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

Published: May-2015 | Format: PDF | GBI Research | Number of pages: 91 | Code: MRS - 18029

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

Summary

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 $435m, and it is forecast to grow at a Compound Annual Growth Rate (CAGR) of 8.4% between 2014 and 2021 to reach $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 Köebner 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: Epidemiology by Top 20 Most Common Cancer Sites, 2012 11
Table 2: Epidemiology by Top 20 Most Common Cancer Sites, 2012 12
Table 3: Epidemiology by Top 20 Most Common Cancer Sites, 2012 13
Table 4: Epidemiology by Top 20 Most Common Cancer Sites, 2012 14
Table 5: TNM Staging, 2015 22
Table 6: Karnofsky Scores and Equivalent ECOG Staging, 2015 24
Table 7: Optimal and Actual Radiation Therapy Usage Rates in US, 1995–2000 26
Table 8: Optimal and Actual Chemotherapy Usage Rates in Australia, 2010 28
Table 9: Optimal and Actual Chemotherapy Usage Rates in the US, 2008 28
Table 10: Frequency of Mutations in Components in PI3K Alpha Catalytic Isoform, by Cancer Type 70
Table 11: Frequency of Mutations in Components in Akt Proteins, by Cancer Type 72


1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987–2013 6
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006–2013 8
Figure 3: Relative Survival Rates for the Top 20 Cancers by Site, 2014 23
Figure 4: Molecule Types and Molecular Targets of Marketed Products for Oncology, 2015 31
Figure 5: Molecular Targets of Versatile Marketed Product for Oncology, 2015 32
Figure 6: Summary of Five-Year Survival Rate, Incidence and Mortality by Site, 2012 33
Figure 7: Pipeline Products by Therapy Area and Pipeline Oncology Products by Tumor Site, 2015 34
Figure 8: Developmental Pipeline Overview 36
Figure 9: Developmental Pipeline Overview by Molecular Target 37
Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products, 2015 38
Figure 11: First-in-Class Pipeline by Therapy Area and Site, 2015 39
Figure 12: Summary of Incidence, Mortality, Mortality Rates and Pipeline Activity by Tumor Site, 2015 40
Figure 13: Overview of First-in-Class Oncology Products, 2015 41
Figure 14: Overview of First-in-Class Oncology Products, 2015 42
Figure 15: Versatility of First-in-Class Oncology Pipeline Products 43
Figure 16: Versatility of First-in-Class Oncology Pipeline Products, as Inferred by Molecular Target 43
Figure 17: Versatility of First-in-Class Oncology Pipeline Products and Potential Additional Indications 44
Figure 18: Overview of Highly Versatile First-in-Class Pipeline Oncology Products, 2015 45
Figure 19: Overview of Highly Versatile First-in-Class Pipeline Oncology Products by Molecular Target, 2015 47
Figure 20: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 48
Figure 21: Versatile First-in-Class Products in Oncology Pipeline, Part 1, 2015 50
Figure 22: Versatile First-in-Class Products in Oncology Pipeline, Part 2, 2015 51
Figure 23: Versatile First-in-Class Products in Oncology Pipeline, Part 3, 2015 52
Figure 24: Versatile First-in-Class Products in Oncology Pipeline, Part 4, 2015 53
Figure 25: Signaling Networks of Functional Families in Oncology, Part 1 55
Figure 26: Signaling Networks of Functional Families in Oncology, Part 2 56
Figure 27: Versatile First-in-Class Molecular Target Analysis Matrix, Part 1 58
Figure 28: Versatile First-in-Class Molecular Target Analysis Matrix, Part 2 59
Figure 29: Versatile First-in-Class Molecular Target Analysis Matrix, Part 3 60
Figure 30: Pipeline Programs Targeting Fibroblast Growth Factor Receptor-3 64
Figure 31: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-3 67
Figure 32: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-4 68
Figure 33: Pipeline Programs Targeting Phosphoinositide 3-Kinase Alpha 71
Figure 34: Pipeline Programs Targeting Akt-1 73
Figure 35: Pipeline Programs Targeting Akt-2 74
Figure 36: Pipeline Programs Targeting Akt-3 74
Figure 37: Pipeline Programs Targeting Telomerase Reverse Transcriptase 76
Figure 38: Pipeline Programs Targeting Heat Shock Protein 90 79
Figure 39: Pipeline Programs Targeting Focal Adhesion Kinase 81
Figure 40: Pipeline Programs Targeting DNA-Dependent Protein Kinase 83
Figure 41: Pipeline Program Targeting Programmed Death Ligand-1 85
Figure 42: Industry-Wide Deals by Stage of Development, 2006–2014 87
Figure 43: Industry Licensing Deal Values by Stage of Development ($m), 2006–2014 88
Figure 44: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2014 89
Figure 45: Regional Network of Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015 90
Figure 46: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006–2015 91
Figure 47: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006–2015 92
Figure 48: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015, Part 1 93
Figure 49: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015, Part 2 94
Figure 50: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2014 95
Figure 51: Regional Network of Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015 96
Figure 52: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006–2015 97
Figure 53: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006–2015 98
Figure 54: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015 99

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