PharmaPoint: Pediatric Respiratory Syncytial Virus (RSV) Prophylactics - US Drug Forecast and Market Analysis to 2022

London (PRWEB) September 18, 2013

Summary

Respiratory syncytial virus (RSV) is a common cause of pediatric respiratory infections and virtually all children will have been infected by the virus by the age of two. RSV transmission typically occurs during the winter and early spring months. The virus is spread through the air by an infected person’s sneeze or cough, or through direct and indirect contact with nasal secretions of an infected person. The majority of RSV infections present as mild upper respiratory illnesses that often self-resolve within two weeks, but about 1% of the cases develop serious lower respiratory complications requiring hospitalization. Children under the age of two with certain health conditions are most at risk for severe RSV infections and are therefore recommended to receive RSV prophylaxis treatments. The only FDA-approved prophylactic intervention in the US is AstraZeneca’s Synagis (palivizumab), a humanized monoclonal antibody against the fusion protein of the virus.

Highlights

Key Questions Answered

• What are the treatment algorithms and what do most pediatricians and neonatologists adhere to?
• What unmet needs still remain and what do key opinion leaders think?
• How likely is it that Synagis’ biosimilars will enter the market during the forecast period?
• What promising interventions are in the pipeline for this narrow patient segment?
• What are the likely changes in future guidelines as expected by key opinion leaders?

Key Findings

• The majority of physicians adhere to the AAP guidelines limiting the number of doses and narrowing the use of Synagis
• AstraZeneca, with Synagis, will continue its stronghold of the RSV market for the forecast period
• Pipeline prophylactic indications will be first in class (active/maternal immunization), and will cover complementary populations

Scope

• Overview of RSV, including epidemiology, etiology, general symptoms from infection, and US prophylaxis guidelines comparison (American Academy of Pediatrics vs National Perinatal Association).
• Annualized RSV market revenue, annual cost of therapy and utilization pattern data from 2012 and forecast for ten years to 2022.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs and remaining opportunities, clinical trial overview and implications for the RSV market.
• Pipeline analysis: analysis of two pipeline vaccines and potential market and clinical position in the RSV market.
• Analysis of the current and future RSV market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Benefits

• 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 for RSV prophylaxis.
• Develop business strategies by understanding the trends shaping and driving the US RSV market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the US and global RSV market in future.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Track RSV prophylactics sales in the US market from 2012–2022.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 12
2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Pathophysiology 18
3.1.2 Prognosis 19
3.1.3 Quality of Life 19
3.2 Symptoms 20
4 Epidemiology 21
4.1 Risk Factors and Comorbidities 22
4.1.1 Re-hospitalization rate increases with lower gestational age 22
4.1.2 Congenital respiratory or neuromuscular diseases are more often re-hospitalized 22
4.1.3 Re-hospitalization is more frequent in chronic lung disease infants 22
4.1.4 More complications in children with hemodynamically significant congenital heart disease 23
4.1.5 Hospitalized cases likely to develop long-term respiratory problems 23
4.2 Trends in the US 24
4.2.1 RSV Infections and Hospitalization Rates 24
4.2.2 Preterm Births and Infant Mortality 24
4.2.3 Congenital Respiratory or Neuromuscular Diseases 24
4.2.4 Neonatal Chronic Lung Disease 25
4.2.5 Hemodynamically Significant Congenital Heart Diseases 25
4.3 Forecast Methodology 26
4.3.1 Sources Used 28
4.3.2 Forecast Assumptions and Methods (US) 30
4.3.3 Sources Not Used 35
4.4 Epidemiological Forecast of RSV Infections and Prophylactic Populations 36
4.4.1 Primary, Secondary, and Hospitalizations of RSV Infections 36
4.4.2 Preterm Population 38
4.4.3 Congenital Respiratory or Neuromuscular Diseases Population 42
4.4.4 Neonatal Chronic Lung Disease Population 42
4.4.5 Hemodynamically Significant Congenital Heart Diseases Population 43
4.4.6 RSV Infections and Prophylactic Populations Segmented by Sex 44
4.5 Discussion 46
4.5.1 Conclusions on Epidemiological Trends and Forecast 46
4.5.2 Limitations of the Analysis 47
4.5.3 Strengths of the Analysis 48
5 Disease Management 49
5.1 Treatment Overview 49
5.2 Diagnosis 50
5.3 Clinical Practice 52
6 Competitive Assessment 56
6.1 Overview 56
6.2 Product Profiles – Major Brands 57
6.2.1 Synagis (palivizumab) 57
7 Opportunity and Unmet Need 62
7.1 Overview 62
7.2 Unmet Needs 63
7.2.1 Unmet Need: Lack of Prophylactic Vaccines 63
7.2.2 Unmet Need: Increased Bioavailability of Monoclonal Antibody 64
7.2.3 Unmet Need: Lower-Cost Prophylactic Interventions 65
7.2.4 Unmet Need: Updated Guidelines with Wider Inclusion Criteria 66
7.3 Unmet Needs Gap Analysis 67
7.4 Opportunities 68
7.4.1 Opportunity: Novel Approaches to Prophylactic Vaccine Development 68
7.4.2 Opportunity: Small-Molecule Option 68
7.4.3 Opportunity: Maternal Immunization 69
7.4.4 Opportunity: Adult Vaccination to Confer Herd Immunity 69
8 Pipeline Assessment 70
8.1 Overview 70
8.2 Clinical Trial Mapping 71
8.3 Clinical Trials by Phase and Trial Status 72
8.4 Promising Prophylactic Interventions in Clinical Development 73
8.4.1 RSV F-Protein Vaccine 74
8.5 Promising Prophylactic Interventions in Early Clinical Development 78
8.5.1 MEDI-559 78
9 Current and Future Players 81
9.1 Overview 81
9.2 Trends in Corporate Strategy 82
9.3 Company Profiles 84
9.3.1 AstraZeneca (MedImmune) 84
9.3.2 Novavax 86
10 Market Outlook 89
10.1 US 89
10.1.1 Forecast 89
10.1.2 Key Events 91
10.1.3 Drivers and Barriers – Global Issues 91
11 Appendix 96
11.1 Bibliography 96
11.2 Abbreviations 107
11.3 Methodology 109
11.4 Forecasting Methodology 109
11.4.1 Number of eligible patients for prophylaxis 109
11.4.2 Utilization rates of Synagis 110
11.4.3 Patient share and generic erosion 111
11.4.4 Weight of high risk infants 111
11.4.5 Cost per day 111
11.4.6 Number of prophylaxis days per year 111
11.4.7 Annual cost of therapy 112
11.4.8 Patient compliance 112
11.4.9 Total sales 112
11.4.10 Drugs Included in Each Therapeutic Class 112
11.4.11 Launch and Patent Expiry Dates 112
11.4.12 General Pricing Assumptions 113
11.4.13 Individual Drug Assumptions 113
11.5 Physicians and Specialists Included in this Study 114
11.6 About the Authors 115
11.6.1 Authors 115
11.6.2 Epidemiologist 116
11.6.3 Global Head of Healthcare 116
11.7 About GlobalData 117
11.8 Contact Us 117
11.9 Disclaimer 117

List of Tables

Table 1: Symptoms of RSV infection 20
Table 2: Sources Used for Incidence or Prevalence 27
Table 3: Definitions of Neonatal Chronic Lung Disease 34
Table 4: Respiratory Syncytial Virus Infections, 0–2 Years, Boys and Girls, N (Column %)*, Select Years 2012–2022 36
Table 5: Preterm Population, Boys and Girls, 0–2 Years, N (Column %)*, Select Years 2012–2022 39
Table 6: Congenital Respiratory or Neuromuscular Diseases Population*, Boys and Girls, 0–2 Years, N (Column %), Select Years 2012–2022 42
Table 7: Neonatal Chronic Lung Disease Population, Boys and Girls, Age 0, N (Column %), Select Years 2012–2022 42
Table 8: Hemodynamically Significant Congenital Heart Diseases Population, Boys and Girls, N (Column %), 0–2 Years, Select Years 2012–2022 43
Table 9: RSV Infection and Prophylactic Populations by Sex, 0–2 Years, N (Row %), 2012 44
Table 10: Treatment Guidelines for Pediatric RSV Prevention 49
Table 11: Most Prescribed Prophylactics for Pediatric RSV in the US, 2013 49
Table 12: Leading Prophylactic Treatments for Pediatric RSV, 2012 57
Table 13: Product Profile – Synagis 58
Table 14: Synagis SWOT Analysis, 2012 60
Table 15: US Sales Forecasts ($m) for Synagis, 2012–2022 61
Table 16: Overall Unmet Needs – Current Level of Attainment 62
Table 17: Clinical Unmet Needs – Gap Analysis, 2012 67
Table 18: Clinical Trials for RSV Prophylaxis and Treatment by Phase and Status, 2012 72
Table 19: Pediatric RSV Prophylactic Vaccines – Phase Pipeline, 2013 73
Table 20: Comparison of Therapeutic Classes in Development for RSV, 2012 73
Table 21: Product Profile – RSV F-Protein Vaccine 74
Table 22: RSV F-protein vaccine SWOT Analysis, 2012 77
Table 23: Product Profile – MEDI-559 79
Table 24: MEDI-559 SWOT Analysis, 2012 80
Table 25: Key Companies in the Pediatric RSV Prophylactic Market – United States, 2012 81
Table 26: AstraZeneca’s RSV Prophylactics Portfolio Assessment, 2013 85
Table 27: AstraZeneca SWOT Analysis, 2012 85
Table 28: Novavax’s Pediatric RSV Prophylactics Portfolio Assessment, 2012 87
Table 29: Novavax SWOT Analysis, 2012 88
Table 30: US Sales Forecasts ($m) for Synagis, 2012–2022 90
Table 31: Key Events Impacting Sales for RSV Prophylactics in the US, 2012 91
Table 32: Pediatric RSV Market – Drivers and Barriers, 2012 91
Table 33: Key Launch Date 112
Table 34: Key Patent Expiries 112

List of Figures

Figure 1: Schematic Representation of the RSV Virion 16
Figure 2: Population Estimate and Births Forecast in the US, Boys and Girls, 1997—2022 32
Figure 3: Respiratory Syncytial Virus Infections by Age and Infection Type, Boys and Girls, N (Millions), 2012 and 2022 37
Figure 4: Preterm Population, Boys and Girls, 0–2 Years, N (Millions), 2012–2022 40
Figure 5: Preterm Population (
Figure 6: Respiratory Syncytial Virus Infections Segmented by Sex, 0–2 Years, N (Millions), 2012 45
Figure 7: Respiratory Syncytial Virus Prophylactic Populations Segmented by Sex, 0–2 Years, N (Thousands), 2012 45
Figure 8: Clinical Trials for RSV Treatment Versus Prophylaxis in the US, 2012 71
Figure 9: Competitive Assessment of Early-Stage Pipeline Agents in Pediatric RSV, 2012–2022 73
Figure 10: Company Portfolio Gap Analysis in Pediatric RSV, 2012–2022 81

Companies Mentioned
AstraZeneca (MedImmune)
Novavax

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PharmaPoint: Pediatric Respiratory Syncytial Virus (RSV) Prophylactics - US Drug Forecast and Market Analysis to 2022

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