Respiratory Syncytial Virus Vaccines Market Size, Share & Trends Analysis Report By Type (Passive Immunization, Preventive Vaccines), By Technology, By Targeted Population, By Distribution Channel, By Region, And Segment Forecasts, 2025 - 2030

Respiratory Syncytial Virus Vaccines Market Summary

As awareness of RSV's impact increases, so does the urgency to develop and adopt effective preventive solutions, including vaccines and monoclonal antibodies. Technological advances, such as mRNA platforms, recombinant proteins, and virus-like particles, have diversified the pipeline. Historically, treatment options were limited to supportive care and monoclonal antibodies for high-risk infants, but the emergence of preventive vaccines has transformed the landscape. The market was significantly catalyzed by the U.S. FDA’s approval of Arexvy in May 2023, developed by GSK, marking the first-ever RSV vaccine approved in the United States. Arexvy is approved for individuals aged 60 and older to prevent lower respiratory tract disease caused by RSV. This milestone represents a shift in RSV management, opening up the adult vaccine segment and setting the stage for wider market expansion.

Maternal vaccination is a major step forward in protecting infants from RSV during their most vulnerable months. This preventive approach aims to provide passive immunity from mother to child, reducing the likelihood of severe infections and hospitalizations. In September 2023, the CDC recommended Pfizer’s Abrysvo for pregnant individuals, making it the first RSV vaccine approved for use during pregnancy in the U.S. Abrysvo is a bivalent RSVpreF vaccine that showed a 57% reduction in RSV-related hospitalizations in babies during their first six months of life.

Since RSV is the leading cause of hospitalization among U.S. infants, this strategy significantly broadens the preventive toolkit beyond direct infant immunization. Maternal immunization not only protects infants but also contributes to reducing the strain on pediatric care systems during RSV season. This development has spurred greater interest in perinatal vaccine strategies and is expected to accelerate market growth in both high- and middle-income countries.

While vaccines are vital, monoclonal antibodies (mAbs) continue to play a crucial role in RSV prevention, especially in infants who are not eligible for vaccination. mAbs provide passive immunity, delivering immediate but temporary protection against the virus. Historically, Synagis (palivizumab) was the mainstay of RSV prophylaxis in high-risk infants. However, newer and longer-acting antibodies like Beyfortus (nirsevimab) have improved convenience and coverage. A major development occurred in October 2024, when Merck (MSD) announced positive Phase 2b/3 results for clesrovimab (MK-1654). This investigational mAb is designed to protect infants through their first RSV season with a single dose. The promising trial outcomes strengthen Merck’s position in the RSV market and highlight the growing role of antibodies in both pediatric and potentially adult segments. Monoclonals are particularly attractive in low-resource settings where cold-chain-dependent vaccines may face distribution hurdles. They are expected to account for a significant share of the RSV prevention market.

Collaborations between biotechnology firms, research institutions, and healthcare organizations are catalyzing innovation in RSV vaccines. For example, in April 2024, Regeneron Pharmaceuticals invested USD 100 million in Mammoth Biosciences to leverage their compact Cas enzymes for in vivo gene-editing therapies across multiple tissue types. These partnerships accelerate the development of new CRISPR tools by combining technical expertise, financial resources, and manufacturing capabilities. Such strategic collaborations not only enhance enzyme and diagnostic tool development but also expand the targeted populations of CRISPR technologies into new therapeutic and diagnostic areas. By fostering interdisciplinary research and commercialization, these partnerships are expected to drive market expansion significantly. With a growing pipeline of collaborative projects, the RSV vaccines sector is well-positioned for rapid growth over the next several years.

Market Concentration & Characteristics

The RSV (Respiratory Syncytial Virus) vaccines industry is experiencing high innovation, with platforms like mRNA, virus-like particles (VLP), and long-acting monoclonal antibodies transforming prevention strategies. Breakthroughs such as maternal immunization and nasal vaccines reflect a diverse, rapidly evolving pipeline. Companies are developing multi-pathogen vaccines and pursuing differentiated delivery methods, which enhance immunogenicity and access. Innovation is critical in addressing RSV's broad impact across age groups and global health systems.

M&A activity in the RSV vaccine space is intensifying as large pharmaceutical firms acquire biotech innovators to access novel platforms. Notable deals include Pfizer's acquisition of ReViral and Sanofi’s alliance with AstraZeneca for Beyfortus. These consolidations are driven by the need to expand RSV portfolios, reduce development timelines, and secure competitive advantage in a crowded, high-potential market. Future M&A is expected to focus on next-gen platforms and intranasal technologies.

Regulatory agencies like the FDA and EMA have played a pivotal role by accelerating approvals through fast-track designations and priority reviews. These pathways enabled rapid market entry for vaccines like Arexvy and Abrysvo. Updated guidance on maternal and pediatric immunization has also created structured demand. However, stringent post-approval monitoring and global harmonization challenges remain. Regulatory clarity continues to drive investor confidence and influence development pipelines globally.

The RSV (Respiratory Syncytial Virus) vaccines industry is expanding beyond single-pathogen solutions, with companies developing combination vaccines that target RSV alongside influenza or COVID-19. There is also a shift toward maternal, pediatric, and adult formulations tailored to specific risk groups. Innovations in dose formulation, storage stability, and delivery methods (e.g., intranasal) are supporting broader use. This trend is diversifying product offerings, increasing market competitiveness, and improving overall access and convenience.

Regional Expansion: RSV vaccine adoption is growing in North America and Europe, with initial approvals and rollouts targeting older adults and pregnant women. Expansion into Latin America, Asia, and Africa is gaining momentum through partnerships, WHO prequalification, and GAVI involvement. Regional strategies emphasize affordability, cold-chain infrastructure, and local trial data. As awareness of RSV’s burden rises, demand in emerging markets is expected to boost global vaccine uptake and equity significantly.

Type Insights

The passive immunization segment led the market with the largest revenue share of 75.02% in 2024, primarily driven by advancements in monoclonal antibody (mAb) therapies. Traditionally dominated by palivizumab (Synagis), the segment has expanded significantly with the approval of nirsevimab (Beyfortus), a long-acting mAb providing season-long protection with a single dose. This innovation has improved coverage and compliance, especially for all infants regardless of risk status. Furthermore, Merck’s investigational antibody clesrovimab (MK-1654) has shown promising Phase 2b/3 results, potentially expanding competition and treatment options. As global health authorities recognize the need for RSV protection in neonates and infants, demand for passive immunization is growing, particularly where vaccine eligibility or availability is limited.

The preventive vaccines segment is projected to grow at the fastest CAGR of 49.52% over the forecast period, fueled by recent regulatory approvals and increasing disease awareness. The approval of Arexvy (GSK) for older adults and Abrysvo (Pfizer) for both older adults and pregnant individuals has marked a turning point in RSV prevention. These vaccines target high-risk groups and are expected to be integrated into seasonal immunization schedules. Rising RSV-related hospitalizations and growing support from health agencies like the CDC and WHO further accelerate demand. The segment is projected to grow rapidly, reaching multi-billion-dollar valuations globally within the next decade.

Technology Insights

The monoclonal antibodies (mAbs) segment accounted for the largest market revenue share in 2024. mAbs offer immediate passive immunity, making them ideal for protecting high-risk populations such as newborns and immunocompromised individuals. The approval of nirsevimab (Beyfortus) by Sanofi and AstraZeneca marked a major milestone, offering season-long protection with a single dose for all infants, not just those at high risk. Furthermore, Merck’s investigational antibody clesrovimab (MK-1654) has demonstrated strong efficacy in Phase 2b/3 trials, potentially expanding the range of protective options. These advancements are addressing key unmet needs in pediatric care and are increasingly being integrated into national immunization strategies. With growing global awareness, supportive regulatory frameworks, and increasing investment in antibody engineering, the mAbs segment is expected to experience strong double-digit CAGR, significantly contributing to the overall RSV market expansion.

The recombinant protein + adjuvant segment is projected to expand at the fastest CAGR over the forecast period. This segment gained significant momentum with the approval of Arexvy by GSK in May 2023-the first-ever RSV vaccine approved in the United States, utilizing a recombinant RSV F protein combined with AS01E adjuvant to enhance immune response. This technology offers high immunogenicity and a favorable safety profile, especially important for aging populations with declining immune function. The success of Arexvy has validated the platform, leading other developers to pursue similar formulations for broader applications. The combination of recombinant proteins and adjuvants allows for more durable protection, dose-sparing potential, and targeted immune activation, making it a reliable and scalable option. As demand for adult RSV vaccines grows globally, the Recombinant Protein + Adjuvant segment is projected to see strong CAGR, driving a significant share of the overall market growth.

Targeted Population Insights

The infants and children led the market with the largest revenue share of 75.02% in 2024, due to the high disease burden and recent preventive breakthroughs. RSV is the leading cause of hospitalization in infants globally, prompting urgent demand for effective protective measures. Traditionally reliant on monoclonal antibodies like Synagis, the market has evolved with the approval of Beyfortus (nirsevimab), offering season-long protection with a single dose for all infants, not just high-risk groups. In addition, the CDC's 2023 recommendation of Pfizer’s Abrysvo for use in pregnant women enables maternal immunization, which transfers antibodies to newborns and reduces hospitalization risk by 57% in the first six months of life. Clinical advancements such as Merck’s clesrovimab (MK-1654) further expand protective options. As global health agencies emphasize early-life RSV prevention, this segment is expected to experience double-digit CAGR, with significant contributions from both passive immunization (mAbs) and maternal vaccination strategies tailored to neonatal needs.

The adults segment is expected to grow at the fastest CAGR over the forecast period, driven by rising awareness of RSV’s impact on older populations. Adults aged 60 and above, especially those with chronic conditions like COPD, heart disease, or diabetes, are at higher risk for severe RSV-related complications. This unmet need was addressed with the FDA approval of Arexvy (GSK) and Abrysvo (Pfizer) in 2023, the first vaccines specifically targeting older adults. These recombinant protein-based vaccines use adjuvants to boost immune responses in aging populations, offering strong protection against lower respiratory tract infections. As RSV joins influenza and COVID-19 in seasonal respiratory illness concerns, healthcare systems are increasingly integrating RSV vaccines into annual immunization schedules for seniors. Public health recommendations, government procurement programs, and growing vaccine confidence among older adult’s further support market expansion.

Distribution Channel Insights

The hospital & retail pharmacies segment led the market with the largest revenue share of 53.8% in 2024, fueled by rising demand, vaccine accessibility, and expanding immunization programs. As RSV vaccines like Arexvy and Abrysvo are primarily administered to older adults and pregnant women, key demographics frequently accessing healthcare, hospital pharmacies play a crucial role in ensuring timely and safe administration during routine visits, checkups, or prenatal care. Simultaneously, retail pharmacies are becoming essential access points for adult vaccinations due to their widespread presence, extended hours, and convenience, especially in countries like the U.S. and Europe.

The government suppliers segment is expected to grow at the fastest CAGR over the forecast period, driven by increasing public health prioritization and global efforts to reduce RSV-related morbidity and mortality. Governments are actively procuring RSV vaccines and monoclonal antibodies for vulnerable populations, especially infants, pregnant women, and older adults, through national immunization programs. Following the FDA and CDC approvals of Arexvy, Abrysvo, and Beyfortus, countries have begun incorporating RSV immunization into public health strategies, often subsidized or provided free of cost. Organizations like GAVI, UNICEF, and PAHO are also facilitating access in low- and middle-income countries, aiming to close immunization gaps.

Regional Insights

The RSV (Respiratory Syncytial Virus) vaccines market in North America holds a substantial share, attributed to the high prevalence of RSV infections and advanced healthcare infrastructure. In 2023, the U.S. Centers for Disease Control and Prevention (CDC) introduced a national campaign to raise awareness about RSV and available vaccines, boosting adoption rates. However, in June 2024, the CDC narrowed its recommendations, advising RSV vaccination primarily for adults aged 75 and older, and those aged 60-74 with specific medical conditions.

U.S. RSV (Respiratory Syncytial Virus) Vaccines Market Trends

The RSV (Respiratory Syncytial Virus) vaccines market in the U.S. is rapidly expanding, fueled by a supportive regulatory environment and milestone approvals. The U.S. market is characterized by intense competition among major pharmaceutical companies. GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRESVIA are the primary vaccines approved for older adults. In 2023, Arexvy captured two-thirds of retail vaccinations, generating USD 859 million in its first full commercial quarter.

Europe RSV (Respiratory Syncytial Virus) Vaccines Market Trends

The RSV (Respiratory Syncytial Virus) vaccines market in Europe is witnessing steady growth, supported by high healthcare expenditure and active vaccination programs. In June 2024, Germany's vaccine advisory panel recommended AstraZeneca and Sanofi's antibody therapy for all infants, bolstering prophylaxis demand. The UK's Joint Committee on Vaccination and Immunisation (JCVI) also recommended a national RSV immunisation programme in September 2023. These initiatives, coupled with the presence of key pharmaceutical companies, drive regional growth.

The UK RSV (Respiratory Syncytial Virus) vaccines market is expanding rapidly. The UK launched the world's first national RSV vaccination program in September 2024, targeting infants and pregnant women. This proactive approach has positioned the UK as a leader in RSV prevention. GSK's Arexvy, approved in the UK, has contributed to the country's robust vaccination efforts. The government's commitment to immunisation programs and public health awareness campaigns continues to influence market growth.

The RSV (Respiratory Syncytial Virus) vaccines market in Germany is experiencing significant growth, driven by strong healthcare infrastructure and proactive immunisation policies. In June 2024, the country's vaccine advisory panel recommended AstraZeneca and Sanofi's antibody therapy for all infants, enhancing prophylaxis demand. The presence of leading pharmaceutical companies and ongoing research initiatives further supports market expansion.

Asia Pacific RSV (Respiratory Syncytial Virus) Vaccines Market Trends

Asia Pacific dominated the RSV (Respiratory Syncytial Virus) vaccines market with the largest revenue share of 30.55% in 2024. This growth is attributed to increasing awareness of RSV, expanding healthcare infrastructure, and a large patient population. In Japan, RSV caused an estimated 65,600 cases and $403.5 million in direct medical costs for older adults in 2023. Governments in countries like China and India are focusing on pediatric health initiatives, further driving demand for RSV therapeutics.

The RSV (Respiratory Syncytial Virus) vaccines market in China is poised for rapid expansion, due to its large population and increasing healthcare investments. The government's emphasis on improving pediatric healthcare and immunisation programs contributes to market growth. Collaborations with international pharmaceutical companies and ongoing clinical trials are expected to enhance vaccine availability and adoption in the coming years.

The Japan RSV (Respiratory Syncytial Virus) vaccines market is poised for rapid expansion. In September 2023, Japan's Ministry of Health, Labour and Welfare approved GSK's Arexvy, the country's first RSV vaccine for older adults. This approval aims to protect approximately 43.5 million Japanese people aged 60 and older. RSV causes an estimated 63,000 hospitalisations and 4,500 in-hospital deaths annually among this age group in Japan. The approval is based on a comprehensive phase III program, which enrolled over 1,000 Japanese participants.

Latin America RSV (Respiratory Syncytial Virus) Vaccines Market Trends

The RSV (Respiratory Syncytial Virus) vaccines market in Latin America is expanding, driven by increasing awareness and government-led immunisation programs. Countries like Brazil and Argentina are investing in healthcare infrastructure and collaborating with international pharmaceutical companies to enhance vaccine availability. The region's focus on maternal and child health initiatives further supports market expansion.

Middle East and Africa RSV (Respiratory Syncytial Virus) Vaccines Market Trends

The RSV (Respiratory Syncytial Virus) vaccines market in the Middle East and Africa is experiencing accelerating growth due to rising awareness and healthcare investments. Increased government initiatives and collaborations with global health organizations aim to improve vaccine accessibility and coverage. Efforts to strengthen healthcare systems and address infectious diseases contribute to the region's market development.

Key Respiratory Syncytial Virus VaccinesCompany Insights

The global RSV (Respiratory Syncytial Virus) vaccines industry is highly competitive, with key players such as AstraZeneca, Sanofi, GSK, Pfizer, Moderna, Icosavax, Meissa Vaccines, Codagenix, Blue Lake Biotechnology, and Merck, focusing on enhancing the vaccine. These companies prioritize new product development, research & development (R&D) investments, and strategic mergers and acquisitions to strengthen their market position.

For instance, in October 2024, Merck shared positive outcomes from its Phase 2b/3 clinical trial (MK-1654-004) assessing clesrovimab, an investigational monoclonal antibody aimed at protecting infants against respiratory syncytial virus (RSV) during their first RSV season. These results, along with interim data from the ongoing Phase 3 trial (MK-1654-007), were presented at IDWeek 2024, held from October 16-19 in Los Angeles, California.

Recent Developments

• In April 2025, Pfizer Inc. announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) had voted to broaden its recommendation for RSV vaccines to include adults aged 50-59 who are at increased risk of RSV-related lower respiratory tract disease (LRTD). This updated guidance covers ABRYSVO (Respiratory Syncytial Virus Vaccine), which received FDA approval in October 2024 for preventing RSV-associated LRTD in at-risk adults aged 18 to 59.

• In May 2024, Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved mRESVIA (mRNA-1345), the company’s mRNA-based vaccine for respiratory syncytial virus (RSV), for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older. Granted under the FDA’s breakthrough therapy designation, this marks Moderna’s second approved mRNA product.

• In June 2024, GSK plc announced that the FDA approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for preventing RSV-related lower respiratory tract disease (LRTD) in adults aged 50 to 59 who are at increased risk. In the U.S., Arexvy is already approved for use in adults aged 60 and older and is recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) through shared clinical decision-making.

Respiratory Syncytial Virus Vaccines Market Report Scope

Global Respiratory Syncytial Virus Vaccines Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global respiratory syncytial virus vaccines market report based on type, technology, targeted population, distribution channel, and region.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Passive Immunization

  • Preventive Vaccines

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Monoclonal Antibodies

  • Recombinant Protein + Adjuvant

  • mRNA-Based Vaccine

  • Virus-Like Particle (VLP)

• Targeted Population Outlook (Revenue, USD Million, 2018 - 2030)

  • Adults

  • Infants and children

• Distribution Channel Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital & Retail Pharmacies

  • Government Suppliers

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait