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.
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?
- 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.
- 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
- 2.1. 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
- 4.1. 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
- 4.4. 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
- 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)