Market Overview

The global influenza diagnostics market was valued at USD 492.42 million in 2018, and is estimated to be valued at USD 731.97 million in 2024, witnessing a CAGR of 6.83%. Certain factors that are driving the market growth include increasing prevalence of influenza and related chronic diseases, growth in research funding for influenza diagnostics, and rising demand for early diagnosis and control of influenza.

Influenza is 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. According to WHO, in 2018, influenza caused severe sickness or death mainly in patients at a high risk and illness range from mild to severe and even death. Also, this annual increase is projected to result in about 3-5 million cases of severe illness, and about 290,000-650,000 deaths, globally.

Various initiatives and research funding are bolstering the growth of the market. For instance, National Institute of Allergy and Infectious Disease (NIAID) has supported a broad portfolio of the influenza research, which includes studies that are informing the development of vaccines, diagnostics, and therapeutics against seasonal and pandemic influenza. Similarly, in 2018, a non-profit association between academic, government, and industry medical researchers, called Human Vaccine Project, launched the Universal Influenza Vaccine Initiative. Thus, growth in research funding by the government and companies for influenza diagnostics is driving the market.

However, it is critical to ensure that all the rapid antigen flu tests meet new FDA requirements for approval. Hence, the stringent FDA regulations act as significant restraints for the market.

Scope of the Report

Influenza, also known as flu, is a highly contagious infectious disease caused by a virus. This is an infection of the respiratory passages, which causes fever and severe aches. The influenza diagnostic market includes the tests that are conducted for the diagnosis of influenza cases. As per the scope of this report, only the test kits and reagents that are being used for the diagnosis of influenza have been taken into account for the calculation of the total market size.

Key Market Trends

Rapid Influenza Diagnostic Test (RIDT) is Expected to hold its Highest Market Share in the Test Type Segment

In the test type segment of the influenza diagnostics market, among all traditional diagnostic tests, the rapid influenza diagnostic test (RIDT) is believed to have the largest market size and is expected to witness a CAGR of 6.87% during the forecast period.

Rapid influenza diagnostic tests (RIDTs) are immunoassays, which help to identify the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens and qualitatively provide the results. It can diagnose patients, who are present with influenza-like illness, mainly if it is performed within the first four days of the onset of symptoms.

The rising popularity of RIDT is due to the benefits of faster result and simple usage. Some of the RIDTs are also 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.

However, one of the major drawback associated with RIDT is that it gives false negative results, due to its low to moderate sensitivities (50-70%). Healthcare policymakers began to recognize the impact of its low sensitivity in 2009, when the novel H1N1 influenza epidemic occurred.

North America Dominates the Market and is Expected to do the Same in the Forecast Period

North America currently dominates the market for influenza diagnostics and is expected to continue its stronghold for a few more years.

As per data published by the Centers for Disease Control and Prevention (CDC), RIDTs are commonly available across the region. The reason behind the wide availability of the test is the reduced time span needed to generate results. RIDT can yield results in 15 minutes. With increasing influenza-associated hospitalization and pediatric deaths and the interest of government organizations to better manage the disease, the North American influenza diagnostics market is expected to grow in the future.

Competitive Landscape

The influenza diagnostics market is highly competitive and consists of a few major players. In terms of market share, few of the major players currently dominate the market. Companies, like Coris BioConcept, DiaSorin SpA, F. Hoffmann-La Roche AG, Luminex Corporation, Meridian Bioscience Inc., Quidel Corporation, and Sekisui Diagnostics., among others, hold the substantial share in the market.

Various developments have recently been taking place in the market; for instance, in March 2018, Sekisui Diagnostics launched the Silaris Influenza A and B test, developed in collaboration with Mesa Biotech. Also, in October 2017, Abbott Laboratories acquired Alere Inc. (Alere), a diagnostic device and service provider, which strengthened the company’s diagnostics presence.

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1 INTRODUCTION
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Prevalence of Influenza and Related Chronic Diseases
4.2.2 Growth in Research Funding for Influenza Diagnostics
4.2.3 Rising Demand for Early Diagnosis and Control of Influenza
4.3 Market Restraints
4.3.1 Product Safety and High Cost of Development
4.3.2 Stringent Government Regulations
4.3.3 Variability in Sensitivity and Specificity among Influenza Diagnostic Tests
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
5.1 Test Type
5.1.1 Traditional Diagnostic Test
5.1.1.1 Rapid Influenza Diagnostic Test (RIDT)
5.1.1.2 Viral Culture
5.1.1.3 Direct Fluorescent Antibody (DFA) Test
5.1.1.4 Serological Assay
5.1.2 Molecular Diagnostic Assay
5.1.2.1 RT-PCR
5.1.2.2 Nucleic Acid Sequence-based Amplification (NASBA) Test
5.1.2.3 Loop-mediated Isothermal Amplification-based Assay (LAMP)
5.1.2.4 Simple Amplification-based Assay (SAMBA)
5.1.2.5 Other Molecular Diagnostic Assays
5.2 End User
5.2.1 Hospital
5.2.2 Research Laboratory
5.2.3 Other End Users
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East & Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East & Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Abbott
6.1.2 Becton, Dickinson and Company
6.1.3 Coris BioConcept
6.1.4 DiaSorin SpA
6.1.5 F. Hoffmann-La Roche Ltd
6.1.6 Luminex Corporation
6.1.7 Meridian Bioscience Inc.
6.1.8 Quidel Corporation
6.1.9 Sekisui Diagnostics
6.1.10 Thermo Fisher Scientific Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

MARKET SEGMENTATION

Test Type
Traditional Diagnostic Test
Rapid Influenza Diagnostic Test (RIDT)
Viral Culture
Direct Fluorescent Antibody (DFA) Test
Serological Assay
Molecular Diagnostic Assay
RT-PCR
Nucleic Acid Sequence-based Amplification (NASBA) Test
Loop-mediated Isothermal Amplification-based Assay (LAMP)
Simple Amplification-based Assay (SAMBA)
Other Molecular Diagnostic Assays

End User
Hospital
Research Laboratory
Other End Users

Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa
GCC
South Africa
Rest of Middle East & Africa
South America
Brazil
Argentina
Rest of South America