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OpportunityAnalyzer:全球糖尿病足部潰傷(DFU)市場:市場機會分析與未來預測

OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2025

出版商 GlobalData 商品編碼 290454
出版日期 內容資訊 英文 166 Pages
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OpportunityAnalyzer:全球糖尿病足部潰傷(DFU)市場:市場機會分析與未來預測 OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2025
出版日期: 2016年12月17日 內容資訊: 英文 166 Pages
簡介

隨著全球各國糖尿病患者逐漸增加,糖尿病足部潰傷(DFU)患者也增加了。到目前為止只有Becaplermin治療藥,而且功效也有限,不過近幾年開發了以Trafermin為首的各種治療藥,打算投入市場。

本報告提供糖尿病足部潰傷(以下DFU)治療法研究以及開發的最新趨勢調查、相關的市場預測、疾病概要和目前的治療方法、未滿足需求與市場機會的評估、今後10年發病數量的預測值、臨床試驗的進展、新治療藥的開發平台評估、今後的市場趨勢等調查預測,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病情和病因
  • 糖尿病腳潰瘍(DFU)的評估
    • 病歷與視診
    • 神經症的檢驗
    • 血管狀態的檢驗
    • 感染疾病的鑑定
  • DFU的分類
  • 預測

第4章 流行病學

  • 疾病的背景情況
  • 風險要素和共生病症
    • 糖尿病發病狀況下,DFU的發病風險增加為3倍
    • 男性的糖尿病患者,比女性患者發病風險高
  • 全球各國趨勢
    • 美國
    • 歐洲主要5個國家
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的假設、手法:診出糖尿病的患病人數
    • 預測的假設、手法:糖尿病足部潰傷(DFU)
  • DFU的流行病學的預測(今後10年份)
    • DFU的得病率(整體)
    • DFU的得病率(各年齡)
    • DFU的得病率(男女)
    • 糖尿病足部感染疾病的得病率(整體)
  • 議論
    • 流行病學的趨勢相關結論
    • 分析的限制
    • 分析的優勢

第5章 目前治療選擇

  • 概要
  • 產品簡介:傷口護理藥
    • Regranex(Becaplermin)凝膠
  • 產品簡介:體細胞來源的皮膚替代產品
    • Dermagraft(人類纖維母細胞來源的皮膚替代產品)
    • Apligraf(雙層皮膚替代產品)
    • Grafix(人類細胞修復矩陣)

第6章 未滿足需求的評估與機會分析

  • 概要
  • 未滿足需求分析
    • 患者、醫生教育的進步:強調減壓重要性
    • 透過通用通訊協定改善患者治療的跨領域整合方法
    • 神經缺血創傷(Neuroischemic Ulcers)的更有效的治療方法
    • 已感染DFU的更有效的抗菌治療方法
    • 可利用的產品和醫療費給付的改善
    • 早期預防DFU的家庭用偵測系統
  • 市場機會分析
    • 治療神經缺血創傷的傷口護理藥
    • DFU治療的局部抗生素
    • 酵素的創傷清創劑

第7章 研究開發(R&D)策略

  • 概要
    • 成長因素、生理活性肽的局部給藥
    • 細胞治療:白血球、血小板、幹細胞
    • 創傷企業之間的收購、許可證交付契約
  • 臨床實驗的設計
    • 目前臨床實驗的設計
    • 清創、減壓的標準化
    • 獲取臨床實驗階段中患者的迴響

第8章 開發平台分析

  • 概要
  • 臨床實驗階段有前途的傷口護理藥
    • CureXcell(活性白血球的懸浮液)
    • DSC127 (NorLeu3-angiotensin1-7)
    • Trafermin(基因改造型人類纖維母細胞生長因子噴霧劑)
    • CVBT-141B(典型的人類纖維母細胞生長因子-1)
  • 臨床實驗階段有前途的抗菌物質
    • Cogenzia(建它黴素膠原蛋白海綿)
    • Locilex (pexiganan acetate cream)
    • 早期階段的創新方法

第9章 開發平台評估分析

  • 主要的開發平台藥物臨床方面的標準
  • 主要的開發平台藥物商業方面的標準
  • 競爭力的評估
  • 今後5年的銷售額預測
    • 美國
    • 歐洲主要5個國家

第10章 附錄

圖表一覽

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目錄

Diabetic Foot Ulcer (DFU) and Diabetic Foot Infection (DFI) market is set to triple in value from $292.1 Million in 2015 to $873.4 Million by 2025, representing a compound annual growth rate of 11.6%, this relatively strong growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven by a number of factors. These include the rising number of patients suffering from DFU, the introduction of new drug Granexin, and an increased emphasis on the cost-effectiveness of advanced DFU treatments in preventing serious complications.

The US is the largest market for DFU, DFI therapies, contributing approximately 62% of total sales in the base year and it is estimated that a novel wound healing therapy (FirstString's Granexin) to be the strongest driver of growth in the DFU market in the 7MM, reaching sales of $570.3M in 2025.

According to Jesus Cuaron, Senior Analyst, the DFU market is expected to experience moderate changes over the next decade, with prospects for treatments entering the space looking bleak. Currently, FirstString's Phase III candidate Granexin is the most promising drug in the DFU space. It statistically increases the rate of 100% wound closure compared to DFU standard of care.

Indeed, a number of wound-healing pipeline agents have recently failed clinical trials, primarily due to the lack of improved efficacy compared to current DFU standard-of-care practices, including products such as CytoTools' DermaPro, an intralesional formulation of diperoxochloric acid, and Olympus Biotech's topical trafermin spray. Overall, the development of novel DFU products has been very risky.

The report "OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2025" provides a detail overview of DFUs and DFIs, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, treatment guidelines and analysis of the current and future market competition in the global DFU and DFI therapeutics market.

Companies mentioned in this report: Advanced BioHealing, Advanced Tissue Sciences, CoDa Therapeutics, FirstString Research, Genentech, GlaxoSmithKline (GSK), Johnson & Johnson (J&J), Healthpoint Biotherapeutics Kaken Pharmaceutical, Lakewood-Amedex, MiMedx, Relief Therapeutics, Scios, Shire, Shire Regenerative Medicine, Smith & Nephew, Stryker Biotech, Olympus, Olympus Biotech, Organogenesis, Osiris Therapeutics.

Scope

  • Overview of DFUs and DFIs, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized DFU therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DFU and DFI therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global DFU and DFI 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. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global DFU and DFI therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global DFU therapeutics market in 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.
  • Track drug sales in the global DFU and DFI therapeutics market from 2015-2025.
  • 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 7

  • 1.1 List of Tables 11
  • 1.2 List of Figures 13

2 Introduction 14

  • 2.1 Catalyst 14
  • 2.2 Related Reports 14

3 Disease Overview 15

  • 3.1 Etiology and Pathophysiology 15
    • 3.1.1 Etiology 15
    • 3.1.2 Pathophysiology 16
  • 3.2 Assessment of DFUs 17
    • 3.2.1 Patient Symptoms, History, and Visual Examination 18
    • 3.2.2 Testing for Neuropathy 18
    • 3.2.3 Testing Vascular Status 19
    • 3.2.4 Identifying Infection 19
  • 3.3 Classification of Diabetic Foot Ulcers 21
  • 3.4 Prognosis and Quality of Life 22

4 Epidemiology 24

  • 4.1 Disease Background 24
  • 4.2 Risk Factors and Comorbidities 25
  • 4.3 Global Trends 26
    • 4.3.1 Diagnosed Incidence and Total Prevalence 28
  • 4.4 Forecast Methodology 31
    • 4.4.1 Sources Used Tables 32
    • 4.4.2 Forecast Assumptions and Methods 34
    • 4.4.3 Sources Not Used 46
  • 4.5 Epidemiological Forecast of DFU (2015-2025) 47
    • 4.5.1 Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population 47
    • 4.5.2 Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population 56
  • 4.6 Discussion 63
    • 4.6.1 Epidemiological Forecast Insight 63
    • 4.6.2 Limitations of the Analysis 64
    • 4.6.3 Strengths of the Analysis 65

5 Current Treatment Options 66

  • 5.1 Overview 66
  • 5.2 Treatment 67
    • 5.2.1 Treatment Guidelines and Leading Prescribed Drugs 67
    • 5.2.2 Clinical Practice 68
  • 5.3 Product Profiles - Wound-Healing Agents 72
    • 5.3.1 Regranex (Becaplermin) Gel 72
    • 5.3.2 Fiblast (Trafermin) Spray 77
  • 5.4 Product Profiles - Cell-Based Skin Substitutes, Membrane Allografts 80
    • 5.4.1 Dermagraft (Human Fibroblast-Derived Dermal Substitute) 80
    • 5.4.2 Apligraf (Bi-layered Skin Substitute) 84
    • 5.4.3 Grafix (Human Cellular Repair Matrix) 88
    • 5.4.4 Epifix (Dehydrated Human Amnion/Chorion Membrane Allograft) 92
  • 5.5 Additional Therapies for DFUs and DFIs 95
    • 5.5.1 Vasodilators 95
    • 5.5.2 Antibiotics 96

6 Unmet Needs Assessment and Opportunity Analysis 99

  • 6.1 Overview 99
  • 6.2 Unmet Needs Analysis 100
    • 6.2.1 Improved Physician and Patient Education 100
    • 6.2.2 More Effective Treatments: Agents Promoting Quicker Wound Closure and Targeting Neuroischemic DFUs 103
    • 6.2.3 More Effective Antibacterial Treatments for DFIs 104
    • 6.2.4 Affordable Products and Improved Reimbursement 106
    • 6.2.5 Better Understanding of Wound Healing Processes 108

7 Research and Development Strategies 110

  • 7.1 Overview 110
    • 7.1.1 Growth Factors and Bioactive Peptides 110
    • 7.1.2 Cellular Therapies: Platelets and Stem Cells 111
    • 7.1.3 Wound Care Company Acquisitions and Licensing Agreements 112
  • 7.2 Clinical Trial Design 113
    • 7.2.1 Current Clinical Trial Design 114
    • 7.2.2 Future Clinical Trial Design Considerations 116

8 Pipeline Assessment 119

  • 8.1 Overview 119
  • 8.2 Promising Wound-Healing Agent in Clinical Development 119
    • 8.2.1 Granexin (Synthetic Peptide) 119
  • 8.3 Innovative Early-Stage Approaches, Drugs in Development 123

9 Pipeline Valuation Analysis 125

  • 9.1 Clinical Benchmark of Key Pipeline Drugs 125
  • 9.2 Commercial Benchmark of Key Pipeline Drugs 126
  • 9.3 Competitive Assessment 127
  • 9.4 Top-Line Ten-Year Forecast 128
    • 9.4.1 US 130
    • 9.4.2 5EU 132
    • 9.4.3 Japan 134

10 Appendix 137

  • 10.1 Bibliography 137
  • 10.2 Abbreviations 149
  • 10.3 Methodology 152
  • 10.4 Forecast Methodology 152
    • 10.4.1 Percent Diagnosed Patients 152
    • 10.4.2 Percent Drug-Treated Patients 153
    • 10.4.3 Drugs Included in Each Therapeutic Class 153
    • 10.4.4 Launch and Patent Expiry Dates 154
    • 10.4.5 General Pricing Assumptions 154
    • 10.4.6 Individual Drug Assumptions 155
  • 10.5 Physicians and Specialists Included in This Study 158
  • 10.6 About the Authors 161
    • 10.6.1 Senior Analyst, Cardiovascular and Metabolic Disorders 161
    • 10.6.2 Director, Cardiovascular and Metabolic Disorders 161
    • 10.6.3 Epidemiologists 162
    • 10.6.4 Global Therapy of Therapy Analysis and Epidemiology 163
  • 10.7 About GlobalData 164
  • 10.8 Disclaimer 164

List of Tables

1.1 List of Tables

  • Table 1: Typical Features and Characterization of DFUs According to Etiology 17
  • Table 2: DFU Risk Factors 18
  • Table 3: Wagner Classification System for DFUs 22
  • Table 4: University of Texas Classification System for DFUs 23
  • Table 5: Risk Factors and Comorbidities of DFUs 27
  • Table 6: 7MM, Diagnosed Incidence of DFU Among the Diabetic Population from 1993-2008 28
  • Table 7: 7MM, Total Prevalence of DFU Among the Diabetic Population from 1990-2008 29
  • Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population 33
  • Table 9: 7MM, Sources Used for the Classification of DFUs Among the DFU-Diagnosed Incident Population 34
  • Table 10: 7MM, Sources Used to Forecast DFI and PAD Cases Among the DFU-Diagnosed Incident Population 34
  • Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population 35
  • Table 12: 7MM, Sources Not Used in Epidemiological Analysis of DFU 47
  • Table 13: 7MM, Diagnosed Incident Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025 48

Table 14. 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N (Row %), 2015 50

  • Table 15: 7MM, Diagnosed Incident Cases of DFU, by Sex, Ages ≥20 Years, N (Row %), 2015 52
  • Table 16: 7MM, Total Prevalent Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025 58

Table 17. 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N (Row %), 2015 60

  • Table 18: 7MM, Total Prevalent Cases of DFU, by Sex, Ages ≥20 Years, N (Row %), 2015 62
  • Table 19: Treatment Guidelines for DFUs 68
  • Table 20: Leading Advanced Wound Care Treatments Used to Treat DFUs 69
  • Table 21: Product Profile - Regranex Gel 75
  • Table 22: Regranex Gel SWOT Analysis, 2016 78
  • Table 23: Product Profile - Fiblast 79
  • Table 24: Fiblast SWOT Analysis, 2016 80
  • Table 25: Product Profile - Dermagraft 84
  • Table 26: Product Profile - Apligraf 88
  • Table 27: Product Profile - Grafix 91
  • Table 28: Product Profile - EpiFix 94
  • Table 29: Leading Antibiotics Prescribed for DFIs Across 7MM 98
  • Table 30: Overall Unmet Needs - Current Level of Attainment 101
  • Table 31: DFUs - Late Stage Pipeline, 2016 120
  • Table 32: Product Profile - Granexin 122
  • Table 33: Granexin SWOT Analysis, 2016 124
  • Table 34: Early-Stage Pipeline Products for DFUs and DFIs 125
  • Table 35: Clinical Benchmark of Key Pipeline Drugs - Wound-Healing Agents 126
  • Table 36: Commercial Benchmark of Key Pipeline Drugs - Wound-Healing Agents 127
  • Table 37: Top-Line Sales Forecasts ($M) for the DFU and DFI Market 2015-2025 130
  • Table 38: Key Events Impacting Sales in the DFU, 2015-2025 131
  • Table 39: DFU Market - Drivers and Barriers, 2015-2025 131
  • Table 40: Sales Forecasts ($M) for DFUs and DFIs in the US, 2015-2025 132
  • Table 41: Sales Forecasts ($M) for DFUs and DFIs in the 5EU, 2015-2025 134
  • Table 42: Sales Forecasts ($M) for DFUs and DFIs in Japan, 2015-2025 136
  • Table 43: Key Events Impacting Sales in the DFU Market, 2015-2025 155
  • Table 44: Number of High-Prescribing Physicians Surveyed 161

List of Figures

1.2 List of Figures

  • Figure 1: DFI Characteristics 21
  • Figure 2: 7MM, Diagnosed Incident Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025 49
  • Figure 3: 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N, 2015 51
  • Figure 4: 7MM, Diagnosed Incident Cases of DFU, Ages ≥20 Years, by Sex, N , 2015 53
  • Figure 5: 7MM, Age-Standardized Diagnosed Incidence of DFU, Ages ≥20 Years, by Sex, Cases per 100,000 Diabetic Population, 2015 54
  • Figure 6: 7MM, Diagnosed Incident Cases of DFU by Classification, Both Sexes, Ages ≥20 Years, 2015 55
  • Figure 7: 7MM, DFI Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages ≥20 Years, 2015 56
  • Figure 8: 7MM, PAD Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages ≥20 Years, 2015 57
  • Figure 9: 7MM, Total Prevalent Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025 59
  • Figure 10: 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N, 2015 61
  • Figure 11: 7MM, Total Prevalent Cases of DFU, Ages ≥20 Years, by Sex, N , 2015 63
  • Figure 12: 7MM, Age-Standardized Total Prevalence of DFU, Ages ≥20 Years, by Sex, %, 2015 64
  • Figure 13: DFU Management 70
  • Figure 14: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2015-2025 129
  • Figure 15: DFU and DFI Sales by Region, 20152025 130
  • Figure 16: Sales for DFUs and DFIs by Drug in the US, 2015 and 2025 133
  • Figure 17: Sales for DFUs and DFIs by Drug in the 5EU, 2015 and 2025 135
  • Figure 18: Sales for DFUs and DFIs by Drug in Japan, 2015 and 2025 137
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