumptions 121
10.4.7 Generic Erosion 123
10.4.8 Pricing of Pipeline agents 123
10.5 Physicians and Specialists Included in This Study 124
10.6 Primary Research - Prescriber Survey 125
10.7 About the Authors 126
10.7.1 Author/Reviewer 126
10.7.2 Global Head of Healthcare 126
10.8 About GlobalData 127
10.9 Disclaimer 127

1.1 List of Tables

Table 1: Symptoms of CD 18
Table 2: Treatment Guidelines for CD 22
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 24
Table 4: Leading Branded Drugs Used to Treat CD 30
Table 5: Product Profile - Remicade 32
Table 6: Remicade SWOT Analysis, 2013 35
Table 7: Product Profile - Humira 37
Table 8: Humira SWOT Analysis, 2013 40
Table 9: Product Profile - Cimzia 42
Table 10: Cimzia SWOT Analysis, 2013 44
Table 11: Summary of the Minor Therapeutic Classes in CD, 2013 45
Table 12: Biosimilars Pipeline, 2013 48
Table 13: Overall Unmet Needs in CD - Current Level of Attainment 52
Table 14: Clinical Unmet Needs in CD - Gap Analysis, 2013 55
Table 15: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 58
Table 16: Comparison of Therapeutic Classes in Development for CD, 2013 59
Table 17: Product Profile - Entyvio 61
Table 18: Efficacy of Entyvio in GEMINI II Studies of CD 62
Table 19: Entyvio SWOT Analysis, 2013 70
Table 20: Product Profile - Stelara 72
Table 21: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 74
Table 22: Stelara SWOT Analysis, 2013 77
Table 23: Product Profile - Vercirnon 79
Table 24: Vercirnon SWOT Analysis, 2013 84
Table 25: Product Profile - Prochymal 86
Table 26: Prochymal SWOT Analysis, 2013 89
Table 27: Product Profile - Cx601 91
Table 28: Cx601 SWOT Analysis, 2013 92
Table 29: Product Profile - RHB-104 94
Table 30: RHB-104 SWOT Analysis, 2013 96
Table 31: Global CD Market - Drivers and Barriers, 2012-2022 97
Table 32: Sales Forecasts ($) for CD in Canada, 2012-2022 104
Table 33: Key Events Impacting Sales for CD in Canada, 2012-2022 106
Table 34: CD Market in Canada - Drivers and Barriers, 2012-2022 106
Table 35: Key Launch Dates 119
Table 36: Key Patent Expiries 119
Table 37: Physicians Surveyed, By Country 125

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 15
Figure 2: Potential Biologic Drug Targets for CD 17
Figure 3: Patient Care Path for CD 23
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 58
Figure 5: Sales for CD in Canada by Drug Class, 2012-2022 105

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