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Entyvio (Crohn’s Disease) - 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.

Takeda has developed vedolizumab (MLN0002, formerly known as MLN02 and LDP-02) for the treatment of CD and UC, which is currently undergoing regulatory review in the US and EU. On December 10, 2013, Takeda announced that the FDA’s Gastrointestinal Drugs Advisory Committee had unanimously voted to recommend Entyvio for approval as a treatment for adults with moderately to severely active CD and UC.

Scope

- Overview of Crohn’s disease (CD), including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Entyvio including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Entyvio for the top eight countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Canada

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 Entyvio performance
- Obtain sales forecast for Entyvio from 2012-2022 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Canada)

Table Of Contents

Entyvio (Crohn’s Disease) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.2 Symptoms 16
3.3 Prognosis 17
3.4 Quality of Life 17
4 Disease Management 18
4.1 Treatment Overview 19
5 Competitive Assessment 24
5.1 Overview 24
5.2 Strategic Competitor Assessment 25
6 Opportunity and Unmet Need 27
6.1 Overview 27
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 28
6.3 More Therapies for Anti-TNF-Refractory Patients 29
6.4 Unmet Needs Gap Analysis 30
6.5 Targeted Therapies 31
6.6 Predictive Tools for Early Diagnosis and Treatment 32
7 Pipeline Assessment 33
7.1 Overview 33
7.2 Promising Drugs in Clinical Development 33
8 Entyvio (vedolizumab) 36
8.1 Overview 36
8.2 Efficacy 37
8.3 Safety 40
8.4 Dosing and Formulation 42
8.5 Potential Clinical Positioning 43
8.6 Potential Commercial Positioning 45
8.7 Pricing and Reimbursement 45
8.8 SWOT Analysis 46
8.9 Forecast 47
9 Appendix 49
9.1 Bibliography 49
9.2 Abbreviations 52
9.3 Methodology 55
9.4 Forecasting Methodology 55
9.4.1 Diagnosed CD Patients 55
9.4.2 Percent Drug-Treated Patients 56
9.4.3 General Pricing Assumptions 56
9.4.4 Generic Erosion 58
9.4.5 Pricing of Pipeline agents 58
9.5 Physicians and Specialists Included in This Study 59
9.6 Primary Research - Prescriber Survey 61
9.7 About the Authors 62
9.7.1 Author/Reviewer 62
9.7.2 Global Head of Healthcare 62
9.8 About GlobalData 63
9.9 Disclaimer 63

1.1 List of Tables

Table 1: Symptoms of CD 16
Table 2: Treatment Guidelines for CD 20
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 22
Table 4: Leading Branded Drugs Used to Treat CD 26
Table 5: Overall Unmet Needs in CD - Current Level of Attainment 28
Table 6: Clinical Unmet Needs in CD - Gap Analysis, 2013 31
Table 7: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 34
Table 8: Comparison of Therapeutic Classes in Development for CD, 2013 35
Table 9: Product Profile - Entyvio 37
Table 10: Efficacy of Entyvio in GEMINI II Studies of CD 38
Table 11: Entyvio SWOT Analysis, 2013 46
Table 12: Global Sales Forecasts ($) for Entyvio, 2012-2022 48
Table 13: Physicians Surveyed, By Country 61

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 13
Figure 2: Potential Biologic Drug Targets for CD 15
Figure 3: Patient Care Path for CD 21
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 34

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