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市場調查報告書

Frontier Pharma:皮膚科學 - 細胞內信號傳達物質和細胞激素信號傳達系分子優勢

Frontier Pharma: Dermatology - Intracellular Signal Transducers and Cytokine Signaling Molecules Dominate Pipeline and First-in-Class Innovation

出版商 GBI Research 商品編碼 524531
出版日期 內容資訊 英文 98 Pages
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Frontier Pharma:皮膚科學 - 細胞內信號傳達物質和細胞激素信號傳達系分子優勢 Frontier Pharma: Dermatology - Intracellular Signal Transducers and Cytokine Signaling Molecules Dominate Pipeline and First-in-Class Innovation
出版日期: 2017年06月01日 內容資訊: 英文 98 Pages
簡介

本報告提供皮膚科學調查分析,革新案例,概要,開發中產品的評估,計劃的評估,策略性整合等系統性資訊。

第1章 目錄

第2章 摘要整理

第3章 革新案例

  • 生技藥品的機會擴大
  • 分子標的多樣化
  • 創新的First-in-Class產品 (劃時代的醫藥品)的開發現在也富有魅力
  • 法規、償付政策,對First-in-Class產品的革新有利
  • 持續革新
  • 報告指南

第4章 臨床、商業性情形

  • 治療領域概要
  • 症狀
  • 免疫學與病因
  • 病理生理學
  • 合併症和併發症
  • 治療
  • 上市產品概要

第5章 開發中產品革新的評估

  • 開發平台:各開發階段,各分子類型,各分子標的
  • 以新的分子標做成為目標的First-in-Class計劃

第6章 信號 (信號傳達) 網路,疾病的因果關係,革新的調整

  • 信號傳達網路的複雜
  • 信號傳達途徑和First-in-Class分子標的整合
  • First-in-Class矩陣的評估

第7章 First-in-Class目標與開發平台計劃的評估

第8章 策略性整合

  • 產業整體First-in-Class交易
  • 授權交易
  • 共同開發交易
  • 事前參與/不參與授權/共同開發交易的First-in-Class計劃

第9章 附錄

目錄
Product Code: GBIHC444MR

Executive Summary

Dermatology is a highly diverse therapy area that deals with diseases of the skin, hair and nails. Over 3,000 distinct dermatological conditions are thought to exist, ranging from rare autoimmune disorders such as scleroderma to very common conditions such as acne vulgaris. The scope of dermatological disorders is diverse in terms of severity and clinical presentation, and if a condition is not sufficiently kept under control it can significantly impair the patient's quality of life. For example, patients with severe atopic dermatitis may experience mobility impairments and debilitating itching, which may interfere with daily activities. Furthermore, disease visibility can have a profoundly negative impact on patient confidence.

Dermatological conditions are some of the most common types of disorders worldwide, and approximately one-third of the US population suffers from at least one active condition. Although dermatological diseases are disparate in terms of their symptoms and key patient demographics, many are characterized by increased inflammation and linked by an aberrant immune response resulting in skin barrier dysfunction. Infections and dysfunctions in wound healing are further common causes of dermatological diseases.

For the past decade the majority of the therapeutic dermatology market has been saturated and highly genericized. There is a significant unmet need for more efficacious and safer treatment options, as physicians often cite poor efficacy, low patient compliance and problematic safety profiles as issues with the long-term use of many available treatments. Various treatment options exist within the therapy area, including topical glucocorticosteroids, retinoids, antihistamines and immunosuppressive agents, all of which are heavily genericized. The majority of marketed products within dermatology are small molecules, which account for 98.2% of all products. There are only a small number of other more novel molecule types, such as monoclonal antibodies (mAb), proteins and cell therapies, available in the market.

Overall, the dermatology pipeline is considerably innovative, owing to the advancements in understanding of the disease pathways of many skin disorders. Analysis by molecular target highlights that there is a strong degree of innovation and diversity beyond the current market landscape. There is a clear emphasis, demonstrated particularly by biologics in mid-to-late stage clinical development, on developing effective targeted therapies aimed at key molecules in disease pathology, which represents an innovative approach that will benefit the market in the coming years. On the other hand, therapeutic molecular target classes that are already present in the market - such as histamine receptors, retinoic acid receptors, glucocorticoid receptors, and tumor necrosis factor - also maintain a presence in the pipeline, which indicates that developing established therapeutic classes remains attractive.

The report "Frontier Pharma: Dermatology - Intracellular Signal Transducers and Cytokine Signaling Molecules Dominate Pipeline and First-in-Class Innovation" is a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.

Specifically, this report provides the following analysis -

  • Visualize the composition of the dermatology market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
  • Analyze the dermatology pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating dermatological diseases, including rare conditions.
  • Assess the therapeutic potential of first-in-class targets. Using proprietary matrices, first-in-class products have been assessed and ranked according to clinical potential. The matrices have been split into three categories: inflammatory diseases, infectious diseases, and wounds/scars. Promising targets have been reviewed in greater detail.
  • Identify commercial opportunities in the dermatology deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.

Companies mentioned in this report: Bristol-Myers Squibb, Pfizer, Nimbus Therapeutics, Sareum, Genentech, Portola Pharmaceuticals, Oncostellae.

Scope

  • With 961 products in active development, the pipeline is considerably large. How will pipeline innovation affect the future dermatology market?
  • There are 197 first-in-class products in the dermatology pipeline. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
  • The majority of first-in-class products are in development for indications involving inflammation. Which first-in-class targets are most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
  • A significant number of first-in-class products have been identified with no prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy

  • Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
  • Visualize the composition of the dermatology market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
  • Analyze the dermatology pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating dermatological diseases, including rare conditions.
  • Assess the therapeutic potential of first-in-class targets. Using proprietary matrices, first-in-class products have been assessed and ranked according to clinical potential. The matrices have been split into three categories: inflammatory diseases, infectious diseases, and wounds/scars. Promising targets have been reviewed in greater detail.
  • Identify commercial opportunities in the dermatology deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.

1 Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 3
  • 1.2 List of Figures 3

2 Executive Summary 5

  • 2.1 Large Therapy Area Characterized by a High Degree of Pathophysiological Crossover 5
  • 2.2 Biologics and mAbs Growing in Prominence in Dermatology Therapy Area 5
  • 2.3 Highly Diversified Range of Innovative Programs in Early Pipeline 5
  • 2.4 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products Landscape 6

3 The Case for Innovation 7

  • 3.1 Growing Opportunities for Biologic Products 8
  • 3.2 Diversification of Molecular Targets 8
  • 3.3 Innovative First-in-Class Development Remains Attractive 9
  • 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9
  • 3.5 Sustained Innovation 10
  • 3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 11

  • 4.1 Therapy Area Introduction 11
  • 4.2 Symptoms 11
  • 4.3 Epidemiology and Etiology 12
    • 4.3.1 Atopic Dermatitis 12
    • 4.3.2 Acne Vulgaris 13
    • 4.3.3 Psoriasis 13
  • 4.4 Pathophysiology 14
    • 4.4.1 Atopic Dermatitis 14
    • 4.4.2 Acne Vulgaris 15
    • 4.4.3 Psoriasis 15
  • 4.5 Co-morbidities and Complications 16
  • 4.6 Treatment 17
    • 4.6.1 Topical Corticosteroids 17
    • 4.6.2 Calcineurin Inhibitors 18
    • 4.6.3 Retinoids 18
    • 4.6.4 Systemic Immunosuppressive Agents 19
    • 4.6.5 Biologics 19
    • 4.6.6 Antihistamines 19
    • 4.6.7 Hormonal Therapy 19
    • 4.6.8 Moisturizers 20
  • 4.7 Overview of Marketed Products in Dermatology 20

5 Assessment of Pipeline Product Innovation 22

  • 5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 22
  • 5.2 First-in-Class Programs Targeting Novel Molecular Targets 25

6 Signaling Network, Disease Causation and Innovation Alignment 42

  • 6.1 Complexity of Signaling Networks in Dermatology 42
  • 6.2 Signaling Pathways and First-in-Class Molecular Target Integration 42
  • 6.3 First-in-Class Matrix Assessment 42

7 First-in-Class Target and Pipeline Program Evaluation 48

  • 7.1 Pipeline Programs Targeting Non-Receptor Tyrosine-Protein Kinase TYK2 48
  • 7.2 Pipeline Programs Targeting Granzyme B 51
  • 7.3 Pipeline Programs Targeting ORAI1 53
  • 7.4 Pipeline Programs Targeting CC motif chemokine 11 55
  • 7.5 Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily A Member 3 57
  • 7.6 Pipeline Programs Targeting Toll-like Receptor 8 59
  • 7.7 Pipeline Programs Targeting CC Chemokine Receptor Type 6 61
  • 7.8 Pipeline Programs Targeting Targeting Spleen Tyrosine Kinase 63
  • 7.9 Pipeline Programs Targeting Galectin-3 65
  • 7.10 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 6 67
  • 7.11 Pipeline Programs Targeting Sphingosine 1-phosphate receptor 4 69
  • 7.12 Pipeline Programs Targeting Protein-Lysine 6-Oxidase 70
  • 7.13 Pipeline Programs Targeting Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6 72
  • 7.14 Conclusion 73

8 Strategic Consolidations 74

  • 8.1 Industry-Wide First-in-Class Deals 74
  • 8.2 Licensing Deals 75
    • 8.2.1 Deals by Region, Value and Year 75
    • 8.2.2 Deals by Stage of Development and Value 77
    • 8.2.3 Deals by Molecule Type, Molecular Target and Value 77
    • 8.2.4 List of Deals with Disclosed Deal Values 79
  • 8.3 Codevelopment Deals 81
    • 8.3.1 Deals by Region, Value and Year 81
    • 8.3.2 Deals by Stage of Development and Value 82
    • 8.3.3 Deals by Molecule Type, Molecular Target and Value 82
    • 8.3.4 List of Deals with Disclosed Deal Values 84
  • 8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals 85

9 Appendix 90

  • 9.1 References 90
  • 9.2 Abbreviations 96
  • 9.3 Research Methodology 96
  • 9.4 Secondary Research 97
    • 9.4.1 Market Analysis 97
    • 9.4.2 Pipeline Analysis 97
    • 9.4.3 First-in-Class Matrix Assessment 98
    • 9.4.4 First-in-Class Target Profiles 98
    • 9.4.5 Licensing and Co-Development Deals 98
  • 9.5 Contact Us 98
  • 9.6 Disclaimer 98

1.1 List of Tables

  • Table 1: Dermatology Therapeutics Market, Main Symptoms of Atopic Dermatitis, Acne Vulgaris and Psoriasis, 2017 12
  • Table 2: Dermatology Therapeutics Market, Global, Epidemiology of Dermatological Disorders, 2017 12
  • Table 3: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Non-Receptor Tyrosine-Protein Kinase TYK2, 2017 49
  • Table 4: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Non-Receptor Tyrosine-Protein Kinase TYK2, 2017 50
  • Table 5: Dermatology Therapeutics Market, Global, Key Features of Granzyme B, 2017 52
  • Table 6: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Granzyme B, 2017 53
  • Table 7: Dermatology Therapeutics Market, Global, Key Features of ORAI1, 2017 54
  • Table 8: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting ORAI1, 2017 55
  • Table 9: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of CCL11, 2017 56
  • Table 10: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting CCL11, 2017 56
  • Table 11: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Voltage-Gated Channel Subfamily A Member 3, 2017 58
  • Table 12: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Voltage-Gated Channel Subfamily A Member 3, 2017 58
  • Table 13: Dermatology Therapeutics Market, Global, Key Features of TLR8, 2017 60
  • Table 14: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting TLR8, 2017 61
  • Table 15: Dermatology Therapeutics Market, Global, Key Features of CC Chemokine Receptor Type 6, 2017 62
  • Table 16: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting CC Chemokine Receptor Type 6, 2017 62
  • Table 17: Dermatology Therapeutics Market, Global, Key Features of Spleen Tyrosine Kinase, 2017 64
  • Table 18: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Spleen Tyrosine Kinase, 2017 64
  • Table 19: Dermatology Therapeutics Market, Global, Key Features and Pipeline Activity of Galectin-3, 2017 66
  • Table 20: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Galectin-3, 2017 66
  • Table 21: Dermatology Therapeutics Market, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 6, 2017 68
  • Table 22: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 6, 2017 68
  • Table 23: Dermatology Therapeutics Market, Global, Key Features of Sphingosine 1-Phosphate Receptor 4, 2017 70
  • Table 24: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Sphingosine 1-Phosphate Receptor 4, 2017 70
  • Table 25: Dermatology Therapeutics Market, Global, Key Features of Protein Lysine 6 Oxidase, 2017 71
  • Table 26: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Protein Lysine 6 Oxidase, 2017 72
  • Table 27: Dermatology Therapeutics Market, Global, Key Features of Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6, 2017 73
  • Table 28: Dermatology Therapeutics Market, Global, Pipeline Programs Targeting Leucine-Rich Repeat-Containing G-Protein Coupled Receptor 6, 2017 73

1.1 List of Figures

  • Figure 1: Dermatology Therapeutics Market, US, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Product Approvals, 1987-2014 8
  • Figure 2: Dermatology Therapeutics Market, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013 9
  • Figure 3: Dermatology Therapeutics Market, Global, Marketed Products by Molecule Type, 2017 20
  • Figure 4: Dermatology Therapeutics Market, Global, Marketed Products by Molecular Target, 2017 21
  • Figure 5: Dermatology Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 22
  • Figure 6: Dermatology Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2017 23
  • Figure 7: Dermatology Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2017 25
  • Figure 8: Dermatology Therapeutics Market, Global, Distribution of Pipeline First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target, 2017 26
  • Figure 9: Dermatology Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development (%), 2017 27
  • Figure 10: Dermatology Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target (%), 2017 27
  • Figure 11: Dermatology Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development, 2017 27
  • Figure 12: Dermatology Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Molecular Target, 2017 28
  • Figure 13: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 1) 28
  • Figure 14: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 2) 29
  • Figure 15: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 3) 30
  • Figure 16: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 4) 31
  • Figure 17: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 5) 32
  • Figure 18: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 6) 33
  • Figure 19: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 7) 33
  • Figure 20: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 8) 34
  • Figure 21: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 9) 35
  • Figure 22: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 10) 36
  • Figure 23: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 11) 37
  • Figure 24: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 12) 38
  • Figure 25: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 13) 39
  • Figure 26: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 14) 40
  • Figure 27: Dermatology Therapeutics Market, Global, Pipeline Products, 2017 (Part 15) 41
  • Figure 28: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 1) 43
  • Figure 29: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 2) 44
  • Figure 30: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 3) 44
  • Figure 31: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 4) 45
  • Figure 32: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Inflammatory Diseases), 2017 (Part 5) 45
  • Figure 33: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Infectious Diseases), 2017 46
  • Figure 34: Dermatology Therapeutics Market, Global, First-in-Class Matrix Assessment (Wounds/Scars), 2017 47
  • Figure 35: Dermatology Therapeutics Market, Global, Industry-Wide Deals by Stage of Development and First-in-Class Status, 2006-2014 74
  • Figure 36: Dermatology Therapeutics Market, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status, 2006-2014 75
  • Figure 37: Dermatology Therapeutics Market, Global, Licensing Deals by Region, Value and Year, 2006-2017 76
  • Figure 38: Dermatology Therapeutics Market, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017 77
  • Figure 39: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2017 77
  • Figure 40: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2017 78
  • Figure 41: Dermatology Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 (Part 1) 79
  • Figure 42: Dermatology Therapeutics, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 (Part 2) 80
  • Figure 43: Dermatology Therapeutics Market, Global, Co-development Deals by Region, Value and Year, 2006-2017 81
  • Figure 44: Dermatology Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 82
  • Figure 45: Dermatology Therapeutics Market, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2017 82
  • Figure 46: Dermatology Therapeutics Market, Global, Number of Co-development Deals by Molecular Target, 2006-2017 83
  • Figure 47: Dermatology Therapeutics Market, Global, Co-development Deals with Disclosed Deal Values, 2006-2017 84
  • Figure 48: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with Prior Involvement in Licensing or Co-development Deals, 2017 85
  • Figure 49: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 1), 2017 86
  • Figure 50: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 2), 2017 87
  • Figure 51: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 3), 2017 88
  • Figure 52: Dermatology Therapeutics Market, Global, First-in-Class Pipeline Products with No Disclosed Prior Involvement in Licensing or Co-development Deals (Part 4), 2017 89
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