Introduction
Within the herpes and respiratory antiviral subcategory HSV/VZV products have been key growth drivers, accounting for 77% of a market worth $2,190m in 2004. Despite lost of US branded Valtrex in 2009, the continued uptake of flu and post-transplant CMV antivirals along with the anticipated launch of first-in-class RSV antiviral, A-60444 will to some extent offset revenue loss by 2014.
Scope
- Market overview by geographical area and disease indication, with value analysis of clinical and commercial factors underlying product performance
- Assessment of country-specific drivers and resistors likely to impact the herpes and respiratory antiviral market
- Case study analysis of the key players in the market and further the success of follow-up products Valtrex for HSV/VZV and Valcyte for CMV
- Future market outlook per disease indication and individual products taking into account key market events in particular, patent expiries
Highlights
The anti-infective vaccine market is poised for explosive growth, leading to a shift of R&D focus from antiviral therapy to preventative vaccination and hence a dwindling herpes and respiratory antiviral pipeline. However, clinical unmet needs mainly in CMV, VZV related post-herpetic neuralgia (PHN) and RSV maintain the call for new products.Capitalizing on the Zovirax legacy, a large number of indication expansions and effective marketing strategies by ID leader GSK, sales of follow-up product Valtrex have experienced accelerated growth. In 2004, Valtrex achieved blockbuster status, selling $1,090m in the seven major markets.
Currently available RSV therapies are sub-optimal and expensive, being reserved for ’at risk’ immunocompromised patient groups such as neonates. With successful development and positioning of first-in-class RSV small molecule inhibitor A-60444, Arrow/Novartis could establish a new treatment paradigm in RSV.
Reasons to Purchase
- Identify key environmental opportunities and threats that will impact the use and uptake of new and existing products
- Select effective lifecycle management strategies through best-in-class case study analysis of key players in the market
- Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the herpes and respiratory antivirals market 3
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 11
Market definition for this report 11
Pathogens and disease indications 13
Herpesviruses 13
Herpes simplex virus (HSV) 14
Varicella zoster virus (VZV) 18
Cytomegalovirus (CMV) 20
Respiratory viruses 23
Influenza (flu) 23
Respiratory syncytial virus (RSV) 25
Unmet needs in the herpes and respiratory antiviral market 28
Current market situation 29
Higher pricing fuels double-digit growth 31
Herpes products dominate 35
Brands account for the majority of sales 37
Herpes drug Valtrex propels GSK to market leader 38
Activity in the herpes and respiratory antiviral pipeline is low 40
Indication expansion favored over new drug development 41
Novartis and Medivir take the lead in the herpes and RSV antiviral pipelines 42
Influenza and RSV are the main vaccine pipeline drivers 43
Future market outlook 44
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 46
Current and future opportunities and threats in the herpes and respiratory antiviral market 46
Global opportunities and threats 46
Opportunities 46
Threats 53
US: opportunities and threats 58
Herpes and respiratory antiviral market overview 58
Opportunities 61
Threats 64
Japan: opportunities and threats 64
Herpes and respiratory antiviral market overview 64
Opportunities 67
Threats 68
France: opportunities and threats 70
Herpes and respiratory antiviral market overview 70
Opportunities 73
Threats 75
Germany: opportunities and threats 77
Herpes and respiratory antiviral market overview 77
Opportunities 80
Threats 82
Italy: opportunities and threats 85
Herpes and respiratory antiviral market overview 85
Opportunities 88
Threats 89
Spain: opportunities and threats 91
Herpes and respiratory antiviral market overview 91
Opportunities 94
Threats 96
UK: opportunities and threats 98
Herpes and respiratory antiviral market overview 98
Opportunities 100
Threats 101
Summary of environmental issues affecting the herpes and respiratory antiviral market size 105
CHAPTER 4 FORECAST ANALYSIS 106
Assumptions and events 106
Events excluded from the forecast 106
Product-specific events 107
Valtrex (valacyclovir) 109
Zovirax (acyclovir) 110
Valcyte (valganciclovir) 110
Tamiflu (oseltamivir) 111
Relenza (zanamivir) 113
Patent expiries 114
General assumptions for the assessment of generic incursion following patent expiry 115
Overview of patent expiries expected to occur in the forecast period 116
Cytovene – effective switching to Valcyte discourages generic manufacturers from market entry 116
Valtrex is expected to suffer the same fate as predecessor Zovirax 117
Famvir – attractive target in the US 119
Vistide – limited use and toxicity likely to deter generic competition 119
Relenza – poor historic and anticipated future performance in the influenza prescription market is unlikely to attract generic incursion 120
Valcyte 120
New drug launches 120
Valomaciclovir – efficacy in treating PHN provides competitive edge 121
A60444 – first-in-class RSV antiviral with blockbuster potential 123
CS8958 (R118958) – too similar to Relenza to be successful? 126
Limitations of data 126
Standard units 126
Japanese market data 127
Regional launch dates for new products 127
Forecasts 127
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 128
Introduction 128
Portfolio management of the top herpes and respiratory antiviral players 128
Modest market with few significant players and little new product development 128
GSK is both ID and herpes market leader 132
Roche – strong present and future position in CMV and influenza 142
Novartis – pioneer of the RSV antiviral market? 153
Achieving and maintaining market leadership 162
Valtrex – leading in herpes simplex and herpes zoster 162
Cytovene and Valcyte – gold standards in the CMV transplant market 173
APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 183
Definition of the Pacific Rim 183
Market forecast data 184
Global herpes and respiratory antiviral market forecasts, 2005–2014 184
M5EU herpes and respiratory antiviral market forecasts, 2005–2014 185
US herpes and respiratory antiviral market forecasts, 2005–2014 186
Pacific Rim herpes and respiratory antiviral market forecasts, 2005–2014 187
France herpes and respiratory antiviral market forecasts, 2005–2014 188
Germany herpes and respiratory antiviral market forecasts, 2005–2014 189
Italy herpes and respiratory antiviral market forecasts, 2005–2014 190
Spain herpes and respiratory antiviral market forecasts, 2005–2014 191
UK herpes and respiratory antiviral market forecasts, 2005–2014 192
Global herpes and respiratory antiviral market data 193
HSV and VZV antivirals market data 194
CMV antivirals market data 199
Influenza antivirals market data 203
RSV antivirals market data 207
APPENDIX B 208
Bibliography 208
Journals 208
Clinical guidelines 209
Datamonitor reports 209
Clinical trial data 210
Miscellaneous 210
Press releases 212
Websites 216
Report methodology 217
Disclaimer 218
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