Respiratory Syncytial Virus (RSV) Therapeutics Market Size, Share & Industry Analysis, By Drug Class (Prophylaxis and Treatment), By End-user (Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy) and Regional Forecast, 2020-2027

The global respiratory syncytial virus (RSV) therapeutics market size stood at USD 1,111.3 million in 2019. The market is projected to grow from USD 609.2 million in 2020 to USD 4,003.4 million in 2027 at a CAGR of 30.9% in the 2020-2027 period. The sudden rise in the CAGR of this market is attributable to the potential launch of new products by 2023. North America dominated the respiratory syncytial virus therapeutics market with a market share of 35.63% in 2019.

The respiratory syncytial virus is one of the major causative organisms for Lower Respiratory Tract Infection (LRTI) among infants. It is estimated that there are around 33 million RSV infections in children below the age of 5 years, which leads to around 3.3 million hospitalizations and 60,000 deaths globally every year. Combined with this, there is a huge unmet need for RSV drugs and vaccines in the market. Currently, there are only two approved drugs for the prevention and treatment of RSV infection. The rising prevalence of the RSV infection, combined with the potential launch of new therapies, is estimated to augment RSV therapeutics market growth in the coming years.

Global Respiratory Syncytial Virus (RSV) Therapeutics Market Overview

Market Size:

• 2019 Value: USD 1,111.3  million
• 2020 Value: USD 609.2 million 
• 2027 Forecast Value: USD 4,003.4 million, with a CAGR of 30.9% from 2020–2027

Market Share:

• Regional Leader: North America held a 35.63% market share in 2019, driven by high RSV prevalence, advanced healthcare infrastructure, and strong access to treatments.
• Fastest-Growing Region: Asia Pacific is projected to grow significantly, driven by expanding healthcare access in emerging markets like India and China, and high RSV burden in pediatric populations.
• End-User Leader:Hospital pharmacy segment led the market in 2019, supported by professional drug administration and inpatient treatment settings.

Industry Trends:

• Cost-Effective Therapeutics: Rising focus on affordable monoclonal antibodies like nirsevimab (~USD 600) compared to palivizumab (~USD 6,000).
• Collaborative R&D Models: Increasing partnerships (e.g., Sanofi & AstraZeneca) for vaccine and antibody development.
• Shift Toward Prophylaxis: Strong clinical pipelines focus on preventative treatment, including maternal vaccines.
• Clinical Trial Resilience: Despite COVID-19 disruptions, companies remain focused on completing Phase 3 trials for key candidates.

Driving Factors:

• High Global Disease Burden: ~33 million RSV infections annually in children <5, causing ~3.3 million hospitalizations and 60,000 deaths globally.
• Strong Pipeline Candidates: Innovative therapies like nirsevimab showing ~70–78% reduction in RSV-related LRTI and hospitalizations.
• Strategic Acquisitions: Example – Sobi acquired Synagis rights from AstraZeneca for USD 1.5 billion to strengthen RSV portfolio.
• Government Surveillance & Public Health Initiatives: Programs (e.g., Public Health England) actively track RSV trends to inform vaccine policy.

Clinical Trials and R&D Activities to Get Affected due to COVID-19 Pandemic  

The sudden emergence of the pandemic has disrupted the pharma companies regarding the day-to-day activities and shifted the focus on minimizing the effects caused. In July 2020, the representatives of Sanofi remarked that the outbreak of COVID-19 had disrupted the clinical trials for the study of nirsevimab. The challenges include patient recruitment and patient retention during the trials. The company also stated that the COVID-19 outbreak could also impact the RSV infection season, making it difficult to evaluate the drug's efficacy during clinical trials.

LATEST TRENDS

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Persistent Focus on Reducing RSV Infection Treatment Cost to Become a Vital Trend

Investing in the development of a novel mechanism to enhance efficacy and reduce the drug's cost is one of the key trends exhibited by the market players. Nirsevimab, which is slated to launch in 2023, is estimated to be priced at USD 600 compared to a whopping USD 6,000 price tag of palivizumab. A collaborative approach towards discovering the treatment and preventative therapeutics for RSV infection is among the predominant trends experienced in the market.  In addition, key players are focusing on partnerships to increase their chances for discovery of the treatment and capture the unmet demand from the infected population.

DRIVING FACTORS

Strategic Acquisitions and Collaborations among Industry Players to Spur Market Opportunities

Collaborative efforts of key players aim at launching a cost-effective and efficacious molecule to treat the RSV disease. The aforementioned factor is anticipated to positively impact the market value during the forecast duration. Additionally, the healthcare landscape has significantly changed owing to the collaborative approach between the non-traditional and the existing traditional players to innovate more efficient and cost-effective treatment for RSV.

For instance, in January 2019, Swedish Orphan Biovitrum Ab (Sobi) acquired distribution rights of Synagis, an RSV prophylactic drug from AstraZeneca, for a whopping USD 1.5 billion. As per the terms and conditions of the agreement, Sobi also gained 50% rights to the future revenues generated by MEDI8896, a drug currently under clinical trials and sponsored by AstraZeneca.

Strong Pipeline of Products Showing Promising Results to Propel Unmet Demand

The use of monoclonal antibodies in infants to cause passive immunization is one of the key approaches being pursued by the pharmaceutical companies in their fight against RSV. The pipeline products offer significant benefits over Synagis and the other approach of vaccinating pregnant mothers to provide passive immunization to infants. Factors, such as novel mechanisms, lower cost, and protection for the entire season through one injection and immediate protection against the disease are estimated to augment market growth.

For instance, Nirsevimab, which is being developed jointly by Sanofi and AstraZeneca, is proving to be the most promising candidate among these pipeline products.  Phase 2 results showed around 70% reduction in medically attended RSV-associated LRTI and around 78% reduction in RSV-associated LRTI related hospitalizations. Hence, the focus of companies to develop new drugs to treat and prevent RSV infection is driving the market growth.

RESTRAINING FACTORS

Failure of Pipeline Products in Clinical Trials to Hamper Growth

Pharmaceutical companies have faced significant challenges in the development of drugs for the treatment of RSV, which is evident from the approval of only one product, i.e. Synagis, in the past two decades. A large number of monoclonal antibody and vaccine candidates have failed to meet the required efficacy and suffered severe setbacks in the late stage of development. Last stage clinical failure of such drugs has negatively impacted the growth of the RSV therapeutics market.

For instance, In July 2019, Ablynx terminated a Phase 2 clinical trial of its investigational drug named ALX-0171 that was indicated to treat RSV infection in infants younger than two years. The manufacturer decided to discontinue the trials due to a lack of evidence supporting the efficacy of the drug in treating the disease.

SEGMENTATION

By Drug Class Analysis

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Prophylaxis Segment Held the Highest Market Share in 2019

Based on drug type, the market is categorized into prophylaxis and treatment. The prophylaxis segment dominated the market in 2019. Potential approvals and the launch of maternal vaccines by Pfizer and GSK are estimated to propel the segment growth in the foreseen years.

The treatment segment holds a smaller share in the global RSV therapeutics market. An increase in research and development to develop drugs indicated to treat RSV infection is estimated to propel the global market during the forecast duration.

By End-user Analysis

Hospital Pharmacy Segment Ruled the Market in 2019

Based on end-user, the market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. Among the end-users, the hospital pharmacy segment dominated the global market. The growth of the segment is influenced by the factor that the existing treatment and prevention options require administration of the molecule by a healthcare professional. Hence, the segment is also estimated to have the highest CAGR in the coming years.

REGIONAL INSIGHTS

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The North America respiratory syncytial virus therapeutics market stood at USD 396.0 million in 2019 and will tremendously grow throughout the forecast period. The growth is attributable to the higher prevalence of RSV infection as well as larger access for the treatment of the disease. According to the Center for Disease Control and Prevention (CDC), RSV infection leads to almost 2.1 million outpatient visits among children younger than five years of age annually in the U.S. alone.

The growth of the market in Europe is attributable to various factors such as developed healthcare infrastructure, an active government initiative to track RSV seasons, and a well-established reimbursement system for hospitals, among others. In addition, Public Health England is actively updating the burden of RSV infection in the country and linking it to economic burden, statistical modeling, and calculating the cost-effectiveness of vaccinations. Such studies will encourage the market growth in the region.

On the other hand, the Asia Pacific market is anticipated to showcase considerable growth during the forecast duration. The region includes countries with diverse economic and financial statuses with varying trends in the RSV market. Countries including Japan and Australia have advanced healthcare infrastructure combined with higher penetration of treatment for RSV. The varying ethnicity and climate create a difference in the prevalence of RSV in various countries of Asia Pacific.

Considerable growth in the RSV therapeutics market is anticipated during the forecast years in the countries of Latin America and the Middle East and Africa, enabling significant expansion opportunities for the market players. Even though the governments in these regions are emphasizing increasing healthcare accessibility, there is significant room for growth.

KEY INDUSTRY PLAYERS

Key Companies Focus on Launching Cost-effective Treatment Options

The global market is highly consolidated with two major players accounting for more than 90% of the market share. AbbVie Inc. dominates the market with the largest share followed by Swedish Orphan Biovitrum AB (Sobi). However, the competitive landscape of the RSV therapeutics market is estimated to shift due to the potential launch of prophylaxis and treatment drugs in the coming years tremendously. AstraZeneca aims to capture the predominant share in the coming years by introducing cost-effective nirsevimab into the market by 2023.

LIST OF KEY COMPANIES PROFILED:

• AstraZeneca (U.K)
• Bausch Health Companies Inc. (U.S)
• AbbVie (U.S)
• Johnson and Johnson Services Inc. (U.S)
• Sanofi (France)
• Merck & Co., Inc. (U.S)
• Celltrion Inc. (South Korea)
• mAbxience (Spain)
• Enanta Pharmaceuticals, Inc (U.S)

KEY INDUSTRY DEVELOPMENTS:

• June 2021– AstraZeneca announced that they have received positive safety and tolerability results for their long acting antibody drug of nirsevimab developed for the treatment of infants suffering from high risk of respiratory syncytial virus (RSV) during the MEDLEY Phase II/III trial.
• October 2020: Moderna, Inc. announced that they have regained the rights to the respiratory syncytial virus (RSV) vaccine (mRNA-1172) from Merck & Co., Inc. The pipeline candidate of mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered Phase 1 development in 2019.
• September 2019: The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson announced that they have been granted the Breakthrough Therapy Designation (BTD) for their investigational prophylactic vaccine of JNJ-64400141. This vaccine is being developed to treat adults who are 60 years and older suffering from RSV mediated lower respiratory tract diseases.

REPORT COVERAGE

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The respiratory syncytial virus therapeutics market report provides qualitative and quantitative insights on the RSV therapeutics industry and a detailed analysis of market size and growth rate for all possible segments in the market. Along with this, the report provides an elaborative analysis of the market dynamics and competitive landscape. Various key insights provided in the report are the prevalence of RSV infections by key regions, key industry trends, pipeline analysis, and analysis of COVID-19 on the global market, the number of patients prescribed, and palivizumab among others.

Report Scope & Segmentation