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市場調查報告書

PharmaPoint:克隆氏症 - 全球醫藥品的預測與市場分析

PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2026

出版商 GlobalData 商品編碼 298050
出版日期 內容資訊 英文 226 Pages
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PharmaPoint:克隆氏症 - 全球醫藥品的預測與市場分析 PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2026
出版日期: 2017年09月21日 內容資訊: 英文 226 Pages
簡介

克隆氏症(CD)治療藥市場由於新生物療法的出現而非常活絡。由於抗TBF上市藥專利的到期,造成新興生技仿製藥的興起。譬如Remicade的生技仿製藥、Hospira的Inflectra(infliximab)等。

本報告提供全球克隆氏症(CD)治療藥市場相關調查分析,提供疾病的概要與指南,競爭情形,主要藥物的詳細資訊(產品說明,安全性,有效性),彙整SWOT分析,銷售額預測,影響分析(趨勢,推動因素·阻礙因素)等,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因·病理生理學
    • 病因
    • 病理生理學
  • 症狀
  • 預測
  • 生活品質(QOL)

第4章 流行病學

  • 危險因素和共生病症
    • 最大60%的CD患者經歷過骨骼密度低
    • 3分之一的CD患者患有精神疾病
    • 25%的CD患者關節炎發病
    • 部分CD患者也頻繁併發腸胃疾病
  • 全球趨勢
    • 美國
    • 歐洲5個國家
    • 日本
    • 加拿大
    • 中國
    • 印度
  • 預測手法
  • 利用之資訊來源
  • 預測的前提條件與手法
  • CD的流行病學預測
  • 議論
  • 分析的限制
  • 分析的優勢

第5章 疾病的管理

  • 治療概要
  • 美國
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 加拿大
  • 中國
  • 印度

第6章 競爭評估

  • 概要
  • 策略性競爭企業的評估
  • 產品簡介 - 領導品牌
  • 生技仿製藥

第7章 機會及未滿足需求

  • 概要
  • 個別治療用生物標記的需求
  • 抗TNF難治型患者的治療
  • 未滿足需求的差距分析
  • 標靶治療
  • 早期診斷·治療的預測工具

第8章 開發平台評估

  • 概要
  • 臨床實驗設計
  • 臨床實驗:Phase別·各階段
  • 臨床開發中的潛力藥物
  • 其他後期開發中產品

第9章 現在/未來的主要企業

  • 概要
  • 企業策略趨勢
  • 企業簡介
    • Johnson & Johnson
    • AbbVie
    • UCB
    • Biogen Idec
    • 武田藥品工業
    • ChemoCentryx

第10章 市場預測

  • 全球市場
  • 美國
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 加拿大
  • 中國
  • 印度

第11章 附錄

圖表

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目錄
Product Code: GDHC160PIDR

Inflammatory bowel disease (IBD) refers to two chronic autoimmune diseases that cause intestinal inflammation: Crohn's disease (CD) and ulcerative colitis (UC). In CD, chronic inflammation may affect any part of the gastrointestinal (GI) tract from the mouth to the anal area. However, CD occurs most commonly in the lower part of the small intestine (ileum) and in the large intestine. The disease also may affect only some segments of the intestinal tract while leaving normal segments between the affected areas.

In 2016, it is estimated that the global CD market was valued at over US$9 billion across the 7MM. By the end of the forecast period in 2026, sales across these markets will have grown steadily to reach almost US$13.5 billion, representing a Compound Annual Growth Rate (CAGR) of around 3.8% over the 10-year timeframe, which includes six new market entrants and the launch of biosimilars.

Major growth drivers in the CD market over the forecast period include -

  • The anticipated launches of interleukin (IL) inhibitors and anti-integrin therapies, including AbbVie's risankizumab, Genentech's etrolizumab, and Takeda's subcutaneous Entyvio (Entyvio SC), as well as Galapagos/Gilead's filgotinib, Celgene's mongersen sodium, and Shire's SHP-647, will provide more treatment options for physicians to choose from.
  • The number of diagnosed prevalent CD cases will increase to over 1.8 million in 2026 at an annual growth rate (AGR) of 2.3%. Total treated cases will grow to almost 1.2 million at an AGR of 2.3% during the 10-year period of 2016-2026.
  • Strong uptake of J&J's IL-12/23 inhibitor Stelarawill continue, generating sales of about US$1.2 billion across the 7MM in 2026.
  • The high unmet need for improved medical management of perianal fistulas presents an untapped market opportunity.

The report "PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2026", providesoverview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

In depth, this report provides the following -

  • Topline CD market revenue from 2016-2026. ACOT and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting CD therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global CD therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Scope

  • Overview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline CD market revenue from 2016-2026. ACOT and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting CD therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global CD 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 CD therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CD therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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

1 Table of Contents 2

  • 1.1 List of Tables 5
  • 1.2 List of Figures 7

2 Executive Summary 8

  • 2.1 Launch of Non-Anti-TNF Therapies Will Fuel CD Market Growth to 2026 9
  • 2.2 R&D and Corporate Strategies Will Be Focused on the Competitive Biologics Space 11
  • 2.3 A Number of Clinical Unmet Needs Exist in the CD Treatment Realm 12
  • 2.4 Treatments for the Management of Perianal Fistulas Remain Elusive 13
  • 2.5 Novel Biologics and Biosimilars Will Reshape the CD Competitive Landscape 13
  • 2.6 What Do Physicians Think? 14

3 Introduction 17

  • 3.1 Catalyst 17
  • 3.2 Related Reports 18
  • 3.3 Upcoming Related Reports 18

4 Disease Overview 19

  • 4.1 Etiology and Pathophysiology 19
  • 4.2 Biomarkers/Targets of Interest 22
  • 4.3 Symptoms 22
  • 4.4 Prognosis 23
  • 4.5 Quality of Life 24

5 Epidemiology 25

  • 5.1 Disease Background 25
  • 5.2 Risk Factors and Comorbidities 26
  • 5.3 Global and Historical Trends 27
  • 5.4 Forecast Methodology 30
  • 5.5 Epidemiological Forecast for Crohn's Disease 43
  • 5.6 Alternate Epidemiological Forecast for Crohn's Disease (2016-2026) 49
  • 5.7 Discussion 51

6 Disease Management 54

  • 6.1 Diagnosis Overview 54
  • 6.2 Treatment Overview 54
  • 6.3 US 57
  • 6.4 5EU 59
  • 6.5 Japan 61

7 Competitive Assessment 63

  • 7.1 Overview 63
  • 7.2 Remicade (infliximab) 63
  • 7.3 Humira (adalimumab) 70
  • 7.4 Cimzia (certolizumab pegol) 74
  • 7.5 Entyvio (vedolizumab) 78
  • 7.6 Stelara (ustekinumab) 83
  • 7.7 Inflectra/Remsima (infliximab biosimilar) 88
  • 7.8 Renflexis/Flixabi (infliximab biosimilar) 92
  • 7.9 Amjevita/Amgevita (adalimumab biosimilar) 95
  • 7.10 Biosimilar Assessment 97
  • 7.11 Other Therapeutic Classes 105

8 Unmet Needs and Opportunity Assessment 106

  • 8.1 Overview 106
  • 8.2 Improved Drug Efficacy and Safety in the Maintenance Therapy Setting 107
  • 8.3 Biomarkers to Predict Responsiveness to Therapy and Prognosis 109
  • 8.4 Improve Medical Management of Perianal Fistulas 111
  • 8.5 Patient Adherence to Maintenance Therapy 112

9 Pipeline Assessment 115

  • 9.1 Overview 115
  • 9.2 Clinical Trial Mapping 117
  • 9.3 Promising Drugs in Clinical Development 118
  • 9.4 Etrolizumab 120
  • 9.5 Mongersen 126
  • 9.6 Filgotinib 132
  • 9.7 SHP-647 139
  • 9.8 Risankizumab 143
  • 9.9 Other Drugs in Early-Stage Development 148
  • 9.10 Other Promising Drugs in Development 149

10 Current and Future Players 153

  • 10.1 Overview 153
  • 10.2 Trends in Corporate Strategy 155
  • 10.3 Johnson & Johnson 156
  • 10.4 AbbVie 158
  • 10.5 UCB 160
  • 10.6 Takeda 162
  • 10.7 Roche 163
  • 10.8 Celgene 165
  • 10.9 Galapagos 166
  • 10.10 Shire 167

11 Market Outlook 169

  • 11.1 Global Markets 169
  • 11.2 US 172
  • 11.3 5EU 176
  • 11.4 Japan 180

12 Appendix 184

  • 12.1 Bibliography 184
  • 12.2 Abbreviations 204
  • 12.3 Methodology 207
  • 12.4 Primary Research - KOLs Interviewed for This Report 214
  • 12.5 Primary Research - Prescriber Survey 217
  • 12.6 About the Authors 218
  • 12.7 About GlobalData 220
  • 12.8 Contact Us 221
  • 12.9 Disclaimer 221

List of Tables

1.1 List of Tables

  • Table 1: Crohn's Disease: Key Metrics in the 7MM 13
  • Table 2: Symptoms of Crohn's Disease 28
  • Table 3: Risk Factors and Comorbidities for Crohn's Disease 31
  • Table 4: 7MM, Diagnosed Incident Cases of CD, All Ages, Both Sexes, Select Years 2016-2026 49
  • Table 5: 7MM, Diagnosed Prevalent Cases of CD, Men and Women, All Ages, Select Years 2016-2026 50
  • Table 6: Treatment Guidelines for Crohn's Disease 61
  • Table 7: Most Prescribed Drugs for Crohn's Disease by Class in the Global Markets, 2016 61
  • Table 8: Country Profile - US 63
  • Table 9: Country Profile - 5EU 65
  • Table 10: Country Profile - Japan 67
  • Table 11: Product Profile - Remicade 70
  • Table 12: Safety Data From the ACCENT II Study Up to Week 54 73
  • Table 13: Remicade SWOT Analysis, 2017 74
  • Table 14: Product Profile - Humira 76
  • Table 15: Humira SWOT Analysis, 2017 78
  • Table 16: Product Profile - Cimzia 80
  • Table 17: Cimzia SWOT Analysis, 2017 82
  • Table 18: Product Profile - Entyvio 84
  • Table 19: Efficacy Data From the Phase III GEMINI II Maintenance Study 85
  • Table 20: Safety Data for Entyvio from the GEMINI II Study 86
  • Table 21: Entyvio SWOT Analysis, 2017 87
  • Table 22: Product Profile - Stelara 89
  • Table 23: Efficacy Data From the IM-UNITI Phase III Study 90
  • Table 24: Safety Data for Stelara from the IM-UNITI Study 91
  • Table 25: Stelara SWOT Analysis, 2017 92
  • Table 26: Product Profile - Inflectra/Remsima 94
  • Table 27: Inflectra/Remsima SWOT Analysis, 2017 96
  • Table 28: Product Profile - Renflexis/Flixabi 97
  • Table 29: Renflexis/Flixabi SWOT Analysis, 2017 99
  • Table 30: Product Profile - Amjevita 101
  • Table 31: Amjevita SWOT Analysis, 2017 102
  • Table 32: Marketed and Pipeline Biosimilars for CD, 2017 105
  • Table 33: Biosimilar Legislation Across the 7MM 109
  • Table 34: Summary of Minor Therapeutic Classes, 2017 110
  • Table 35: Comparison of Therapeutic Classes in Development for Crohn's Disease, 2016-2026 125
  • Table 36: Product Profile - Etrolizumab 126
  • Table 37: Phase II Safety Data for Etrolizumab in UC 128
  • Table 38: Etrolizumab SWOT Analysis, 2017 130
  • Table 39: Product Profile - Mongersen 132
  • Table 40: Phase II Efficacy Data for Mongersen Sodium 133
  • Table 41: Phase II Safety Data for Mongersen Sodium 134
  • Table 42: Mongersen Sodium SWOT Analysis, 2017 136
  • Table 43: Product Profile - Filgotinib 139
  • Table 44: Phase II Efficacy Data for Filgotinib from the FITZROY Study 140
  • Table 45: Phase II Safety Data for Filgotinib 140
  • Table 46: Filgotinib SWOT Analysis, 2017 143
  • Table 47: Product Profile - SHP-647 145
  • Table 48: Phase II Efficacy Data for SHP-647 from the OPERA Study 145
  • Table 49: SHP-647 SWOT Analysis, 2017 147
  • Table 50: Product Profile - Risankizumab 149
  • Table 51: Phase II Safety Data for Risankizumab 150
  • Table 52: Risankizumab SWOT Analysis, 2017 151
  • Table 53: Drugs in Development for CD, 2017 153
  • Table 54: Drugs in Development for Crohn's Disease, 2017 154
  • Table 55: Key Companies in the Crohn's Disease Market in the 7MM, 2017 158
  • Table 56: J&J's Disease Portfolio Assessment, 2017 162
  • Table 57: J&J SWOT Analysis, 2017 163
  • Table 58: AbbVie's Disease Portfolio Assessment, 2017 164
  • Table 59: AbbVie SWOT Analysis, 2017 165
  • Table 60: UCB's Disease Portfolio Assessment, 2017 166
  • Table 61: UCB SWOT Analysis, 2017 166
  • Table 62: Takeda's Disease Portfolio Assessment, 2017 168
  • Table 63: Takeda SWOT Analysis, 2017 168
  • Table 64: Roche/Genentech's Disease Portfolio Assessment, 2017 169
  • Table 65: Roche/Genentech SWOT Analysis, 2017 169
  • Table 66: Celgene's Disease Portfolio Assessment, 2017 170
  • Table 67: Celgene SWOT Analysis, 2017 171
  • Table 68: Galapagos' Disease Portfolio Assessment, 2017 172
  • Table 69: Galapagos SWOT Analysis, 2017 172
  • Table 70: Shire's Disease Portfolio Assessment, 2017 173
  • Table 71: Shire SWOT Analysis, 2017 173
  • Table 72: Crohn's Disease Market - Global Drivers and Barriers, 2016-2026 177
  • Table 73: Key Events Impacting Sales for Crohn's Disease in the US, 2016-2026 180
  • Table 74: Crohn's Disease Market - Drivers and Barriers in the US, 2016-2026 180
  • Table 75: Key Events Impacting Sales for Crohn's Disease in the 5EU, 2016-2026 184
  • Table 76: Crohn's Disease Market -Drivers and Barriers in the 5EU, 2016-2026 184
  • Table 77: Key Events Impacting Sales for Crohn's Disease in Japan, 2016-2026 188
  • Table 78: Crohn's Disease Market - Global Drivers and Barriers in Japan, 2016-2026 188
  • Table 79: Key Historical and Projected Launch Dates for Crohn's Disease 214
  • Table 80: Key Historical and Projected Patent Expiry Dates for Crohn's Disease 214
  • Table 81: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 222

List of Figures

1.2 List of Figures

  • Figure 1: Global (7MM) Sales Forecast by Country for Crohn's Disease in 2016 and 2026 15
  • Figure 2: Analysis of the Company Portfolio Gap in Crohn's Disease During the Forecast Period 17
  • Figure 3: Crohn's Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016-2026 19
  • Figure 4: 7MM, Age-Adjusted Diagnosed Prevalence of CD (%), Men, All Ages, 2006 to 2026 32
  • Figure 5: 7MM, Age-Adjusted Diagnosed Prevalence (%) of CD, Women, All Ages, 2006-2026 33
  • Figure 6: Sources Used and Not Used, Diagnosed Incident Cases of CD 36
  • Figure 7: Sources Used and Not Used, Diagnosed Prevalent Cases of CD 37
  • Figure 8: Sources Used, Diagnosed Prevalent Cases of CD with Comorbid Autoimmune Diseases 38
  • Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of CD, Both Sexes, 2016 50
  • Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of CD, All Ages, 2016 51
  • Figure 11: 7MM, Diagnosed Prevalent Cases of CD by Severity, Both Sexes, All Ages, 2016 52
  • Figure 12: 7MM, Diagnosed Prevalent Cases of CD with PsO, Ankylosing Spondylitis, and Pyoderma Gangrenosum, Both Sexes, All Ages, 2016 53
  • Figure 13: US and 5EU, Alternate Diagnosed Incident Cases of CD, Both Sexes, All Ages, 2016 54
  • Figure 14: Germany, Spain, Italy, and the UK, Alternate Diagnosed Prevalent Cases of CD, Both Sexes, All Ages, 2016 55
  • Figure 15: Unmet Need and Opportunity in Crohn's Disease, 2017 111
  • Figure 16: Overview of the Development Pipeline for CD 121
  • Figure 17: CD Therapeutics - Phase III Commercial Clinical Trials by Class of Therapy, 2017 122
  • Figure 18: Key Phase II/III Trials for Promising Pipeline Agents for Crohn's Disease, 7MM, 2016-2026 123
  • Figure 19: Crohn's Disease, Late-Stage Pipeline Agents, Competitive Assessment, 2016-2026 124
  • Figure 20: Clinical and Commercial Positioning of Etrolizumab 129
  • Figure 21: Clinical and Commercial Positioning of Mongersen Sodium 136
  • Figure 22: Clinical and Commercial Positioning of Filgotinib 142
  • Figure 23: Clinical and Commercial Positioning of SHP-647 146
  • Figure 24: Clinical and Commercial Positioning of Risankizumab 151
  • Figure 25: Global Sales of Branded Products for Crohn's Disease by Company in 2016 and 2026 159
  • Figure 26: Analysis of the Company Portfolio Gap in Crohn's Disease During the Forecast Period 160
  • Figure 27: Global (7MM) Sales Forecast by Country for Crohn's Disease in 2016 and 2026 176
  • Figure 28: Sales Forecast by Class for Crohn's Disease in the US in 2016 and 2026 179
  • Figure 29: Sales Forecast by Class for Crohn's Disease in the 5EU in 2016 and 2026 183
  • Figure 30: Sales Forecast by Class for Crohn's Disease in Japan in 2016 and 2026 187
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