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

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

Summary

Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense...
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OpportunityAnalyzer: 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.

Additional Information

Additional Information

Publisher name GlobalData.
Format PDF
Page count 289
Publication date 1 Jan 2016
Table of contents

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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
3.1.1 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

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