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Stelara (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.

Janssen Biotech (a J&J subsidiary) is developing Stelara for the treatment of patients with moderate to severe CD (see the Disease Overview section for further discussion). Stelara is an IgG1 mAb that simultaneously targets the common p40 subunit of the IL-12/IL-23 cytokines, which are implicated in CD. According to J&J’s October 15, 2013 product pipeline, Stelara is currently undergoing Phase III trials in CD patients who have failed anti-TNF therapies (UNITI-1 trial), as well as in those who have failed conventional corticosteroid and immunomodulator therapies (UNITI-2 trial).

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 Stelara including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Stelara 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 Stelara performance
- Obtain sales forecast for Stelara from 2012-2022 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Canada)

Table Of Contents

Stelara (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 Stelara (ustekinumab) 36
8.1 Overview 36
8.2 Efficacy 37
8.3 Safety 39
8.4 Dosing and Formulation 40
8.5 Potential Clinical Positioning 40
8.6 Potential Commercial Positioning 41
8.7 Pricing and Reimbursement 41
8.8 SWOT Analysis 42
8.9 Forecast 42
9 Appendix 45
9.1 Bibliography 45
9.2 Abbreviations 48
9.3 Methodology 51
9.4 Forecasting Methodology 51
9.4.1 Diagnosed CD Patients 51
9.4.2 Percent Drug-Treated Patients 52
9.4.3 General Pricing Assumptions 52
9.4.4 Generic Erosion 54
9.4.5 Pricing of Pipeline agents 54
9.5 Physicians and Specialists Included in This Study 55
9.6 Primary Research - Prescriber Survey 57
9.7 About the Authors 58
9.7.1 Author/Reviewer 58
9.7.2 Global Head of Healthcare 58
9.8 About GlobalData 59
9.9 Disclaimer 59

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 - Stelara 37
Table 10: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 39
Table 11: Stelara SWOT Analysis, 2013 42
Table 12: Global Sales Forecasts ($) for Stelara, 2012-2022 44
Table 13: Physicians Surveyed, By Country 57

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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