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

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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 Grnenthal'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.

READ MORE

Table Of Content

Scope

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: Grnenthal'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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Products and Companies


Companies

Pfizer

Grunethal

Daiichi-Sankyo

Depomed

ViroMed

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 Grnenthal'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.

READ MORE

Scope

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: Grnenthal'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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