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

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.

The obesity epidemic in the US, which will lead to an increased prevalence of PDN, and the launch and uptake of seven pipeline drugs, will also be key growth drivers. Among these pipeline drugs, DS-5565, which is in development for PDN, is anticipated to offer an improvement upon Lyrica’s efficacy and safety, and as such, it is expected to be the market-leading brand-name drug at the end of the forecast period, with sales of $389m in 2022.

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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 the US.

Table Of Contents

PharmaPoint: Neuropathic Pain - US Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 13
3 Disease Overview 15
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 17
3.1.1 Painful Diabetic Neuropathy 19
3.1.2 Postherpetic Neuralgia 20
3.1.3 Trigeminal Neuralgia 20
3.2 Etiology and Pathophysiology 21
3.2.1 Etiology 22
3.2.2 Pathophysiology 23
4 Disease Management 31
4.1 Diagnosis and Treatment Overview 31
4.1.1 Diagnosis 31
4.1.2 Treatment Overview and Guidelines 38
4.2 US 47
4.2.1 Diagnosis and Referral 47
4.2.2 Drug Treatment 49
5 Competitive Assessment 53
5.1 Overview 53
5.2 Tricyclic Antidepressants 57
5.2.1 Overview 57
5.2.2 Efficacy 58
5.2.3 Safety 59
5.3 Calcium Channel Alpha-2-Delta Ligands (Anticonvulsants) 60
5.3.1 Overview 60
5.3.2 Efficacy 61
5.3.3 Safety 63
5.3.4 Lyrica 63
5.4 Sodium Channel-Blocking Anticonvulsants (TN) 67
5.4.1 Overview 67
5.4.2 Efficacy 68
5.4.3 Safety 68
5.5 Serotonin-Norepinephrine Reuptake Inhibitors (Antidepressants) 69
5.5.1 Overview 69
5.5.2 Efficacy 70
5.5.3 Safety 70
5.5.4 Cymbalta 70
5.6 Opioids 73
5.6.1 Overview 73
5.6.2 Efficacy 74
5.6.3 Safety 75
5.6.4 Nucynta ER/Palexia SR 75
5.7 Topical Therapies 78
5.7.1 Overview 78
5.7.2 Efficacy 79
5.7.3 Safety 79
5.7.4 Lidoderm/Versatis 80
5.7.5 Qutenza 82
6 Unmet Need and Opportunity 86
6.1 Overview 86
6.2 Physician Knowledge or Awareness 87
6.2.1 Unmet Need 87
6.2.2 Gap Analysis 88
6.2.3 Opportunity 89
6.3 Diagnostic Challenges 89
6.3.1 Unmet Need 89
6.3.2 Gap Analysis 90
6.3.3 Opportunity 90
6.4 Low Treatment Rate and Underdosing of Medications 90
6.4.1 Unmet Need 90
6.4.2 Gap Analysis 92
6.4.3 Opportunity 92
6.5 Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments 93
6.5.1 Unmet Need 93
6.5.2 Gap Analysis 93
6.5.3 Opportunity 94
6.6 Elderly Patient Population - Drug Tolerability 95
6.6.1 Unmet Need 95
6.6.2 Gap Analysis 95
6.6.3 Opportunity 96
6.7 Rational or Personalized Therapies 96
6.7.1 Unmet Need 96
6.7.2 Gap Analysis 97
6.7.3 Opportunity 97
7 Pipeline Assessment 99
7.1 Overview 99
7.2 Promising Drugs in Clinical Development 100
7.2.1 Eslicarbazepine Acetate 102
7.2.2 Topical Clonidine Gel 106
7.2.3 Cebranopadol 109
7.2.4 DS-5565 112
7.2.5 CNV-2197944 116
7.2.6 CNV-1014802 119
7.2.7 Eladur (bupivacaine patch) 122
8 Market Outlook 126
8.1 Drivers and Barriers - Global Issues 126
8.1.1 Driver: Aging Population in the 7MM 126
8.1.2 Driver: Increase in Prevalence and Diagnosis of Type 2 Diabetes Will Grow the PDN Market 126
8.1.3 Driver: Approval of New NP Drugs 127
8.1.4 Barrier: NP Market Dominated by Generics 127
8.1.5 Barrier: Challenges Selecting the Most Relevant Pathophysiological Targets for Drug Development 127
8.1.6 Barrier: Underserved Trigeminal Neuralgia Indication 128
8.1.7 Barrier: Competition from Interventional Therapies 128
8.2 United States 128
8.2.1 Forecast 128
8.2.2 Key Events 139
8.2.3 Drivers and Barriers 139
9 Appendix 142
9.1 Bibliography 142
9.2 Abbreviations 152
9.3 Methodology 157
9.4 Forecasting Methodology 157
9.4.1 Diagnosed PDN, PHN, and TN Patients 157
9.4.2 Percent Drug-Treated Patients 158
9.4.3 Drugs Included In Each Therapeutic Class 158
9.4.4 Launch and Patent Expiry Dates 158
9.4.5 General Pricing Assumptions 159
9.4.6 Individual Drug Assumptions 159
9.4.7 Generic Erosion 163
9.4.8 Pricing of Pipeline Agents 163
9.5 Physicians and Specialists Included in This Study 164
9.6 About the Authors 166
9.6.1 Author 166
9.6.2 Global Head of Healthcare 167
9.7 About GlobalData 168
9.8 Disclaimer 168

1.1 List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage 17
Table 2: Signs and Symptoms of NP 18
Table 3: Screening Tools for NP 32
Table 4: NP-Related Signs and Symptoms 34
Table 5: Treatment Guidelines for NP 39
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 45
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 47
Table 8: US - NP Diagnosis and Referral Metrics 49
Table 9: US - NP Treatment Metrics 52
Table 10: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 55
Table 11: Select Products Used for NP Treatment, 2013 57
Table 12: Product Profile - Lyrica 64
Table 13: Lyrica SWOT Analysis, 2013 66
Table 14: Product Profile - Cymbalta 71
Table 15: Cymbalta SWOT Analysis, 2013 73
Table 16: Product Profile - Nucynta ER/Palexia SR 76
Table 17: Nucynta ER/Palexia SR SWOT Analysis, 2013 77
Table 18: Product Profile - Lidoderm/Versatis 81
Table 19: Lidoderm/Versatis SWOT Analysis, 2013 82
Table 20: Product Profile - Qutenza 83
Table 21: Qutenza SWOT Analysis, 2013 85
Table 22: Unmet Need and Opportunity in NP 87
Table 23: NP - Promising Drugs in Clinical Development 101
Table 24: Comparison of Drugs in Development for NP, 2014 101
Table 25: Product Profile - Eslicarbazepine Acetate 103
Table 26: Phase II: Efficacy of Eslicarbazepine Acetate in PHN 104
Table 27: Phase II: Efficacy of Eslicarbazepine Acetate in PDN 104
Table 28: Eslicarbazepine Acetate SWOT Analysis, 2013 106
Table 29: Product Profile - Topical Clonidine Gel 107
Table 30: Topical Clonidine Gel SWOT Analysis, 2013 109
Table 31: Product Profile - Cebranopadol 110
Table 32: Cebranopadol SWOT Analysis, 2013 112
Table 33: Product Profile - DS-5565 114
Table 34: DS-5565 SWOT Analysis, 2013 116
Table 35: Product Profile - CNV-2197944 117
Table 36: CNV-2197944 SWOT Analysis, 2013 119
Table 37: Product Profile - CNV1014802 120
Table 38: CNV-1014802 SWOT Analysis, 2013 122
Table 39: Product Profile - Eladur 123
Table 40: Eladur SWOT Analysis, 2013 125
Table 41: NP Market - Drivers and Barriers, 2012-2022 126
Table 42: Sales Forecasts ($) for NP in the United States, 2012-2022 131
Table 43: Sales Forecasts ($) for PDN in the United States, 2012-2022 133
Table 44: Sales Forecasts ($) for PHN in the United States, 2012-2022 135
Table 45: Sales Forecasts ($) for TN in the United States, 2012-2022 137
Table 46: Key Events Impacting Sales for NP in the United States, 2012-2022 139
Table 47: NP Market - Drivers and Barriers in the United States, 2012-2022 139
Table 48: Key Launch Dates 158
Table 49: Key Patent/Exclusivity Expiries 159

1.2 List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 16
Figure 2: Etiology and Pathophysiology of NP 21
Figure 3: Pain Pathway - Somatosensory System 24
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 28
Figure 5: Pathophysiological Targets of NP Drugs 29
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 35
Figure 7: General Treatment Algorithm for NP 44
Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022 102
Figure 9: Sales for NP in the United States by Drug Class, 2012-2022 132
Figure 10: Sales for PDN in the United States by Drug Class, 2012-2022 134
Figure 11: Sales for PHN in the United States by Drug Class, 2012-2022 136
Figure 12: Sales for TN in the United States by Drug Class, 2012-2022 138

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