Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion

Table of Contents

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Datamonitor insight into the fibromyalgia market
• Related reports

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
  • Class market dynamics
• Future seven major market assessment
  • Scenario forecast overview
  • Base scenario - EMEA fibromyalgia approvals for Savella, Lyrica and Xyrem
  • Alternative scenario - no products gain EU approval
• 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

BRAND DYNAMICS

• Overview of competitive landscape
  • Brand dynamics
• Approved brands
  • Lyrica (pregabalin; Pfizer)
  • Cymbalta (duloxetine; Eli Lilly and Boehringer Ingelheim)
  • Savella (milnacipran; Pierre Fabre, Cypress and Forest)
• Forecasted pipeline products
  • Xyrem (sodium oxybate; Jazz Pharma and UCB)
• Unforecasted pipeline products
  • Vimpat (lacosamide, UCB)
  • Terguride (ErgoNex)
  • Effirma (Oral flupirtine, Adeona Pharmaceuticals)
  • Droxidopa (Chelsea Therapeutics)
• Recently discontinued or on-hold products
  • Neupro (rotigotine patch, UCB)
  • Esreboxetine (Pfizer)
  • Pristiq (desvenlafaxine, Wyeth)
  • AD-337 (Sosei Group)
  • Pramipexole ER (Boehringer Ingelheim)

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

TABLES

• Table: Key events impacting the fibromyalgia market, 2007 - 2018
• Table: Sales forecasts in fibromyalgia in the seven major markets ($m), 2008 - 2018
• Table: Key fibromyalgia epidemiology study results, 1995 - 2006
• Table: Approved and forecasted late-stage drug sales ($m) for fibromyalgia in the seven major markets, 2008 - 2018
• Table: FDA-approved fibromyalgia brands - key facts, 2009
• Table: Datamonitor' s estimated launch dates for fibromyalgia products in the seven major markets, 2009 - 2018
• Table: Patent expiry dates for the approved fibromyalgia brands in the seven major markets, 2009 - 2019

FIGURES

• Figure: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2005 - 08
• Figure: Fibromyalgia market sales volume (IMS standard units sold, million) in the US, 5EU and Japan, 2005 - 08
• Figure: Fibromyalgia market volume (standard units) sales dynamics by class in the US, 5EU and Japan, 2008
• Figure: Fibromyalgia market volume (standard units, million) and value ($m) sales by class in the seven major markets, 2005 - 08
• Figure: Datamonitor' s seven major fibromyalgia market forecasts based on two possible scenarios, 2008 - 2018
• Figure: Fibromyalgia market sales value ($m) in the US, 5EU and Japan, 2006 - 2018
• Figure: Fibromyalgia-specific sales ($m), growth (CAGR) and market share (%) by region in the seven major markets, 2005 - 2018
• Figure: Fibromyalgia market volume (IMS standard units sold, millions) and value ($m) by class in the seven major markets, 2006 - 2018
• Figure: Fibromyalgia-specific sales ($m) of key brands in the seven major markets, 2008 and 2018
• Figure: Datamonitor' s 5EU fibromyalgia market scenario forecasts, 2008 - 2018
• Figure: Comparison of Datamonitor' s updated seven major market fibromyalgia market forecast to 2018 with its previous market forecast to 2017
• Figure: Timeline: fibromyalgia therapy approval dates, 2007 - 09
• Figure: Datamonitor' s fibromyalgia-specific sales ($m) forecast for Pfizer' s Lyrica (pregabalin) in the seven major markets, 2008 - 2018
• Figure: Datamonitor' s 2008 and updated fibromyalgia-specific sales ($m) forecast for Eli Lilly and Boehringer Ingelheim' s Cymbalta (duloxetine) in the seven major markets, 2008 - 2018
• Figure: Datamonitor' s fibromyalgia-specific sales ($m) forecast for Pierre Fabre, Cypress and Forest' s Savella (milnacipran) in the seven major markets, 2008 - 2018
• Figure: Sodium oxybate Phase III fibromyalgia clinical program overview
• Figure: Datamonitor' s 2008 and updated fibromyalgia-specific sales ($m) forecast for Jazz and UCB' s Xyrem (sodium oxybate) in the seven major markets, 2009 - 2018
• Figure: Phase II droxidopa fibromyalgia clinical trial design overview