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市場調查報告書

Frontier Pharma:女性的健康

Frontier Pharma: Women's Health - An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline

出版商 GlobalData 商品編碼 611855
出版日期 內容資訊 英文 86 Pages
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Frontier Pharma:女性的健康 Frontier Pharma: Women's Health - An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline
出版日期: 2018年02月01日內容資訊: 英文 86 Pages
簡介

本報告提供女性的健康調查分析,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
  • 持續的革新
  • 報告指南

第4章 臨床、商業形勢

  • 治療領域概要
  • 疾病概要、症狀
  • 診斷
  • 流行病學、病因
  • 病理生理學
  • 合併症、併發症
  • 治療
  • 上市產品概要

第5章 開發平台的評估

  • 概要
  • 開發平台:各開發階段,各分子類型
  • 開發平台:分子各標的
  • 市場與開發平台間的計劃比較分佈:各分子標的類別
  • 以的分子標的為目標的First-in-Class計劃
  • 對First-in-Class標的First-in-Class產品的比率
  • 全部的開發中產品的清單

第6章 訊號 (訊號傳達) 網路,因果關係,革新的調整

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

第7章 First-in-Class標的評估

第8章 策略性整合

  • 有/沒有事前參與授權交易共同開發交易的First-in-Class產品
  • 授權交易
  • 共同開發交易
  • 有/沒有事前參與First-in-Class計劃

第9章 附錄

目錄
Product Code: GBIHC467MR

Abstractt

  • Frontier Pharma: Women's Health - An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline
  • Summary
  • The women's health therapy area covers medical disorders that affect females only, primarily disorders of the female reproductive system, including those associated with menstruation, conception, pregnancy, childbirth and menopause. Many of these disorders are highly prevalent among the female population.
  • Despite this, the women's health market is relatively small. This reflects diagnostic barriers and high levels of non-treatment for women's health disorders, as well as high levels of genericization and relatively limited innovation within recent decades.
  • Consequently, there is strong rationale for continued R&D investment in women's health therapeutics due to high levels of unmet need across many indications.
  • This report assesses first-in-class innovation across the women's health therapy area, with a particular focus on three key indications: endometriosis, polycystic ovarian syndrome (PCOS) and cervical intraepithelial neoplasia (CIN).
  • Scope
  • - Many women's health disorders are highly prevalent. How do epidemiology trends vary for endometriosis, PCOS and CIN?
  • - Innovation within women's health has been relatively limited over recent decades. What are the most prominent unmet needs across this therapy area?
  • - There are 261 pipeline programs in active development for women's health. What proportion of these products are first-in-class? How does first-in-class innovation vary by indication, development stage and molecular target class?
  • - Although the first-in-class pipeline is relatively modest in size it is considerably diverse with eight distinct molecular target classes represented. Which first-in-class targets have been identified as most promising for women's health conditions?
  • - Over 200 licensing deals relating to women's health have been completed since 2006. Do women's health products typically attract high deal values? Which first-in-class products have prior deal involvement?
  • Reasons to buy
  • - Understand the current clinical and commercial landscape. This includes a comprehensive study of symptoms, epidemiology, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment options.
  • - Visualize the composition of the women's health market in terms of dominant molecule types and molecular targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
  • - Analyze the women's health pipeline and stratify by stage of development, molecule type and molecular target.
  • - Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising first-in-class targets have been reviewed in greater detail.
  • - Recognize commercial opportunities in the women's health deals landscape by analyzing trends in licensing and co-development deals, and identifying women's health therapies that have not yet been involved in deals and may offer potential investment opportunities.

Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 4
  • 1.2 List of Figures 4

2 Executive Summary 6

  • 2.1 Expanding Pipeline Has Potential to Address Unmet Needs of Large Prevalence Population 6
  • 2.2 First-in-Class Innovation Concentrated Across Endometriosis, Polycystic Ovarian Syndrome and Cervical Intraepithelial Neoplasia 6
  • 2.3 Despite High Licensing Deal Activity, Most First-in-Class Products Have No Prior Deal Involvement 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 Product Developments Remain Attractive 8
  • 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9
  • 3.5 Sustained Innovation in Women's Health 9
  • 3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 11

  • 4.1 Therapy Area Overview 11
  • 4.2 Disease Overview and Symptoms 11
    • 4.2.1 Endometriosis 11
    • 4.2.2 Polycystic Ovarian Syndrome 12
    • 4.2.3 Cervical Intraepithelial Neoplasia 12
  • 4.3 Diagnosis 13
    • 4.3.1 Endometriosis 13
    • 4.3.2 Polycystic Ovarian Syndrome 13
    • 4.3.3 Cervical Intraepithelial Neoplasia 14
  • 4.4 Epidemiology and Etiology 14
    • 4.4.1 Endometriosis 14
    • 4.4.2 Polycystic Ovarian Syndrome 15
    • 4.4.3 Cervical Intraepithelial Neoplasia 16
  • 4.5 Pathophysiology 16
    • 4.5.1 Endometriosis 16
    • 4.5.2 Polycystic Ovarian Syndrome 17
    • 4.5.3 Cervical Intraepithelial Neoplasia 18
  • 4.6 Co-morbidities and Complications 18
    • 4.6.1 Endometriosis 18
    • 4.6.2 Polycystic Ovarian Syndrome 19
    • 4.6.3 Cervical Intraepithelial Neoplasia 19
  • 4.7 Treatment 19
    • 4.7.1 Treatment Options 19
    • 4.7.2 Treatment Algorithms 23
  • 4.8 Overview of Marketed Products within Women's Health 24

5 Pipeline Assessment 26

  • 5.1 Overview 26
  • 5.2 Pipeline by Stage of Development and Molecule Type 26
  • 5.3 Pipeline by Molecular Target 29
  • 5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 32
  • 5.5 First-in-Class Programs Targeting Novel Molecular Targets 33
  • 5.6 Ratio of First-in-Class Products to First-in-Class Targets 35
  • 5.7 List of All Pipeline Products 36

6 Signalling Network, Disease Causation and Innovation Alignment 46

  • 6.1 Complexity of Signaling Networks 46
  • 6.2 Signaling Pathways and First-in-Class Molecular Target Integration 46
  • 6.3 First-in-Class Matrix Assessments 46

7 First-in-Class Target Evaluation 50

  • 7.1 First-in-Class Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4) for Endometriosis 50
  • 7.2 First-in-Class Programs Targeting Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2) for Endometriosis, PCOS and Ovarian Hyperstimulation Syndrome 51
  • 7.3 First-in-Class Programs Targeting Glutamyl Aminopeptidase (ENPEP) for Endometriosis 53
  • 7.4 First-in-Class Programs Targeting Prostaglandin E Synthase (PTGES) for Endometriosis 54
  • 7.5 First-in-Class Programs Targeting Kiss 1 Receptor (KISS1R) for Endometriosis, PCOS and Infertility 55
  • 7.6 First-in-Class Programs Targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4) for Endometriosis 57
  • 7.7 First-in-Class Programs Targeting Type 2 Angiotensin II Receptor (AGTR2) for PCOS 58
  • 7.8 First-in-Class Programs Targeting Neuromedin K Receptor (TACR3) for PCOS, Endometriosis, Uterine Fibroids and Vasomotor Symptoms of Menopause 59
  • 7.9 First-in-Class Programs Targeting Eukaryotic Translation Initiation Factor 2 Alpha Kinase 3 (EIF2AK3) for CIN 61
  • 7.10 First-in-Class Programs Targeting Human Papillomavirus Protein E6 (E6) and Human Papillomavirus Protein E7 for CIN 62

8 Strategic Consolidations 65

  • 8.1 First-in-Class Products with and without Prior Deal Involvement in Licensing and Co-development Deals 65
    • 8.1.1 Industry-Wide First-in-Class Deals 65
  • 8.2 Licensing Deals 67
    • 8.2.1 Deals by Region, Value and Year 67
    • 8.2.2 Deals by Stage of Development and Value 68
    • 8.2.3 Deals by Molecule Type, Molecular Target and Value 68
    • 8.2.4 List of Deals with Disclosed Deal Values 69
  • 8.3 Co-Development Deals 71
    • 8.3.1 Deals by Region, Value and Year 71
    • 8.3.2 Deals by Stage of Development and Molecule Type 72
    • 8.3.3 Deals by Molecule Type, Molecular Target and Aggregate Deal value 73
    • 8.3.4 List of Deals with Disclosed Deal Values 74
  • 8.4 First-in-Class Programs with and without Prior Deal Involvement 74

9 Appendix 77

  • 9.1 References 77
  • 9.2 Abbreviations 83
  • 9.3 Pipeline Disease List 84
  • 9.4 Research Methodology 84
    • 9.4.1 Data integrity 84
    • 9.4.2 Innovative and meaningful analytical techniques and frameworks 84
    • 9.4.3 Evidence based analysis and insight 84
  • 9.5 Secondary Research 85
    • 9.5.1 Market Analysis 85
    • 9.5.2 Pipeline Analysis 85
    • 9.5.3 Licensing and Co-development Deals 86
  • 9.6 Contact Us 86
  • 9.7 Disclaimer 86

1.1 List of Tables

  • Table 1: Women's Health, Global, Classification of CIN, 2018 12
  • Table 2: Women's Health, Global, PCOS Diagnostic Criteria for NIH, Rotterdam and AE-PCOS Classification Systems, 2018 14
  • Table 3: Women's Health, Global, Types of Female Contraceptives, 2018 20
  • Table 4: Women's Health, Global, Key Details of Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51
  • Table 5: Women's Health, Global, Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51
  • Table 6: Women's Health, Global, Key Details of Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52
  • Table 7: Women's Health, Global, Women's Health, Global, Pipeline Programs Patatin-like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52
  • Table 8: Women's Health, Global, Key Details of Glutamyl Aminopeptidase (ENPEP), 2018 53
  • Table 9: Women's Health, Global, Pipeline Programs Targeting Glutamyl Aminopeptidase (ENPEP), 2018 53
  • Table 10: Women's Health, Global, Key Details of Prostaglandin E synthase (PTGES), 2018 55
  • Table 11: Women's Health, Global, Pipeline Programs Targeting Prostaglandin E synthase (PTGES), 2018 55

1.2 List of Figures

  • Figure 1: Women's Health, US, Innovation Trends in Product Approvals, 1987-2014 7
  • Figure 2: Women's Health, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 9
  • Figure 3: Women's Health, Global, Market by Molecule Type, 2018 24
  • Figure 4: Women's Health, Global, Market by Molecular Target, 2018 25
  • Figure 5: Women's Health, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018 26
  • Figure 6: Women's Health, Global, Pipeline by Stage of Development and Molecule Type, 2018 27
  • Figure 7: Women's Health, Global, Key Indications by Stage of Development, 2018 28
  • Figure 8: Women's Health, Global, Key Indications by Molecule Type, 2018 29
  • Figure 9: Women's Health, Global, Pipeline by Molecular Target, 2018 30
  • Figure 10: Women's Health, Global, Breakdown of Key Molecular Target Classes, 2018 31
  • Figure 11: Women's Health, Global, Key Indications by Molecular Target Class, 2018 32
  • Figure 12: Women's Health, Global, Pipeline and Marketed Products by Molecular Target Class, 2018 33
  • Figure 13: Women's Health, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2018 34
  • Figure 14: Women's Health, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2018 35
  • Figure 15: Women's Health, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018 36
  • Figure 16: Women's Health, Global, List of All Pipeline Products, 2018 (part 1) 37
  • Figure 17: Women's Health, Global, List of All Pipeline Products, 2018 (part 2) 38
  • Figure 18: Women's Health, Global, List of All Pipeline Products, 2018 (part 3) 39
  • Figure 19: Women's Health, Global, List of All Pipeline Products, 2018 (part 4) 40
  • Figure 20: Women's Health, Global, List of All Pipeline Products, 2018 (part 5) 41
  • Figure 21: Women's Health, Global, List of All Pipeline Products, 2018 (part 6) 42
  • Figure 22: Women's Health, Global, List of All Pipeline Products, 2018 (part 7) 43
  • Figure 23: Women's Health, Global, List of All Pipeline Products, 2018 (part 8) 44
  • Figure 24: Women's Health, Global, List of All Pipeline Products, 2018 (part 9) 44
  • Figure 25: Women's Health, Global, List of All Pipeline Products, 2018 (part 10) 45
  • Figure 26: Women's Health, Global, First-in-Class Matrix Assessment for Endometriosis, 2018 48
  • Figure 27: Women's Health, Global, First-in-Class Matrix Assessment for PCOS, 2018 48
  • Figure 28: Women's Health, Global, First-in-Class Matrix Assessment for CIN (Human Proteins), 2018 48
  • Figure 29: Women's Health, Global, First-in-Class Matrix Assessment for CIN (Viral Proteins), 2018 49
  • Figure 30: Women's Health, Global, All First-in-Class Molecular Targets Across the Women's Health Pipeline, 2018 49
  • Figure 31: Women's Health, Global, Industry-Wide Licensing Deals by Stage of Development and First-in-Class Product Status, 2006-2015 65
  • Figure 32: Women's Health, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Product Status ($m), 2006-2015 66
  • Figure 33: Women's Health, Global, Licensing Deals by Region, Value and Year, 2018 67
  • Figure 34: Women's Health, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2018 68
  • Figure 35: Women's Health, Global, Licensing Deals by Molecule Type, Molecular Target and Aggregate Deal Value, 2018 69
  • Figure 36: Women's Health, Global, Licensing Deals with Disclosed Deal Values, 2018 (part 1) 70
  • Figure 37: Women's Health, Global, Licensing Deals with Disclosed Deal Values, 2018 (part 2) 71
  • Figure 38: Women's Health, Global, Co-development Deals by Region, Value and Year, 2018 72
  • Figure 39: Women's Health, Global, Licensing Deals by Region, Value and Year, 2018 73
  • Figure 40: Women's Health, Global, Licensing Deals by Region, Value and Year, 2018 73
  • Figure 41: Women's Health, Global, Co-development with Disclosed Deal Values, 2018 74
  • Figure 42: Women's Health, Global, First-in-Class Products with and without Prior Involvement in Licensing and Co-development Deals, 2018 (part 1) 75
  • Figure 43: Women's Health, Global, First-in-Class Products with and without Prior Involvement in Licensing and Co-development Deals, 2018 (part 2) 76