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Opportunity Analyzer: Respiratory Syncytial Virus (RSV) - Opportunity Analysis and Forecasts to 2024

Summary

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. GlobalData 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.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the RSV marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
- What research and development (R&D) strategies will companies leverage to compete in the future RSV marketplace?
- Which patient population(s) are most likely to be targeted by novel RSV prophylactic and therapeutic agents?
- What clinical and commercial factors are likely to influence RSV product uptake in the 7MM?

Key Findings

- 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. GlobalData 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).
- 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.
- 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.

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.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting RSV product sales in the 7MM.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global RSV market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global RSV market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the RSV market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Table Of Contents

Opportunity Analyzer: Respiratory Syncytial Virus (RSV) - Opportunity Analysis and Forecasts to 2024
1 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
3.1.1 Etiology 22
3.1.2 Pathophysiology 26
3.2 Symptoms and Prognosis 28
3.2.1 Symptoms 28
3.2.2 Prognosis 30
3.3 Quality of Life 31
3.4 Disease Management 31
3.4.1 Diagnosis of RSV Infection 32
3.4.2 Prevention of RSV Infection 34
3.4.3 Treatment of RSV Infection 37
4 Epidemiology 40
4.1 Disease Background 40
4.2 Risk Factors and Comorbidities 41
4.3 Global Trends 43
4.3.1 Preterm Infants and Children Born Preterm and Survived to Two Years of Age 44
4.3.2 Infants with Neonatal CLD 44
4.3.3 Children with Hemodynamically Significant Congenital Heart Disease 45
4.3.4 Children with Congenital Respiratory or Neuromuscular Diseases That Compromise Respiratory Function 45
4.3.5 Third-Trimester Pregnant Women 46
4.3.6 Hospitalizations for RSV Infection 47
4.4 Forecast Methodology 48
4.4.1 Sources Used 54
4.4.2 Sources Not Used 62
4.4.3 Forecast Assumptions and Methods 63
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
4.5.3 Neonatal CLD 79
4.5.4 Third-Trimester Pregnant Women 80
4.5.5 RSV Hospitalizations in Children 81
4.6 Discussion 83
4.6.1 Epidemiological Forecast Insight 83
4.6.2 Limitations of the Analysis 85
4.6.3 Strengths of the Analysis 85
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
5.3.1 Virazole (aerosolized ribavirin) 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
6.2.2 Gap Analysis 106
6.2.3 Opportunity 108
6.3 Prophylactic Vaccines 109
6.3.1 Unmet Need 109
6.3.2 Gap Analysis 111
6.3.3 Opportunity 113
6.4 A Prophylactic mAb with an Increased Half-Life 114
6.4.1 Unmet Need 114
6.4.2 Gap Analysis 115
6.4.3 Opportunity 116
6.5 Point-of-care Testing for RSV in Adult Patients 117
6.5.1 Unmet Need 117
6.5.2 Gap Analysis 118
6.5.3 Opportunity 119
6.6 Increased Awareness of RSV Infections in Adults 119
6.6.1 Unmet Need 119
6.6.2 Gap Analysis 120
6.6.3 Opportunity 120
7 Research and Development Strategies 122
7.1 Overview 122
7.2 Development of Novel Prophylactic Antibodies with Increased Cost-Effectiveness 124
7.3 Technological Approaches to Vaccine Development 126
7.3.1 Vaccine Antigen Selection 127
7.3.2 Development of Maternal Vaccines 132
7.4 Leveraging the FDA's Fast Track Program 135
7.5 Development of RSV Therapeutics 136
7.6 Clinical Trial Design 141
7.6.1 Clinical Trial Design of Key Pipeline Prophylactics 141
7.6.2 Demonstration of Protective Efficacy for Vaccines and Prophylactic Antibodies 147
7.6.3 Clinical Trial Design of Key Pipeline Therapeutics 149
7.6.4 Design and Limitations of Clinical Challenge Studies 153
7.6.5 From Challenge Studies to Demonstrating Efficacy in Naturally Infected Patients 154
8 Pipeline Assessment 156
8.1 Overview 156
8.2 Promising Drugs in Clinical Development - Prophylactic Agents 158
8.2.1 Novavax RSV F Vaccine 158
8.2.2 GSK3003891A 172
8.2.3 MEDI8897 176
8.2.4 REGN2222 184
8.3 Promising Drugs in Clinical Development - Therapeutic Agents 188
8.3.1 ALS-8176 188
8.3.2 ALX-0171 192
8.3.3 GS-5806 (presatovir) 197
8.3.4 JNJ-678 203
8.4 Innovative Early-Stage Approaches 206
9 Pipeline Valuation 209
9.1 Overview 209
9.2 Clinical Benchmark of Key Pipeline Products 209
9.2.1 Prophylactic Agents 209
9.2.2 Therapeutic Agents 210
9.3 Commcercial Benchmark of Key Pipeline Products 211
9.3.1 Prophylactic Agents 211
9.3.2 Therapeutic Agents 213
9.4 Competitive Assessment 214
9.4.1 Prophylactic Agents 214
9.4.2 Therapeutic Agents 216
9.5 Top-Line 10-Year Forecast 217
9.5.1 US 225
9.5.2 5EU 227
9.5.3 Japan 230
10 Appendix 234
10.1 Bibliography 234
10.2 Abbreviations 264
10.3 Methodology 270
10.4 Forecasting Methodology 270
10.4.1 RSV Patient Population Segmentation 270
10.4.2 Percent Drug-Treated Patients 271
10.4.3 Products Included in Each Therapeutic Class 271
10.4.4 Launch and Patent Expiry Dates 272
10.4.5 General Pricing Assumptions 273
10.4.6 Individual Drug Assumptions 274
10.4.7 Pricing of Pipeline Agents 279
10.5 Primary Research - KOLs and Payers Interviewed for this Report 281
10.5.1 KOLs 281
10.5.2 Payers 284
10.6 Primary Research - Prescriber Survey 285
10.7 About the Authors 286
10.7.1 Analyst 286
10.7.2 Epidemiologist 286
10.7.3 Therapy Area Director 286
10.7.4 Global Director of Therapy Analysis and Epidemiology 287
10.7.5 Global Head of Healthcare 287
10.8 About GlobalData 288
10.9 Disclaimer 288

1.1 List of Tables
Table 1: Symptoms of RSV Infection in Infants 29
Table 2: Symptoms of RSV Infection in Elderly and High-Risk Adults 30
Table 3: Guidelines for the Prevention of RSV 36
Table 4: Risk Factors and Comorbidities for Severe RSV Infection 42
Table 5: 7MM, Sources Used to Determine the Preterm Infant Population, 2014 49
Table 6: 7MM, Sources Used to Determine the Incidence of Neonatal CLD, 2014 50
Table 7: 7MM, Sources Used to Determine the Incidence of Hemodynamically Significant Heart Disease in Children, 2014 51
Table 8: 7MM, Sources Used to Determine the Diagnosed Prevalence of Congenital Respiratory and Neuromuscular Diseases That Compromise Respiratory Function in Children, 2014 52
Table 9: 7MM, Sources Used to Determine the Third-Trimester Pregnant Women Population, 2014 53
Table 10: NICHD Neonatal CLD Severity Categorization 57
Table 11: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ?2 Years, N, 2014 74
Table 12: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ?2 Years, N, 2024 75
Table 13: 7MM, Preterm Births, Boys and Girls, Table 14: 7MM, Incident Cases of Neonatal CLD by Severity, Boys and Girls, Table 15: 7MM, Third-Trimester Pregnant Women, N, 2014 and 2024 81
Table 16: 7MM, Confirmed RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014 82
Table 17: 7MM, Estimated RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014 82
Table 18: Leading Drug-Based Interventions for RSV, 2015 88
Table 19: Product Profile - Synagis 91
Table 20: Synagis' Efficacy in the Impact-RSV Study 93
Table 21: Synagis SWOT Analysis, 2015 95
Table 22: Product Profile - Virazole 97
Table 23: Virazole's Efficacy in Mechanically Ventilated Infants with Severe RSV LRTI 98
Table 24: Serious Cardiovascular and Pulmonary AEs Associated with Virazole Treatment 100
Table 25: Virazole SWOT Analysis, 2015 101
Table 26: Unmet Needs and Opportunities in RSV, 2015 104
Table 27: FDA Regulatory Decisions Accelerating the Development of RSV Pipeline Agents, 2015 136
Table 28: Key Phase III and Phase II Clinical Trials of Pipeline Prophylactics 142
Table 29: Key Phase I Clinical Trials of Pipeline Prophylactics 145
Table 30: Key Phase II Clinical Trials of Pipeline Therapeutics 150
Table 31: Key Phase I Clinical Trials of Pipeline Therapeutics 152
Table 32: RSV Therapies and Prophylactics - Late-Stage Pipeline, 2015 158
Table 33: Product Profile - Novavax RSV F Vaccine 166
Table 34: A Phase II Clinical Trial Of Novavax's RSV F Vaccine in Third-Trimester Pregnant Women 169
Table 35: Novavax RSV F Vaccine SWOT Analysis, 2015 171
Table 36: Product Profile - GSK3003891A 174
Table 37: GSK3003891A SWOT Analysis, 2015 176
Table 38: Product Profile - MEDI8897 181
Table 39: Clinical Trials Assessing MEDI8897's Safety 182
Table 40: MEDI8897 SWOT Analysis, 2015 183
Table 41: Product Profile - REGN2222 186
Table 42: REGN2222 SWOT Analysis, 2015 187
Table 43: Product Profile - ALS-8176 190
Table 44: ALS-8176 SWOT Analysis, 2015 192
Table 45: Product Profile - ALX-0171 195
Table 46: ALX-0171 SWOT Analysis, 2015 196
Table 47: Product Profile - GS-5806 200
Table 48: GS-5806 Dosing Cohorts in a Phase IIa Challenge Study 201
Table 49: GS-5806 SWOT Analysis, 2015 202
Table 50: Product Profile - JNJ-678 205
Table 51: JNJ-678 SWOT Analysis, 2015 206
Table 52: RSV Therapies and Prophylactics - Early-Stage Clinical Pipeline, 2015 208
Table 53: Clinical Benchmarking of Key RSV Prophylactic Agents, 2015 210
Table 54: Clinical Benchmarking of Key RSV Therapeutic Agents, 2015 211
Table 55: Commercial Benchmarking of Key RSV Prophylactic Agents, 2015 213
Table 56: Commercial Benchmarking of Key RSV Therapeutic Agents, 2015 214
Table 57: Top-Line Global Sales ($m) Forecasts for RSV, 2014-2024 219
Table 58: 7MM, Key Events Impacting Sales for RSV, 2014-2024 223
Table 59: Global RSV Market - Drivers and Barriers, 2014-2024 224
Table 60: Key Historical and Projected Launch Dates for RSV Across the 7MM 272
Table 61: Key Historical and Projected Patent Expiry Dates for RSV Across the 7MM 272
Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 285

1.2 List 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 (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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