Global Infectious Disease In Vitro Diagnostics Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Instruments, Reagents, and SoftwareBy Technology;
Immunochemistry, Microbiology, and Molecular DiagnosticsBy Test Location;
Point of Care, Central Laboratories, and OthersBy Application;
MRSA, Streptococcus, Clostridium Difficile , Vancomycin-Resistant Enterococci, Carbapenem-Resistant Bacteria Testing, Respiratory Virus, Candida, Tuberculosis and Drug-Resistant TB, Gastro-Intestinal Panel Testing, Chlamydia, Gonorrhea, HPV, HIV, Hepatitis C, Hepatitis B, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Infectious Disease In Vitro Diagnostics Market Overview
Infectious Disease In Vitro Diagnostics Market (USD Million)
Infectious Disease In Vitro Diagnostics Market was valued at USD 2,079.00 million in the year 2024. The size of this market is expected to increase to USD 2,944.93 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 5.1%.
Global Infectious Disease In Vitro Diagnostics Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 5.1 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 5.1 % |
Market Size (2024) | USD 2,079.00 Million |
Market Size (2031) | USD 2,944.93 Million |
Market Concentration | Medium |
Report Pages | 390 |
Major Players
- 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
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Infectious Disease In Vitro Diagnostics Market
Fragmented - Highly competitive market without dominant players
The increasing prevalence of infectious diseases is a major catalyst for the growth of in vitro diagnostics (IVD). These diagnostic tools have become essential for early detection and efficient disease control. As the global healthcare community focuses more on rapid and accurate diagnostic methods, IVD solutions are witnessing significant demand for their ability to deliver precise results quickly.
Shift Toward Preventive and Personalized Healthcare
Healthcare systems are increasingly prioritizing preventive care and personalized treatment strategies, and this is strongly reflected in the rise of infectious disease testing within the IVD sector. Currently, such diagnostics contribute to over 30% of all IVD applications. Molecular diagnostic technologies are being widely adopted to support tailored medical approaches, enabling clinicians to detect infections early and customize treatment plans more effectively.
Technological Innovations Enhancing Test Capabilities
Advanced technologies are reshaping the IVD landscape by offering enhanced performance, faster processing, and greater diagnostic accuracy. Innovations like real-time PCR, digital immunoassays, and lab-on-a-chip platforms have significantly boosted test sensitivity and reliability—by up to 25%. These improvements are crucial in ensuring timely and targeted treatment decisions in infectious disease management.
Regulatory and Industry Collaborations Accelerating Market Expansion
Strategic partnerships among diagnostics companies, regulators, and research organizations are playing a pivotal role in fast-tracking innovation and improving access. Regulatory pathways have been streamlined, cutting approval timelines by approximately 40%, especially during urgent health crises. These efforts are enabling the swift introduction of new diagnostic products, fostering robust growth in the infectious disease IVD market.
Infectious Disease In Vitro Diagnostics Market Recent Developments
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In November 2023, the U.S. Food and Drug Administration (FDA) granted approval for the first-ever at-home test designed for the early detection of chlamydia and gonorrhea. This breakthrough allows individuals to screen for these common sexually transmitted infections (STIs) without needing to visit a clinic or healthcare provider. The test provides a private, convenient, and accessible option, encouraging more people to take proactive steps toward their sexual health. With rising STI rates, this innovation is expected to improve early diagnosis and treatment, helping to reduce transmission and long-term complications. -
In February 2023, Thermo Fisher Scientific Inc. announced a strategic partnership with MyLab to enhance the availability of RT-PCR testing kits for the detection of multiple infectious diseases, including tuberculosis and HIV. This collaboration aims to strengthen diagnostic capabilities by delivering accurate and reliable test solutions across broader healthcare settings. By combining Thermo Fisher’s technological expertise with MyLab’s distribution network, the initiative supports faster disease identification and promotes timely treatment. The move is expected to boost access to high-precision molecular diagnostics, especially in resource-limited environments.
Infectious Disease In Vitro Diagnostics Market Segment Analysis
In this report, the Infectious Disease In Vitro Diagnostics Market has been segmented by Product, Technology, Test Location, Application, and Geography.
Infectious Disease In Vitro Diagnostics Market, Segmentation by Product
The Infectious Disease In Vitro Diagnostics Market has been segmented by Product into Instruments, Reagents and Software.
Instruments
Instruments dominate the infectious disease in vitro diagnostics market, holding approximately 45% of the total market share. These devices are essential for diagnostic testing, offering high accuracy and efficiency in detecting various infectious diseases. The increasing demand for point-of-care diagnostics and automated systems is driving the growth of this segment.
Reagents
Reagents contribute around 40% to the market. These chemical compounds are vital in the diagnostic process, used to detect pathogens or specific markers in blood and tissue samples. The growing prevalence of infectious diseases and the increasing need for rapid diagnostic tests are significantly boosting the demand for reagents.
Software
Software solutions in the diagnostics market make up about 15% of the market share. With the growing adoption of digital technologies in healthcare, diagnostic software plays a crucial role in interpreting test results, managing data, and improving workflow efficiency. As healthcare becomes increasingly data-driven, the software segment is expected to grow rapidly in the coming years.
Infectious Disease In Vitro Diagnostics Market, Segmentation by Technology
The Infectious Disease In Vitro Diagnostics Market has been segmented by Technology into Immunochemistry, Microbiology and Molecular Diagnostics.
Immunochemistry
Immunochemistry technology holds the largest share in the infectious disease in vitro diagnostics market, contributing approximately 50%. This method uses antibodies and antigens to detect and quantify disease markers, offering high specificity and sensitivity. The widespread adoption of immunoassays for detecting infectious agents is driving the growth of this segment.
Microbiology
Microbiology technology accounts for about 30% of the market. It involves the use of cultures and other diagnostic tools to identify microorganisms responsible for infectious diseases. The growing demand for microbiological tests, particularly for bacterial infections, is a key driver for this segment’s growth.
Molecular Diagnostics
Molecular diagnostics is a rapidly expanding segment, contributing approximately 20% to the market. This technology uses genetic material from pathogens to provide highly accurate and fast diagnoses. The increasing prevalence of infectious diseases, coupled with advancements in genomic technologies, is propelling the growth of molecular diagnostics.
Infectious Disease In Vitro Diagnostics Market, Segmentation by Test Location
The Infectious Disease In Vitro Diagnostics Market has been segmented by Test Location into Point of Care, Central Laboratories and Others.
Point of Care
Point of care diagnostics account for around 40% of the market share. The increasing demand for rapid, accessible diagnostic solutions in non-laboratory settings is accelerating growth. With advancements in technology, testing is now available in various locations, including healthcare clinics and even at home, contributing significantly to the expansion of this segment.
Central Laboratories
Central laboratories dominate the market, holding approximately 50% of the market share. These labs are critical for performing large-scale diagnostic tests and complex procedures. Their capacity to handle a high volume of tests and deliver accurate results, especially for serious infectious diseases, makes them essential to healthcare systems globally.
Others
The "Others" segment, which represents about 10% of the market, includes diagnostics conducted in specialized or non-centralized settings, such as mobile testing units, research labs, and smaller diagnostic centers. This segment is expanding as decentralized testing options become more viable due to innovations in diagnostic tools and technology.
Infectious Disease In Vitro Diagnostics Market, Segmentation by Application
The Infectious Disease In Vitro Diagnostics Market has been segmented by Application into MRSA, Streptococcus, Clostridium Difficile, Vancomycin-Resistant Enterococci, Carbapenem-Resistant Bacteria Testing, Respiratory Virus, Candida, Tuberculosis and Drug-Resistant TB, Gastro-Intestinal Panel Testing, Chlamydia, Gonorrhea, HPV, HIV, Hepatitis C, Hepatitis B and Other Infectious Diseases.
MRSA (Methicillin-Resistant Staphylococcus Aureus)
MRSA testing accounts for approximately 12% of the infectious disease diagnostics market. This antibiotic-resistant pathogen causes serious infections, particularly in healthcare settings. The rising global prevalence of MRSA and the increasing need for rapid diagnostics contribute to the growth of this segment.
Streptococcus
Streptococcus infections represent about 8% of the market. These bacterial infections can lead to conditions like strep throat, pneumonia, and scarlet fever. The high incidence of these infections, especially in children, is driving the demand for reliable and quick diagnostic testing.
Clostridium Difficile
Clostridium difficile testing holds a market share of around 6%. This pathogen is a major cause of healthcare-associated infections, particularly in hospitalized patients. With increasing cases of antibiotic-resistant C. difficile, the demand for effective diagnostic tools is rising.
Vancomycin-Resistant Enterococci
Vancomycin-resistant enterococci (VRE) testing contributes approximately 5% to the market. This infection is commonly seen in immunocompromised patients, and the growing resistance to antibiotics is driving increased demand for testing.
Carbapenem-Resistant Bacteria Testing
Carbapenem-resistant bacteria testing accounts for about 7% of the market. These multidrug-resistant pathogens present a serious challenge to healthcare systems globally, driving a surge in demand for diagnostics capable of detecting such resistant strains.
Respiratory Virus
Respiratory virus testing, including tests for influenza and COVID-19, makes up 10% of the market. The demand for rapid and accurate testing during flu seasons and pandemics contributes significantly to the growth of this segment.
Candida
Candida infections, responsible for conditions like yeast infections, represent approximately 4% of the diagnostics market. As these infections become more prevalent, particularly in immunocompromised individuals, the demand for effective diagnostic solutions increases.
Tuberculosis (TB) and Drug-Resistant TB
TB and drug-resistant TB testing account for roughly 15% of the market. With the ongoing global burden of tuberculosis, especially in developing countries, the demand for accurate and timely testing is critical in controlling the spread of the disease.
Gastro-Intestinal Panel Testing
Gastro-intestinal panel testing holds a share of about 6%. This testing is essential in diagnosing various digestive system infections caused by bacteria, viruses, and parasites, especially in regions with high prevalence.
Chlamydia
Chlamydia testing contributes about 5% to the market. This common sexually transmitted infection (STI) has a high global incidence, driving the demand for accurate and accessible diagnostic tools.
Gonorrhea
Gonorrhea testing, another STI, makes up approximately 4% of the market. The increasing prevalence of drug-resistant strains has led to a greater emphasis on developing effective diagnostic methods for early detection.
HPV (Human Papillomavirus)
HPV testing represents about 5% of the market. As a leading cause of cervical cancer, HPV testing is crucial for early detection and prevention. The rising awareness of HPV and its link to cancer is contributing to market growth.
HIV (Human Immunodeficiency Virus)
HIV testing holds a significant market share of around 8%. With the continued global effort to combat the HIV/AIDS epidemic, the demand for accurate, fast, and reliable diagnostic tests remains high.
Hepatitis C
Hepatitis C testing contributes about 7% to the market. The rising number of hepatitis C cases worldwide, coupled with advancements in antiviral treatments, is driving the growth of diagnostic testing for this virus.
Hepatitis B
Hepatitis B testing holds a market share of approximately 5%. With millions of people globally affected by hepatitis B, the demand for early detection and screening tests is crucial in controlling the spread of the disease.
Other Infectious Diseases
Other infectious diseases, including a wide range of bacterial, viral, and parasitic infections, make up 10% of the market. This diverse category includes diseases with varying diagnostic needs and drives demand for specialized tests across different regions.
Infectious Disease In Vitro Diagnostics Market, Segmentation by Geography
In this report, the Infectious Disease In Vitro Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Infectious Disease In Vitro Diagnostics Market Share (%), by Geographical Region
North America
North America holds a dominant position in the market, accounting for approximately 35% of the global share. The region benefits from advanced healthcare infrastructure, high adoption of new diagnostic technologies, and a well-established healthcare system. The growing prevalence of infectious diseases and demand for rapid diagnostics further drives the market in this region.
Europe
Europe is a key player, contributing around 30% to the global market. The region’s strong healthcare system and focus on innovation in diagnostics are pivotal to the growth of in vitro diagnostics. Increasing government initiatives aimed at improving healthcare accessibility and the rise in chronic infectious diseases contribute to the market expansion.
Asia Pacific
Asia Pacific represents a rapidly growing market, with a share of about 20%. The region’s expanding healthcare sector, rising healthcare awareness, and large population base make it a promising market for diagnostic solutions. Technological advancements and increasing investments in healthcare infrastructure are key drivers of the market in this region.
Middle East and Africa
The Middle East and Africa region holds a smaller share, around 10%, in the market. However, it is witnessing gradual growth due to improvements in healthcare infrastructure and rising investments in medical technology. The demand for advanced diagnostics is growing, especially in countries with better access to healthcare services.
Latin America
Latin America accounts for approximately 5% of the market share. Despite its smaller size, the region is experiencing growth driven by improvements in healthcare facilities and government initiatives to enhance healthcare access. The increasing burden of infectious diseases is also contributing to the demand for diagnostic solutions in the region.
Infectious Disease In Vitro Diagnostics Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Infectious Disease In Vitro Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
---|---|---|---|---|---|
Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Rising global burden of infectious diseases
- Growing demand for rapid diagnostics
- Technological advancements in molecular testing
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Expansion of point-of-care testing - The rising adoption of point-of-care (POC) testing is significantly propelling the Infectious Disease In Vitro Diagnostics Market. By delivering rapid diagnostic results directly at the site of patient care, POC testing plays a critical role in improving the speed and accuracy of infectious disease detection. This approach minimizes delays associated with centralized laboratory testing and enables clinicians to begin targeted treatments without waiting for off-site analysis.
The growing need for immediate clinical decision-making, especially in remote or under-resourced areas, is accelerating demand for POC diagnostics. These solutions enhance treatment initiation timelines, reduce disease transmission, and support more efficient healthcare delivery. Additionally, the integration of portable diagnostic devices and user-friendly testing platforms is making POC solutions more accessible, even in non-traditional settings like pharmacies, urgent care centers, and home environments.
Restraints
- High cost of diagnostic equipment
- Limited access in low-income regions
- Regulatory challenges for new approvals
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Shortage of skilled laboratory professionals - The persistent shortage of skilled laboratory professionals poses a major challenge to the expansion of the Infectious Disease In Vitro Diagnostics Market. The accuracy and reliability of diagnostic results rely on well-trained personnel who can perform tests, maintain equipment, and interpret findings effectively. Without sufficient expertise, even the most advanced diagnostic tools risk being underutilized or misapplied.
This shortage is especially pronounced in low-resource and rural regions, where access to specialized training programs remains limited. As the demand for infectious disease testing continues to rise globally, the lack of qualified technicians could lead to diagnostic errors, delayed treatment, and reduced confidence in test outcomes. Addressing this gap is essential to maximizing the potential of in vitro diagnostics in both emergency response and routine healthcare.
Opportunities
- Integration of AI in diagnostics
- Rising demand for home test kits
- Expansion in emerging healthcare markets
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Public-private collaborations in disease surveillance - Expanding public-private collaborations in the field of disease surveillance is unlocking valuable opportunities for the Infectious Disease In Vitro Diagnostics Market. These partnerships bring together government bodies, research institutions, and diagnostic companies to enhance the global response to infectious threats. By combining resources and technical expertise, such alliances improve the efficiency and reach of surveillance programs.
Joint efforts are driving the development and distribution of advanced diagnostic technologies that can rapidly identify pathogens and monitor outbreaks. Public agencies benefit from private-sector innovation, while diagnostic companies gain access to funding, regulatory support, and large-scale deployment platforms. This mutually beneficial model accelerates innovation and ensures timely access to critical testing tools across diverse healthcare systems.
These collaborations are also fostering the growth of integrated data-sharing networks and real-time monitoring systems, which are essential for early outbreak detection and informed public health responses. In vitro diagnostics are at the core of these systems, delivering accurate and timely data that support evidence-based strategies for containment and treatment.
Infectious Disease In Vitro Diagnostics Market Competitive Landscape Analysis
Key players in 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
In this report, the profile of each market player provides following information:
- Company Overview
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Technology
- Market Snapshot, By Test Location
- Market Snapshot, By Application
- Market Snapshot, By Region
- Infectious Disease In Vitro Diagnostics Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Rising global burden of infectious diseases
- Growing demand for rapid diagnostics
- Technological advancements in molecular testing
- Expansion of point-of-care testing
- Restraints
- High cost of diagnostic equipment
- Limited access in low-income regions
- Regulatory challenges for new approvals
- Shortage of skilled laboratory professionals
- Opportunities
- Integration of AI in diagnostics
- Rising demand for home test kits
- Expansion in emerging healthcare markets
- Public-private collaborations in disease surveillance
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Infectious Disease In Vitro Diagnostics Market, By Product, 2021 - 2031 (USD Million)
- Instruments
- Reagents
- Software
- Infectious Disease In Vitro Diagnostics Market, By Technology, 2021 - 2031 (USD Million)
- Immunochemistry
- Microbiology
- Molecular Diagnostics
-
Infectious Disease In Vitro Diagnostics Market, By Test Location, 2021 - 2031 (USD Million)
-
Point of Care
-
Central Laboratories
-
Others
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- Infectious Disease In Vitro Diagnostics Market, By Application, 2021 - 2031 (USD Million)
- MRSA
- Streptococcus
- Clostridium Difficile
- Vancomycin-Resistant Enterococci
- Carbapenem-Resistant Bacteria Testing
- Respiratory virus
- Candida
- Tuberculosis and Drug-Resistant TB
- Gastro-Intestinal Panel Testing
- Chlamydia
- Gonorrhea
- HPV
- HIV
- Hepatitis C
- Hepatitis B
- Other Infectious Diseases
- Infectious Disease In Vitro Diagnostics Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN(Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Infectious Disease In Vitro Diagnostics Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- 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
- Company Profiles
- Analyst Views
- Future Outlook of the Market