Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion:

Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion

Published Date: June 2009

Published By: Datamonitor

Page Count: 80

Order Code: R313-52291

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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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