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市場調查報告書

OpportunityAnalyzer:糖尿病足潰瘍 (DFU) - 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:糖尿病足潰瘍 (DFU) - 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

糖尿病足潰瘍 (DFU) 與糖尿病足感染症 (DFI) 市場規模ゾ、2015年的2億9210萬美元、預計2025年將達8億7340萬美元、以每年11.6%的速度成長。市場成長背景為DFU患者數量增加、最新成本效率的治療藥物上市。

本報告針對糖尿病足潰瘍(以下DFU)治療法研究、開發最新動向調查、相關市場未來預測、疾病概要與現階段治療方法、未滿足需求、市場機會評價、今後10年發作數量預測、臨床實驗進行狀況、新治療藥物生產線評價、今後市場動向調查、預測。

第1章 目錄

第2章 介紹

第3章 疾病概要

  • 病徵與病因
  • 糖尿病足潰瘍 (DFU) 評價
    • 患者症狀、病歷、視診
    • 神經症檢查
    • 血管狀態檢查
    • 感染症鑑定
  • DFU分類
  • 術後、生活品質 (QoL)

第4章 疫病學

  • 疾病背景
  • 風險因素與併存症
  • 世界趨勢
    • 接受診斷的發作者數量與患病者總數
  • 預測方法
    • 使用的情報來源
    • 預測的推測方法
    • 不使用的情報來源
  • DFU疫病學預測 (11年份)
    • 糖尿病患者中DFU診斷的發作者數量
    • 糖尿病患者中DFU患病人數
  • 議論
    • 疫病學預測結果相關考察
    • 分析極限
    • 分析優勢

第5章 現在治療選項

  • 概要
  • 治療
    • 治療指南與主要處方藥
    • 臨床診療
  • 製品檔案:傷口護理藥
    • Regranex凝膠
    • Fiblast噴霧
  • 製品檔案: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)
    • Epifix (乾燥人類羊膜/絨毛膜同型移植片)
  • 糖尿病足潰瘍 (DFU)/糖尿病足感染症 (DFI) 補充療法
    • 血管擴張劑
    • 抗生素

第6章 未滿足需求的評價與機會分析

  • 概要
  • 未滿足需求分析
    • 患者、醫生教育的進步
    • 更有效的治療法:傷口閉合促進劑、Neuroischemic DFU標的藥劑
    • DFI的有效抗菌治療
    • 低價產品的出現、醫療費給付的改善
    • 對傷口治療的理解擴大

第7章 研究開發 (R&D) 策略

  • 概要
    • 成長因素與生理活性□
    • 細胞治療:血小板、幹細胞
    • 創傷治療藥市場之間的收購、證照交付契約
  • 臨床實驗的設計
    • 現在的實驗設計
    • 未來的實驗設計相關考察

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
    • Granexin (合成□)
  • 初期階段革新的技術:實驗中的藥品

第9章 開發平台評價分析

  • 主要開發平台藥劑臨床面基準
  • 主要開發平台藥劑商業面基準
  • 競爭力評價
  • 主要國家市場未來預測 (今後10年)
    • 美國
    • 歐洲主要國 (5EU)
    • 日本

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

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

2. Introduction

  • 2.1. Catalyst
  • 2.2. 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 Symptoms, 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 and Quality of Life

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Diagnosed Incidence and Total Prevalence
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used Tables
    • 4.4.2. Forecast Assumptions and Methods
    • 4.4.3. Sources Not Used
  • 4.5. Epidemiological Forecast of DFU (2015-2025)
    • 4.5.1. Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population
    • 4.5.2. Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population
  • 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. Treatment
    • 5.2.1. Treatment Guidelines and Leading Prescribed Drugs
    • 5.2.2. Clinical Practice
  • 5.3. Product Profiles - Wound-Healing Agents
    • 5.3.1. Regranex (Becaplermin) Gel
    • 5.3.2. Fiblast (Trafermin) Spray
  • 5.4. Product Profiles - Cell-Based Skin Substitutes, Membrane Allografts
    • 5.4.1. Dermagraft (Human Fibroblast-Derived Dermal Substitute)
    • 5.4.2. Apligraf (Bi-layered Skin Substitute)
    • 5.4.3. Grafix (Human Cellular Repair Matrix)
    • 5.4.4. Epifix (Dehydrated Human Amnion/Chorion Membrane Allograft)
  • 5.5. Additional Therapies for DFUs and DFIs
    • 5.5.1. Vasodilators
    • 5.5.2. Antibiotics

6. Unmet Needs Assessment and Opportunity Analysis

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

7. Research and Development Strategies

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

8. Pipeline Assessment

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

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 Ten-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

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 and Patent Expiry 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. Senior Analyst, Cardiovascular and Metabolic Disorders
    • 10.6.2. Director, Cardiovascular and Metabolic Disorders
    • 10.6.3. Epidemiologists
    • 10.6.4. Global Therapy of Therapy Analysis and Epidemiology
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Typical Features and Characterization 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 and Comorbidities of DFUs
  • Table 6: 7MM, Diagnosed Incidence of DFU Among the Diabetic Population from 1993-2008
  • Table 7: 7MM, Total Prevalence of DFU Among the Diabetic Population from 1990-2008
  • Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population
  • Table 9: 7MM, Sources Used for the Classification of DFUs Among the DFU-Diagnosed Incident Population
  • Table 10: 7MM, Sources Used to Forecast DFI and PAD Cases Among the DFU-Diagnosed Incident Population
  • Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population
  • Table 12: 7MM, Sources Not Used in Epidemiological Analysis of DFU
  • Table 13: 7MM, Diagnosed Incident Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025
  • Table 14. 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N (Row %), 2015
  • Table 15: 7MM, Diagnosed Incident Cases of DFU, by Sex, Ages ≥20 Years, N (Row %), 2015
  • Table 16: 7MM, Total Prevalent Cases of DFU, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025
  • Table 17. 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N (Row %), 2015
  • Table 18: 7MM, Total Prevalent Cases of DFU, by Sex, Ages ≥20 Years, N (Row %), 2015
  • Table 19: Treatment Guidelines for DFUs
  • Table 20: Leading Advanced Wound Care Treatments Used to Treat DFUs
  • Table 21: Product Profile - Regranex Gel
  • Table 22: Regranex Gel SWOT Analysis, 2016
  • Table 23: Product Profile - Fiblast
  • Table 24: Fiblast SWOT Analysis, 2016
  • Table 25: Product Profile - Dermagraft
  • Table 26: Product Profile - Apligraf
  • Table 27: Product Profile - Grafix
  • Table 28: Product Profile - EpiFix
  • Table 29: Leading Antibiotics Prescribed for DFIs Across 7MM
  • Table 30: Overall Unmet Needs - Current Level of Attainment
  • Table 31: DFUs - Late Stage Pipeline, 2016
  • Table 32: Product Profile - Granexin
  • Table 33: Granexin SWOT Analysis, 2016
  • Table 34: Early-Stage Pipeline Products for DFUs and DFIs
  • Table 35: Clinical Benchmark of Key Pipeline Drugs - Wound-Healing Agents
  • Table 36: Commercial Benchmark of Key Pipeline Drugs - Wound-Healing Agents
  • Table 37: Top-Line Sales Forecasts ($M) for the DFU and DFI Market 2015-2025
  • Table 38: Key Events Impacting Sales in the DFU, 2015-2025
  • Table 39: DFU Market - Drivers and Barriers, 2015-2025
  • Table 40: Sales Forecasts ($M) for DFUs and DFIs in the US, 2015-2025
  • Table 41: Sales Forecasts ($M) for DFUs and DFIs in the 5EU, 2015-2025
  • Table 42: Sales Forecasts ($M) for DFUs and DFIs in Japan, 2015-2025
  • Table 43: Key Events Impacting Sales in the DFU Market, 2015-2025
  • Table 44: Number of High-Prescribing Physicians Surveyed

List of Figures

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