Infectious Disease In-vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Application, By Technology (Immunoassay, Molecular Diagnostics), By End-use, By Region, And Segment Forecasts, 2021 - 2028

Report Overview 

The global infectious disease in-vitro diagnostics market size was valued at USD 56.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 3.9% from 2021 to 2028. The growth can be attributed to the growing geriatric population, technological advancements, and external funding for R&D. Growing prevalence of infectious diseases is also boosting the market growth. The rising demand for PoC testing attributable to government support and rising consumer awareness about faster diagnostics are propelling the demand. Furthermore, the introduction of high-quality and cheap medical solutions for lab automation can be a significant driver for the market.

The geriatric population is expected to grow at a fast pace in Latin America, with a 71% increase in the population of 60 years and above, followed by Asia (66%), Africa (64%), North America (41%), and Europe (23%) between 2015 and 2030. Aging is the leading risk factor for the development of diseases, such as cardiovascular and neurological diseases. Therefore, the fact that the global geriatric population is expected to grow over the forecast period is anticipated to be a high-impact rendering driver of the market for infectious diseases in-vitro diagnostics.

Diagnostics for SARS-CoV-2 detection are being continuously launched for catering to markets that have specific regulatory requirements. For instance, in March 2020, the ID Now COVID-19 test by Abbott also received emergency use authorization. In July 2020, NIH invested USD 248.7 million to support the scaling-up of diagnostic test production under its Rapid Acceleration of Diagnostics (RADx) initiative. The launch of new products is continuously increasing competition in the market for infectious diseases in-vitro diagnostics, making the market dynamics and process of choosing products highly complex.

In addition, the growing incidence of STIs, such as HIV and HPV, is expected to provide the market with a large target population. According to the WHO, 37.9 million individuals across the globe were living with HIV infection in 2018. About 1.7 million new cases of HIV were reported in 2018. Moreover, people suffering from HIV are highly susceptible to other infections, such as tuberculosis, which is considered to be the leading cause of death among HIV-affected people. In 2018, 862,000 people with HIV were estimated to be suffering from tuberculosis and 251,000 people suffering from HIV were estimated to have died due to tuberculosis. This prevalence is expected to boost the demand for diagnostics.

Product Insights

The reagents segment dominated the market for infectious diseases in-vitro diagnostics and accounted for the largest revenue share of 65.6% in 2020. It is anticipated to grow at a significant rate in upcoming years owing to its wide usage in diagnostics. Furthermore, the launch of new products is boosting the growth of the segment. Some recent launches include GeneFinder COVID-19 Plus RealAmp Kit in 2020, and VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.

Furthermore, the growing use of instruments to detect coronavirus, which were earlier developed for other infectious diseases, is anticipated to boost the growth of the market for infectious diseases in-vitro diagnostics. For instance, in March 2020, Abbott received Emergency Use Authorization (EUA) for RealTime SARS-CoV-2 EUA tests to be used on the m2000 RealTime System.

Increasing adoption of in vitro diagnostic systems with analyzer software at diagnostic centers is anticipated to fuel the growth of the market for infectious diseases in-vitro diagnostics. For instance, in January 2018, Mobidiag Ltd. entered into an agreement with Pro Med Diagnostics for Novodiag solution and Amplidiag solution distribution in African countries. Amplidiag solution consists of Amplidiag Analyzer Software that automates the complete process of detection of Helicobacter pylori and clarithromycin infection, C. difficile infection, and other infectious diseases.

Application Insights

The COVID-19 segment dominated the market for infectious diseases in-vitro diagnostics and accounted for the largest revenue share of 71.0% in 2020. The segment is anticipated to grow at a significant rate in upcoming years owing to increasing technological advancements to enable automated and high-throughput testing. The presence of favorable and flexible regulatory scenarios due to the increasing number of cases and prevalence rate of infectious diseases is anticipated to boost the market growth. For instance, in March 2020, bioMérieux received EUA from the U.S. FDA for the Biofire COVID-19 test that runs on FILMARRAY 2.0 and FILMARRAY TORCH platforms.

Carbapenem-resistant bacteria are gram-negative bacteria resistant to carbapenem and almost all classes of antibiotics. The infection is prevalent in hospital patients using ventilators, urinary catheters, and intravenous catheters and patients on long-term antibiotic therapy. The rising incidence of hospital-acquired infections and chronic diseases is expected to fuel the growth of the carbapenem-resistant bacteria testing market in the near future.

The prevalence of C. difficile infections depends on antibiotic prescription patterns, patient population, and endemic strains. The prevalence of CDIs may be as high as 50% in hospitalized patients. In addition, the presence of key market players, such as Quidel Corporation, F. Hoffmann-La Roche Ltd, Abbott, and Luminex Corporation, that have a range of in vitro diagnostic tests for detection is anticipated to boost the market growth. For instance, Quidel Corporation offers a range of assays, such as AmpliVue C. difficile Assay, Lyra Direct C. difficile Assay, and Solana C. difficile Assay, for diagnosis of C. difficile infection.

End-use Insights

The central laboratories segment dominated the market for infectious diseases in-vitro diagnostics and held the largest revenue share of 60.2% in 2020. The significant presence of these laboratories in emerging and underdeveloped markets can be attributed to its large share. The presence of extensive ancillary support with respect to manpower and infrastructure is also a key propeller of growth. Moreover, regulatory authorities are undertaking initiatives to improve laboratory services and ease the process of diagnosis.

There is an increasing interest in the development of molecular diagnostic platforms that can also be used in PoC settings. Therefore, various companies are designing assays and molecular diagnostic platforms for POC or near-patient testing. In addition, the growing development of new assays that offer quick PoC results is anticipated to boost the growth of the market for infectious diseases in-vitro diagnostics. For instance, in October 2018, U.S. FDA cleared Abbott’s Influenza A and B2 and Strep A2 assay for PoC testing, which can be used on the ID NOW platform.

Kits used for self-testing, which are used at home, independent of any health care specialist, are available on the internet and OTC and are categorized under this segment. Self-testing assists in early diagnosis and constant patient monitoring. In addition, self-test diagnostics aid in curbing costs associated with healthcare establishments and practitioners. A few of the home diagnostics tests are the Home Access Express HIV-1 Test and Home Access Hepatitis C Test developed by Home Access Health Corp and ADEXUSDx HIV 1/2 Test developed by NOWDiagnostics.

Technology Insights

The immunoassay segment accounted for a revenue share of 31.2% in 2020 in the infectious disease in-vitro diagnostics market. This is attributed to its use in the detection of infectious microorganisms such as viruses, bacteria, and fungus and their toxins and coat antigens. An increase in the outbreak of infectious diseases and a rise in the need for early diagnosis are among the key drivers responsible for the increased demand for immunoassay methods involving different types of Enzyme-Linked Immunosorbent Assay (ELISA).

Molecular diagnostics is considered as the basis of medical diagnosis for all major viral, bacterial, and parasitic infections. Increasing use of high-throughput PCR technology to detect infectious diseases is expected to drive the market for infectious diseases in-vitro diagnostics. For instance, in April 2020, Mobidiag Ltd. received EUA for Amplidiag COVID-19 for use in clinical laboratories in Finland. The EUA of the product is underway in France, Sweden, and the U.K.

Antibiotic susceptibility testing is considered one of the fastest-growing applications in microbiology testing. An increase in multidrug resistance is driving the demand for microbiological tests for increasing the efficiency of drugs against microorganisms. The rise in the prevalence of pathogenic diseases is expected to fuel the growth of the microbiology segment. In addition, extensive R&D being conducted for the identification of pathogens is expected to further enhance the market growth.

Regional Insights

North America dominated the infectious disease in-vitro diagnostics market and accounted for the largest revenue share of 36.5% in 2020. The region is expected to maintain its lead over the forecast period. This is attributed to the rising epidemiology of infectious diseases, thus, encouraging the R&D activities, thereby boosting the market growth.

Asia Pacific is anticipated to exhibit the fastest CAGR of 5.4 % during the forecast period. The presence of developing economies such as China and India that have a high prevalence of infectious diseases and access to healthcare is gradually rising. Increasing healthcare expenditure in the region is anticipated to fuel the market for infectious diseases in-vitro diagnostics.

Key Companies & Market Share Insights

Approximately 70% to 75% of the market is dominated by international players such as F. Hoffmann-La Roche Ltd.; BD; Abbott; Alere; Siemens Healthcare; and bioMérieux. Therefore, local companies and new organizations have little scope to enter the market and ensure sustainability.

The market for infectious diseases in-vitro diagnostics is competitive in nature. Consequently, manufacturers are required to innovate products in terms of specificity, accuracy, precision, speed, and other parameters in order to gain a competitive edge. For instance, in February 2019, Abbott received CE Mark for DETERMINE HBSAG 2 test for detection and diagnosis of hepatitis B surface antigen. Some of the prominent players in the infectious disease in-vitro diagnostics market include:

• BD

• bioMérieux SA

• Abbott

• Quidel Corporation

• OraSure Technologies, Inc.

• Hologic, Inc. (Gen Probe)

• Danaher

• QIAGEN

• F. Hoffmann-La Roche, Ltd.

• Siemens Healthineers AG

• Bio-Rad Laboratories, Inc.

Infectious Disease In-vitro Diagnostics Market Report Scope

Segments Covered in the Report

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-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global infectious disease in-vitro diagnostics market report on the basis of the product, technology, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2017 - 2028)

  • Instruments

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

  • Reagents

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

  • Services

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB and Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others

• Technology Outlook (Revenue, USD Million, 2017 - 2028)

  • Immunoassay

  • Molecular Diagnostics

  • Microbiology

  • Others

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • MRSA

  • Streptococcus

  • Clostridium Difficile

  • VRE

  • CRE

  • Respiratory Virus

  • Candida

  • TB and Drug-resistant TB

  • Gastro-intestinal Panel Testing

  • Chlamydia

  • Gonorrhea

  • HPV

  • HIV

  • Hepatitis C

  • Hepatitis B

  • COVID-19

  • Others

• End-use Outlook (Revenue, USD Million, 2017 - 2028)

  • Point of care

  • Central Laboratories

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia