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Painful Diabetic Neuropathy Market Report- Growth Analysis, Future Trends, Global Drug Forecast and Market Analysis to 2026

ReportsnReports added a new report on The Painful Diabetic Neuropathy Market report that delivers the clean elaborated structure of the Report comprising each and every business-related information of the market at a global level. The in-depth study on the current state which focuses on the major drivers and restraints for the key players. Painful Diabetic Neuropathy Market Industry research report provides granular analysis of the market share, segmentation, revenue forecasts, geographic regions of the market and analytical tools such as SWOT analysis to generate a whole set of trade based studies regarding the Painful Diabetic Neuropathy Market.

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Painful diabetic neuropathy is a late-stage complication that occurs in patients suffering from diabetes mellitus and is thought to affect up to half of patients with the disease. PDN manifests itself as a variety of syndromes which differ in clinical course, distribution, fibre involvement and, pathophysiology. Symptoms will vary from patient to patient however; the most common pain symptoms are reported to be numbness, tingling, burning, sharp, and dull/ache-like, which are often localized to the extremities, affecting the feet and hands.

Currently, there are only three approved therapies for the treatment of PDN, Pfizer’s Lyrica, Eli Lilly’s Cymbalta, and Grünenthal’s Nucynta ER. Acorda Therapeutics has marketed an 8% capsaicin patch (Qutenza) which is approved for peripheral neuropathic pain and may be used in certain PDN syndromes. Outside of these drugs the market consists of off label use and generics.

ReportsnReports estimates that drug sales for PDN in 2016 were approximately $3.1B across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $7.1B at a CAGR of 8.7%. This growth will be driven by the launch of four late-stage pipeline products. The two highest selling drugs are expected to be ViroMed’s VM202 and Daiichi-Sankyo’s mirogabalin besylate, which both address some of the unmet needs in the market.

Scope of this Report-
– Overview of PDN, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
– Annualized PDN therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in two patient segments (typical and atypical) forecast from 2016 to 2026.
– Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the PDN therapeutics market
– Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for PDN therapy. The most promising candidates in Phase III development are profiled.
– Analysis of the current and future market competition in the global PDN 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 this Report-
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.
– Develop business strategies by understanding the trends shaping and driving the global PDN therapeutics market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global PDN therapeutics market in the 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.
– 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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Table of Contents in this Report-
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 9
2 Painful Diabetic Neuropathy: Executive Summary 11
2.1 PDN Market Is Expected to Reach $7B by 2026 12
2.2 Partnerships and Licensing Agreements Are the Most Commonly Used Strategy 13
2.3 Drugs with Improved Safety and Efficacy Profiles Top the Unmet Needs 16
2.4 Big Opportunities for Companies Willing to Invest In Pathophysiology Research 17
2.5 Gene Therapy Is a Key Driver of Growth in the Global PDN Market 17
2.6 What Do the Physicians Think? 19
3 Introduction 24
3.1 Catalyst 24
3.2 Related Reports 25
4 Disease Overview 26
4.1 Overview 26
4.2 Classification or Staging Systems 28
4.3 Etiology and Pathophysiology 30
4.3.1 Etiology 30
4.3.2 Pathophysiology 31
4.4 Symptoms 33
4.5 Prognosis 35
4.6 Quality of Life 35
5 Epidemiology 36
5.1 Disease Background 36
5.2 Risk Factors and Comorbidities 37
5.3 Global and Historical Trends 37
5.3.1 US 38
5.3.2 5EU 39
5.3.3 Japan 39
5.4 Forecast Methodology 40
5.4.1 Sources 41
5.4.2 Forecast Assumptions and Methods 44
5.5 Epidemiological Forecast for PDN (2016-2026) 53
5.5.1 Total Prevalent Cases of PDN 53
5.5.2 Age-Specific Total Prevalent Cases of PDN 54
5.5.3 Sex-Specific Total Prevalent Cases of PDN 56
5.5.4 Total Prevalent Cases of PDN by Severity of Neuropathy 56
5.5.5 Total Prevalent Cases of Typical and Atypical PDN 57
5.5.6 Diagnosed Prevalent Cases of PDN 58
5.6 Discussion 59
5.6.1 Epidemiological Forecast Insight 59
5.6.2 Limitations of the Analysis 60
5.6.3 Strengths of the Analysis 61
6 Disease Management 62
6.1 Diagnosis Overview 62
6.2 Treatment Overview 66
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 67
6.2.2 Clinical Practice 68
6.2.3 Non-pharmacological Treatments 74
6.3 US 75
6.4 5EU 78
6.5 Japan 83
7 Competitive Assessment 87
7.1 Overview 87
7.2 Nucynta ER/Palexia SR (tapentadol) 88
7.2.1 Overview 88
7.2.2 Efficacy 90
7.2.3 Safety 91
7.2.4 SWOT Analysis 92
7.2.5 Forecast 92
7.3 Lyrica (pregabalin) 93
7.3.1 Overview 93
7.3.2 Efficacy 95
7.3.3 Safety 95
7.3.4 SWOT Analysis 97
7.3.5 Forecast 97
7.4 Cymbalta (duloxetine) 97
7.4.1 Overview 97
7.4.2 Efficacy 100
7.4.3 Safety 100
7.4.4 SWOT Analysis 101
7.4.5 Forecast 101
7.5 Qutenza (8% capsaicin patch) 101
7.5.1 Overview 101
7.5.2 Efficacy 104
7.5.3 Safety 104
7.5.4 SWOT Analysis 105
7.5.5 Forecast 105
7.6 Tricyclic Antidepressants 106
7.6.1 Overview 106
7.6.2 Efficacy 107
7.6.3 Safety 107
7.6.4 SWOT Analysis 108
7.6.5 Forecast 108
7.7 Serotonin-Norepinephrine Reuptake Inhibitors 109
7.7.1 Overview 109
7.7.2 Efficacy 110
7.7.3 Safety 110
7.7.4 SWOT Analysis 111
7.7.5 Forecast 111
7.8 Anticonvulsants 111
7.8.1 Overview 111
7.8.2 Efficacy 112
7.8.3 Safety 113
7.8.4 SWOT Analysis 113
7.8.5 Forecast 113
7.9 Opioids 114
7.9.1 Overview 114
7.9.2 Efficacy 115
7.9.3 Safety 116
7.9.4 SWOT Analysis 116
7.9.5 Forecast 116
7.10 Non-Pharmacological Treatments 117
7.10.1 Overview 117
8 Unmet Needs and Opportunity Assessment 119
8.1 Overview 119
8.2 Need for Drugs with an Improved Safety and Tolerability Profile 121
8.2.1 Unmet Need 121
8.2.2 Gap Analysis 122
8.2.3 Opportunity 122
8.3 Need for Drugs with an Improved Efficacy Profile 123
8.3.1 Unmet Need 123
8.3.2 Gap Analysis 124
8.3.3 Opportunity 125
8.4 Need for a Curative or Disease-Modifying Agent 126
8.4.1 Unmet Need 126
8.4.2 Gap Analysis 127
8.4.3 Opportunity 128
8.5 Need to Improve Physician and Public Recognition of PDN 129
8.5.1 Unmet Need 129
8.5.2 Gap Analysis 130
8.5.3 Opportunity 131
9 Pipeline Assessment 133
9.1 Overview 133
9.2 Clinical Trial Mapping 135
9.2.1 Clinical Trials by Country 135
9.3 Promising Drugs in Clinical Development 135
9.4 Mirogabalin Besylate 138
9.4.1 Overview 138
9.4.2 Efficacy 141
9.4.3 Safety 141
9.4.4 SWOT Analysis 142
9.4.5 Dosing and Formulation 143
9.4.6 Potential Clinical and Commercial Positioning 143
9.4.7 Forecast 143
9.5 VM202 144
9.5.1 Overview 144
9.5.2 Efficacy 146
9.5.3 Safety 147
9.5.4 SWOT Analysis 147
9.5.5 Dosing and Formulation 148
9.5.6 Potential Clinical and Commercial Positioning 148
9.5.7 Forecast 148
9.6 AmiKet 148
9.6.1 Overview 148
9.6.2 Efficacy 151
9.6.3 Safety 152
9.6.4 SWOT Analysis 152
9.6.5 Dosing and Formulation 153
9.6.6 Potential Clinical and Commercial Positioning 153
9.6.7 Forecast 153
9.7 MR309 153
9.7.1 Overview 153
9.7.2 Efficacy 155
9.7.3 Safety 155
9.7.4 SWOT Analysis 156
9.7.5 Dosing and Formulation 156
9.7.6 Potential Clinical and Commercial Positioning 156
9.7.7 Forecast 157
9.8 Cebranopadol 157
9.8.1 Overview 157
9.8.2 Efficacy 159
9.8.3 Safety 160
9.8.4 SWOT Analysis 160
9.8.5 Dosing and Formulation 161
9.8.6 Potential Clinical and Commercial Positioning 161
9.8.7 Forecast 161
9.9 Off Label Drugs in Development 161
9.10 Other Drugs in Development 162
10 Current and Future Players 163
10.1 Overview 163
10.2 Trends in Corporate Strategy 165
10.3 Pfizer 167
10.3.1 Overview 167
10.3.2 Portfolio Assessment 167
10.4 Grunethal 168
10.4.1 Overview 168
10.4.2 Portfolio Assessment 169
10.5 Daiichi-Sankyo 169
10.5.1 Overview 169
10.5.2 Portfolio Assessment 170
10.6 Depomed 170
10.6.1 Overview 170
10.6.2 Portfolio Assessment 171
10.7 ViroMed 172
10.7.1 Overview 172
10.7.2 Portfolio Assessment 172
11 Market Outlook 173
11.1 Global Markets 173
11.1.1 Forecast 173
11.1.2 Drivers and Barriers – Global Issues 176
11.2 US 176
11.2.1 Forecast 176
11.2.2 Key Events 178
11.2.3 Drivers and Barriers 179
11.3 5EU 179
11.3.1 Forecast 179
11.3.2 Key Events 181
11.3.3 Drivers and Barriers 181
11.4 Japan 182
11.4.1 Forecast 182
11.4.2 Key Events 183
11.4.3 Drivers and Barriers 184
12 Appendix 185
12.1 Bibliography 185
12.2 Abbreviations 200
12.3 Methodology 204
12.3.1 Forecasting Methodology 204
12.3.2 Diagnosed Patients 204
12.3.3 Percent Drug-Treated Patients 205
12.3.4 Drugs Included in Each Therapeutic Class 205
12.3.5 Launch and Patent Expiry Dates 205
12.3.6 General Pricing Assumptions 206
12.3.7 Individual Drug Assumptions 207
12.3.8 Generic Erosion 211
12.3.9 Pricing of Pipeline Agents 211
12.4 Primary Research – KOLs Interviewed for This Report 212
12.5 Primary Research – Payers Interviewed for This Report 213
12.6 Primary Research – Prescriber Survey 214
12.7 About the Authors 214
12.7.1 Analyst 214
12.7.2 Therapy Area Director 214
12.7.3 Epidemiologist 215
12.7.4 Managing Epidemiologist 215
12.7.5 Global Director of Therapy Analysis and Epidemiology 215
12.7.6 Global Head and EVP of Healthcare Operations and Strategy 216

and more…