OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2017

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OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2017
http://www.reportlinker.com/p01921051/OpportunityAnalyzer-Diabetic-Foot-Ulcers---Opportunity-Analysis-and-Forecast-to-2017.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

OpportunityAnalyzer: Diabetic Foot Ulcers - Opportunity Analysis and Forecast to 2017

Summary

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.

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 to 2017Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications
- 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
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 17
3.2 Assessment of DFUs 18
3.2.1 Patient History and Visual Examination 19
3.2.2 Testing for Neuropathy 19
3.2.3 Testing Vascular Status 19

3.2.4 Identifying Infection 20
3.3 Classification of Diabetic Foot Ulcers 20
3.4 Prognosis 22
4 Epidemiology 23
4.1 Disease Background 23
4.2 Risk Factors and Comorbidities 23
4.2.1 An increased duration of diabetes triples the risk of DFUs 24
4.2.2 Men diabetics are at higher risk for DFUs than women diabetics 25
4.3 Global Trends 25
4.3.1 US 26
4.3.2 5EU 27
4.4 Forecast Methodology 28
4.4.1 Sources Used 29
4.4.2 Sources Not Used 31
4.4.3 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes 32
4.4.4 Forecast Assumptions and Methods, Diabetic Foot Ulcers 35
4.5 Epidemiological Forecast for DFUs (2012-2022) 38
4.5.1 Total Prevalent Cases of DFUs 38
4.5.2 Age-Specific Total Prevalent Cases of DFUs 40

4.5.3 Sex-Specific Total Prevalent Cases of DFUs 42
4.5.4 Total Prevalent Cases of Diabetic Foot Infections 43
4.6 Discussion 45
4.6.1 Epidemiological Forecast Insight 45
4.6.2 Limitations of the Analysis 45
4.6.3 Strengths of the Analysis 46
5 Current Treatment Options 47
5.1 Overview 47
5.2 Product Profiles - Wound-Healing Agents 51
5.2.1 Regranex (becaplermin) Gel 51
5.3 Product Profiles - Cell-Based Skin Substitutes 58
5.3.1 Dermagraft (human fibroblast-derived dermal substitute) 58
5.3.2 Apligraf (bi-layered skin substitute) 62
5.3.3 Grafix (human cellular repair matrix) 65
6 Unmet Needs Assessment and Opportunity Analysis 70
6.1 Overview 70
6.2 Unmet Needs Analysis 71
6.2.1 Improved Patient and Physician Education: Emphasis on the Importance of Off-Loading 71
6.2.2 Improved Multidisciplinary Approach to Patient Treatment with Common Protocols 73
6.2.3 More Effective Treatments for Neuroischemic Wounds 75
6.2.4 More Effective Antibacterial Treatments for Infected DFUs 76

6.2.5 Affordable Products and Improved Reimbursement 76
6.2.6 In-Home Sensing Systems for the Early Prevention of DFUs 78
6.3 Opportunity Analysis 79
6.3.1 Wound-Healing Agents for the Treatment of Neuroischemic Ulcers 79
6.3.2 Topical Antibiotics for the Treatment of DFUs 79
6.3.3 Enzymatic Debriding Agents 80
7 Research and Development Strategies 82
7.1 Overview 82
7.1.1 Local Administration of Growth Factors and Bioactive Peptides 82
7.1.2 Cellular Therapies: Leukocytes, Platelets, and Stem Cells 83
7.1.3 Acquisitions and Licensing Agreements Between Wound Care Companies 84
7.2 Clinical Trial Design 85
7.2.1 Current Clinical Trial Design 86
7.2.2 Standardization of Debridement and Off-Loading 87
7.2.3 Inclusion of Representative Patient Populations in Clinical Trials 89
8 Pipeline Assessment 91
8.1 Overview 91
8.2 Promising Wound-Healing Agents in Clinical Development 92
8.2.1 CureXcell (activated leukocyte suspension) 92
8.2.2 DSC127 (NorLeu3-angiotensin[1-7]) 98
8.2.3 Trafermin (recombinant human basic fibroblast growth factor spray) 103

8.2.4 CVBT-141B (topical human fibroblast growth factor-1) 108
8.3 Promising Antimicrobial Agents in Clinical Development 109
8.3.1 Cogenzia (gentamicin-collagen sponge) 109
8.3.2 Locilex (pexiganan acetate cream) 115
8.3.3 Innovative Early-Stage Approaches 120
9 Pipeline Valuation Analysis 123
9.1 Clinical Benchmark of Key Pipeline Drugs 123
9.2 Commercial Benchmark of Key Pipeline Drugs 125
9.3 Competitive Assessment 126
9.4 Top-Line Five-Year Forecast 130
9.4.1 US 132
9.4.2 5EU 133
10 Appendix 134
10.1 Bibliography 134
10.2 Abbreviations 145
10.3 Methodology 148
10.4 Forecast Methodology 148
10.4.1 Percent Diagnosed Patients 149
10.4.2 Percent Drug-Treated Patients 149
10.4.3 Drugs Included in Each Therapeutic Class 149
10.4.4 Launch Dates 150

10.4.5 General Pricing Assumptions 150
10.4.6 Individual Drug Assumptions 151
10.5 Physicians and Specialists Included in This Study 155
10.6 About the Authors 156
10.6.1 Analyst, Cardiovascular and Metabolic Disorders 156
10.6.2 Senior Epidemiologist 156
10.6.3 Therapy Director - CVMD and Infectious Disease 157
10.6.4 Global Head of Healthcare 157
10.7 About GlobalData 158
10.8 Disclaimer 158

ist of Tables

Table 1: Typical Features of DFUs According to Etiology 16
Table 2: DFU Risk Factors 18
Table 3: Wagner Classification System for DFUs 21
Table 4: University of Texas Classification System for DFUs 21
Table 5: Risk Factors for DFUs 24
Table 6: Epidemiological Sources Used to Forecast the Total Prevalence of DFUs and Diabetic Foot Infections in the Diagnosed Diabetic Population 29
Table 7: 6MM, Total Prevalent Cases of DFUs, Ages ?20 Years, Both Sexes, N, 2012-2022 39
Table 8: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, (Row %), 2012 41
Table 9: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ?20 years, N (Row %), 2012 42
Table 10: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ?20 years, Both Sexes, N, 2012-2022 44
Table 11: Leading Advanced Wound Care Treatments for DFUs 51
Table 12: Product Profile - Regranex Gel 53
Table 13: Regranex Gel SWOT Analysis, 2013 57
Table 14: Product Profile - Dermagraft 60
Table 15: Product Profile - Apligraf 64
Table 16: Product Profile - Grafix 67
Table 17: Overall Unmet Needs - Current Level of Attainment 71
Table 18: DFUs - Late Stage Pipeline, 2013 92

Table 19: Product Profile - CureXcell 94
Table 20: CureXcell SWOT Analysis, 2013 97
Table 21: Product Profile - DSC127 99
Table 22: DSC127 SWOT Analysis, 2013 102
Table 23: Product Profile - Trafermin 104
Table 24: Trafermin SWOT Analysis, 2013 107
Table 25: Product Profile - Cogenzia 111
Table 26: Cogenzia SWOT Analysis, 2013 114
Table 27: Product Profile - Locilex 117
Table 28: Locilex SWOT Analysis, 2013 119
Table 29: Early-Stage Pipeline Products for DFUs 120
Table 30: Clinical Benchmark of Key Pipeline Drugs - Wound-Healing Agents 123
Table 31: Clinical Benchmark of Key Pipeline Drugs - Topical Antibacterials 124
Table 32: Commercial Benchmark of Key Pipeline Drugs - Wound-Healing Agents 125
Table 33: Commercial Benchmark of Key Pipeline Drugs - Topical Antibacterials 126
Table 34: Top-Line Sales Forecasts ($m) for the DFU Market 2012-2017 130
Table 35: Key Events Impacting Sales in the DFU, 2012-2019 131
Table 36: DFU Market - Drivers and Barriers, 2012-2017 133
Table 37: Launch Dates in the DFU Market, 2012-2017 150

List of Figures

Figure 1: 6MM, Total Prevalent Cases of DFUs, Ages ?20 Years, Both Sexes, N, 2012-2022 39
Figure 2: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, 2012 41
Figure 3: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages ?20 Years, N, 2012 43
Figure 4: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages ?20 Years, Both Sexes, N, 2012-2022 44
Figure 5: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2012-2017 128
Figure 6: Competitive Assessment of the Late-Stage Pipeline Topical Antibacterials in DFUs, 2012-2017 129
Figure 7: Sales for the DFU Market, US and 5EU (2012?2017) 131

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http://www.reportlinker.com/p01921051/OpportunityAnalyzer-Diabetic-Foot-Ulcers---Opportunity-Analysis-and-Forecast-to-2017.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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