Respiratory Syncytial Virus Prevention Market Accelerates on FDA Approvals and Next-Gen Vaccines; Pharma Giants and Biotechs Target Massive Pediatric Burden | DelveInsight

DelveInsight's comprehensive Respiratory Syncytial Virus (RSV) market report shows USD 1,300M market size in 2023 with 8.6M incident cases across 7MM. Key players Pfizer (ABRYSVO), GSK (AREXVY), Sanofi/AstraZeneca (BEYFORTUS), Moderna (mRNA-1345), Janssen (VAC 18193) driving transformation from supportive care to preventive treatments through breakthrough vaccines and monoclonal antibodies, revolutionizing RSV prevention landscape.
Respiratory Syncytial Virus Key Takeaways

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Respiratory Syncytial Virus Market size projection: As per DelveInsight's analysis, the total market size of Respiratory Syncytial Virus treatment in the 7MM was around USD 1,300 million in 2023, with expectations of significant surge during the forecast period 2024-2034.

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Respiratory Syncytial Virus Patient population data: The report provides the total Respiratory Syncytial Virus incident cases of approximately 8,600,000 across the 7MM in 2023, with the US accounting for the majority at 56% of total cases.

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Respiratory Syncytial Virus Key companies: Leading Respiratory Syncytial Virus companies, such as Pfizer, GlaxoSmithKline (GSK), Sanofi/AstraZeneca, Moderna, Janssen, BAVARIAN NORDIC, REVIRAL, Clover Biopharmaceuticals, AIM Vaccine, QIAGEN, and Vicebio are driving innovation in the RSV treatment landscape.

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Respiratory Syncytial Virus Pipeline assets: Some of the key Respiratory Syncytial Virus therapies in the pipeline include mRNA-1345 (Moderna), VAC 18193 (Janssen), SCB-1019 (Clover Biopharmaceuticals), and others representing diverse therapeutic approaches.

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August 2025: The FDA issued the final approval letter for Arexvy's expanded indication, formalizing its authorization for adults aged 18-49 at increased risk, ahead of the 2025-2026 RSV season.

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July 2025: The FDA accepted GSK's supplemental Biologics License Application to extend Arexvy's indication to adults aged 18-49 at increased risk for severe RSV infection

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On 12 June 2025, Moderna's mRESVIA (mRNA-1345) received FDA approval for an expanded adult indication, covering individuals aged 18-59 years at increased risk for RSV-related lower respiratory tract disease, based on strong Phase III immunogenicity and safety data.

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June 2025: The FDA approved Merck's ENFLONSIA Trademark (clesrovimab-cfor) for the prevention of RSV lower respiratory tract disease in neonates and infants entering their first RSV season.

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In May 2025, a meta-analysis published in The Lancet Child and Adolescent Health confirmed that nirsevimab (Beyfortus) reduced RSV-related hospitalizations by 83% and ICU admissions by 81% in infants aged less than or equal to 12 months, demonstrating strong real-world effectiveness outside clinical trial settings.

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April 2025: European Commission approved expanded indication for Pfizer's ABRYSVO for adults aged 18-59 years

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March 2025: AIM Vaccine's mRNA RSV vaccine received FDA clinical trial approval; March 2025 - Clover Biopharmaceuticals announced FDA IND clearance for SCB-1019 Phase I trial

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November 2024: UK court ruled in Pfizer's favor over GSK in RSV vaccine patent dispute

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October 2024: FDA cleared QIAGEN's QIAstat-Dx Respiratory Panel Mini test

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September 2024: Vicebio secured $100 million Series B financing led by TCGX.

Discover more recent advancements in the Respiratory Syncytial Virus landscape @ Respiratory Syncytial Virus Recent Developments [https://www.delveinsight.com/sample-request/respiratory-syncytial-virus-rsv-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Respiratory Syncytial Virus Market Dynamics

The Respiratory Syncytial Virus treatment market has undergone a revolutionary transformation, marking 2023 as a pivotal turning point in RSV prevention and treatment. The market size of USD 1,300 million in 2023 across the 7MM represents the beginning of a new era, transitioning from limited supportive care options to comprehensive preventive strategies through innovative vaccines and monoclonal antibodies.

According to DelveInsight's comprehensive Respiratory Syncytial Virus Market Insight, Epidemiology And Market Forecast [https://www.delveinsight.com/report-store/respiratory-syncytial-virus-rsv-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr] report, the market is being driven by unprecedented scientific breakthroughs and regulatory approvals that have fundamentally altered the treatment paradigm. Until 2023, supportive care including hydration, nasal obstruction clearing, and nutritional support remained the primary intervention for RSV bronchiolitis. The FDA's approval of AREXVY, the world's first RSV vaccine for individuals 60 years and older, followed by ABRYSVO's approval for pregnant individuals and BEYFORTUS for broad infant protection, has created substantial market momentum and established new standards of care.

The scientific rationale underlying current therapeutic approaches focuses on prefusion F protein stabilization and enhanced neutralizing antibody responses. ABRYSVO utilizes bivalent RSV prefusion F proteins optimized against RSV A and B strains, while BEYFORTUS employs single-dose long-acting antibody technology with YTE enhancement for extended protection. Moderna's mRNA-1345 leverages messenger RNA technology encoding prefusion F glycoprotein to elicit superior neutralizing responses, representing the next generation of RSV prevention.

The Respiratory Syncytial Virus clinical development activity demonstrates robust pipeline engagement with multiple Phase III and Phase II candidates advancing toward commercialization. Moderna expects regulatory approvals beginning in 2024, while Janssen's VAC 18193 leverages unique adenovector platform features for prophylactic protection in seniors. The diversity of approaches, from mRNA technology to adenoviral vectors and protein subunit vaccines, indicates a maturing competitive landscape with multiple viable therapeutic pathways.

The Respiratory Syncytial Virus competitive landscape reflects intensive industry participation from both established pharmaceutical giants and emerging biotechnology companies. Pfizer's breakthrough designation for ABRYSVO, combined with GSK's fast-track and breakthrough designations for AREXVY, demonstrates regulatory recognition of significant therapeutic advancement. Patent disputes, notably the UK court ruling favoring Pfizer over GSK, highlight the substantial commercial stakes and competitive dynamics shaping market evolution.

Challenges persist in developing safe and effective RSV interventions, particularly regarding stringent safety requirements for pediatric and maternal populations. Cost-effectiveness considerations, reimbursement landscapes, and global accessibility represent ongoing hurdles. However, opportunities abound as the substantial disease burden-with RSV affecting nearly all children by age 2-creates enormous market potential for effective preventive interventions.

Future outlook indicates sustained growth driven by expanding indications, improved vaccine uptake, and emerging therapeutic modalities. The shift toward prevention-focused strategies, combined with increasing awareness of RSV consequences among healthcare providers and families, positions the market for continued expansion throughout the forecast period to 2034.

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Respiratory Syncytial Virus Epidemiology

The epidemiology of Respiratory Syncytial Virus across the 7MM reveals substantial disease burden with approximately 8,600,000 total incident cases in 2023, demonstrating the significant public health impact requiring comprehensive therapeutic intervention. The United States dominates the epidemiological landscape, accounting for 56% of total incident cases across the 7MM, reflecting both population size and reporting infrastructure capabilities.

Epidemiological segmentation demonstrates distinct age-related patterns, with the highest incident cases occurring in children below 5 years of age, representing nearly 50% of total RSV incident cases in 2023. This pediatric predominance is followed by cases in individuals 65 years and above, while the 5-64 years age group shows the lowest incidence rates. The substantial pediatric burden, with approximately 2,800,000 incident cases in the below 5 years category, underscores the critical need for effective preventive interventions targeting this vulnerable population.

Geographic segmentation across the 7MM shows varied distribution patterns, with the US leading in absolute case numbers, followed by EU4 countries (Germany, France, Italy, Spain), the United Kingdom, and Japan. The epidemiological model indicates that severity-specific incident cases in children show mild cases representing the highest proportion, while severity-specific cases in adults demonstrate different distribution patterns requiring age-appropriate therapeutic approaches.

The forecast period from 2020-2034 projects continued substantial case burdens, with total incident cases maintaining high levels across all geographic regions. Visit-specific incident cases reveal healthcare utilization patterns that inform market sizing and therapeutic demand projections. The epidemiological data supports the rationale for preventive interventions, as RSV's widespread nature-affecting nearly all children by age 2-creates predictable patient populations for vaccine and monoclonal antibody interventions.

Discover evolving trends in the Respiratory Syncytial Virus epidemiology forecasts @ Respiratory Syncytial Virus Patient Pool Analysis [https://www.delveinsight.com/sample-request/respiratory-syncytial-virus-rsv-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Respiratory Syncytial Virus Key Companies and Treatment Market Context

The clinical and regulatory landscape for Respiratory Syncytial Virus treatment has evolved dramatically with the introduction of breakthrough preventive therapies that have redefined treatment paradigms. Current treatment options now encompass both supportive care measures and innovative preventive interventions, creating a comprehensive approach to RSV management across different patient populations.

The Respiratory Syncytial Virus clinical pipeline activity demonstrates robust development phases with multiple companies advancing through Phase III and Phase II studies. The regulatory environment has proven receptive to innovative RSV interventions, with the FDA granting breakthrough and fast-track designations to multiple candidates, recognizing the substantial unmet medical need in RSV prevention and treatment.

Key Respiratory Syncytial Virus players include Pfizer (ABRYSVO/RSVpreF), GlaxoSmithKline (AREXVY/GSK3844766A), Sanofi/AstraZeneca (BEYFORTUS/nirsevimab), Moderna (mRNA-1345), Janssen (VAC 18193/Ad26.RSV.preF), BAVARIAN NORDIC, REVIRAL, Clover Biopharmaceuticals (SCB-1019), AIM Vaccine, QIAGEN, and Vicebio, each contributing distinct therapeutic approaches and technological innovations to address the substantial RSV disease burden.

Market positioning reflects the transition from reactive supportive care to proactive prevention strategies. ABRYSVO serves dual populations-pregnant individuals for infant protection and adults 60 and older for direct protection. BEYFORTUS provides single-dose passive immunization for broad infant populations, including healthy, preterm, and high-risk infants. AREXVY targets the senior population with adjuvanted vaccine technology for enhanced immune responses in older adults.

Respiratory Syncytial Virus Drug profiles demonstrate diverse mechanisms of action and development strategies. ABRYSVO utilizes bivalent prefusion F proteins with intramuscular administration, while BEYFORTUS employs long-acting antibody technology with YTE enhancement for extended half-life. Moderna's mRNA-1345 leverages messenger RNA encoding for prefusion F glycoprotein, representing next-generation vaccine technology. Janssen's VAC 18193 utilizes adenovector platform advantages for prophylactic senior protection.

Development milestones reflect accelerated regulatory pathways and successful clinical outcomes. Recent approvals, expanded indications, and ongoing Phase III studies demonstrate the maturity of the development landscape. Commercial arrangements include strategic partnerships between AstraZeneca and Sanofi for BEYFORTUS commercialization, licensing agreements, and substantial venture financing rounds, such as Vicebio's $100 million Series B funding, indicating strong investor confidence in RSV therapeutic potential.

Delve deeper into the major and specialised companies in the Respiratory Syncytial Virus market @ Respiratory Syncytial Virus Competitive Landscape [https://www.delveinsight.com/sample-request/respiratory-syncytial-virus-rsv-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Conclusion

The Respiratory Syncytial Virus treatment market represents a transformative therapeutic landscape where innovative vaccines and monoclonal antibodies are revolutionizing patient care from reactive supportive treatment to proactive prevention strategies. With a market size of USD 1,300 million in 2023 and approximately 8.6 million incident cases across the 7MM, the substantial disease burden creates significant opportunities for continued market growth and therapeutic innovation throughout the forecast period to 2034.

Scope of the Respiratory Syncytial Virus Market Report

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Study Period and Forecast Coverage: Comprehensive analysis spanning 2020-2034 with detailed forecast period from 2024-2034 across all major markets

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Geographic Coverage: Complete 7MM analysis including United States, EU4 countries (Germany, France, Italy, Spain), United Kingdom, and Japan

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Respiratory Syncytial Virus Epidemiological Segmentation: Total Respiratory Syncytial Virus incident cases, age-specific incident cases, severity-specific incident cases in both children and adults, and visit-specific incident cases across all regions

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Respiratory Syncytial Virus Market Analysis: Detailed Respiratory Syncytial Virus drugs market analysis segmented by region and therapies, including market share distribution and therapeutic uptake patterns

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Respiratory Syncytial Virus Pipeline Assessment: Comprehensive evaluation of Phase III and Phase II pipeline candidates with development timelines and commercial potential analysis

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Expert Insights on Respiratory Syncytial Virus: KOL views and expert opinions from 30+ industry experts across leading medical institutions including University of Miami, University of Georgia, NHS Trust, and Imperial College London

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Strategic Analysis: SWOT analysis, conjoint analysis, competitive landscape assessment, and therapeutic positioning evaluation

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Regulatory and Reimbursement: Market access analysis, reimbursement scenarios, cost-effectiveness evaluation, and regulatory pathway assessment

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Respiratory Syncytial Virus Commercial Intelligence: Drug uptake analysis, market attractiveness evaluation, patient journey mapping, and treatment preference insights

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Respiratory Syncytial Virus Company Profiles: Detailed analysis of key market participants, their pipeline assets, development strategies, and commercial positioning

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Respiratory Syncytial Virus Market Unmet Needs Assessment: Comprehensive evaluation of existing treatment gaps and opportunities for therapeutic innovation and market expansion

Table of Contents

1. Key Insights

2. Executive Summary of Respiratory Syncytial Virus

3. Competitive Intelligence Analysis for Respiratory Syncytial Virus

4. Respiratory Syncytial Virus Market Overview at a Glance

5. Respiratory Syncytial Virus: Disease Background and Overview

6. Respiratory Syncytial Virus Patient Journey

7. Respiratory Syncytial Virus Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Respiratory Syncytial Virus Unmet Needs

10. Key Endpoints of Respiratory Syncytial Virus Treatment

11. Respiratory Syncytial Virus Marketed Products

12. Respiratory Syncytial Virus Emerging Therapies

13. Respiratory Syncytial Virus: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Respiratory Syncytial Virus

17. KOL Views

18. Respiratory Syncytial Virus Market Drivers

19. Respiratory Syncytial Virus Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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