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Respiratory Syncytial Virus (RSV) Diagnostic Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

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  • 120 Pages
  • June 2022
  • Region: Global
  • Mordor Intelligence
  • ID: 5616951
UP TO OFF until Dec 31st 2023
The Respiratory Syncytial Virus (RSV) Diagnostic Market is expected to grow at a significant CAGR of 10.1% during the study period, 2022-2027.

The use of multiplex diagnostic panels including diagnostic for COVID-19 and RSV infections during the pandemic has increased in hospitals for early and rapid detection of covid-19 in critically ill respiratory patients. COVID-19 has a wide range of effects on diagnostics procedures, including labor force and staffing difficulties, procedural prioritizing, and intraoperative viral transmission risk. Although COVID-19 has led to shortage in essential diagnostic tests during the early pandemic, the multiplex diagnostics have played an important role in providing quick and rapid results for COVID-19 diagnostics. However, the launch of products is propelling the growth of market. For Instance, For instance, in February 2022, Avellino Labs USA, Inc. launched AvellinoCoV2 - Respiratory Test, a multi-panel RT-PCR-based virus assay that accurately detects four viral infections in one patient sample - COVID-19, respiratory syncytial virus (RSV), influenza A and influenza B. Thus, the COVID-19 has positively impacted the growth of the studied market and it is expected to boost the growth of the market over the period.

The factors propelling the studied market growth are growing burden of respiratory syncytial virus infections globally, rise in investments, technological advancements, product approvals and launches, government initiatives and other key strategies adopted by the key market players.

According to the article “Deaths Attributed to Respiratory Syncytial Virus in Young Children in High-Mortality Rate Settings: Report from Child Health and Mortality Prevention Surveillance (CHAMPS)” published in September 2021, RSV was detected in 5.5% of postmortem specimens' deaths. Also, 6.5% of all deaths in younger infants were attributed to RSV. This indicates that RSV as a huge burden on the global healthcares system, which increases the demand for its early diagnosis, thereby driving the market growth.

The growing product launches for effective diagnosis of RSV infections is expected to boost the studied market growth. For Instance, in November 2021, QIAGEN has launched and CE-marking of the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test for the QIAstat-Dx system to quickly identify whether patients have common seasonal respiratory infections or SARS-CoV-2.

Additionally, in September 2021, Roche launched three molecular polymerase chain reaction (PCR) diagnostic test panels to detect and differentiate common respiratory pathogens at the same time which include include influenza A, influenza B and respiratory syncytial virus (RSV); adenovirus (ADV), human metapneumovirus (hMPV) and enterovirus/rhinovirus (EV/RV); and parainfluenza 1, 2, 3 and 4.

Moreover, strategic initiatives such as mergers, acquisitions, partnerships and other initiatives adopted by key market players is expected to propel the marlet growth significantly. In February 2022, Seegene Inc. signed a supply deal with the Ministry of Health of Brazil to deliver four million Allplex SARS-CoV-2/FluA/FluB/RSV Assay, capable of identifying respiratory viruses including COVID-19, Flu A/B as well as RSV in a single test. Such steps will boost the studied market growth during study period.

Therefore, owing to aforementioned factors, the studied market is expected to grow significantly during the study period. However, strict regulatory norms and low detection limits of immunoassays is expected to hinder the market growth during study period.

Key Market Trends

Rapid Antigen Detection Tests Segment is Expected to Account for the Largest Market Share During the Forecast Period

A rapid antigen test (RAT), sometimes called a rapid antigen detection test (RADT), antigen rapid test (ART), or loosely just a rapid test, is a rapid diagnostic test suitable for point-of-care testing that directly detects the presence or absence of an antigen.

These tests provide results within 15 to 30 minutes, require minimal training or infrastructure, and have significant cost advantages. RATs are based on the principle of antigen-antibody interaction. Antigen-antibody reactions are a mainstay for the rapid detection of proteins. Antibodies recognize proteins based on their structure as well as content, and can be very specific, binding to only a small part of an antigen, and discriminating between highly similar antigens. Older adults are at greater risk than young adults for serious complications from RSV because of the poor immune system.

The rising research studies roving the efficacies of rapid antigen tests over other methods, rising product launches, and key initiatives taken by market players and government is expected to boost the segment growth during the study period. In the study “Performance Assessment of a Rapid Molecular Respiratory Syncytial Virus Point-of-Care Test: A Prospective Community Study in Older Adults” published in February 2022, the positive percentage agreement of Xpert Xpress Flu/RSV, a rapid antigen test, compared to routine RT-PCR is high for RSV detection in home-dwelling older adults. The assay is fast and easy to use at the point of care. Such advantages of RATs will propel the segment growth.

Additionally, the rising investments to boost the product development in the studied segment will drive the segment growth. For instance, in March 2021, National Institute of Health launched a Rapid Acceleration of Diagnostics Tech (RADx) initiative, with a total investment of USD 29.3 million focusing at increase testing capacity at the point-of-care settings. Further, through this investment Meridian Biosciences is developing respiratory panel that includes SARS-CoV-2, Influenza A/B, and RSV in one test.

Additionally, in March 2021, Quidel Corporation opened a new manufacturing facility in Carlsbad, California that will be dedicated to the production of QuickVue line of products which includes test for Influenza, RSV, Strep A and other diseases and conditions.

Thus, due to the above-mentioned factors, the studied segment is expected to contribute to the significant growth of the market.

North America is Expected to Hold a Significant Share in the Market and Expected to do Same Over the Forecast Period

The primary driving factors for the growth of the North American respiratory syncytial virus (RSV) market are growing burden of respiratory syncytial virus infections in the region, growing research and development activities, increasing investments, supporting government initiatives and key initiatives taken by the key market players.

The United States within North America is expected to hold a significant share of the studied market during study period. For instance, According to the article “Increased Interseasonal Respiratory Syncytial Virus (RSV) Activity in Parts of the Southern United States” published by Center for Disease Control and Prevention in June 2021, every year in the United States, RSV leads to on average approximately 58,000 hospitalizations with 100-500 deaths among children younger than 5 years old and 177,000 hospitalizations with 14,000 deaths among adults aged 65 years or older. Thus, the burden of RSV infections is increasing in the country, which is boosting the demand for its diagnostics, thus driving the market.

Moreover, product approvals in the regions will also boost the diagnostic procedures in the region, driving the market growth. For instance, in May 2022, the United States Food and Drug Administration authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19.

Additionally, in December 2021, Applied BioCode has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration for its BioCode CoV-2 Flu Plus Assay. This PCR-based, multiplex molecular diagnostic assay can simultaneously detect and differentiate between SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3, Influenza B), and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens.

Furthermore, in January 2022, Under Health Canada's Interim Order, Seegene Inc. South Korea's one of the leading molecular diagnostic company, has received approval for its Allplex SARS CoV-2 FluA/FluB/RSV Assay. The Allplex SARS CoV-2 FluA/FluB/RSV Assay from Seegene is a multiplex real-time PCR assay that allows for both amplification and differentiation of respiratory symptoms. It can distinguish between Influenza A, B, RSV, and COVID-19 in a single test.

Therefore, due to the above-mentioned factors, the studied market is expected to lead to lucrative growth of the market in North America.

Competitive Landscape

The studied market is fragmented and moderately competitive. The strategies such as acquisitions, partnerships, distribution agreements, and others are readily adopted by key market players to boost the market. The major players operating in the market are bioMerieux SA, Becton, Dickinson and Company, Abbott, F. Hoffmann-La Roche Ltd, ThermoFisher Scientific Inc., and others.

Additional Benefits:

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Table of Contents

1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Burden of Syncytial Virus Infections
4.2.2 Increasing Approvals for Syncytial Virus Diagnostic Products
4.3 Market Restraints
4.3.1 Stringent Regulations and Low Detection Limits of Immunoassays
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - in USD Million)
5.1 By Product
5.1.1 Kits and Assays
5.1.2 Instruments
5.1.3 Others
5.2 By Method
5.2.1 Molecular Diagnostics
5.2.2 Rapid Antigen Detection Tests
5.2.3 Immunoassays
5.2.4 Flow Cytometry
5.2.5 Chromatography
5.2.6 Others
5.3 By End User
5.3.1 Hospitals and Clinics
5.3.2 Clinical Laboratories
5.3.3 Others
5.4 Geography
5.4.1 North America United States Canada Mexico
5.4.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.4.4 Middle East and Africa GCC South Africa Rest of Middle East and Africa
5.4.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 bioMerieux SA
6.1.2 Becton, Dickinson and Company
6.1.3 Abbott Laboratories
6.1.4 F. Hoffmann-La Roche Ltd
6.1.5 ThermoFisher Scientific Inc.
6.1.6 Luminex Corporation
6.1.7 Qiagen
6.1.8 Hologic, Inc.
6.1.9 DiaSorin Inc.
6.1.10 Bio-Rad Laboratories, Inc.
6.1.11 Merck KGaA
6.1.12 Sartorius AG

Companies Mentioned

A selection of companies mentioned in this report includes:

  • bioMerieux SA
  • Becton, Dickinson and Company
  • Abbott Laboratories
  • F. Hoffmann-La Roche Ltd
  • ThermoFisher Scientific Inc.
  • Luminex Corporation
  • Qiagen
  • Hologic, Inc.
  • DiaSorin Inc.
  • Bio-Rad Laboratories, Inc.
  • Merck KGaA
  • Sartorius AG