Abstract
Introduction
RSV mostly causes upper respiratory tract infections (URTI), resulting in the common cold. However, in certain risk groups, RSV can cause more severe lower respiratory tract infections (LRTI) leading to bronchiolitis. These risk groups include elderly people, patients with underlying pulmonary or cardiac disease, premature infants, children under four years old and immunocompromised patients.
Scope of this report
- Discusses disease background, providing insight in RSV epidemiology, etiology and symptoms
- Gives a breakdown of RSV (hospitalization) prevalence in the seven major markets
- Examines current diagnosis and treatment trends, providing physicians' opinions
- Examines the RSV pipeline by type treatment, prophylaxis and vaccines, including a short discussion of each pipeline product
Research and analysis highlights
Some physicians do not value the importance of a correct RSV diagnosis, since there is no effective treatment available. Furthermore, the American Academy of Pediatrics does not recommend routine testing for RSV in bronchiolitis. However, there are reasons why proper diagnosis should be considered, and there is a range of tests available for that.
The RSV market is currently dominated by MedImmune' s Synagis, a prophylactic monoclonal antibody. As RespiGam' s successor, Synagis was first launched in 1998 and now has sales of around $750 million per RSV season. Due to its high costs though, Synagis is only prescribed to a very limited group of individuals.
Although the most important unmet need in RSV is an effective treatment or vaccine, many companies have discontinued their developments in this field. Only two companies have an RSV treatment in clinical development (Novartis/Arrow Therapeutics and Alnylam) and MedImmune dominates the limited vaccine development.
Key reasons to read this report
- Gain insight into the issues of current diagnosis and treatment for RSV through key opinion leader comments
- Review the unmet needs and the clinical and commercial factors driving new product decisions
- Identify the opportunities and threats presented by the RSV pipeline and predict the future shape of the market
Table of Contents
- ABOUT HEALTHCARE
- About the Infectious Diseases and Respiratory (ID&R) analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Contributing experts
- CHAPTER 2 DISEASE BACKGROUND
- Etiology of the RSV virus
- RSV is easily transmitted
- Immune response does not sufficiently protect from further infection
- Symptoms and classification
- Groups at risk of severe disease caused by RSV infection
- Young children and premature infants
- Elderly
- People with underlying cardiac or pulmonary disease
- Immunocompromised patients
- Nosocomial RSV infections
- RSV reinfection
- The seasonality of RSV
- Mortality is low in most risk groups
- Hospitalization expenses make RSV infections costly
- CHAPTER 3 DIAGNOSIS
- Viral culture is the current gold standard
- Polymerase chain reaction may become new gold standard
- Antigen detection assays are fast but lack sensitivity
- Bronchiolitis guidelines
- CHAPTER 4 CURRENT TREATMENT AND PREVENTION OPTIONS
- Synagis has monopoly in RSV infection prophylaxis
- The Phase III IMpact trial showed efficacy and safety
- Separate trial in children with congenital heart disease leads to
indication expansion
- Synagis' s cost-effectiveness is doubtful
- Virazole' s reputation is damaged by negative trials
- Lack of evidence for use of pharmacological symptom treatment
- Beta2-agonists
- Ipratropium bromide
- Epinephrine
- Corticosteroids
- Non-pharmacological symptom treatments show some improvement in
subpopulations
- Bronchiolitis guidelines
- Prescribing trends
- CHAPTER 5 FUTURE TRENDS
- Most important unmet need is the lack of RSV treatment and vaccines
- Future trends in treatment
- The antivirals class is the most advanced (Phase II)
- RNA interference (RNAi) as antiviral is a promising approach
- Antisense drugs not in clinical trials yet
- An RSV treatment used in the hospital could have peak sales of
$700-750 million
- An RSV treatment used in the community could have peak sales of more
than $1 billion
- Future trends in prophylaxis
- Future trends in vaccines
- Types of vaccines in development for RSV
- Strategies of a vaccination program
- MedImmune also dominates limited RSV vaccine development
- APPENDIX A BIBLIOGRAPHY
- APPENDIX B COMMERICALLY AVAILABLE ANTIGEN DETECTION ASSAYS
- Disclaimer
- List of Tables
- Table 1: RSV prevalence in the seven major markets, 2006
- Table 2: RSV prevalence in the US, 2006
- Table 3: RSV prevalence in Japan, 2006
- Table 4: RSV prevalence in France, 2006
- Table 5: RSV prevalence in Germany, 2006
- Table 6: RSV prevalence in Italy, 2006
- Table 7: RSV prevalence in Spain, 2006
- Table 8: RSV prevalence in the UK, 2006
- Table 9: Children under four years of age with RSV infection, 2006
- Table 10: RSV infection in premature babies in the seven major
markets, 2006
- Table 11: Elderly infected with RSV virus, 2006 and 2015
- Table 12: Group of CHF patients in class II or higher, at risk of RSV
infection, 2006
- Table 13: High-risk population with RSV infection including CHF,
asthma and COPD patients, 2006
- Table 14: Bone marrow transplant recipients with RSV infection, 2006
- Table 15: Summary of Synagis trials
- Table 16: Cost-benefit of Synagis
- Table 17: Institutional variation of medical management of
bronchiolitis caused by RSV
- Table 18: Percentage of respondents applying different treatment
options in infants hospitalized with acute bronchiolitis
- Table 19: Non serious adverse events of RSV-604 in Phase I trial
- Table 20: RSV hospitalizations in different high risk groups in the
seven major markets
- List of Figures
- Figure 1: Respiratory syncytial viral structure
- Figure 2: A schematic representation of RSV infection of the
respiratory epithelium
- Figure 3: RSV disease severity over four consecutive seasons
- Figure 4: RSV is a major pediatric pathogen
- Figure 5: Example of definition of high-risk chronic heart failure
patients in the US, 2005
- Figure 6: Group of adults over 21 years of age with or without
underlying disease that are annually hospitalized due to an RSV infection
- Figure 7: Several factors increase the likelihood of nosocomial
infection
- Figure 8: Positive RSV tests in the US (%), July 2004-October 2006
- Figure 9: Laboratory reports to CDSC* of infections due to RSV,
England and Wales, by date of report 1990-2006 (4 weekly)
- Figure 10: The process of polymerase chain reaction (PCR)
- Figure 11: Overview of several antigen detection assays commercially
available
- Figure 12: RSV product sales in the seven major markets by year, Q3
2001-Q2 2006 (RespiGam only US)
- Figure 13: Synagis is currently the only marketed RSV prophylaxis
- Figure 14: Synagis sales in the seven major markets by quarter, Q3
2001-Q2 2006
- Figure 15: Small Particle Aerosol Generator Model-2 (SPAG-2)
- Figure 16: Virazole sales in the seven major markets by quarter, Q3
2001-Q2 2006
- Figure 17: The American Academy of Pediatrics (AAP) bronchiolitis
guidelines
- Figure 18: Proportion of clinical episodes in which inhaled and
systemic treatment approaches were used
- Figure 19: Future trends in RSV treatment, prophylaxis and vaccines
- Figure 20: Overview of companies involved in development of RSV
treatment, 2006
- Figure 21: Percentage of RSV hospitalizations in pivotal Numax trial
- Figure 22: Size of very high risk vaccine target populations across
the seven major markets, 2006
- Figure 23: Size of pediatric vaccine target populations across the
seven major markets, birth cohort and catch-up pool, 2006
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