有痛性糖尿病性神経障害治療薬の世界市場予測・分析 2026年

GlobalDataが発行した調査報告書(GDHC164PIDR)
◆英語タイトル:PharmaPoint: Painful Diabetic Neuropathy - Global Drug Forecast and Market Analysis to 2026
◆商品コード:GDHC164PIDR
◆発行会社(リサーチ会社):GlobalData
◆発行日:2018年1月9日
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【レポートの概要】

PharmaPoint: Painful Diabetic Neuropathy – Global Drug Forecast and Market Analysis to 2026
Summary

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.

GlobalData 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

- 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

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.

【レポートの目次】

1 Table of Contents
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
12.8 About GlobalData 216
12.9 Contact Us 217
12.10 Disclaimer 217

1.1 List of Tables
Table 1: PDN: Key Metrics in the 7MM 12
Table 2: Classification of Diabetic Neuropathies 30
Table 3: PDN Staging System 30
Table 4: Symptoms of PDN Pain 35
Table 5: Risk Factors and Comorbidities for PDN 38
Table 6: Total Prevalent Cases of PDN, Men and Women, Ages ≥18 Years, Select Years 2016-2026 55
Table 7: Diagnosed Prevalent Cases of PDN, Men and Women, Ages ≥18 Years, Select Years 2016-2026 60
Table 8 shows the various types of pain questionnaires that are used in diagnosis and what they cover. 65
Table 9: Treatment Guidelines for PDN 68
Table 10: Targets of Management for PDN 71
Table 11: Most Prescribed Drugs for PDN by Class in the Global Markets, 2017 75
Table 12: Country Profile - US 79
Table 13: Country Profile - 5EU 83
Table 14: Country Profile - Japan 87
Table 15: Product Profile - Nucynta ER 91
Table 16: Nucynta ER SWOT Analysis, 2017 93
Table 17: Product Profile - Lyrica 96
Table 18: Lyrica SWOT Analysis, 2017 98
Table 19: Product Profile - Cymbalta 100
Table 20: Cymbalta SWOT Analysis, 2017 102
Table 21: Product Profile - Qutenza 104
Table 22: Qutenza SWOT Analysis, 2017 106
Table 23: TCA SWOT Analysis, 2017 109
Table 24: SNRI SWOT Analysis, 2017 112
Table 25: Anticonvulsants SWOT Analysis, 2017 114
Table 26: Opioid SWOT Analysis, 2017 117
Table 27: Comparison of Therapeutic Classes in Development for PDN, 2016-2026 138
Table 28: Product Profile - Mirogabalin Besylate 140
Table 29: Pipeline Mirogabalin Besylate SWOT Analysis, 2017 142
Table 30: Product Profile - VM202 145
Table 31: VM202 SWOT Analysis, 2017 147
Table 32: Product Profile - AmiKet 150
Table 33: AmiKet SWOT Analysis, 2017 152
Table 34: Product Profile - MR309 154
Table 35: MR309 SWOT Analysis, 2017 155
Table 36: Product Profile - Cebranopadol 159
Table 37: Cebranopadol SWOT Analysis, 2017 160
Table 38: Drugs in Development for Other Pain Indications 161
Table 39: Drugs in Development for PDN, 2017 162
Table 40: Key Companies in the PDN Market in the 7MM, 2016 164
Table 41: Pfizer’s Disease Portfolio Assessment, 2016 167
Table 42: Grünenthal’s Disease Portfolio Assessment, 2016 169
Table 43: Daiichi-Sankyo’s Disease Portfolio Assessment, 2016 170
Table 44: Depomed’s Disease Portfolio Assessment, 2016 171
Table 45: ViroMed’s Disease Portfolio Assessment, 2016 172
Table 46: PDN Market - Global Drivers and Barriers, 2016-2026 176
Table 47: Key Events Impacting Sales for PDN in the US, 2016-2026 178
Table 48: PDN Market - Global Drivers and Barriers in the US, 2016-2026 179
Table 49: Key Events Impacting Sales for PDN in the 5EU, 2016-2026 181
Table 50: PDN Market - Global Drivers and Barriers in the 5EU, 2016-2026 181
Table 51: Key Events Impacting Sales for PDN in Japan, 2016-2026 183
Table 52: PDN Market - Global Drivers and Barriers in Japan, 2016-2026 184
Table 53: Key Projected Launch Dates for PDN 205
Table 54: Key Historical and Projected Patent Expiry Dates for PDN 206
Table 55: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 214

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for PDN in 2016 and 2026 13
Figure 2: Analysis of the Company Portfolio Gap in PDN During the Forecast Period 15
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents Expected to be Licensed for the Treatment of PDN, 2016-2026 18
Figure 4: Types of Pain Split by Nociceptive Pain and NP Origins 27
Figure 5: The Etiology of PDN. 30
Figure 6: Pain Pathway - Somatosensory System 31
Figure 7: Case Flow Map 40
Figure 8: Sources Used and Not Used for Diagnosed Prevalent Cases of T2D Among the General Population 41
Figure 9: Sources Used for Diagnosed Prevalent Cases of T1D Among the General Population 42
Figure 10: Sources Used for Total Prevalent Cases of PDN Among the Diagnosed Diabetic Population 42
Figure 11: Sources Used for Total Prevalent Cases of PDN by Severity of Neuropathy 43
Figure 12: Sources Used for Total Prevalent Cases of Typical and Atypical PDN 43
Figure 13: Sources Used for Diagnosed Prevalent Cases of PDN 44
Figure 14: 7MM, Age-Specific Total Prevalent Cases of PDN, Men and Women, Ages ≥18 Years, 2016 55
Figure 15: 7MM, Sex-Specific Total Prevalent Cases of PDN, Men, Women, Ages ≥18 Years, 2016 56
Figure 16: 7MM, Total Prevalent Cases of PDN by Severity of Neuropathy, Men and Women, Ages ≥18 Years, 2016 57
Figure 17: 7MM, Total Prevalent Cases of Typical and Atypical PDN, Men and Women, Ages ≥18 Years, 2016 58
Figure 18: The Treatment Algorithm for PDN 71
Figure 19: The Major Unmet Needs in the PDN Market 120
Figure 20: Overview of the Development Pipeline in PDN 134
Figure 21: Current PDN Trials, by Location and Phase, 2012-2017 135
Figure 22: Key Phase II/III Trials for the Promising Pipeline Agents Expected to be Licensed for PDN in the 7MM, 2016-2026 136
Figure 23: Competitive Assessment of the Late-Stage Pipeline Agents Expected to be Licensed for the Treatment of PDN, 2016-2026 137
Figure 24: Clinical and Commercial Positioning of Pipeline Drug Mirogabalin Besylate 143
Figure 25: Clinical and Commercial Positioning of VM202 148
Figure 26: Clinical and Commercial Positioning of Pipeline Drug Amiket 153
Figure 27: Clinical and Commercial Positioning of MR309 156
Figure 28: Clinical and Commercial Positioning of Pipeline Drug Cebranopadol 161
Figure 29: Global Sales of Branded Products for PDN by Company in 2016 and 2026 165
Figure 30: Analysis of the Company Portfolio Gap in PDN During the Forecast Period 166
Figure 31: Global (7MM) Sales Forecast by Country for PDN in 2016 and 2026 176
Figure 32: Sales Forecast by Class for PDN in the US in 2016 and 2026 179
Figure 33: Sales Forecast Showing the Breakdown of the 5EU PDN Market by Country During the Forecast Period. 181
Figure 34: Sales Forecast by Class for PDN in the Japan in 2016 and 2026 184

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