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Prochymal (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.

Osiris Therapeutics is developing Prochymal (remestemcel-L) for the treatment of moderate to severe CD. Prochymal is a preparation of mesenchymal stem cells (MSCs) obtained from the bone marrow of healthy donors between the ages of 18 and 30 years, which are cultured and formulated for IV infusion. MSCs have the capacity to form a variety of highly specialized cell types, including bone, cartilage, muscle, tendon, fat, and liver cells, and they also display the ability to assist in tissue repair. Osiris Therapeutics’ novel cell-based therapeutic approach aims to address localized inflammation in CD without targeting specific systemic components of the innate and adaptive immune systems, the former being the case with all the existing therapies.

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 Prochymal including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Prochymal from 2012 to 2022.
- Sales information covered for the US 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 Prochymal performance
- Obtain sales forecast for Prochymal from 2012-2022 in the US Canada

Table Of Contents

Prochymal (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 Opportunity and Unmet Need 26
6.1 Overview 26
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 27
6.3 More Therapies for Anti-TNF-Refractory Patients 28
6.4 Unmet Needs Gap Analysis 29
6.5 Targeted Therapies 30
6.6 Predictive Tools for Early Diagnosis and Treatment 31
7 Pipeline Assessment 32
7.1 Overview 32
7.2 Promising Drugs in Clinical Development 32
8 Prochymal (remestemcel-L) 35
8.1 Overview 35
8.2 Efficacy 36
8.3 Safety 37
8.4 Dosing and Formulation 37
8.5 Potential Clinical Positioning 37
8.6 Potential Commercial Positioning 38
8.7 Pricing and Reimbursement 38
8.8 SWOT Analysis 39
8.9 Forecast 40
9 Appendix 42
9.1 Bibliography 42
9.2 Abbreviations 45
9.3 Methodology 47
9.4 Forecasting Methodology 47
9.4.1 Diagnosed CD Patients 48
9.4.2 Percent Drug-Treated Patients 48
9.4.3 General Pricing Assumptions 48
9.4.4 Generic Erosion 50
9.4.5 Pricing of Pipeline agents 50
9.5 Physicians and Specialists Included in This Study 50
9.6 Primary Research - Prescriber Survey 52
9.7 About the Authors 53
9.7.1 Author/Reviewer 53
9.7.2 Global Head of Healthcare 53
9.8 About GlobalData 54
9.9 Disclaimer 54

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: Overall Unmet Needs in CD - Current Level of Attainment 27
Table 6: Clinical Unmet Needs in CD - Gap Analysis, 2013 30
Table 7: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 33
Table 8: Comparison of Therapeutic Classes in Development for CD, 2013 34
Table 9: Product Profile - Prochymal 36
Table 10: Prochymal SWOT Analysis, 2013 39
Table 11: Global Sales Forecasts ($) for Prochymal, 2012-2022 41
Table 12: Physicians Surveyed, By Country 52

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
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 33

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