Infectious Disease In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents, Software), By Technology, By Application, By Test Location, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global infectious disease in vitro diagnostics (IVD) market size was estimated at USD 84.63 billion in 2022 and is expected to decline at a compounded annual growth rate of (CAGR) -11.5% from 2023 to 2030. The decline in CAGR is only due to the impact of COVID-19 pandemic. However, infectious disease in vitro diagnostics (without the impact of COVID-19) is expected to expand at a CAGR of 4.3% from 2023 to 2030. The global industry is witnessing growth due to the factors, such as the growing geriatric population susceptible to infectious diseases, high demand for PoC testing owing to the pandemic, rising awareness about early testing, and rising prevalence of infectious diseases. The market witnessed a paradigm shift during the pandemic due to the launch of novel and innovative products for SARS-CoV-2 testing and amplified adoption of these products resulting in the exponential growth of the industry in 2020 and 2021. Furthermore, the rapid installation of PCR instruments has created an opportunity for the usage of PCR tests for other infectious diseases, such as influenza, owing to the SARS-CoV-2 tests declining significantly in 2022. Aging is the leading risk factor for the development of diseases, such as cardiovascular & neurological diseases, therefore, the growing geriatric population is expected to be a high-impact rendering driver of this market.

As aging weakens the immune system and increases a patient’s susceptibility to infectious diseases, the growing geriatric population in Asian nations, such as Japan & China, and the presence of numerous untapped opportunities in these countries are factors expected to propel the industry growth during the forecast period. The rising prevalence of infectious diseases is a major factor driving steep revenue generation. For instance, as per the National Conference of State Legislatures in 2021, the rate of gonorrhea infections in the U.S.increased by 56% since 2015, chlamydia increased by 19%, and hepatitis A increased by 1,325%.

Furthermore, 40% of HIV cases are transmitted by people unaware of their positivity status. This demonstrates an unmet need for diagnostic tests for HIV. The acquisition is becoming a prominent strategy for growth and portfolio diversification. For instance, in December 2021, Advanced Conceptions, Inc. and Idaho Molecular, Inc.’s portfolio was acquired by Co-Diagnostics, Inc. allowing it to gain access to intellectual property rights, streamlining the commercialization of its integrated product line for infectious diseases. The multiplex assays targeting STI, respiratory and other infections accommodated in the PCR device of the company broadens the customer base.

Product Insights

The reagents segment held the highest share of 66.72% of the overall revenue in 2022. This can be attributed to the high-volume usage of reagents for conducting tests. Moreover, the COVID-19 testing programs to confirm positive, as well as negative tests, are escalating the usage of reagents. For instance, in February 2022, SRL Inc. announced the introduction of a new laboratory service “IVD and COVID-19 testing” designed to accurately confirm negative tests. The instruments segment demonstrated a steep rise in 2020 and 2021 attributed to the rise in PCR instrument installation for SARS-CoV-2 tests.

Rapid innovation is becoming a key factor in the focus to achieve a competitive edge. For instance, in April 2022, InspectIR COVID-19 Breathalyzer was approved by the FDA for rapid testing in locations, such as mobile testing laboratories and doctors’ offices. The device was approved under IVD emergency use authorization. Consumer demands in the software segment are evolving continuously; the use of the software is not limited to laboratories. For instance, some consumers prefer cloud computing while others opt for concierge services and need a team of professionals for software management. Companies, such as DNAS, provide PanelPlex, which is an up-to-date cloud-based product to resolve issues associated with multiplex molecular diagnostics for infectious diseases.

Application Insights

The COVID-19 application segment dominated in 2022 and accounted for the highest share of more than 77.0%. The high share of the segment can be attributed to the increased adoption of SARS-CoV-2 testing to limit the spread of the infection. Furthermore, government initiatives to enhance public testing have acted as one of the major drivers for the segment growth along with the launch of innovative products. The fast growth rate of TB and HIV segments can be attributed to enhanced testing. Furthermore, influenza testing in the respiratory virus segment has also picked up pace owing to the launch of new diagnostic tests that allow testing of SARS-CoV-2 as well as influenza with differentiation between the two conditions to expedite treatment.

Tuberculosis is a communicable infection caused by the bacteria Mycobacterium tuberculosis. As per the WHO in 2021, the estimated number of people having tuberculosis is around 10.6 million across the globe; however, the rate of tuberculosis infection has decreased in the past years. For instance, a 9% decline was registered between 2015 and 2019. Globally, South-East Asia has accounted for 44% of the overall cases. Growing economies like India, China, and Indonesia top the charts with the highest number of tuberculosis infections. The WHO has recommended the use of the molecular diagnostic technique NAAT for the diagnosis of tuberculosis instead of traditional smear microscopy for improving the accuracy of disease detection. In addition, the use of next-gen sequencing assists in the easier diagnosis of drug resistance.

Test Location Insights

The central laboratories segment dominated in 2022 and accounted for the highest share of 54.24% of the overall revenue. Laboratory-based tests ensure higher accuracy when compared to point-of-care tests, which makes them reliable. Other advantages include the availability of complex tests that cannot be conducted in PoC and homecare settings. In addition, the availability of tests that allow for sample collection at home and sending it to the laboratories for testing makes testing highly convenient for the patients. For instance, in October 2021, Labcorp received EUA from the FDA for its home collection kit that allows testing for flu as well as SARS-CoV-2 simultaneously.

The high demand for faster turnaround time has escalated the demand for point-of-care tests. COVID-19 has strengthened segment growth and created an intensified demand for these products. The rapid turnaround time and low complexity are giving products of this segment a competitive edge. Hospitals are considered niche healthcare settings. The most significant advantage of hospitals conducting infectious disease IVD tests is that they can provide test results even in emergencies. Since IVD tests are becoming simpler in use, the adoption rate in hospitals has increased. With the increased number of hospitals aiming to provide all services under one roof for patients, the advancements in hospital laboratories become essential to meet the changing patient demands.

Technology Insights

Based on technologies, the global industry has been further categorized into immunoassay, molecular diagnostics, microbiology, and others. The molecular diagnostics segment held the highest share of 57.90% in 2022. Molecular diagnostics are used for all major parasitic, bacterial, and viral infections. These tests are advanced and overcome the drawbacks, such as irregular growth of microorganisms in manually prepared media, longer turnaround duration, and poor sensitivity of traditional testing methods.

The demand for immunoassay technology is expected to increase over the forecast period. Companies are focusing on the development and commercialization of immunoassays for COVID-19 diagnosis, due to increased demand for rapid PoC tests. For instance, Creative Diagnostics introduced SARS-CoV-2 immunoassay kits for the diagnosis of SARS-CoV-2 antigens and antibodies in October 2020. Increasing use of serology testing, such as ELISA, for detection of the different infectious diseases are expected to increase in the coming years.

Regional Insights

North America accounted for the maximum share of more than 40.0% in 2022. The region is expected to expand further at a significant growth rate over the forecast period. The presence of a favorable & flexible regulatory framework, the presence of major industry players, and the focus on increasing disease surveillance by conducting more tests are major drivers for the North America region. The Asia Pacific region is estimated to register the fastest CAGR from 2023 to 2030 due to the high prevalence of infectious diseases.

Furthermore, growing healthcare access in developing economies, such as India, is boosting the region’s growth. The rising geriatric population in nations, such as Japan, is also acting as a driver for the adoption of IVD tests. In India, consumer awareness has led to an increase in the number of tests & diagnostics for infectious diseases over the past few years. Although earlier molecular diagnostics testing was affordable only to the upper class, the rapid economic development of the country has raised the purchasing capacity of people, thereby increasing market penetration of infectious diseases molecular diagnostics in India.

In addition, the demand for better diagnostics is expected to increase the growth potential of the infectious diseases molecular diagnostics market. The French healthcare system provides insurance for both private & public hospitals, medical specialists, doctors, and general physicians. The insurance policy covers all French nationals, irrespective of their status, income, or age. Such proactive government initiatives enhance accessibility to diagnostic options like IVD. In June 2022, Eurobio Scientific announced the launch of two novel tests for Monkeypox and SARS-CoV-2 (for variants Omicron BA.2, BA.1, and BA.4/BA.5) in France.

Key Companies & Market Share Insights

A new product launch has been a key strategy used by most companies to enhance revenue generation. This included the launch of immunoassays as well as multiplex tests to cater to multiple needs of the patients. For instance, in March 2023, Quidel Corporation received De Novo U.S. FDA authorization for the commercialization its novel Sofia 2 SARS Antigen+ FIA. It is the first rapid antigen test to receive FDA clearance that detects COVID-19.It is intended for prescription use only and is designed for point-of-care settings. Furthermore, key players are entering into collaborations to improve access to high-quality, innovative laboratory services for patients & healthcare providers. Some of the key players in the global infectious disease in vitro diagnostics market include:

• QIAGEN

• BD

• bioMérieux SA

• F. Hoffmann-La Roche, Ltd.

• Hologic, Inc. (Gen Probe)

• Abbott

• Quidel Corporation

• Siemens Healthineers AG

• Bio-Rad Laboratories, Inc.

• Danaher Corporation

• OraSure Technologies, Inc.

Infectious Disease In Vitro Diagnostics (IVD) Market Report Scope

Global Infectious Disease In Vitro Diagnostics (IVD) Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the infectious disease in vitro diagnostics (IVD) market on the basis of product, technology, application, test location and regions

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • 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

  • Software 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 Billion, 2018 - 2030)

  • Immunoassay

  • Molecular Diagnostics

    • Polymerase Chain Reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips And Microarrays

    • Sequencing & NGS

    • Transcription Mediated Amplification

    • Others

  • Microbiology

  • Others

• Application Outlook (Revenue, USD Billion, 2018 - 2030)

  • 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

• Test Location Outlook (Revenue, USD Billion, 2018 - 2030)

  • Point of Care

  • Central Laboratories

  • Others

• Regional Outlook (Revenue, USD Billion; 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia

    • Kuwait