HTF Market Intelligence released a new research report of 166 pages on title ‘OpportunityAnalyzer: Diabetic Foot Ulcers – Opportunity Analysis and Forecast to 2025’ with detailed analysis, forecast and strategies.
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.
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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?
– 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.
– 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.
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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…. View Detailed Table of Content @ https://www.htfmarketreport.com/reports/304234-opportunityanalyzer-13
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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CRAIG FRANCIS (PR & Marketing Manager)
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