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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Respiratory Syncytial Virus (RSV) is responsible for many chronic conditions such as pneumonia, bronchitis, asthma, and respiratory disease. It primarily affects neonates, infants and adults and is responsible for outpatient visits, hospitalization and death in some cases. Therefore, diagnosis of  RSV- associated diseases is crucial to avoid further medical severity.

Symptoms of RSV presence include, rhinorrhea, cough, wheeze, respiratory distress, and hypoxemia. Molecular diagnostic is most widely used techniques for diagnosing RSV.

Respiratory Syncytial Virus Diagnostics Market - Market Dynamics

High prevalence of respiratory infections due to RSV is a major factor driving growth of the respiratory syncytial virus diagnostics market. According to a report by the Lancet, 2017, around 33·1 million episodes of RSV induced acute lower respiratory infections that resulted in around 3·2 million hospitalizations and around 59,600 in-hospital deaths in children younger than 5 years of age, worldwide, in 2015. Moreover, the report stated that the overall RSV- acute lower respiratory infections- related mortality was around 118200 in 2015.

Furthermore, high prevalence of several chronic conditions such as pneumonia and other respiratory tract infections due to RSV is a major factor contributing to growth of the market over the forecast period. For instance, according to a report by World Health Organization (WHO), May 2018, chronic obstructive pulmonary disease (COPD) and lower respiratory tract infection are amongst top five chronic diseases with highest mortality rate, worldwide. The report stated that around 3 million each deaths were registered due to COPD and lower respiratory tract infection in 2016, worldwide.

Respiratory Syncytial Virus Diagnostics Market - Regional Insights

On the basis of Geography, respiratory syncytial virus diagnostics market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to be dominant in the respiratory syncytial virus diagnostics market over the forecast period.

According to study published in journal American Family Physician in 2017, around 2% to 3% of infants, younger than 12 months are hospitalized with an RSV infection, annually, in the U.S. As per same source, Around 57,500 hospitalizations and 2.1 million outpatient visits are associated with RSV infections in children younger than five years, annually, in the U.S. It can be concluded from epidemiological data that the U.S. has high potential for respiratory syncytial virus diagnostics market. Presence of key players and their products in North America would be another important driver for the market growth.

Asia Pacific and Latin America would witness highest CAGR in respiratory syncytial virus diagnostics market. According to study published in the Lancet in September 2017, lower middle income countries witnessed around 43,600 deaths due to RSV-ALRI whereas upper middle income countries witnessed around 17900 deaths, in 2015.

Furthermore, children in this region often do not receive adequate vaccination, which leads to frequent infection incidences from variety of diseases including RSV. According to World Health Organization (WHO) 2018, worldwide, around 86% of infants are vaccinated against 26 diseases. However, around 19.5 million children remain unvaccinated that leads to around 2-3 million deaths, annually, of which around 90% belong to low and middle income countries.

WHO is running the pilot projects of vaccination in countries of developing regions such Latin America, Africa, and Asia Pacific to achieve100% detection of the RSV infections amongst infants, neonates and children under five years of age.This is expected to reduce the mortality rate  and hospitalization from RSV associated acute lower respiratory infections (ALRI). It would also establish RSV diagnostic centers over the forecast period in these regions.

Respiratory Syncytial Virus Diagnostics Market - Competitive Landscape

Key players operating in the respiratory syncytial virus diagnostics market include, F. Hoffmann La-Roche AG , Becton, Dickinson and Company, Novartis AG, Abbott Laboratories, Ortho Clinical Diagnostics, Thermo Fisher Scientific Inc., Bio-Rad Laboratories Inc., BioMerieux, DiaSorin SPA, Millipore-sigma, Quidel Corporation, Alere Inc., Coris BioConcept, Fast-track Diagnostics, and Quest Diagnostics.

Moreover, the key players are focused on new product launches to expand their market share. For instance,

  • In 2016, BD (Becton, Dickinson and Company) launched its wireless rapid diagnostic system named—Veritor Plus— for detection of respiratory syncytial virus (RSV), influenza A and B, and group A strep—with new traceability and secure patient-health record documentation features and functionality.
  • In October 2017, Abbott Laboratories completed acquisition of the Alere, Inc. which provides RSV diagnostic system such as ALERE i RSV.

Key Development

  • In May 2019, QIAGEN N.V. received 510 (k) clearance from US Food and Drug administration (FDA) for its QIAstat-Dx syndromic testing system
  • In 2016, BD (Becton, Dickinson and Company) launched its next generation wireless rapid diagnostic system Veritor Plus.
  • In 2017, Abbott Laboratories completed acquisition of the Alere, Inc. which provides RSV diagnostic system such as ALERE i RSV.
  • In 2016, Abbott Laboratories received the US Food and Drug Administration (FDA) approval and CLIA waivers for its Alere i RSV Rapid Molecular Test and Alere Reader Lateral Flow Assay Analyzer respectively.
  • In September 2015, Roche Diagnostics received CLIA from the US Food and Drug Administration (FDA) for detection of flu A/B, RSV, and Strep A using the cobas Liat System. Post the approval the system may be used in pharmacy clinics, hospitals, physician offices, and other healthcare providing facilities.
  • In 2014, bioMérieux acquired BioFire Diagnostics Inc., which is a privately held U.S.-based company specialized in manufacturing molecular biology.

Respiratory Syncytial Virus Diagnostics Market - Market Taxonomy  

On the basis of diagnostic techniques, the global respiratory syncytial virus diagnostics market is segmented into:

  • Molecular Diagnostics
  • Direct Fluorescent Antibody (DFA) Method
  • Rapid Antigen Diagnostic Test
  • Monoclonal Antibodies
  • Flow Cytometry
  • Diagnostic Imaging
  • Immnunochromgraphic Assay
  • Gel Microdroplets
  • Others

 On the basis of end user, the global respiratory syncytial virus diagnostics market is segmented    into:                              

  • Hospitals
  • Diagnostic Centers
  • Commercial Radioisotope Manufacturers

On the basis of region, the global respiratory syncytial virus diagnostics market is segmented into:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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