Influenza Diagnostics Market - Segmented by Test Type (Traditional Diagnostic Test, and Molecular Diagnostic Assay), End User (Hospital, Research Laboratory, and Other End Users), and Geography - Growth, Trends, and Forecast (2018 - 2023)
The Global Influenza Diagnostics Market was valued at USD 460.94 million in 2017 and is expected to register a CAGR of 6.83%, during the forecast period, 2018 to 2023. The key factors propelling the market growth include the increasing prevalence of influenza and related chronic diseases, growth in research funding for influenza diagnostics, rising demand for early diagnosis and control of influenza, and the emergence of technologically advanced influenza diagnostic tests.
Increasing Prevalence of Influenza and Related Chronic Diseases
Influenza has been recognized as a crucial cause of morbidity and mortality in the human population, which is leading to the development and use of diagnostics that are intended for reducing consequent health and economic impacts. There are four types of seasonal influenza viruses including A, B, C, and D. and according to WHO, influenza A and B viruses circulate and cause seasonal epidemics of disease. According to WHO, in 2018, influenza can cause severe sickness or death mainly in patients at a high risk and illness range from mild to severe and even death. In addition, this annual increase is projected to result in about 3-5 million cases of severe illness, and about 290 000-650 000 deaths globally. In addition, according to the estimates from Centers for Disease and Prevention 2017, between 291,000 and 646,000 people worldwide die from seasonal influenza-related respiratory illnesses each year, which is higher than 2016, estimates of 250,000 to 500,000. In industrialized countries, most of the deaths associated with influenza occur among people age 65 or older, and it has been estimated that in developing countries 99% of deaths in children are under 5 years of age with influenza-related lower respiratory tract infections. According to the Internal Journal of Environmental Research and Public Health in 2018, influenza is among the top ten health problems in America. In addition, influenza affects mainly older adults, which are 75 years and older in the world’s poorest region. For instance, people living in sub-Saharan African countries experienced the highest rates of flu-associated respiratory deaths. Patients with severe clinical illness associated with influenza virus infection should be treated with therapies available, and thus, with the increasing prevalence of influenza, the market is spurring.
Stringent Government Regulations
Due to their ease of use and availability of fast results Rapid influenza diagnostic tests (RIDTs) are often used at a point of care. Most tests are lateral flow immunoassays that detect chromatographic changes if an influenza antigen is present in the respiratory specimen. These tests have a high specificity (therefore, a positive is almost certainly a true positive) but low sensitivity. On May 22, 2014, FDA has reclassified antigen-based rapid influenza virus antigen detection test systems, envisioned for identification of influenza virus directly from clinical samples that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. The new minimum performance requirements for these tests detecting influenza virus antigens are likely to lower the number of misdiagnosed flu contaminations, by increasing the number of devices that can consistently identify the influenza infection. Thus, for achieving the great performance of RIDT a special control is mandatory for an annual and emergency analytical reactivity testing, which provide a process for continued monitoring of the performance of antigen-based RIDTs. Additionally, as the part of the process, the Centers for Disease Control and Prevention (CDC) and FDA may collaborate in efforts to ensure that there is an influenza virus analytical reactivity test panel available to all manufacturers of antigen-based RIDTs for evaluation of the analytical reactivity of their assays with circulating viruses on an annual basis. Additionally, it is critical to ensure that all the rapid antigen flu test should meet new FDA requirements for the approval, and thus, these stringent FDA regulations are the acting as a major restraint for the market.
Market Segmentation Insights for the Influenza Diagnostics Market
Under the Test Type segment, there are two sub-segments defined for the market- Traditional Diagnostic Test, and Molecular Diagnostic Assay. The larger share under the Test Type segment is controlled by Traditional Diagnostic Test in the current market, while the higher growth rate is expected for the Molecular Diagnostic Assay category. Under the Traditional Diagnostic Test sub-segment, largest share is controlled by Rapid Influenza Diagnostic Test (RDIT) in the current market. The largest share of RDIT is primarily due to the growing popularity of RIDT because of its ability to provide a fast result and simple usage. Some of the RIDTs are also are approved for office/bedside use as well. The RIDT segment is also expected to witness rapid growth, as a result of their common usage in point of care settings.
The North America region holds the largest share in the Global Influenza Diagnostics Market. The fastest growing region is expected to be the South America region. The largest share of the North America region in the global market can be attributed to the ease of access of RDITs in both the US and Canada (data derived from Centre for Disease Control & Prevention-CDC). The high growth for the South America region over the forecasted period has been predicted in the light of nation-wide Influenza vaccination programs that was initiated in 2018 in Argentina.
Key Developments in the Market
- March 2018- Sekisui Diagnostics launched the Silaris Influenza A and B test developed in collaboration with Mesa Biotech
- October 2017- Abbott Laboratories acquired Alere Inc. (Alere), a diagnostic device and service provider, which strengthens the company's diagnostics presence.
Major Players - Abbott Laboratories, Becton Dickinson & Company, Coris BioConcept, DiaSorin SpA, F. Hoffmann-La Roche AG, Luminex Corporation, Meridian Bioscience Inc., Quidel Corporation, Sekisui Diagnostics, and Thermo Fischer Scientific Inc., among others.
Reasons to Purchase the Report
- Current and future of Influenza Diagnostics Market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3 months analyst support, along with the market estimate sheet (in Excel)
Customization of the Influenza Diagnostics Market Report
- This report can be customized to meet your requirements. Please connect with our representative, who will ensure you to get a report that suits your needs