PharmaPoint: Neuropathic Pain - Japan Drug Forecast and Market Analysis to 2022

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Jul 16, 2014, 06:44 ET

NEW YORK, July 16, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

PharmaPoint: Neuropathic Pain - Japan Drug Forecast and Market Analysis to 2022

http://www.reportlinker.com/p02114392/PharmaPoint-Neuropathic-Pain---Japan-Drug-Forecast-and-Market-Analysis-to-2022.html

Summary

Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability.

Similar to the rest of the global markets, this will be fueled predominantly by the growing incidence of NP as a result of the increasing elderly population, which is even more pronounced in Japan. However, unlike the other countries in the 7MM, most of the growth in the NP market in Japan will not be due to the entry of numerous pipeline drugs, but rather will be the result of the delayed launch and continued growth of both Lyrica and Cymbalta. Both these drugs launched in Japan approximately five years after their launch in the US and EU. Furthermore, both drugs are subject to extended exclusivity in Japan, with the patent for Lyrica not set to expire in Japan until 2022, and the post-marketing exclusivity for Cymbalta estimated to extend to 2017.

Scope

- Overview of Neuropathic Pain including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan Neuropathic Pain market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Neuropathic Pain.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2012-2022 in Japan.
1 Table of Contents
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 12
3 Disease Overview 14
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 16
3.1.1 Painful Diabetic Neuropathy 18
3.1.2 Postherpetic Neuralgia 19
3.1.3 Trigeminal Neuralgia 19
3.2 Etiology and Pathophysiology 20
3.2.1 Etiology 21
3.2.2 Pathophysiology 22
4 Disease Management 30
4.1 Diagnosis and Treatment Overview 30
4.1.1 Diagnosis 30
4.1.2 Treatment Overview and Guidelines 37
4.2 Japan 47
4.2.1 Diagnosis and Referral 47
4.2.2 Drug Treatment 48
5 Competitive Assessment 50
5.1 Overview 50
5.2 Tricyclic Antidepressants 55
5.2.1 Overview 55
5.2.2 Efficacy 56
5.2.3 Safety 57
5.3 Calcium Channel Alpha-2-Delta Ligands (Anticonvulsants) 58
5.3.1 Overview 58
5.3.2 Efficacy 59
5.3.3 Safety 60
5.3.4 Lyrica 61
5.4 Sodium Channel-Blocking Anticonvulsants (TN) 65
5.4.1 Overview 65
5.4.2 Efficacy 66
5.4.3 Safety 66
5.5 Serotonin-Norepinephrine Reuptake Inhibitors (Antidepressants) 67
5.5.1 Overview 67
5.5.2 Efficacy 68
5.5.3 Safety 68
5.5.4 Cymbalta 68
5.6 Opioids 71
5.6.1 Overview 71
5.6.2 Efficacy 72
5.6.3 Safety 73
5.7 Topical Therapies 73
5.7.1 Overview 73
5.7.2 Efficacy 75
5.7.3 Safety 75
6 Unmet Need and Opportunity 76
6.1 Overview 76
6.2 Physician Knowledge or Awareness 77
6.2.1 Unmet Need 77
6.2.2 Gap Analysis 78
6.2.3 Opportunity 79
6.3 Diagnostic Challenges 79
6.3.1 Unmet Need 79
6.3.2 Gap Analysis 80
6.3.3 Opportunity 80
6.4 Low Treatment Rate and Underdosing of Medications 80
6.4.1 Unmet Need 80
6.4.2 Gap Analysis 82
6.4.3 Opportunity 82
6.5 Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments 83
6.5.1 Unmet Need 83
6.5.2 Gap Analysis 83
6.5.3 Opportunity 84
6.6 Elderly Patient Population - Drug Tolerability 85
6.6.1 Unmet Need 85
6.6.2 Gap Analysis 85
6.6.3 Opportunity 86
6.7 Rational or Personalized Therapies 86
6.7.1 Unmet Need 86
6.7.2 Gap Analysis 87
6.7.3 Opportunity 87
7 Pipeline Assessment 89
7.1 Overview 89
7.2 Promising Drugs in Clinical Development 90
7.2.1 DS-5565 92
8 Market Outlook 96
8.1 Drivers and Barriers - Global Issues 96
8.1.1 Driver: Aging Population in the 7MM 96
8.1.2 Driver: Increase in Prevalence and Diagnosis of Type 2 Diabetes Will Grow the PDN Market 96
8.1.3 Driver: Approval of New NP Drugs 97
8.1.4 Barrier: NP Market Dominated by Generics 97
8.1.5 Barrier: Challenges Selecting the Most Relevant Pathophysiological Targets for Drug Development 97
8.1.6 Barrier: Underserved Trigeminal Neuralgia Indication 98
8.1.7 Barrier: Competition from Interventional Therapies 98
8.2 Japan 99
8.2.1 Forecast 99
8.2.2 Key Events 109
8.2.3 Drivers and Barriers 109
9 Appendix 112
9.1 Bibliography 112
9.2 Abbreviations 122
9.3 Methodology 127
9.4 Forecasting Methodology 127
9.4.1 Diagnosed PDN, PHN, and TN Patients 127
9.4.2 Percent Drug-Treated Patients 128
9.4.3 Drugs Included In Each Therapeutic Class 128
9.4.4 Launch and Patent Expiry Dates 128
9.4.5 General Pricing Assumptions 129
9.4.6 Individual Drug Assumptions 129
9.4.7 Generic Erosion 132
9.4.8 Pricing of Pipeline Agents 132
9.5 Physicians and Specialists Included in This Study 133
9.6 About the Authors 135
9.6.1 Author 135
9.6.2 Global Head of Healthcare 136
9.7 About GlobalData 137
9.8 Disclaimer 137

1.1 List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage 16
Table 2: Signs and Symptoms of NP 17
Table 3: Screening Tools for NP 31
Table 4: NP-Related Signs and Symptoms 33
Table 5: Treatment Guidelines for NP 38
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 44
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 46
Table 8: Japan - NP Diagnosis and Referral Metrics 48
Table 9: Japan - NP Treatment Metrics 49
Table 10: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 52
Table 11: Select Products Used for NP Treatment, 2013 54
Table 12: Product Profile - Lyrica 62
Table 13: Lyrica SWOT Analysis, 2013 64
Table 14: Product Profile - Cymbalta 69
Table 15: Cymbalta SWOT Analysis, 2013 71
Table 16: Unmet Need and Opportunity in NP 77
Table 17: NP - Promising Drugs in Clinical Development 91
Table 18: Comparison of Drugs in Development for NP, 2014 91
Table 19: Product Profile - DS-5565 93
Table 20: DS-5565 SWOT Analysis, 2013 95
Table 21: NP Market - Drivers and Barriers, 2012-2022 96
Table 22: Sales Forecasts ($) for NP in Japan, 2012-2022 101
Table 23: Sales Forecasts ($) for PDN in Japan, 2012-2022 103
Table 24: Sales Forecasts ($) for PHN in Japan, 2012-2022 105
Table 25: Sales Forecasts ($) for TN in Japan, 2012-2022 107
Table 26: Key Events Impacting Sales for NP in Japan, 2012-2022 109
Table 27: NP Market - Drivers and Barriers in Japan, 2012-2022 109
Table 28: Key Launch Dates 128
Table 29: Key Patent/Exclusivity Expiries 129

1.2 List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 15
Figure 2: Etiology and Pathophysiology of NP 20
Figure 3: Pain Pathway - Somatosensory System 23
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 27
Figure 5: Pathophysiological Targets of NP Drugs 28
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 34
Figure 7: General Treatment Algorithm for NP 43
Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022 92
Figure 9: Sales for NP in Japan by Drug Class, 2012-2022 102
Figure 10: Sales for PDN in Japan by Drug Class, 2012-2022 104
Figure 11: Sales for PHN in Japan by Drug Class, 2012-2022 106
Figure 12: Sales for TN in Japan by Drug Class, 2012-2022 108