Abstract
Overview
Introduction
Mainly affecting women, fibromyalgia syndrome affects six million people in the US alone. This relatively common yet poorly understood syndrome is characterized by widespread muscle pain and fatigue and remains substantially underserved by the medical profession and the pharmaceutical industry. Currently, there are no drugs licensed to treat fibromyalgia in the US, Japan or Europe.
Scope
- Analysis of the patient potential, main unmet needs, and clinical trial design in fibromyalgia, with an estimation of market size
- Insight into current treatment controversies, including referral and prescribing patterns across the seven major markets
- Detailed profiles of Cymbalta, Lyrica, and milnacipran for use in fibromyalgia, with indication-specific sales forecasts of these drugs to 2016
- Discussion of key fibromyalgia market drivers, such as strategies that improve public awareness and physician education
Report Highlights
Following FDA approvals, Datamonitor foresees a dramatic rise in market value resulting from an upsurge in diagnosis and treatment rates. Estimated at $367m in 2006 in the US and 5EU, the market is forecast to grow to $1.7 billion in 2016.
Commercial success of new fibromyalgia brands will encourage other companies to consider investment, and will see the R&D pipeline for new therapies increase over the coming years. A defined regulatory pathway will also attract future investors.
Polypharmacotherapy will become commonplace in fibromyalgia management and Lyrica with Cymbalta will be a popular combination. This is good news for Lilly and Pfizer as it will effectively expand their market by reducing competition.
Reasons to Purchase
- Quantify the future market size in order to weigh up the risk of investing in fibromyalgia or to validate internal forecasts for pipeline products
- Gain insight into opinion leaders' thoughts on the major opportunities and challenges facing the fibromyalgia market
- Assess the six major market (US and 5EU) sales forecasts of key late-stage pipeline drugs to 2016; and examine their clinical and commercial potential
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- Datamonitor' s therapeutic area studies comprise thefollowing features:
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the fibromyalgia market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Contributing experts
- CHAPTER 2 DISEASE OVERVIEW
- Definition and etiology
- The cause and underlying mechanisms of fibromyalgia remainunknown
- Research finds various chemical imbalances in patients
- Comorbidities
- There are significant overlaps with other conditions
- Epidemiology of fibromyalgia
- Prevalence and incidence
- Fibromyalgia is around seven times more common in womenthan men and increases with age
- Experts and patient groups believe fibromyalgia is morecommon
- Diagnosis and treatment rates
- Over half of the fibromyalgia population remainundiagnosed
- Nearly all diagnosed patients receive drug therapy of somesort
- Prevalence and incidence
- Market sizing calculations
- Assumptions and caveats
- Clinical unmet needs
- Need for a better understanding of disease etiology andpathophysiology
- Need to improve pain reduction and control
- Need to reduce sleep disturbances
- Definition and etiology
- CHAPTER 3 CURRENT TREATMENT CONTROVERSIES
- Pharmacological treatment - review of published clinicaltrial data
- Antidepressants
- Tricyclic antidepressants (TCAs)
- Serotonin and noradrenaline reuptake inhibitors
- Selective serotonin reuptake inhibitors
- Analgesics
- Tramadol
- Anticonvulsants
- Alpha 2 delta antagonists
- Hormones
- Other medications
- Antidepressants
- Treatment guidelines
- US guidelines - the 2004 American Pain Society Guidelineswill soon be
outdated
- APS guidelines developed by an interdisciplinary panel of13 pain management experts
- APS guidelines recommend physicians start patients with aTCA or cyclobenzaprine
- New guidelines need to include new possible first-lineoptions
- European guidelines - EULAR evidence-based guidelines duein mid to
late 2007
- Objectives - to provide evidence-based recommendations forthe treatment of fibromyalgia
- Methodology - developed by a multidisciplinaryfibromyalgia task force representing 11 European countries
- Results - 145 pharmacologic and non-pharmacologic studieswere evaluated
- Conclusion - Lyrica, Cymbalta and milnacipran arerecommended therapies
- US guidelines - the 2004 American Pain Society Guidelineswill soon be
outdated
- Datamonitor' s physician survey
- Referral patterns - rheumatologists are key targetphysicians
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Prescribing patterns - physicians adopt a ' trial anderror' approach
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Referral patterns - rheumatologists are key targetphysicians
- Pharmacological treatment - review of published clinicaltrial data
- CHAPTER 4 ASSESSMENT CRITERIA AND CLINICAL TRIAL DESIGN
- Assessment criteria
- American College of Rheumatology (1990) research criteriafor
fibromyalgia
- 1. History of widespread pain has been present for atleast 3 months
- 2. Pain in 11 of 18 tender point sites on digitalpalpation
- American College of Rheumatology (1990) research criteriafor
fibromyalgia
- Clinical trial design
- Limitations of previous clinical trials in fibromyalgia
- Current FDA requirements for fibromyalgia claims
- Trials need to show improvements in both pain scores andfunction
- The FDA will require more mechanism-based outcomes as moreis known about the disease
- OMERACT aims to standardize fibromyalgia endpointrequirements and
measures
- Agencies will review their clinical trial requirementsbased on OMERACT findings
- Function endpoints and measures will be assessed
- Assessment criteria
- CHAPTER 5 PIPELINE ANALYSIS AND FORECASTS
- Pipeline overview
- Pipeline mainly consists of drugs indicated for other CNSindications
- Eli Lilly and Pfizer in race to be first to market
- Market will expand rapidly following drug approvals
- A defined regulatory pathway will attract future investors
- Innovative early stage pipeline
- Opinion leaders are encouraged by dopamine modulators
- Comparative forecasts
- Comparative Datamonitor drug assessment summaries
- Key late-stage R&D product profiles
- Lyrica (pregabalin)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Cymbalta (duloxetine)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Milnacipran
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other pipeline drugs
- Desvenlafaxine (Pristiq)
- Sodium oxybate (Xyrem)
- Lacosamide
- Rotigotine (Neupro)
- Reboxetine
- Radafaxine
- Eszopiclone (Lunesta)
- Neurotropin
- Ibutamoren mesylate (MK-0677)
- Interferon-alpha (buccal lozenge)
- Tropisetron (Navoban)
- Buspirone (transdermal spray)
- Casopitant
- CR-3124
- AD-337
- Eplivanserin
- NC-003
- Lyrica (pregabalin)
- Pipeline overview
- CHAPTER 6 INCREASING FIBROMYALGIA MARKET OPPORTUNITIES
- Summary of market opportunities
- Improving public awareness
- There are regional variations in fibromyalgia awareness
- Current information available to the public is of mixedquality
- DTC advertising will play a big part in increasing USpublic awareness
- Fibromyalgia patient groups and associations
- The National Fibromyalgia Association is considered themost influential US group
- Recruitment through patient group websites can bebeneficial
- Educating primary care physicians
- Supporting education initiatives is beneficial
- Combination therapy
- Opinion leaders predict combination therapy will becommonplace
- Combination of Lyrica with an antidepressant or a sleepaid will be popular
- BIBLIOGRAPHY
- Journal articles
- Websites
- APPENDIX
- Methodology
- Datamonitor forecast methodology
- Market sizing
- Product forecasts
- Definition of a standard unit
- Datamonitor drug assessment summary
- Datamonitor forecast methodology
- Contributing experts
- About Datamonitor
- Datamonitor Healthcare' s research and analysismethodologies
- Datamonitor Healthcare' s therapy area capabilities
- Disclaimer
- List of Tables
- Table 1: Forecast sales of key pipeline products forfibromyalgia in the US and 5EU ($m), 2006-2016
- Table 2: Prevalence of symptoms in fibromyalgia patients
- Table 3: Key fibromyalgia epidemiology study results,1995-2006
- Table 4: Prevalence of fibromyalgia across the sevenmajor markets, 2007
- Table 5: Fibromyalgia prevalence as quoted by variousfibromyalgia organizations/associations, 2007
- Table 6: The total fibromyalgia market value across thesix major markets, 2003-05
- Table 7: Stepwise fibromyalgia management as recommendedby the 2004 APS treatment guidelines
- Table 8: Summary of findings from pharmacologicalstudies in fibromyalgia according to Arnold (2006)
- Table 9: Fibromyalgia referral patterns across the sevenmajor markets, 2003
- Table 10: Comparison of three late-stage fibromyalgiaclinical trial designs
- Table 11: Randomized controlled trials of pregabalin,milnacipran, and duloxetine in fibromyalgia
- Table 12: Pipeline drugs in clinical development forfibromyalgia, 2007
- Table 13: Lyrica: key facts
- Table 14: Baseline characteristic of patients* enrolledin the Crofford et al. (2005) pregabalin trial
- Table 15: Key events, approval and launch datesimpacting Lyrica revenue forecasts for fibromyalgia in the US and 5EU,2007-2016
- Table 16: Cymbalta: key facts
- Table 17: Results of the Arnold et al. (2005) duloxetinetrial
- Table 18: Key events, approval and launch datesimpacting Cymbalta revenue forecasts for fibromyalgia in the US and 5EU,2007-2016
- Table 19: Milnacipran: key facts
- Table 20: Key events, approval and launch datesimpacting milnacipran revenue forecasts for fibromyalgia in the US and5EU, 2007-2016
- Table 21: Weightings of research and clinical factorsused for pipeline drug assessment
- Table 22: Weightings of commercial factors used forpipeline drug assessment
- List of Figures
- Figure 1: Datamonitor' s competitive positioning analysisfor Cymbalta, Lyrica and milnacipran in the fibromyalgia market, 2007-2016
- Figure 2: Summary of fibromyalgia treatment in the US,2003
- Figure 3: Summary of fibromyalgia treatment in Japan,2003
- Figure 4: Summary of fibromyalgia treatment in France,2003
- Figure 5: Summary of fibromyalgia treatment in Germany,2003
- Figure 6: Summary of fibromyalgia treatment in Italy,2003
- Figure 7: Summary of fibromyalgia treatment in Spain,2003
- Figure 8: Summary of fibromyalgia treatment in the UK,2003
- Figure 9: The fibromyalgia ' tender points'
- Figure 10: Datamonitor' s comparative forecast of totalUS and 5EU sales of Cymbalta, Lyrica and milnacipran for fibromyalgia($m), 2007-2016
- Figure 11: Datamonitor' s competitive positioninganalysis for Cymbalta, Lyrica and milnacipran in the fibromyalgia market,2007-2016
- Figure 12: SWOT analysis of Lyrica in the fibromyalgiamarket, 2007
- Figure 13: Diagram of patient flow in the Crofford etal. (2005) pregabalin trial
- Figure 14: Datamonitor' s total US and 5EU forecast salesof Lyrica for fibromyalgia ($m), 2006-2016
- Figure 15: Datamonitor' s competitive positioninganalysis for Lyrica in the US and 5EU fibromyalgia market, 2007-2016
- Figure 16: SWOT analysis of Cymbalta in the fibromyalgiamarket, 2007
- Figure 17: Diagram of patient flow in the Arnold et al.(2005) duloxetine trial
- Figure 18: Cymbalta home page, 2007
- Figure 19: Datamonitor' s total US and 5EU forecast salesof Cymbalta for fibromyalgia ($m), 2006-2016
- Figure 20: Datamonitor' s competitive positioninganalysis for Cymbalta in the US and 5EU for fibromyalgia market, 2007-2016
- Figure 21: SWOT analysis of milnacipran in thefibromyalgia market, 2007
- Figure 22: Diagram of patient flow in the Vitton et al.(2004) milnacipran trial
- Figure 23: Datamonitor' s total US and 5EU forecast salesof milnacipran for fibromyalgia ($m), 2006-2016
- Figure 24: Datamonitor' s competitive positioninganalysis for milnacipran in the US and 5EU fibromyalgia market, 2007-2016
- Figure 25: The Forest/Cypress sponsored FibromyalgiaResource Center homepage, 2007
- Methodology
