片頭痛治療薬市場

Abstract

Overview

Introduction

With the seven triptan brands continuing to dominate acute migraine treatment and Ortho-McNeil' s Topamax (topiramate) driving sales in the prophylactic market, 7MM revenues of anti-migraine drugs increased by 8.1% from 2005 to $3.7 billion in 2006. The US accounted for 80% of the 7MM total in 2006, Whilst in the 5EU, France is the largest market for migraine-specific drug sales.

Scope

• This report focuses on acute and prophylactic drugs used to treat migraine, with indication- and country-specific sales and volume forecasts to 2016
• Assessment of current and future opportunities and threats in the migraine market across the 7MMs and in individual regions
• Analysis and quantification of future market events expected to impact anti-migraine drug revenues over the next decade
• Case study analysis of successful lifecycle management strategies and scenario forecasts provide further market insight and key recommendations

Highlights

GSK has executed a number of well-timed lifecycle management strategies that have ensured Imitrex' s market leadership. However, Imitrex' s impending patent expiry will result in generic sumatriptan flooding the US market in late 2008, and crucial delays to Trexima' s launch will signal the end of GSK' s dominance of the migraine market.

There remains substantial opportunity in the migraine prophylaxis market. In spite of US Topamax patent expiry in 2008, the large number of untreated patients and poor tolerability profiles of existing treatments means the prophylactic market will remain highly attractive over the forecast period.

Menstrual migraine (MM) represents an unknown, yet potentially rewarding market opportunity. Endo and Vernalis' s Frova (frovatriptan) awaits the FDA' s decision on its application for the short-term prevention of MM. This outcome will be crucial to the drug' s future and will also influence other triptan manufacturers' decision to pursue MM.

Reasons to Purchase

• Quantify the future size of the migraine market, in terms of prescription volume and value, in each of the seven major markets
• Assess the impact of future events such as patent expiries, indication expansions, and new product launches on the sales of key marketed brands
• Identify key lifecycle management strategies and market opportunities that can ensure growth in the competitive anti-migraine pharmaceutical arena

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Migraine pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
  • Datamonitor insight into the migraine market
  • Market forecast summary
  • Contributing experts
  • Related reports
• CHAPTER 2 MARKET DEFINITION AND OVERVIEW
  • Market definition for this report
  • Current market situation
    • Seven major migraine market growth shows signs of slowing
      • Sales in the US dominate the total seven major migraine market
      • France is the largest migraine market in the 5EU
    • Triptans remain gold-standard class for the acute treatment of migraine
      • Imitrex maintains leadership of acute treatment market
      • Zomig outdoes Imitrex to become 5EU treatment of choice
    • Rapid Topamax uptake into immature prophylaxis market represents key growth driver
  • Strategic scoping and focus
• CHAPTER 3 COUNTRY MARKET ASSESSMENTS
  • Summary of environmental issues affecting migraine market size
  • Seven major market opportunities and threats
    • Opportunities
      • Substantial revenue exists in the prophylactic migraine market
      • Patient and physician education will expand patient pool and improve the quality of migraine management
      • Niche indications represent opportunities to increase revenue
      • Desire for improved patient acceptability promotes the development of different delivery methods
      • OTC availability substantially widens customer base
    • Threats
      • Generics
      • Cost-containment measures impact treatment choice and duration
      • OTC medications continue to provide strong competition to prescription drugs
      • Triptan safety issues limit their use
  • US: opportunities and threats
    • Opportunities
      • Advocacy and DTC campaigns drive public awareness of migraine
      • Comparatively high price of branded drugs possible in US market
      • Direct access to specialist physicians helps patients receive optimal treatment quicker
    • Threats
      • Insurance companies limit access to migraine medications
      • High drug prices increases the threatening impact of genericization
      • New migraine treatments will suffer as a result of restricted DTC advertising
  • Japan: opportunities and threats
    • Opportunities
      • Japanese migraine market shows scope for greater development
      • Plans to improve the drug approval review system in Japan
      • Governmental funding for clinical trials could benefit research into migraine
    • Threats
      • Public education greatly needed to raise poor awareness of migraine in Japan
      • Government plans to double the use of generics by the end of 2012
  • France: opportunities and threats
    • Opportunities
      • Large and well-treated French market is an attractive region to launch new therapies
      • Innovative drug development encouraged by price premium and high-level reimbursement
      • France currently has low generic incursion
      • High prescriptions of triptans for cluster headaches in France make it a target additional indication
    • Threats
      • After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future
  • Germany: opportunities and threats
    • Opportunities
      • German government initiative to boost biopharma R&D
      • OTC availability increases presence of brand availability
    • Threats
      • Pharmaceutical-Prescribing-Efficiency-Act - bonus-malus encourages generic prescribing
  • Italy: opportunities and threats
    • Opportunities
      • National migraine campaigns drive public awareness
    • Threats
      • Italy forces drug firms to give licenses for generics rivals
  • Spain: opportunities and threats
    • Opportunities
      • Low brand prices reduce the threat of genericization
      • Primary care interest in migraine is high
    • Threats
      • R&D activity expected to decline
  • UK: opportunities and threats
    • Opportunities
      • Highest 5EU price point achievable in the UK
      • New BASH guidelines clarify treatment algorithm and promote the use of triptans
    • Threats
      • Genericization is a big threat in the UK market
      • UK government looks to renegotiate the Pharmaceutical Price Regulation Scheme
      • Slow Topamax uptake shows that prophylactic treatment is restricted in the UK
• CHAPTER 4 FORECAST ANALYSIS
  • Key events
    • New product launches
      • Frova launches in France
      • Trexima (sumatriptan +naproxen sodium combination)
      • PRO-513
      • Sumatriptan Intraject
      • Sumatriptan oral spray
      • MK-0974
      • Botox (botulinum toxin type-A)
      • Dysport (botulinum toxin type-A)
    • New product launches in Japan
      • Botox (botulinum toxin type-A)
      • MK-0974
    • Additional indications
      • Frova gains menstrual migraine indication approval
    • Patent expiries
      • Imitrex (sumatriptan)
      • Amerge (naratriptan)
      • Maxalt (rizatriptan)
      • Zomig (zolmitriptan)
      • Relpax (eletriptan)
      • Axert (almotriptan)
      • Frova (frovatriptan)
      • Depakote (valproate semisodium)
      • Topamax (Topiramate)
  • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
      • Sales calculations
    • Generic erosion and pricing assumptions
    • Definition of the migraine prophylaxis market - assumptions and caveats
  • Forecasts
  • Forecast methodology
• CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
  • Introduction
  • Portfolio management strategies to increase revenue and offset triptan genericization
    • Case study 1: GSK' s migraine franchise lifecycle management strategies
      • GSK' s migraine franchise will suffer as Trexima will only partially offset sumatriptan genericization
      • Understanding Imitrex' s path to success
      • Plan complementary product launches carefully - GSK failed to substantially bolster its portfolio with Amerge
      • Overcoming Imitrex' s US patent expiry poses a daunting challenge for GSK
      • OTC switch looks to continue the UK Imigran brand sales long after patent expiry of the prescription molecule
      • Trexima is key to the future of GSK' s US migraine franchise
      • Trexima scenario forecast
  • Significant opportunity remains in the largely underserved prophylactic market
    • Case study 2: Topamax indication expansion into migraine prophylaxis proves highly successful
      • Topamax' s weight loss effect increases acceptance among patients
      • Topamax' s migraine website provides patients with extensive information
      • Topamax 360 targets educating healthcare professionals
    • New anticonvulsants may offer superior efficacy and tolerability profiles
      • Lyrica shows potential in migraine prophylaxis
      • Non-significant results of zonisamide (Zonegran) hinder potential future in migraine
      • Keppra has been shown to benefit patients with chronic migraine
    • High price-point means triptans are unlikely to enter the prophylactic market
      • Naratriptan has shown promise in patients with chronic migraine
    • Therapies with migraine prevention as the primary indication would offer a better defined treatment approach
      • Minster' s tonabersat is the most promising late-stage migraine-specific preventive therapy
  • Menstrual migraine represents an unknown yet potentially attractive niche market
    • Case study 3: Frova targets approval for the short-term prevention of menstrual migraine
      • FDA delays indication expansion decision for a second time
      • European indication expansion planned under the mutual recognition procedure
      • Positive results from pivotal menstrual migraine studies led to 2006 filing
      • Frova scenario forecast
    • Four triptans have been studied for either acute or preventive therapy of menstrual migraine
      • Randomized controlled evaluations show sumatriptan and zolmitriptan are effective acute therapies
      • Triptan evaluations as intermittent preventive therapy show those with a longer half-life may be better equipped
      • Proposed algorithm for the use of triptans in menstrual migraine shows where opportunities exist for each triptan
    • Longer, post-treatment trials will show if attacks are truly prevented or merely delayed
• BIBLIOGRAPHY
  • Journal papers
  • Websites
  • Newspaper articles
  • Datamonitor reports
• APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
  • ATC classes included in ' others' to define the migraine market
  • Menstrual migraine market sizing calculations
  • Summary migraine market data
  • Triptan market data
  • Anticonvulsant market data
• APPENDIX B - MARKET FORECAST DATA
  • Seven major markets
  • 5EU market forecasts
  • US market forecasts
  • Japan market forecasts
  • France market forecasts
  • Germany market forecasts
  • Italy market forecasts
  • Spain market forecasts
  • UK market forecasts
• APPENDIX C
  • Contributing experts
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the CNS analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Key players in the migraine market, 2007
    • Table 2: Summary of environmental issues in the migraine market across the seven major markets, 2007
    • Table 3: Summary of environmental issues in the seven individual major migraine markets, 2007
    • Table 4: Average standard unit prices ($) of the drug classes prescribed for migraine prophylaxis in the seven major markets, 2003-06
    • Table 5: Summary of over-the-counter triptan drug availability, 2007
    • Table 6: Estimated launch dates for migraine products in the 5EU and US, 2007-2016
    • Table 7: Japan launch dates for migraine pipeline products, 2007-2016
    • Table 8: Key patent expiries of migraine brands across the seven major markets, 2007-2016
    • Table 9: Summary of Frova Phase III results in menstrual migraine
    • Table 10: Other ATC classes included for migraine market definition
    • Table 11: Projected menstrually-related migraine patient potential across the seven major markets, 2010
    • Table 12: Projected pure menstrual migraine patient potential across the seven major markets, 2010
    • Table 13: Migraine summary market data, 2006
    • Table 14: Imitrex: key facts
    • Table 15: Amerge: key facts
    • Table 16: Zomig: key facts
    • Table 17: Maxalt: key facts
    • Table 18: Axert: key facts
    • Table 19: Relpax: key facts
    • Table 20: Frova: key facts
    • Table 21: Topamax: key facts
    • Table 22: Depakote: key facts
    • Table 23: Seven major market migraine drug sales forecasts ($m), 2007-2016
    • Table 24: 5EU migraine drug sales forecasts ($m), 2007-2016
    • Table 25: US migraine drug sales forecasts ($m), 2007-2016
    • Table 26: Japan migraine drug sales forecasts ($m), 2007-2016
    • Table 27: France migraine drug sales forecasts ($m), 2007-2016
    • Table 28: Germany migraine drug sales forecasts ($m), 2007-2016
    • Table 29: Italy migraine drug sales forecasts ($m), 2007-2016
    • Table 30: Spain migraine drug sales forecasts ($m), 2007-2016
    • Table 31: UK migraine drug sales forecasts ($m), 2007-2016
  • List of Figures
    • Figure 1: Datamonitor' s migraine market forecast across the seven major markets, 2007-2016
    • Figure 2: Migraine-specific sales revenue across the seven major markets ($m), 2003-06
    • Figure 3: Performance of the seven major migraine markets ($m), 2005-06
    • Figure 4: Migraine-specific sales volume across the seven major markets (SUs), 2003-06
    • Figure 5: Migraine-specific sales revenue in the 5EU ($m), 2003-06
    • Figure 6: Performance of the nine key migraine therapies across the seven major markets ($m), 2005-06
    • Figure 7: Total triptan migraine-specific sales revenues across the seven major markets by brand (%), 2006
    • Figure 8: Value of the seven major migraine prophylactic market vs. the acute migraine market, 2003-06
    • Figure 9: Migraine-specific sales in the seven major markets for the four leading migraine prophylaxis drug classes ($m), 2003-06
    • Figure 10: Migraine-specific standard units prescribed in the seven major markets for the four leading migraine prophylaxis drug classes, 2003-06
    • Figure 11: Total Topamax brand sales ($m) by indication in the US, 2003-06
    • Figure 12: Percentage of Imitrex sales attributable to cluster headache across the seven major markets, 2006
    • Figure 13: Maxalt 5EU migraine-specific sales by delivery method ($m), 2003-06
    • Figure 14: Generic sumatriptan' s impact in the German, Spanish and UK migraine markets ($m and SUs), 2006
    • Figure 15: Forecasted impact of Imitrex and Topamax patent expiry on the US migraine market ($ billion), 2006-2016
    • Figure 16: Performance of the key migraine therapies in the US ($m), 2005-06
    • Figure 17: Screenshot of the purple Granger in GSK' s Imitrex advert
    • Figure 18: Average triptan standard unit price across the seven major markets ($), 2003-06
    • Figure 19: Performance of the key migraine therapies in Japan ($m), 2005-06
    • Figure 20: Japan migraine-specific triptan sales ($m), 2003-06
    • Figure 21: Performance of the key migraine therapies in France ($m), 2005-06
    • Figure 22: 5EU migraine market by triptan standard units, 2003-06
    • Figure 23: The French cluster headache market ($m), 2004-06
    • Figure 24: Average triptan standard unit price in the 5EU countries ($), 2003-06
    • Figure 25: Performance of the key migraine therapies in Germany ($m), 2005-06
    • Figure 26: Migraine-specific Amerge sales in Germany ($m and SUs), 2003-06
    • Figure 27: Performance of the key migraine therapies in Italy ($m), 2005-06
    • Figure 28: Performance of the key migraine therapies in Spain ($m), 2005-06
    • Figure 29: Migraine-specific quarterly impact of Imitrex genericization in Spain ($m), 2006
    • Figure 30: Performance of the key migraine therapies in the UK ($m), 2005-06
    • Figure 31: Migraine-specific impact of Imitrex genericization in the UK, Germany and Spain ($m), 2005-06
    • Figure 32: Quarterly 5EU migraine-specific Topamax sales ($000s), 2005-06
    • Figure 33: UK migraine-specific anticonvulsant sales, ($m), 2003-06
    • Figure 34: Key events and their impact on the migraine market, 2007-2016
    • Figure 35: Forecasted GSK migraine franchise ($m), 2007-2016
    • Figure 36: SWOT analysis of Imitrex, 2007
    • Figure 37: Migraine-specific seven major market Imitrex sales split by formulation ($m), 2003-06
    • Figure 38: Migraine-specific sales of Imitrex and generic sumatriptan in Germany, Spain and the UK ($m), 2006-07
    • Figure 39: The 2007 Imigran recovery commercial image and strapline
    • Figure 40: Impact of Trexima scenario forecast on GSK' s US migraine franchise ($m), 2006-2016
    • Figure 41: Forecasted seven major market migraine-specific Topamax sales ($m), 2007-2016
    • Figure 42: Seven major market migraine-specific Topamax prescriptions and sales, 2003-06
    • Figure 43: Ortho-McNeil Neurologics Topamax patient website
    • Figure 44: Frova scenario forecast for US and 5EU migraine-specific sales ($m), 2006-2016
    • Figure 45: Proposed algorithm for the use of triptans in menstrual migraine