- Home
- »
- Clinical Diagnostics
- »
-
Infectious Disease In Vitro Diagnostics Market Report, 2033GVR Report cover
![Infectious Disease In Vitro Diagnostics Market (2026 - 2033)Report]()
Infectious Disease In Vitro Diagnostics Market (2026 - 2033)
Size, Share & Trends Analysis Report By Product (Instruments, Reagents, Software), By Technology (Immunoassay, Molecular diagnostics, Microbiology), By Application, By Test Location, By Region, And Segment Forecasts
Market Size, 2025
$24.7BMarket Estimate, 2026
$25.3BMarket Forecast, 2033
$30.2BCAGR, 2026–2033
2.6%Infectious Disease In Vitro Diagnostics Market Summary
The global infectious disease in vitro diagnostics market size was valued at USD 24.7 billion in 2025 and is projected to grow from USD 25.3 billion in 2026 to USD 30.2 billion by 2033, at a CAGR of 2.6% from 2026 to 2033. North America dominated the market, accounting for a revenue share of 39.5% in 2025. The growing geriatric population susceptible to infectious diseases, rising awareness about early testing, high demand for PoC testing owing to the pandemic, and rising prevalence of infectious diseases are key factors driving the market over the forecast period.
Key Market Trends & Insights
- By product: Reagents segment dominated the market, with a revenue share of 68.0% in 2025.
- By technology: Immunoassay segment held the largest market share of 35.9% in 2025.
- By application: COVID-19 segment held the largest revenue share of 12.5% in 2025.
- By test location: Central laboratories segment accounted for the largest revenue share of 46.9% in 2025.
Regional Highlights
- Largest regional market: North America (39.5% revenue share, 2025)
- Fastest-growing regional market: Asia Pacific (highest CAGR, 2026-2033)
- By country: The U.S. held the largest market share in 2025.
Market Size & Forecast
- Market size in 2025: USD 24.7 Billion
- Estimated market size in 2026: USD 25.3 Billion
- Projected market size by 2033: USD 30.2 Billion
- CAGR (2026-2033): 2.6%
The industry witnessed a paradigm shift during the pandemic due to the launch of novel and innovative products for SARS-CoV-2 testing. It amplified the adoption of these products, resulting in the exponential growth of the industry in recent years.
The growing geriatric population globally and numerous untapped opportunities in developing countries are factors expected to propel the infectious disease in vitro diagnostics industry growth during the forecast period. For instance, in December 2024, a Moroccan biotech firm Moldiag launched Africa's first domestically produced mpox test kits, marking a significant step toward reducing the continent's reliance on imported medical supplies. The testing kits were developed in response to the World Health Organization declaring mpox a global emergency. The Africa CDC has approved the tests for USD 5 and is distributing them across Burundi, Uganda, Congo, Senegal, and Nigeria. The rising prevalence of infectious diseases is a major factor driving steep revenue generation. In addition, aged people have to be tested regularly to avoid severe infections, which creates growth opportunities for in Vitro Diagnostic (IVD) tests in countries such as Russia, Japan, Germany, and the U.S., which have higher elderly populations globally.
Furthermore, 40% of HIV cases are transmitted by people unaware of their positive status. This demonstrates an unmet need for diagnostic tests for HIV. The acquisition, expansion, and new product development are becoming a prominent strategy for growth and portfolio diversification. For instance, in November 2024, QIAGEN announced that it is expanding its operations by establishing a new Esplugues de Llobregat facility near Barcelona, Spain, set to open in early 2026. This 8,000-square-meter site will serve as a global innovation hub for the QIAstat-Dx system, which is used for rapid syndromic testing to identify illnesses such as respiratory, gastrointestinal, and meningitis/encephalitis conditions. Moreover, in January 2025, bioMérieux, a global leader in IVDs, announced the acquisition of Norwegian diagnostics firm SpinChip Diagnostics ASA for USD 154.57 million to improve its point-of-care testing capabilities. SpinChip's innovative benchtop analyzer delivers lab-quality results from whole blood samples within 10 minutes. In addition, the availability of at-home collection and self-testing kits reduces patient visits to clinics and supports patient discretion. In November 2023, the U.S. FDA approved an at-home test for chlamydia and gonorrhea for early detection of these sexually transmitted infections.
Market Dynamics
The infectious disease in vitro diagnostics market continues to evolve as healthcare systems prioritize rapid pathogen detection, antimicrobial resistance surveillance, and expansion of routine diagnostic testing to improve clinical decision making and strengthen public health preparedness. Growing adoption of molecular diagnostics, immunoassays, microbiology testing, and automated laboratory workflows is improving diagnostic accuracy while enhancing laboratory efficiency across hospitals, reference laboratories, and public health institutions. Although testing volumes normalized following the exceptional demand generated during the COVID 19 pandemic, sustained investments in laboratory modernization, infectious disease surveillance, and decentralized diagnostic services continue to support stable market growth. Recent regulatory approvals are further strengthening the commercialization of advanced infectious disease diagnostic solutions. For instance, in February 2025, bioMérieux received U.S. FDA clearance for the BIOFIRE FILMARRAY Gastrointestinal Panel Mid, a multiplex PCR assay capable of detecting 11 of the most common bacterial, viral, and parasitic pathogens associated with gastroenteritis from a single patient sample within approximately one hour. The approval expanded the company's molecular diagnostics portfolio and supported broader adoption of rapid syndromic testing across clinical laboratories. Such developments continue to strengthen diagnostic capabilities while supporting sustained growth across the infectious disease in vitro diagnostics market.
The increasing adoption of automated molecular diagnostics and syndromic testing platforms is a key factor driving the growth of the infectious disease in vitro diagnostics market. Healthcare providers are expanding investments in integrated diagnostic systems that enable rapid pathogen identification, improve laboratory efficiency, and support timely clinical decision making across hospitals and reference laboratories. Rising testing volumes associated with respiratory infections, healthcare associated infections, sexually transmitted diseases, antimicrobial resistance, and emerging infectious diseases are further accelerating the transition toward high throughput and automated diagnostic workflows. Continuous improvements in multiplex testing technologies, laboratory digitalization, and sample to answer platforms are also strengthening diagnostic capabilities while reducing turnaround times. Recent strategic investments further demonstrate the industry's focus on expanding infectious disease diagnostic capabilities. For instance, in February 2025, Quest Diagnostics acquired select laboratory assets of Spectra Laboratories, expanding its diagnostic testing network and strengthening its capacity to deliver specialized laboratory services, including infectious disease diagnostics, across a broader healthcare customer base. This expansion is expected to improve testing accessibility, increase laboratory capacity, and support sustained growth of the infectious disease in vitro diagnostics market.
The infectious disease in vitro diagnostics market continues to face challenges associated with the high cost of advanced molecular diagnostic systems, laboratory automation, and multiplex testing platforms, particularly across low- and middle-income countries. The adoption of sophisticated diagnostic technologies often requires substantial capital investment, specialized laboratory infrastructure, skilled personnel, and ongoing maintenance, creating barriers for smaller healthcare facilities and resource constrained laboratories. In addition, variations in reimbursement policies, regulatory requirements, and healthcare funding across different regions continue to limit the widespread implementation of advanced infectious disease diagnostics. These challenges can delay technology adoption despite the growing clinical demand for rapid and accurate testing. Limited access to quality assurance programs, inconsistent laboratory standardization, and shortages of trained diagnostic professionals further constrain the effective deployment of advanced testing technologies. As a result, disparities in diagnostic capacity and healthcare infrastructure continue to moderate the pace of market expansion, particularly in resource constrained healthcare systems.
The increasing integration of molecular diagnostics, microbiology, laboratory automation, and digital diagnostic technologies is creating substantial opportunities for growth in the infectious disease in vitro diagnostics market. Healthcare systems are investing in advanced diagnostic platforms that improve laboratory efficiency, expand testing capacity, and support comprehensive infectious disease surveillance. Growing emphasis on decentralized testing, antimicrobial resistance monitoring, and rapid syndromic diagnostics is further encouraging manufacturers to develop integrated solutions capable of supporting diverse clinical applications across hospitals, reference laboratories, and public health institutions. Strategic industry consolidation is also accelerating innovation by combining complementary diagnostic technologies and expanding global commercial capabilities. For instance, in February 2026, BD completed the combination of its Biosciences and Diagnostic Solutions business with Waters Corporation, creating an expanded life sciences and diagnostics company with strengthened capabilities across molecular diagnostics, microbiology, laboratory automation, and analytical technologies. This strategic combination is expected to accelerate product innovation, enhance laboratory workflow solutions, and create new opportunities for the adoption of advanced infectious disease in vitro diagnostic technologies worldwide.
Market Concentration & Characteristics
The growth stage is low, and the pace of the market growth is accelerating. The industry is characterized by a high degree of innovation owing to the rapid technological advancements driven by increasing development of novel molecular diagnostics & immunoassays and point-of-care tests for infectious diseases. Moreover, market players are continuously involved in the development of novel POC testing products to capture the market opportunities.
The industry is also characterized by a high level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to gain access to new regions and technologies and the need to consolidate in a rapidly growing market.
The industry is also subject to increasing regulatory scrutiny. The regulatory framework for product approvals has always been one of the major restraining factors in the clinical diagnostic industry. The regulatory framework for the diagnostic sector is very stringent in countries where the market has a high potential to grow due to the availability of a large patient pool. Such a discrete and uncertain regulatory scenario for IVDs products creates confusion among manufacturers regarding commercialization.
There are a very limited number of direct substitute products and services for IVDs. The use of imaging tools to monitor infections can, to some extent, hamper the market's growth. However, IVD tests for infectious diseases overcome the threat of substitutes due to their accuracy and cost-effectiveness.
End use concentration is a significant factor in the market. The presence of several end users, such as hospitals, clinics, laboratories, and patients, is driving the demand for IVD tests. Moreover, increasing demand for rapid and self-tests for multiple infectious diseases creates new market opportunities for market players in different end-use applications.
Analyst Perspective
The infectious disease in vitro diagnostics market is transitioning from pandemic driven testing demand to sustainable long-term growth supported by routine infectious disease surveillance, molecular diagnostics, and laboratory modernization. Increasing adoption of multiplex testing, automated laboratory workflows, and point of care diagnostics is improving testing efficiency while enabling earlier disease detection and better clinical decision making. Growing investments in antimicrobial resistance monitoring and public health preparedness are further strengthening market demand. Although high implementation costs and infrastructure limitations remain challenges in some regions, continuous technological innovation, expanding diagnostic accessibility, and increasing healthcare investments are expected to support steady market expansion throughout the forecast period.
Product Insights
Based on products, the reagents segment led the market with the largest revenue share of 68.0% in 2025 and anticipated to grow at fastest CAGR over the forecast period. This can be attributed to the high-volume usage of reagents and test kits for the diagnosis of infectious diseases. Moreover, the COVID-19 testing programs to screen SARS-CoV-2 infection, are escalating the usage of reagents. For instance, as of May 2023, the U.S. FDA approved 449 tests and collection devices for COVID-19 infection detection. Out of the 449 products available in the market, around 116 can be used as OTC or the samples can be collected at home.
Rapid innovation is becoming a key factor in the focus on achieving a competitive edge. For instance, in February 2024, the Diagnostic Microbiology and Infectious Disease cited that identifying and diagnosing pathogenic microorganisms and viruses has significantly evolved with the adoption of advanced molecular techniques in clinical microbiology labs. Next-generation sequencing (NGS), which focuses on detecting nucleic acids and genetic profiling, has brought significant transformation in identifying infectious agents. Consumer demands in the software segment are evolving continuously; the use of the software is not limited to laboratories. Some consumers prefer cloud computing, while others opt for concierge services and need a team of professionals for software management. In January 2023, QIAGEN launched EZ2 Connect MDx platform to propel its automation capabilities in sample processing.
Technology Insights
Based on technology, the immunoassay segment led the market with the largest revenue share of 35.9% in 2025. Companies are focusing on the development and commercialization of immunoassays for infectious diseases due to increased demand for rapid tests. In June 2024, MP Biomedicals completed its infectious disease diagnostic test series with advanced rapid immunochromatographic tests. These new diagnostic kits offer accurate and fast detection of Helicobacter pylori, Salmonella typhi, and Vibrio cholerae (O1 and O139), improving gastrointestinal diagnostics. Hence, the use of immunoassays to detect different infectious diseases is expected to increase in the coming years.
The microbiology technology segment is expected to increase over the forecast period. This can be attributed to the rising global incidence of infectious diseases, such as tuberculosis, HIV, and hepatitis, and emerging viral threats like COVID-19 and monkeypox. Growing awareness among patients and healthcare providers about the importance of early disease detection contributes to the increased use of infectious disease IVDs. Moreover, key players are engaged in launching novel instruments and expanding their product portfolios for microbiology technology. For instance, in June 2024, QIAGEN launched digital PCR Microbial DNA Detection Assays to enable a timely response during public health emergencies or health crises, such as infectious disease outbreaks. These assays provide highly accurate and sensitive pathogen detection, supporting quick intervention measures and effectively monitoring disease transmission.
Application Insights
Based on application, the COVID-19 segment led the market with the largest revenue share of 12.5% in 2025. 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 and government initiatives to enhance public testing. Moreover, the introduction of rapid combination tests for multiple infections is expected to support segment growth over the forecast period. For instance, in June 2024, Roche announced that it received Emergency Use Authorization (EUA) from the U.S. FDA for its cobas liat SARS-CoV-2, Influenza A/B, and RSV nucleic acid test. This automated, real-time PCR test can detect multiple viruses at once, including COVID-19, flu A and B, and RSV, using the cobas liat system.
HIV is projected to witness the fastest growth rate over the forecast period. Increasing introduction of novel tests, high prevalence of HIV, and rising initiatives by market players to improve access to cost-effective HIV tests are anticipated to drive the segment growth. For instance, in February 2023, Thermo Fisher Scientific Inc. partnered with MyLab to procure RT-PCR kits for various infectious diseases, such as tuberculosis & HIV. Moreover, self-testing kits for HIV are attracting more customers.
Test Location Insights
Based on test location, the central laboratories companies segment led the market with the largest revenue share of 46.9% in 2025. Laboratory-based tests ensure higher accuracy when compared to point-of-care tests, which makes them reliable. 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. Most of the key market players offer laboratory-based molecular diagnostic solutions across the globe, and these players are continuously involved in developing novel molecular diagnostic tests. In April 2023, EliTech announced its plan to launch EliVerse, a high-throughput molecular diagnostics instrument, in the Europe infectious disease in vitro diagnostics industry in 2024.
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 give the products of this segment a competitive edge. Increasing demand for patient-centric healthcare services and growing adoption of technologically advanced testing products at point-of-care facilities, such as clinics and retail pharmacies, are further projected to drive the market expansion over the forecast period. For instance, in February 2023, Huwel Lifesciences designed a portable RT-PCR machine to test types of viruses.
Regional Insights
North America dominated the infectious disease in vitro diagnostics market with the largest revenue share of 39.5% in 2025. The region is expected to expand further at a lucrative rate over the forecast period. The presence of a favorable & flexible regulatory framework, the presence of major infectious disease in vitro diagnostics industry players offering novel IVD products, and the focus on increasing disease surveillance by conducting more tests are major drivers of the regional market. For instance, in March 2023, BD received 510(k) clearance from U.S. FDA for the BD Vaginal Panel on the BD COR System to detect infectious causes of vaginitis.
U.S. Infectious Disease In Vitro Diagnostics Market Trends
The infectious disease in vitro diagnostics market in the U.S. held the largest share in the North America region in 2025. The COVID-19 outbreak dramatically changed the market landscape, as companies were engaged in developing tests with quicker turnaround times and efficacy. Post-pandemic, other infectious disease segments, such as respiratory, flu, and STIs, are garnering a higher share.
Europe Infectious Disease In Vitro Diagnostics Market Trends
The infectious disease in vitro diagnostics market in Europe was identified as a lucrative region in this industry. New IVD regulations are estimated to present a more robust and sustainable framework for compliance with IVD devices. IVD infectious disease tests are launched at various conferences, symposiums, and other events to provide early visibility.
The UK infectious disease in vitro diagnostics market is expected to grow over the forecast period due to the presence of several key companies in the diagnostic industry, and significant awareness initiatives undertaken by the government and nonprofit organizations.
The infectious disease in vitro diagnostics market in France is expected to grow over the forecast period. Technological advancements, high disease prevalence & diagnosis rate, and product reach are factors expected to drive the market over the coming years.
Germany infectious disease in vitro diagnostics market is expected to grow over the forecast period due to the strong presence of several companies in Germany, such as Roche Diagnostics, QIAGEN, bioMérieux, Siemens Healthineers, and Agilent Technologies, involved in the development of IVD infectious disease panels & reagents, stringent regulations, and government support
Asia Pacific Infectious Disease In Vitro Diagnostics Market Trends
The infectious disease in vitro diagnostics market in Asia Pacific is anticipated to witness significant growth in the infectious disease IVD market. This growth can be attributed to the high prevalence of infectious diseases and growing healthcare access in emerging economies, such as India and China. The high geriatric population in countries such as Japan also drives the adoption of IVD tests. The rapid economic development in the region and the presence of emerging market players are expected to increase the adoption of novel tests for infectious disease diagnostics in the region.
China infectious disease in vitro diagnostics market is expected to grow over the forecast period. Increased need for early diagnosis, high focus on developing instruments with novel technologies, and a rising number of collaborations between key companies & private laboratories are factors driving the market.
The infectious disease in vitro diagnostics market in Japan is expected to grow over the forecast period, owing to various initiatives undertaken by the government, favorable reimbursement scenarios, and major key players operating in the U.S. expanding in Asia Pacific countries such as Japan.
Latin America Infectious Disease In Vitro Diagnostics Market Trends
The infectious disease in vitro diagnostics market in Latin America is primarily driven by government focus on improving regulatory reforms & reimbursement scenarios, increasing patient awareness, and rising investment and funding for developing products with faster turnaround time.
Brazil infectious disease in vitro diagnostics market is expected to grow over the forecast period due to the rising prevalence of chronic diseases in the country, due to the moderate standards of living, further increasing the need for advanced diagnostic and treatment options.
Middle East and Africa Infectious Disease In Vitro Diagnostics Market Trends
The infectious disease in vitro diagnostics market in the Middle East and Africa was identified as a lucrative region in this industry. The increasing prevalence of chronic diseases created a significant need for enhanced diagnostic tools and therapeutic alternatives in the country.
Saudi Arabia infectious disease in vitro diagnostics market is expected to grow over the forecast period owing to the rapid launch of new products in the region, the increasing number of government initiatives, and the rising prevalence of infectious diseases.
Key Infectious Disease in Vitro Diagnostics Companies Insights
Key players operating in the infectious disease in vitro diagnostics market are undertaking various initiatives to strengthen their presence and increase the reach of their products and services. Strategies such as expansion activities and partnerships are key in propelling the market growth.
Key Infectious Disease in Vitro Diagnostics Companies:
The following key companies have been profiled for this study on the infectious disease in vitro diagnostics market.
-
QIAGEN
-
BD
-
bioMérieux SA
-
F. Hoffmann-La Roche, Ltd.
-
Hologic, Inc. (Gen Probe)
-
Abbott
-
Quidel Corporation
-
Siemens Healthineers AG
-
Bio-Rad Laboratories, Inc.
-
Danaher
-
OraSure Technologies, Inc.
Competitive Benchmarking
Category
Operating Strategies
Competitive Edge
Weakness
Well Established Players (F. Hoffmann-La Roche Ltd., Abbott, Danaher, Siemens Healthineers AG, BD, bioMérieux SA, QIAGEN)
- Expand infectious disease diagnostic portfolios through molecular diagnostics, immunoassays, microbiology platforms, syndromic testing, laboratory automation, and digital diagnostic solutions. Focus on product innovation, regulatory approvals, strategic collaborations, acquisitions, and expansion of decentralized and high throughput testing capabilities to strengthen global market presence.
- Extensive infectious disease testing portfolios established global distribution networks, strong regulatory expertise, broad installed instrument base, advanced research and development capabilities, and integrated laboratory solutions. Ability to support hospitals, reference laboratories, public health agencies, and point of care settings through comprehensive diagnostic platforms, consumables, software, and technical services.
- Large organizational structures may increase product development and commercialization timelines. Premium pricing, complex regulatory requirements, and dependence on reimbursement policies may limit adoption in price sensitive and resource constrained healthcare markets.
Emerging Players (Hologic, Inc. (Gen Probe), Quidel Corporation, Bio-Rad Laboratories, Inc., OraSure Technologies, Inc.)
- Focus on expanding molecular diagnostics, rapid point of care testing, home based infectious disease diagnostics, multiplex assay development, and strategic partnerships to strengthen product portfolios. Emphasize innovation in decentralized testing, workflow simplification, digital connectivity, and expansion into underserved infectious disease applications.
- Specialized expertise in rapid infectious disease diagnostics, flexible product development, faster commercialization, and strong focus on decentralized and point of care testing solutions. Ability to address evolving diagnostic needs through targeted molecular assays, rapid antigen testing, self-collection technologies, and home testing platforms.
- Comparatively narrower product portfolios, smaller global commercial footprint, and limited manufacturing scale relative to multinational diagnostics companies. Dependence on selected product categories and regional markets may limit competitiveness across the broader infectious disease diagnostics landscape.
Recent Developments
-
In December 2024, OraSure Technologies, a leader in point-of-care and other diagnostic tests, acquired Sherlock Biosciences, a global health company, to improve its diagnostic offerings, particularly in molecular diagnostics. Sherlock's first asset is the rapid, over-the-counter self-test for Chlamydia and Gonorrhea, delivering results in under 30 minutes using isothermal amplification from self-collected swabs.
-
In October 2024, Quest Diagnostics secured several contracts from the U.S. Centers for Disease Control and Prevention (CDC) to support testing capabilities for two emerging infectious diseases: H5 avian influenza and the Oropouche virus. Under these agreements, Quest will launch a new molecular diagnostic test for the H5N1 strain of bird influenza by the end of October 2024, available by prescription and conducted at its San Juan Capistrano, California laboratory.
-
In March 2024, SEKISUI Diagnostics, a global leader in medical diagnostics manufacturing, obtained EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test. It is approved for use in both professional and home testing settings.
-
In April 2023, EliTech announced its plan to launch ELITe InGenius in 2024. EliVerse is a novel high-throughput molecular diagnostics instrument for more than 50 CE-IVD parameters.
Infectious Disease In Vitro Diagnostics Market Report Scope
Report Attribute
Details
Market size in 2025
USD 24.7 billion
Estimated market size in 2026
USD 25.3 billion
Projected market size by 2033
USD 30.2 billion
Growth rate
CAGR of 2.6% from 2026 to 2033
Historical data
2021 - 2024
Forecast period
2026 - 2033
Quantitative units
Revenue in USD billion and CAGR from 2026 to 2033
Report coverage
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Segments covered
Product, technology, application, test location, region
Regional scope
North America; Europe; Asia Pacific; Latin America; MEA
Country scope
U.S.; Canada; Mexico; Germany; UK; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; South Korea; Australia; Thailand; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait
Key companies profiled
QIAGEN, BD, bioMérieux SA, F. Hoffmann-La Roche Ltd., Hologic, Inc. (Gen-Probe), Abbott, Quidel Corporation, Siemens Healthineers AG, Bio-Rad Laboratories, Inc., Danaher, OraSure Technologies, Inc.
Customization scope
Free report customization (equivalent up to 8 analysts' working days) with purchase. Addition or alteration to country, regional & segment scope.
Pricing and purchase options
Avail customized purchase options to meet your exact research needs. Explore purchase options
Global Infectious Disease In Vitro Diagnostics Market Report 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-segments from 2021 to 2033. For this study, Grand View Research has segmented the global infectious disease in vitro diagnostics market report based on products, technology, application, test location, and region:
-
Product Outlook (Revenue, USD Billion, 2021 - 2033)
-
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
-
Other Infectious Diseases
-
-
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
-
Other Infectious Diseases
-
-
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
-
Other Infectious Diseases
-
-
-
Technology Outlook (Revenue, USD Billion, 2021 - 2033)
-
Immunoassay
-
Molecular diagnostics
-
Microbiology
-
Others
-
-
Application Outlook (Revenue, USD Billion, 2021 - 2033)
-
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
-
Other Infectious Diseases
-
-
Test Location Outlook (Revenue, USD Billion, 2021 - 2033)
-
Point of Care
-
Central Laboratories
-
Others
-
-
Regional Outlook (Revenue, USD Billion, 2021 - 2033)
-
North America
-
U.S.
-
Canada
-
Mexico
-
-
Europe
-
Germany
-
UK
-
Spain
-
France
-
Italy
-
Denmark
-
Sweden
-
Norway
-
-
Asia Pacific
-
Japan
-
China
-
India
-
South Korea
-
Australia
-
Thailand
-
-
Latin America
-
Brazil
-
Argentina
-
-
Middle East and Africa (MEA)
-
South Africa
-
Saudi Arabia
-
UAE
-
Kuwait
-
-
Research Methodology
The infectious disease in vitro diagnostics market figures in this report are based on a proven research process that combines executive interviews with secondary research from proprietary databases, company filings, and recognized regulatory and institutional sources. Market size is built through value-chain sizing - reconciling supply-side and demand-side estimates - and triangulated with bottom-up and top-down approaches. Every estimate passes multiple levels of expert validation before publication, with each ifectious disease in vitro diagnostics segment quantified using the revenue-capture definitions in the table below.
Segment Definition
Segment - Product
Revenue capture definition
Instruments
Revenue is primarily captured through molecular diagnostic analyzers, immunoassay systems, microbiology platforms, automated sample preparation instruments, nucleic acid extraction systems, blood culture analyzers, and integrated diagnostic equipment used for infectious disease detection and laboratory testing workflows.
Reagents
Revenue flows from assay kits, molecular reagents, PCR master mixes, primers, probes, antibodies, culture media, controls, calibrators, stains, and other consumables specifically designed for infectious disease detection, confirmation, and routine diagnostic testing across laboratory settings.
Software
Market value is derived from laboratory software platforms, diagnostic data management systems, workflow management solutions, instrument connectivity software, result interpretation applications, quality control software, and reporting solutions supporting infectious disease diagnostic operations and laboratory efficiency.
Segment - Technology
Revenue capture definition
Immunoassay
Revenue is primarily captured through immunoassay based infectious disease tests, including antigen, antibody, and serological assays, together with associated reagents, consumables, analyzers, and supporting software used for qualitative and quantitative pathogen detection.
Molecular Diagnostics
Market value is derived from nucleic acid based infectious disease testing technologies, including PCR, RT PCR, isothermal amplification, sequencing, multiplex molecular assays, related instruments, reagents, consumables, and software supporting pathogen detection and characterization.
Microbiology
Revenue flows from culture based diagnostics, microbial identification systems, antimicrobial susceptibility testing platforms, blood culture systems, microbiology reagents, culture media, consumables, and laboratory software used for infectious pathogen identification and resistance testing.
Others
Commercial demand is captured through infectious disease diagnostic technologies not classified under immunoassay, molecular diagnostics, or microbiology, including biosensor based assays, mass spectrometry, cytology, microscopy, and other emerging diagnostic platforms with related consumables and software.
Segment - Application
Revenue capture definition
MRSA
Revenue is primarily captured through diagnostic products whose primary clinical application is the detection, confirmation, screening, or surveillance of methicillin resistant Staphylococcus aureus infections. Multiplex assays are included only when MRSA is the principal intended target.
Streptococcus
Market value is derived from diagnostic products primarily intended for detecting Streptococcus infections, including Group A, Group B, and other clinically significant species. Multiplex assays are included only when streptococcal detection is the principal clinical application.
Clostridium difficile
Revenue flows from diagnostic products primarily intended for the detection and diagnosis of Clostridioides difficile infection. Multiplex gastrointestinal assays are included only when C. difficile represents the primary intended clinical application.
VRE
Commercial demand is captured through diagnostic products primarily intended for the detection and surveillance of vancomycin resistant Enterococcus infections. Broader antimicrobial resistance assays are excluded unless VRE represents the principal clinical indication.
CRE
Market revenue is attributed to diagnostic products primarily intended for detecting carbapenem resistant Enterobacterales and related carbapenem resistant bacterial infections. Broad antimicrobial resistance diagnostics are classified according to their principal intended application.
Respiratory Virus
Revenue is primarily captured through diagnostic products primarily intended for detecting respiratory viral infections excluding those principally classified under COVID 19 testing. Multiplex respiratory panels are included only when non COVID respiratory viruses are the primary indication.
Candida
Revenue streams originate from diagnostic products primarily intended for detecting Candida infections across invasive and noninvasive clinical settings. Diagnostic products designed principally for other fungal pathogens are excluded from this segment.
TB and Drug Resistant TB
Market value is generated through diagnostic products primarily intended for detecting Mycobacterium tuberculosis complex and associated drug resistance markers. Products assigned to broader respiratory disease testing are excluded unless tuberculosis is the primary application.
Gastrointestinal Panel Testing
Revenue is captured through multiplex syndromic diagnostic products primarily intended for simultaneous detection of gastrointestinal pathogens associated with infectious gastroenteritis. Individual pathogen assays are excluded unless gastrointestinal panel testing is the principal intended application.
Chlamydia
Commercial revenue is derived from diagnostic products primarily intended for detecting and managing Chlamydia trachomatis infection. Multiplex sexually transmitted infection assays are included only when chlamydia represents the principal clinical indication.
Gonorrhea
Revenue is primarily obtained from diagnostic products primarily intended for detecting Neisseria gonorrhoeae infection. Multiplex sexually transmitted infection assays are classified within this segment only when gonorrhea is the primary intended clinical application.
HPV
Market revenue flows from diagnostic products primarily intended for detecting and managing human papillomavirus infection, including screening, genotyping, and confirmatory testing. Cytology procedures performed without HPV diagnostic testing are excluded.
HIV
Commercial value is captured through diagnostic products primarily intended for HIV screening, confirmation, viral load monitoring, disease staging, and treatment management. Diagnostic products intended for opportunistic infections are excluded from this segment.
Hepatitis C
Revenue is generated through diagnostic products primarily intended for detecting, confirming, and monitoring hepatitis C virus infection. Products principally designed for hepatitis B or other viral hepatitis applications are excluded.
Hepatitis B
Market demand is captured through diagnostic products primarily intended for detecting, confirming, and monitoring hepatitis B virus infection. Diagnostic products allocated to hepatitis C or other viral hepatitis applications are excluded.
COVID 19
Revenue is primarily captured through diagnostic products primarily intended for detecting, confirming, or monitoring SARS CoV 2 infection, including molecular, antigen, and serological assays. Multiplex panels are included only when COVID 19 is the primary indication.
Other Infectious Diseases
Commercial revenue is derived from diagnostic products intended for infectious diseases not separately classified within the defined applications, including vector borne, parasitic, fungal, tropical, zoonotic, and emerging infectious diseases not allocated elsewhere.
Segment - Test location
Revenue capture definition
Point of Care
Revenue is primarily captured through infectious disease diagnostic products performed at or near the patient care site, including portable analyzers, rapid molecular systems, lateral flow assays, cartridges, consumables, and associated software supporting immediate clinical decision making.
Central Laboratories
Market value is derived from infectious disease diagnostic testing performed within hospital, reference, public health, and independent laboratories using high throughput analyzers, laboratory automation systems, reagents, consumables, and laboratory information management software.
Others
Commercial demand is captured through infectious disease diagnostic testing performed outside point of care and central laboratories, including physician office laboratories, community clinics, mobile laboratories, pharmacies, home testing environments, and other decentralized testing settings.
Estimation Model
The Infectious Disease In Vitro Diagnostics market size was estimated by identifying leading manufacturers and benchmarking their infectious disease diagnostic product portfolios across instruments, reagents, and software. Revenue generated from key products was assessed and mapped to individual technologies and applications using existing market trends and patient uptake data. The revenues were then aggregated and validated by considering the market share of major industry participants to derive the overall market size.
Delivered Customizations
This report has been delivered with the following In-depth customizations
Client Request
Customization Delivered
Value Adds
Infectious Disease In Vitro Diagnostics Competitive Landscape & Technology Assessment
Assessed the global infectious disease in vitro diagnostics market across molecular diagnostics, immunoassays, microbiology, point of care diagnostics, laboratory automation, and digital diagnostic solutions. Evaluated competitive positioning, product portfolios, technology advancements, strategic developments, and adoption trends across hospitals, reference laboratories, public health agencies, and decentralized healthcare settings.
Helped the client identify technology adoption opportunities, benchmark competitive capabilities, evaluate product differentiation, prioritize strategic investments, and assess market expansion opportunities across the infectious disease diagnostics industry.
Infectious Disease In Vitro Diagnostics Product & Technology Benchmarking Study
Delivered comprehensive benchmarking of infectious disease diagnostic platforms across molecular diagnostics, immunoassays, microbiology systems, rapid diagnostics, laboratory software, and workflow automation solutions. Assessed technology performance, diagnostic accuracy, throughput, workflow efficiency, automation capabilities, ease of integration, and product differentiation among leading market participants.
Enabled the client to evaluate technology competitiveness, identify innovation opportunities, benchmark product development strategies, and prioritize investments in molecular diagnostics, laboratory automation, syndromic testing, and point of care diagnostic technologies.
Infectious Disease In Vitro Diagnostics Laboratory Adoption & Commercialization Assessment
Assessed healthcare infrastructure, infectious disease testing trends, laboratory modernization initiatives, public health surveillance programs, reimbursement landscape, regulatory environment, procurement practices, and decision-making pathways influencing the adoption of infectious disease diagnostic solutions across major regional markets.
Supported commercialization planning by identifying market opportunities, evaluating customer adoption patterns, assessing operational and technical challenges, determining commercialization risks, and strengthening long-term strategic relationships among diagnostic laboratories, public health institutions, and healthcare providers.
Frequently Asked Questions About This Report
The global infectious disease in vitro diagnostics market size was valued at USD 24.7 billion in 2025 and is estimated to reach USD 25.3 billion in 2026.
The global infectious disease in vitro diagnostics market is projected to grow at a compound annual growth rate of 2.6% from 2026 to 2033 to reach USD 30.2 billion in 2033.
North America dominated the Infectious Disease In Vitro Diagnostics Market with the largest revenue share of 39.5% in 2025.
The infectious disease in vitro diagnostics market in Asia Pacific is anticipated to witness significant growth in the infectious disease IVD market. This growth can be attributed to the high prevalence of infectious diseases and growing healthcare access in emerging economies, such as India and China.
Based on technology, the Immunoassay segment led the market with the largest revenue share of 35.9% in 2025. The region is expected to expand further at a lucrative rate over the forecast period.
Based on application, the COVID-19 segment led the market with the largest revenue share of 12.5% in 2025. 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 and government initiatives to enhance public testing.
The reagents segment dominated the global infectious diseases IVD market and accounted for the largest revenue share of 68.0% in 2025. This can be attributed to the high-volume usage of reagents for conducting tests.
The central laboratories segment dominated the global infectious diseases IVD market and held the largest revenue share of 46.9% in 2025. Attributable to higher accuracy when compared to point-of-care tests, which makes them reliable.
Based on technology, the immunoassay segment led the market with the largest revenue share of 35.9% in 2025.
About the Author(s)
Clinical Diagnostics Research Team
Healthcare · Clinical DiagnosticsThis report was authored by the clinical diagnostics research team at Grand View Research - comprising two research analysts, one senior research analyst, and one industry expert - with specialized expertise in the clinical diagnostics segment of the healthcare industry. All findings are based on proprietary healthcare databases, executive interviews, and regulatory analysis, subject to internal peer review prior to publication.
Last Updated:
Speak to Analyst
Customize this report to your needs — add regions, segments, or data points, with 20% free customization.
Or view our licence options:
ISO 9001:2015 & 27001:2022 Certified
We are GDPR and CCPA compliant! Your transaction & personal information is safe and secure. For more details, please read our privacy policy.
