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Stakeholder Opinions: Respiratory Syncytial Virus (RSV) - A market yet to reach its full potential

Published by: Datamonitor

Published: Dec. 21, 2006 - 150 Pages


Table of Contents


TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 4

Scope of the report 4

Contributing experts 4

Datamonitor insight into the respiratory syncytial virus (RSV) market 5

CHAPTER 2 DISEASE BACKGROUND 12

Etiology of the RSV virus 12

RSV is easily transmitted 16

Immune response does not sufficiently protect from further infection 17

Symptoms and classification 18

Groups at risk of severe disease caused by RSV infection 20

Young children and premature infants 30

Elderly 35

People with underlying cardiac or pulmonary disease 37

Immunocompromised patients 43

Nosocomial RSV infections 44

RSV reinfection 45

The seasonality of RSV 45

Mortality is low in most risk groups 48

Hospitalization expenses make RSV infections costly 49

CHAPTER 3 DIAGNOSIS 52

Viral culture is the current gold standard 54

Polymerase chain reaction may become new gold standard 54

Antigen detection assays are fast but lack sensitivity 57

Bronchiolitis guidelines 58

CHAPTER 4 CURRENT TREATMENT AND PREVENTION OPTIONS 61

Synagis has monopoly in RSV infection prophylaxis 63

The Phase III IMpact trial showed efficacy and safety 66

Separate trial in children with congenital heart disease leads to indication expansion 68

Synagis’s cost-effectiveness is doubtful 71

Virazole’s reputation is damaged by negative trials 73

Lack of evidence for use of pharmacological symptom treatment 76

Beta2-agonists 77

Ipratropium bromide 79

Epinephrine 79

Corticosteroids 80

Non-pharmacological symptom treatments show some improvement in subpopulations 81

Bronchiolitis guidelines 82

Prescribing trends 84

CHAPTER 5 FUTURE TRENDS 88

Most important unmet need is the lack of RSV treatment and vaccines 89

Future trends in treatment 91

The antivirals class is the most advanced (Phase II) 93

RNA interference (RNAi) as antiviral is a promising approach 95

Antisense drugs not in clinical trials yet 97

An RSV treatment used in the hospital could have peak sales of $700-750 million 98

An RSV treatment used in the community could have peak sales of more than $1 billion 100

Future trends in prophylaxis 102

Future trends in vaccines 104

Types of vaccines in development for RSV 107

Strategies of a vaccination program 111

MedImmune also dominates limited RSV vaccine development 115

APPENDIX A BIBLIOGRAPHY 118

Press releases 144

APPENDIX B COMMERICALLY AVAILABLE ANTIGEN DETECTION ASSAYS 146

Disclaimer 150





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
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
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.

Reasons to Purchase
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


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