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 8
1.1 List of Tables 12
1.2 List of Figures 14

2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 16
2.3 Upcoming Related Reports 16

3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.2 Assessment of DFUs 19
3.2.1 Patient History and Visual Examination 20
3.2.2 Testing for Neuropathy 20
3.2.3 Testing Vascular Status 20
3.2.4 Identifying Infection 21
3.3 Classification of Diabetic Foot Ulcers 21
3.4 Prognosis 23

4 Epidemiology 24
4.1 Disease Background 24
4.2 Risk Factors and Comorbidities 24
4.2.1 An increased duration of diabetes triples the risk of DFUs 25
4.2.2 Men diabetics are at higher risk for DFUs than women diabetics 26
4.3 Global Trends 26
4.3.1 US 27
4.3.2 5EU 28
4.4 Forecast Methodology 29
4.4.1 Sources Used 30
4.4.2 Sources Not Used 32
4.4.3 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes 33
4.4.4 Forecast Assumptions and Methods, Diabetic Foot Ulcers 36
4.5 Epidemiological Forecast for DFUs (2012-2022) 40
4.5.1 Total Prevalent Cases of DFUs 40
4.5.2 Age-Specific Total Prevalent Cases of DFUs 42
4.5.3 Sex-Specific Total Prevalent Cases of DFUs 44
4.5.4 Total Prevalent Cases of Diabetic Foot Infections 45
4.6 Discussion 47
4.6.1 Epidemiological Forecast Insight 47
4.6.2 Limitations of the Analysis 47
4.6.3 Strengths of the Analysis 48

5 Current Treatment Options 49
5.1 Overview 49
5.2 Product Profiles - Wound-Healing Agents 53
5.2.1 Regranex (becaplermin) Gel 53
5.3 Product Profiles - Cell-Based Skin Substitutes 60
5.3.1 Dermagraft (human fibroblast-derived dermal substitute) 60
5.3.2 Apligraf (bi-layered skin substitute) 65
5.3.3 Grafix (human cellular repair matrix) 69

6 Unmet Needs Assessment and Opportunity Analysis 73
6.1 Overview 73
6.2 Unmet Needs Analysis 74
6.2.1 Improved Patient and Physician Education: Emphasis on the Importance of Off-Loading 74
6.2.2 Improved Multidisciplinary Approach to Patient Treatment with Common Protocols 76
6.2.3 More Effective Treatments for Neuroischemic Wounds 78
6.2.4 More Effective Antibacterial Treatments for Infected DFUs 79
6.2.5 Affordable Products and Improved Reimbursement 79
6.2.6 In-Home Sensing Systems for the Early Prevention of DFUs 81
6.3 Opportunity Analysis 82
6.3.1 Wound-Healing Agents for the Treatment of Neuroischemic Ulcers 82
6.3.2 Topical Antibiotics for the Treatment of DFUs 82
6.3.3 Enzymatic Debriding Agents 84

7 Research and Development Strategies 85
7.1 Overview 85
7.1.1 Local Administration of Growth Factors and Bioactive Peptides 85
7.1.2 Cellular Therapies: Leukocytes, Platelets, and Stem Cells 86
7.1.3 Acquisitions and Licensing Agreements Between Wound Care Companies 87
7.2 Clinical Trial Design 89
7.2.1 Current Clinical Trial Design 89
7.2.2 Standardization of Debridement and Off-Loading 91
7.2.3 Inclusion of Representative Patient Populations in Clinical Trials 93

8 Pipeline Assessment 95
8.1 Overview 95
8.2 Promising Wound-Healing Agents in Clinical Development 96
8.2.1 CureXcell (activated leukocyte suspension) 96
8.2.2 DSC127 (NorLeu3-angiotensin[1-7]) 102
8.2.3 Trafermin (recombinant human basic fibroblast growth factor spray) 107
8.2.4 CVBT-141B (topical human fibroblast growth factor-1) 112
8.3 Promising Antimicrobial Agents in Clinical Development 113
8.3.1 Cogenzia (gentamicin-collagen sponge) 113
8.3.2 Locilex (pexiganan acetate cream) 119
8.4 Innovative Early-Stage Approaches 124

9 Pipeline Valuation Analysis 127
9.1 Clinical Benchmark of Key Pipeline Drugs 128
9.2 Commercial Benchmark of Key Pipeline Drugs 129
9.3 Competitive Assessment 130
9.4 Top-Line Five-Year Forecast 134
9.4.1 US 136
9.4.2 5EU 137

10 Appendix 139
10.1 Bibliography 139
10.2 Abbreviations 150
10.3 Methodology 153
10.4 Forecast Methodology 153
10.4.1 Percent Diagnosed Patients 154
10.4.2 Percent Drug-Treated Patients 154
10.4.3 Drugs Included in Each Therapeutic Class 154
10.4.4 Launch Dates 155
10.4.5 General Pricing Assumptions 155
10.4.6 Individual Drug Assumptions 156
10.5 Physicians and Specialists Included in This Study 160
10.6 About the Authors 161
10.6.1 Analyst, Cardiovascular and Metabolic Disorders 161
10.6.2 Senior Epidemiologist 161
10.6.3 Therapy Director - CVMD and Infectious Disease 162
10.6.4 Global Head of Healthcare 162
10.7 About GlobalData 163
10.8 Disclaimer 163

List of Tables

Table 1: Typical Features of DFUs According to Etiology 17
Table 2: DFU Risk Factors 19
Table 3: Wagner Classification System for DFUs 22
Table 4: University of Texas Classification System for DFUs 22
Table 5: Risk Factors for DFUs 25
Table 6: Epidemiological Sources Used to Forecast the Total Prevalence of DFUs and Diabetic Foot Infections in the Diagnosed Diabetic Population 30
Table 7: 6MM, Total Prevalent Cases of DFUs, Ages ?20 Years, Both Sexes, N, 2012-2022 41
Table 8: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, (Row %), 2012 42
Table 9: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ?20 years, N (Row %), 2012 44
Table 10: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ?20 years, Both Sexes, N, 2012-2022 46
Table 11: Leading Advanced Wound Care Treatments for DFUs 53
Table 12: Product Profile - Regranex Gel 55
Table 13: Regranex Gel SWOT Analysis, 2013 59
Table 14: Product Profile - Dermagraft 63
Table 15: Product Profile - Apligraf 67
Table 16: Product Profile - Grafix 70
Table 17: Overall Unmet Needs - Current Level of Attainment 74
Table 18: DFUs - Late Stage Pipeline, 2013 96
Table 19: Product Profile - CureXcell 98
Table 20: CureXcell SWOT Analysis, 2013 101
Table 21: Product Profile - DSC127 103
Table 22: DSC127 SWOT Analysis, 2013 106
Table 23: Product Profile - Trafermin 108
Table 24: Trafermin SWOT Analysis, 2013 111
Table 25: Product Profile - Cogenzia 115
Table 26: Cogenzia SWOT Analysis, 2013 118
Table 27: Product Profile - Locilex 121
Table 28: Locilex SWOT Analysis, 2013 123
Table 29: Early-Stage Pipeline Products for DFUs 124
Table 30: Clinical Benchmark of Key Pipeline Drugs - Wound-Healing Agents 128
Table 31: Clinical Benchmark of Key Pipeline Drugs - Topical Antibacterials 128
Table 32: Commercial Benchmark of Key Pipeline Drugs - Wound-Healing Agents 129
Table 33: Commercial Benchmark of Key Pipeline Drugs - Topical Antibacterials 130
Table 34: Top-Line Sales Forecasts ($m) for the DFU Market 2012-2017 134
Table 35: Key Events Impacting Sales in the DFU, 2012-2019 136
Table 36: DFU Market - Drivers and Barriers, 2012-2017 138
Table 37: Launch Dates in the DFU Market, 2012-2017 155

List of Figures

Figure 1: 6MM, Total Prevalent Cases of DFUs, Ages ?20 Years, Both Sexes, N, 2012-2022 41
Figure 2: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, 2012 43
Figure 3: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ?20 Years, N, 2012 45
Figure 4: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ?20 Years, Both Sexes, N, 2012-2022 46
Figure 5: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2012-2017 132
Figure 6: Competitive Assessment of the Late-Stage Pipeline Topical Antibacterials in DFUs, 2012-2017 133
Figure 7: Sales for the DFU Market, US and 5EU (2012?2017) 135