Infectious Respiratory Disease Diagnostics Market Size, Share & Trends Analysis By Product Type (Instruments, Services), By Sample Type (Blood, NPS), By Application, By Technology, And Segment Forecasts, 2022 - 2030

Report Overview

The global infectious respiratory disease diagnostics market size was estimated at USD 63.7 billion in 2021 and is expected to decline at a compound annual growth rate (CAGR) of - 1.8% from 2022 to 2030. This can be attributed to a decline in COVID-19 testing during the forecast period. Rising incidence of infectious respiratory diseases, such as tuberculosis and pneumonia, technological advancements in diagnostic technology, and increasing R&D investments by key players, government, and nonprofit organizations for diagnostic testing will be major factors driving the market. Furthermore, increased demand for assays and consumables during the pandemic coupled with increased product launches lead to a spike in the market in 2020 and 2021.

As of August 2022, 439 tests were approved by the U.S. FDA for the diagnosis of COVID-19 under Emergency Use of Authorization (EUAs). The market is being saturated with new molecular diagnostic tests for the detection of SARS-CoV-2. Rapid technological advancements-leading to accurate results, portability, and cost-effectiveness-are expected to be a high-impact rendering driver for this market. In April 2020, Canon Medical Systems launched the Aquilion Prime SP CT system for the rapid diagnosis of viral infectious diseases. This product offers an in-built decontamination tool that sanitizes the whole equipment by utilizing automated UV-C technology after use for other patients.

Key players are investing in R&D and commercialization of multiplex tests for the simultaneous diagnosis of RSV, COVID-19, and influenza, as these diseases have similar symptoms. Multiplex testing enables simultaneous targeting of multiple genes, thereby reducing the time & cost involved in performing conventional PCR. In September 2021, Cepheid received EUA for Xpert Xpress Flu/SARS-CoV-2/RSV combination test. This four-in-one test provides results in around 30 minutes by using GeneXpert Systems. Similarly, in March 2021, QIAGEN received EUA for the introduction of NeuMoDx RSV/Flu A-B/SARS-CoV-2 Vantage Test.

Increasing adoption of self-testing products and point-of-care products may further propel the growth. In December 2020, Abbott received EUA for the introduction of the BinaxNOW COVID-19 Ag Card rapid test that delivers results at home in 15 minutes. As of August 2021, around 59 at-home testing products have been authorized by the U.S. FDA for COVID-19 diagnosis, which uses home-collected specimens. In addition, 6 antigens Over the Counter (OTC) at-home tests, 3 antigen prescription at-home tests, 2 molecular OTC at-home tests, and 1 molecular prescription at-home test were also authorized by the U.S. FDA for self-testing of COVID-19.

Product Type Insights

On the basis of product types, the global industry has been further categorized into instruments, consumables, and services. The consumables segment dominated the global industry in 2021 and accounted for the maximum share of more than 65.15% of the overall revenue. The segment is anticipated to maintain its dominance over the forecast period owing to the increased testing volumes. The segment is also anticipated to exhibit the fastest growth rate during the forecast period. The consumables segment includes reagents and reagent kits that are used for performing in vitro diagnostic tests for respiratory diseases.

In September 2021, the U.S. FDA authorized around 261 molecular diagnostics products, 88 serological diagnostics tests, and 34 antigen diagnostics tests for the diagnosis of COVID-19. The instrument was the second-largest revenue-generating segment in 2021 owing to the introduction of innovative products to aid physicians in diagnosing COVID-19 patients. For instance, in March 2021, Vyaire Medical, Inc. introduced AioCare for diagnosing respiratory diseases in European Union, Middle East countries, and Australia. The product is a mobile spirometry system that provides accurate results as hospital-grade spirometers and enables the physician to monitor patients with advanced digital connectivity at home.

Sample Type Insights

On the basis of sample types, the global industry has been further categorized into saliva, Nasopharyngeal Swabs (NPS), anterior nasal region, blood, and others. The nasopharyngeal swabs sample type segment dominated the global industry in 2021 with a revenue share of more than 60.40% owing to a wide application scope in conducting various tests including rapid antigen detection tests, direct fluorescent antibodies, Polymerase Chain Reaction (PCR), and others coupled with increased demand. In response to the COVID-19 pandemic, multiple companies have drastically increased their swab manufacturing capacities.

The saliva sample type segment is estimated to witness a lucrative growth rate over the forecast period. This growth is owing to the increasing use of samples in testing coupled with an urgent need for noninvasive tests. In a study published in May 2020, researchers established the sensitivity and specificity of the saliva sample test, which were found to be around 84.2% and 98.9%, respectively. As a result, industry players started developing and commercializing no-swabs saliva-based tests. For instance, in March 2021, BATM Advanced Communications Ltd. introduced an RT-PCR kit that utilizes Salivette for the self-collection of samples for COVID-19 diagnosis.

Technology Insights

On the basis of technologies, the global industry has been segmented into immunoassay, molecular diagnostics, microbiology, and other technologies. The molecular diagnostics segment dominated the global industry in 2021 and accounted for the maximum share of more than 64.45% of the overall revenue. This high share can be attributed to the increased requirements of RT-PCR tests for the diagnosis of COVID-19, RSV, influenza, and others. PCR is the most conventional and trusted gold standard technology for amplification of DNA material to perform molecular diagnosis.

The companies are introducing multiplex tests that can be used for the diagnosis of infectious respiratory diseases using a single swab. For instance, in December 2020, GENETWORx, LLC launched a breakthrough test that can detect three respiratory viruses (SARS-COV-2, RSV, & Influenza A & B) in a single sample. The immunoassays segment is estimated to exhibit the fastest growth rate over the forecast period owing to the factors, such as technological advancements and the commercialization of innovative products. In April 2021, Bio-Rad Laboratories, Inc. launched a blood-based immunoassay kit to detect IgM, IgA, and IgG antibodies for diagnosis of COVID-19 patients. This immunoassay kit launch is expected to accelerate the diagnosis of COVID-19, thereby, driving the overall industry growth.

Application Insights

The COVID-19 segment dominated the global industry in 2021 with a revenue share of more than 90.95% owing to a high incidence of COVID-19, increased product approvals, and a rise in R&D. However, the increasing vaccination rates are expected to reduce the severity of the disease and the testing rates are expected to decline during the forecast period. Key players are introducing direct-to-consumer testing kits that eliminate the requirement of trained personnel for sample collection and shorten the turnaround time. The tuberculosis segment is estimated to witness a considerable growth rate during the forecast period. This is owing to increased government focus and R&D funding for the development of diagnostics.

According to the WHO, in 2020, globally, 10 million people suffered from TB and approximately 86% of all new cases of TB were reported in the 30 high disease burden countries. Two-thirds of new cases were registered in Indonesia, Philippines, India, China, Nigeria, Bangladesh, South Africa, and Pakistan. The increasing number of launches of highly sensitive and flexible molecular tests for the diagnosis of TB is expected to fuel segment growth. For instance, in October 2021, QIAGEN launched CE-IVD-certified QuantiFERON & QlAreach test that can diagnose TB in 20 minutes with a one-day patient visit. Such test launches accelerate the disease diagnosis and help address unmet diagnosis needs of patients in developing and low-middle income countries.

End-use Insights

The diagnostic laboratories end-use segment dominated the global industry in 2021 and accounted for the maximum share of more than 42.00% of the overall revenue. According to the CDC's August 2020 report, around 79.6 million tests were conducted in public health laboratories. Moreover, laboratories are entering into strategic initiatives with various organizations to offer COVID-19 testing to combat the rising incidence of the disease. For instance, in March 2020, Bio-Rad Laboratories, Inc., partnered with Assurance Scientific Laboratories in Birmingham & Alabama, and other laboratories to provide its real-time qPCR products, such as Reliance One-Step Multiplex RT-qPCR Supermix, CFX RT-PCR Detection Systems, and CFX384 Touch Real-Time PCR Detection System for COVID-19 screening.

The physician offices end-use segment is estimated to witness a significant growth rate over the forecast period owing to increased preference of patients and increased focus of manufacturers on the development of PoC diagnostics. The introduction of novel assays that provide quick PoC results is anticipated to boost segment growth. For instance, in April 2021, Chembio Diagnostics, Inc., introduced a rapid PoC COVID-19/Flu A&B test, which is suitable for differentiating patients with influenza or COVID-19 in a shorter turnaround time in traditional & decentralized settings.

Regional Insights

Asia Pacific dominated the global industry in 2021 and accounted for the largest share of more than 33.95% of the overall revenue. North America accounted for the second-largest share of the global industry in 2021. This was attributed to the high testing rates, proactive government measures, improvements in healthcare infrastructure, technological advancements, and the presence of major players in the North America region. Favorable government initiatives and reimbursement policies are likely to drive the region’s growth. However, the shortage of supply of materials during the COVID-19 pandemic, such as reagents, required to perform diagnostic tests may impede the industry growth to some extent.

According to the Academy Society for Microbiology, around 47.5% of laboratories in the U.S. reported a shortage of reagents used for the diagnosis of pneumonia, followed by tuberculosis with 29.4% of laboratories. Europe is estimated to witness a significant growth rate over the forecast period. The region’s growth can be attributed to the rising prevalence of respiratory indications and increasing testing rates. According to the European Center for Disease Prevention and Control (ECDC), in 2022, around 90,644 new cases of influenza were reported across Europe, out of this, approximately 98% and 2% were type A and type B viruses.

Key Companies & Market Share Insights

Major players are adopting various strategies, such as geographical expansion, to gain a higher share of the market. In addition, companies are focusing on gaining market approvals for innovative products for the diagnosis of various infectious respiratory diseases. For instance, in September 2020, F. Hoffmann-La Roche Ltd. launched the Elecsys Anti-SARS-CoV-2 S antibody test in markets accepting CE marking. In addition, the company filed for EUA to introduce the product in the U.S. region. Companies are also focusing on the launch of multiplex diagnostic tests for COVID-19, influenza, and RSV. Some of the prominent players in the global infectious respiratory disease diagnostics market include:

• Abbott

• Thermo Fisher Scientific, Inc.

• Koninklijke Philips N.V.

• F. Hoffmann-La Roche Ltd.

• BD

• bioMérieux SA

• Bio-Rad Laboratories, Inc.

• Quidel Corporation

• Siemens Healthcare GmbH

• Danaher

• Qiagen

Infectious Respiratory Disease Diagnostics Market Report Scope

Global Infectious Respiratory Disease Diagnostics Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-markets from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global infectious respiratory disease diagnostics market report on the basis of product type, sample type, technology, application, end-use, and region:

• Product Type Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • Instruments

    • Imaging Tests

    • Respiratory Measurement Devices

    • Other Instruments

  • Consumables

  • Services

• Sample Type Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • Saliva

  • Nasopharyngeal Swabs (NPS)

  • Anterior Nasal Region

  • Blood

  • Others

• Application Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • COVID-19

  • Influenza

  • RSV (Respiratory Syncytial Virus)

  • Tuberculosis

  • Streptococcus Testing

  • Other Respiratory Disease Testing

• Technology Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • Immunoassay

  • Molecular Diagnostics

  • Microbiology

  • Other technologies

• End-use Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Diagnostic Laboratories

  • Physician Offices

  • Other End Users

• Regional Outlook (Volume ‘000; Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • India

    • China

    • Japan

    • Australia

    • South Korea

    • Singapore

  • Latin America

    • Argentina

    • Brazil

    • Mexico

  • Middle East & Africa

    • Saudi Arabia

    • UAE

    • South Africa