Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion
Published By: Datamonitor
June 2009
R313-52291
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Description
Introduction
Until regulatory hurdles in the EU are overcome, the US offers the greatest commercial potential and will be the primary growth market for all current and future brands indicated for fibromyalgia. Datamonitor forecasts the fibromyalgia market to more than double in value from 2008 to total $2.5 billion by 2018 across the seven major regions.
Scope- Strategic analysis of the likely impact that recent events, such as regulatory decisions, will have on the future fibromyalgia market
- Fibromyalgia-specific prescription sales data analysis across the seven major markets from 200508
- Sales forecasts for key brands (Lyrica, Cymbalta, Savella), generics, and key pipeline agents across the seven major markets to 2018
- Scenario forecasts assessing the potential outcome of EU non-approvals for key brands, supported by key opinion leader comments
Highlights
The probability of non-approval for fibromyalgia in the EU appears to be higher than in the US. Since 2008, the EMEA has declined marketing applications for both Cymbalta (duloxetine, Eli Lilly/Boehringer Ingelheim) and Lyrica (pregabalin, Pfizer).
Savella (milnacipran, Pierre Fabre, Cypress and Forest) became the third FDA-approved product for fibromyalgia. With a response from the EMEA anticipated shortly, Datamonitor believes the unique development program involving a composite analysis endpoint and specific EU-based Phase III study will be viewed favorably by the regulatory body.
Datamonitor has marginally downgraded its sales forecast for Xyrem (sodium oxybate, Jazz Pharma and UCB). This stems from a newly-highlighted concern over the robustness of the Phase III development program design and the negative perception surrounding the drug's formulation, its prescription constraints and abuse potential.
Reasons to Purchase- Quantify the current and future size of the fibromyalgia market
- Assess the impact of recent and anticipated events (patent expiries, new product launches, regulatory approval) on the fibromyalgia market
- Understand the country-specific impact of key events in the fibromyalgia market during the forecast period 2009 to 2018
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Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the fibromyalgia market
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Fibromyalgia market definition
- Countries and regions included in this report
- Current seven major market assessment
- Regional market dynamics
- The seven major fibromyalgia market value topped $1 billion in 2008
- The US is by far the largest geographical market both in terms of value and volume
- Class market dynamics
- Drug use varies considerably between regions
- Increasing uptake of branded anticonvulsants and antidepressants have shaped recent market dynamics
- Future seven major market assessment
- Scenario forecast overview
- Base scenario - EMEA fibromyalgia approvals for Savella, Lyrica and Xyrem
- 5EU and Japan rollout will support continued US uptake
- Emerging European market growth lessens US dominance
- Anticonvulsant and antidepressant drug classes to dominate market by 2018
- Fibromyalgia market to become far more brand-centric
- Alternative scenario - no products gain EU approval
- Sales in the 5EU remain entirely off-label as no product meets the EMEA's approval specifications
- Comparison with previous forecast
- Datamonitor's total market forecast remains relatively unchanged
- Rest of the world assessment
- Epidemiology of fibromyalgia in the rest of world
- CHAPTER 3 BRAND DYNAMICS
- Overview of competitive landscape
- Brand dynamics
- Three FDA approvals in 3 years, no approvals yet in Japan and the EU
- Pfizer's Lyrica to remain leading fibromyalgia brand through to 2018
- Approved brands
- Lyrica (pregabalin; Pfizer)
- First product approved by the FDA for the treatment of fibromyalgia
- CHMP negative opinion is a setback for EU market penetration
- Japan approval predicted for 2012
- Datamonitor comment and forecasts - despite EU setback, strong continued uptake is expected in all three regions
- Cymbalta (duloxetine; Eli Lilly and Boehringer Ingelheim)
- Second product to gain FDA approval for the management of fibromyalgia
- Negative opinion from EU regulators as efficacy data are deemed insufficient to warrant approval
- Datamonitor comment and forecasts - no EU approval predicted
- Savella (milnacipran; Pierre Fabre, Cypress and Forest)
- Third product to gain FDA approval for fibromyalgia - as correctly predicted by Datamonitor
- Specific Phase III EU study and adoption of composite responder analysis endpoint bodes well for European submission
- Study assessing combination with pregabalin could strengthen milnacipran's market position
- Datamonitor comment and forecasts - potential first-to-market status in EU
- Forecasted pipeline products
- Xyrem (sodium oxybate; Jazz Pharma and UCB)
- Companies remain on-track for 2009 submission but lack of plans for long-term placebo-controlled efficacy trial may be an issue
- Positive top-line results from first Phase III trial as sodium oxybate meets its primary endpoint
- Study to assess the potential of a sodium oxybate oral tablet formulation shows intent to address current administration issues
- Datamonitor comment and forecasts - Xyrem forecasts downgraded
- Unforecasted pipeline products
- Vimpat (lacosamide, UCB)
- Inconclusive proof-of-concept study results adds risk to further developments of lacosamide in fibromyalgia
- Terguride (ErgoNex)
- Phase II study outcome unknown but fate of other dopamine agonists indicates limited potential in fibromyalgia
- Effirma (Oral flupirtine, Adeona Pharmaceuticals)
- Phase II clinical trial in treatment-refractory fibromyalgia gets the green light
- Droxidopa (Chelsea Therapeutics)
- Phase II study will specifically assess the central effect of norepinephrine in fibromyalgia
- Recently discontinued or on-hold products
- Neupro (rotigotine patch, UCB)
- Failed Phase IIa proof-of-concept study leads to belief that Neupro development has been discontinued
- Esreboxetine (Pfizer)
- Tactical termination of potential Lyrica follow-on as Pfizer streamlines pipeline
- Pristiq (desvenlafaxine, Wyeth)
- Intentions to target fibromyalgia finally come to a close as latest Phase II study is terminated
- AD-337 (Sosei Group)
- Project assumed on hold or terminated following non-significant Phase IIa study results in 2007
- Pramipexole ER (Boehringer Ingelheim)
- Phase II trial of extended-release pramipexole terminated 3 years after the product's potential in fibromyalgia was formerly established
- BIBLIOGRAPHY
- Journal papers
- Websites
- Datamonitor reports
- APPENDIX A
- Market Assumptions
- New product launches (as in base forecast)
- Patent expiries
- Data definitions, limitations and assumptions
- Standard units
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- APPENDIX B
- Contributing experts
- Conferences attended
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the central nervous system analysis team
- Disclaimer
- List of Tables
- Table 1: Key events impacting the fibromyalgia market, 2007-2018
- Table 2: Sales forecasts in fibromyalgia in the seven major markets ($m), 2008-2018
- Table 3: Key fibromyalgia epidemiology study results, 1995-2006
- Table 4: Approved and forecasted late-stage drug sales ($m) for fibromyalgia in the seven major markets, 2008-2018
- Table 5: FDA-approved fibromyalgia brands - key facts, 2009
- Table 6: Datamonitor's estimated launch dates for fibromyalgia products in the seven major markets, 2009-2018
- Table 7: Patent expiry dates for the approved fibromyalgia brands in the seven major markets, 2009-2019
- List of Figures
- Figure 1: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2005-08
- Figure 2: Fibromyalgia market sales volume (IMS standard units sold, million) in the US, 5EU and Japan, 2005-08
- Figure 3: Fibromyalgia market volume (standard units) sales dynamics by class in the US, 5EU and Japan, 2008
- Figure 4: Fibromyalgia market volume (standard units, million) and value ($m) sales by class in the seven major markets, 2005-08
- Figure 5: Datamonitor's seven major fibromyalgia market forecasts based on two possible scenarios, 2008-2018
- Figure 6: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2006-2018
- Figure 7: Fibromyalgia-specific sales ($m), growth (CAGR) and market share (%) by region in the seven major markets, 2005-2018
- Figure 8: Fibromyalgia market volume (IMS standard units sold, millions) and value ($m) by class in the seven major markets, 2006-2018
- Figure 9: Fibromyalgia-specific sales ($m) of key brands in the seven major markets, 2008 and 2018
- Figure 10: Datamonitor's 5EU fibromyalgia market scenario forecasts, 2008-2018
- Figure 11: Comparison of Datamonitor's updated seven major market fibromyalgia market forecast to 2018 with its previous market forecast to 2017
- Figure 12: Timeline: fibromyalgia therapy approval dates, 2007-09
- Figure 13: Datamonitor's fibromyalgia-specific sales ($m) forecast for Pfizer's Lyrica (pregabalin) in the seven major markets, 2008-2018
- Figure 14: Datamonitor's 2008 and updated fibromyalgia-specific sales ($m) forecast for Eli Lilly and Boehringer Ingelheim's Cymbalta (duloxetine) in the seven major markets, 2008-2018
- Figure 15: Datamonitor's fibromyalgia-specific sales ($m) forecast for Pierre Fabre, Cypress and Forest's Savella (milnacipran) in the seven major markets, 2008-2018
- Figure 16: Sodium oxybate Phase III fibromyalgia clinical program overview
- Figure 17: Datamonitor's 2008 and updated fibromyalgia-specific sales ($m) forecast for Jazz and UCB's Xyrem (sodium oxybate) in the seven major markets, 2009-2018
- Figure 18: Phase II droxidopa fibromyalgia clinical trial design overview
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