Respiratory Syncytial Virus: Opportunity Analysis and Forecasts to 2028

Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense RNA orthopneumovirus 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. The most common clinical scenario for RSV is an upper respiratory tract infection which is typically mild and self-limiting. However, RSV is the leading cause of lower respiratory tract infections (LRTIs) in infants, with a peak age of hospitalization between 2-3 months of age. Severe respiratory disease can manifest as bronchiolitis and pneumonia, which can progress to respiratory failure or death in rare occasions. RSV is also an important cause of hospitalizations and deaths in elderly adults.

The burden of RSV-associated illness is well known; however, challenges stemming from both product and clinical trial design have resulted in several high-profile product failures across all classes of agents including antivirals and prophylactic vaccines and antibodies. Further, the RSV market has seen contraction as the only approved prophylactic antibody, AbbVie and AstraZeneca’s Synagis (palivizumab), received an updated recommendation from the American Academy of Pediatrics (AAP) in 2014 for a more narrow population than the antibody is labeled for (i.e., pediatric patients at increased risk of hospitalization due to RSV). These difficulties have limited options for patients currently at risk for complications due to RSV; however, they have driven strong developer interest in addressing RSV across multiple therapeutic avenues.

Key Questions Answered

How will the RSV therapeutic market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) change from 2018–2028?

What are the most promising late-stage pipeline drugs for RSV?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the remaining unmet needs in RSV treatment management?

What drivers and barriers will affect RSV therapeutics sales in the 7MM over the forecast period?

Scope

Overview of RSV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline RSV market revenue from 2018–2028. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment and prophylactic options, unmet needs and opportunities, and the drivers and barriers affecting RSV therapeutics 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 therapeutics and prophylactics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to:

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.

Develop business strategies by understanding the trends shaping and driving the global RSV market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the RSV therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Companies mentioned

Ark Biosciences

AstraZeneca

Bavarian Nordic

Enanta Pharmaceuticals

GlaxoSmithKline

Janssen

Merck & Co.

Novavax

Pfizer

Pulmocide

ReViral

Ark Biosciences

AstraZeneca

Bavarian Nordic

Enanta Pharmaceuticals

GlaxoSmithKline

Janssen

Merck & Co.

Novavax

Pfizer

Pulmocide

ReViral

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Respiratory Syncytial Virus: Executive Summary

2.1 Strong Growth Projected for the RSV ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Respiratory Syncytial Virus: Executive Summary

2.1 Strong Growth Projected for the RSV Market from 2018 to 2028

2.2 Both Large and Small Developers Are Focused on the Untapped RSV Therapeutics Market

2.3 The Market for Cost-Effective RSV Prophylaxis Is Highly Competitive

2.4 Despite Projected Entrance of Novel Products, Opportunities Remain for Current and Future Players

2.5 Future RSV Management Strategies Will Include Multiple Products

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used and Not Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for RSV Hospitalized Population (2018–2028)

5.5.1 Number of Hospitalized Adults with Positive RSV Test

5.5.2 Number of Children Hospitalized for RSV

5.6 Epidemiological Forecast for RSV Prophylactic Population (2018–2028)

5.6.1 Number of Preterm Births by Gestational Age

5.6.2 Premature Infants with CLD

5.6.3 Number of Live Births with Hemodynamically Significant Heart Disease

5.6.4 Diagnosed Prevalent Cases of DMD

5.6.5 Number of Diagnosed Prevalent Cases of SMA

5.6.6 Number of Third Trimester Pregnant Women

5.6.7 Number of Adults Living in Nursing Homes/Long-Term Care Institutions

5.7 Discussion

5.7.1 Epidemiological Forecast Insight

5.7.2 Limitations of Analysis

5.7.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Improved Cost-Effective Passive Prophylaxis

7.2.1 Unmet Need

7.2.2 Gap Analysis and Opportunity

7.3 Prophylactic Vaccines

7.3.1 Unmet Need

7.3.2 Gap Analysis and Opportunity

7.4 Effective Therapeutic Antivirals

7.4.1 Unmet Need

7.4.2 Gap Analysis and Opportunity

7.5 Increased Research and Awareness of Long-term Sequela

7.5.1 Unmet Need

7.5.2 Gap Analysis and Opportunity

8 R&D Strategies

8.1 Overview

8.1.1 Development of RSV Antiviral Therapeutics with Diverse Mechanisms of Action

8.1.2 Leveraging Novel Vaccine Technologies and Strategies

8.1.3 Development of Prophylactic Antibodies with Improved Dosing and Efficacy

8.2 Clinical Trials Design

8.2.1 Clinical Trials Design of Pipeline Prophylactics for Maternal Immunization

8.2.2 Clinical Trials Design of Pipeline Prophylactics for Pediatric Immunization

8.2.3 Clinical Trials Design of Pipeline Prophylactics for Adult Immunization

8.2.4 Demonstration of Efficacy for Fusion Inhibitor Antivirals

8.2.5 Demonstration of Efficacy for Replication Inhibitor Antivirals

9 Pipeline Assessment

9.1 Overview

9.1.1 Recently Discontinued Pipeline Products

9.2 Innovative Early-Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.1.1 Therapeutic Agents

10.1.2 Prophylactic Agents

10.2 Commercial Benchmark of Key Pipeline Drugs

10.2.1 Therapeutic Agents

10.2.2 Prophylactic Agents

10.3 Competitive Assessment

10.3.1 Therapeutic Agents

10.3.2 Prophylactic Agents

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: Respiratory Syncytial Virus: Key Metrics in the 7MM

Table 2: Risk Factors for Severe RSV

Table 3: Treatment Guidelines for RSV

Table 4: ...

Table 1: Respiratory Syncytial Virus: Key Metrics in the 7MM

Table 2: Risk Factors for Severe RSV

Table 3: Treatment Guidelines for RSV

Table 4: Leading Treatments for RSV, 2019

Table 5: Clinical Trial Designs for RSV Vaccines for Maternal Immunization

Table 6: Clinical Trial Designs for RSV Prophylactics for Pediatric Patients

Table 7: Clinical Trial Designs for RSV Prophylactics for Adult Patients

Table 8: Clinical Trial Designs for RSV Fusion Inhibitor Therapeutics

Table 9: Clinical Trial Designs for RSV Replication Inhibitor Therapeutics

Table 10: Innovative Early Stage Approaches for RSV, 2019

Table 11: Drugs in Development for RSV, 2019

Table 12: Clinical Benchmark of Key Pipeline Therapeutics

Table 13: Clinical Benchmark of Key Pipeline Prophylactics – RSV mAbs

Table 14: Clinical Benchmark of Key Pipeline Prophylactics – RSV Vaccines

Table 15: Commercial Benchmark of Key Pipeline Therapeutics

Table 16: Commercial Benchmark of Key Pipeline Prophylactics – RSV mAbs

Table 17: Commercial Benchmark of Key Pipeline Prophylactics – RSV Vaccines

Table 18: Key Events Impacting Sales for RSV, 2018–2028

Table 19: RSV Market – Global Drivers and Barriers, 2018–2028

Table 20: Key Historical and Projected Launch Dates for RSV

Table 21: Key Historical and Projected Patent Expiry Dates for RSV

Table 22: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for RSV in 2018 and 2028

Figure 2: Competitive Assessment of Pipeline Therapeutics Benchmarked Against Janssen’s Experimental Antiviral ...

Figure 1: Global Sales Forecast by Country for RSV in 2018 and 2028

Figure 2: Competitive Assessment of Pipeline Therapeutics Benchmarked Against Janssen’s Experimental Antiviral JNJ-53718678

Figure 3: Competitive Assessment of the Marketed and Pipeline Prophylactics Benchmarked Against AstraZeneca’s Synagis

Figure 4: Structure of the Human RSV Virion

Figure 5: Replication Cycle of RSV

Figure 6: 7MM, Children, Boys and Girls, 0–2 Years Old, Confirmed RSV Hospitalizations, N, 2008–2018

Figure 7: 7MM, Rate of Preterm Births (per 1,000 Live Births), 2008–2018

Figure 8: 7MM, Percentage of Adults Living in Long-Term Care, Ages ≥55 Years, 2008–2018

Figure 9: 7MM, Sources Used to Forecast the Number of Adults Hospitalized Who Test Positive for RSV, 2018–2028

Figure 10: 7MM, Sources Used to Forecast the Number of Children Hospitalized with Confirmed RSV

Figure 11: 7MM, Sources Used to Forecast the Number of Preterm Births

Figure 12: 7MM, Sources Used to Forecast the Number of Preterm Births with CLD, 2018–2028

Figure 13: 7MM, Sources Used to Forecast the Number of Live Births with Hemodynamically Significant Heart Disease

Figure 14: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of DMD

Figure 15: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SMA

Figure 16: 7MM, Sources Used to Forecast the Number of Third Trimester Pregnancies

Figure 17: 7MM, Sources Used to Forecast the Number of Adults Living in Long-Term Care

Figure 18: 7MM, Number of Hospitalized Adults, Ages ≥60 Years, with Positive RSV Test, Men and Women, 2018

Figure 19: 7MM, Number of Children, Ages 0–2 Years, Boys and Girls, Hospitalized for RSV, 2018

Figure 20: 7MM, Number of Preterm Births by Gestational Age, N, 2018

Figure 21: 7MM, Number of Preterm Infants with CLD, N, 2018–2028

Figure 22: 7MM, Number of Live Births with Hemodynamically Significant Heart Disease, 2018–2028

Figure 23: 7MM, Diagnosed Prevalent Cases of DMD in Boys, Ages 0–2 Years, 2018–2028

Figure 24: 7MM, Diagnosed Prevalent Cases of SMA, Boys and Girls, Ages 0–2 Years, 2018–2028

Figure 25: 7MM, Number of Third Trimester Pregnant Women, N, 2018–2028

Figure 26: 7MM, Number of Adults Living in Care Institutions, Ages ≥55 Years, N, 2018–2028

Figure 27: Unmet Needs and Opportunities in RSV

Figure 28: Overview of the Development Pipeline in RSV

Figure 29: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for RSV in the 7MM During the Forecast Period

Figure 30: Competitive Assessment of Pipeline Antivirals

Figure 31: Competitive Assessment of Pipeline Prophylactics Benchmarked Against the Current SOC

Figure 32: Global (7MM) Sales Forecast by Country for RSV in 2018 and 2028

Figure 33: Global Sales Forecast by Product for RSV in 2028

Figure 34: Therapeutic Sales Forecast by Product for RSV in the US from 2018 to 2028

Figure 35: Prophylactic Sales Forecast by Class for RSV in the US from 2018 to 2028

Figure 36: Therapeutic Sales Forecast by Product for RSV in the 5EU from 2018 to 2028

Figure 37: Prophylactic Sales Forecast by Class for RSV in the 5EU from 2018 to 2028

Figure 38: Therapeutic Sales Forecast by Product for RSV in Japan from 2018 to 2028

Figure 39: Prophylactic Sales Forecast by Class for RSV in Japan from 2018 to 2028

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