Stakeholder Opinions: Fibromyalgia - Potentially lucrative market soon to become reality
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- Datamonitor's therapeutic area studies comprise the following features: - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the fibromyalgia market - page 3
- Key metrics - page 5
- Datamonitor Pipeline Assessment Summary - page 6
- Contributing experts - page 6
- CHAPTER 2 DISEASE OVERVIEW - page 9
- Definition and etiology - page 10
- The cause and underlying mechanisms of fibromyalgia remain unknown - page 10
- Research finds various chemical imbalances in patients - page 12
- Comorbidities - page 13
- There are significant overlaps with other conditions - page 13
- Epidemiology of fibromyalgia - page 14
- Prevalence and incidence - page 15
- Fibromyalgia is around seven times more common in women than men and increases with age - page 16
- Experts and patient groups believe fibromyalgia is more common - page 17
- Diagnosis and treatment rates - page 19
- Over half of the fibromyalgia population remain undiagnosed - page 19
- Nearly all diagnosed patients receive drug therapy of some sort - page 19
- Prevalence and incidence - page 15
- Market sizing calculations - page 21
- Assumptions and caveats - page 22
- Clinical unmet needs - page 23
- Need for a better understanding of disease etiology and pathophysiology - page 24
- Need to improve pain reduction and control - page 25
- Need to reduce sleep disturbances - page 25
- Definition and etiology - page 10
- CHAPTER 3 CURRENT TREATMENT CONTROVERSIES - page 27
- Pharmacological treatment - review of published clinical trial data - page 28
- Antidepressants - page 28
- Tricyclic antidepressants (TCAs) - page 28
- Serotonin and noradrenaline reuptake inhibitors - page 30
- Selective serotonin reuptake inhibitors - page 30
- Analgesics - page 31
- Tramadol - page 31
- Anticonvulsants - page 33
- Alpha 2 delta antagonists - page 33
- Hormones - page 33
- Other medications - page 33
- Antidepressants - page 28
- Treatment guidelines - page 34
- US guidelines - the 2004 American Pain Society Guidelines will soon be outdated - page 34
- APS guidelines developed by an interdisciplinary panel of 13 pain management experts - page 34
- APS guidelines recommend physicians start patients with a TCA or cyclobenzaprine - page 35
- New guidelines need to include new possible first-line options - page 35
- European guidelines - EULAR evidence-based guidelines due in mid to late 2007 - page 37
- Objectives - to provide evidence-based recommendations for the treatment of fibromyalgia - page 37
- Methodology - developed by a multidisciplinary fibromyalgia task force representing 11 European countries - page 37
- Results - 145 pharmacologic and non-pharmacologic studies were evaluated - page 38
- Conclusion - Lyrica, Cymbalta and milnacipran are recommended therapies - page 38
- US guidelines - the 2004 American Pain Society Guidelines will soon be outdated - page 34
- Datamonitor's physician survey - page 39
- Referral patterns - rheumatologists are key target physicians - page 39
- US - page 42
- Japan - page 43
- France - page 44
- Germany - page 45
- Italy - page 45
- Spain - page 45
- UK - page 46
- Prescribing patterns - physicians adopt a 'trial and error' approach - page 46
- US - page 47
- Japan - page 48
- France - page 49
- Germany - page 50
- Italy - page 51
- Spain - page 52
- UK - page 53
- Referral patterns - rheumatologists are key target physicians - page 39
- Pharmacological treatment - review of published clinical trial data - page 28
- CHAPTER 4 ASSESSMENT CRITERIA AND CLINICAL TRIAL DESIGN - page 55
- Assessment criteria - page 56
- American College of Rheumatology (1990) research criteria for fibromyalgia - page 56
- 1. History of widespread pain has been present for at least 3 months - page 57
- 2. Pain in 11 of 18 tender point sites on digital palpation - page 57
- American College of Rheumatology (1990) research criteria for fibromyalgia - page 56
- Clinical trial design - page 59
- Limitations of previous clinical trials in fibromyalgia - page 59
- Current FDA requirements for fibromyalgia claims - page 61
- Trials need to show improvements in both pain scores and function - page 62
- The FDA will require more mechanism-based outcomes as more is known about the disease - page 65
- OMERACT aims to standardize fibromyalgia endpoint requirements and measures - page 65
- Agencies will review their clinical trial requirements based on OMERACT findings - page 66
- Function endpoints and measures will be assessed - page 66
- Assessment criteria - page 56
- CHAPTER 5 PIPELINE ANALYSIS AND FORECASTS - page 68
- Pipeline overview - page 69
- Pipeline mainly consists of drugs indicated for other CNS indications - page 69
- Eli Lilly and Pfizer in race to be first to market - page 71
- Market will expand rapidly following drug approvals - page 71
- A defined regulatory pathway will attract future investors - page 72
- Innovative early stage pipeline - page 73
- Opinion leaders are encouraged by dopamine modulators - page 73
- Comparative forecasts - page 75
- Comparative Datamonitor drug assessment summaries - page 76
- Key late-stage R&D product profiles - page 76
- Lyrica (pregabalin) - page 76
- Drug overview - page 77
- Clinical trial data - page 78
- Patient potential - page 82
- Marketing factors - page 84
- Forecasts to 2016 - page 85
- Datamonitor drug assessment summary - page 86
- Cymbalta (duloxetine) - page 87
- Drug overview - page 87
- Clinical trial data - page 89
- Patient potential - page 93
- Marketing factors - page 94
- Forecasts to 2016 - page 97
- Datamonitor drug assessment summary - page 98
- Milnacipran - page 99
- Drug overview - page 99
- Clinical trial data - page 101
- Patient potential - page 105
- Marketing factors - page 106
- Forecasts to 2016 - page 107
- Datamonitor drug assessment summary - page 109
- Other pipeline drugs - page 109
- Desvenlafaxine (Pristiq) - page 110
- Sodium oxybate (Xyrem) - page 112
- Lacosamide - page 114
- Rotigotine (Neupro) - page 114
- Reboxetine - page 115
- Radafaxine - page 116
- Eszopiclone (Lunesta) - page 117
- Neurotropin - page 118
- Ibutamoren mesylate (MK-0677) - page 119
- Interferon-alpha (buccal lozenge) - page 119
- Tropisetron (Navoban) - page 121
- Buspirone (transdermal spray) - page 121
- Casopitant - page 121
- CR-3124 - page 122
- AD-337 - page 122
- Eplivanserin - page 122
- NC-003 - page 122
- Lyrica (pregabalin) - page 76
- Pipeline overview - page 69
- CHAPTER 6 INCREASING FIBROMYALGIA MARKET OPPORTUNITIES - page 124
- Summary of market opportunities - page 125
- Improving public awareness - page 125
- There are regional variations in fibromyalgia awareness - page 127
- Current information available to the public is of mixed quality - page 127
- DTC advertising will play a big part in increasing US public awareness - page 130
- Fibromyalgia patient groups and associations - page 131
- The National Fibromyalgia Association is considered the most influential US group - page 131
- Recruitment through patient group websites can be beneficial - page 133
- Educating primary care physicians - page 134
- Supporting education initiatives is beneficial - page 134
- Combination therapy - page 135
- Opinion leaders predict combination therapy will be commonplace - page 135
- Combination of Lyrica with an antidepressant or a sleep aid will be popular - page 135
- BIBLIOGRAPHY - page 137
- Journal articles - page 137
- Websites - page 145
- APPENDIX - page 149
- Methodology - page 149
- Datamonitor forecast methodology - page 149
- Market sizing - page 149
- Product forecasts - page 149
- Definition of a standard unit - page 149
- Datamonitor drug assessment summary - page 151
- Datamonitor forecast methodology - page 149
- Contributing experts - page 152
- About Datamonitor - page 154
- Datamonitor Healthcare's research and analysis methodologies - page 154
- Datamonitor Healthcare's therapy area capabilities - page 154
- Disclaimer - page 156
- Methodology - page 149
- List of Tables
- Table 1: Forecast sales of key pipeline products for fibromyalgia in the US and 5EU ($m), 2006-2016* - page 5
- Table 2: Prevalence of symptoms in fibromyalgia patients - page 11
- Table 3: Key fibromyalgia epidemiology study results, 1995-2006 - page 15
- Table 4: Prevalence of fibromyalgia across the seven major markets, 2007 - page 16
- Table 5: Fibromyalgia prevalence as quoted by various fibromyalgia organizations/associations, 2007 - page 19
- Table 6: The total fibromyalgia market value across the six major markets, 2003-05 - page 21
- Table 7: Stepwise fibromyalgia management as recommended by the 2004 APS treatment guidelines - page 35
- Table 8: Summary of findings from pharmacological studies in fibromyalgia according to Arnold (2006) - page 36
- Table 9: Fibromyalgia referral patterns across the seven major markets, 2003 - page 40
- Table 10: Comparison of three late-stage fibromyalgia clinical trial designs - page 62
- Table 11: Randomized controlled trials of pregabalin, milnacipran, and duloxetine in fibromyalgia - page 63
- Table 12: Pipeline drugs in clinical development for fibromyalgia, 2007 - page 69
- Table 13: Lyrica: key facts - page 77
- Table 14: Baseline characteristic of patients* enrolled in the Crofford et al. (2005) pregabalin trial - page 80
- Table 15: Key events, approval and launch dates impacting Lyrica revenue forecasts for fibromyalgia in the US and 5EU, 2007-2016 - page 85
- Table 16: Cymbalta: key facts - page 88
- Table 17: Results of the Arnold et al. (2005) duloxetine trial - page 92
- Table 18: Key events, approval and launch dates impacting Cymbalta revenue forecasts for fibromyalgia in the US and 5EU, 2007-2016 - page 97
- Table 19: Milnacipran: key facts - page 100
- Table 20: Key events, approval and launch dates impacting milnacipran revenue forecasts for fibromyalgia in the US and 5EU, 2007-2016 - page 108
- Table 21: Weightings of research and clinical factors used for pipeline drug assessment - page 151
- Table 22: Weightings of commercial factors used for pipeline drug assessment - page 152
- List of Figures
- Figure 1: Datamonitor's competitive positioning analysis for Cymbalta, Lyrica and milnacipran in the fibromyalgia market, 2007-2016 - page 6
- Figure 2: Summary of fibromyalgia treatment in the US, 2003 - page 47
- Figure 3: Summary of fibromyalgia treatment in Japan, 2003 - page 48
- Figure 4: Summary of fibromyalgia treatment in France, 2003 - page 49
- Figure 5: Summary of fibromyalgia treatment in Germany, 2003 - page 50
- Figure 6: Summary of fibromyalgia treatment in Italy, 2003 - page 52
- Figure 7: Summary of fibromyalgia treatment in Spain, 2003 - page 53
- Figure 8: Summary of fibromyalgia treatment in the UK, 2003 - page 54
- Figure 9: The fibromyalgia 'tender points' - page 58
- Figure 10: Datamonitor's comparative forecast of total US and 5EU sales of Cymbalta, Lyrica and milnacipran for fibromyalgia ($m), 2007-2016 - page 75
- Figure 11: Datamonitor's competitive positioning analysis for Cymbalta, Lyrica and milnacipran in the fibromyalgia market, 2007-2016 - page 76
- Figure 12: SWOT analysis of Lyrica in the fibromyalgia market, 2007 - page 78
- Figure 13: Diagram of patient flow in the Crofford et al. (2005) pregabalin trial - page 81
- Figure 14: Datamonitor's total US and 5EU forecast sales of Lyrica for fibromyalgia ($m), 2006-2016 - page 86
- Figure 15: Datamonitor's competitive positioning analysis for Lyrica in the US and 5EU fibromyalgia market, 2007-2016 - page 87
- Figure 16: SWOT analysis of Cymbalta in the fibromyalgia market, 2007 - page 89
- Figure 17: Diagram of patient flow in the Arnold et al. (2005) duloxetine trial - page 90
- Figure 18: Cymbalta home page, 2007 - page 96
- Figure 19: Datamonitor's total US and 5EU forecast sales of Cymbalta for fibromyalgia ($m), 2006-2016 - page 98
- Figure 20: Datamonitor's competitive positioning analysis for Cymbalta in the US and 5EU for fibromyalgia market, 2007-2016 - page 99
- Figure 21: SWOT analysis of milnacipran in the fibromyalgia market, 2007 - page 101
- Figure 22: Diagram of patient flow in the Vitton et al. (2004) milnacipran trial - page 102
- Figure 23: Datamonitor's total US and 5EU forecast sales of milnacipran for fibromyalgia ($m), 2006-2016 - page 108
- Figure 24: Datamonitor's competitive positioning analysis for milnacipran in the US and 5EU fibromyalgia market, 2007-2016 - page 109
- Figure 25: The Forest/Cypress sponsored Fibromyalgia Resource Center homepage, 2007 - page 129
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