Clinical Trials

Dublin, Dec. 20, 2024 (GLOBE NEWSWIRE) -- The "Respiratory Syncytial Virus Prophylaxis: Eight-Market Drug Forecast and Market Analysis - Update" report has been added to ResearchAndMarkets.com's offering.

The report provides an in-depth assessment of the RSV prophylaxis market including disease overview, epidemiology, disease management, current treatment options, unmet needs and opportunities, R&D strategies, pipeline assessment, current and future players, and market outlook.

Up until recently, there was only one marketed pharmaceutical product indicated for the prevention of RSV infections. AstraZeneca/AbbVie's Synagis (palivizumab), a prophylactic, humanized, mouse monoclonal antibody (mAb), has been indicated for the prophylaxis of RSV in infants at a high risk of severe infection since 1998. Synagis is licensed in all of the 8MM and has been shown to be effective for preventing severe RSV infection in infants and children with prematurity, bronchopulmonary dysplasia (BPD), and congenital heart defects (CHD).

However, the 20-day half-life of Synagis, requirement for monthly dosing during the RSV season, and prohibitively high cost has led to its decreased use over time. Significant strides have been made in the RSV space in recent years with the approval of four new prophylactic products. Sanofi's Beyfortus (nirsevimab) is a human recombinant mAb used for the prevention of RSV lower respiratory tract disease (LRTD) in neonates and infants during their first RSV season, and children up to 24 months of age who are considered vulnerable to severe RSV disease during their second RSV season. It has been marketed in all 8MM. Pfizer's Abrysvo is a bivalent vaccine composed of two recombinant RSV fusion surface glycoproteins selected to optimize protection against RSV A and B strains.

It is indicated for the prevention of LRTD caused by RSV in both adults aged 60 or older, as well as in infants from birth up to six months of age by active immunization of pregnant individuals in all 8MM. The FDA has just approved Abrysvo for use in adults aged 18-59 at an increased risk of infection too, and the other 7MM will likely follow suit shortly. GSK's Arexvy, an adjuvanted subunit vaccine, has been approved for use in adults aged 60 and older in all 8MM, as well as those between 50-59 years old at an increased risk of infection in the EU and US, for the prevention of LRTD caused by RSV. New positive Phase IIIb data for Arexvy in 18-49-year-olds at high risk of infection shows potential for further label expansion. Moderna's mRESVIA is the first mRNA vaccine to join the market, approved for use in adults aged 60 years and older in the US and EU.

The analyst projects the global RSV marketplace-which, for the purposes of this report, comprises eight major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Japan, and Australia)-to experience continued growth during the forecast period. The launch of Merck and Co's clesrovimab in the US and EU (2025), Australia (2026) and Japan (2027) will compete with Beyfortus and together they will replace Synagis as the standard-of-care prophylaxis for high-risk infants.

SP-0125 is currently in a Phase III clinical trial and is expected to launch in 2027, being the first pediatric vaccine to reach the market. The recent approval of several therapies for adult, maternal, and pediatric use, such as Pfizer's Abrysvo, GSK's Arexvy, Sanofi's Beyfortus, and Moderna's mRESVIA, will fulfill a major unmet need, and will have a significant effect on the overall size of the RSV prophylactics market. The US will dominate the global RSV market throughout the entire 2020-30 forecast period.

Scope

• Overview of RSV including etiology, pathophysiology and epidemiology.
• Key topics covered include current market landscape, strategic competitor assessment, unmet needs and opportunities, R&D trends, pipeline assessment, and current and future players.
• RSV prophylaxis market outlook from 2020-2030, including annual cost of therapy per patient, and total sales revenues per product for each of the 8MM.

A selection of companies mentioned in this report includes, but is not limited to:

• Abbvie
• Advaccine
• AstraZenca
• Codagenix
• Daiichi Sankyo
• Euclidean LLC
• GSK
• Icosavax
• Meissa Vaccines
• Merck
• Moderna
• Morningside ventures
• Nanodimension Inc
• Pfizer
• Sanofi
• Sobi

Key Topics Covered:

1 Respiratory Syncytial Virus Prophylaxis: Executive Summary - Updated Nov 2024, based on events up to Nov 2024
1.1 RSV prophylaxis market to reach $6.2B by 2030
1.2 Unmet needs remain despite influx of novel products
1.3 Prophylactic options to continue to diversify due to strength of late-stage pipeline
1.4 What do physicians think?

2 Introduction - Updated Nov 2024, based on events up to Nov 2024
2.1 Catalyst
2.2 Related Reports

3 Disease Overview - Updated Nov 2024, based on events up to Nov 2024
3.1 Etiology and pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology

4 Epidemiology - Updated Aug 2021, based on events up to Aug 2021
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 (2020-30)
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 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 Limitations of the analysis
4.5.3 Strengths of the analysis

5 Disease Management - Updated Nov 2024, based on events up to Nov 2024
5.1 Diagnosis
5.2 Prophylaxis
5.3 Treatment
5.4 KOL insights on disease management

6 Current Treatment Options - Updated Nov 2024, based on events up to Nov 2024
6.1 Overview

7 Unmet Needs and Opportunity Assessment - Updated Nov 2024, based on events up to Nov 2024
7.1 Overview
7.2 Increased diagnostic testing.
7.3 Increased research and awareness of long-term sequelae
7.4 Combination vaccines
7.5 Prophylaxis for immunocompromised patients

8 R&D Strategies - Updated Nov 2024, based on events up to Nov 2024
8.1 Overview
8.1.1 Leveraging novel vaccine technologies and strategies
8.1.2 Development of prophylactic antibodies with improved dosing and efficacy
8.2 Clinical trial design
8.2.1 Clinical trial design for RSV prophylactics for maternal immunization
8.2.2 Clinical trial design for RSV prophylactics for pediatric immunization
8.2.3 Clinical trial design for RSV prophylactics for adult immunization

9 Pipeline Assessment - Updated Nov 2024, based on events up to Nov 2024
9.1 Overview
9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis - Updated Nov 2024, based on events up to Nov 2024
10.1 Overview
10.2 Competitive assessment
10.2.1 Pipeline products for passive prophylaxis in infants
10.2.2 Pipeline maternal vaccine products
10.2.3 Pipeline vaccine products for adults

11 Current and Future Players - Updated Nov 2024, based on events up to Nov 2024
11.1 Overview
11.2 Deal-making trends

12 Market Outlook - Updated Nov 2024, based on events up to Nov 2024

For more information about this report visit https://www.researchandmarkets.com/r/ah2vgr

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