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市場調查報告書

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 Forecasts To 2017 - Event-Driven Update

出版商 GlobalData 商品編碼 290454
出版日期 內容資訊 英文 164 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 Forecasts To 2017 - Event-Driven Update
出版日期: 2014年01月31日 內容資訊: 英文 164 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
Product Code: GDHC033POA

Diabetic foot ulcers (DFUs) are a common complication of diabetes, and with the increasing prevalence of diabetes across all markets, the number of patients suffering from DFUs is also expected to rise. Despite the availability of various treatment modalities, there are currently few advanced wound care products available to treat hard-to-heal chronic wounds. In addition, for the past 15 years, Regranex (becaplermin) has been the only pharmacologic wound-healing agent available; however, it is rarely used due a perceived lack of efficacy.

The DFU market is now set to enter an exciting phase with the potential launch of three wound-healing agents in the next five years; Olympus Biotech's trafermin (recombinant human basic fibroblast growth factor), Macrocure's CureXcell (activated leukocyte suspension), and Derma Sciences' DSC127 (NorLeu3-A[1-7]). The first two topical antibacterials, Innocoll's Cogenzia (gentamicin-collagen sponge) and Dipexium Pharmaceuticals' Locilex (pexiganan acetate cream 1%), are also expected to launch in the US and the five major EU markets (5EU). Both pipeline agents offer an alternative way to treat infection by localizing an antibiotic directly at the wound site.

With the advent of these new product launches, the size of the DFU market is expected to grow substantially during the five-year forecast period.

Highlights

Key Questions Answered

  • The DFU market is marked by the presence of a number of unmet needs. What are the main unmet needs in the treatment of DFUs? Will the drugs under development fulfil the unmet needs of the DFU market?
  • The late-stage DFU pipeline contains a diverse array of both wound-healing agents and topical antibacterials. Will the late-stage drugs make a significant impact on the DFU market? Which of these drugs will have the highest peak sales at the end of the forecast period, and why?
  • There is currently only one pharmacologic wound-healing agent available to treat DFUs. Will the launch of novel wound-healing agents change the drug treatment landscape for DFUs? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Key Findings

  • The major drivers of the growth of the DFU market include the introduction of several novel wound-healing agents, which are administrated as a topical ointment or spray, or are injected directly into the wound bed. In addition, the first topical antibacterials indicated specifically for the treatment of diabetic foot infections will launch, and will be used as an adjunct to systemic antibiotic therapy, or to treat mild infections.
  • The second major driver will be the growing number of patients suffering from a DFU due to an overall increase in the prevalence of diabetes across all the markets.
  • To ensure uptake of novel DFU treatments it will be essential for companies to demonstrate a high level of efficacy in well-designed clinical trials; that demonstrate that advanced wound-care products are superior to the current standard of care.
  • With different treatment modalities becoming available to treat DFUs, more established companies that already offer wound care dressings and medical devices are diversifying their portfolios, by adding wound-healing agents through acquisitions and licensing agreements.

Scope

  • Overview of DFUs, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized DFU therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012, and forecast for five years to 2017.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DFU 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 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

  • 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 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 therapeutics market from 2012-2017.
  • 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

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Assessment of DFUs
    • 3.2.1. Patient History and Visual Examination
    • 3.2.2. Testing for Neuropathy
    • 3.2.3. Testing Vascular Status
    • 3.2.4. Identifying Infection
  • 3.3. Classification of Diabetic Foot Ulcers
  • 3.4. Prognosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
    • 4.2.1. An increased duration of diabetes triples the risk of DFUs
    • 4.2.2. Men diabetics are at higher risk for DFUs than women diabetics
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes
    • 4.4.4. Forecast Assumptions and Methods, Diabetic Foot Ulcers
  • 4.5. Epidemiological Forecast for DFUs (2012-2022)
    • 4.5.1. Total Prevalent Cases of DFUs
    • 4.5.2. Age-Specific Total Prevalent Cases of DFUs
    • 4.5.3. Sex-Specific Total Prevalent Cases of DFUs
    • 4.5.4. Total Prevalent Cases of Diabetic Foot Infections
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles - Wound-Healing Agents
    • 5.2.1. Regranex (becaplermin) Gel
  • 5.3. Product Profiles - Cell-Based Skin Substitutes
    • 5.3.1. Dermagraft (human fibroblast-derived dermal substitute)
    • 5.3.2. Apligraf (bi-layered skin substitute)
    • 5.3.3. Grafix (human cellular repair matrix)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Improved Patient and Physician Education: Emphasis on the Importance of Off-Loading
    • 6.2.2. Improved Multidisciplinary Approach to Patient Treatment with Common Protocols
    • 6.2.3. More Effective Treatments for Neuroischemic Wounds
    • 6.2.4. More Effective Antibacterial Treatments for Infected DFUs
    • 6.2.5. Affordable Products and Improved Reimbursement
    • 6.2.6. In-Home Sensing Systems for the Early Prevention of DFUs
  • 6.3. Opportunity Analysis
    • 6.3.1. Wound-Healing Agents for the Treatment of Neuroischemic Ulcers
    • 6.3.2. Topical Antibiotics for the Treatment of DFUs
    • 6.3.3. Enzymatic Debriding Agents

7. Research and Development Strategies

  • 7.1. Overview
    • 7.1.1. Local Administration of Growth Factors and Bioactive Peptides
    • 7.1.2. Cellular Therapies: Leukocytes, Platelets, and Stem Cells
    • 7.1.3. Acquisitions and Licensing Agreements Between Wound Care Companies
  • 7.2. Clinical Trial Design
    • 7.2.1. Current Clinical Trial Design
    • 7.2.2. Standardization of Debridement and Off-Loading
    • 7.2.3. Inclusion of Representative Patient Populations in Clinical Trials

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Wound-Healing Agents in Clinical Development
    • 8.2.1. CureXcell (activated leukocyte suspension)
    • 8.2.2. DSC127 (NorLeu3-angiotensin[1-7])
    • 8.2.3. Trafermin (recombinant human basic fibroblast growth factor spray)
    • 8.2.4. CVBT-141B (topical human fibroblast growth factor-1)
  • 8.3. Promising Antimicrobial Agents in Clinical Development
    • 8.3.1. Cogenzia (gentamicin-collagen sponge)
    • 8.3.2. Locilex (pexiganan acetate cream)
  • 8.4. Innovative Early-Stage Approaches

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecast Methodology
    • 10.4.1. Percent Diagnosed Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Drug Assumptions
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. About the Authors
    • 10.6.1. Analyst, Cardiovascular and Metabolic Disorders
    • 10.6.2. Senior Epidemiologist
    • 10.6.3. Therapy Director - CVMD and Infectious Disease
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Typical Features of DFUs According to Etiology
  • Table 2: DFU Risk Factors
  • Table 3: Wagner Classification System for DFUs
  • Table 4: University of Texas Classification System for DFUs
  • Table 5: Risk Factors for DFUs
  • Table 6: Epidemiological Sources Used to Forecast the Total Prevalence of DFUs and Diabetic Foot Infections in the Diagnosed Diabetic Population
  • Table 7: 6MM, Total Prevalent Cases of DFUs, Ages ≥20 Years, Both Sexes, N, 2012-2022
  • Table 8: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, (Row %), 2012
  • Table 9: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ≥20 years, N (Row %), 2012
  • Table 10: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ≥20 years, Both Sexes, N, 2012-2022
  • Table 11: Leading Advanced Wound Care Treatments for DFUs
  • Table 12: Product Profile - Regranex Gel
  • Table 13: Regranex Gel SWOT Analysis, 2013
  • Table 14: Product Profile - Dermagraft
  • Table 15: Product Profile - Apligraf
  • Table 16: Product Profile - Grafix
  • Table 17: Overall Unmet Needs - Current Level of Attainment
  • Table 18: DFUs - Late Stage Pipeline, 2013
  • Table 19: Product Profile - CureXcell
  • Table 20: CureXcell SWOT Analysis, 2013
  • Table 21: Product Profile - DSC127
  • Table 22: DSC127 SWOT Analysis, 2013
  • Table 23: Product Profile - Trafermin
  • Table 24: Trafermin SWOT Analysis, 2013
  • Table 25: Product Profile - Cogenzia
  • Table 26: Cogenzia SWOT Analysis, 2013
  • Table 27: Product Profile - Locilex
  • Table 28: Locilex SWOT Analysis, 2013
  • Table 29: Early-Stage Pipeline Products for DFUs
  • Table 30: Clinical Benchmark of Key Pipeline Drugs - Wound-Healing Agents
  • Table 31: Clinical Benchmark of Key Pipeline Drugs - Topical Antibacterials
  • Table 32: Commercial Benchmark of Key Pipeline Drugs - Wound-Healing Agents
  • Table 33: Commercial Benchmark of Key Pipeline Drugs - Topical Antibacterials
  • Table 34: Top-Line Sales Forecasts ($m) for the DFU Market 2012-2017
  • Table 35: Key Events Impacting Sales in the DFU, 2012-2019
  • Table 36: DFU Market - Drivers and Barriers, 2012-2017
  • Table 37: Launch Dates in the DFU Market, 2012-2017

List of Figures

  • Figure 1: 6MM, Total Prevalent Cases of DFUs, Ages ≥20 Years, Both Sexes, N, 2012-2022
  • Figure 2: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, 2012
  • Figure 3: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ≥20 Years, N, 2012
  • Figure 4: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ≥20 Years, Both Sexes, N, 2012-2022
  • Figure 5: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2012-2017
  • Figure 6: Competitive Assessment of the Late-Stage Pipeline Topical Antibacterials in DFUs, 2012-2017
  • Figure 7: Sales for the DFU Market, US and 5EU (2012-2017)
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