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.
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1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Symptoms and Prognosis
3.2.1 Symptoms
3.2.2 Prognosis
3.3 Quality of Life
3.4 Disease Management
3.4.1 Diagnosis of RSV Infection
3.4.2 Prevention of RSV Infection
3.4.3 Treatment of RSV Infection
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 Preterm Infants and Children Born Preterm and Survived to Two Years of Age
4.3.2 Infants with Neonatal CLD
4.3.3 Children with Hemodynamically Significant Congenital Heart Disease
4.3.4 Children with Congenital Respiratory or Neuromuscular Diseases That Compromise Respiratory Function
4.3.5 Third-Trimester Pregnant Women
4.3.6 Hospitalizations for RSV Infection
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Sources Not Used
4.4.3 Forecast Assumptions and Methods
4.5 Epidemiological Forecast for RSV Infection (2014-2024)
4.5.1 Risk Groups for Severe RSV Infection in Children Less than Two Years
4.5.2 Preterm Births
4.5.3 Neonatal CLD
4.5.4 Third-Trimester Pregnant Women
4.5.5 RSV Hospitalizations in Children
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.2 Product Profiles - RSV Prophylactics
5.2.1 Synagis (palivizumab)
5.3 Product Profiles - RSV Therapeutics
5.3.1 Virazole (aerosolized ribavirin)
5.4 Other Supportive Measures
6 Unmet Needs and Opportunities
6.1 Overview
6.2 Effective Therapeutic Interventions
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Prophylactic Vaccines
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 A Prophylactic mAb with an Increased Half-Life
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Point-of-care Testing for RSV in Adult Patients
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Increased Awareness of RSV Infections in Adults
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
7 Research and Development Strategies
7.1 Overview
7.2 Development of Novel Prophylactic Antibodies with Increased Cost-Effectiveness
7.3 Technological Approaches to Vaccine Development
7.3.1 Vaccine Antigen Selection
7.3.2 Development of Maternal Vaccines
7.4 Leveraging the FDA’s Fast Track Program
7.5 Development of RSV Therapeutics
7.6 Clinical Trial Design
7.6.1 Clinical Trial Design of Key Pipeline Prophylactics
7.6.2 Demonstration of Protective Efficacy for Vaccines and Prophylactic Antibodies
7.6.3 Clinical Trial Design of Key Pipeline Therapeutics
7.6.4 Design and Limitations of Clinical Challenge Studies
7.6.5 From Challenge Studies to Demonstrating Efficacy in Naturally Infected Patients
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development - Prophylactic Agents
8.2.1 Novavax RSV F Vaccine
8.2.2 GSK3003891A
8.2.3 MEDI8897
8.2.4 REGN2222
8.3 Promising Drugs in Clinical Development - Therapeutic Agents
8.3.1 ALS-8176
8.3.2 ALX-0171
8.3.3 GS-5806 (presatovir)
8.3.4 JNJ-678
8.4 Innovative Early-Stage Approaches
9 Pipeline Valuation
9.1 Overview
9.2 Clinical Benchmark of Key Pipeline Products
9.2.1 Prophylactic Agents
9.2.2 Therapeutic Agents
9.3 Commcercial Benchmark of Key Pipeline Products
9.3.1 Prophylactic Agents
9.3.2 Therapeutic Agents
9.4 Competitive Assessment
9.4.1 Prophylactic Agents
9.4.2 Therapeutic Agents
9.5 Top-Line 10-Year Forecast
9.5.1 US
9.5.2 5EU
9.5.3 Japan
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 RSV Patient Population Segmentation
10.4.2 Percent Drug-Treated Patients
10.4.3 Products Included in Each Therapeutic Class
10.4.4 Launch and Patent Expiry Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Drug Assumptions
10.4.7 Pricing of Pipeline Agents
10.5 Primary Research - KOLs and Payers Interviewed for this Report
10.5.1 KOLs
10.5.2 Payers
10.6 Primary Research - Prescriber Survey
10.7 About the Authors
10.7.1 Analyst
10.7.2 Epidemiologist
10.7.3 Therapy Area Director
10.7.4 Global Director of Therapy Analysis and Epidemiology
10.7.5 Global Head of Healthcare
10.8 About Us
10.9 Disclaimer
1.1 List of Tables
Table 1: Symptoms of RSV Infection in Infants
Table 2: Symptoms of RSV Infection in Elderly and High-Risk Adults
Table 3: Guidelines for the Prevention of RSV
Table 4: Risk Factors and Comorbidities for Severe RSV Infection
Table 5: 7MM, Sources Used to Determine the Preterm Infant Population, 2014
Table 6: 7MM, Sources Used to Determine the Incidence of Neonatal CLD, 2014
Table 7: 7MM, Sources Used to Determine the Incidence of Hemodynamically Significant Heart Disease in Children, 2014
Table 8: 7MM, Sources Used to Determine the Diagnosed Prevalence of Congenital Respiratory and Neuromuscular Diseases That Compromise Respiratory Function in Children, 2014
Table 9: 7MM, Sources Used to Determine the Third-Trimester Pregnant Women Population, 2014
Table 10: NICHD Neonatal CLD Severity Categorization
Table 11: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2014
Table 12: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2024
Table 13: 7MM, Preterm Births, Boys and Girls, <37 Weeks’ GA, N (Row %), 2014
Table 14: 7MM, Incident Cases of Neonatal CLD by Severity, Boys and Girls, <32 Weeks GA, N (Row %), 2014
Table 15: 7MM, Third-Trimester Pregnant Women, N, 2014 and 2024
Table 16: 7MM, Confirmed RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
Table 17: 7MM, Estimated RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
Table 18: Leading Drug-Based Interventions for RSV, 2015
Table 19: Product Profile - Synagis
Table 20: Synagis’ Efficacy in the Impact-RSV Study
Table 21: Synagis SWOT Analysis, 2015
Table 22: Product Profile - Virazole
Table 23: Virazole’s Efficacy in Mechanically Ventilated Infants with Severe RSV LRTI
Table 24: Serious Cardiovascular and Pulmonary AEs Associated with Virazole Treatment
Table 25: Virazole SWOT Analysis, 2015
Table 26: Unmet Needs and Opportunities in RSV, 2015
Table 27: FDA Regulatory Decisions Accelerating the Development of RSV Pipeline Agents, 2015
Table 28: Key Phase III and Phase II Clinical Trials of Pipeline Prophylactics
Table 29: Key Phase I Clinical Trials of Pipeline Prophylactics
Table 30: Key Phase II Clinical Trials of Pipeline Therapeutics
Table 31: Key Phase I Clinical Trials of Pipeline Therapeutics
Table 32: RSV Therapies and Prophylactics - Late-Stage Pipeline, 2015
Table 33: Product Profile - Novavax RSV F Vaccine
Table 34: A Phase II Clinical Trial Of Novavax’s RSV F Vaccine in Third-Trimester Pregnant Women
Table 35: Novavax RSV F Vaccine SWOT Analysis, 2015
Table 36: Product Profile - GSK3003891A
Table 37: GSK3003891A SWOT Analysis, 2015
Table 38: Product Profile - MEDI8897
Table 39: Clinical Trials Assessing MEDI8897’s Safety
Table 40: MEDI8897 SWOT Analysis, 2015
Table 41: Product Profile - REGN2222
Table 42: REGN2222 SWOT Analysis, 2015
Table 43: Product Profile - ALS-8176
Table 44: ALS-8176 SWOT Analysis, 2015
Table 45: Product Profile - ALX-0171
Table 46: ALX-0171 SWOT Analysis, 2015
Table 47: Product Profile - GS-5806
Table 48: GS-5806 Dosing Cohorts in a Phase IIa Challenge Study
Table 49: GS-5806 SWOT Analysis, 2015
Table 50: Product Profile - JNJ-678
Table 51: JNJ-678 SWOT Analysis, 2015
Table 52: RSV Therapies and Prophylactics - Early-Stage Clinical Pipeline, 2015
Table 53: Clinical Benchmarking of Key RSV Prophylactic Agents, 2015
Table 54: Clinical Benchmarking of Key RSV Therapeutic Agents, 2015
Table 55: Commercial Benchmarking of Key RSV Prophylactic Agents, 2015
Table 56: Commercial Benchmarking of Key RSV Therapeutic Agents, 2015
Table 57: Top-Line Global Sales ($m) Forecasts for RSV, 2014-2024
Table 58: 7MM, Key Events Impacting Sales for RSV, 2014-2024
Table 59: Global RSV Market - Drivers and Barriers, 2014-2024
Table 60: Key Historical and Projected Launch Dates for RSV Across the 7MM
Table 61: Key Historical and Projected Patent Expiry Dates for RSV Across the 7MM
Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: The RSV Virion
Figure 2: Life Cycle of RSV
Figure 3: Case Flow Map for RSV Prophylactic and Therapeutic Populations
Figure 4: Population Estimates and Births Forecast for the US, Boys and Girls, 1997-2024
Figure 5: 7MM, Children Born Preterm (<37 Weeks’ GA) Surviving to Ages 0-2 Years, Boys and Girls, N, 2014 and 2024
Figure 6: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2014
Figure 7: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2024
Figure 8: Competitive Assessment of Key RSV Prophylactic Agents, 2014-2024
Figure 9: Competitive Assessment of Key RSV Therapeutic Agents, 2014-2024
Figure 10: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014 and 2024
Figure 11: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014-2024
Figure 12: Global Sales ($m) for RSV Therapeutics and Prophylactics by Product Class, 2014-2024
Figure 13: Sales ($m) for RSV Prophylactics in the US, 2014-2024
Figure 14: Sales ($m) for RSV Therapeutics in the US, 2024
Figure 15: Sales ($m) for RSV Prophylactics in the 5EU, 2014-2024
Figure 16: Sales ($m) for RSV Therapeutics in the 5EU, 2024
Figure 17: Sales ($m) for RSV Prophylactics in Japan, 2014-2024
Figure 18: Sales ($m) for RSV Therapeutics in Japan, 2024
1.1 List of Tables
Table 1: Symptoms of RSV Infection in Infants
Table 2: Symptoms of RSV Infection in Elderly and High-Risk Adults
Table 3: Guidelines for the Prevention of RSV
Table 4: Risk Factors and Comorbidities for Severe RSV Infection
Table 5: 7MM, Sources Used to Determine the Preterm Infant Population, 2014
Table 6: 7MM, Sources Used to Determine the Incidence of Neonatal CLD, 2014
Table 7: 7MM, Sources Used to Determine the Incidence of Hemodynamically Significant Heart Disease in Children, 2014
Table 8: 7MM, Sources Used to Determine the Diagnosed Prevalence of Congenital Respiratory and Neuromuscular Diseases That Compromise Respiratory Function in Children, 2014
Table 9: 7MM, Sources Used to Determine the Third-Trimester Pregnant Women Population, 2014
Table 10: NICHD Neonatal CLD Severity Categorization
Table 11: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2014
Table 12: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages =2 Years, N, 2024
Table 13: 7MM, Preterm Births, Boys and Girls, <37 Weeks’ GA, N (Row %), 2014
Table 14: 7MM, Incident Cases of Neonatal CLD by Severity, Boys and Girls, <32 Weeks GA, N (Row %), 2014
Table 15: 7MM, Third-Trimester Pregnant Women, N, 2014 and 2024
Table 16: 7MM, Confirmed RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
Table 17: 7MM, Estimated RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
Table 18: Leading Drug-Based Interventions for RSV, 2015
Table 19: Product Profile - Synagis
Table 20: Synagis’ Efficacy in the Impact-RSV Study
Table 21: Synagis SWOT Analysis, 2015
Table 22: Product Profile - Virazole
Table 23: Virazole’s Efficacy in Mechanically Ventilated Infants with Severe RSV LRTI
Table 24: Serious Cardiovascular and Pulmonary AEs Associated with Virazole Treatment
Table 25: Virazole SWOT Analysis, 2015
Table 26: Unmet Needs and Opportunities in RSV, 2015
Table 27: FDA Regulatory Decisions Accelerating the Development of RSV Pipeline Agents, 2015
Table 28: Key Phase III and Phase II Clinical Trials of Pipeline Prophylactics
Table 29: Key Phase I Clinical Trials of Pipeline Prophylactics
Table 30: Key Phase II Clinical Trials of Pipeline Therapeutics
Table 31: Key Phase I Clinical Trials of Pipeline Therapeutics
Table 32: RSV Therapies and Prophylactics - Late-Stage Pipeline, 2015
Table 33: Product Profile - Novavax RSV F Vaccine
Table 34: A Phase II Clinical Trial Of Novavax’s RSV F Vaccine in Third-Trimester Pregnant Women
Table 35: Novavax RSV F Vaccine SWOT Analysis, 2015
Table 36: Product Profile - GSK3003891A
Table 37: GSK3003891A SWOT Analysis, 2015
Table 38: Product Profile - MEDI8897
Table 39: Clinical Trials Assessing MEDI8897’s Safety
Table 40: MEDI8897 SWOT Analysis, 2015
Table 41: Product Profile - REGN2222
Table 42: REGN2222 SWOT Analysis, 2015
Table 43: Product Profile - ALS-8176
Table 44: ALS-8176 SWOT Analysis, 2015
Table 45: Product Profile - ALX-0171
Table 46: ALX-0171 SWOT Analysis, 2015
Table 47: Product Profile - GS-5806
Table 48: GS-5806 Dosing Cohorts in a Phase IIa Challenge Study
Table 49: GS-5806 SWOT Analysis, 2015
Table 50: Product Profile - JNJ-678
Table 51: JNJ-678 SWOT Analysis, 2015
Table 52: RSV Therapies and Prophylactics - Early-Stage Clinical Pipeline, 2015
Table 53: Clinical Benchmarking of Key RSV Prophylactic Agents, 2015
Table 54: Clinical Benchmarking of Key RSV Therapeutic Agents, 2015
Table 55: Commercial Benchmarking of Key RSV Prophylactic Agents, 2015
Table 56: Commercial Benchmarking of Key RSV Therapeutic Agents, 2015
Table 57: Top-Line Global Sales ($m) Forecasts for RSV, 2014-2024
Table 58: 7MM, Key Events Impacting Sales for RSV, 2014-2024
Table 59: Global RSV Market - Drivers and Barriers, 2014-2024
Table 60: Key Historical and Projected Launch Dates for RSV Across the 7MM
Table 61: Key Historical and Projected Patent Expiry Dates for RSV Across the 7MM
Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
MedImmune
Novavax
GlaxoSmithKline
Regeneron
Janssen (Johnson & Johnson)
Gilead Sciences
Ablynx
Ark Biosciences
Biota Pharmaceuticals
Romark Laboratories
Spring Bank Pharmaceuticals
Immunovaccine, Inc.
Crucell
Bavarian Nordic
Meda Pharmaceuticals
