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

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

• 1.1 Scope of the Analysis
• 1.2 Datamonitor insight into diabetic neuropathic pain
• 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.
• 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.
• 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.
• 1.3 Diabetic Neuropathic Pain Insight: methodology

CHAPTER 2 INTRODUCTION

CHAPTER 3 PATIENT POTENTIAL

• 3.1 Definition and classification of diabetic neuropathy
• 3.2 Epidemiology across the seven major markets
• Prevalence
• Breakdown by severity

CHAPTER 4 ASSESSMENT AND TREATMENT

• 4.1 Referral patterns
• Overview
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• 4.2 Importance of therapeutic endpoints in diabetic neuropathic pain on prescribing decisions
• Overview
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• 4.3 Pharmacotherapy
• Introduction
• Aldose reductase inhibitors
• Antidepressants
• Anticonvulsants
• Opioids
• Other drugs
• 4.4 Treatment of diabetic neuropathic pain in the seven major markets
• Overview of commonly used drugs
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• 4.5 R&D drugs
• Pipeline overview
• Protein Kinase C Inhibitors
• Aldose reductase inhibitors
• Anticonvulsants
• Antidepressants
• NMDA antagonists
• 4.6 Unmet needs

CHAPTER 5 APPENDIX A

• 5.1 Bibliography
• References
• Websites
• 5.2 Contributing experts
• 5.3 Physician research methodology
• Introduction
• Our research partners
• Research objectives
• Questionnaire development
• Research methodology
• Data processing
• Quality control
• 5.4 Neuropathic Pain Insight Questionnaire

CHAPTER 6 APPENDIX B

• 6.1 About Datamonitor
• About Datamonitor Healthcare
• Datamonitor Healthcare's research and analysis methodologies
• 6.2 Datamonitor Healthcare's therapy area capabilities
• About the CNS analysis team
• Datamonitor Healthcare's Consulting expertise
• Key therapy team members
• About the Author
• Disclaimer

List of Tables

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

List of Figures

• Figure 1: Breakdown of DNP patients by pain severity in the US, 2003
• Figure 2: Breakdown of DNP patients by pain severity in Japan, 2003
• Figure 3: Breakdown of DNP patients by pain severity in France, 2003
• Figure 4: Breakdown of DNP patients by pain severity in Germany, 2003
• Figure 6: Breakdown of DNP patients by pain severity in Spain, 2003
• Figure 7: Breakdown of DNP patients by pain severity in the UK, 2003
• Figure 8: Importance of key therapeutic endpoints in DNP, 2003
• Figure 9: Top three first line drug treatments for DNP across the seven major markets, 2003
• Figure 10: Summary of DNP treatment in the US, 2003
• Figure 11: Summary of DNP treatment in Japan, 2003
• Figure 12: Summary of DNP treatment in France, 2003
• Figure 13: Summary of DNP treatment in Germany, 2003
• Figure 14: Summary of DNP treatment in Italy, 2003
• Figure 15: Summary of DNP treatment in Spain, 2003
• Figure 16: Summary of DNP treatment in the UK, 2003
• Figure 17: Primary Research Process
• Figure 18: Datamonitor's Healthcare Consultancy
• Figure 19: Datamonitor Healthcare's Therapeutic Consulting capabilities