Respiratory Syncytial Virus (RSV) – Forecast in Asia-Pacific Markets to 2028

Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense RNA orthopneumovirus belonging to the family of Pneumoviridae. 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 is limited in scope as the only approved prophylactic antibody, AbbVie and AstraZeneca’s Synagis (palivizumab), is recommended for a more narrow population than the antibody is labeled for (i.e., pediatric patients at increased risk of hospitalization due to RSV), and it is not licensed in either India or urban China. 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 5GM (India, urban China, Australia, South Korea and 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 5GM 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 5GM.

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.

Key Highlights

During the 10-year forecast period, there are 14 products that are on track to launch, contributing to a forecast growth in the 5GM from $37.19M in 2018 to $1.48B in 2028, which represents a CAGR of 44.7%.

The market in the 5GM in 2018 consists of a single monoclonal antibody product, AstraZeneca/AbbVie’s Synagis (palivizumab). As Synagis is not licensed in India or urban China, these markets do not contribute to total sales in the baseline year. The launch of AstraZeneca's prophylactic monoclonal antibody MEDI8897 in Australia, South Korea and Japan (2024), India (2025) and urban China (2026) will be a key driver of growth, replacing Synagis as standard of care prophylaxis for high risk infants. The launch of several vaccines for both adult and pediatric patients, such as Janssen's Ad26.RSV.preF and GlaxoSmithKline's GSK3844766A, will fulfill a major unmet need, and will have a significant effect on the overall size of the RSV prophylactics market. The Japan market has the highest base year sales, however, due to its large patient population urban China will have the highest sales in 2028.

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 Asia-Pacific 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

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 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 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 Confirmed RSV

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

5.6.1 Number of Preterm Births by Gestational Age

5.6.2 Preterm 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 in Asia-Pacific

7.1 Overview

7.2 Improved Cost-Effective Passive Prophylaxis

7.3 Prophylactic Vaccines

7.4 Effective Antivirals

8 R&D Strategies in Asia-Pacific

8.1 Overview

8.1.1 Leveraging Novel Vaccine Technologies and Strategies

8.1.2 Development of Prophylactic Antibodies with Improved Dosing and Efficacy

8.1.3 Development of RSV Antiviral Therapeutics with Diverse Mechanisms of Action

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 in Asia-Pacific

9.1 Overview

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 India

10.4.2 Urban China

10.4.3 Australia

10.4.4 South Korea

10.4.5 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

11.5 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 5GM

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: 5GM 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: 5GM, Children, Boys and Girls, 0–2 Years Old, Confirmed RSV Hospitalizations, N, 2008 and 2018

Figure 7: 5GM, Rate of Preterm Births (per 1,000 Live Births), 2008–2018

Figure 8: 5GM, Percentage of Adults Living in Long-Term Care, Ages ≥55 Years, 2008–2018

Figure 9: 5GM, Sources Used to Forecast the Number of Adults Hospitalized Who Test Positive for RSV, 2018–2028

Figure 10: 5GM, Sources Used to Forecast the Number of Children Hospitalized with Confirmed RSV

Figure 11: 5GM, Sources Used to Forecast the Number of Preterm Births

Figure 12: 5GM, Sources Used to Forecast the Number of Preterm Births with CLD, 2018–2028

Figure 13: 5GM, Sources Used to Forecast the Number of Live Births with Hemodynamically Significant Heart Disease

Figure 14: 5GM, Sources Used to Forecast Diagnosed Prevalent Cases of DMD

Figure 15: 5GM, Sources Used to Forecast the Diagnosed Prevalent Cases of SMA

Figure 16: 5GM, Sources Used to Forecast the Number of Third Trimester Pregnancies

Figure 17: 5GM, Sources Used to Forecast the Number of Adults Living in Long-Term Care

Figure 18: 5GM, Number of Hospitalized Adults with Positive RSV Test, Ages ≥60 Years, Men and Women, 2018

Figure 19: 5GM, Number of Children Hospitalized for Confirmed RSV, Ages 0–2 Years, Boys and Girls, 2018

Figure 20: 5GM, Number of Preterm Births by Gestational Age, N, 2018

Figure 21: 5GM, Number of Preterm Infants with CLD, N, 2018–2028

Figure 22: 5GM, Number of Live Births with Hemodynamically Significant Heart Disease, 2018–2028

Figure 23: 5GM, Diagnosed Prevalent Cases of DMD in Boys, Ages 0–2 Years, 2018–2028

Figure 24: 5GM, Diagnosed Prevalent Cases of SMA, Boys and Girls, Ages 0–2 Years, 2018–2028

Figure 25: 5GM, Number of Third Trimester Pregnant Women, N, 2018–2028

Figure 26: 5GM, Number of Adults Living in Long-Term 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 5GM During the Forecast Period

Figure 30: Competitive Assessment of Pipeline Antivirals

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

Figure 32: 5GM 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 India from 2018 to 2028

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

Figure 36: Therapeutic Sales Forecast by Product for RSV in Urban China from 2018 to 2028

Figure 37: Prophylactic Sales Forecast by Class for RSV in Urban China from 2018 to 2028

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

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

Figure 40: Therapeutic Sales Forecast by Product for RSV in South Korea from 2018 to 2028

Figure 41: Prophylactic Sales Forecast by Class for RSV in South Korea from 2018 to 2028

Figure 42: Therapeutic Sales Forecast by Product for RSV in Japan from 2018 to 2028

Figure 43: Prophylactic Sales Forecast by Class for RSV in Japan from 2018 to 2028

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