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市場調查報告書

OpportunityAnalyzer:葡萄膜炎 - 市場機會的分析與未來預測

OpportunityAnalyzer: Uveitis - Opportunity Analysis and Forecasts to 2026

出版商 GlobalData 商品編碼 604383
出版日期 內容資訊 英文 244 Pages
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OpportunityAnalyzer:葡萄膜炎 - 市場機會的分析與未來預測 OpportunityAnalyzer: Uveitis - Opportunity Analysis and Forecasts to 2026
出版日期: 2017年11月10日 內容資訊: 英文 244 Pages
簡介

世界主要七國(美國、法國、德國、義大利、西班牙、英國、日本)中葡萄膜炎療法的市場在2016年來到4億1650萬美金規模。未來10年內可望以8.0%的CAGR成長,在2026年時市場規模可望達到8億9710美金。

本報告分析了葡萄膜炎療法相關最新研究、開發動向、以及未來市場趨勢預測,並調查了疾病概要、現階段療法、未滿足需求、市場機會評估、未來10年的發病件數與市場規模的預測值、臨床試驗的進行狀況、新療法的候補藥物評估、未來市場與技術動向等內容,彙整提供如後。

第1章 目次

第2章 摘要整理

第3章 前言

第4章 疾病概要

  • 病原學與病理生理學
  • 病程分類
    • 葡萄膜炎與全身疾病
  • 症狀
  • 預後
  • 生活品質 (QoL)

第5章 流行病學

  • 疾病的背景
  • 風險要素與共病症
  • 過去的世界傾向(美國、歐洲、日本)
  • 預測方法
    • 情報來源
    • 預測的前提條件與方法
  • 葡萄膜炎的流行病學預測(共11年份)
    • 確診的發病件數
    • 確診的患者數量 有病者數
    • 確診的患者數量:依年齡
    • 確診的患者數量:依男女
    • 確診的患者數量:依解剖學部位
    • 確診的患者數量:依病因
  • 討論
    • 流行病學預測結果相關考察
    • 分析限制
    • 分析優勢

第6章 目前的治療選項

  • 概要
  • 診斷與治療
    • 診斷
    • 治療守則與代表性處方藥物
  • 臨床診療
  • Humira
    • 概要
    • 效能
    • 安全性
    • SWOT分析
  • Retisert (Fluocinolone Acetonide)
  • Retisert (Fluocinolone Acetonide)
  • Ozurdex (Dexamethasone Acetate)

第7章 未滿足需求與市場機會評估

  • 概要
  • 為了確保視野與抑制炎症的治療方法
    • 未滿足需求
    • 差距分析
    • 市場機會
  • 改善安全檔案的療法
  • 改善持久性與效能的療法
  • 醫師教育的擴大以及治療守則的改善
  • 各種葡萄膜炎的生物標記與診斷藥物之開發

第8章 研究開發 (R&D) 策略

  • 概要
    • 作為輔助性注射藥物對象的葡萄膜炎
    • 作為新藥最初適用症狀的葡萄膜炎
    • 眼科投藥路徑的開發
    • 非類固醇新藥物的開發
  • 試驗設計
    • 缺乏高品質的成果評估方法
    • 缺乏成果評估的相關共識
    • 皮質類固醇抑制型療法

第9章 候補藥物產品的評估

  • 概要
  • Opsiria/DE-109 (Sirolimus)
    • 概要
    • 效能
    • 安全性
    • SWOT分析
  • Durasert (Fluocinolone Acetonide)
  • EGP-437 (Iontophoretic Dexamethasone Phospaste)
  • CLS-TA (Triamcinolone Acetonide)
  • ADX-102
  • 生物仿藥的評估
  • Amjevita (Adalimumab生物仿藥)
    • 概要、SWOT分析
  • Imraldi (Adalimumab生物仿藥)
  • 在試驗早期階段的革新方法
    • Tesidolumab (LFG-316)
    • Orencia (Abatacept)
    • Dexamethasone Acetate (DexNP)
    • LME-636
    • Optiquel (B27-PD)
    • Filgotinib
  • 試驗中的其他產品

第10章 Pipeline Valuation Analysis 185

  • 主要候補藥物的臨床比較分析
  • 主要候補藥物的商業化基準分析
  • 各企業的評估
  • 主要國家市場的預測(未來10年份)
    • 美國
    • 歐洲主要五國 (EU5)
    • 日本

第11章 附錄

目錄
Product Code: GDHC075POA

Uveitis is an inflammatory condition of the eye affecting mainly the uvea. It encompasses a heterogeneous collection of disorders characterized by ocular inflammation. Currently, there is only a limited number of approved drugs for the treatment of uveitis. Based on the diverse nature of uveitis , there is a high unmet need for varied therapy approaches. Significant efforts are being made to develop new treatments for uveitis, as current pharmacologic management, which is dominated by competitively priced corticosteroids and also immunosuppressive drugs, is notorious for the development of adverse side effects.

GlobalData estimates the drug sales for uveitis in 2016 were approximately $416.5M across the 7MM covered in this report. Over the 10-year forecast period, the market is expected to grow to $897.1M at a CAGR of 8.0%.

The anticipated introduction of five new drugs will further drive the market by offering novel treatment mechanisms, including new drug delivery routes and novel, non-corticosteroid drug molecules. These new drugs will expand the options available to treat uveitis patients and contribute to overall market growth.

Scope

  • Overview of uveitis: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized uveitis market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including non-infectious mild and moderate anterior uveitis, non-infectious severe anterior uveitis, non-infectious intermediate, posterior and panuveitis), forecast from 2016 to 2026.
  • Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the uveitis therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for uveitis therapy. The most promising candidate in Phase III (and Phase II/III) development is profiled.
  • Analysis of the current and future market competition in the global uveitis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global uveitis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global uveitis therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 7
  • 1.2 List of Figures 8

2 Executive Summary 9

  • 2.1 Significant Growth Is Expected in the Uveitis Market from 2016 to 2026 9
  • 2.2 R&D and Corporate Strategies Within the Uveitis Market 11
  • 2.3 A Long-Acting Treatment That Permanently Controls Inflammation, With a Good Short- and Long-Term Safety Profile, Remains Elusive 12
  • 2.4 Market Opportunities for New Entrants 13
  • 2.5 Late-Stage Pipeline Drugs Entering the Uveitis Market Will Be a Key Driver of Growth 14
  • 2.6 What Do Physicians Think? 16

3 Introduction 19

  • 3.1 Catalyst 19
  • 3.2 Related Reports 19

4 Disease Overview 20

  • 4.1 Etiology and Pathophysiology 20
    • 4.1.1 Etiology 21
    • 4.1.2 Pathophysiology 24
  • 4.2 Classification or Staging Systems 26
    • 4.2.1 Uveitis and Systemic Diseases 27
  • 4.3 Symptoms 29
  • 4.4 Prognosis 30
  • 4.5 Quality of Life 31

5 Epidemiology 32

  • 5.1 Disease Background 32
  • 5.2 Risk Factors and Comorbidities 33
  • 5.3 Global and Historical Trends 34
    • 5.3.1 US 36
    • 5.3.2 5EU 37
    • 5.3.3 Japan 38
  • 5.4 Forecast Methodology 39
    • 5.4.1 Sources 40
    • 5.4.2 Forecast Assumptions and Methods 44
  • 5.5 Epidemiological Forecast for Uveitis (2016-2026) 54
    • 5.5.1 Diagnosed Incident Cases of Uveitis 54
    • 5.5.2 Diagnosed Prevalent Cases of Uveitis 55
    • 5.5.3 Age-Specific Diagnosed Prevalent Cases of Uveitis 56
    • 5.5.4 Sex-Specific Diagnosed Prevalent Cases of Uveitis 57
    • 5.5.5 Diagnosed Prevalent Cases by Anatomical Site of Inflammation 58
    • 5.5.6 Diagnosed Prevalent Cases by Etiology 59
  • 5.6 Discussion 60
    • 5.6.1 Epidemiological Forecast Insight 60
    • 5.6.2 Limitations of the Analysis 60
    • 5.6.3 Strengths of the Analysis 61

6 Current Treatment Options 63

  • 6.1 Overview 63
  • 6.2 Diagnosis and Treatment 63
    • 6.2.1 Diagnosis 63
    • 6.2.2 Treatment Guidelines and Leading Prescribed Drugs 64
  • 6.3 Clinical Practice 66
  • 6.4 Humira (Adalimumab) 73
    • 6.4.1 Overview 73
    • 6.4.2 Efficacy 78
    • 6.4.3 Safety 79

6.4.4 SWOT Analysis 81

  • 6.5 Retisert (Flucinolone Acetonide) 81
    • 6.5.1 Overview 81
    • 6.5.2 Efficacy 83
    • 6.5.3 Safety 84

6.5.4 SWOT Analysis 86

  • 6.6 Ozurdex (Dexamethasone Acetate) 86
    • 6.6.1 Overview 86
    • 6.6.2 Efficacy 89
    • 6.6.3 Safety 90

6.6.4 SWOT Analysis 92

7 Unmet Needs and Opportunity Assessment 93

  • 7.1 Overview 93
  • 7.2 Therapies That Maintain Vision and Control Inflammation 94
    • 7.2.1 Unmet Need 94
    • 7.2.2 Gap Analysis 95
    • 7.2.3 Opportunity 97
  • 7.3 Therapies With Improved Safety Profiles 98
    • 7.3.1 Unmet Need 98
    • 7.3.2 Gap Analysis 99
    • 7.3.3 Opportunity 103
  • 7.4 Long-Acting and More Efficient Treatment 104
    • 7.4.1 Unmet Need 104
    • 7.4.2 Gap Analysis 106
    • 7.4.3 Opportunity 109
  • 7.5 Increased Physician Education and Improved Treatment Guidelines 110
    • 7.5.1 Unmet Need 110
    • 7.5.2 Gap Analysis 111
    • 7.5.3 Opportunity 114
  • 7.6 Development of Biomarkers and Different Diagnostic Tests for Various Uveitic Types 115
    • 7.6.1 Unmet Need 115
    • 7.6.2 Gap Analysis 117
    • 7.6.3 Opportunity 117

8 R&D Strategies 118

  • 8.1 Overview 118
    • 8.1.1 Uveitis as an Add-On Indication 118
    • 8.1.2 Uveitis as a First Indication for a New Drug 119
    • 8.1.3 Development of Ophthalmic Routes of Administration 120
    • 8.1.4 Development of Novel Non-steroid Therapies 120
  • 8.2 Clinical Trials Design 121
    • 8.2.1 Lack of High-Quality Outcome Measures 121
    • 8.2.2 Lack of Consensus on Outcome Measures 123
    • 8.2.3 Corticosteroid-Sparing Therapy 123

9 Pipeline Assessment 125

  • 9.1 Overview 125
  • 9.2 Opsiria/DE-109 (Sirolimus) 127
    • 9.2.1 Overview 127
    • 9.2.2 Efficacy 131
    • 9.2.3 Safety 133

9.2.4 SWOT Analysis 134

  • 9.3 Durasert (Fluocinolone Acetonide) 134
    • 9.3.1 Overview 134
    • 9.3.2 Efficacy 140
    • 9.3.3 Safety 141

9.3.4 SWOT Analysis 143

  • 9.4 EGP-437 (Iontophoretic Dexamethasone Phospaste) 144
    • 9.4.1 Overview 144
    • 9.4.2 Efficacy 148
    • 9.4.3 Safety 149

9.4.4 SWOT Analysis 150

  • 9.5 CLS-TA (Triamcinolone Acetonide) 150
    • 9.5.1 Overview 150
    • 9.5.2 Efficacy 156
    • 9.5.3 Safety 157

9.5.4 SWOT Analysis 158

  • 9.6 ADX-102 159
    • 9.6.1 Overview 159
    • 9.6.2 Efficacy 162
    • 9.6.3 Safety 163

9.6.4 SWOT Analysis 164

  • 9.7 Biosimilars Assessment 164
  • 9.8 Amjevita (Adalimumab Biosimilar) 168
    • 9.8.1 Overview 168

9.8.2 SWOT Analysis 170

  • 9.9 Imraldi (Adalimumab Biosimilar) 170
    • 9.9.1 Overview 170

9.9.2 SWOT Analysis 172

  • 9.10 Innovative Early Stage Approaches 173
    • 9.10.1 Tesidolumab (LFG-316) 173
    • 9.10.2 Orencia (Abatacept) 174
    • 9.10.3 Dexamethasone Acetate (DexNP) 177
    • 9.10.4 LME-636 180
    • 9.10.5 Optiquel (B27-PD) 181
    • 9.10.6 Filgotinib 182
  • 9.11 Other Drugs in Development 184

10 Pipeline Valuation Analysis 185

  • 10.1 Clinical Benchmark of Key Pipeline Drugs 185
  • 10.2 Commercial Benchmark of Key Pipeline Drugs 187
  • 10.3 Competitive Assessment 189
  • 10.4 Top-Line 10-Year Forecast 192
    • 10.4.1 US 196
    • 10.4.2 5EU 199
    • 10.4.3 Japan 203

11 Appendix 206

  • 11.1 Bibliography 206
  • 11.2 Abbreviations 220
  • 11.3 Methodology 224
    • 11.3.1 Forecasting Methodology 224
    • 11.3.2 Diagnosed Prevalent Cases 226
    • 11.3.3 Diagnosed Prevalent Cases by Anatomical Site of Inflammation 226
    • 11.3.4 Diagnosed Cases and Drug-Treated Prevalence 226
    • 11.3.5 Disease Severity 227
    • 11.3.6 Drugs Included in Each Therapeutic Class 227
    • 11.3.7 Launch and Patent Expiry Dates 228
    • 11.3.8 General Pricing Assumptions 229
    • 11.3.9 Individual Drug Assumptions 230
    • 11.3.10 Generic Erosion 234
    • 11.3.11 Pricing of Pipeline Agents 235
  • 11.4 Primary Research - KOLs Interviewed for This Report 237
  • 11.5 Primary Research - Prescriber Survey 239
  • 11.6 About the Authors 240
    • 11.6.1 Analyst 240
    • 11.6.2 Therapy Area Director 240
    • 11.6.3 Epidemiologist 240
    • 11.6.4 Managing Epidemiologist 241
    • 11.6.5 Global Director of Therapy Analysis and Epidemiology 241
    • 11.6.6 Global Head and EVP of Healthcare Operations and Strategy 242
  • 11.7 About GlobalData 243
  • 11.8 Contact Us 243
  • 11.9 Disclaimer 244

List of Tables

  • Table 1: Uveitis: Key Metrics in the 7MM 9
  • Table 2: SUN Working Group Anatomic Classification of Uveitis 26
  • Table 3: SUN Working Group Descriptors in Uveitis 27
  • Table 4: SUN Working Group Descriptors in Uveitis 27
  • Table 5: Systemic Diseases Associated with Uveitis 28
  • Table 6: Symptoms and Ocular Comorbidities of Uveitis 29
  • Table 7: Prognosis for Uveitis Patients 30
  • Table 8: Risk Factors, Comorbidities, and Associated Diseases for Uveitis 33
  • Table 9: 7MM, Diagnosed Incident Cases of Uveitis, Both Sexes, All Ages, N, Select Years, 2016-2026 54
  • Table 10: 7MM, Diagnosed Prevalent Cases of Uveitis, Both Sexes, All Ages, N, Select Years, 2016-2026 55
  • Table 11: Treatment Guidelines for Uveitis 65
  • Table 12: Most Prescribed Drugs for Uveitis by Class in the Global Markets, 2016 66
  • Table 13: Summary of Minor Therapeutic Classes, 2016 72
  • Table 14: Product Profile - Humira 77
  • Table 15: Humira SWOT Analysis, 2017 81
  • Table 16: Product Profile - Retisert 83
  • Table 17: Retisert SWOT Analysis, 2017 86
  • Table 18: Product Profile - Ozurdex 89
  • Table 19: Ozudex SWOT Analysis, 2017 92
  • Table 20: Comparison of Therapeutic Classes in Development for Non-infectious Uveitis, 2016-2026 126
  • Table 21: Product Profile - Opsiria 131
  • Table 22: Opsiria SWOT Analysis, 2017 134
  • Table 23: Product Profile - Durasert 140
  • Table 24: Durasert SWOT Analysis, 2017 143
  • Table 25: Product Profile - EGP-437 148
  • Table 26: EGP-437 SWOT Analysis, 2017 150
  • Table 27: Product Profile - CLS-TA 156
  • Table 28: CLS-TA SWOT Analysis, 2017 158
  • Table 29: Product Profile - ADX-102 162
  • Table 30: ADX-102 SWOT Analysis, 2017 164
  • Table 31: Adalimumab Biosimilars Being Developed in the 7MM/Globally 165
  • Table 32: Product Profile - Amjevita 169
  • Table 33: Amjevita SWOT Analysis, 2017 170
  • Table 34: Product Profile - Imraldi 172
  • Table 35: IMRALDI SWOT Analysis, 2017 172
  • Table 36: Innovative Early Stage Approaches for Non-infectious Uveitis, 2017 173
  • Table 37: Drugs in Development for Uveitis, 2017 184
  • Table 38: Clinical Benchmark of Key Pipeline Drugs - Anterior Uveitis 186
  • Table 39: Clinical Benchmark of Key Pipeline Drugs - Posterior Segment Uveitis 187
  • Table 40: Commercial Benchmark of Key Pipeline Drugs - Anterior Uveitis 188
  • Table 41: Commercial Benchmark of Key Pipeline Drugs - Posterior Segment Uveitis 189
  • Table 42: Key Events Impacting Sales for Uveitis, 2016-2026 195
  • Table 43: Uveitis Market - Global Drivers and Barriers, 2016-2026 196
  • Table 44: Key Historical and Projected Launch Dates for Uveitis 228
  • Table 45: Key Historical and Projected Patent Expiry Dates for Uveitis 229
  • Table 46: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 239
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