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

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


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Executive Summary

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

Summary

GlobalData estimates sales of diabetic foot ulcer (DFU) and diabetic foot infection (DFI) drugs to be approximately $292.1M across the 7MM in 2015, encompassing the US, 5EU, and Japan. DFU sales alone accounting for $118.7M across the 7MM. The DFU, DFI market will grow at a CAGR of 11.6% over the forecast period, reaching sales of $873.4M by 2025. The US is the largest market for DFU, DFI therapies, contributing approximately 62% of total sales in the base year. GlobalData expects the uptake 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. Despite the anticipated launch of Granexin, there is ample opportunity for pipeline drugs targeting the subset of DFUs that are ischemic. Difficulty of successfully developing a DFU or DFI candidate is expected to be the strongest barrier. There have been multiple Phase III DFU and DFI clinical trial terminations in the past five years alone (mainly due to trials failing to meet primary endpoints), leaving the market void of any new DFU drugs for almost two decades.

Highlights

Key Questions Answered

In addition to standard of care (SOC), Regranex and Fiblast have been the only wound healing pharmacological drugs used to treat DFUs in the US and Japan respectively. The efficacy of these agents is disputed among KOLs, with the majority of experts expressing dissatisfaction with these limited options. Therefore, there is a considerable need for additional therapies within the indication. What are the other main unmet needs in this market?

The current late-stage DFU pipeline encompasses one novel synthetic bioactive peptide, FirstString's Granexin, which binds the ZO1 protein, and stabilizes connexin 43 gap junctions to reduce excessive inflammation and promote normal tissue regeneration. Will Granexin make a significant impact on the DFU market?

There continues to be an increase in DFU diagnosed prevalence across the 7MM over the past 10 years. How will epidemiological changes impact the growth of the future market? Overall, which of the major markets is the most lucrative within the DFU space?

Key Findings

Prevalence of diabetes and resulting DFUs, DFIs are increasing across the 7MM. Off-loading, debridement, and revascularization if needed, remain the SOC for DFU patients.

The lack of therapies that target ischemic DFUs remains a significant unmet need. Additionally, therapies that decrease healing time, is an important attribute for next generation DFU wound healing agents.

Additional DFI therapies warranted for hard to treat/resistant infections. Late stage pipeline is currently empty.

Granexin belongs to same class (growth factor, bioactive peptide) as marketed DFU drugs, yet with incremental advantages. Despite Granexin's promise, multiple DFU trial terminations in recent years reflects a barrier, with no DFU wound healing pharmacological agent reaching the 7MM for nearly two decades.

Japanese DFU drug market is stable and will be difficult to penetrate in comparison to US and 5EU markets. 5EU remains without a DFU specific wound healing agent since the withdrawal of Regranex in 2011.

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.



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1 Table of Contents

1 Table of Contents 7

1.1 List of Tables 11

1.2 List of Figures 13

2 Introduction 14

2.1 Catalyst 14

2.2 Related Reports 14

3 Disease Overview 15

3.1 Etiology and Pathophysiology 15

3.1.1 Etiology 15

3.1.2 Pathophysiology 16

3.2 Assessment of DFUs 17

3.2.1 Patient Symptoms, History, and Visual Examination 18

3.2.2 Testing for Neuropathy 18

3.2.3 Testing Vascular Status 19

3.2.4 Identifying Infection 19

3.3 Classification of Diabetic Foot Ulcers 21

3.4 Prognosis and Quality of Life 22

4 Epidemiology 24

4.1 Disease Background 24

4.2 Risk Factors and Comorbidities 25

4.3 Global Trends 26

4.3.1 Diagnosed Incidence and Total Prevalence 28

4.4 Forecast Methodology 31

4.4.1 Sources Used Tables 32

4.4.2 Forecast Assumptions and Methods 34

4.4.3 Sources Not Used 46

4.5 Epidemiological Forecast of DFU (2015-2025) 47

4.5.1 Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population 47

4.5.2 Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population 56

4.6 Discussion 63

4.6.1 Epidemiological Forecast Insight 63

4.6.2 Limitations of the Analysis 64

4.6.3 Strengths of the Analysis 65

5 Current Treatment Options 66

5.1 Overview 66

5.2 Treatment 67

5.2.1 Treatment Guidelines and Leading Prescribed Drugs 67

5.2.2 Clinical Practice 68

5.3 Product Profiles-Wound-Healing Agents 72

5.3.1 Regranex (Becaplermin) Gel 72

5.3.2 Fiblast (Trafermin) Spray 77

5.4 Product Profiles-Cell-Based Skin Substitutes, Membrane Allografts 80

5.4.1 Dermagraft (Human Fibroblast-Derived Dermal Substitute) 80

5.4.2 Apligraf (Bi-layered Skin Substitute) 84

5.4.3 Grafix (Human Cellular Repair Matrix) 88

5.4.4 Epifix (Dehydrated Human Amnion/Chorion Membrane Allograft) 92

5.5 Additional Therapies for DFUs and DFIs 95

5.5.1 Vasodilators 95

5.5.2 Antibiotics 96

6 Unmet Needs Assessment and Opportunity Analysis 99

6.1 Overview 99

6.2 Unmet Needs Analysis 100

6.2.1 Improved Physician and Patient Education 100

6.2.2 More Effective Treatments: Agents Promoting Quicker Wound Closure and Targeting Neuroischemic DFUs 103

6.2.3 More Effective Antibacterial Treatments for DFIs 104

6.2.4 Affordable Products and Improved Reimbursement 106

6.2.5 Better Understanding of Wound Healing Processes 108

7 Research and Development Strategies 110

7.1 Overview 110

7.1.1 Growth Factors and Bioactive Peptides 110

7.1.2 Cellular Therapies: Platelets and Stem Cells 111

7.1.3 Wound Care Company Acquisitions and Licensing Agreements 112

7.2 Clinical Trial Design 113

7.2.1 Current Clinical Trial Design 114

7.2.2 Future Clinical Trial Design Considerations 116

8 Pipeline Assessment 119

8.1 Overview 119

8.2 Promising Wound-Healing Agent in Clinical Development 119

8.2.1 Granexin (Synthetic Peptide) 119

8.3 Innovative Early-Stage Approaches, Drugs in Development 123

9 Pipeline Valuation Analysis 125

9.1 Clinical Benchmark of Key Pipeline Drugs 125

9.2 Commercial Benchmark of Key Pipeline Drugs 126

9.3 Competitive Assessment 127

9.4 Top-Line Ten-Year Forecast 128

9.4.1 US 130

9.4.2 5EU 132

9.4.3 Japan 134

10 Appendix 137

10.1 Bibliography 137

10.2 Abbreviations 149

10.3 Methodology 152

10.4 Forecast Methodology 152

10.4.1 Percent Diagnosed Patients 152

10.4.2 Percent Drug-Treated Patients 153

10.4.3 Drugs Included in Each Therapeutic Class 153

10.4.4 Launch and Patent Expiry Dates 154

10.4.5 General Pricing Assumptions 154

10.4.6 Individual Drug Assumptions 155

10.5 Physicians and Specialists Included in This Study 158

10.6 About the Authors 161

10.6.1 Senior Analyst, Cardiovascular and Metabolic Disorders 161

10.6.2 Director, Cardiovascular and Metabolic Disorders 161

10.6.3 Epidemiologists 162

10.6.4 Global Therapy of Therapy Analysis and Epidemiology 163

10.7 About GlobalData 164

10.8 Disclaimer 164

1.2 List of Figures

Figure 1: DFI Characteristics 21

Figure 2: 7MM, Diagnosed Incident Cases of DFU, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 49

Figure 3: 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N, 2015 51

Figure 4: 7MM, Diagnosed Incident Cases of DFU, Ages ?20 Years, by Sex, N , 2015 53

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of DFU, Ages ?20 Years, by Sex, Cases per 100,000 Diabetic Population, 2015 54

Figure 6: 7MM, Diagnosed Incident Cases of DFU by Classification, Both Sexes, Ages ?20 Years, 2015 55

Figure 7: 7MM, DFI Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages ?20 Years, 2015 56

Figure 8: 7MM, PAD Cases Among the DFU-Diagnosed Incident Population, Both Sexes, Ages ?20 Years, 2015 57

Figure 9: 7MM, Total Prevalent Cases of DFU, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 59

Figure 10: 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N, 2015 61

Figure 11: 7MM, Total Prevalent Cases of DFU, Ages ?20 Years, by Sex, N , 2015 63

Figure 12: 7MM, Age-Standardized Total Prevalence of DFU, Ages ?20 Years, by Sex, %, 2015 64

Figure 13: DFU Management 70

Figure 14: Competitive Assessment of the Late-Stage Pipeline Wound-Healing Agents for DFUs, 2015-2025 129

Figure 15: DFU and DFI Sales by Region, 2015?2025 130

Figure 16: Sales for DFUs and DFIs by Drug in the US, 2015 and 2025 133

Figure 17: Sales for DFUs and DFIs by Drug in the 5EU, 2015 and 2025 135

Figure 18: Sales for DFUs and DFIs by Drug in Japan, 2015 and 2025 137

1.1 List of Tables

Table 1: Typical Features and Characterization of DFUs According to Etiology 17

Table 2: DFU Risk Factors 18

Table 3: Wagner Classification System for DFUs 22

Table 4: University of Texas Classification System for DFUs 23

Table 5: Risk Factors and Comorbidities of DFUs 27

Table 6: 7MM, Diagnosed Incidence of DFU Among the Diabetic Population from 1993-2008 28

Table 7: 7MM, Total Prevalence of DFU Among the Diabetic Population from 1990-2008 29

Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of DFU Among the Diagnosed Diabetic Population 33

Table 9: 7MM, Sources Used for the Classification of DFUs Among the DFU-Diagnosed Incident Population 34

Table 10: 7MM, Sources Used to Forecast DFI and PAD Cases Among the DFU-Diagnosed Incident Population 34

Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of DFU Among the Diagnosed Diabetic Population 35

Table 12: 7MM, Sources Not Used in Epidemiological Analysis of DFU 47

Table 13: 7MM, Diagnosed Incident Cases of DFU, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 48

Table 14. 7MM, Diagnosed Incident Cases of DFU, by Age, Both Sexes, N (Row %), 2015 50

Table 15: 7MM, Diagnosed Incident Cases of DFU, by Sex, Ages ?20 Years, N (Row %), 2015 52

Table 16: 7MM, Total Prevalent Cases of DFU, Ages ?20 Years, Both Sexes, N, Selected Years 2015-2025 58

Table 17. 7MM, Total Prevalent Cases of DFU, by Age, Both Sexes, N (Row %), 2015 60

Table 18: 7MM, Total Prevalent Cases of DFU, by Sex, Ages ?20 Years, N (Row %), 2015 62

Table 19: Treatment Guidelines for DFUs 68

Table 20: Leading Advanced Wound Care Treatments Used to Treat DFUs 69

Table 21: Product Profile-Regranex Gel 75

Table 22: Regranex Gel SWOT Analysis, 2016 78

Table 23: Product Profile-Fiblast 79

Table 24: Fiblast SWOT Analysis, 2016 80

Table 25: Product Profile-Dermagraft 84

Table 26: Product Profile-Apligraf 88

Table 27: Product Profile-Grafix 91

Table 28: Product Profile-EpiFix 94

Table 29: Leading Antibiotics Prescribed for DFIs Across 7MM 98

Table 30: Overall Unmet Needs-Current Level of Attainment 101

Table 31: DFUs-Late Stage Pipeline, 2016 120

Table 32: Product Profile-Granexin 122

Table 33: Granexin SWOT Analysis, 2016 124

Table 34: Early-Stage Pipeline Products for DFUs and DFIs 125

Table 35: Clinical Benchmark of Key Pipeline Drugs-Wound-Healing Agents 126

Table 36: Commercial Benchmark of Key Pipeline Drugs-Wound-Healing Agents 127

Table 37: Top-Line Sales Forecasts ($M) for the DFU and DFI Market 2015-2025 130

Table 38: Key Events Impacting Sales in the DFU, 2015-2025 131

Table 39: DFU Market-Drivers and Barriers, 2015-2025 131

Table 40: Sales Forecasts ($M) for DFUs and DFIs in the US, 2015-2025 132

Table 41: Sales Forecasts ($M) for DFUs and DFIs in the 5EU, 2015-2025 134

Table 42: Sales Forecasts ($M) for DFUs and DFIs in Japan, 2015-2025 136

Table 43: Key Events Impacting Sales in the DFU Market, 2015-2025 155

Table 44: Number of High-Prescribing Physicians Surveyed 161

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