Summary
Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense RNA orthopneumovirus belonging to the family of Pneumoviridae. 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. Only one marketed drug is indicated for the prevention of RSV infections, Sobi/AbbVie’s monoclonal antibody (mAb) Synagis (palivizumab) for the prophylaxis of RSV in infants at a high risk of severe infection.
GlobalData projects the global (8MM) RSV to experience high growth during the forecast period. There are 8 prophylactic products expected to launch in the 8MM by 2030. The launch of AstraZeneca/Sanofi's improved prophylactic mAb nirsevimab and Merck’s mAb clesrovimab will be a key driver of growth, replacing Synagis as standard of care prophylaxis for high-risk infants. The launch of several vaccines for adult, maternal, and pediatric patients from Pfizer, GlaxoSmithKline, Johnson & Johnson, and Bavarian Nordic will fulfill a major unmet need, and will have a significant effect on the overall size of the RSV prophylactics market.
Key Highlights
- During the 10-year forecast period, there are eight major pipeline products that are on track to launch, driving a forecast growth in the 8MM from $455M in 2020 to $6.3B in 2030, which represents a CAGR of 30.1%.
- To combat the unmet need of an improved passive prophylaxis, new monoclonal antibodies from AstraZeneca/Sanofi (nirsevimab) and Merck (clesrovimab) will enter the RSV prophylactic market in 2023 and 2025, respectively, and take over a combined market share of 57.5% in 2030.
- Further market entries will be maternal RSV vaccines from Pfizer (PF-06928316/RSVpreF) and GlaxoSmithKline (GSK-3888550A/RSV MAT), RSV vaccines for the elderly from GlaxoSmithKline (GSK-3844766A/RSVPreF3 OA) , Johnson & Johnson (JNJ-64213175/RSV preF) , and Bavarian Nordic (MVA-BN RSV), as well a vaccine for both pediatric and adult RSV patients from Johnson & Johnson (JNJ-64400141/Ad26.RSV.preF), resulting in forecasted 2030 RSV vaccines sales of $2.7B.
Key Questions Answered
- How will the RSV market landscape in the 8MM (US, France, Germany, Italy, Spain, UK, Japan, Australia) change from 2020-2030?
- What are the most promising late-stage pipeline products for RSV prophylaxis?
- How do the clinical and commercial attributes of late-stage pipeline products compare with one another, and against existing RSV prevention options?
- What are the remaining unmet needs in RSV prophylaxis?
- What drivers and barriers will affect RSV prophylaxis sales in the 8MM over the forecast period?
Scope
- Overview of RSV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline RSV prophylaxis market revenue from 2020-2030. Annual cost of therapy and major pipeline product sales in this forecast period are included.
- Key topics covered include current RSV prophylaxis , unmet needs and opportunities, and the drivers and barriers affecting CHB treatment sales in the 8MM.
- 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 prophylaxis market. Insightful review of the key industry drivers, constraints, 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 prophylactic market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the RSV prophylaxis 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.
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Table of Contents
1 Respiratory Syncytial Virus: Executive Summary
1.1 Strong Growth Projected for the RSV Market from 2020 to 2030
1.2 The Market for RSV Prophylaxis Is Untapped and Highly Competitive
1.3 Remaining Opportunities for Current and Future Players
1.4 Future RSV Management Strategies Will Include Multiple Products
1.5 What Do Physicians Think?
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
4 Epidemiology
4.1 Disease Background
4.1.1 Risk Factors and Comorbidities
4.2 Global and Historical Trends
4.3 Forecast Methodology
4.3.1 Sources
4.3.2 Forecast Assumptions and Methods
4.4 Epidemiological Forecast for RSV Prophylactic Population (2020-2030)
4.4.1 Number of Preterm Births by Gestational Age
4.4.2 Preterm Infants with CLD
4.4.3 Number of Live Births with Hemodynamically Significant Heart Disease and Congenital Lung Disease
4.4.4 Diagnosed Prevalent Cases of DMD
4.4.5 Number of Diagnosed Prevalent Cases of SMA
4.4.6 Number of Third-Trimester Pregnant Women
4.4.7 Number of Adults Living in Nursing Homes/Long-Term Care Institutions
4.5 Discussion
4.5.1 Epidemiological Forecast Insight
4.5.2 COVID-19 Impact
4.5.3 Limitations of the Analysis
4.5.4 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.2 KOL Insights on Disease Management
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Improved Passive Prophylaxis
7.3 Prophylactic Vaccines
7.4 Effective Therapeutic Antivirals
7.5 Increased Diagnostic Testing
7.6 Increased Research and Awareness of Long-Term Sequelae
8 R&D Strategies
8.1 Overview
8.1.1 Leveraging Novel Vaccine Technologies and Strategies
8.2 Clinical Trials Design
8.2.1 Clinical Trial Designs for RSV Vaccines for Maternal Immunization
8.2.2 Clinical Trials Designs for RSV Prophylactics for Pediatric Patients
8.2.3 Clinical Trials Design of Pipeline Prophylactics for Adult Immunization
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive Assessment
11 Current and Future Players
11.1 Overview
11.2 Deal-Making Trends
12 Market Outlook
12.1 Global Markets
12.1.1 Forecast
12.1.2 Drivers and Barriers - Global Issues
12.2 US
12.2.1 Forecast
12.2.2 Key Events
12.2.3 Drivers and Barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key Events
12.3.3 Drivers and Barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key Events
12.4.3 Drivers and Barriers
12.5 Australia
12.5.1 Forecast
12.5.2 Key Events
12.5.3 Drivers and Barriers
13 Appendix
List of Tables
Table 1: Respiratory Syncytial Virus: Key Metrics in the 8MM
Table 2: Risk Factors for Severe RSV
Table 3: Leading Treatments for RSV, 2021
Table 4: Treatment Guidelines for RSV
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: Innovative Early-Stage Approaches for RSV, 2021
Table 9: Drugs in Early-Stage Development for RSV, 2021
Table 10: RSV Prophylactics Market - Global Drivers and Barriers, 2020-2030
Table 11: Key Events Impacting Sales for RSV Prophylactics in the US, 2020-2030
Table 12: RSV Prophylactics Market - Drivers and Barriers in the US, 2020-2030
Table 13: Key Events Impacting Sales for RSV Prophylactics in the 5EU, 2020-2030
Table 14: RSV Prophylactics Market - Drivers and Barriers in the 5EU, 2020-2030
Table 15: Key Events Impacting Sales for RSV Prophylactics in Japan, 2020-2030
Table 16: RSV Prophylactics Market - Drivers and Barriers in Japan, 2020-2030
Table 17: Key Events Impacting Sales for RSV Prophylactics in Australia, 2020-2030
Table 18: RSV Prophylactics Market - Drivers and Barriers in Australia, 2020-2030
Table 19: RSV Prophylaxis Launch Dates
Table 20: RSV Prophylaxis Patent Expiration Dates
Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for Respiratory Syncytial Virus in 2020 and 2030
Figure 2: Analysis of the Company Portfolio Gap in Respiratory Syncytial Virus During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of RSV During the Forecast Period
Figure 4: Structure of Human RSV Virion
Figure 5: RSV Life Cycle
Figure 6: 8MM, Rate of Preterm Births (per 1,000 Live Births), 2020-2030
Figure 7: 8MM, Percentage of Adults Living in Long-Term Care, Ages ≥55 Years, 2020-2030
Figure 8: 8MM, Sources Used to Forecast the Number of Preterm Births
Figure 9: 8MM, Sources Used to Forecast the Number of Preterm Births with CLD
Figure 10: 8MM, Sources Used to Forecast the Number of Live Births with Hemodynamically Significant Heart Disease
Figure 11: 8MM, Sources Used to Forecast the Number of Live Births with Congenital Lung Disease
Figure 12: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of DMD
Figure 13: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SMA
Figure 14: 8MM, Sources Used to Forecast the Number of Third-Trimester Pregnancies
Figure 15: 8MM, Sources Used to Forecast the Number of Adults Living in Long-Term Care
Figure 16: 8MM, Number of Preterm Births by Gestational Age, N, 2020
Figure 17: 8MM, Number of Preterm Infants with CLD, N, 0-Year, 2020-2030
Figure 18: 8MM, Number of Live Births with Hemodynamically Significant Heart Disease and Congenital Lung Disease, 2020, 0-Year
Figure 19: 8MM, Diagnosed Prevalent Cases of DMD in Boys, Ages 0-2 Years, 2020-2030
Figure 20: 8MM, Diagnosed Prevalent Cases of SMA, Boys and Girls, Ages 0-2 Years, 2020-2030
Figure 21: 8MM, Number of Third-Trimester Pregnant Women, N, 2020-2030
Figure 22: 8MM, Number of Adults Living in Care Institutions, Ages ≥55 Years, N, 2020-2030
Figure 23: Unmet Needs and Opportunities in RSV
Figure 24: Overview of the Development Pipeline in RSV
Figure 25: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for RSV in the 8MM During the Forecast Period
Figure 26: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of RSV During the Forecast Period
Figure 27: Clinical and Commercial Scores of Key Pipeline Prophylactics Against the SOC, Synagis
Figure 28: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Synagis
Figure 29: Analysis of the Company Portfolio Gap in RSV Prophylaxis During the Forecast Period
Figure 30: Global (8MM) Sales Forecast by Country for RSV Prophylactics in 2020 and 2030
Figure 31: Sales Forecast by Class for Pediatric and Adult RSV Prophylactics in the US in 2030
Figure 32: Sales Forecast by Class for RSV Prophylactics in the 5EU in 2020 and 2030
Figure 33: Sales Forecast by Class for Pediatric and Adult RSV Prophylactics in Japan in 2030
Figure 34: Sales Forecast by Class for Pediatric and Adult RSV Prophylactics in Australia in 2030
