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

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

Summary

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.


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
1.1 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
1.2 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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