PharmaPoint: Painful Diabetic Neuropathy-Global Drug Forecast and Market Analysis to 2026
April 2018
218
About the Report
About the Report
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 USD3.1B across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to USD7.1B 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.
Products
Companies
Pfizer
Grunethal
Daiichi-Sankyo
Depomed
ViroMed
Table of Contents
Table of Contents
1 Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Painful Diabetic Neuropathy: Executive Summary
2.1 PDN Market Is Expected to Reach USD7B by 2026
2.2 Partnerships and Licensing Agreements Are the Most Commonly Used Strategy
2.3 Drugs with Improved Safety and Efficacy Profiles Top the Unmet Needs
2.4 Big Opportunities for Companies Willing to Invest In Pathophysiology Research
2.5 Gene Therapy Is a Key Driver of Growth in the Global PDN Market
2.6 What Do the Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
4 Disease Overview
4.1 Overview
4.2 Classification or Staging Systems
4.3 Etiology and Pathophysiology
4.3.1 Etiology
4.3.2 Pathophysiology
4.4 Symptoms
4.5 Prognosis
4.6 Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.3.1 US
5.3.2 5EU
5.3.3 Japan
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for PDN (2016-2026)
5.5.1 Total Prevalent Cases of PDN
5.5.2 Age-Specific Total Prevalent Cases of PDN
5.5.3 Sex-Specific Total Prevalent Cases of PDN
5.5.4 Total Prevalent Cases of PDN by Severity of Neuropathy
5.5.5 Total Prevalent Cases of Typical and Atypical PDN
5.5.6 Diagnosed Prevalent Cases of PDN
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Disease Management
6.1 Diagnosis Overview
6.2 Treatment Overview
6.2.1 Treatment Guidelines and Leading Prescribed Drugs
6.2.2 Clinical Practice
6.2.3 Non-pharmacological Treatments
6.3 US
6.4 5EU
6.5 Japan
7 Competitive Assessment
7.1 Overview
7.2 Nucynta ER/Palexia SR (tapentadol)
7.2.1 Overview
7.2.2 Efficacy
7.2.3 Safety
7.2.4 SWOT Analysis
7.2.5 Forecast
7.3 Lyrica (pregabalin)
7.3.1 Overview
7.3.2 Efficacy
7.3.3 Safety
7.3.4 SWOT Analysis
7.3.5 Forecast
7.4 Cymbalta (duloxetine)
7.4.1 Overview
7.4.2 Efficacy
7.4.3 Safety
7.4.4 SWOT Analysis
7.4.5 Forecast
7.5 Qutenza (8% capsaicin patch)
7.5.1 Overview
7.5.2 Efficacy
7.5.3 Safety
7.5.4 SWOT Analysis
7.5.5 Forecast
7.6 Tricyclic Antidepressants
7.6.1 Overview
7.6.2 Efficacy
7.6.3 Safety
7.6.4 SWOT Analysis
7.6.5 Forecast
7.7 Serotonin-Norepinephrine Reuptake Inhibitors
7.7.1 Overview
7.7.2 Efficacy
7.7.3 Safety
7.7.4 SWOT Analysis
7.7.5 Forecast
7.8 Anticonvulsants
7.8.1 Overview
7.8.2 Efficacy
7.8.3 Safety
7.8.4 SWOT Analysis
7.8.5 Forecast
7.9 Opioids
7.9.1 Overview
7.9.2 Efficacy
7.9.3 Safety
7.9.4 SWOT Analysis
7.9.5 Forecast
7.10 Non-Pharmacological Treatments
7.10.1 Overview
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Need for Drugs with an Improved Safety and Tolerability Profile
8.2.1 Unmet Need
8.2.2 Gap Analysis
8.2.3 Opportunity
8.3 Need for Drugs with an Improved Efficacy Profile
8.3.1 Unmet Need
8.3.2 Gap Analysis
8.3.3 Opportunity
8.4 Need for a Curative or Disease-Modifying Agent
8.4.1 Unmet Need
8.4.2 Gap Analysis
8.4.3 Opportunity
8.5 Need to Improve Physician and Public Recognition of PDN
8.5.1 Unmet Need
8.5.2 Gap Analysis
8.5.3 Opportunity
9 Pipeline Assessment
9.1 Overview
9.2 Clinical Trial Mapping
9.2.1 Clinical Trials by Country
9.3 Promising Drugs in Clinical Development
9.4 Mirogabalin Besylate
9.4.1 Overview
9.4.2 Efficacy
9.4.3 Safety
9.4.4 SWOT Analysis
9.4.5 Dosing and Formulation
9.4.6 Potential Clinical and Commercial Positioning
9.4.7 Forecast
9.5 VM202
9.5.1 Overview
9.5.2 Efficacy
9.5.3 Safety
9.5.4 SWOT Analysis
9.5.5 Dosing and Formulation
9.5.6 Potential Clinical and Commercial Positioning
9.5.7 Forecast
9.6 AmiKet
9.6.1 Overview
9.6.2 Efficacy
9.6.3 Safety
9.6.4 SWOT Analysis
9.6.5 Dosing and Formulation
9.6.6 Potential Clinical and Commercial Positioning
9.6.7 Forecast
9.7 MR309
9.7.1 Overview
9.7.2 Efficacy
9.7.3 Safety
9.7.4 SWOT Analysis
9.7.5 Dosing and Formulation
9.7.6 Potential Clinical and Commercial Positioning
9.7.7 Forecast
9.8 Cebranopadol
9.8.1 Overview
9.8.2 Efficacy
9.8.3 Safety
9.8.4 SWOT Analysis
9.8.5 Dosing and Formulation
9.8.6 Potential Clinical and Commercial Positioning
9.8.7 Forecast
9.9 Off Label Drugs in Development
9.10 Other Drugs in Development
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Pfizer
10.3.1 Overview
10.3.2 Portfolio Assessment
10.4 Grunethal
10.4.1 Overview
10.4.2 Portfolio Assessment
10.5 Daiichi-Sankyo
10.5.1 Overview
10.5.2 Portfolio Assessment
10.6 Depomed
10.6.1 Overview
10.6.2 Portfolio Assessment
10.7 ViroMed
10.7.1 Overview
10.7.2 Portfolio Assessment
11 Market Outlook
11.1 Global Markets
11.1.1 Forecast
11.1.2 Drivers and Barriers-Global Issues
11.2 US
11.2.1 Forecast
11.2.2 Key Events
11.2.3 Drivers and Barriers
11.3 5EU
11.3.1 Forecast
11.3.2 Key Events
11.3.3 Drivers and Barriers
11.4 Japan
11.4.1 Forecast
11.4.2 Key Events
11.4.3 Drivers and Barriers
12 Appendix
12.1 Bibliography
12.2 Abbreviations
12.3 Methodology
12.3.1 Forecasting Methodology
12.3.2 Diagnosed Patients
12.3.3 Percent Drug-Treated Patients
12.3.4 Drugs Included in Each Therapeutic Class
12.3.5 Launch and Patent Expiry Dates
12.3.6 General Pricing Assumptions
12.3.7 Individual Drug Assumptions
12.3.8 Generic Erosion
12.3.9 Pricing of Pipeline Agents
12.4 Primary Research-KOLs Interviewed for This Report
12.5 Primary Research-Payers Interviewed for This Report
12.6 Primary Research-Prescriber Survey
12.7 About the Authors
12.7.1 Analyst
12.7.2 Therapy Area Director
12.7.3 Epidemiologist
12.7.4 Managing Epidemiologist
12.7.5 Global Director of Therapy Analysis and Epidemiology
12.7.6 Global Head and EVP of Healthcare Operations and Strategy
12.8 About GlobalData
12.9 Contact Us
12.10 Disclaimer
List of Figure
1.2 List of Figures
Figure 1: Global Sales Forecast by Country for PDN in 2016 and 2026
Figure 2: Analysis of the Company Portfolio Gap in PDN During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents Expected to be Licensed for the Treatment of PDN, 2016-2026
Figure 4: Types of Pain Split by Nociceptive Pain and NP Origins
Figure 5: The Etiology of PDN.
Figure 6: Pain Pathway-Somatosensory System
Figure 7: Case Flow Map
Figure 8: Sources Used and Not Used for Diagnosed Prevalent Cases of T2D Among the General Population
Figure 9: Sources Used for Diagnosed Prevalent Cases of T1D Among the General Population
Figure 10: Sources Used for Total Prevalent Cases of PDN Among the Diagnosed Diabetic Population
Figure 11: Sources Used for Total Prevalent Cases of PDN by Severity of Neuropathy
Figure 12: Sources Used for Total Prevalent Cases of Typical and Atypical PDN
Figure 13: Sources Used for Diagnosed Prevalent Cases of PDN
Figure 14: 7MM, Age-Specific Total Prevalent Cases of PDN, Men and Women, Ages ?18 Years, 2016
Figure 15: 7MM, Sex-Specific Total Prevalent Cases of PDN, Men, Women, Ages ?18 Years, 2016
Figure 16: 7MM, Total Prevalent Cases of PDN by Severity of Neuropathy, Men and Women, Ages ?18 Years, 2016
Figure 17: 7MM, Total Prevalent Cases of Typical and Atypical PDN, Men and Women, Ages ?18 Years, 2016
Figure 18: The Treatment Algorithm for PDN
Figure 19: The Major Unmet Needs in the PDN Market
Figure 20: Overview of the Development Pipeline in PDN
Figure 21: Current PDN Trials, by Location and Phase, 2012-2017
Figure 22: Key Phase II/III Trials for the Promising Pipeline Agents Expected to be Licensed for PDN in the 7MM, 2016-2026
Figure 23: Competitive Assessment of the Late-Stage Pipeline Agents Expected to be Licensed for the Treatment of PDN, 2016-2026
Figure 24: Clinical and Commercial Positioning of Pipeline Drug Mirogabalin Besylate
Figure 25: Clinical and Commercial Positioning of VM202
Figure 26: Clinical and Commercial Positioning of Pipeline Drug Amiket
Figure 27: Clinical and Commercial Positioning of MR309
Figure 28: Clinical and Commercial Positioning of Pipeline Drug Cebranopadol
Figure 29: Global Sales of Branded Products for PDN by Company in 2016 and 2026
Figure 30: Analysis of the Company Portfolio Gap in PDN During the Forecast Period
Figure 31: Global (7MM) Sales Forecast by Country for PDN in 2016 and 2026
Figure 32: Sales Forecast by Class for PDN in the US in 2016 and 2026
Figure 33: Sales Forecast Showing the Breakdown of the 5EU PDN Market by Country During the Forecast Period.
Figure 34: Sales Forecast by Class for PDN in the Japan in 2016 and 2026
List of Table
1.1 List of Tables
Table 1: PDN: Key Metrics in the 7MM
Table 2: Classification of Diabetic Neuropathies
Table 3: PDN Staging System
Table 4: Symptoms of PDN Pain
Table 5: Risk Factors and Comorbidities for PDN
Table 6: Total Prevalent Cases of PDN, Men and Women, Ages ?18 Years, Select Years 2016-2026
Table 7: Diagnosed Prevalent Cases of PDN, Men and Women, Ages ?18 Years, Select Years 2016-2026
Table 8 shows the various types of pain questionnaires that are used in diagnosis and what they cover.
Table 9: Treatment Guidelines for PDN
Table 10: Targets of Management for PDN
Table 11: Most Prescribed Drugs for PDN by Class in the Global Markets, 2017
Table 12: Country Profile-US
Table 13: Country Profile-5EU
Table 14: Country Profile-Japan
Table 15: Product Profile-Nucynta ER
Table 16: Nucynta ER SWOT Analysis, 2017
Table 17: Product Profile-Lyrica
Table 18: Lyrica SWOT Analysis, 2017
Table 19: Product Profile-Cymbalta
Table 20: Cymbalta SWOT Analysis, 2017
Table 21: Product Profile-Qutenza
Table 22: Qutenza SWOT Analysis, 2017
Table 23: TCA SWOT Analysis, 2017
Table 24: SNRI SWOT Analysis, 2017
Table 25: Anticonvulsants SWOT Analysis, 2017
Table 26: Opioid SWOT Analysis, 2017
Table 27: Comparison of Therapeutic Classes in Development for PDN, 2016-2026
Table 28: Product Profile-Mirogabalin Besylate
Table 29: Pipeline Mirogabalin Besylate SWOT Analysis, 2017
Table 30: Product Profile-VM202
Table 31: VM202 SWOT Analysis, 2017
Table 32: Product Profile-AmiKet
Table 33: AmiKet SWOT Analysis, 2017
Table 34: Product Profile-MR309
Table 35: MR309 SWOT Analysis, 2017
Table 36: Product Profile-Cebranopadol
Table 37: Cebranopadol SWOT Analysis, 2017
Table 38: Drugs in Development for Other Pain Indications
Table 39: Drugs in Development for PDN, 2017
Table 40: Key Companies in the PDN Market in the 7MM, 2016
Table 41: Pfizer's Disease Portfolio Assessment, 2016
Table 42: Grünenthal's Disease Portfolio Assessment, 2016
Table 43: Daiichi-Sankyo's Disease Portfolio Assessment, 2016
Table 44: Depomed's Disease Portfolio Assessment, 2016
Table 45: ViroMed's Disease Portfolio Assessment, 2016
Table 46: PDN Market-Global Drivers and Barriers, 2016-2026
Table 47: Key Events Impacting Sales for PDN in the US, 2016-2026
Table 48: PDN Market-Global Drivers and Barriers in the US, 2016-2026
Table 49: Key Events Impacting Sales for PDN in the 5EU, 2016-2026
Table 50: PDN Market-Global Drivers and Barriers in the 5EU, 2016-2026
Table 51: Key Events Impacting Sales for PDN in Japan, 2016-2026
Table 52: PDN Market-Global Drivers and Barriers in Japan, 2016-2026
Table 53: Key Projected Launch Dates for PDN
Table 54: Key Historical and Projected Patent Expiry Dates for PDN
Table 55: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country
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