Respiratory Syncytial Virus (RSV) Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Drug and Vaccines), By End User (Hospitals and Clinics, Ambulatory Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.25 Billion
CAGR (2026-2031)	7.34%
Fastest Growing Segment	Vaccines
Largest Market	North America
Market Size (2031)	USD 3.44 Billion

Market Overview

The Global Respiratory Syncytial Virus (RSV) Therapeutics Market will grow from USD 2.25 Billion in 2025 to USD 3.44 Billion by 2031 at a 7.34% CAGR. The Global Respiratory Syncytial Virus (RSV) Therapeutics Market is defined by a portfolio of pharmaceutical interventions, including prophylactic vaccines, monoclonal antibodies, and antiviral compounds designed to prevent or treat infections caused by the respiratory syncytial virus. The primary drivers propelling market trajectory include the escalating burden of severe respiratory disease among vulnerable pediatric and geriatric populations, alongside the recent regulatory approvals of novel immunization agents. Furthermore, advancements in rapid molecular diagnostics are facilitating earlier and more accurate detection, effectively expanding the addressable patient population requiring clinical management.

However, the market encounters a significant impediment regarding the successful uptake and widespread adoption of these newly approved products. Vaccine hesitancy and the logistical complexities of administering immunization programs to adult populations often limit market penetration, leaving a large portion of the target demographic unprotected. This gap in utilization is evident in recent coverage metrics. According to the American Lung Association, in 2024, only 24% of eligible older adults in the United States had received an RSV vaccine, highlighting a critical disparity between therapeutic availability and actual preventative application.

Key Market Drivers

The Rapid Adoption of Long-Acting Prophylactic Monoclonal Antibodies is acting as a transformative force in the Global Respiratory Syncytial Virus (RSV) Therapeutics Market, shifting the paradigm from symptom management to active prevention in pediatric populations. This driver is characterized by the swift integration of immunization agents like nirsevimab into national healthcare protocols, addressing the high unmet need among infants. The substantial market demand for these preventative measures is evidenced by their immediate financial impact; according to Sanofi, January 2025, in the 'Q4 sales growth of 10.3%' press release, Beyfortus sales reached €1.7 billion in 2024, achieving blockbuster status in its first full year. This commercial uptake is correlated with significant clinical outcomes, validating the strategy of widespread prophylaxis. According to the Centers for Disease Control and Prevention (CDC), in 2025, RSV-associated hospitalization rates among infants aged less than 8 months were 28% to 43% lower during the 2024-2025 season compared to pre-pandemic levels, underscoring the direct market benefit of these adoption trends.

The Commercialization of Novel RSV Vaccines and Antivirals represents the second critical driver, expanding the therapeutic frontier to include vulnerable older adults. This factor involves the regulatory approval and rollout of protein subunit and mRNA vaccines, which have established a new revenue stream and standard of care for geriatric respiratory health. Although the long-term trajectory is positive, the segment is currently experiencing volatility as healthcare systems refine usage guidelines. For example, according to BioPharma Dive, February 2025, in the 'GSK, Pfizer sales of RSV shots slow' article, GSK reported that Arexvy sales declined 69% year-over-year in the fourth quarter due to narrowing age-based recommendations. Despite these short-term fluctuations, the successful commercialization of these biological agents remains the foundational element propelling the broader market's expansion and maturity.

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Key Market Challenges

The primary impediment restricting the expansion of the Global Respiratory Syncytial Virus (RSV) Therapeutics Market is the significant gap between regulatory approval and widespread patient adoption. While pharmaceutical companies have successfully developed efficacious immunization agents, the market effectively stagnates if these interventions do not reach the intended demographic. This challenge is rooted in deep-seated vaccine hesitancy and the logistical difficulties inherent in deploying adult immunization infrastructures, which are historically less robust than pediatric programs. Consequently, the commercial viability of these therapeutics is directly undermined, as low uptake translates to reduced sales volume and a slower return on investment for manufacturers who have poured substantial capital into research and development.

This disparity between market potential and actual penetration is quantified by recent industry data regarding patient intent. According to the National Foundation for Infectious Diseases, in 2024, among United States adults for whom an RSV vaccine is recommended, only 21% indicated they would definitely get vaccinated. This statistic underscores a critical resistance within the addressable market, demonstrating that despite the availability of preventative measures, a vast majority of the target population remains uncaptured. Until adoption rates align with product availability, the financial growth of the RSV therapeutics sector will remain constrained below its projected capacity.

Key Market Trends

The Adoption of Maternal Immunization for Neonatal Protection is establishing a preventative pathway distinct from direct infant prophylaxis. This approach utilizes vaccines administered during pregnancy to transfer passive immunity, effectively addressing gaps in pediatric healthcare delivery. The segment's expanding commercial relevance is driven by intensified distribution strategies targeting prenatal care providers. According to BioPharma Dive, October 2024, in the 'Pfizer sales of RSV vaccine ebb, but company gains market share' article, Pfizer reported that it shipped 56% more units of Abrysvo to obstetricians and gynecologists during the season's first four weeks compared to the previous year. This uptake highlights the increasing reliance on maternal immunization as a critical strategy to secure neonatal health.

Simultaneously, the Integration of mRNA Technology in RSV Vaccine Pipelines is redefining the competitive architecture by challenging established protein subunit modalities. This technological shift facilitates the rapid development of scalable formulations, offering a streamlined approach to addressing respiratory pathogens and enabling future combination vaccines. The tangible market entry of this platform is evidenced by the commercialization of novel mRNA agents. According to Moderna, November 2024, in the 'Third Quarter 2024 Financial Results' press release, the company recorded $10 million in net product sales for mRESVIA, marking the foundational revenue stream for mRNA RSV therapeutics. This integration signals a pivotal transition toward more adaptable and rapidly deployable vaccine technologies.

Segmental Insights

The Vaccines segment has emerged as the fastest-growing category within the Global Respiratory Syncytial Virus (RSV) Therapeutics Market due to a fundamental shift from symptomatic management to preventative care. This rapid expansion is attributed to recent regulatory approvals by the U.S. Food and Drug Administration (FDA) for the first immunization agents targeting older adults and infants via maternal vaccination. These approvals addressed a longstanding unmet medical need, as previous options were largely restricted to supportive therapies. Consequently, the immediate uptake of these newly authorized preventative measures has accelerated segment development significantly.

Regional Insights

North America maintains a leading position in the global Respiratory Syncytial Virus (RSV) therapeutics market, driven by established healthcare infrastructure and widespread disease awareness. The region benefits from a supportive regulatory environment, notably through the United States Food and Drug Administration (FDA), which accelerates the approval of new treatment options. Additionally, the concentrated presence of major pharmaceutical manufacturers fosters continuous product development and commercial availability. Favorable reimbursement policies and high diagnostic rates further consolidate the region's dominance by ensuring consistent patient access to necessary therapies.

Recent Developments

• In October 2024, Merck presented positive topline results from a Phase 2b/3 clinical trial evaluating clesrovimab (MK-1654), its investigational prophylactic monoclonal antibody for infants. The data, shared at a major infectious disease conference, revealed that a single fixed dose of the therapeutic significantly reduced the incidence of RSV-associated medically attended lower respiratory infections and hospitalizations in healthy preterm and full-term infants compared to placebo. Meeting all primary safety and efficacy endpoints, these findings positioned the antibody as a potential competitor in the global market for infant RSV protection, with the company planning to submit the data to global regulatory authorities for review.
• In October 2024, Pfizer received approval from the U.S. FDA for its respiratory syncytial virus vaccine, Abrysvo, to prevent lower respiratory tract disease in adults aged 18 through 59 years who are at increased risk due to chronic medical conditions. This regulatory action significantly broadened the vaccine's market reach, making it the only RSV immunization indicated for this wide age range of at-risk adults. The approval was grounded in data from the Phase 3 MONeT study, which demonstrated that the vaccine generated neutralizing antibody responses in younger adults with chronic conditions that were non-inferior to those observed in adults aged 60 years and older.
• In June 2024, GSK announced that the U.S. FDA expanded the approved indication for its respiratory syncytial virus vaccine, Arexvy, to include adults aged 50 through 59 years who are at increased risk for lower respiratory tract disease. This approval made the vaccine the first available option for this specific demographic, addressing the needs of over 13 million adults in the United States with underlying medical conditions such as chronic obstructive pulmonary disease, asthma, and heart failure. The decision was based on positive results from a Phase 3 trial which confirmed that the vaccine elicited a robust immune response and maintained an acceptable safety profile in this younger at-risk population.
• In May 2024, Moderna received approval from the U.S. Food and Drug Administration for mRESVIA (mRNA-1345), its mRNA-based respiratory syncytial virus vaccine, for use in adults aged 60 years and older. This regulatory milestone established the product as the company’s second approved mRNA therapeutic and the first of its kind for a disease other than COVID-19. The authorization was supported by data from the Phase 3 ConquerRSV trial, which demonstrated a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease. Additionally, the company highlighted that mRESVIA is the only RSV vaccine available in a pre-filled syringe, designed to streamline administration for healthcare providers.

Key Market Players

• AbbVie, Inc.
• AstraZeneca PLC
• Bausch Health Companies Inc.
• F. Hoffmann-La Roche AG
• Gilead Sciences, Inc.
• GlaxoSmithKline PLC
• Merck & Co., Inc.
• ReViral Ltd.
• Teva Pharmaceutical Industries Ltd.
• Johnson & Johnson

By Type	By End User	By Region
Drug and Vaccines	Hospitals and Clinics Ambulatory Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Respiratory Syncytial Virus (RSV) Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Respiratory Syncytial Virus (RSV) Therapeutics Market, By Type:

• Drug and Vaccines

• Respiratory Syncytial Virus (RSV) Therapeutics Market, By End User:

• Hospitals and Clinics
• Ambulatory Centers
• Others

• Respiratory Syncytial Virus (RSV) Therapeutics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE