OpportunityAnalyzer: Respiratory Syncytial Virus (RSV) - Opportunity Analysis and Forecasts to 2024 Telephone: +1 (800) 910-6452 Mail at: sales@researchbeam.com
Report Overview Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense ribonucleic acid (RNA) pneumovirus belonging to the family of Paramyxoviridae. The virus was discovered in 1956, first as an isolate from a laboratory chimpanzee displaying symptoms of the common cold, and later from infants suffering from respiratory disease. RSV can cause upper respiratory tract infections (the common cold) and is the most important cause of lower respiratory tract infections, such as bronchiolitis and pneumonia, in infants. RSV is also an important cause of hospitalizations and deaths in elderly adults. Today, Medimmune’s Synagis (palivizumab) is the only licensed intervention for the prevention of RSV in infants at a high risk of severe infection. This humanized, mouse monoclonal antibody (mAb) was first approval in 1998, and while it is an efficacious prophylactic intervention, its short 20-day half-life necessitates monthly dosing during the RSV season. Moreover, the high cost of Synagis limits its use to certain subgroups of infants who are at high risk of severe RSV infection, and it is not indicated for use in elderly adults, leaving a key population of high-risk individuals unprotected. Furthermore, due to the absence of effective RSV-specific antivirals, the treatment of RSV infections is largely restricted to a number of supportive treatment options. This projects the global RSV marketplace - which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan) - to experience unprecedented growth from 2014-2024, driven by the arrival of novel approaches to prevention and management of RSV. Scope - Overview of RSV infections, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies. - Topline RSV market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
Report Overview Key Findings
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The global RSV marketplace - which, for the purposes of this report, encompasses the sales of products for the prevention or treatment of RSV in the 7MM - was worth approximately $640m in 2014. This projects the market to surpass $2.3bn in sales by 2024, at a compound annual growth rate (CAGR) of 29.9% from 2014-2024. The sales are projected to originate predominantly from the US (a 62% market share), followed distantly by the 5EU (a 29% market share).
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The anticipated arrival of novel prophylactic mAbs that boast improved dosing criteria compared with Synagis, led by MedImmune’s MEDI8897, will be a principal driver of RSV market growth across the 7MM. The licensure of the first adult vaccine to offer protection against RSV, Novavax’s RSV-F Vaccine, will also stimulate rapid growth in a previously untapped segment of the marketplace.
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A persistent lack of patient and physician awareness of RSV in adult patients - specifically the infection’s substantial impact on morbidity and mortality in the elderly - will serve as a key impediment to market growth from 2014-2024.
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Table of Contents 1 Table of Contents 10 1.1 List of Tables 15 1.2 List of Figures 18 2 Introduction 19 2.1 Catalyst 19 2.2 Related Reports 20 2.3 Upcoming Related Reports 21 3 Disease Overview 22 3.1 Etiology and Pathophysiology 22 3.2 Symptoms and Prognosis 28 3.3 Quality of Life 31 3.4 Disease Management 31 4 Epidemiology 40 4.1 Disease Background 40 4.2 Risk Factors and Comorbidities 41 4.3 Global Trends 43 4.4 Forecast Methodology 48 4.4.1 Sources Used 54 4.4.2 Sources Not Used 62 4.5 Epidemiological Forecast for RSV Infection (2014-2024) 72 4.5.1 Risk Groups for Severe RSV Infection in Children Less than Two Years 72 4.5.2 Preterm Births 78
Table of Contents 5 Current Treatment Options 87 5.1 Overview 87 5.2 Product Profiles - RSV Prophylactics 89 5.2.1 Synagis (palivizumab) 89 5.3 Product Profiles - RSV Therapeutics 95 5.4 Other Supportive Measures 101 6 Unmet Needs and Opportunities 103 6.1 Overview 103 6.2 Effective Therapeutic Interventions 105 6.2.1 Unmet Need 105 7 Research and Development Strategies 122 8 Pipeline Assessment 156 8.1 Overview 156 8.2 Promising Drugs in Clinical Development - Prophylactic Agents 158 9 Pipeline Valuation 209 9.1 Overview 209 9.2 Clinical Benchmark of Key Pipeline Products 209 9.2.1 Prophylactic Agents 209 10 Appendix 234 10.1 Bibliography 234 10.2 Abbreviations 264 10.3 Methodology 270 10.4 Forecasting Methodology 270
Table of Figures Figure 1: The RSV Virion 24 Figure 2: Life Cycle of RSV 26 Figure 3: Case Flow Map for RSV Prophylactic and Therapeutic Populations 54 Figure 4: Population Estimates and Births Forecast for the US, Boys and Girls, 1997-2024 64 Figure 5: 7MM, Children Born Preterm (<37 Weeksâ&#x20AC;&#x2122; GA) Surviving to Ages 0-2 Years, Boys and Girls, N, 2014 and 2024 76 Figure 6: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ?2 Years, N, 2014 77 Figure 7: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ?2 Years, N, 2024 78 Figure 8: Competitive Assessment of Key RSV Prophylactic Agents, 2014-2024 215 Figure 9: Competitive Assessment of Key RSV Therapeutic Agents, 2014-2024 217 Figure 10: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014 and 2024 220 Figure 11: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014-2024 221 Figure 12: Global Sales ($m) for RSV Therapeutics and Prophylactics by Product Class, 2014-2024 222 Figure 13: Sales ($m) for RSV Prophylactics in the US, 2014-2024 226 Figure 14: Sales ($m) for RSV Therapeutics in the US, 2024 227 Figure 15: Sales ($m) for RSV Prophylactics in the 5EU, 2014-2024 229 Figure 16: Sales ($m) for RSV Therapeutics in the 5EU, 2024 230 Figure 17: Sales ($m) for RSV Prophylactics in Japan, 2014-2024 232 Figure 18: Sales ($m) for RSV Therapeutics in Japan, 2024 233
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