Market Report Source

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.

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 the following 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 remain unknown
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 women than men and increases with age
Experts and patient groups believe fibromyalgia is more common
Diagnosis and treatment rates
Over half of the fibromyalgia population remain undiagnosed
Nearly all diagnosed patients receive drug therapy of some sort
Market sizing calculations
Assumptions and caveats
Clinical unmet needs
Need for a better understanding of disease etiology and pathophysiology
Need to improve pain reduction and control
Need to reduce sleep disturbances

CHAPTER 3 CURRENT TREATMENT CONTROVERSIES
Pharmacological treatment – review of published clinical trial data
Antidepressants
Tricyclic antidepressants (TCAs)
Serotonin and noradrenaline reuptake inhibitors
Selective serotonin reuptake inhibitors
Analgesics
Tramadol
Anticonvulsants
Alpha 2 delta antagonists
Hormones
Other medications
Treatment guidelines
US guidelines – the 2004 American Pain Society Guidelines will soon be outdated
APS guidelines developed by an interdisciplinary panel of 13 pain management experts
APS guidelines recommend physicians start patients with a TCA or cyclobenzaprine
New guidelines need to include new possible first-line options
European guidelines – EULAR evidence-based guidelines due in mid to late 2007
Objectives – to provide evidence-based recommendations for the treatment of fibromyalgia
Methodology – developed by a multidisciplinary fibromyalgia task force representing 11 European countries
Results – 145 pharmacologic and non-pharmacologic studies were evaluated
Conclusion – Lyrica, Cymbalta and milnacipran are recommended therapies
Datamonitor’s physician survey
Referral patterns – rheumatologists are key target physicians
US
Japan
France
Germany
Italy
Spain
UK
Prescribing patterns – physicians adopt a ‘trial and error’ approach
US
Japan
France
Germany
Italy
Spain
UK

CHAPTER 4 ASSESSMENT CRITERIA AND CLINICAL TRIAL DESIGN
Assessment criteria
American College of Rheumatology (1990) research criteria for fibromyalgia
1. History of widespread pain has been present for at least 3 months
2. Pain in 11 of 18 tender point sites on digital palpation
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 and function
The FDA will require more mechanism-based outcomes as more is known about the disease
OMERACT aims to standardize fibromyalgia endpoint requirements and measures
Agencies will review their clinical trial requirements based on OMERACT findings
Function endpoints and measures will be assessed

CHAPTER 5 PIPELINE ANALYSIS AND FORECASTS
Pipeline overview
Pipeline mainly consists of drugs indicated for other CNS indications
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

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 mixed quality
DTC advertising will play a big part in increasing US public awareness
Fibromyalgia patient groups and associations
The National Fibromyalgia Association is considered the most influential US group
Recruitment through patient group websites can be beneficial
Educating primary care physicians
Supporting education initiatives is beneficial
Combination therapy
Opinion leaders predict combination therapy will be commonplace
Combination of Lyrica with an antidepressant or a sleep aid 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
Contributing experts
About Datamonitor
Datamonitor Healthcare’s research and analysis methodologies
Datamonitor Healthcare’s therapy area capabilities
Disclaimer

List of Tables
Table 1: Forecast sales of key pipeline products for fibromyalgia 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 seven major markets, 2007
Table 5: Fibromyalgia prevalence as quoted by various fibromyalgia organizations/associations, 2007
Table 6: The total fibromyalgia market value across the six major markets, 2003-05
Table 7: Stepwise fibromyalgia management as recommended by the 2004 APS treatment guidelines
Table 8: Summary of findings from pharmacological studies in fibromyalgia according to Arnold (2006)
Table 9: Fibromyalgia referral patterns across the seven major markets, 2003
Table 10: Comparison of three late-stage fibromyalgia clinical trial designs
Table 11: Randomized controlled trials of pregabalin, milnacipran, and duloxetine in fibromyalgia
Table 12: Pipeline drugs in clinical development for fibromyalgia, 2007
Table 13: Lyrica: key facts
Table 14: Baseline characteristic of patients* enrolled in the Crofford et al. (2005) pregabalin trial
Table 15: Key events, approval and launch dates impacting 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) duloxetine trial
Table 18: Key events, approval and launch dates impacting Cymbalta revenue forecasts for fibromyalgia in the US and 5EU, 2007-2016
Table 19: Milnacipran: key facts
Table 20: Key events, approval and launch dates impacting milnacipran revenue forecasts for fibromyalgia in the US and 5EU, 2007-2016
Table 21: Weightings of research and clinical factors used for pipeline drug assessment
Table 22: Weightings of commercial factors used for pipeline drug assessment

List of Figures
Figure 1: Datamonitor’s competitive positioning analysis for 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 total US and 5EU sales of Cymbalta, Lyrica and milnacipran for fibromyalgia ($m), 2007-2016
Figure 11: Datamonitor’s competitive positioning analysis for Cymbalta, Lyrica and milnacipran in the fibromyalgia market, 2007-2016
Figure 12: SWOT analysis of Lyrica in the fibromyalgia market, 2007
Figure 13: Diagram of patient flow in the Crofford et al. (2005) pregabalin trial
Figure 14: Datamonitor’s total US and 5EU forecast sales of Lyrica for fibromyalgia ($m), 2006-2016
Figure 15: Datamonitor’s competitive positioning analysis for Lyrica in the US and 5EU fibromyalgia market, 2007-2016
Figure 16: SWOT analysis of Cymbalta in the fibromyalgia market, 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 sales of Cymbalta for fibromyalgia ($m), 2006-2016
Figure 20: Datamonitor’s competitive positioning analysis for Cymbalta in the US and 5EU for fibromyalgia market, 2007-2016
Figure 21: SWOT analysis of milnacipran in the fibromyalgia market, 2007
Figure 22: Diagram of patient flow in the Vitton et al. (2004) milnacipran trial
Figure 23: Datamonitor’s total US and 5EU forecast sales of milnacipran for fibromyalgia ($m), 2006-2016
Figure 24: Datamonitor’s competitive positioning analysis for milnacipran in the US and 5EU fibromyalgia market, 2007-2016
Figure 25: The Forest/Cypress sponsored Fibromyalgia Resource Center homepage, 2007