Stakeholder Opinions: Respiratory viral infections - Respiratory syncytial virus, parainfluenza virus and human metapneumovirus as promising new targets

Introduction

The 2009/10 influenza H1N1 pandemic has boosted awareness of respiratory viral infections. Stockpiling has been pivotal for the strong growth of the influenza antivirals market, with 2009 seven major market sales reaching $1,772m. As the pandemic recedes, other promising targets in the sector include respiratory syncytial virus (RSV), parainfluenza virus (PIV) and human metapneumovirus (hMPV).

Scope

*Analysis of the market for respiratory viral infections across the US, Japan, France, Italy, Germany, Spain and the UK

*Strategic analysis of key marketed brands and pipeline candidates

*Thorough assessment of key developments shaping the sector

*In-depth discussion of opportunities and threats for respiratory antivirals across the seven major markets

Highlights

The pandemic threat has fuelled growth of the influenza antivirals market, with total 7MM sales of $1,772m in 2009 and a compound annual growth rate of 31.9% from 2005-09. Convenient oral dosing makes Roche's Tamiflu the market leader, with 2009 sales of $1,426m in the 7MM.

The role of rapid point-of-care diagnostics divides opinion, with uptake deterred by high cost and poor performance, although reimbursement in Japan facilitates greater antiviral usage for seasonal influenza. Growing resistance to Tamiflu highlights the need for new oral or infrequently dosed inhaled antivirals with a strong resistance profile.

A vaccine is a key unmet need for RSV, with physicians divided on the need for and efficacy of antivirals for RSV treatment. Synagis saw 7MM sales of $1,218m in 2009, although high cost is increasingly hindering its commercial prospects, highlighting the growing opportunity for vaccines and an additional potential role for cheaper therapeutics.

Reasons to Purchase

*Identify key opportunities that will impact the use and uptake of new and existing products

*Understand key internal and external factors shaping the therapeutic landscape for respiratory antivirals

*Gain competitive advantage by identifying key product characteristics and potential roles for new therapies

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Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Infectious Diseases pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
Market definition for this report 3
Datamonitor insight into the respiratory viral infections market 3
Related reports 5
Upcoming reports 5
Table of Contents 6
1. Patient Potential 7
Key findings 7
Respiratory viral infections - an overview 8
Influenza 9
Respiratory syncytial virus (RSV) 11
Parainfluenza virus (PIV) 12
Human metapneumovirus (hMPV) 12
Epidemiology 13
Seven major markets 13
Respiratory viral infections represent a huge burden across the seven major markets 13
US 17
Up to one-fifth of the US population suffers from seasonal influenza each year 17
Population-based data suggest a significantly greater burden from RSV than from influenza in young children 17
PIV burden justifies allocation of resources for vaccine candidate development 19
Japan 20
Nearly 10% of the Japanese population contracts influenza each year 20
High burden of RSV in Japan is comparable with that of the US 20
Five major EU markets 21
RSV linked with notably more infant hospitalizations than influenza A and B 21
UK data suggest RSV is the dominant viral respiratory pathogen in young children 22
Population-based data suggest a higher incidence of hMPV than influenza in Spanish infants 22
Rest of the world 22
Current treatment options 26
Influenza - Tamiflu and Relenza dominate the antivirals market 29
RSV - blockbuster status for Synagis 30
No treatments are available for PIV or hMPV 31
Patient care path 31
Trigger point 1: Pharmaceutical companies should attempt to increase awareness of RVIs among physicians and the general public 33
Trigger point 2: Use of laboratory diagnostics can identify the causative virus and affect the treatment choice 34
Trigger point 3: Influence initial brand choice 34
Unmet need in respiratory viral infections 34
Influenza: there is a large unmet need for new antivirals with improved resistance profiles and efficacy 34
New oral antivirals with improved resistance profiles and efficacy are required to overcome the emerging shortcomings of Tamiflu 35
There is an attractive market gap for an intravenously administered influenza antiviral in hospital inpatients 36
RSV: high disease burden necessitates investment in new treatment options and vaccine development 36
PIV and hMPV: potentially attractive new markets for therapeutics and vaccines 38
Target product profile versus current level of attainment 38
2. Market Potential 42
Key findings 42
Current market overview 43
Influenza 43
Government stockpiling contracts make Roche's Tamiflu the clear market leader 43
US 46
Japan 47
Five major EU countries 49
Rest of the World 50
Respiratory syncytial virus (RSV) 54
MedImmune's Synagis demonstrates the potential of the RSV market 54
Opportunities and threats 59
Opportunities 60
Pandemic threat increases public awareness of influenza and other respiratory viral infections and fuels the demand for prevention and treatment 60
Growing use of point-of-care diagnostics 60
Emergence of antiviral resistance to current therapies 61
Growing viral respiratory infection burden as a result of aging populations 61
Limited generic competition in the respiratory antivirals sector 62
Threats 62
Cost of point-of-care rapid diagnostics deters use in some markets 62
Negative press and publicity during the influenza A (H1N1) pandemic could reduce the future market opportunity for influenza antivirals 62
3. Brand Dynamics 63
Key findings 63
Overview of the competitive landscape 64
Influenza 64
Respiratory syncytial virus (RSV) 66
Tamiflu (oseltamivir, Roche) 67
Drug profile 67
Product positioning 68
SWOT analysis 69
Relenza (zanamivir, GlaxoSmithKline) 71
Drug profile 71
Product positioning 73
SWOT analysis 74
Synagis (palivizumab, MedImmune/AstraZeneca) 75
Drug profile 75
Product positioning 77
SWOT analysis 77
4. Pipeline Analysis 80
Key findings 80
Influenza 81
Pipeline overview 81
Rapiacta (peramivir; BioCryst/Shionogi) 82
Drug profile 82
Development overview 84
Product positioning 87
SWOT analysis 87
Laninamivir (Daiichi Sankyo/Biota) 89
Drug profile 89
Development overview 90
Product positioning 93
SWOT analysis 93
Favipiravir (T-705, Toyama) 95
Fludase (DAS181, NexBio) 96
Key early-stage compounds 98
Respiratory syncytial virus (RSV) 99
Pipeline overview 99
ALN-RSV01 (Alnylam Pharmaceuticals/Cubist) 100
RSV604 (Arrow Therapeutics/Novartis) 102
Motavizumab (MedImmune/AstraZeneca) 103
Key early-stage compounds 105
Late-stage development compounds recently discontinued 107
Parainfluenza virus (PIV) and human metapneumovirus (hMPV) 108
Outlook - The future of treatment in Respiratory Viral Infections 109
More favorable cost and improved performance characteristics are required in order to make rapid point-of-care diagnostics more attractive 109
New intravenous or infrequently inhaled influenza antivirals have a promising market opportunity 111
RSV antiviral drugs show promise, although a vaccine remains a distant possibility 112
Vaccines for PIV and hMPV are needed, while developers shun antivirals 117
Rhinovirus identified by physicians as a potentially lucrative antiviral target 119
Bibliography 120
Journals 120
Websites 125
Datamonitor reports 132
Appendix A 133
Data definitions, limitations and assumptions 133
Standard units 133
Country group definitions 133
Rest of European Union 133
Middle East and North Africa (MENA) 133
Rest of World 133
Exchange rates 133
Appendix B 135
Contributing experts 135
Conferences attended 135
Report methodology 135
About Datamonitor 136
About Datamonitor Healthcare 136
About the Infectious Disease and Respiratory analysis team 137
Disclaimer 139
List of Tables
Table 1: Country-specific annual incidence, hospitalization, and mortality data for influenza 14
Table 2: Country-specific annual incidence, hospitalization, and mortality data for respiratory syncytial virus (RSV) 15
Table 3: Country-specific annual incidence and hospitalization data for parainfluenza virus (PIV) in the US 16
Table 4: Country-specific annual incidence data for human metapneumovirus (hMPV) 16
Table 5: Leading treatments for influenza in the seven major markets, 2010 27
Table 6: Leading treatments for respiratory syncytial virus (RSV), parainfluenza virus (PIV), and human metapneumovirus (hMPV) in the seven major markets, 2010 28
Table 7: Target product profile (TPP) for influenza antiviral drugs, 2010 40
Table 8: Influenza antiviral drug and class sales dynamics across the seven major markets ($m), 2005-09 45
Table 9: Global sales dynamics of the influenza antivirals market ($m), 2005-09 51
Table 10: Global influenza market sales by region, 2005-09 54
Table 11: Respiratory syncytial virus (RSV) drug sales dynamics across the seven major markets ($m), 2005-09 57
Table 12: Summary of opportunities and threats in the respiratory viral infection (RVI) market across the seven major markets, 2010 60
Table 13: Tamiflu (oseltamivir) - drug profile, 2010 68
Table 14: Relenza (zanamivir) - drug profile, 2010 73
Table 15: Synagis (palivizumab) - drug profile, 2010 76
Table 16: Products in late-stage clinical development for influenza treatment, 2010 81
Table 17: Rapiacta (peramivir) - drug profile, 2010 83
Table 18: Summary of key clinical trials Rapiacta (peramivir) 86
Table 19: Laninamivir - drug profile, 2010 90
Table 20: Summary of key clinical trials for laninamivir, 2010 92
Table 21: Favipiravir - drug profile, 2010 95
Table 22: Fludase - drug profile, 2010 98
Table 23: Key products in the early-stage R&D pipeline for influenza treatment and prophylaxis, 2010 99
Table 24: Products in late-stage clinical development for respiratory syncytial virus (RSV), 2010 100
Table 25: ALN-RSV01 - drug profile, 2010 101
Table 26: RSV604 - drug profile, 2010 102
Table 27: Motavizumab - drug profile, 2010 105
Table 28: Key products in early-stage R&D pipeline for respiratory syncytial virus (RSV) treatment and prevention, 2010 106
Table 29: Discontinued R&D projects for respiratory syncytial virus (RSV), 2010 108
Table 30: Key products in the R&D pipeline for parainfluenza virus (PIV), 2010 108
Table 31: Vaccines in clinical development for respiratory syncytial virus (RSV), 2010 114
Table 32: Key products in R&D pipeline for parainfluenza virus (PIV), 2010 117
Table 33: Exchange rates, 2009 134
List of Figures
Figure 1: Epidemiology and burden of respiratory viral infections in selected Rest of the World countries 25
Figure 2: Infectious Diseases Society of America clinical practice guidelines for seasonal influenza, 2009 30
Figure 3: Respiratory viral infections patient path 33
Figure 4: Key unmet needs for the treatment of influenza, 2010 35
Figure 5: Key unmet needs for the treatment of respiratory syncytial virus (RSV), parainfluenza virus (PIV), and human metapneumovirus (hMPV), 2010 37
Figure 6: Sales value of the influenza antiviral market across the seven major markets ($m), 2005-09 44
Figure 7: Regional sales dynamics of the influenza antiviral market ($m), 2005-09 46
Figure 8: Market share of influenza antivirals in the US (%), 2005-09 47
Figure 9: Market share of influenza antivirals in Japan (%), 2005-09 49
Figure 10: Market share of different influenza antivirals in the five major EU markets (%), 2005-09 50
Figure 11: Global influenza antiviral market sales ($m), 2005-09 52
Figure 12: Global influenza antiviral market volume use (IMS standard units sold) and value sales (%). 2009 53
Figure 13: Synagis (palivizumab; MedImmune/AstraZeneca) sales across the seven major markets ($m), 2005-09 56
Figure 14: Global Synagis (palivizumab MedImmune/AstraZeneca) sales by value (%) and volume (SU), 2009 58
Figure 15: Regional sales dynamics of Synagis (palivizumab, MedImmune/AstraZeneca) in the seven major markets ($m), 2005-09 59
Figure 16: Tamiflu - SWOT analysis, 2010 70
Figure 17: Relenza - SWOT analysis, 2010 74
Figure 18: Synagis - SWOT analysis, 2010 78
Figure 19: Rapiacta - SWOT analysis, 2010 88
Figure 20: Laninamivir - SWOT analysis, 2010 94
Figure 21: Favipiravir (T-705) mechanism of action 95

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