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Systemic Psoriasis Therapeutics in Asia-Pacific Markets to 2021-Advent of Novel Biologics and Expanding Treatment Pool to Drive Growth

Systemic Psoriasis Therapeutics in Asia-Pacific Markets to 2021-Advent of Novel Biologics and Expanding Treatment Pool to Drive Growth


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Executive Summary

Systemic Psoriasis Therapeutics in Asia-Pacific Markets to 2021-Advent of Novel Biologics and Expanding Treatment Pool to Drive Growth

GBI Research, the leading business intelligence provider, has released its latest research, "Systemic Psoriasis Therapeutics in Asia-Pacific Markets to 2021-Advent of Novel Biologics and Expanding Treatment Pool to Drive Growth", which provides insights into psoriasis therapeutics in the Asia-Pacific (APAC) market. For the purposes of this report, APAC refers to the market in China, India, Japan, and Australia only. The report estimates the market size for 2014, along with forecasts until 2021. It also covers disease epidemiology, treatment algorithms, treatment use patterns, in-depth analysis of pipeline molecules, clinical trial failure rates, and analysis of recent deals. It is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis carried out by GBI Research's team of industry experts.

In 2014, the value of the psoriasis therapeutics market in APAC amounted to an estimated USD 435m, and it is forecast to grow at a Compound Annual Growth Rate (CAGR) of 8.4% between 2014 and 2021 to reach USD 773m. The psoriasis treatment landscape is a particularly complex one. More than 80% of patients fall into the mild-or-moderate category, for which the first line of treatment is topical drugs, phototherapy, or a combination. In the case of severe patients, non-steroidal drugs such as methotrexate, cyclosporine, and acitretin are practiced as first-line treatment; however, they come with toxicity concerns and so cannot be prescribed for long durations. Biologics such as TNF inhibitors (adalimumab, etanercept, infliximab) and ustekinumab are largely prescribed as second-line therapy when none of the aforementioned options provide the desired results. However, during the forecast period, biologics are likely gain a significant market share due to healthcare plans in APAC and awareness regarding the effectiveness of biologics. Among the recently launched biologics, Cosentyx (secukinumab) from Novartis has shown better efficacy than Enbrel (etanercept), and is a novel molecule that targets Interluekin-17 (IL-7). Biocon India has launched Alzumab (itolizumab), which is a first-in-class novel molecule that targets CD6 protein. It is anticipated to be the leading biologic in India by the end of forecast period. Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) are expected to lose their patent during the forecast period, but will be compensated for by biosimilar versions.

Scope

The report analyzes treatment use patterns, market characterization, the pipeline, and key licensing and co-development deals for psoriasis in the APAC markets of China, India, Japan, and Australia.The report includes

A brief introduction to psoriasis, including pathophysiology, etiology, diagnosis, and treatment algorithms

In-depth analysis of currently marketed drugs, including analysis of safety, efficacy, treatment patterns, and strengths/weaknesses, along with a heat map comparing them in terms of safety and efficacy

A comprehensive review of the pipeline for psoriasis, including individual analysis of a number of late-stage pipeline drugs likely to enter the market during the forecast period; the pipeline is further analyzed on the basis of phase distribution, molecule type, program type, mechanism of action, and molecular target

Additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration, and program failure rate for each molecule type

Multi-scenario forecast data for the market to 2021, taking into account how it might be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across the key developed markets

Discussion of the drivers of and barriers to market growth

In-depth analysis of all licensing and co-development deals that have occurred in the psoriasis market since 2006

Reasons To Buy

The report will enhance your decision-making capability by allowing you to

Understand the psoriasis pipeline and the factors that indicate that it is becoming more innovative

Analyze detailed profiles for promising pipeline products and gain insights into how they are likely to compete in the market and who their main competitors will be

Follow the trends in psoriasis clinical trial size and duration in relation to industry averages

Assess the potential risk of future developmental programs for psoriasis therapeutics by mechanism of action using recorded clinical trial failure rates

Analyze the potential growth patterns expected for the psoriasis market over the forecast period

Identify the countries that are expected to contribute the most to this growth and devise a more effectively tailored country strategy through an understanding of key drivers and barriers

Accelerate and strengthen your market position by identifying key companies for strategic partnerships

1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 8

1.2 List of Figures 9

2 Introduction 10

2.1 Symptoms 11

2.1.1 Skin Manifestations 11

2.1.2 Psychological Impact 11

2.2 Etiology, Co-morbidities and Risk Factors 11

2.2.1 Genetics 11

2.2.2 Psoriatic Arthritis 11

2.2.3 Mental Health Disorders 12

2.2.4 Metabolic Syndrome, Smoking, Diet and Alcohol Consumption 12

2.2.5 Infections 12

2.2.6 K�ebner Phenomenon 13

2.2.7 Other Immune-Mediated Diseases 13

2.3 Pathophysiology 13

2.4 Diagnosis 14

2.5 Epidemiology 14

2.6 Treatment and Management 15

2.6.1 Pharmacological Therapies 16

2.6.2 Non-pharmacological Therapies 17

2.6.3 Combination and Rotational Therapies 18

2.6.4 Quality of Life Assessments 18

2.6.5 Summary 18

3 Marketed Products 19

3.1 Overview 19

3.2 Methotrexate-Based Products 19

3.3 Sandimmune/Neoral (cyclosporine/modified cyclosporin)-Novartis 20

3.4 Humira (adalimumab)-AbbVie 21

3.5 Enbrel (etanercept)-Amgen 23

3.6 Remicade (infliximab)-Janssen Biotech 25

3.7 Stelara (ustekinumab)-Janssen Biotech 26

3.8 Comparative Efficacy and Safety 28

4 Psoriasis Market to 2021-Pipeline Products 29

4.1 Overview 29

4.2 Overall Pipeline 29

4.3 Pipeline Analysis by Molecule Type 31

4.4 Pipeline Analysis by Molecular Target 32

4.5 Clinical Trials 34

4.5.1 Overall Failure Rate 34

4.5.2 Failure Rate by Molecule Type 35

4.5.3 Failure Rate by Molecular Target 36

4.5.4 Patient Enrollment and Clinical Trial Size 37

4.5.5 Duration 38

4.5.6 Summary of Psoriasis Clinical Trials 39

4.6 Promising Drug Candidates in the Pipeline 40

4.6.1 LY2439821 (ixekizumab)-Eli Lilly 40

4.6.2 Xeljanz (tofacitinib)-Pfizer 41

4.6.3 Brodalumab-Amgen 42

5 Market Forecast to 2021 44

5.1 Geographical Markets 44

5.1.1 Asia-Pacific Market Overview 44

5.1.2 China 46

5.1.3 India 49

5.1.4 Japan 51

5.1.5 Australia 53

5.2 Drivers and Barriers 55

5.2.1 Drivers 55

5.2.2 Barriers 55

6 Deals and Strategic Consolidations 57

6.1 Major Co-development Deals 57

6.1.1 AbbVie Enters into Co-development Agreement with Biotest for Tregalizumab 61

6.1.2 Lycera Enters into Research Agreement with Merck 61

6.1.3 LEO Pharma Enters into Research Agreement with 4SC Discovery for Inflammatory Skin Diseases 62

6.1.4 Amgen Enters into Co-Development Agreement with AstraZeneca for Five Human Monoclonal Antibodies Including Brodalumab 62

6.2 Major Licensing Deals 63

6.2.1 Leo Pharma Enters into Licensing Agreement with Virobay for Psoriasis Drug 66

6.2.2 Foamix Enters into Licensing Agreement with Dr. Reddy's Laboratories 66

6.2.3 Cipher Pharmaceuticals Enters into Licensing Agreement with IBSA Institut Biochimique for Betesil Patch 66

6.2.4 Phenex Pharmaceuticals Enters into Licensing Agreement with Janssen Biotech for Retinoid-Acid Receptor-Related Orphan Receptor Gamma t Program 67

7 Appendix 68

7.1 All Pipeline Drugs by Phase 68

7.1.1 Discovery 68

7.1.2 Preclinical 70

7.1.3 IND/CTA-Filed 73

7.1.4 Phase I 74

7.1.5 Phase II 77

7.1.6 Phase III 81

7.1.7 Pre-registration 82

7.2 Market Forecasts to 2021 82

7.2.1 Asia-Pacific 82

7.2.2 China 83

7.2.3 India 83

7.2.4 Japan 83

7.2.5 Australia 84

7.3 Market Definitions 84

7.4 Abbreviations 84

7.5 References 85

7.6 Research Methodology 90

7.6.1 Coverage 90

7.6.2 Secondary Research 90

7.6.3 Primary Research 90

7.6.4 Therapeutic Landscape 91

7.6.5 Geographical Landscape 93

7.6.6 Pipeline Analysis 94

7.7 Expert Panel Validation 94

7.8 Contact Us 94

7.9 Disclaimer 94

1.1 List of Tables

Table 1: Psoriasis Market, Global, Types of Psoriasis, 2015 10

Table 2: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Discovery, 2014 68

Table 3: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 70

Table 4: Psoriasis Market, Therapeutics, Global, All Pipeline Products, IND/CTA-Filed, 2014 73

Table 5: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Phase I, 2014 74

Table 6: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Phase II, 2014 77

Table 7: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Phase III, 2014 81

Table 8: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Pre-registration, 2014 82

Table 9: Psoriasis Market, Asia-Pacific, Forecast Data, 2014-2021 82

Table 10: Psoriasis Market, China, Forecast Data, 2014-2021 83

Table 11: Psoriasis Market, India, Forecast Data, 2014-2021 83

Table 12: Psoriasis Market, Japan, Forecast Data, 2014-2021 83

Table 13: Psoriasis Market, Australia, Forecast Data, 2014-2021 84

1.2 List of Figures

Figure 1: Psoriasis Market, Global, Composite Treatment Algorithm, 2015 16

Figure 2: Psoriasis Market, Global, Humira (adalimumab), Annual Sales (USD bn), 2007-2014 22

Figure 3: Psoriasis Market, Global, Enbrel (etanercept), Annual Sales (USD bn), 2007-2014 24

Figure 4: Psoriasis Market, Global, Remicade (infliximab), Annual Sales (USD bn), 2007-2014 26

Figure 5: Psoriasis Market, Global, Stelara (ustekinumab), Annual Sales (USD bn), 2010-2014 27

Figure 6: Psoriasis Market, Global, Comparative Safety and Efficacy of Marketed Products Heatmap (1/2), 2015 28

Figure 7: Psoriasis Market, Global, Comparative Safety and Efficacy of Marketed Products Heatmap (2/2), 2015 28

Figure 8: Psoriasis Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2015 30

Figure 9: Psoriasis Market, Global, Pipeline by Molecule Type and Stage of Development, 2015 31

Figure 10: Psoriasis Market, Global, Pipeline by Molecular Target (1/2), 2015 32

Figure 11: Psoriasis Market, Global, Pipeline by Molecular Target (2/2), 2015 33

Figure 12: Psoriasis Market, Global, Pipeline by Molecular Target, Molecule Type and Stage of Development, 2015 34

Figure 13: Psoriasis Market, Global, Clinical Trial Failure Rate (%), 2015 35

Figure 14: Psoriasis Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015 36

Figure 15: Psoriasis Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2015 37

Figure 16: Psoriasis Market, Global, Clinical Trial Size, 2015 38

Figure 17: Psoriasis Market, Global, Clinical Trial Duration (months), 2015 39

Figure 18: Psoriasis Systemic Therapy Market, Asia-Pacific, Treatment Use Patterns and Market Size (USD m), 2014-2021 46

Figure 19: Psoriasis Systemic Therapy Market, China, Treatment Use Patterns, Annual Cost of Therapy (USD ) and Market Size (USD m), 2014-2021 48

Figure 20: Psoriasis Systemic Therapy Market, India, Treatment Use Patterns, Annual Cost of Therapy (USD ), and Market Size (USD m), 2014-2021 50

Figure 21: Psoriasis Systemic Therapy Market, Japan, Treatment Use Patterns, Annual Cost of Therapy (USD ), Market Size (USD m), 2014-2021 52

Figure 22: Psoriasis Systemic Therapy Market, Australia, Treatment Use Patterns, Annual Cost of Therapy (USD ), Market Size (USD m), 2014-2021 54

Figure 23: Psoriasis Market, Global, Co-development Deals by Geography, Deals by Value, 2006-2014 58

Figure 24: Psoriasis Market, Global, Co-development Deals by Year, Deals by Phase and Molecule Type, 2006-2014 59

Figure 25: Psoriasis Market, Global, Co-development Deals by Molecule Type and Deal Value, Deals by Molecular Target and Deal Value, 2006-2014 60

Figure 26: Psoriasis Market, Global, Co-development Deals by Geography, 2006-2014 61

Figure 27: Psoriasis Market, Global, Licensing Deals by Geography and Value, 2006-2014 63

Figure 28: Psoriasis Market, Global, Licensing Deals by Year, Licensing Deals by Phase and Molecule Type, 2006-2014 64

Figure 29: Psoriasis Market, Global, Licensing Deals by Year and by Phase, 2006-2014 65

Figure 30: Psoriasis Market, Global, Licensing Deals by Geography, 2006-2014 66

Figure 31: GBI Research Market Forecasting Model (Example) 93

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