RSウイルス - 市場考察、疫学、市場予測（2034年）

主なハイライト

• 主要7市場のRSウイルスの市場規模は、2023年に約13億米ドルでした。
• RSウイルスは一般的な呼吸器ウイルスで、鼻、喉、肺、呼吸通路に感染します。
• DelveInsightの疫学モデルによると、RSウイルスの総患者数は5歳未満がもっとも多く、次いで65歳以上でした。
• ワクチンやモノクローナル抗体が上市される前の2023年まで、RSウイルス治療細気管支炎は支持療法が中心でした。支持療法には、水分補給（経口または点滴）、生理食塩水点鼻別鼻閉の除去、病院での鼻吸引器または深部吸引、患者への栄養補給などが含まれます。
• 2023年は、米国食品医薬品局（FDA）が、60歳以上のRSウイルスによる下気道疾患（LRTD）の予防を目的とした世界初のワクチン、AREXVY（Respiratory Syncytial Virus Vaccine, Adjuvanted）/RSVPreF3を承認したことで、RSウイルスとの戦いに転機が訪れた年でした。
• 2023年5月、米国FDAはもう1つのワクチンであるABRYSVO（RSVPreF）を、60歳以上のRSウイルスによる下気道疾患の予防を適応として承認しました。さらに、ABRYSVOは妊娠中に推奨される唯一のRSウイルスワクチンです。
• 2024年3月、AstraZenecaとSanofiの長時間作用型モノクローナル抗体であるBEYFORTUS（Nirsevimab）は、最初のRSウイルスシーズンを迎えるすべての新生児、乳児と小児におけるRSウイルスによる下気道疾患（LRTD）の予防、ならびに最初のRSウイルスシーズンまたは第2シーズンを迎える新生児、乳児と重篤なRSウイルス感染リスクのある小児におけるRSウイルスLRTDの予防を適応症として、日本で承認されました。
• BEYFORTUS（Nirsevimab）はすでに欧米で承認されています。この薬剤は、健康な出生児、正期産児、早産児、特定の健康状態にある幼児を含む、幅広い乳幼児を対象とした唯一の単回投与RSウイルス受動免疫療法です。
• RSウイルスの大きな負担は、特に高齢者やリスクの高い人々の間で、RSウイルス感染の結果に対する認識を高める必要性を浮き彫りにしています。特に呼吸不全や死亡といった重篤な転帰をたどるリスクのある人々のワクチン接種を最適化するために、付随する政策を検討する必要があります。
• 予防が最大の防御策であることに変わりはありません。しかし、予防の選択肢は限られており、世界中の乳幼児にとってRSウイルス感染が公衆衛生上の大きな問題であることは、親や家族にまだあまり知られていません。そのため、RSウイルスのアンメットニーズの認知と予防は高く、患者支援団体がRSウイルス予防の認知を高める重要な促進要因となっています。

RSウイルス市場の見通し

RSウイルスの病態とウイルスの生態に対する理解は時間の経過とともに深まっていますが、ウイルスの予防はまだ不十分であり、しばしば重篤な疾病負担を伴います。2023年まで、RSウイルス感染に対する治療オプションは、支持療法や予防抗体の使用などに限られていました。しかし、AREXVYやABRYSVOのような新ワクチンの上市により、治療パターンは劇的に変化すると予測されます。

数年前までは、呼吸困難、喘鳴、気管支炎、上気道感染などの一般的な症状に対して、気管支拡張薬や抗生物質などの呼吸器系の支持療法を行うのが一般的でした。しかし、近年ワクチンやモノクローナル抗体が上市され、予防治療に焦点が移ってきています。BEYFORTUS（Nirsevimab）は、2回目のRSウイルスシーズンまで重症RSウイルス疾患に罹患しやすい生後24ヵ月までの小児を対象とした、幅広い新生児・乳児層に対する初めての単回投与RSウイルス予防オプションとなっています。

それでもなお、抗ウイルス治療や半減期延長mAbを含む、臨床的に有効で安全かつ費用対効果の高い予防・治療オプションに対するアンメットニーズが存在します。安全で効果的なRSウイルスワクチンやモノクローナルを開発する際に必ず直面する課題として、対象となる小児や妊産婦集団における厳格な安全対策があります。新規RSウイルスワクチンの開発により、RSウイルスによる世界の負担が軽減されることが期待されます。

当レポートでは、RSウイルスの主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 RSウイルス市場の概要

• 主要7市場のRSウイルスの市場シェアの分布：治療法別（2020年）
• 主要7市場のRSウイルスの市場シェアの分布：治療法別（2034年）

第4章 RSウイルスのエグゼクティブサマリー

第5章 主な出来事

第6章 疾患の背景と概要

• イントロダクション
• RSウイルスの構造
• RSウイルスの伝染
• RSウイルスの複製
• 病態生理学
• 兆候と症状

第7章 診断

第8章 治療と管理

第9章 予防

第10章 治療ガイドライン

• American Academy of Pediatrics（2014年）
• 高リスク乳児におけるRSウイルスによる重篤な感染症の予防としてpalivizumabを使用するSpanish Society of Neonatologyの提言の改訂
• American Academy of Pediatrics（RSウイルス感染症予防に関するガイドライン）（2022年）

第11章 調査手法

第12章 疫学と患者人口

• 主な調査結果
• 前提条件と根拠
• 主要7市場のRSウイルスの総患者数
• 米国
• 欧州4ヶ国・英国の疫学
• 日本

第13章 ペイシェントジャーニー

第14章 上市済みの製品

• 主な競合
• BEYFORTUS（nirsevimab）：Sanofi/AstraZeneca
• ABRYSVO（RSVpreF）：Pfizer

第15章 新治療法

• 主な競合
• mRNA-1345：Moderna
• VAC 18193：Janssen

第16章 RSウイルスの主要7市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
• 主要7市場の市場規模
  • 主要7市場のRSウイルスの総市場規模
  • 主要7市場のRSウイルスの市場規模：治療法別
• 米国の市場規模
  • 米国のRSウイルスの総市場規模
  • 米国のRSウイルスの市場規模：治療法別
• 欧州4ヶ国・英国の市場規模
  • 欧州4ヶ国・英国のRSウイルスの総市場規模
  • 欧州4ヶ国・英国のRSウイルスの市場規模：治療法別
• 日本の市場規模
  • 日本のRSウイルスの総市場規模
  • 日本のRSウイルスの市場規模：治療法別

第17章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
• RSウイルスの償還

第18章 KOLの見解

第19章 アンメットニーズ

第20章 SWOT分析

第21章 付録

第22章 DelveInsightのサービス内容

第23章 免責事項

第24章 DelveInsightについて

List of Tables

• Table 1: Summary of Respiratory Syncytial Virus (2020-2034)
• Table 2: Key Events
• Table 3: Diagnosed Incident Cases of Respiratory syncytial virus (RSV) in the 7MM in '000 (2020-2034)
• Table 4: Total Incident Cases of Respiratory syncytial virus (RSV) in the United States in '000 (2020-2034)
• Table 5: Total Incident Cases of Respiratory syncytial virus (RSV) in the United States in '000 (2020-2034)
• Table 6: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in the United States in '000 (2020-2034)
• Table 7: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in the United States in '000 (2020-2034)
• Table 8: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in the United States in '000 (2020-2034)
• Table 9: Total Incident Cases of Respiratory syncytial virus (RSV) in EU4 and the UK in '000 (2020-2034)
• Table 10: Age-specific Incident Cases of Respiratory syncytial virus (RSV) in EU4 and the UK in '000 (2020-2034)
• Table 11: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in EU4 and the UK in '000 (2020-2034)
• Table 12: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in EU4 and the UK in '000 (2020-2034)
• Table 13: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in EU4 and the UK in '000 (2020-2034)
• Table 14: Diagnosed Incident Cases of Respiratory syncytial virus (RSV) in Japan in '000 (2020-2034)
• Table 15: Age-specific Incident Cases of Respiratory syncytial virus (RSV) in Japan in '000 (2020-2034)
• Table 16: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in Japan in '000 (2020-2034)
• Table 17: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in Japan in '000 (2020-2034)
• Table 18: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in adults Japan in '000 (2020-2034)
• Table 19: Comparison of marketed drugs of RSV
• Table 20: Incidence of RSV Hospitalization by Treatment Group
• Table 21: Comparison of emerging drugs under development for RSV
• Table 22: RSVPreF3; Clinical Trial Description, 2024
• Table 23: mRNA-1345; Clinical Trial Description, 2024
• Table 24: Key Market Forecast Assumptions for MEDI8897 (nirsevimab)
• Table 25: Key Market Forecast Assumptions for RSVPreF3 (GSK3844766A)
• Table 26: Key Market Forecast Assumptions for RSVpreF (PF-06928316)
• Table 27: Key Market Forecast Assumptions for mRNA-1345
• Table 28: Market Size of RSV in the 7MM, USD million (2020-2034)
• Table 29: Market Size of RSV by Therapies in the 7MM, USD million (2020-2034)
• Table 30: Market Size of RSV in the United States, USD million (2020-2034)
• Table 31: Market Size of RSV by Therapies in the United States, USD million (2020-2034)
• Table 32: Market Size of RSV in EU4 and the UK, USD million (2020-2034)
• Table 33: Market Size of RSV by Therapies in EU4 and the UK, USD million (2020-2034)
• Table 34: Market Size of RSV in Japan, USD million (2020-2034)
• Table 35: Market Size of RSV by Therapies in Japan, USD million (2020-2034)
• Table 36: Key HTA Decisions

List of Figures

• Figure 1: RSV Genome and Proteins
• Figure 2: Replication Cycle of RSV
• Figure 3: Viral, Host, and Environmental Factors Involved in RSV Pathogenesis
• Figure 4: Pathogenesis Cycle of RSV
• Figure 5: Signs and Symptoms in Mild Cases of RSV
• Figure 6: Signs and Symptoms in Severe Cases of RSV in Adults
• Figure 7: Signs and Symptoms in Severe Cases of RSV in Infants
• Figure 8: Total Incident Cases of Respiratory syncytial virus (RSV) in the 7MM (2020-2034)
• Figure 9: Total Incident Cases of Respiratory syncytial virus (RSV) in the United States (2020-2034)
• Figure 10: Total Incident Cases of Respiratory syncytial virus (RSV) in the United States (2020-2034)
• Figure 11: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in the United States (2020-2034)
• Figure 12: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in the United States (2020-2034)
• Figure 13: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in the United States (2020-2034)
• Figure 14: Total Incident Cases of Respiratory syncytial virus (RSV) in the EU4 and the UK (2020-2034)
• Figure 15: Age-specific Incident Cases of Respiratory syncytial virus (RSV) in EU4 and the UK (2020-2034)
• Figure 16: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in EU4 and the UK (2020-2034)
• Figure 17: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in EU4 and the UK (2020-2034)
• Figure 18: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in EU4 and the UK (2020-2034)
• Figure 19: Total Incident Cases of Respiratory syncytial virus (RSV) in Japan (2020-2034)
• Figure 20: Age-specific Incident Cases of Respiratory syncytial virus (RSV) in Japan (2020-2034)
• Figure 21: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in children in Japan (2020-2034)
• Figure 22: Severity-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in Japan (2020-2034)
• Figure 23: Visit-specific Incident Cases of Respiratory syncytial virus (RSV) in adults in Japan (2020-2034)
• Figure 24: Patient Journey
• Figure 25: Market Size of RSV in the 7MM, USD million (2020-2034)
• Figure 26: Total Market size of RSV by Therapies in the 7MM, USD million (2020-2034)
• Figure 27: Market Size of RSV in the United States, USD million (2020-2034)
• Figure 28: Total Market size of RSV by Therapies in the United States, USD million (2020-2034)
• Figure 29: Market Size of RSV in EU4 and the UK, USD million (2020-2034)
• Figure 30: Total Market size of RSV by Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 31: Market Size of RSV in Japan, USD million (2020-2034)
• Figure 32: Total Market size of RSV by Therapies in Japan USD million (2020-2034)
• Figure 33: Health Technology Assessment
• Figure 34: Reimbursement Process in Germany
• Figure 35: Reimbursement process in France
• Figure 36: Reimbursement process in Italy
• Figure 37: Reimbursement process in Spain
• Figure 38: Reimbursement process in the United Kingdom
• Figure 39: Reimbursement process in Japan
• Figure 40: Unmet Needs

Key Highlights:

• According to DelveInsight's patient-based forecasting model, the total Respiratory Syncytial Virus Market Size in the 7MM was around USD 1,300 million in 2023.
• Respiratory syncytial virus (RSV) is a common respiratory virus that infects the nose, throat, lungs, and breathing passages.
• According to DelveInsight's Epidemiology Model, total Respiratory Syncytial Virus incident cases were found highest, i.e. ~2,800,000 in the below 5 years category, followed by 65 years and above, and the least number of cases were found in 5 to 64 years age group in the 7MM.
• Supportive care was the mainstay of Respiratory Syncytial Virus treatment bronchiolitis till 2023, before the launch of vaccines and monoclonal antibodies. Supportive care includes hydration (i.e., oral or intravenous), clearing nasal obstruction with saline nose drops, nasal bulb suction or deep suctioning in the hospital, and nutrition for the patient.
• 2023 was the turning point in the battle against respiratory syncytial virus (RSV) as the US Food and Drug Adminsitration (FDA) approved the world's first vaccine, i.e. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)/RSVPreF3 for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.
• In May 2023, the US FDA approved another vacine, ABRYSVO (RSVPreF) for the prevention of LRTD caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Moreover, ABRYSVO is the only RSV vaccine recommended during pregnancy.
• In March 2024, AstraZeneca and Sanofi's BEYFORTUS (Nirsevimab), a long-acting monoclonal antibody, has been approved in Japan for the prophylaxis of lower respiratory tract disease (LRTD) caused by RSV in all neonates, infants and children entering their first RSV season, and the prevention of RSV LRTD in neonates, infants and children at risk of serious RSV infection entering their first or second RSV season
• BEYFORTUS (Nirsevimab) has already received approval in Europe and the US. The drug is the only single-dose RSV passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
• The substantial burden of RSV highlights the need to raise awareness of the consequences of RSV infection, particularly among older and high-risk individuals. Accompanying policies would need to be considered to optimize vaccine uptake, particularly among those at risk of serious outcomes such as respiratory failure and death.
• Prevention remains the greatest form of defense. However, preventive options are limited, and RSV infection as a major public health issue for infants and young children around the world is still not well known by parents and families. Thus, there is a high Respiratory Syncytial Virus unmet needs awareness and prevention, and patient advocacy groups are a key driver in raising awareness of Respiratory Syncytial Virus prevention.
• Respiratory Syncytial Virus Drugs Market Report Summary
• The Respiratory Syncytial Virus drugs market report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent Respiratory Syncytial Virus therapies that would impact the current Respiratory Syncytial Virus treatment market landscape and result in an overall market shift has been provided in the report.
• The Respiratory Syncytial Virus drugs market report also encompasses a comprehensive analysis of the Respiratory Syncytial Virus therapeutics market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the Respiratory Syncytial Virus market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The Respiratory Syncytial Virus drugs market report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Respiratory Syncytial Virus therapeutics market.

The table given below further depicts the key segments provided in the report:

Respiratory Syncytial Virus Treatment Market

Respiratory Syncytial Virus belongs to the genus Orthopneumovirus within the family Pneumoviridae and order Mononegavirales. Members of this genus include human RSV, bovine RSV, and murine pneumonia virus. Two major antigenic subtypes of human RSV (A and B) are determined mainly by antigenic drift and duplications in RSV-G sequences but accompanied by genome-wide sequence divergence, including within RSV-F.

Respiratory Syncytial Virus spreads through contact with respiratory droplets (coughing, sneezing, or kissing) from an infected person or touching surfaces contaminated with the virus and then touching eyes, nose, or mouth. Respiratory Syncytial Virus can survive on hard surfaces such as tables and crib rails for many hours. The virus typically lives on soft surfaces such as tissues and hands for a shorter time. Children are often exposed to RSV outside the home, in school, or in daycare centers. They can then transmit the virus to other members of the family. RSV is so widespread that almost all children will have had an RSV infection by the age of 2 years.

Respiratory Syncytial Virus Diagnosis

The American Academy of Pediatrics does not recommend routine laboratory testing for RSV because treatment is supportive, and diagnosis does not change the disease management for most patients; however, laboratory testing may be warranted to confirm Respiratory Syncytial Virus infection in high-risk groups if the result will inform clinical decisions. For example, infants hospitalized with bronchiolitis receiving palivizumab should have testing to confirm whether Respiratory Syncytial Virus is the etiologic agent so the treatment can be discontinued. RSV testing methodologies include nucleic acid amplification testing (NAAT), polymerase chain reaction (PCR) and rapid antigen detection tests (RADTs), and cell culture. The preferred testing methodology depends on the patient's age and the clinical scenario.

Repirtaory Syncytial Virus Treatment

Till recently, supportive care including hydration (i.e., oral or intravenous), clearing nasal obstruction with saline nose drops, nasal bulb suction or deep suctioning in the hospital was the mainstay of treatment for RSV bronchiolitis. However, with the launch of vaccines, AREXVY and ABRYSVO and monoclonal antibodies such as BEYFORTUS and others, the treatment pattern for RSV is expected to change significantly over the forecast period.

Respiratory Syncytial Virus Epidemiology

The Respiratory Syncytial Virus epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of RSV, Age-specific Incident Cases of RSV, Severity-specific Incident Cases of RSV in Children, Severity-specific Incident Cases of RSV in Adults and Visit-specific Incident Cases of RSV in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, total Respiratory Syncytial Virus incident cases were ~8,600,000 in the 7MM and the US accounted for majority of the cases i.e. ~56%.
• Respiratory Syncytial Virus Incident cases were the highest in below 5 years of age, which accounted for nearly 50% of the total Respiratory Syncytial Virus incident cases in the 7MM in 2023.
• As per the severity of Respiratory Syncytial Virus infection in children, mild cases of RSV were the highest in 2023 in the US, whereas severity-specific cases in adults recorded highest number of moderate cases.
• In 2023, nearly 90% of the outpatient cases based on visit-specific Respiratory Syncytial Virus incident cases in adults, were found in the United States.

Recent Developments Activities in the Respiratory Syncytial Virus Market

• On October 29, 2024, QIAGEN announced that the FDA has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. This marks the third test to receive FDA clearance for QIAstat-Dx systems in 2024.
• On 23 September 2024, Vicebio Ltd, a biopharmaceutical company focused on developing innovative vaccines for life-threatening respiratory viral infections, has successfully raised $100 million in Series B financing. The funding round was led by TCGX, with significant contributions from Goldman Sachs Alternatives, Avoro Ventures, venBio, as well as continued support from UniQuest and founding investor Medicxi.

Respiratory Syncytial Virus Drugs Market Chapters

The drug chapter segment of the Respiratory Syncytial Virus drugs market report encloses a detailed analysis of the marketed and late-stage (Phase III) Respiratory Syncytial Virus pipeline drug. The Respiratory Syncytial Virus marketed drugs segment encloses drugs such as ABRYSVO (Pfizer), BEYFORTUS (Sanofi/AstraZeneca), AREXVY (GlaxoSmithKline), and others. Furthermore, the current key Respiratory Syncytial Virus companies for emerging drugs and their respective drug candidates include VAC 18193 (Janssen), mRNA-1345 (Moderna), and others. The drug chapter also helps understand the RSV clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest Respiratory Syncytial Virus news and press releases.

Respiratory Syncytial Virus Marketed Drugs

• ABRYSVO (RSVpreF): Pfizer

ABRYSVO, an intramuscular injection, is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective. In May 2023, Pfizer announced that the US FDA has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

• BEYFORTUS (nirsevimab): Sanofi/AstraZeneca

BEYFORTUS (nirsevimab) is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca's YTE technology. It is designed to protect infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Recently, in March 2024 BEYFORTUS has been approved also in Japan for the prophylaxis of lower respiratory tract disease (LRTD) caused by RSV in all neonates, infants and children entering their first RSV season, and the prevention of RSV LRTD in neonates, infants and children at risk of serious RSV infection entering their first or second RSV season. BEYFORTUS is anticipated to be available for the upcoming 2024/25 RSV season, in line with existing Japanese guidelines.

Respiratory Syncytial Virus Emerging Drugs

• mRNA-1345: Moderna

The mRNA-1345 vaccine is a messenger RNA (mRNA) vaccine. This mRNA is entirely made in a laboratory and instructs the body to build small pieces of proteins. Moderna's mRNA-1345 RSV vaccine candidate encodes for a prefusion F glycoprotein, eliciting a superior neutralizing antibody response. Moderna has filed for regulatory approvals for its vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults ages 60 years or older (mRNA-1345). The Company expects regulatory approvals beginning in the first half of 2024.

• VAC 18193 (Ad26.RSV.preF): Janssen

VAC 18193 is Janssen's investigational prophylactic RSV senior vaccine, which is being investigated to prevent RSV-mediated lower respiratory tract disease in adults aged 60 or older. The prophylactic RSV senior vaccine candidate leverages unique features of Janssen's adenovector platform (AdVac). The investigational vaccine contains the gene encoding for the fusion protein of the RSV virus as an antigen.

Respiratory Syncytial Virus Market Outlook

While the understanding of Respiratory Syncytial Virus pathogenesis and viral biology has increased over time, prevention of the virus is still lacking, often with severe disease burdens. Till 2023, there was a limited treatment options for Respiratory Syncytial Virus infection including supportive care and prophylactic antibody use. However, the treatment pattern is expected to change dramatically with the launch of novel vaccines such as AREXVY and ABRYSVO.

A few years back, Respiratory Syncytial Virus treatment typically involved respiratory supportive care for common symptoms, such as dyspnea, wheezing, bronchitis, and upper respiratory infection, including bronchodilators and antibiotics. However, with the recent launch of vaccines and monoclonal antibodies, focus has shifted to preventive treatment. BEYFORTUS (nirsevimab) has become the first single-dose RSV preventative option for the broad newborn and infant population for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Still, there is an Respiratory Syncytial Virus unmet need for clinically effective, safe, and cost-effective prevention and treatment options, including antiviral treatments, and extended half-life mAbs. Challenges that must be encountered while generating safe and effective Respiratory Syncytial Virus vaccines or monoclonals include stringent safety measures in targeted pediatric and maternal populations. The generation of novel RSV vaccines will hopefully help reduce the global burden caused by Respiratory Syncytial Virus.

Respiratory Syncytial Virus Drugs Market

• In 2023, the US accounted for the highest Respiratory Syncytial Virus market size among the 7MM, covering approximately 71% of the total Respiratory Syncytial Virus market size.
• Among all the therapies, BEYFORTUS (nirsevimab), AREXVY (GSK3844766A) Vaccine, and ABRYSVO (PF-06928316) are expected to have a major influence in the market throughout the forecast period (2024-2034).
• Among EU4 and the UK, the UK accounted for the highest Respiratory Syncytial Virus market size in 2023, which was followed by Germany.

Respiratory Syncytial Virus Drugs Uptake

This section focuses on the uptake rate of potential Respiratory Syncytial Virus drugs expected to be launched in the market during 2024-2034. The Respiratory Syncytial Virus treatment landscape has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians and the entire healthcare community in their tireless pursuit of Respiratory Syncytial Virus care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Respiratory Syncytial Virus Pipeline Development Activities

The Respiratory Syncytial Virus pipeline segment provides insights into therapeutic candidates in Phase III and Phase II. It also analyzes key Respiratory Syncytial Virus companies involved in developing targeted therapeutics. Respiratory Syncytial Virus companies like Moderna and Janssen actively engage in mid and late-stage research and development efforts for RSV. The Respiratory Syncytial Virus pipeline possesses few potential drugs. However, there is a positive outlook for the Respiratory Syncytial Virus therapeutics market, with expectations of growth during the forecast period (2024-2034).

Respiratory Syncytial Virus Pipeline Development Activities

The Respiratory Syncytial Virus pipeline segment covers information on collaborations, acquisitions and mergers, licensing, and patent details for Respiratory Syncytial Virus emerging therapy.

KOL- Views

To keep up with current Respiratory Syncytial Virus Treatment Market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving Respiratory Syncytial Virus Treatment Market Landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including pulmonologists, physician, and others.

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the United States. Centers such as the University of Miami, University of Georgia, NHS Trust, Imperial College London, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or RSV market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Respiratory Syncytial Virus unmet needs.

Qualitative Analysis

We perform Qualitative and Respiratory Syncytial Virus Treatment Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for RSV, the most important primary endpoints include, the efficacy of reducing RSV-associated infections, an increase in RSV-neutralizing antibodies, and a reduction in hospitalization rate. Based on these, the overall efficacy is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Respiratory Syncytial Virus Therapeutics Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the Respiratory Syncytial Virus Therapeutics Market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The Respiratory Syncytial Virus drugs market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Respiratory Syncytial Virus Therapeutics Market Report Scope

• The Respiratory Syncytial Virus therapeutics maket size report covers a segment of key events, an executive summary, and a descriptive overview, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the Respiratory Syncytial Virus epidemiology segments and forecasts, disease progression, and Respiratory Syncytial Virus treatment market guidelines has been provided.
• Additionally, an all-inclusive account of the Respiratory Syncytial Virus emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Respiratory Syncytial Virus treatment market landscape.
• A detailed review of the Respiratory Syncytial Virus drugs market, historical and forecasted Respiratory Syncytial Virus market size, Respiratory Syncytial Virus market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Respiratory Syncytial Virus therapeutics market report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Respiratory Syncytial Virus therapeutics market.

Respiratory Syncytial Virus Treatment Market Report Insights

• Patient-based Respiratory Syncytial Virus Market Forecasting
• Therapeutic Approaches
• Respiratory Syncytial Virus Pipeline Analysis
• Respiratory Syncytial Virus Market Size
• Respiratory Syncytial Virus Market Trends
• Existing and Future Respiratory Syncytial Virus Drugs Market Opportunity

Respiratory Syncytial Virus Treatment Market Report Key Strengths

• 11 Years- Respiratory Syncytial Virus Market Forecast
• The 7MM Coverage
• Respiratory Syncytial Virus Epidemiology Segmentation
• Key Cross Competition
• Respiratory Syncytial Virus Drugs Uptake
• Key Respiratory Syncytial Virus Market Forecast Assumptions

Respiratory Syncytial Virus Treatment Market Report Assessment

• Current Respiratory Syncytial Virus Treatment Market Practices
• Respiratory Syncytial Virus Unmet Needs
• Respiratory Syncytial Virus Pipeline Drugs Analysis Profiles
• Respiratory Syncytial Virus Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

FAQs:

• What was the Respiratory Syncytial Virus market size, the Respiratory Syncytial Virus treatment market size by therapies, Respiratory Syncytial Virus drugs market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among the United States for approved therapies?
• What can be the future treatment paradigm for Respiratory Syncytial Virus?
• What are the disease risks, burdens, and Respiratory Syncytial Virus unmet needs? What will be the growth opportunities in the United States concerning the patient population with RSV?
• Who is the major competitor of BEYFORTUS in the market?
• How much market share will AREXVY capture by 2034?
• What are the current options for the Respiratory Syncytial Virus treatment? What are the current guidelines for treating Respiratory Syncytial Virus in the 7MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing Respiratory Syncytial Virus therapies?
• What is the patient share in Respiratory Syncytial Virus?

Reasons to Buy:

• The Respiratory Syncytial Virus market outlook report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Respiratory Syncytial Virus therapeutics market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Respiratory Syncytial Virus therapeutics market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the 7MM.
• Identifying strong upcoming Respiratory Syncytial Virus companies in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the Respiratory Syncytial Virus unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Respiratory syncytial virus (RSV) Market Overview at a Glance

• 3.1 Market Share (%) Distribution of Respiratory syncytial virus (RSV) by Therapies in the 7MM in 2020
• 3.2 Market Share (%) Distribution of Respiratory syncytial virus (RSV) by Therapies in the 7MM in 2034

4. Executive Summary of Respiratory syncytial virus (RSV)

5. Key events

6. Disease Background and Overview

• 6.1 Introduction
• 6.2 Structure of Respiratory syncytial virus (RSV)
• 6.3 Transmission of Respiratory syncytial virus (RSV)
• 6.4 Replication of Respiratory syncytial virus (RSV)
• 6.5 Pathophysiology
• 6.6 Signs and Symptoms

7. Diagnosis

8. Treatment and Management

9. Prevention

10. Treatment Guidelines

• 10.1. American Academy of Pediatrics (2014)
• 10.2. An update of the recommendations of the Spanish neonatology society for the use of palivizumab as prophylaxis for severe infections due to syncytial respiratory virus in high-risk infants
• 10.3. American Academy of Pediatrics (Guidance on RSV Prophylaxis) (2022)

11. Methodology

12. Epidemiology and Patient Population

• 12.1 Key Findings
• 12.2 Assumptions and Rationale
• 12.3 Total Incident cases of Respiratory syncytial virus (RSV) in the 7MM
• 12.4. The United States
  • 12.4.1 Total incident cases of Respiratory syncytial virus (RSV) in the United States
  • 12.4.2 Age-specific Incident cases of Respiratory syncytial virus (RSV) in the United States
  • 12.4.3 Severity-specific incident cases of Respiratory syncytial virus (RSV) in children in the United States
  • 12.4.4 Severity-specific incident cases of Respiratory syncytial virus (RSV) in adults in the United States
  • 12.4.5 Visit-specific incident cases of Respiratory syncytial virus (RSV) in the US
• 12.5. EU4 and the UK Epidemiology
  • 12.5.1 Total Incident Cases of Respiratory syncytial virus (RSV) in EU4 and the UK
  • 12.5.2 Age-specific incident cases of Respiratory syncytial virus (RSV) in EU4 and the UK
  • 12.5.3 Severity-specific incident cases of Respiratory syncytial virus (RSV) in children in EU4 and the UK
  • 12.5.4 Severity-specific incident cases of Respiratory syncytial virus (RSV) in adults in EU4 and the UK
  • 12.5.5 Visit-specific incident cases of Respiratory syncytial virus (RSV) in EU4 and the UK
• 12.6. Japan
  • 12.6.1 Total Incident cases of Respiratory syncytial virus (RSV) in Japan
  • 12.6.2 Age-specific incident cases of Respiratory syncytial virus (RSV) in Japan
  • 12.6.3 Severity-specific incident cases of Respiratory syncytial virus (RSV) in children in Japan
  • 12.6.4 Severity-specific incident cases of Respiratory syncytial virus (RSV) in adults in Japan
  • 12.6.5 Visit-specific incident cases of Respiratory syncytial virus (RSV) in Japan

13. Patient Journey

14. Marketed Products

• 14.1 Key-cross
• 14.2 BEYFORTUS (nirsevimab): Sanofi/AstraZeneca
  • 14.2.1 Product Description
  • 14.2.2 Regulatory Milestones
  • 14.2.3 Other Developmental Activities
  • 14.2.4 Safety and Efficacy
• 14.3 ABRYSVO (RSVpreF): Pfizer
  • 14.3.1 Product Description
  • 14.3.2 Regulatory Milestones
  • 14.3.3 Other Developmental Activities
  • 14.3.4 Safety and Efficacy

15. Emerging Therapies

• 15.1 Key Cross Competition
• 15.2 mRNA-1345: Moderna
  • 15.2.1 Product description
  • 15.2.2 Other developmental activity
  • 15.2.3 Clinical development
  • 15.2.4 Safety and efficacy
• 15.3. VAC 18193: Janssen
  • 15.3.1 Product description
  • 15.3.2 Other developmental activity
  • 15.3.3 Clinical development
  • 15.3.4 Safety and efficacy

16 Respiratory Syncytial Virus (RSV) Seven Major Market Analysis

• 16.1 Key Findings
• 16.2 Market Outlook
• 16.3 Conjoint Analysis
• 16.4 Key Market Forecast Assumptions
• 16.5 The Seven Major Market Size
  • 16.5.1 Total Market size of RSV in the 7MM
  • 16.5.2 Total Market size of RSV by Therapies in the 7MM
• 16.6 The United States Market Size
  • 16.6.1 Total Market size of RSV in the United States
  • 16.6.2 Total Market size of RSV by Therapies in the United States
• 16.7 EU4 and the UK Market Size
  • 16.7.1 Total Market size of RSV in the EU4 and the UK
  • 16.7.2 Total Market size of RSV by Therapies in the EU4 and the UK
• 16.8 Japan Market Size
  • 16.8.1 Total Market size of RSV in Japan
  • 16.8.2 Total Market size of RSV by Therapies in Japan

17 Market Access and Reimbursement

• 17.1 The United States
  • 17.1.1 Centre for Medicare and Medicaid Services (CMS)
• 17.2 EU4 and the UK
  • 17.2.1 Germany
  • 17.2.2 France
  • 17.2.3 Italy
  • 17.2.4 Spain
  • 17.2.5 United Kingdom
• 17.3 Japan
  • 17.3.1 MHLW
• 17.4. RSV Reimbursement

18 KOL Views

19 Unmet Needs

20 SWOT Analysis

21 Appendix

• 21.1 Report Methodology
• 21.2 Bibliography

22 DelveInsight Capabilities

23 Disclaimer

24 About DelveInsight