Infectious Disease In Vitro Diagnostics Market (By Product: Instruments, Reagents; By Application: HPV, HIV; By Technology; By Test Location) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022-2030

The global infectious disease in vitro diagnostics market was surpassed at USD 113.7 billion in 2021 and is expected to hit around USD 56.89 billion by 2030, growing at a CAGR of -7.41% from 2022 to 2030.

Report Highlights

• The reagents segment held the highest share of more than 66.4% of the overall revenue in 2021. 
• The COVID-19 application segment dominated the global industry in 2021 and accounted for the highest share of more than 42.52% of the overall revenue. 
• The central laboratories test location segment dominated the global industry in 2021 and accounted for the highest share of more than 54.96% of the overall revenue.
• The molecular diagnostics technology segment dominated the global industry in 2021 and held the highest share of more than 44.78% of the overall revenue. 
• North America dominated the global industry in 2021 and accounted for the maximum share of more than 42.36% of the overall revenue. 

The rising prevalence of infectious diseases, such as tuberculosis & COVID-19, and technological advancements are projected to drive the product demand in the coming years. The rising prevalence of multi-drug resistant infections is enhancing the early diagnosis of infectious diseases. For instance, MDR infections are highly common in ICU patients, as per the Microbial Drug Resistance Journal in 2021, the prevalence of MDR infections in critically ill SARS-CoV-2 patients ranged between14% and 50%.

The delay in diagnosis and treatment with antibiotics before infection diagnosis is further escalating the prevalence of drug resistant-bacteria, creating a lucrative opportunity for industry growth. The industry is witnessing a significant number of product launches to meet the demands of consumers. For instance, in May 2022, BD introduced its automated diagnostic platform for infectious diseases in the U.S. The system allows the loading of 1700 specimens and the need for specimen sorting is also eliminated, thereby, reducing errors. Products offered by various competitors have been strategically priced to increase competitive rivalry.

However, complexity in buying behavior increases prominently when consumers have to choose between PoC and lab-based tests owing to differences in sensitivity and beliefs. The industry is oligopolistic with companies, such as Hoffmann-La Roche Ltd., Alere, bioMérieux, and BD, holding the majority of the share collectively. The global industry is price-sensitive, creating rigorous competition among players in terms of manufacturing cost-effective and efficient products. Competitive rivalry is estimated to increase during the forecast period owing to the expected launch of novel biomarker kits. Competitors are adopting key strategies, such as product launches and organizing awareness programs, to gain higher market shares.

Scope of The Report

Product Insights

The reagents segment held the highest share of more than 66.4% of the overall revenue in 2021. 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 the global industry in 2021 and accounted for the highest share of more than 42.52% of the overall revenue. 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 2020, the incidence of tuberculosis is 130 new cases per 100,000 each year and is an epidemic; 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 test location segment dominated the global industry in 2021 and accounted for the highest share of more than 54.96% 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 technology segment dominated the global industry in 2021 and held the highest share of more than 44.78% of the overall revenue. 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 immunoassay technology segment is estimated to expand at a steady CAGR from 2022 to 2030. 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 novel coronavirus, is anticipated to boost the industry growth.

Regional Insights

North America dominated the global industry in 2021 and accounted for the maximum share of more than 42.36% of the overall revenue. 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 2022 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 Players

• QIAGEN
• BD
• bioMérieux SA
• F. Hoffmann-La Roche, Ltd.
• Hologic, Inc. (Gen-Probe)
• Abbott
• Quidel Corp.
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Danaher Corp.
• OraSure Technologies, Inc.

Market Segmentation

• By Product Outlook
• Instruments

• MRSAs
• 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
• 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
• By Technology Outlook
• 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
• By Application Outlook
• 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
• By Test Location Outlook
• Point of Care
• Central Laboratories
• Others
• By Regional Outlook
• 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