Report title: Commercial Insight: Migraine - Opportunities will exist in the wake of generic attack
from Datamonitor Premium Research Reports
187 page (57580 word) report published Sep 26, 2007

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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


Brief Excerpt: ...With the seven triptan brands continuing to dominate acute migraine treatment and Ortho- McNeil s Topamax (topiramate) driving sales in the prophylactic market, seven major market revenues increased by 8.1% from 2005 to $3.7 billion in 2006. The launch of pipeline drugs will only periodically offset genericization of GSK s Imitrex (sumatriptan) and Topamax. Further triptan genericization will dictate market dynamics through to 2016. Nevertheless, the largely under served prophylactic market and additional indications such as menstrual migraine will conti nue to present attractive opportunities to both current and future market players. Coverage: Seven major markets (US, Franc e, Germany, Italy, Spain, UK, and Japan) ...

Report Type: Report
Industry(ies): Diversified Services
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Table of Contents:ABOUT DATAMONITOR HEALTHCARE 2
About the Migraine pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the migraine market 3
Market forecast summary 5
Contributing experts 5
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Current market situation 9
Seven major migraine market growth shows signs of slowing 9
Sales in the US dominate the total seven major migraine market 9
France is the largest migraine market in the 5EU 11
Triptans remain gold-standard class for the acute treatment of migraine 12
Imitrex maintains leadership of acute treatment market 12
Zomig outdoes Imitrex to become 5EU treatment of choice 13
Rapid Topamax uptake into immature prophylaxis market represents key growth driver 14
Strategic scoping and focus 17
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 18
Summary of environmental issues affecting migraine market size 18
Seven major market opportunities and threats 20
Opportunities 20
Substantial revenue exists in the prophylactic migraine market 20
Patient and physician education will expand patient pool and improve the quality of migraine management 26
Niche indications represent opportunities to increase revenue 27
Desire for improved patient acceptability promotes the development of different delivery methods 31
OTC availability substantially widens customer base 33
Threats 34
Generics 34
Cost-containment measures impact treatment choice and duration 36
OTC medications continue to provide strong competition to prescription drugs 38
Triptan safety issues limit their use 40
US: opportunities and threats 42
Opportunities 43
Advocacy and DTC campaigns drive public awareness of migraine 43
Comparatively high price of branded drugs possible in US market 45
Direct access to specialist physicians helps patients receive optimal treatment quicker 46
Threats 47
Insurance companies limit access to migraine medications 47
High drug prices increases the threatening impact of genericization 49
New migraine treatments will suffer as a result of restricted DTC advertising 49
Japan: opportunities and threats 51
Opportunities 51
Japanese migraine market shows scope for greater development 51
Plans to improve the drug approval review system in Japan 53
Governmental funding for clinical trials could benefit research into migraine 53
Threats 54
Public education greatly needed to raise poor awareness of migraine in Japan 54
Government plans to double the use of generics by the end of 2012 54
France: opportunities and threats 55
Opportunities 55
Large and well-treated French market is an attractive region to launch new therapies 55
Innovative drug development encouraged by price premium and high-level reimbursement 57
France currently has low generic incursion 57
High prescriptions of triptans for cluster headaches in France make it a target additional indication 58
Threats 59
After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future 59
Germany: opportunities and threats 61
Opportunities 62
German government initiative to boost biopharma R&D 62
OTC availability increases presence of brand availability 63
Threats 64
Pharmaceutical-Prescribing-Efficiency-Act - bonus-malus encourages generic prescribing 64
Italy: opportunities and threats 66
Opportunities 67
National migraine campaigns drive public awareness 67
Threats 67
Italy forces drug firms to give licenses for generics rivals 67
Spain: opportunities and threats 69
Opportunities 69
Low brand prices reduce the threat of genericization 69
Primary care interest in migraine is high 70
Threats 71
R&D activity expected to decline 71
UK: opportunities and threats 72
Opportunities 73
Highest 5EU price point achievable in the UK 73
New BASH guidelines clarify treatment algorithm and promote the use of triptans 73
Threats 76
Genericization is a big threat in the UK market 76
UK government looks to renegotiate the Pharmaceutical Price Regulation Scheme 77
Slow Topamax uptake shows that prophylactic treatment is restricted in the UK 78
CHAPTER 4 FORECAST ANALYSIS 81
Key events 81
New product launches 82
Frova launches in France 82
Trexima (sumatriptan +naproxen sodium combination) 83
PRO-513 85
Sumatriptan Intraject 86
Sumatriptan oral spray 88
MK-0974 89
Botox (botulinum toxin type-A) 91
Dysport (botulinum toxin type-A) 94
New product launches in Japan 95
Botox (botulinum toxin type-A) 95
MK-0974 96
Additional indications 96
Frova gains menstrual migraine indication approval 96
Patent expiries 97
Imitrex (sumatriptan) 97
Amerge (naratriptan) 99
Maxalt (rizatriptan) 99
Zomig (zolmitriptan) 100
Relpax (eletriptan) 100
Axert (almotriptan) 100
Frova (frovatriptan) 100
Depakote (valproate semisodium) 101
Topamax (Topiramate) 101
Data definitions, limitations and assumptions 102
Standard units 102
Japanese market data 102
Derivation of sales forecasts and pricing trends 102
Sales calculations 103
Generic erosion and pricing assumptions 103
Definition of the migraine prophylaxis market - assumptions and caveats 103
Forecasts 104
Forecast methodology 104
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 105
Introduction 105
Portfolio management strategies to increase revenue and offset triptan genericization 105
Case study 1: GSK's migraine franchise lifecycle management strategies 106
GSK's migraine franchise will suffer as Trexima will only partially offset sumatriptan genericization 106
Understanding Imitrex's path to success 107
Plan complementary product launches carefully - GSK failed to substantially bolster its portfolio with Amerge 110
Overcoming Imitrex's US patent expiry poses a daunting challenge for GSK 111
OTC switch looks to continue the UK Imigran brand sales long after patent expiry of the prescription molecule 112
Trexima is key to the future of GSK's US migraine franchise 115
Trexima scenario forecast 117
Significant opportunity remains in the largely underserved prophylactic market 119
Case study 2: Topamax indication expansion into migraine prophylaxis proves highly successful 120
Topamax's weight loss effect increases acceptance among patients 123
Topamax's migraine website provides patients with extensive information 123
Topamax 360 targets educating healthcare professionals 124
New anticonvulsants may offer superior efficacy and tolerability profiles 125
Lyrica shows potential in migraine prophylaxis 125
Non-significant results of zonisamide (Zonegran) hinder potential future in migraine 126
Keppra has been shown to benefit patients with chronic migraine 127
High price-point means triptans are unlikely to enter the prophylactic market 127
Naratriptan has shown promise in patients with chronic migraine 127
Therapies with migraine prevention as the primary indication would offer a better defined treatment approach 128
Minster's tonabersat is the most promising late-stage migraine-specific preventive therapy 128
Menstrual migraine represents an unknown yet potentially attractive niche market 129
Case study 3: Frova targets approval for the short-term prevention of menstrual migraine 130
FDA delays indication expansion decision for a second time 130
European indication expansion planned under the mutual recognition procedure 131
Positive results from pivotal menstrual migraine studies led to 2006 filing 131
Frova scenario forecast 132
Four triptans have b

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