Stakeholder Insight: Fibromyalgia - Substantial Growth Opportunity for SNRI Antidepressants

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Publication Date: 2004-03-19

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Fibromyalgia is a relatively common chronic pain syndrome, affecting around 2% of the population. This little understood market suffers from high unmet need both at the level of drug research and current clinical practice. Several leading industry players, including Pfizer, Eli Lilly, and Wyeth, have expressed an interest in this niche thus highlighting the commercial opportunity it offers.

Scope

Quantitative treatment data from over 260 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 fibromyalgia, including analysis of duloxetine, pregabalin, and milnacipran
Coverage of the hot topics including the potential of SNRI antidepressants and the need to push regulatory agencies to recognize fibromyalgia

Report Highlights
Fibromyalgia is a common syndrome that is substantially under served by the medical profession and the pharmaceutical industry. The challenge facing investors is to provide improved understanding of the biologic and physiologic processes responsible for the symptoms, in order to develop better pain medications that can improve quality of life.

The biggest commercial opportunity is for manufacturers of serotonin and noradrenaline reuptake inhibitors (SNRIs). Forest�s SNRI milnacipran is the closest to entering the market, although competition from Eli Lilly and Wyeth can be expected in the near future.

Companies aiming to enter the fibromyalgia market need to push regulatory agencies to recognize the condition as a single clinical entity. Until this is achieved, companies will be unable to gain labeling for fibromyalgia.

Reasons to Purchase

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

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

Predict trends in the treatment of fibromyalgia 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 fibromyalgia - page 3
  - Fibromyalgia is a common syndrome that is substantially underserved by the medical profession and the pharmaceutical industry. The challenge facing investors is to provide improved understanding of the biological and physiological processes responsible for the symptoms, in order to develop better pain medications that can improve quality of life. - page 4
  - The popularity of amitriptyline among physicians for treating fibromyalgia has paved the way for the uptake of newer antidepressants. The biggest commercial opportunity is for manufacturers of serotonin and noradrenaline reuptake inhibitors (SNRIs). Forest's SNRI milnacipran is the closest to entering the market, although competition from Eli Lilly and Wyeth can be expected in the near future. - page 5
  - Datamonitor recommends companies aiming to enter the fibromyalgia market push regulatory agencies to recognize the condition as a single clinical entity. Until this is achieved companies will be unable to gain a labeling for fibromyalgia. - page 6
- 1.3 Fibromyalgia Insight: methodology - page 7
TABLE OF CONTENTS - page 9
CHAPTER 2 INTRODUCTION - page 16
CHAPTER 3 PATIENT POTENTIAL - page 17
- 3.1 Definition of fibromyalgia - page 17
- 3.2 Epidemiology across the seven major markets - page 18
  - Prevalence - page 18
  - Breakdown by severity - page 19
CHAPTER 4 ASSESSMENT AND TREATMENT - page 24
- 4.1 Diagnosis - page 24
- 4.2 Referral patterns - page 26
  - Overview - page 26
  - US - page 26
  - Japan - page 27
  - France - page 28
  - Germany - page 29
  - Italy - page 30
  - Spain - page 31
  - UK - page 32
- 4.3 Importance of therapeutic endpoints in fibromyalgia on prescribing decisions - page 33
  - Overview - page 33
  - US - page 34
  - Japan - page 35
  - France - page 36
  - Germany - page 36
  - Italy - page 38
  - Spain - page 38
  - UK - page 39
- 4.4 Pharmacotherapy - page 40
  - Introduction - page 40
- 4.5 Treatment of fibromyalgia in the seven major markets - page 41
  - Overview - page 41
  - US - page 45
  - Japan - page 49
  - France - page 53
  - Germany - page 58
  - Italy - page 62
  - Spain - page 67
  - UK - page 71
- 4.6 R&D drugs - page 75
  - Pipeline overview - page 75
  - Milnacipran - page 76
  - Duloxetine - page 76
  - Venlafaxine - page 77
  - Pregabalin - page 78
- 4.7 Unmet needs - page 79
CHAPTER 5 APPENDIX A - page 81
- 5.1 Bibliography - page 81
  - References - page 81
  - Websites - page 85
- 5.2 Contributing experts - page 86
- 5.3 Physician research methodology - page 89
  - Introduction - page 89
  - Our research partners - page 91
  - Research objectives - page 92
  - Questionnaire development - page 94
  - Research methodology - page 94
  - Data processing - page 97
  - Quality control - page 97
- 5.4 Neuropathic Pain Insight Questionnaire - page 97
CHAPTER 6 APPENDIX B - page 104
- 6.1 About Datamonitor - page 104
  - About Datamonitor Healthcare - page 104
  - Datamonitor Healthcare's research and analysis methodologies - page 105
- 6.2 Datamonitor Healthcare's therapy area capabilities - page 105
  - About the CNS analysis team - page 106
  - Datamonitor Healthcare's Consulting expertise - page 107
  - Key therapy team members - page 108
  - About the Author - page 109
  - Disclaimer - page 111

List of Tables
Table 1: Sample size of the Fibromyalgia Insight study, 2003 - page 7
Table 2: The fibromyalgia patient population across the seven major markets, 2003 - page 19
Table 3: Fibromyalgia referral patterns across the seven major markets, 2003 - page 26
Table 4: Referral patterns of fibromyalgia patients in the US, 2003 - page 27
Table 5: Referral patterns of fibromyalgia patients in Japan, 2003 - page 28
Table 6: Referral patterns of fibromyalgia patients in France, 2003 - page 28
Table 7: Referral patterns of fibromyalgia patients in Germany, 2003 - page 29
Table 8: Referral patterns of fibromyalgia patients in Italy, 2003 - page 30
Table 9: Referral patterns of fibromyalgia patients in Spain, 2003 - page 31
Table 10: Referral patterns of fibromyalgia patients in the UK, 2003 - page 32
Table 11: Importance of key therapeutic endpoints in fibromyalgia according to US physicians, 2003 - page 34
Table 12: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Japan, 2003 - page 35
Table 13: Importance of key therapeutic endpoints in fibromyalgia according to physicians in France, 2003 - page 36
Table 14: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Germany, 2003 - page 37
Table 15: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Italy, 2003 - page 38
Table 16: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Spain, 2003 - page 39
Table 17: Importance of key therapeutic endpoints in fibromyalgia according to physicians in the UK, 2003 - page 40
Table 18: Top ten most widely adopted first-line treatments of fibromyalgia in the US, 2003 - page 47
Table 19: Progression of fibromyalgia patients to second-line therapy in the US, 2003 - page 47
Table 20: Top ten most widely adopted second-line treatments of fibromyalgia in the US, 2003 - page 48
Table 21: Progression of fibromyalgia patients to third-line therapy in the US, 2003 - page 48
Table 22: Top ten most widely adopted third-line treatments of fibromyalgia in the US, 2003 - page 49
Table 23: Top ten first-line treatments of fibromyalgia in Japan, 2003 - page 50
Table 24: Progression of fibromyalgia patients to second-line therapy in Japan, 2003 - page 51
Table 25: Top ten most widely adopted second-line treatments of fibromyalgia in Japan, 2003 - page 51
Table 26: Progression of fibromyalgia patients to third-line therapy in Japan, 2003 - page 52
Table 27: Top ten most widely adopted third-line treatments of fibromyalgia in Japan, 2003 - page 52
Table 28: Top ten first-line treatments of fibromyalgia in France, 2003 - page 55
Table 29: Progression of fibromyalgia patients to second-line therapy in France, 2003 - page 56
Table 30: Top ten most widely adopted second-line treatments of fibromyalgia in France, 2003 - page 56
Table 31: Progression of fibromyalgia patients to third-line therapy in France, 2003 - page 57
Table 32: Top ten most widely adopted third-line treatments of fibromyalgia in France, 2003 - page 57
Table 33: Top first-line treatments of fibromyalgia in Germany, 2003 - page 59
Table 34: Progression of fibromyalgia patients to second-line therapy in Germany, 2003 - page 60
Table 35: Top ten most widely adopted second-line treatments of fibromyalgia in Germany, 2003 - page 60
Table 36: Progression of fibromyalgia patients to third-line therapy in Germany, 2003 - page 61
Table 37: Top ten most widely adopted third-line treatments of fibromyalgia in Germany, 2003 - page 61
Table 38: Top ten first-line treatments of fibromyalgia in Italy, 2003 - page 64
Table 39: Progression of fibromyalgia patients to second-line therapy in Italy, 2003 - page 64
Table 40: Top ten most widely adopted second-line treatments of fibromyalgia in Italy, 2003 - page 65
Table 41: Progression of fibromyalgia patients to third-line therapy in Italy, 2003 - page 66
Table 42: Top ten most widely adopted third-line treatments of fibromyalgia in Italy, 2003 - page 66
Table 43: Top ten first-line treatments of fibromyalgia in Spain, 2003 - page 68
Table 44: Progression of fibromyalgia patients to second-line therapy in Spain, 2003 - page 69
Table 45: Top ten most widely adopted second-line treatments of fibromyalgia in Spain, 2003 - page 69
Table 46: Progression of fibromyalgia patients to third-line therapy in Spain, 2003 - page 70
Table 47: Top ten most widely adopted third-line treatments of fibromyalgia in Spain, 2003 - page 70
Table 48: Top ten first-line treatments of fibromyalgia in the UK, 2003 - page 72
Table 49: Progression of fibromyalgia patients to second-line therapy in the UK, 2003 - page 73
Table 50: Top ten most widely adopted second-line treatments of fibromyalgia in the UK, 2003 - page 73
Table 51: Progression of fibromyalgia patients to third-line therapy in the UK, 2003 - page 74
Table 52: Top ten most widely adopted third-line treatments of fibromyalgia in the UK, 2003 - page 74
Table 53: R&D compounds for fibromyalgia, 2004 - page 75
Table 54: Stakeholder and Multiclient Insight Studies by Therapy Area, 2003 - page 90

List of Figures
Figure 1: Breakdown of fibromyalgia patients by severity in the US, 2003 - page 20
Figure 2: Breakdown of fibromyalgia patients by severity in Japan, 2003 - page 21
Figure 4: Breakdown of fibromyalgia patients by severity in Germany, 2003 - page 21
Figure 5: Breakdown of fibromyalgia patients by severity in Italy, 2003 - page 22
Figure 6: Breakdown of fibromyalgia patients by severity in Spain, 2003 - page 22
Figure 7: Breakdown of fibromyalgia patients by severity in the UK, 2003 - page 23
Figure 8: The fibromyalgia 'tender points' - page 24
Figure 9: Importance of key therapeutic endpoints in fibromyalgia, 2003 - page 33
Figure 10: Summary of fibromyalgia treatment in the US, 2003 - page 46
Figure 11: Summary of fibromyalgia treatment in Japan, 2003 - page 50
Figure 12: Summary of fibromyalgia treatment in France, 2003 - page 53
Figure 13: Summary of fibromyalgia treatment in Germany, 2003 - page 58
Figure 14: Summary of fibromyalgia treatment in Italy, 2003 - page 62
Figure 15: Summary of fibromyalgia treatment in Spain, 2003 - page 67
Figure 16: Summary of fibromyalgia treatment in the UK, 2003 - page 71
Figure 17: Primary Research Process - page 90
Figure 18: Datamonitor's Healthcare Consultancy - page 107
Figure 19: Datamonitor Healthcare's Therapeutic Consulting capabilities - page 108

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Stakeholder Insight: Fibromyalgia - Substantial Growth Opportunity for SNRI Antidepressants

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