RSウイルス予防：8市場の医薬品予測と市場分析 - 更新版

世界のRSウイルスの主要8市場（米国、フランス、ドイツ、イタリア、スペイン、英国、日本、オーストラリア）は、予測期間（2020年～2030年）に継続的に成長する見込みです。米国とEU（2025年）、オーストラリア（2026年）、日本（2027年）で発売されるMerck and Coのclesrovimabは、Beyfortusと競合し、Synagisに代わって高リスク乳幼児の標準予防薬となります。SP-0125は現在フェーズ3臨床試験中で、2027年に発売される見込みであり、上市する最初の小児用ワクチンとなります。PfizerのAbrysvo、GSKのArexvy、SanofiのBeyfortus、ModernaのmRESVIAなど、成人用、妊婦用、小児用の複数の治療薬が近年承認されたことは大きなアンメットニーズを満たすものであり、RSV予防の市場規模全体に大きな影響を与えると見られます。予測期間全体を通じて、米国が世界のRSV市場を独占します。

当レポートでは、RSウイルス予防の主要7市場について調査分析し、疾患の概要、疫学、疾患の管理、現在の治療オプション、アンメットニーズと機会、研究開発戦略、パイプラインの評価、現在と将来の参入企業、市場見通しなど、市場の詳細な評価を提供しています。

目次

第1章 RSウイルス予防：エグゼクティブサマリー - 2024年11月更新、2024年11月までの出来事に基づく

• RSウイルス予防の市場規模は、2030年までに62億米ドルに達する
• 新しい製品の流入にもかかわらず、アンメットニーズは残っている
• 後期段階のパイプラインの強さにより予防オプションは多様化し続ける
• 医師の考え

第2章 イントロダクション - 2024年11月更新、2024年11月までの出来事に基づく

• カタリスト
• 関連レポート

第3章 疾患の概要 - 2024年11月更新、2024年11月までの出来事に基づく

• 病因と病態生理学

第4章 疫学-2021年8月までの出来事に基づいて2021年8月に更新

• 疾患の背景
  • 危険因子と合併症
• 世界の過去の動向
• 予測手法
  • 情報源
  • 予測の前提条件と手法
• RSウイルス予防人口の疫学予測（2020年～2030年）
  • 早産の数：妊娠週数別
  • CLDを有する早産児
  • 血行動態上重篤な心疾患と先天性肺疾患を有する出生児の数
  • DMDと診断された患者数
  • SMAと診断された患者数
  • 妊娠後期の妊婦の数
  • 老人ホーム/長期ケア施設に入居している成人の数
• 議論
  • 疫学予測の考察
  • 分析の限界
  • 分析の強み

第5章 疾病管理 - 2024年11月更新、2024年11月までの出来事に基づく

• 診断
• 予防
• 治療
• 疾病管理に関するKOLの見解

第6章 現在の治療オプション - 2024年11月更新、2024年11月までの出来事に基づく

• 概要

第7章 アンメットニーズと機会の評価 - 2024年11月更新、2024年11月までの出来事に基づく

• 概要
• 診断検査の増加
• 長期的後遺症に関する研究と認識の向上
• 混合ワクチン
• 免疫不全患者向けの予防

第8章 R&D戦略 - 2024年11月更新、2024年11月までの出来事に基づく

• 概要
  • 新しいワクチン技術と戦略の活用
  • 投与と有効性を改良した予防抗体の開発
• 臨床試験設計
  • 妊婦の予防接種に用いるRSウイルス予防薬の臨床試験設計
  • 小児の予防接種に用いるRSウイルス予防薬の臨床試験設計
  • 成人の予防接種に用いるRSウイルス予防薬の臨床試験設計

第9章 パイプラインの評価 - 2024年11月更新、2024年11月までの出来事に基づく

• 概要
• 臨床開発中の有望な医薬品

第10章 パイプラインの評価分析 - 2024年11月更新、2024年11月までの出来事に基づく

• 概要
• 競合の評価
  • 乳児の受動的予防向けパイプライン製品
  • 妊婦用ワクチン製品のパイプライン
  • 成人向けパイプラインワクチン製品

第11章 現在と将来の参入企業 - 2024年11月更新、2024年11月までの出来事に基づく

• 概要
• 取引の動向

第12章 市場見通し - 2024年11月更新、2024年11月までの出来事に基づく

• 世界市場
  • 予測
  • 促進要因と障壁
• 米国
  • 予測
  • 主な出来事
  • 促進要因と障壁
• 5EU
  • 予測
  • 主な出来事
  • 促進要因と障壁
• 日本
  • 予測
  • 主な出来事
  • 促進要因と障壁
• オーストラリア
  • 予測
  • 主な出来事
  • 促進要因と障壁

第13章 付録

List of Tables

• Table 1: Respiratory Syncytial Virus: Key Metrics in the 8MM
• Table 2: Risk factors for severe RSV
• Table 3: Leading therapies for RSV prophylaxis, 2024
• Table 4: Guidelines for RSV Prophylaxis
• Table 5: Clinical trial designs for RSV vaccines for maternal immunization
• Table 6: Clinical trial designs for RSV prophylactics for pediatric patients
• Table 7: Clinical trial designs for RSV prophylactics for adult patients
• Table 8: Top 5 deals by value, 2019-24
• Table 9: RSV prophylactics market - global drivers and barriers, 2020-30
• Table 10: Key events impacting sales for RSV prophylaxis in the US, 2020-30
• Table 11: RSV prophylactics market - drivers and barriers in the US, 2020-30
• Table 12: Key events impacting sales for RSV prophylaxis in the 5EU, 2020-30
• Table 13: RSV prophylactics market - drivers and barriers in the 5EU, 2020-30
• Table 14: Key events impacting sales for RSV prophylaxis in Japan, 2020-30
• Table 15: RSV prophylactics market - drivers and barriers in Japan, 2020-30
• Table 16: Key events impacting sales for RSV prophylaxis in Australia, 2020-30
• Table 17: RSV prophylactics market - drivers and barriers in Australia, 2020-30
• Table 18: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

• Figure 1: Global (8MM) sales forecast by country for RSV prophylactics in 2020 and 2030
• Figure 2: Structure of human RSV virion
• Figure 3: RSV life cycle
• Figure 4: 8MM, rate of preterm births (per 1,000 live births), 2020-30
• Figure 5: 8MM, percentage of adults living in long-term care, ages >=55 years, 2020-30
• Figure 6: 8MM, sources used to forecast the number of preterm births
• Figure 7: 8MM, sources used to forecast the number of preterm births with CLD
• Figure 8: 8MM, sources used to forecast the number of live births with hemodynamically significant heart disease
• Figure 9: 8MM, sources used to forecast the number of live births with congenital lung disease
• Figure 10: 8MM, sources used to forecast the diagnosed prevalent cases of DMD
• Figure 11: 8MM, sources used to forecast the diagnosed prevalent cases of SMA
• Figure 12: 8MM, sources used to forecast the number of third-trimester pregnancies
• Figure 13: 8MM, sources used to forecast the number of adults living in long-term care
• Figure 14: 8MM, number of preterm births by gestational age, N, 2020
• Figure 15: 8MM, number of preterm infants with CLD, N, 0-year, 2020-30
• Figure 16: 8MM, number of live births with hemodynamically significant heart disease and congenital lung disease, 2020, 0-year
• Figure 17: 8MM, diagnosed prevalent cases of DMD in boys, ages 0-2 years, 2020-30
• Figure 18: 8MM, diagnosed prevalent cases of SMA, boys and girls, ages 0-2 years, 2020-30
• Figure 19: 8MM, number of third-trimester pregnant women, N, 2020-30
• Figure 20: 8MM, number of adults living in care institutions, ages >=55 years, N, 2020-30
• Figure 21: Unmet needs and opportunities in RSV
• Figure 22: Overview of the development pipeline in RSV
• Figure 23: Key late-stage trials for the promising pipeline agents that GlobalData expects to be licensed for RSV in the 8MM during the forecast period
• Figure 24: Competitive assessment of pipeline products for passive prophylaxis in infants, benchmarked against Synagis and Beyfortus
• Figure 25: Competitive assessment of pipeline maternal vaccine products, benchmarked against Abrysvo
• Figure 26: Competitive assessment of pipeline vaccines for adults, benchmarked against Arexvy, Abrysvo and mRESVIA
• Figure 27: Analysis of the company portfolio gap in RSV prophylaxis during the forecast period
• Figure 28: Global (8MM) sales forecast by country for RSV prophylactics in 2020 and 2030
• Figure 29: US sales forecast by Product for RSV Prophylactics in 2020 and 2030
• Figure 30: 5EU sales forecast by product for RSV prophylactics in 2020 and 2030
• Figure 31: Japan sales forecast by product for RSV prophylactics in 2020 and 2030
• Figure 32: Australia sales forecast by product for RSV prophylactics in 2020 and 2030

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.

Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense RNA orthopneumovirus belonging to the family of Pneumoviridae. The virus was discovered in 1956, first as an isolate from a laboratory chimpanzee displaying symptoms of the common cold, and later from infants suffering from respiratory disease (Chanock et al., 1957). The most common clinical scenario for RSV is an upper respiratory tract infection that 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 2-3 months of age. Severe respiratory disease can manifest as bronchiolitis and pneumonia, which can progress to respiratory failure or death in rare occasions (Borchers et al., 2013). RSV is also an important cause of hospitalizations and deaths in elderly adults (Walsh et al., 2012).

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.

GlobalData 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.

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

• About GlobalData

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

• 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
• 13.7 Contact Us