Respiratory Syncytial Virus Prophylaxis: Eight-Market Drug Forecast and Market Analysis - Update
세계의 RS 바이러스의 주요 8 시장(미국, 프랑스, 독일, 이탈리아, 스페인, 영국, 일본, 호주)은 예측 기간(2020-2030년)에 지속적으로 성장할 전망입니다. 미국과 EU(2025년), 호주(2026년), 일본(2027년)에서 발매되는 Merck and Co clesrovimab은 Beyfortus와 경쟁하며, Synagis를 대신해 고리스크 유아의 표준 예방약으로 사용되어 왔습니다. SP-0125는 현재 단계 3 임상시험중이며, 2027년에 발매되는 전망이며, 출시하는 최초의 소아용 백신이 됩니다. Pfizer Abrysvo, GSK Arexvy, Sanofi Beyfortus, Moderna mRESVIA 등 성인용, 임산부용, 소아용 복수 치료제가 최근 승인된 것은 큰 미충족 요구를 충족하는 것이며, RSV 예방 시장 규모 전체에 큰 영향을 미칠 것으로 보입니다. 예측 기간 전체를 통해 미국이 세계의 RSV 시장을 독점합니다.
RS 바이러스 예방의 주요 7 시장에 대해 조사분석했으며, 질환의 개요, 역학, 질환 관리, 현재 치료 옵션, 미충족 요구와 기회, 연구개발 전략, 파이프라인의 평가, 현재와 향후 참여 기업, 시장 전망 등 시장의 상세한 평가를 제공하고 있습니다.
목차
제1장 RS 바이러스 예방 : 개요 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
- RS 바이러스 예방 시장 규모는 2030년까지 62억 달러에 달한다.
- 새로운 제품의 유입에도 불구하고 미충족 요구는 남아 있다.
- 후기 단계 파이프라인의 힘에 의해 예방 옵션은 계속 다양화한다.
- 의사의 생각
제2장 서론 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제3장질환의 개요 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제4장 역학-2021년 8월까지의 이벤트에 기반해 2021년 8월에 업데이트
- 질환의 배경
- 세계의 과거 동향
- 예측 방법
- RS 바이러스 예방 인구 역학 예측(2020-2030년)
- 조산 수 : 임신주수별
- CLD를 가진 조산아
- 혈행동태상 중증의 심질환과 선천성 폐질환을 가진 출생아 수
- DMD로 진단된 환자 수
- SMA로 진단된 환자 수
- 임신 후기 임산부 수
- 요양원/장기 케어 시설에 입주하고 있는 성인 수
- 논의
제5장 질병 관리 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
- 진단
- 예방
- 치료
- 질병 관리에 관한 KOL의 견해
제6장 현재 치료 옵션 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제7장 미충족 요구와 기회 평가 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
- 개요
- 진단 검사의 증가
- 장기적 후유증에 관한 연구와 인식의 향상
- 혼합 백신
- 면역 부전 환자용 예방
제8장 R&D 전략 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
- 개요
- 새로운 백신 기술과 전략의 활용
- 투여와 유효성을 개량한 예방 항체의 개발
- 임상시험 설계
- 임산부의 예방 접종에 이용하는 RS 바이러스 예방약의 임상시험 설계
- 소아의 예방 접종에 이용하는 RS 바이러스 예방약의 임상시험 설계
- 성인의 예방 접종에 이용하는 RS 바이러스 예방약의 임상시험 설계
제9장 파이프라인 평가 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제10장 파이프라인의 평가 분석 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
- 개요
- 경쟁 평가
- 유아의 수동적 예방용 파이프라인 제품
- 임산부용 백신 제품의 파이프라인
- 성인용 파이프라인 백신 제품
제11장 현재와 향후 참여 기업 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제12장 시장 전망 - 2024년 11월 업데이트, 2024년 11월까지의 이벤트에 기반
제13장 부록
KSA
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
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
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
