Systemic Psoriasis Therapeutics in Major Developed Markets to 2020 - Continued Uptake of Biologics and Novel Pipeline Drugs to Drive Growth

Summary

GBI Research has released its pharma report “Systemic Psoriasis Therapeutics in Major Developed Markets to 2020 - Continued Uptake of Biologics and Novel Pipeline Drugs to Drive Growth”. The systemic psoriasis market is forecast to grow substantially over the forecast period from $5.0 billion in 2013 to $10.4 billion in 2020, across the eight major markets. This growth will be driven by a rising treatment population and the continued uptake of biologics.

Biologics will continue to drive market growth despite leading brands Enbrel (etanercept), Humira (adalimumab) and Remicade (infliximab) losing patent protection in most of the major markets over the forecast period. Although the market will suffer revenue losses as a result of sales erosion from biosimilar competitors, this will be offset by the emergence of novel therapies. Most notably, these include monoclonal antibodies secukinumab, ixekizumab and brodalumab, which are currently being developed by Alcon (Novartis subsidiary), Eli Lilly and Amgen, respectively.

Scope

- An introduction to psoriasis, which includes symptoms, epidemiology, etiology, pathophysiology, diagnosis and treatment
- Analysis of the major systemic therapies in the current psoriasis marketed landscape
- Analysis of the pipeline for psoriasis, which includes a breakdown of pipeline molecules by phase of development, molecule type, molecular target and novelty. Psoriasis clinical trials are analyzed by size, duration and failure rates, and a comparative analysis of the most promising systemic pipeline molecules is also provided.
- Forecast projections for the systemic psoriasis market to 2020. Analysis is provided for the global market and each of the eight major markets. The forecast incorporates projected, low and high variance scenarios based on treatment usage patterns and annual therapy costs in each of the major markets.
- Analysis of strategic consolidations, including co-development and licensing deals, within the psoriasis indication

Reasons to buy

- Understand the current systemic psoriasis marketed products landscape and recognize the dominant therapeutic agents and pharmaceutical players involved
- Identify trends and developments within the psoriasis pipeline and consider how the future competitive environment will be impacted
- Consider market opportunities and potential risks by examining the psoriasis clinical trial landscape in relation to industry averages
- Observe projections for treatment usage patterns, annual therapy costs and market growth in the eight major markets and understand reasons for variance in projected patterns of growth in the eight major markets

Table Of Contents

Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 Overview 8
2.2 Epidemiology 9
2.3 Etiology, Co-morbidities and Risk Factors 10
2.3.1 Genetics 10
2.3.2 Psoriatic Arthritis 10
2.3.3 Mental Health Disorders 11
2.3.4 Metabolic Syndrome, Smoking, Diet and Alcohol Consumption 11
2.3.5 Infections 11
2.3.6 Köebner Phenomenon 12
2.3.7 Other Immune-mediated Diseases 12
2.4 Pathophysiology 12
2.5 Diagnosis 13
2.6 Treatment Options 13
2.6.1 Pharmacological Therapies 14
2.6.2 Non-pharmacological Therapies 15
2.6.3 Combination and Rotational Therapies 15
2.6.4 Quality of Life Assessments 16
2.7 Summary 16
3 Marketed Products 17
3.1 Overview 17
3.2 Methotrexate-based Products 17
3.3 Sandimmune/Neoral (cyclosporine/modified cyclosporine) - Novartis 18
3.4 Soriatane (acitretin) - Steifel Laboratories 19
3.5 Fumaderm (dimethyl fumarate and ethyl fumarate) - Biogen Idec 20
3.6 Humira (adalimumab) - Abbvie Inc. 21
3.7 Enbrel (etanercept) - Amgen Inc. 22
3.8 Remicade (infliximab) - Janssen Biotech 23
3.9 Stelara (ustekinumab) - Janssen Biotech 24
3.10 Marketed Products Heat Map 25
4 Pipeline 28
4.1 Overview 28
4.2 Pipeline Size and Distribution by Phase, Molecule Type and Program Type 29
4.3 Pipeline Distribution by Molecular Target 31
4.4 Clinical Trial Landscape 33
4.4.1 Clinical Trial Duration 33
4.4.2 Clinical Trial Size 37
4.5 Clinical trial failure rates 41
4.6 Primary and Secondary Endpoints 42
4.7 Summary of Psoriasis Clinical Trials 44
4.8 Promising pipeline molecules 44
4.8.1 Ixekizumab - Eli Lilly 44
4.8.2 Xeljanz (tofacitinib) - Pfizer 45
4.8.3 Brodalumab - Amgen 46
4.8.4 Apremilast - Celgene 47
4.8.5 Secukinumab - Alcon 48
4.9 Heat Map for Pipeline Products 48
5 Market Forecast to 2020 53
5.1 Overview 53
5.2 Global Market 53
5.3 North America 56
5.3.1 Treatment Usage Patterns 56
5.3.2 Annual Cost of Treatment 57
5.3.3 Market Size 59
5.4 Top Five EU Markets 60
5.4.1 Treatment Usage Patterns 60
5.4.2 Annual Cost of Treatment 61
5.4.3 Market Size 62
5.5 Japan 63
5.5.1 Treatment Usage Patterns 63
5.5.2 Annual Cost of Treatment 64
5.5.3 Market Size 65
5.6 Drivers and Barriers for the Systemic Psoriasis Therapeutics Market 66
5.6.1 Drivers 66
5.6.2 Barriers 66
6 Co-development and Licensing deals 68
6.1 Co-development Deals 68
6.1.1 Abbvie Enters into Co-development Agreement with Biotest for Tregalizumab 71
6.1.2 Lycera Enters into Research Agreement with Merck and Co. 71
6.1.3 LEO Pharma Enters into Research Agreement with 4SC Discovery for Inflammatory Skin Diseases 71
6.1.4 Amgen Enters into Co-Development Agreement with AstraZeneca for Five Human Monoclonal Antibodies Including Brodalumab 71
6.2 Licensing Deals 73
6.2.1 Leo Pharma Enters into Licensing Agreement with Virobay for Psoriasis Drug 75
6.2.2 Foamix Enters into Licensing Agreement with Dr. Reddy's Labs 75
6.2.3 Cipher Pharma Enters into Licensing Agreement with IBSA Institut Biochimique for Betesil Patch 75
6.2.4 Phenex Pharma Enters into Licensing Agreement with Janssen Biotech for Retinoid-Acid Receptor-Related Orphan Receptor Gamma t Program 75
7 Appendix 76
7.1 All Pipeline Drugs by Phase 76
7.1.1 Discovery 76
7.1.2 Preclinical 78
7.1.3 Phase I 82
7.1.4 Phase II 84
7.1.5 Phase III 86
7.1.6 Undisclosed 87
7.2 Market Forecasts to 2020 87
7.2.1 Major Developed Markets 87
7.2.2 US 88
7.2.3 UK 88
7.2.4 France 89
7.2.5 Germany 89
7.2.6 Italy 90
7.2.7 Spain 90
7.2.8 Japan 91
7.2.9 Canada 91
7.3 Abbreviations 92
7.4 References 93
7.5 References for Heat Maps 98
7.5.1 Marketed Products 98
7.5.2 Pipeline products 98
7.6 Methodology 100
7.6.1 Secondary Research 100
7.6.2 Therapeutic Landscape 100
7.7 Contact Us 100
7.8 Disclaimer 101



List of Tables

Table 1: Type of Psoriasis 9
Table 2: Systemic Psoriasis Therapeutics Market, Global, Pipeline, Discovery, 2014 76
Table 3: Systemic Psoriasis Therapeutics Market, Global, Pipeline, Preclinical/IND/CTA-filed, 2014 78
Table 4: Systemic Psoriasis Therapeutics Market, Global, Pipeline, Phase I, 2014 82
Table 5: Systemic Psoriasis Therapeutics Market, Global, Phase II, Discovery, 2014 84
Table 6: Systemic Psoriasis Therapeutics Market, Global, Pipeline, Phase III/Pre-registration, 2014 86
Table 7: Systemic Psoriasis Therapeutics Market, Global, Pipeline, Undisclosed, 2014 87
Table 8: Systemic Psoriasis Market Forecast, Global, 2013-2020 87
Table 9: Systemic Psoriasis Market Forecast, US, 2013-2020 88
Table 10: Systemic Psoriasis Market Forecast, UK, 2013-2020 88
Table 11: Systemic Psoriasis Market Forecast, France, 2013-2020 89
Table 12: Systemic Psoriasis Market Forecast, Germany, 2013-2020 89
Table 13: Systemic Psoriasis Market Forecast, Italy, 2013-2020 90
Table 14: Systemic Psoriasis Market Forecast, Spain, 2013-2020 90
Table 15: Systemic Psoriasis Market Forecast, Japan, 2013-2020 91
Table 16: Systemic Psoriasis Market Forecast, Canada, 2013-2020 91
Table 17: Breakdown of ‘Others’ Category 99
Table 18: Breakdown of ‘Combination’ Category 99



List of Figures

Figure 1: Psoriasis Treatment Algorithms 14
Figure 2: Heat Map for Marketed Products 25
Figure 3: Heat Map for Marketed Products (continued) 26
Figure 4: Psoriasis Therapeutics Market, Global, Pipeline, 2013 29
Figure 5: Psoriasis Therapeutics Market, Global, Pipeline by Molecular Target, 2013 31
Figure 6: Psoriasis Therapeutics Market, Global, Pipeline by Molecular Target, 2013 32
Figure 7: Psoriasis Therapeutics Market, Global, Pipeline, Clinical Trial Duration by Molecule Type, (months) 2006-2012 34
Figure 8: Psoriasis Therapeutics Market, Global, Pipeline, Clinical Trial Duration by Molecular Target, (months) 2006-2012 36
Figure 9: Psoriasis Therapeutics Market, Global, Pipeline, Clinical Trial Size by Molecule Type, (participants) 2006-2012 38
Figure 10: Psoriasis Therapeutics Market, Global, Pipeline, Clinical Trial Size by Molecular Target, (participants), 2006-2012 40
Figure 11: Psoriasis Therapeutics Market, Global, Clinical Trial Failure Rate, (%), 2006-2013 41
Figure 12: Psoriasis Therapeutics Market, Global, Frequency of Primary Endpoints Measured in Clinical Trials, (%), 2006-2012 42
Figure 13: Psoriasis Therapeutics Market, Global, Frequency of Secondary Endpoints Measured in Clinical Trials, (%), 2006-2012 43
Figure 14: Heat Map for Pipeline Products 49
Figure 15:Heat Map for Marketed Products 50
Figure 16:Heat Map for Marketed Products (continued) 51
Figure 17: Systemic Psoriasis Therapeutics Market, Global, Treatment Patterns (million), 2013-2020 53
Figure 18: Systemic Psoriasis Therapeutics Market, Global, Market Size ($bn), 2013-2020 55
Figure 19: Systemic Psoriasis Therapeutics Market, North America, Treatment Patterns, 2013-2020 56
Figure 20: Systemic Psoriasis Therapeutics Market, North America, Annual Cost of Treatment ($), 2013-2020 57
Figure 21: Systemic Psoriasis Therapeutics Market, North America, Market Size, 2013-2020 59
Figure 22: Systemic Psoriasis Therapeutics Market, Top Five EU Countries, Treatment Patterns (‘000), 2013-2020 60
Figure 23: Systemic Psoriasis Therapeutics Market, Top Five EU Countries, Annual Cost of Treatment ($), 2013-2020 61
Figure 24: Systemic Psoriasis Therapeutics Market, Top Five EU Countries, Market Size ($m), 2013-2020 62
Figure 25: Systemic Psoriasis Therapeutics Market, Japan, Treatment Patterns (‘000), 2013-2020 63
Figure 26: Systemic Psoriasis Therapeutics Market, Japan, Annual Cost of Treatment ($), 2013-2020 64
Figure 27: Systemic Psoriasis Therapeutics Market, Japan, Market Size ($m), 2013-2020 65
Figure 28: Psoriasis Therapeutics Market, Global, Co-development Deals, 2006-2013 68
Figure 29: Psoriasis Therapeutics Market, Global, Co-development Deals by Phase of Development, Molecule Type and Aggregate Deal Value ($m), 2006-2013 70
Figure 30: Psoriasis Therapeutics Market, Global, Licensing Deals, 2006-2013 73
Figure 31: Psoriasis Therapeutics Market, Licensing Deals by Phase, Molecule Type and Aggregate Deal Value ($m), 2006-2013 74

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