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Respiratory Syncytial Virus: Can Antivirals Make the Grade?

Published by: Datamonitor

Published: Mar. 15, 2004 - 54 Pages


Table of Contents


TABLE OF CONTENTS

ABOUT DATAMONITOR HEALTHCARE 2

About the Infectious Disease pharmaceutical analysis team 2

EXECUTIVE SUMMARY 7

Introduction 7

Scope and coverage of the Brief 7

Key findings about the topic 7

Despite high disease incidence and associated mortality, there are currently very few products indicated for the prevention or treatment of respiratory syncitial virus. The high potential of this sector is demonstrated by the strong performance of MedImmune’s Synagis, which achieved sales of almost $600m across the 7 major markets in the year ending June 2003 (MIDAS Sales Data, IMS Health, September 2003). Datamonitor believes that the highest potential in this sector lies in prophylaxis, rather than antiviral treatment, with both the monoclonal antibody and vaccine sectors forecast to achieve peak sales greater than $1 billion; 8

Datamonitor believes that an effective RSV antiviral, positioned as a treatment for severely ill hospitalized patients, could potentially generate peak sales of $300m across the seven major markets. However, as with other acute viral infections, such as influenza, the potential for RSV antivirals in the community sector will be restricted by low presentation rates and poor availability of diagnostic tests. Companies seeking success in this field will benefit from seeking partnerships with diagnostics companies and those marketing other RTIs antivirals in order to provide physicians with a complete treatment package; 9

With adequate stakeholder support and appropriate pricing, Datamonitor believes that the pediatric RSV market could achieve mature market sales of approximately $800m, with an additional $2 billion in revenue available from the catch-up patient pool. In contrast, poor vaccine compliance within the elderly population will limit both uptake and price of products targeting this sector. Success in this field will depend on effective disease awareness campaigns and innovative product designs, such as combination products targeting multiple RTIs. 10

ETIOLOGY AND EPIDEMIOLOGY 12

Disease definition 12

Diagnosis 13

Epidemiology 14

US studies 14

Developing world 16

TREATMENT AND PROPHYLAXIS OVERVIEW 17

Current treatment options 17

Virazole 17

Overview 17

Sales performance 18

Strategic recommendations 19

Current prophylactic options 20

RespiGam 20

Overview 20

Sales performance 21

Synagis 22

Overview 22

Sales performance 23

Strategic recommendations 24

Current market overview 25

Market size 25

Developmental treatment and prophylactic options 29

AventisPasteur’s RSV vaccine 29

Numax 30

FUTURE FOCUS AND ANALYST INSIGHT 31

Future market assessment 31

Therapeutic options 31

Patient potential 32

Coverage 33

Pricing 34

Market potential 34

Monoclonal antibodies 37

Patient potential and price 38

Compliance 38

Market potential 38

Vaccines 39

Patient potential 40

Compliance 41

Pricing 43

Market potential 44

Geriatric vaccine 48

APPENDIX 52

Bibliography 52

Journal articles 52

Websites 52

Research methodology 53

Disclaimer 54





Abstract

Introduction
Respiratory Syncytial Virus (RSV) is the leading cause of viral death and respiratory tract infection (RTI) in children, and furthermore is a significant cause of morbidity in the elderly population. At present there is no effective vaccine or treatment against RSV infection, thereby constituting a considerable unmet medical need.

Scope
Overview of the etiology and epidemiology of RSV infection, discussing the scale and seriousness of this disease

Analysis of current treatment and prophylactic practices, highlighting current unmet needs in this sector

Key RSV pipeline products are listed, with discussion of those in clinical development

An assessment of the commercial prospects for novel RSV products, describing likely sales scenarios and an estimation of peak annual revenue

Report Highlights
The commercial potential of the RSV sector is demonstrated by Synagis, which achieved global sales of almost $600m in the year ending June 2003. Indeed, Datamonitor believes that the highest potential in this sector lies in prophylaxis, with both the monoclonal antibody and vaccine sectors forecast to achieve peak sales greater than $1 billion.

An RSV antiviral positioned as a treatment for hospitalized patients could make peak sales of $300m across the seven major markets, but sales will be restricted in the community by low rates of presentation and diagnosis. Consequently, marketing companies may benefit from partnerships with diagnostics firms and those selling other RTIs antivirals.

The pediatric RSV market could achieve mature market sales of around $800m, with an extra $4 billion in revenue from the catch-up pool. In contrast, poor vaccine compliance within the elderly population will limit revenue in this sector. Success in this field will depend on effective disease awareness campaigns and innovative product designs.

Reasons to Purchase
Gain a clear understanding of the dynamics of the current RSV market, most notably the performance of MedImmune's Sunagis

Assess the potential for new treatments for RSV and understand the limitations associated with community use of antiviral therapies

Evaluate the commercial prospects for new RSV monoclonal and vaccine prophylactics, taking into account stakeholder influences



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