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市場調查報告書

OpportunityAnalyzer:難辨梭狀芽孢桿菌傳染病 (CDI) 的市場機會分析及預測

OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026

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出版日期 內容資訊 英文 281 Pages
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OpportunityAnalyzer:難辨梭狀芽孢桿菌傳染病 (CDI) 的市場機會分析及預測 OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026
出版日期: 2017年07月17日 內容資訊: 英文 281 Pages
簡介

全球主要7個國家難辨梭狀芽孢桿菌傳染病 (CDI) 的預防藥及治療藥市場,預測從2014年約3億5600萬美元以15.8%的年複合成長率成長,到2024年成長超過15億美元的規模。該市場的成長,預測將受到加入標準治療的抗生素之新輔助療法的引進擴大和Merck的抗生劑Dificid利用的擴大,Sanofi Pasteur的全球最初預防疫苗ACAM-CDIFF的興起等因素所推動。

本報告調查難辨梭狀芽孢桿菌傳染病 (CDI) 的治療藥·預防藥市場,提供您疾病及疾病管理概要,全球主要7個國家發病情形,目前治療藥,未滿足需求與市場機會分析,R&D策略,開發平台的主要藥物趨勢,開發平台藥物的基準·競爭分析,彙整主要7個國家市場上治療藥·預防藥的銷售額預測等資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因·病理生理學
  • 風險因素·症狀
  • 疾病管理
    • 診斷
    • 治療指南
    • 臨床診療
    • 預防·管理
  • 預後·QoL

第4章 流行病學

  • 疾病背景
  • 風險因素·並存症
  • 全球趨勢
    • 主要7個國家市場:發病診斷率
    • 主要7個國家市場:發病診斷數與免疫學的因果關係
    • 主要7個國家市場:發病診斷數與復發數
  • 預測手法
  • CDI的流行病學的預測
    • 發病診斷數
    • 發病診斷數:各年齡
    • 發病診斷數:男女
    • 發病診斷率:年齡水平化
    • 復發數
    • 發病診斷數與免疫學的因果關係
  • 討論
    • 流行病學的預測相關考察
    • 預測的規定
    • 預測的優勢

第5章 目前治療藥

  • 概要
  • 產品簡介:推薦抗生素治療
    • Metronidazole
    • Vancomycin
    • Dificid (fidaxomicin)
  • 其他抗生素治療
    • Targocid (teicoplanin)
    • Tygacil (tigecycline)
    • Xifaxan (rifaximin)
  • 其他藥劑治療
    • 免疫療法
  • 非藥物的治療
    • FTM (航班微生物移植)
    • 益生菌
    • 外科手術

第6章 未滿足需求的評估·市場機會分析

  • 概要
  • 改善復發CDI的治療選擇
  • CDI預防產品
  • FMT的長期安全性的標準化·合理化·確認
  • 降低重病併發性CDI患者的盛行率·死亡率的產品
  • 被臨床性證明的CDI風險標準·預測模式
  • 改善感染·流行的監視及迴避策略
    • 未滿足需求
    • 差距分析
    • 市場機會

第7章 R&D策略

  • 概要
  • CDI產品開發的目前方法
    • 抗生素
    • 非抗純粹補助藥
    • 非抗純粹預防
    • 疫苗
  • 臨床試驗設計
    • 治療產品
    • 預防產品
  • 未來臨床開發相關考察

第8章 開發平台的評估

  • 概要
  • 臨床開發確實的產品
  • 治療藥:生物製藥·免疫治療藥
    • Actoxumab·Bezlotoxumab
  • 治療藥:抗生素
    • Cadazolid
    • Surotomycin
    • SMT19969
  • 治療藥:微生物
    • SER-109
    • RBX2660
  • 預防藥:疫苗
    • ACAM-CDIFF
    • VLA84
    • PF-06425090
  • CDI預防·治療的其他創新產品·方法
    • LFF571
    • Ramoplanin
    • VP20621
    • SYN-004
  • 正在開發的其他CDI產品

第9章 開發平台的評估·分析

  • 主要開發中產品的臨床性基準
    • 治療產品
    • 預防產品
  • 主要開發中產品的商業性基準
    • 治療產品
    • 預防產品
  • 競爭評估
    • 治療產品
    • 預防產品
  • top line10年預測
    • 美國
    • 歐盟5國
    • 日本

第10章 附錄

圖表

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目錄
Product Code: GDHC070POA

Clostridium difficile, a Gram-positive, spore-forming, toxin-producing, non-invasive, anaerobic bacterium, is the causative organism of C. difficile infection (CDI), which is commonly associated with colitis, as well as C. difficile-associated diarrhea (CDAD) (ICD-10; A04.7) (ICD-10 Diagnosis Codes, 2016). The pathogen was first described in 1935 and can exist in spore and vegetative forms, with the spore form being resistant to heat, acid, and antibiotics (Hall and O'Toole, 1935).

The report considers Global CDI market to include sales of therapeutic and prophylactic agents aimed at treatment and prevention of CDIs across the 7MM. In 2016, it is estimated the total CDI market to be valued at $628.8m across the 7MM, and the US accounted for 91% of the market. Over the course of the 10-year forecast period, the CDI market will grow at a Compound Annual Growth Rate (CAGR) of 10.2% across the 7MM. The 5EU will experience the fastest growth with a CAGR of 19.2%, while the US and Japan will experience growth of 9.0% and 13.2%, respectively. At the end of 2026, the US will contribute around 81% of global sales, while the 5EU and Japan will account for around 17% and 2% of sales, respectively.

Major drivers in growth for the CDI market include -

  • The projected launch of prophylactic options for the prevention of C. difficile, led by Sanofi Pasteur's toxoid vaccine ACAM-CDIFF.
  • The projected launch of microbiologic approaches for the treatment of recurrent CDI (rCDI), with the potential to leverage the efficacy of fecal microbiota transplants (FMT).
  • The projected launch of novel antibiotics for the treatment of CDI, positioned to reduce the rate of CDI recurrence.
  • A projected increase in the incidence of CDI in the US, driven by a higher incidence of community-associated CDI (CA-CDI).

During the 10-year forecast period, there are nine products that are on track to a launch, contributing to a forecast growth in the 7MM at a CAGR of 10.2% from 2016 to 2026.

The report "OpportunityAnalyzer: Clostridium difficile Infections - Opportunity Analysis and Forecasts to 2026" provides Overview of CDI, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

In particular, this report provides the following -

  • Topline CDI market revenue from 2016-2026. Annual cost of therapy (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 CDI therapeutics and prophylactics 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 CDI therapeutics and prophylactics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report: GlaxoSmithKline, Shire, OpenBiome, Akthelia Pharmaceuticals, MGB Biopharma, Merck & Co.,, Actelion, Summit Therapeutics, Otsuka Pharmaceuticals, Seres Therapeutics, Rebiotix, Sanofi Pasteur, Pfizer, Valneva, Synthetic Biologics.

Scope

  • Overview of CDI, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline CDI market revenue from 2016-2026. Annual cost of therapy (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 CDI therapeutics and prophylactics 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 CDI therapeutics and prophylactics 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 CDI therapeutics and prophylactics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CDI therapeutics and prophylactics 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 7
  • 1.2 List of Figures 9

2 Executive Summary 10

  • 2.1 Significant Growth Is Projected for the CDI Market from 2016 to 2026 10
  • 2.2 Manufacturers Aiming to Provide Physicians Non-Antibiotic Therapies for Treatment and Prevention of CDI 12
  • 2.3 There Remains Significant Unmet Need for CDI Treatment, in Particular to Reduce CDI Recurrence Rates 13
  • 2.4 Opportunities Exist for Products Proven to be Cost-Effective Versus SOC Antibiotics 14
  • 2.5 An Active Pipeline Poised to Partially Satisfy Unmet Needs for CDI 14
  • 2.6 What do Physicians Think? 16

3 Introduction 18

  • 3.1 Catalyst 18
  • 3.2 Related Reports 18
  • 3.3 Upcoming Related Reports 19

4 Disease Overview 20

  • 4.1 Etiology and Pathophysiology 20
    • 4.1.1 Etiology 20
    • 4.1.2 Pathophysiology 24
  • 4.2 Symptoms 26
  • 4.3 Disease Management 27
    • 4.3.1 Diagnosis 28
    • 4.3.2 Treatment Guidelines 32
    • 4.3.3 Clinical Practice 34
    • 4.3.4 Prevention and Control 37
  • 4.4 Prognosis and Quality of Life 39

5 Epidemiology 41

  • 5.1 Disease Background 41
  • 5.2 Risk Factors and Comorbidities 42
  • 5.3 Global and Historical Trends 44
    • 5.3.1 7MM: Diagnosed Incidence 45
    • 5.3.2 7MM: Diagnosed Incident Cases by Recurrence 46
    • 5.3.3 7MM: Diagnosed Incident Cases by Severity 47
  • 5.4 Forecast Methodology 47
    • 5.4.1 Sources 48
    • 5.4.2 Forecast Assumptions and Methods 51
  • 5.5 Epidemiological Forecast for CDI (2016-2026) 57
    • 5.5.1 Diagnosed Incident Cases of CDI 57
    • 5.5.2 Age-Specific Diagnosed Incident Cases of CDI 58
    • 5.5.3 Sex-Specific Diagnosed Incident Cases of CDI 58
    • 5.5.4 CDI Cases by Recurrence 59
    • 5.5.5 CDI Cases by Severity 61
  • 5.6 Discussion 63
    • 5.6.1 Epidemiological Forecast Insight 63
    • 5.6.2 Limitations of Analysis 65
    • 5.6.3 Strengths of Analysis 65

6 Current Treatment Options 67

  • 6.1 Overview 67
  • 6.2 Product Profiles - Recommended Antibiotic Therapies 68
    • 6.2.1 Metronidazole (numerous brand names) 68
    • 6.2.2 Vancomycin (numerous brand names) 73
    • 6.2.3 Dificid (fidaxomicin) 78
  • 6.3 Product Profiles - Antibodies 85
    • 6.3.1 Zinplava (bezlotoxumab) 85
  • 6.4 Other Antibiotic Therapies 90
    • 6.4.1 Targocid (teicoplanin) 90
    • 6.4.2 Tygacil (tigecycline) 91
    • 6.4.3 Xifaxan (rifaximin) 92
  • 6.5 Non-drug Interventions 92
    • 6.5.1 OpenBiome FMT (stool-bank service) 93
    • 6.5.2 Probiotics 94
    • 6.5.3 Surgical Procedures 95

7 Unmet Needs Assessment and Opportunity Analysis 97

  • 7.1 Overview 97
  • 7.2 Improved Treatment Options for rCDIs 99
    • 7.2.1 Unmet Need 99
    • 7.2.2 Gap Analysis 100
    • 7.2.3 Opportunity 101
  • 7.3 Prophylactic Products to Prevent Primary CDI 103
    • 7.3.1 Unmet Need 103
    • 7.3.2 Gap Analysis 104
    • 7.3.3 Opportunity 106
  • 7.4 More Cost-Effective Treatment Options 107
    • 7.4.1 Unmet Need 107
    • 7.4.2 Gap Analysis 108
    • 7.4.3 Opportunity 108
  • 7.5 Standardize, Streamline, and Confirm the Long-Term Safety of FMT 110
    • 7.5.1 Unmet Need 110
    • 7.5.2 Gap Analysis 111
    • 7.5.3 Opportunity 112
  • 7.6 Reduce CDI Morbidity and Mortality In Vulnerable Patients 114
    • 7.6.1 Unmet Need 114
    • 7.6.2 Gap Analysis 115
    • 7.6.3 Opportunity 115
  • 7.7 Improve Surveillance and Prevent Transmission and Outbreaks 116
    • 7.7.1 Unmet Need 116
    • 7.7.2 Gap Analysis 117
    • 7.7.3 Opportunity 118
  • 7.8 Reduce Misdiagnosis of CDI From Diagnostic Testing 118
    • 7.8.1 Unmet Need 118
    • 7.8.2 Gap Analysis 119
    • 7.8.3 Opportunity 120

8 Research and Development Strategies 121

  • 8.1 Overview 121
  • 8.2 Current Approaches to CDI Product Development 122
    • 8.2.1 Therapeutic Agents 122
    • 8.2.2 Prophylactic Agents 128
  • 8.3 Clinical Trial Design 132
    • 8.3.1 Therapeutic Agents 132
    • 8.3.2 Prophylactic Agents 137

9 Pipeline Assessment 140

  • 9.1 Overview 140
  • 9.2 Promising Products in Clinical Development 141
  • 9.3 Therapeutic Agents - Antibiotics 146
    • 9.3.1 Cadazolid 146
    • 9.3.2 Ridinilazole 151
    • 9.3.3 OPS-2071 156
  • 9.4 Therapeutic Agents - Microbiologics 158
    • 9.4.1 SER-109 (firmacute eubacterial spores, purified suspensions, encapsulated) 159
    • 9.4.2 RBX2660 (microbiota suspension) 164
  • 9.5 Prophylactic Agents - Vaccines 170
    • 9.5.1 ACAM-CDIFF 171
    • 9.5.2 PF-06425090 175
    • 9.5.3 VLA84 180
  • 9.6 Prophylactic Agents - Drugs 185
    • 9.6.1 Ribaxamase 186
  • 9.7 Other Innovative Approaches to CDI Prevention and Treatment 191
    • 9.7.1 Fecal Microbiota Transplant 192
    • 9.7.2 DAV-132 195
    • 9.7.3 Surotomycin 197
    • 9.7.4 Ramoplanin 198
    • 9.7.5 VP20621 (non-toxigenic C. difficile strain M3 spores) 200
  • 9.8 Other Products in Clinical Development 202

10 Pipeline Valuation Analysis 203

  • 10.1 Clinical Benchmark of Key Pipeline Products 203
    • 10.1.1 Therapeutic Agents 203
    • 10.1.2 Prophylactic Agents 204
  • 10.2 Commercial Benchmark of Key Pipeline Products 205
    • 10.2.1 Therapeutic Agents 205
    • 10.2.2 Prophylactic Agents 206
  • 10.3 Competitive Assessment 207
    • 10.3.1 Therapeutic Agents 207
    • 10.3.2 Prophylactic Agents 208
  • 10.4 Top-Line 10-Year Forecast 210
    • 10.4.1 US 215
    • 10.4.2 5EU 218
    • 10.4.3 Japan 221

11 Appendix 224

  • 11.1 Bibliography 224
  • 11.2 Abbreviations 257
  • 11.3 Methodology 260
  • 11.4 Forecasting Methodology 260
    • 11.4.1 Diagnosed CDI Patient Population 260
    • 11.4.2 Target Patient Populations for Prophylaxis 261
    • 11.4.3 Percent Drug-Treated Patients 262
    • 11.4.4 Drugs Included in Each Therapeutic Class 262
    • 11.4.5 Launch and Patent Expiry Dates 263
    • 11.4.6 General Pricing Assumptions 263
    • 11.4.7 Individual Drug Assumptions 265
    • 11.4.8 Pricing of Pipeline Agents 269
  • 11.5 Primary Research - KOLs Interviewed for this Report 272
  • 11.6 Primary Research - Prescriber Survey 276
  • 11.7 About the Authors 277
    • 11.7.1 Analysts 277
    • 11.7.2 Therapy Area Director 277
    • 11.7.3 Epidemiologists 278
    • 11.7.4 Director of Epidemiology 279
    • 11.7.5 Global Director of Therapy Analysis and Epidemiology 279
    • 11.7.6 Global Head and EVP of Healthcare Operations and Strategy 279
  • 11.8 About GlobalData 281
  • 11.9 Contact Us 281
  • 11.10 Disclaimer 281

List of Tables

1.1 List of Tables

  • Table 1: Clostridium difficile Infections (CDI): Key Metrics in the 7MM 10
  • Table 2: Antimicrobial Agents that May Induce CDI, CDAD, and Colitis 22
  • Table 3: The Physiological Effects of C. difficile Toxins A and B 26
  • Table 4: Symptoms Associated with CDIs 27
  • Table 5: Summary of Stool Laboratory Diagnostic Testing for C. difficile 32
  • Table 6: CDI Severity Scoring System and Summary of Recommended Treatments 36
  • Table 7: Risk Factors and Comorbidities for CDI 43
  • Table 8: 7MM, Diagnosed Incident Cases of CDI, Ages ≥18 Years, Both Sexes, N, Select Years 2016-2026 57
  • Table 9: Product Profile - Metronidazole 70
  • Table 10: Clinical Successa of Metronidazole versus Vancomycin by CDI Severity 71
  • Table 11: Summary of AEs Observed In Two Phase III Trials Comparing Metronidazole to Vancomycin 72
  • Table 12: Metronidazole SWOT Analysis, 2017 73
  • Table 13: Product Profile - Vancomycin 75
  • Table 14: Clinical Success of Vancomycin-Treated Subjects in Two Clinical Trials 76
  • Table 15: Common AEs for Vancomycin in Treating CDADa 77
  • Table 16: Vancomycin SWOT Analysis, 2017 78
  • Table 17: Product Profile - Dificid 80
  • Table 18: Dificid Pivotal Phase III Clinical Trials Response Rates 81
  • Table 19: Dificid Pivotal Phase III Clinical Trials Sustained Clinical Response at 25 Days After Treatment According to C. difficile Strain 82
  • Table 20: Selected Adverse Reactions with an Incidence of ≥2% Reported in Patients Treated with Dificid in Controlled Trials 84
  • Table 21: Dificid SWOT Analysis, 2017 84
  • Table 22: Product Profile - Zinplava (bezlotoxumab) 87
  • Table 23: Clinical Efficacy of Zinplava with Regard to Recurrence Rates in MODIFY I and MODIFY II Clinical Trials 88
  • Table 24: AEs Associated with Zinplava, Administered Alone or with Actoxumab and Compared to a Placebo Group, as Observed in Both MODIFY I and MODIFY II RCTs 89
  • Table 25: Zinplava SWOT Analysis, 2017 90
  • Table 26: Key Products in the CDI Market by Therapeutic Class, 2017 121
  • Table 27: Clinical Trial Designs for CDI Pipeline Antibiotics 132
  • Table 28: Clinical Trial Designs for CDI Pipeline Antibodies 134
  • Table 29: Clinical Trial Designs for CDI Pipeline Microbiologics 135
  • Table 30: Clinical Trial Designs for CDI Pipeline Vaccines 137
  • Table 31: Clinical Trial Designs for CDI Pipeline Prophylactic Adjuvant Therapies. 139
  • Table 32: Promising Products in Clinical Development for CDIs, 2017 144
  • Table 33: Product Profile - Cadazolid 148
  • Table 34: Efficacy Results from Cadazolid Phase II Trial - Modified Intent-to-Treat Populationa 149
  • Table 35: Cadazolid SWOT Analysis, 2017 151
  • Table 36: Product Profile - Ridinilazole 153
  • Table 37: Clinical Success of Ridinilazole versus Vancomycin as Observed in the CoDIFy Phase II Trial 154
  • Table 38: Adverse Effects Observed in Phase I Trials Assessing the Safety Profile of Ridinilazole 155
  • Table 39: Ridinilazole SWOT Analysis, 2017 156
  • Table 40: Product Profile - OPS-2071 157
  • Table 41: OPS-2071 SWOT Analysis, 2017 158
  • Table 42: Product Profile - SER-109 161
  • Table 43: Results from Three Clinical Trials Assessing the Efficacy of SER-109 162
  • Table 44: SER-109 SWOT Analysis, 2017 164
  • Table 45: Product Profile - RBX2660 166
  • Table 46: Results from Three Clinical Trials Assessing the Efficacy of RBX2660 168
  • Table 47: Reported AEs in the PUNCH CD2 Trial for RBX2660 169
  • Table 48: RBX2660 SWOT Analysis, 2017 170
  • Table 49: Product Profile - ACAM-CDIFF 172
  • Table 50: Formulations and Dosing Schedules and Seroconversion Rate for ACAM-CDIFF Phase II Trial 173
  • Table 51: Adverse Effects Observed in a Phase II Trial Assessing ACAM-CDIFF 174
  • Table 52: ACAM-CDIFF SWOT Analysis, 2017 175
  • Table 53: Product Profile - PF-06425090 177
  • Table 54: Clinical Trials Carried Out to Assess the Safety, Tolerability, and Immunogenicity of PF-06425090 179
  • Table 55: PF-06425090 SWOT Analysis, 2017 180
  • Table 56: Product Profile - VLA84 182
  • Table 57: Seroconversion Rates for VLA84 Observed During a Phase II Trial 183
  • Table 58: Doses and Dosing Schedules in VLA84 Phase I Triala 184
  • Table 59: VLA84 SWOT Analysis, 2017 185
  • Table 60: Product Profile - Ribaxamase 188
  • Table 61: Adverse Effects Observed in Two Phase I Trials Assessing the Safety Profile of Ribaxamase 190
  • Table 62: Ribaxamase SWOT Analysis, 2017 191
  • Table 63: Other Innovative Approaches to CDI Prevention and Treatment, 2017 192
  • Table 64: Comparison of Results from Published RCTs Investigating the Efficacy of FMT for Treating Recurrent CDI 194
  • Table 65: Efficacy Results from Surotomycin Phase III Trial 198
  • Table 66: Efficacy Results from VP20621 Phase III Trial 202
  • Table 67: Other CDI Products in Development, 2017 202
  • Table 68: Clinical Benchmark of Key Pipeline Therapeutics - CDIs 204
  • Table 69: Clinical Benchmark of Key Pipeline Prophylactics - CDIs 205
  • Table 70: Commercial Benchmark of Key Pipeline Therapeutics - CDIs 206
  • Table 71: Clinical Benchmark of Key Pipeline Prophylactics - CDIs 207
  • Table 72: Top-Line Global Sales Forecasts for CDI Therapeutic and Prophylactic Agents, 2016-2026 211
  • Table 73: Key Events Impacting Sales for CDIs, 2016-2026 214
  • Table 74: CDI Market - Global Drivers and Barriers, 2016-2026 215
  • Table 75: Sources Used For Diagnosed CDI Incidence Segmentation in the 7MM 261
  • Table 76: Sources Used For Prophylaxis Target Patient Populations in the 7MM 262
  • Table 77: Key Historical and Projected Launch Dates for CDI 263
  • Table 78: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 276

List of Figures

1.2 List of Figures

  • Figure 1: Global (7MM) Sales Forecast by Country for CDIs in 2016 and 2026 12
  • Figure 2: Competitive Assessment of Marketed and Pipeline Therapeutic Products for CDI Benchmarked Against the SOC, Vancomycin 15
  • Figure 3: Competitive Assessment of Pipeline Prophylactic Products for CDI 16
  • Figure 4: Examples of C. difficile-Associated Diseases 21
  • Figure 5: Overview of the Pathogenesis of CDAD 25
  • Figure 6: CDI Diagnosis Algorithm Recommended by ESCMID Guidelines 30
  • Figure 7: Overview of International Treatment Algorithm for CDI and CDAD 34
  • Figure 8: 7MM, Age-Standardized Diagnosed Incidence of CDI, Ages ≥18 Years, 2016 45
  • Figure 9: Case Flow Map 48
  • Figure 10: Sources Used and Not Used in Epidemiological Analysis of CDI Incidence 49
  • Figure 11: Sources Used and Not Used in Epidemiological Analysis of CDI Recurrences 50
  • Figure 12: Sources Used and Not Used in Epidemiological Analysis of CDI Severity 51
  • Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of CDI, Both Sexes, Ages ≥18 Years, 2016 58
  • Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of CDI, Ages ≥18 Years, 2016 59
  • Figure 15: 5EU and Japan, CDI Recurrences, Both Sexes, Ages ≥18 Years, 2016 60
  • Figure 16: US, CDI Recurrences, Both Sexes, Ages ≥18 Years, 2016 61
  • Figure 17: 5EU and Japan, CDI Cases by Severity, Both Sexes, Ages ≥18 Years, 2016 62
  • Figure 18: US, CDI Cases by Severity, Both Sexes, Ages ≥18 Years, 2016 63
  • Figure 19: Current Treatment Options for CDIs 68
  • Figure 20: Unmet Need and Opportunity in CDI 98
  • Figure 21: Promising Pipeline Products In Development for CDIs with Key Clinical Trials, 2017 143
  • Figure 22: Bullseye Diagram of Products in Clinical Development for CDIs, 2017 145
  • Figure 23: Key Clinical Trial Progress for CDI Pipeline Antibiotics 146
  • Figure 24: Key Clinical Trial Progress for CDI Pipeline Microbiologics 158
  • Figure 25: Key Clinical Trial Progress for CDI Pipeline Vaccines 170
  • Figure 26: Key Clinical Trial Progress for CDI Pipeline Prophylactic Adjuvants 185
  • Figure 27: Competitive Assessment of Marketed and Pipeline Therapeutic Products for CDI Benchmarked Against the SOC, Vancomycin 208
  • Figure 28: Competitive Assessment of Pipeline Prophylactic Products for CDI 209
  • Figure 29: Global (7MM) Sales Forecast by Country for CDIs in 2016 and 2026 212
  • Figure 30: Global (7MM) Sales Forecast by Product Class for CDIs in 2026 213
  • Figure 31: US Sales Forecast By Product Class for CDIs, 2016-2026 216
  • Figure 32: Therapeutic Sales Forecast by Product for CDIs in the US in 2016 and 2026 217
  • Figure 33: Prophylactic Sales Forecast by Product for CDIs in the US in 2026 218
  • Figure 34: 5EU Sales Forecast By Product Class for CDIs, 2016-2026 219
  • Figure 35: Therapeutic Sales Forecast by Product for CDIs in the 5EU in 2016 and 2026 220
  • Figure 36: Prophylactic Sales Forecast by Product for CDIs in the 5EU in 2026 221
  • Figure 37: Japan Sales Forecast By Product Class for CDIs, 2016-2026 222
  • Figure 38: Therapeutic Sales Forecast by Product for CDIs in Japan in 2016 and 2026 223
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