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Tysabri (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.

Tysabri (natalizumab), which was discovered by Elan, is a recombinant humanized immunoglobulin G4 (IgG4) mAb that acts as a selective ?-4 integrin inhibitor. It binds to the ?4-subunit of ?4ß1 and ?4ß7 integrins expressed on the surface of leukocytes and inhibits their ?4-mediated adhesion to mucosal VCAM-1 and MadCAM-1 receptors, respectively. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed tissue. Tysabri was initially approved for the treatment of MS, and gained approval in the US in 2008 for use in CD as a second-line therapy.

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 Tysabri including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Tysabri for the top six countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain and China

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 Tysabri performance
- Obtain sales forecast for Tysabri from 2012-2022 in top six countries (the US, France, Germany, Italy, Spain and China)

Table Of Contents

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

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
2.3 Upcoming Related Reports 10
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 11
3.2 Symptoms 15
3.3 Prognosis 16
3.4 Quality of Life 16
4 Disease Management 17
4.1 Treatment Overview 18
5 Competitive Assessment 23
5.1 Overview 23
5.2 Strategic Competitor Assessment 24
6 Tysabri (natalizumab) 26
6.1 Overview 26
6.2 Efficacy 27
6.3 Safety 28
6.4 SWOT Analysis 29
6.5 Forecast 31
7 Appendix 33
7.1 Bibliography 33
7.2 Abbreviations 36
7.3 Methodology 38
7.4 Forecasting Methodology 38
7.4.1 Diagnosed CD Patients 38
7.4.2 Percent Drug-Treated Patients 39
7.4.3 General Pricing Assumptions 39
7.4.4 Individual Drug Assumptions 40
7.4.5 Generic Erosion 41
7.5 Physicians and Specialists Included in This Study 42
7.6 Primary Research - Prescriber Survey 44
7.7 About the Authors 45
7.7.1 Author/Reviewer 45
7.7.2 Global Head of Healthcare 45
7.8 About GlobalData 46
7.9 Disclaimer 46

1.1 List of Tables

Table 1: Symptoms of CD 15
Table 2: Treatment Guidelines for CD 19
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 21
Table 4: Leading Branded Drugs Used to Treat CD 25
Table 5: Product Profile - Tysabri 27
Table 6: Tysabri SWOT Analysis, 2013 30
Table 7: Global Sales Forecasts ($) for Tysabri, 2012-2022 32
Table 8: Physicians Surveyed, By Country 44

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 12
Figure 2: Potential Biologic Drug Targets for CD 14
Figure 3: Patient Care Path for CD 20

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