呼吸道融合病毒（RSV）預防藥:8市場醫藥品的預測與市場的分析 - 修訂版

在八大主要市場中，RSV 預防市場預計到 2030 年將達到 72 億美元，2020 年至 2030 年的複合年增長率為 28.6%。 2020 年，RSV 預防市場規模為 5.82 億美元，所有銷售額均來自阿斯特捷利康/艾伯維的 Synagis（帕利珠單抗）。 Synagis 是一種單株抗體 (mAb)，適用於高風險嬰幼兒。近年來，呼吸道合胞病毒 (RSV) 預防藥物市場顯著成長，產品也更加多樣化。兩種單株抗體藥物（阿斯特捷利康/賽諾菲的 Beyfortus (nirsevimab) 和默克公司的 Enflonsia (clesrovimab)）以及首批呼吸道合胞病毒 (RSV) 疫苗相繼上市：葛蘭素史克的 Arexvy、輝瑞的 Abrysvo 和 Moderna 的 mRESVIA。此外，五種處於後期研發階段的疫苗也有望推動市場成長：葛蘭素史克的 GSK-3888550A、AdVaccine 的 BARS-13 以及賽諾菲的 SP-0256、SP-0274 和 SP-0125。

本報告分析了八個主要的呼吸道合胞病毒 (RSV) 預防藥物市場（美國、五個歐洲國家、日本和澳洲），並提供了疾病概況、流行病學、現有治療方案、未滿足的需求和機會以及研發策略等方面的資訊。

目錄

第一章：呼吸道合胞病毒 (RSV) 預防藥物：執行摘要 - 更新於 2025 年 7 月，基於截至 2025 年 7 月的事件

• 變更摘要
• RSV 預防藥物市場預計到 2030 年將達到 72 億美元
• 儘管新產品不斷湧入，但仍存在未滿足的需求
• 強大的後期研發管線持續豐富預防方案
• 醫生的看法

第二章：引言 - 更新於 2025 年 7 月，基於截至 2025 年 7 月的事件

第三章：疾病概述 - 更新於 2024 年 11 月，基於截至 11 月的事件2024

• 病因與病理學
  • 病因
  • 病理學

第4章 流行病學，基於截至2021年8月的事件，於2021年8月更新

• 疾病背景
  • 危險因子和合併症
• 過去的全球趨勢
• 預測方法
• 呼吸道合胞病毒 (RSV) 預防族群的流行病學預測（2020-2030 年）
  • 以胎齡劃分的早產兒數量
  • 患有慢性肺部疾病 (CLD) 的早產兒
  • 患有血流動力學顯著的心臟和先天性肺部疾病的出生數量
  • 患有DMD
  • SMA 患者人數
  • 妊娠晚期孕婦人數
  • 療養院/長期照護機構成年住民人數
• 討論
  • 流行病學預測考量
  • 分析的局限性
  • 分析的優勢

第5章 疾病管理 - 更新於 2025 年 7 月，基於截至 2025 年 7 月的事件

• 診斷
• 預防
• 治療
• KOL 對疾病管理的洞察

第6章 目前的治療方案 - 更新於 2025 年 7 月，基於截至 2025 年 7 月的事件2025

• 概要

第7章 評估未滿足的需求和機會 - 更新於2025年7月，基於截至2025年7月的事件

• 摘要
• 加強診斷檢測
• 加強長期後遺症的研究與認知
• 聯合疫苗
• 免疫功能低下患者的預防性治療

第8章 研發策略 - 更新於2025年7月，基於截至2025年7月的活動

• 概述
  • 利用新的疫苗技術和策略
  • 開發具有改良劑量和劑量的保護性抗體療效
• 臨床試驗設計
  • 用於母體免疫的呼吸道合胞病毒預防藥物臨床試驗設計
  • 用於兒科免疫的呼吸道合胞病毒預防藥物臨床試驗設計
  • 成人免疫的呼吸道合胞病毒預防藥物臨床試驗設計

第9章 研發管線評估 - 更新於2025年7月，基於截至2025年7月的事件

• 概述
• 臨床開發中的有前景的藥物

第10章 研發管線評估分析 - 更新於2025年7月，根據截至2025年7月的事件2025

• 概述
• 競爭力評估
  • 孕產婦疫苗產品管線
  • 成人疫苗產品管線

第11章 現有及未來公司 - 更新於2025年7月，基於截至2025年7月的事件

• 概要
• 交易趨勢

第12章 市場展望 - 更新於2025年7月，基於截至2025年7月的事件

• 全球市場
  • 預測
  • 促進因素與阻礙
• 美國
  • 預測
  • 主要的事件
  • 促進因素與阻礙
• 5EU
  • 預測
  • 主要的事件
  • 促進因素與阻礙
• 日本
  • 預測
  • 主要的事件
  • 促進因素與阻礙
• 澳洲
  • 預測
  • 主要的事件
  • 促進因素與阻礙

第13章 附錄

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.

RSV is an enveloped, single-stranded, negative-sense ribonucleic acid (RNA) orthopneumovirus belonging to the Pneumoviridae family. The most common clinical scenario for RSV is an upper respiratory tract infection (URTI), which is typically mild and self-limiting. However, RSV is the leading cause of lower respiratory tract infections (LRTIs) in infants, with a peak age of hospitalization between two to three months of age. Severe respiratory disease can manifest as bronchiolitis and pneumonia, which on rare occasions can progress to respiratory failure or death. RSV is also an important cause of hospitalizations and deaths in elderly adults.

Across the 8MM, GlobalData expects the RSV prophylaxis market to grow at a compound annual growth rate (CAGR) of 28.6% over the 2020-30 forecast period, reaching $7.2 billion by 2030. In 2020, the RSV prophylaxis market was valued at $582M, with all sales attributable to AstraZeneca/AbbVie's Synagis (palivizumab), a monoclonal antibody (mAb) indicated for use in high-risk infants. The RSV prophylaxis market has undergone significant growth and diversification in the following years owing to the launch of two more mAbs, AstraZeneca/Sanofi's Beyfortus (nirsevimab) and Merck &Co's Enflonsia (clesrovimab), as well as the first RSV vaccines, GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRESVIA. Five vaccines in late-stage development will also drive market growth. These are GSK's GSK-3888550A, AdVaccine's BARS-13, and Sanofi's SP-0256, SP-0274, and SP-0125.

Key Highlights

• Report deliverables include a Pdf report and an Excel-based forecast model
• Forecast includes the 8 major markets (8MM)
• Forecast covers the period 2020-2030

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.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies and identify the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the 8MM RSV prophylaxis market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 8MM RSV prophylaxis market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Table of Contents

Table of Contents

1 Respiratory Syncytial Virus Prophylaxis: Executive Summary - Updated July 2025, based on events up to July 2025

• 1.1 Summary of changes
• 1.2 RSV prophylaxis market to reach $7.2 billion by 2030
• 1.3 Unmet needs remain despite influx of novel products
• 1.4 Prophylactic options to continue to diversify due to strength of late-stage pipeline
• 1.5 What do physicians think?

2 Introduction - Updated July 2025, based on events up to July 2025

• 2.1 Catalyst
• 2.2 Related reports
• 2.3 Upcoming 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 July 2025, based on events up to July 2025

• 5.1 Diagnosis
• 5.2 Prophylaxis
• 5.3 Treatment
• 5.4 KOL insights on disease management

6 Current Treatment Options - Updated July 2025, based on events up to July 2025

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment - Updated July 2025, based on events up to July 2025

• 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 July 2025, based on events up to July 2025

• 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 July 2025, based on events up to July 2025

• 9.1 Overview
• 9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis - Updated July 2025, based on events up to July 2025

• 10.1 Overview
• 10.2 Competitive assessment
  • 10.2.1 Pipeline maternal vaccine products
  • 10.2.2 Pipeline vaccine products for adults

11 Current and Future Players - Updated July 2025, based on events up to July 2025

• 11.1 Overview
• 11.2 Deal-making trends

12 Market Outlook - Updated July 2025, based on events up to July 2025

• 12.1 Global markets
  • 12.1.1 Forecast
  • 12.1.2 Drivers and barriers
• 12.2 US
  • 12.2.1 Forecast
  • 12.2.2 Key events
  • 12.2.3 Drivers and barriers
• 12.3 5EU
  • 12.3.1 Forecast
  • 12.3.2 Key events
  • 12.3.3 Drivers and barriers
• 12.4 Japan
  • 12.4.1 Forecast
  • 12.4.2 Key events
  • 12.4.3 Drivers and barriers
• 12.5 Australia
  • 12.5.1 Forecast
  • 12.5.2 Key events
  • 12.5.3 Drivers and barriers

13 Appendix

• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
  • 13.3.1 Forecasting methodology
• 13.4 Primary Research - KOLs interviewed for this report
• 13.5 Primary research - prescriber survey
• 13.6 About the Authors
  • 13.6.1 Analyst
  • 13.6.2 Therapy Area Director
  • 13.6.3 Epidemiologist
  • 13.6.4 Epidemiology Reviewers
  • 13.6.5 Vice President of Disease Intelligence and Epidemiology
  • 13.6.6 Global Head of Pharma Research, Analysis and Competitive Intelligence
• About GlobalData
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