OpportunityAnalyzer: Respiratory Syncytial Virus (RSV) – Opportunity Analysis and Forecasts to 2024
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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.
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.
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?
Janssen (Johnson & Johnson)
*All listed companies have at least 1 product included in GlobalData’s epidemiology-based, 10-year drug sales forecast model.
Other Companies Mentioned
Spring Bank Pharmaceuticals
Table of Contents
1Table of Contents
1.1List of Tables
1.2List of Figures
2.3Upcoming Related Reports
3.1Etiology and Pathophysiology
3.2Symptoms and Prognosis
3.3Quality of Life
3.4.1Diagnosis of RSV Infection
3.4.2Prevention of RSV Infection
3.4.3Treatment of RSV Infection
4.2Risk Factors and Comorbidities
4.3.1Preterm Infants and Children Born Preterm and Survived to Two Years of Age
4.3.2Infants with Neonatal CLD
4.3.3Children with Hemodynamically Significant Congenital Heart Disease
4.3.4Children with Congenital Respiratory or Neuromuscular Diseases That Compromise Respiratory Function
4.3.5Third-Trimester Pregnant Women
4.3.6Hospitalizations for RSV Infection
4.4.2Sources Not Used
4.4.3Forecast Assumptions and Methods
4.5Epidemiological Forecast for RSV Infection (2014–2024)
4.5.1Risk Groups for Severe RSV Infection in Children Less than Two Years
4.5.4Third-Trimester Pregnant Women
4.5.5RSV Hospitalizations in Children
4.6.1Epidemiological Forecast Insight
4.6.2Limitations of the Analysis
4.6.3Strengths of the Analysis
5Current Treatment Options
5.2Product Profiles – RSV Prophylactics
5.3Product Profiles – RSV Therapeutics
5.3.1Virazole (aerosolized ribavirin)
5.4Other Supportive Measures
6Unmet Needs and Opportunities
6.2Effective Therapeutic Interventions
6.4A Prophylactic mAb with an Increased Half-Life
6.5Point-of-care Testing for RSV in Adult Patients
6.6Increased Awareness of RSV Infections in Adults
7Research and Development Strategies
7.2Development of Novel Prophylactic Antibodies with Increased Cost-Effectiveness
7.3Technological Approaches to Vaccine Development
7.3.1Vaccine Antigen Selection
7.3.2Development of Maternal Vaccines
7.4Leveraging the FDA’s Fast Track Program
7.5Development of RSV Therapeutics
7.6Clinical Trial Design
7.6.1Clinical Trial Design of Key Pipeline Prophylactics
7.6.2Demonstration of Protective Efficacy for Vaccines and Prophylactic Antibodies
7.6.3Clinical Trial Design of Key Pipeline Therapeutics
7.6.4Design and Limitations of Clinical Challenge Studies
7.6.5From Challenge Studies to Demonstrating Efficacy in Naturally Infected Patients
8.2Promising Drugs in Clinical Development – Prophylactic Agents
8.2.1Novavax RSV F Vaccine
8.3Promising Drugs in Clinical Development – Therapeutic Agents
8.4Innovative Early-Stage Approaches
9.2Clinical Benchmark of Key Pipeline Products
9.3Commcercial Benchmark of Key Pipeline Products
9.5Top-Line 10-Year Forecast
10.4.1RSV Patient Population Segmentation
10.4.2Percent Drug-Treated Patients
10.4.3Products Included in Each Therapeutic Class
10.4.4Launch and Patent Expiry Dates
10.4.5General Pricing Assumptions
10.4.6Individual Drug Assumptions
10.4.7Pricing of Pipeline Agents
10.5Primary Research – KOLs and Payers Interviewed for this Report
10.6Primary Research – Prescriber Survey
10.7About the Authors
10.7.3Therapy Area Director
10.7.4Global Director of Therapy Analysis and Epidemiology
10.7.5Global Head of Healthcare
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