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Stakeholder Insight: Neuropathic Pain - Treatment Preferences Across the 7 Major Markets

Introduction
Following the success of Pfizer's blockbuster Neurontin (gabapentin), interest in the neuropathic pain market has grown exponentially. The market will continue to grow unabated over the next ten years primarily due to increased public and physician awareness and new drug launches, including generic gabapentin.

Scope

• Analysis based on Datamonitor's Neuropathic Pain Insight survey of over 594 physicians in the US, Japan, France, Germany, Italy, Spain, and the UK
• Referral patterns by indication by country, and treatment of five neuropathic pain types and fibromyalgia
• Analysis of the attributes of current treatments, with an overview of late stage pipeline products and physician awareness of these future treatments
• Physician perception of strategic issues including clinical trial design, unmet needs, and marketing, and the 'indication versus symptoms' debate

Report Highlights

• The current neuropathic pain market suffers from lack of public awareness, poor physician education (often leading to misdiagnosis), under-utilization of effective drugs, inappropriate use of medications, and regional variations in drug availability.
• Datamonitor believes the 'indication versus symptoms' debate is one of the most important issues in the current market. Datamonitor recommends existing and potential players consider the pros and cons of regulatory agency viewpoint and rulings across the seven major markets.
• Branded products can continue their dominance of the market, supported by aggressive promotional campaigns and astute marketing and product positioning strategies. However, with generic gabapentin entering the market, more than ever companies need to be innovative to effectively define and claim market share.

Reasons to Purchase

• Gain a better understanding of the challenges faced by existing and future players in the neuropathic pain market
• Predict future trends in the treatment of neuropathic pain and how to capitalize on forthcoming changes in treatment practice
• Target lucrative areas of the market as defined by physicians, such as fibromyalgia, and understand why these areas offer commercial opportunity

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY - page 3
  • 1.1 Scope of the Analysis - page 3
  • 1.2 Datamonitor insight into neuropathic pain - page 3
    • The current neuropathic pain market suffers from lack of public awareness, poor physician education (often leading to misdiagnosis), under-utilization of effective drugs, inappropriate use of medications, and regional variations in drug availability. Datamonitor believes these are but some of the challenges facing existing and future players in the market. - page 5
    • Although frequently managed with the same treatments, Datamonitor believes it is important that investors are aware of the opportunities and drawbacks of key subtypes in order to optimize product positioning and marketing strategies. Particularly as this aligns with the FDA licensing strategy. - page 8
    • Datamonitor believes the 'indication versus symptoms' debate is one of the most important issues in the current market. Datamonitor recommends existing and potential players consider the pros and cons of regulatory agency viewpoint and rulings across the seven major markets. - page 13
    • Aggressive promotional campaigns and astute marketing and product positioning strategies will ensure branded products can dominate the market. With generic gabapentin entering the market, more than ever companies need to be innovative to effectively define and 'own' a market. Datamonitor has identified several realistic ways of differentiating a new product from gabapentin. - page 17
    • The neuropathic market will continue to grow unabated over the next ten years primarily due to increased public and physician awareness and new drug launches. Pfizer is expected to continue leading the market in terms of revenues with new entrant pregabalin. However, competition will be strong as several top-tier players aim to enter the market with novel and existing compounds. - page 19
  • 1.3 Neuropathic Pain Insight: methodology - page 20
• TABLE OF CONTENTS - page 22
• CHAPTER 2 INTRODUCTION - page 33
  • 2.1 Overview of the Neuropathic Pain Insight Study - page 33
  • 2.2 Sample - page 34
• CHAPTER 3 PATIENT POTENTIAL - page 35
  • 3.1 Introduction - page 35
  • 3.2 Etiology - page 36
    • Diabetic neuropathic pain - page 36
    • Trigeminal neuralgia - page 37
    • Post-herpetic neuralgia - page 37
    • Neuropathic low-back pain - page 37
    • Fibromyalgia - page 38
    • HIV neuropathic pain - page 40
  • 3.3 Epidemiology of neuropathic pain - page 41
  • 3.4 Diagnosis - page 45
    • Breakdown of diagnosis by physician type - page 45
• CHAPTER 4 NEUROPATHIC PAIN TREATMENT - page 47
  • 4.1 Introduction - page 47
  • 4.2 Referral and assessment - page 48
  • 4.3 Pharmacotherapy - page 52
    • Antidepressants - page 53
    • Anticonvulsants - page 54
    • Local anesthetics - page 55
    • Opioids - page 55
    • Topical agents - page 56
  • 4.4 Importance of therapeutic endpoints on prescribing decisions - page 56
  • 4.5 Summary of neuropathic treatment in the seven major markets - page 57
    • First-line therapy - page 58
    • Second-line therapy - page 59
    • Third-line therapy - page 60
  • 4.6 Summary of treatment-Country comparison - page 61
    • US - page 61
    • Japan - page 63
    • Europe - page 64
  • 4.7 Summary of treatment-Indication comparison - page 66
    • Overview - page 66
    • Diabetic neuropathic pain - page 67
    • Trigeminal neuralgia - page 73
    • Post-herpetic neuralgia - page 74
    • Neuropathic low-back pain - page 77
    • Fibromyalgia - page 80
    • HIV associated neuropathic pain - page 84
  • 4.8 Combination therapy - page 86
    • Introduction - page 87
    • Gabapentin + amitriptyline - page 87
    • Gabapentin + opioid - page 87
    • There is no single popular combination in Japan - page 88
    • Polytherapy will remain key to neuropathic pain treatment - page 88
  • 4.9 The commercial potential of interventional techniques in neuropathic pain - page 89
    • Implantable systems - page 89
    • Medtronic's Synergy neurostimulation system for NLBP - page 89
    • A niche market - page 90
• CHAPTER 5 DRUG ANALYSIS - page 92
  • 5.1 Symptoms of neuropathic pain - page 92
  • 5.2 Non-symptom attributes in neuropathic pain - page 94
  • 5.3 Drug attributes - page 95
  • 5.4 Drug profiles - page 96
    • Methodology - page 96
    • Efficacy - page 97
    • Non-efficacy criteria - page 98
    • Overall score - page 100
  • 5.5 R&D drugs - page 108
    • Physician awareness of pipeline products - page 108
    • Late stage pipeline overview - page 112
    • Trend towards a mechanistic approach - page 115
• CHAPTER 6 STRATEGIC ISSUES IN NEUROPATHIC PAIN - page 120
  • 6.1 Clinical trial design - page 120
    • Clinical endpoints - page 121
  • 6.2 Indications versus symptoms - page 122
    • Most physicians prefer companies to target the symptoms of neuropathic pain - page 122
    • Indication-specific labeling in the US and Japan - page 124
    • Broad neuropathic pain labeling in Europe - page 126
    • The goal is to find a shared mechanism - page 127
  • 6.3 Unmet needs - page 128
    • More effective, better tolerated drug - page 128
    • Low cost drug - page 129
    • Need to define and own a market - page 129
  • 6.4 Marketing neuropathic pain compounds - page 130
• CHAPTER 7 APPENDIX A - page 132
  • 7.1 Bibliography - page 132
    • References - page 132
    • Websites - page 140
  • 7.2 Drug profile tables - page 141
  • 7.3 Contributing experts - page 144
    • Neuropathic pain experts - page 145
    • Diabetic neuropathic pain experts - page 146
    • Post-herpetic neuralgia experts - page 147
    • Neuropathic low-back pain experts - page 147
    • Fibromyalgia experts - page 147
    • HIV neuropathic pain experts - page 148
  • 7.4 Physician research methodology - page 148
    • Introduction - page 148
    • Our research partners - page 150
    • Research objectives - page 150
    • Questionnaire development - page 152
    • Research methodology - page 153
    • Data processing - page 155
    • Quality control - page 156
  • 7.5 Neuropathic Pain Insight Questionnaire - page 156
• CHAPTER 8 APPENDIX B - page 171
  • 8.1 About Datamonitor - page 171
    • About Datamonitor Healthcare - page 171
    • Datamonitor Healthcare's research and analysis methodologies - page 172
  • 8.2 Datamonitor Healthcare's therapy area capabilities - page 172
    • About the CNS analysis team - page 173
    • Datamonitor Healthcare's Consulting expertise - page 174
    • Key therapy team members - page 175
    • About the Author - page 176
    • Disclaimer - page 178


• List of Tables
• Table 1: Sample size of the Neuropathic Pain Insight Study sample, 2003 - page 20
• Table 2: Sample size of the Neuropathic Pain Insight Study, 2003 - page 34
• Table 3: Prevalence (000s) of key neuropathic pain subtypes, 2003 - page 42
• Table 4: The DNP patient population across the seven major markets, 2003 - page 42
• Table 5: The TN patient population across the seven major markets, 2003 - page 43
• Table 6: The PHN patient population across the seven major markets, 2003 - page 43
• Table 7: The NLBP patient population across the seven major markets, 2003 - page 44
• Table 8: The fibromyalgia patient population across the seven major markets, 2003 - page 45
• Table 10: DNP referral patterns across the seven major markets, 2003 - page 49
• Table 11: TN referral patterns across the seven major markets, 2003 - page 50
• Table 12: PHN referral patterns across the seven major markets, 2003 - page 50
• Table 13: NLBP referral patterns across the seven major markets, 2003 - page 51
• Table 14: Fibromyalgia referral patterns across the seven major markets, 2003 - page 52
• Table 16: Influence of symptom-based efficacy attributes on drug choice for neuropathic pain, 2003 - page 92
• Table 17: Influence of non-symptom therapy impacts on drug choice for neuropathic pain, 2003 - page 94
• Table 18: Key facts about Neurontin - page 101
• Table 19: Strengths and weaknesses of gabapentin for neuropathic pain treatment, according to interviewed physicians, 2003 - page 101
• Table 20: Key facts about Lidoderm - page 103
• Table 21: Strengths and weaknesses of lidocaine patch for neuropathic pain treatment, according to interviewed physicians, 2003 - page 104
• Table 22: Strengths and weaknesses of opioids for neuropathic pain treatment, according to interviewed physicians, 2003 - page 105
• Table 23: Strengths and weaknesses of amitriptyline for neuropathic pain treatment, according to interviewed physicians, 2003 - page 108
• Table 24: R&D compounds for neuropathic pain, 2004 - page 110
• Table 25: Drugs in late-stage development for neuropathic pain, 2004 - page 111
• Table 26: Six unmet needs in the treatment of neuropathic pain as identified and ranked by physicians across the seven markets, 2003 - page 128
• Table 27: Top five sources of neuropathic pain information by physician type and country, 2003 - page 131
• Table 28: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in the US, 2003 - page 141
• Table 29: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in Japan, 2003 - page 142
• Table 30: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in France, 2003 - page 142
• Table 31: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in Germany, 2003 - page 143
• Table 32: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in Italy, 2003 - page 143
• Table 33: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in Spain, 2003 - page 144
• Table 34: Physician scoring (10 = good // 1 = poor) of neuropathic pain drugs based on performance in several criteria in the UK, 2003 - page 144
• Table 35: Stakeholder and Multiclient Insight Studies by Therapy Area, 2003 - page 149


• List of Figures
• Figure 1: The fibromyalgia 'tender points' - page 39
• Figure 2: Prevalence of key neuropathic pain subtypes across the seven major markets, 2003 - page 41
• Figure 3: Percentage of diagnosed patients by neuropathic pain subtype across the seven markets, 2003 - page 46
• Figure 4: Algorithm for the treatment of neuropathic pain - page 47
• Figure 5: The importance of therapy endpoints across six neuropathic pain subtypes, 2003 - page 56
• Figure 6: Top three most widely adopted first-line treatments by neuropathic pain type and country, 2003 - page 58
• Figure 7: Top three most widely adopted second-line treatments by neuropathic pain type and country, 2003 - page 59
• Figure 8: Top three most widely adopted third-line treatments by neuropathic pain type and country, 2003 - page 60
• Figure 9: Top five drug combinations for neuropathic pain across the seven markets, 2003 - page 86
• Figure 10: Importance of broader drug attributes on therapy choice for neuropathic pain, 2003 - page 96
• Figure 11: Efficacy comparison of key neuropathic pain drugs, 2003 - page 97
• Figure 12: Non-efficacy drug criteria comparison of key neuropathic pain drugs, 2003 - page 98
• Figure 13: A comparison of key drugs/drug classes against ten criteria as a treatment for neuropathic pain, 2003 - page 99
• Figure 14: Overall performance (10 = good // 1 = poor) of neuropathic pain drugs, 2003 - page 100
• Figure 15: Awareness of neuropathic drugs in development by physician type and country, 2003 - page 109
• Figure 16: Influence of clinical trial design on drug choice, 2003 - page 120
• Figure 17: Specific indications versus specific symptoms of neuropathic pain for drug trials in the seven major markets, 2003 - page 123
• Figure 18: Primary Research Process - page 149
• Figure 19: Datamonitor's Healthcare Consultancy - page 174
• Figure 20: Datamonitor Healthcare's Therapeutic Consulting capabilities - page 175

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