Stakeholder Insight: Diabetic Neuropathic Pain - Market Success is Not Limited to Pregabalin

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Publication Date: 2004-04-28

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With millions of diabetes patients suffering from neuropathic pain worldwide and no treatments yet approved for this indication in the US, the diabetic neuropathic pain (DNP) market is set for some dramatic changes. Key market events in the next few years include the launch of novel disease modifying therapies and the flood of generic gabapentin products.

Scope

Quantitative treatment data from over 364 physicians from the US, Japan, France, Germany, Italy, Spain and the UK

Analysis of epidemiology, assessment and referral patterns, first- to third-line treatments, and unmet market needs

Discussion of the R&D drug pipeline for DNP, including analysis of ruboxistaurin, fidarestat, pregabalin, lamotrigine, and duloxetine

Coverage of the hot topics including the upcoming launch of pregabalin and disease modifying therapies

Report Highlights
DNP patients are often referred to neurologists or pain specialists for treatment, where they are likely given gabapentin and/or amitriptyline. However, as these treatments often only provide marginal relief of DNP symptoms, there remains a need for improved long-term pain management.

With the launch of pregabalin in 2004, Pfizer will effectively retain much of its market share when gabapentin finally loses US patent protection. Approval for DNP in the US will be a major advantage in the increasingly competitive neuropathic pain market as currently there are no drugs licensed for this indication.

Over the coming years competition in the market will be fierce; therefore smaller companies will need to establish clear positioning versus major players, requiring significant investment. Such smaller companies should consider alternative strategies to head-to-head DNP monotherapy competition.

Reasons to Purchase

Forecast product sales by understanding key aspects of DNP epidemiology, diagnosis, and treatment

Gain a better understanding of the challenges faced by future players in the DNP market

Predict trends in the treatment of DNP and how to capitalize on forthcoming changes in treatment practice

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- 1.1 Scope of the Analysis - page 3
- 1.2 Datamonitor insight into diabetic neuropathic pain - page 3
  - DNP is a relatively common affliction occurring in advanced diabetes patients. Patients with DNP are often referred to neurologists or pain specialists for treatment, where they are likely given gabapentin and/or amitriptyline. However, as these treatments often only provide marginal relief of DNP symptoms, there remains a need for improved long-term pain management. - page 4
  - With the launch of pregabalin in 2004, Pfizer will effectively retain much of its market share when gabapentin finally loses US patent protection. Approval for DNP in the US will be a major advantage in the increasingly competitive neuropathic pain market as currently there are no drugs licensed for this indication. The niche market will also be impacted by the off-label use and potential launch of various other products for DNP and diabetic neuropathy. - page 5
  - Over the coming years, top-tier CNS players, such as Pfizer, GSK, and Lilly, will dominate the DNP market. Competition will be fierce; therefore smaller companies will need to establish clear positioning versus these major players, requiring significant investment. Such smaller companies should consider alternative strategies to head-to-head DNP monotherapy competition. - page 7
- 1.3 Diabetic Neuropathic Pain Insight: methodology - page 8
TABLE OF CONTENTS - page 9
CHAPTER 2 INTRODUCTION - page 18
CHAPTER 3 PATIENT POTENTIAL - page 19
- 3.1 Definition and classification of diabetic neuropathy - page 19
- 3.2 Epidemiology across the seven major markets - page 21
  - Prevalence - page 22
  - Breakdown by severity - page 24
CHAPTER 4 ASSESSMENT AND TREATMENT - page 29
- 4.1 Referral patterns - page 29
  - Overview - page 29
  - US - page 29
  - Japan - page 30
  - France - page 31
  - Germany - page 32
  - Italy - page 33
  - Spain - page 34
  - UK - page 35
- 4.2 Importance of therapeutic endpoints in diabetic neuropathic pain on prescribing decisions - page 36
  - Overview - page 36
  - US - page 37
  - Japan - page 38
  - France - page 39
  - Germany - page 39
  - Italy - page 40
  - Spain - page 41
  - UK - page 42
- 4.3 Pharmacotherapy - page 43
  - Introduction - page 43
  - Aldose reductase inhibitors - page 44
  - Antidepressants - page 45
  - Anticonvulsants - page 47
  - Opioids - page 48
  - Other drugs - page 48
- 4.4 Treatment of diabetic neuropathic pain in the seven major markets - page 50
  - Overview of commonly used drugs - page 50
  - US - page 57
  - Japan - page 63
  - France - page 67
  - Germany - page 72
  - Italy - page 75
  - Spain - page 79
  - UK - page 84
- 4.5 R&D drugs - page 88
  - Pipeline overview - page 88
  - Protein Kinase C Inhibitors - page 89
  - Aldose reductase inhibitors - page 90
  - Anticonvulsants - page 90
  - Antidepressants - page 95
  - NMDA antagonists - page 96
- 4.6 Unmet needs - page 98
CHAPTER 5 APPENDIX A - page 101
- 5.1 Bibliography - page 101
  - References - page 101
  - Websites - page 108
- 5.2 Contributing experts - page 108
- 5.3 Physician research methodology - page 111
  - Introduction - page 111
  - Our research partners - page 113
  - Research objectives - page 114
  - Questionnaire development - page 116
  - Research methodology - page 117
  - Data processing - page 119
  - Quality control - page 119
- 5.4 Neuropathic Pain Insight Questionnaire - page 119
CHAPTER 6 APPENDIX B - page 126
- 6.1 About Datamonitor - page 126
  - About Datamonitor Healthcare - page 126
  - Datamonitor Healthcare's research and analysis methodologies - page 127
- 6.2 Datamonitor Healthcare's therapy area capabilities - page 127
  - About the CNS analysis team - page 128
  - Datamonitor Healthcare's Consulting expertise - page 129
  - Key therapy team members - page 130
  - About the Author - page 131
  - Disclaimer - page 133

List of Tables
Table 1: Sample size of the Diabetic Neuropathic Pain Insight study - page 8
Table 2: The diabetic neuropathy patient population across the seven major markets, 2003 - page 24
Table 3: DNP referral patterns across the seven major markets, 2003 - page 29
Table 4: Referral patterns of DNP patients in the US, 2003 - page 30
Table 5: Referral patterns of DNP patients in Japan, 2003 - page 31
Table 6: Referral patterns of DNP patients in France, 2003 - page 32
Table 7: Referral patterns of DNP patients in Germany, 2003 - page 32
Table 8: Referral patterns of DNP patients in Italy, 2003 - page 33
Table 9: Referral patterns of DNP patients in Spain, 2003 - page 34
Table 10: Referral patterns of DNP patients in the UK, 2003 - page 35
Table 11: Importance of key therapeutic endpoints in DNP according to US physicians, 2003 - page 37
Table 12: Importance of key therapeutic endpoints in DNP according to physicians in Japan, 2003 - page 38
Table 13: Importance of key therapeutic endpoints in DNP in France, 2003 - page 39
Table 14: Importance of key therapeutic endpoints in DNP according to physicians in Germany, 2003 - page 40
Table 15: Importance of key therapeutic endpoints in DNP according to physicians in Italy, 2003 - page 41
Table 16: Importance of key therapeutic endpoints in DNP according to physicians in Spain, 2003 - page 41
Table 17: Importance of key therapeutic endpoints in DNP according to physicians in the UK, 2003 - page 43
Table 18: Top ten most widely adopted first-line treatments of DNP in the US, 2003 - page 58
Table 19: Progression of DNP patients to second-line therapy in the US, 2003 - page 60
Table 20: Top ten most widely adopted second-line treatments of DNP in the US, 2003 - page 61
Table 21: Progression of DNP patients to third-line therapy in the US, 2003 - page 62
Table 22: Top ten most widely adopted third-line treatments of DNP in the US, 2003 - page 62
Table 23: Top ten most widely adopted first-line treatments of DNP in Japan, 2003 - page 64
Table 24: Progression of DNP patients to second-line therapy in Japan, 2003 - page 65
Table 25: Top ten most widely adopted second-line treatments of DNP in Japan, 2003 - page 66
Table 26: Progression of DNP patients to third-line therapy in Japan, 2003 - page 66
Table 27: Top ten most widely adopted third-line treatments of DNP in Japan, 2003 - page 67
Table 28: Top most widely adopted first-line treatments of DNP in France, 2003 - page 68
Table 29: Progression of DNP patients to second-line therapy in France, 2003 - page 70
Table 30: Top ten most widely adopted second-line treatments of DNP in France, 2003 - page 70
Table 31: Progression of DNP patients to third-line therapy in France, 2003 - page 71
Table 32: Top ten most widely adopted third-line treatments of DNP in France, 2003 - page 71
Table 33: Top ten most widely adopted first-line treatments of DNP in Germany, 2003 - page 73
Table 34: Progression of DNP patients to second-line therapy in Germany, 2003 - page 74
Table 35: Top ten most widely adopted second-line treatments of DNP in Germany, 2003 - page 74
Table 36: Progression of DNP patients to third-line therapy in Germany, 2003 - page 75
Table 37: Top ten most widely adopted third-line treatments of DNP in Germany, 2003 - page 75
Table 38: Top ten most widely adopted first-line treatments of DNP in Italy, 2003 - page 77
Table 39: Progression of DNP patients to second-line therapy in Italy, 2003 - page 78
Table 40: Top ten most widely adopted second-line treatments of DNP in Italy, 2003 - page 78
Table 41: Progression of DNP patients to third-line therapy in Italy, 2003 - page 79
Table 42: Top ten most widely adopted third-line treatments of DNP in Italy, 2003 - page 79
Table 43: Top ten most widely adopted first-line treatments of DNP in Spain, 2003 - page 81
Table 44: Progression of DNP patients to second-line therapy in Spain, 2003 - page 81
Table 45: Top ten most widely adopted second-line treatments of DNP in Spain, 2003 - page 82
Table 46: Progression of DNP patients to third-line therapy in Spain, 2003 - page 83
Table 47: Top ten most widely adopted third-line treatments of DNP in Spain, 2003 - page 83
Table 48: Top most widely adopted first-line treatments of DNP in the UK, 2003 - page 85
Table 49: Progression of DNP patients to second-line therapy in the UK, 2003 - page 85
Table 50: Top ten most widely adopted second-line treatments of DNP in the UK, 2003 - page 86
Table 51: Progression of DNP patients to third-line therapy in the UK, 2003 - page 86
Table 52: Top ten most widely adopted third-line treatments of DNP in the UK, 2003 - page 87
Table 53: R&D compounds for diabetic neuropathy, 2004 - page 88
Table 54: Stakeholder and Multiclient Insight Studies by Therapy Area, 2003 - page 112

List of Figures
Figure 1: Breakdown of DNP patients by pain severity in the US, 2003 - page 25
Figure 2: Breakdown of DNP patients by pain severity in Japan, 2003 - page 25
Figure 3: Breakdown of DNP patients by pain severity in France, 2003 - page 26
Figure 4: Breakdown of DNP patients by pain severity in Germany, 2003 - page 27
Figure 6: Breakdown of DNP patients by pain severity in Spain, 2003 - page 27
Figure 7: Breakdown of DNP patients by pain severity in the UK, 2003 - page 28
Figure 8: Importance of key therapeutic endpoints in DNP, 2003 - page 36
Figure 9: Top three first line drug treatments for DNP across the seven major markets, 2003 - page 51
Figure 10: Summary of DNP treatment in the US, 2003 - page 57
Figure 11: Summary of DNP treatment in Japan, 2003 - page 63
Figure 12: Summary of DNP treatment in France, 2003 - page 68
Figure 13: Summary of DNP treatment in Germany, 2003 - page 72
Figure 14: Summary of DNP treatment in Italy, 2003 - page 76
Figure 15: Summary of DNP treatment in Spain, 2003 - page 80
Figure 16: Summary of DNP treatment in the UK, 2003 - page 84
Figure 17: Primary Research Process - page 113
Figure 18: Datamonitor's Healthcare Consultancy - page 129
Figure 19: Datamonitor Healthcare's Therapeutic Consulting capabilities - page 130

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Stakeholder Insight: Diabetic Neuropathic Pain - Market Success is Not Limited to Pregabalin

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