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PharmaPoint: Crohn’s Disease - US 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.

Owing to a large pool of approximately 600,000 patients and the comparatively high cost of drug therapies for CD, the US was the largest CD market by value and volume in 2012, and will retain this position throughout GlobalData’s 10-year forecast to 2022. New market players will emerge during the early years of the forecast period — namely, Takeda’s Entyvio in 2014 and J&J’s Stelara in 2015. Their launches will fuel further growth in the US CD market, albeit to the detriment of Remicade’s and Humira’s patient shares.

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

Table Of Contents

PharmaPoint: Crohn’s Disease - US Drug Forecast and Market Analysis to 2022
1 Table of Contents

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 20
4 Disease Management 21
4.1 Treatment Overview 22
4.2 US 27
4.2.1 Diagnosis 27
4.2.2 Clinical Practice 27
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 31
5.3 Product Profiles - Major Brands 32
5.3.1 Remicade (infliximab) 32
5.3.2 Humira (adalimumab) 38
5.3.3 Cimzia (certolizumab pegol) 42
5.3.4 Tysabri (natalizumab) 46
5.3.5 Other Marketed Products 51
5.4 Biosimilars 52
5.4.1 Introduction 52
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 53
5.4.3 Biosimilars in the Immunology Community 54
5.4.4 By the Numbers: Biosimilars in Development 54
5.4.5 The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry 57
6 Opportunity and Unmet Need 58
6.1 Overview 58
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 59
6.3 More Therapies for Anti-TNF-Refractory Patients 60
6.4 Unmet Needs Gap Analysis 61
6.5 Targeted Therapies 62
6.6 Predictive Tools for Early Diagnosis and Treatment 63
7 Pipeline Assessment 64
7.1 Overview 64
7.2 Promising Drugs in Clinical Development 64
7.2.1 Entyvio (vedolizumab) 66
7.2.2 Stelara (ustekinumab) 78
7.2.3 Vercirnon (formerly GSK1605786) 84
7.2.4 Prochymal (Remestemcel-L) 91
7.3 Other Late-Stage Pipeline Products 97
7.3.1 Cx601 97
7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 99
8 Market Outlook 104
8.1 Global Markets 104
8.1.1 Drivers and Barriers - Global Issues 104
9 US 109
9.1 Forecast 109
9.2 Key Events 112
9.3 Drivers and Barriers 112
9.3.1 Driver: Launches of the new non-anti-TNF biologics during 2014-2015 will challenge the current anti-TNF market leaders 113
9.3.2 Driver: Establishing a regulatory framework for biosimilar approval 113
9.3.3 Driver: Drugs that currently require high co-payment and/or prior authorization may benefit from US healthcare reform 114
9.3.4 Barrier: Guidance for the use of biosimilars needs to be in place ahead of their arrival 114
9.3.5 Barrier: Brand erosion following the patent expiries of the market leaders from 2015 115
9.3.6 Barrier: The established biologics market creates a challenging environment for new market entrants 115
9.3.7 Barrier: The increasing emphasis on lowering healthcare expenditures may prove to be a hurdle for developers hoping to command premium prices 115
9.3.8 Barrier: Pricing pressures and reimbursement issues 116
10 Appendix 117
10.1 Bibliography 117
10.2 Abbreviations 122
10.3 Methodology 126
10.4 Forecasting Methodology 126
10.4.1 Diagnosed CD Patients 126
10.4.2 Percent Drug-Treated Patients 127
10.4.3 Drugs Included in Each Therapeutic Class 127
10.4.4 Launch and Patent Expiry Dates 127
10.4.5 General Pricing Assumptions 128
10.4.6 Individual Drug Assumptions 129
10.4.7 Generic Erosion 132
10.4.8 Pricing of Pipeline agents 132
10.5 Physicians and Specialists Included in This Study 133
10.6 Primary Research - Prescriber Survey 135
10.7 About the Authors 135
10.7.1 Author/Reviewer 135
10.7.2 Global Head of Healthcare 136
10.8 About GlobalData 137
10.9 Disclaimer 137

1.1 List of Tables

Table 1: Symptoms of CD 19
Table 2: Treatment Guidelines for CD 23
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 25
Table 4: Leading Branded Drugs Used to Treat CD 32
Table 5: Product Profile - Remicade 34
Table 6: Remicade SWOT Analysis, 2013 37
Table 7: Product Profile - Humira 39
Table 8: Humira SWOT Analysis, 2013 42
Table 9: Product Profile - Cimzia 44
Table 10: Cimzia SWOT Analysis, 2013 46
Table 11: Product Profile - Tysabri 47
Table 12: Tysabri SWOT Analysis, 2013 51
Table 13: Summary of the Minor Therapeutic Classes in CD, 2013 52
Table 14: Biosimilars Pipeline, 2013 55
Table 15: Overall Unmet Needs in CD - Current Level of Attainment 59
Table 16: Clinical Unmet Needs in CD - Gap Analysis, 2013 62
Table 17: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 65
Table 18: Comparison of Therapeutic Classes in Development for CD, 2013 66
Table 19: Product Profile - Entyvio 68
Table 20: Efficacy of Entyvio in GEMINI II Studies of CD 69
Table 21: Entyvio SWOT Analysis, 2013 77
Table 22: Product Profile - Stelara 79
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 81
Table 24: Stelara SWOT Analysis, 2013 84
Table 25: Product Profile - Vercirnon 86
Table 26: Vercirnon SWOT Analysis, 2013 91
Table 27: Product Profile - Prochymal 93
Table 28: Prochymal SWOT Analysis, 2013 96
Table 29: Product Profile - Cx601 98
Table 30: Cx601 SWOT Analysis, 2013 99
Table 31: Product Profile - RHB-104 101
Table 32: RHB-104 SWOT Analysis, 2013 103
Table 33: Global CD Market - Drivers and Barriers, 2012-2022 104
Table 34: Sales Forecasts ($) for CD in the United States, 2012-2022 110
Table 35: Key Events Impacting Sales for CD in the US, 2012-2022 112
Table 36: CD Market in the US - Drivers and Barriers, 2012-2022 112
Table 37: Key Launch Dates 127
Table 38: Key Patent Expiries 128
Table 39: Physicians Surveyed, By Country 135

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 18
Figure 3: Patient Care Path for CD 24
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 65
Figure 5: Sales for CD in the US by Drug Class, 2012-2022 111

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