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

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

Published by: Datamonitor

Published: Sep. 26, 2007 - 187 Pages

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

Abstract

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

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

Table of Contents

Abstract