[Report] Migraine Commercial Insight Market Research, Trends, Analysis TOC

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

Commercial Insight: Migraine - Opportunities will exist in the wake of generic attack

Table of Contents