Infectious Disease Diagnostics Market Report, By Product Type (Instruments, Reagents & Kits, Software & Services); Technology (Molecular Diagnostics, PCR, NGS, Microarrays, Immunoassays, ELISA, Rapid Tests, Others); Indication (Bacterial Infections, Viral Infections, Fungal Infections, Parasitic Infections); End User (Hospitals & Clinics, Diagnostic Laboratories, Research Institutes, Point-of-Care Testing); and Regions 2024-2032

Market Overview:

"The global infectious disease diagnostics market was valued at US$ 21.3 Billion in 2023 and is expected to register a CAGR of 7.7% over the forecast period and reach US$ 41.5 Bn in 2032."

Report Attributes	Details
Base Year	2023
Forecast Years	2024-2032
Historical Years	2021-2023
Infectious Disease Diagnostics Market Growth Rate (2024-2032)	7.7%

Infectious diseases are not necessarily observable or show signs of presence openly, but are ever-present and an everyday threat to the health and wellness across the global population. Every individual is at some point in the day exposed to some type of infection, and could contract a disease, or ward off potential danger if the immune system is robust or the infection is weakened. However, with surging infection rates and increasing rates of infection, it is critical for proper and accurate testing is conducted, and that the appropriate preventive measures are taken to combat and halt disease and infection spread to safeguard against any catastrophic outcomes and effects.

Currently, spread of infectious disease and new and emerging pathogens is substantially easier and infection rates are significantly higher than a few decades ago. This can be attributed to ease of global travel, changing lifestyles, population expansion, and unusual or adverse climatic conditions and changes contributing to creation of ideal scenarios and opportunities to expose healthy hosts to existing, new, emerging, and reemerging potential risks. Some highly contagious viruses include Coronavirus infections, such as COVID-19, Severe Acute Respiratory Syndrome (SARS), and MERS, flaviviruses, enteroviruses, influenza, hantavirus, Nipah virus and Hendra virus, Filoviruses, and Human Immunodeficiency Virus (HIV), among others. Also, Marburg virus disease, Lassa fever, Middle East Respiratory Syndrome (MERS) and, Rift Valley fever, and Zika are being keenly researched, with Disease X more recently ringing alarm bells worldwide.

Infectious disease diagnostics refers to a broad range of testing methodologies, and comprises various methods of testing for characterization of infectious organisms such as bacteria, fungi, viruses, and parasites. These testing approaches are majorly reliant on culture-based methods and phenotypic methods for identification of culture organisms and enables presenting of the infections and syndromes caused by microorganisms, and the management of infective diseases and aetiological agents. Infectious disease diagnostics addresses the latex agglutination, immunofluorescent, monoclonal antibody, and nucleic acid also probe investigations. Diagnostic microbiology is also crucial for identifying specific pathogenic microbes that cause disease, as well as to distinguish these from normal flora and from environmental organisms that are not disease-causing. Key components of Infectious disease diagnostics include specimen collection & handling, microbial identification, antimicrobial susceptibility testing, serology and immunology, molecular diagnostics, mycology, virology, and parasitology, infection control & epidemiology, quality control & quality assurance.

The importance of infectious disease diagnostics laboratories has been increasing at various levels, and play a crucial responsibility to provide rapid and accurate diagnostic services for emerging or new, and reemerging infectious diseases. These settings are especially important in the testing and identification of those diseases, for which significant mortality or morbidity may occur as the result of a delay in diagnosis. Also, rising prevalence of infectious diseases and current-day threats associated with bioterrorism and new and emerging pathogens and risks of infection and spread are driving need for rapid diagnosis, increased standardization of testing techniques and approaches, and greater adaptability to identify and deal with new threats from infectious microorganisms.

In addition, ongoing studies on microbes in the medical sector to better understand microorganisms and how these cause disease, and also to enable rapid diagnosis and cure are supporting growth of the infectious disease diagnostics market. Moreover, such studies are resulting in positive outcomes, with researchers discovering benefits of microorganisms in human health as nutrition or medicine, and in the curation of innovative agricultural products. Furthermore, technological advancements in the study of microorganisms, infectious diseases, microbial ecology, plant and animal pathology, and biotechnology are proving to hold major advantages for improving human life and wellbeing, and extending favorable impact on the environment.

Infectious Disease Diagnostics Market Trends and Drivers:

In recent years, medical personnel and researchers, pharmaceutical companies and investors, and governments have been implementing programs and initiatives to address emergence and rising prevalence of infectious diseases, especially since the COVID-19 pandemic and subsequent mass infections and deaths worldwide. Reinforced with real-time data and insights left in the wake of the pandemic, and by the gravity such a realistic threat or event can present in future, research groups, health professionals, technology companies, and government bodies have been undertaking and encouraging, as well as investing in initiatives to be able to combat any such events when required.

Also, keen focus on initiatives to develop more robust approaches in the medical research field, including infectious disease diagnostics, to explore, understand, and and address risks and challenges pathogens continue to present have been ongoing. Emergence of new and also remerging pathogens and resulting disease and infections are driving urgent need for enhanced microbiology testing in clinical settings. Related or associated challenges in healthcare include increasing number of individuals being diagnosed with infections caused by emerging and reemerging pathogens and rising need to advance testing capabilities to diagnose and treat such infections to halt further spread.

Another focus point in the field is the need to improve accuracy and speed of diagnostics as well as services offered in infectious disease diagnostics. Technology continues to serve in crucial current-day needs to enable faster identification and diagnosis of pathogens and infections, as well as enabling faster treatment. Some key innovations in infectious disease diagnostics and emergence of platforms such as Next Generation Sequencing (NGS), automated identification systems, and Polymerase Reaction (PCR) are definitely aiding in addressing existing, new, and emerging challenges. Adoption of new technologies and approaches to address urgent challenges such as need for enhanced speed, accuracy, and sensitivity of various diagnostic procedures, is expected to drive further advancements and development of more innovative and efficient testing and diagnostic breakthroughs in the near future.

Infectious disease diagnostics also plays a major role beyond healthcare, and is crucial in sectors such as the food and beverage industry, where stringent food safety standards and regulations mandate rigorous microbial testing to ensure products are free from contaminants and potential pathogens. Various tests and quality control and assurance procedures are required before products are deemed fit for human consumption, and rising demand for food, development and formulation of new products and manufacturing and processing procedures and techniques, as well as use of various innovative ingredient in food and beverages are driving rise in testing procedures, and this is expected to continue to support market growth.

Infectious disease diagnostics is a mainstay in the pharmaceutical industry and microbiological testing is crucial in drug development and manufacturing processes. Microbiological testing is also crucial in industrial and commercial sectors to ensure quality control ad well as to comply with specific regulations and standards. Large-scale testing and need for approaches to address various challenges and introduce ease and convenience in procedures has resulted in a number of new product developments and novel diagnostic products and solutions more recently. Companies are entering into collaborations and strategic agreements and also adopting merger and acquisition strategies to explore and develop more comprehensive diagnostic products and services. Integration of Artificial Intelligence (AI) and Machine Learning (ML) in infectious disease diagnostics tools and procedures is serving to improve data analysis and predictive capabilities, streamline diagnostic workflows, and also enhance clinical outcomes. In addition, technology integration has been aiding in major advancements in the shift towards personalized medicine and treatment, and AI and ML are assisting in precise pathogen identification and susceptibility testing, apart from speeding up overall approaches and outcomes, enabling targeted and effective treatments, and bringing the world closer to combatting the spread of antibiotic resistant infectious microorganisms and infections and diseases.

Infectious Disease Diagnostics Market Restraining Factors:

Infectious disease diagnostics equipment requires the most stringent and safe environments or need to be 'tropicalized' so as to be able to withstand harsh climatic conditions, humidity, and not be exposed to particles/sand etc. High humidity and extreme temperatures can impact accuracy and functionality of sample results and equipment. Environmental sensitivity is a major concern for equipment such as incubators, centrifuges, and PCR machines, and need for maintaining specific or precise environmental conditions to ensure accurate results can be challenging in certain circumstances and regions.

Condensation within or inside equipment can cause electrical failure and corrosion, and temperature fluctuations can cause changes in humidity levels. Also, durability and robustness are essential in tropical and arid regions, and equipment requires to be ‘tropicalized’ or designed to withstand harsh conditions. Cost of equipment increases significantly as a result of need for reinforced castings, sealed electronics, and protective coatings to prevent damage or impact from dust, sand, or moisture, as well as to ensure less-frequent breakdowns or need for constant maintenance.

In addition, managing sterile conditions is crucial, and equipment exposed to dust or sand can become contaminated, resulting in potential compromised samples and inaccurate results. Ensuring appropriate and safe environments and preventing particulate contamination necessitates use of effective filtration systems and sealing measures and solutions. These can add up to overall costs and restrict adoption or purchase of such systems and equipment, and result in higher preference for use of centers and laboratory services and third-party services and platforms.

Moreover, high costs associated with diagnostic tools and equipment are a significant restraint, especially for more advanced systems and solutions. This is particularly for smaller healthcare facilities and institutions in developing economies. Stringent safety regulations and compliance requirements can also add to the complexity, as adhering can require substantial investment in infrastructure deployment and modification, as well as for training of personnel. Research & Development (R&D) challenges also figure high on the list of factors that can have an impact on market growth. Developing new diagnostic methods and technologies is considerably time-consuming, and can entail significant investment and risk, with uncertain returns. Furthermore, demand for advanced infectious disease diagnostics testing can be impacted by availability of alternative testing approaches and emerging technologies such as rapid antigen tests and biosensors, which are competitive alternatives to conventional microbiological diagnostics.

Infectious Disease Diagnostics Market Opportunities:

Leading companies offering advanced microbiology solutions can leverage opportunities by expanding into emerging markets such as Asia Pacific and Latin America, and leverage avenues arising from increased investments on healthcare infrastructure and rising incidence of infectious diseases. Establishing partnerships with local players and distributors can expand networks and ease market penetration. Investing in development of innovative diagnostic technologies such as NGS and CRISPR-based assays to provide faster and more accurate pathogen identification can open up additional revenue streams. Developing solutions such as point-of-care testing devices that are tailored to remote and resource-strained settings can also serve to address unmet needs and cater to a broader market segment.

Strategic moves, including mergers, acquisitions, and collaborations can enable companies to acquire complementary technologies and expertise, which can also enhance product portfolio and further accelerate development of new solutions. Collaborations with academic institutions and research organizations can support initiatives focused on innovation and expedite product development.

Infectious Disease Diagnostics Market Segmentation:

By Product Type

• Instruments
• Reagents and Kits
• Software & Services

Among the product type segments in the infectious disease diagnostics market, the reagents segment is expected to account for the largest revenue share. This projection is supported by the high and recurring demand for reagents in various diagnostic tests, the crucial role reagents play in accurate and reliable test results, and the continuous advancements in reagent formulations to improve sensitivity and specificity. Also, expanding use of molecular diagnostics and increasing prevalence of infectious diseases are further expected to drive adoption of testing and support revenue growth of the reagents segment.

By Technology

• Molecular Diagnostics
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Microarrays
• Immunoassays
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Rapid Tests
• Others

• Biochemical Tests
• Culture Methods

revenue share. This projection is supported by growing burden of infectious diseases worldwide, driving the need for accurate and timely diagnosis. In addition, advancements in diagnostic technologies, such as molecular testing and automation, enhance the efficiency and accuracy of disease diagnosis. Furthermore, increasing adoption of point-of-care testing and expansion of healthcare infrastructure in emerging markets is expected to continue to contribute to revenue growth of this segment.

By Indication

• Bacterial Infections
• Viral Infections
• Fungal Infections
• Parasitic Infections

laboratories segment is expected to account for the largest revenue share. This projection is supported by the high volume of diagnostic tests performed in these settings, driven by increasing incidence of infectious diseases and the need for accurate and timely diagnosis. Also, hospitals and diagnostic laboratories ideally have well-established infrastructure and resources to support sophisticated microbiology testing.

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes
• Point-of-Care Testing

By Region

North America

• United States
• Canada

Europe

• Germany
• United Kingdom
• France
• Italy
• Spain
• Russia
• Poland
• Benelux
• Nordic
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• South Korea
• ASEAN
• Australia & New Zealand
• Rest of Asia Pacific

Latin America

• Brazil
• Mexico
• Argentina

Middle East & Africa

• Saudi Arabia
• South Africa
• United Arab Emirates
• Israel
• Rest of MEA

The global infectious disease diagnostics market is segmented region-wise into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. The global infectious disease diagnostics market exhibits varying scenarios across regional markets. North America leads among the regional markets, with the United States (US) and Canada accounting for major revenue share contribution, driven by factors such as high healthcare expenditure, technological advancements, and presence of key market players in the region.

In Europe, countries such as Germany, France, and the United Kingdom (UK) contribute significantly in terms of revenue share, supported by robust healthcare infrastructure and increasing investments in R&D. Asia Pacific market continues to register a rapid revenue growth rate, with China, India, and Japan accounting for sizable revenue contribution to the market in the region. This rapid market growth can be attributed to factors such as rising prevalence of infectious diseases, improving healthcare infrastructure, and increasing awareness about the importance of early disease diagnosis and treatment.

Leading Companies in Infectious Disease Diagnostics Market & Competitive Landscape:

The landscape in the global infectious disease diagnostics market is highly competitive with leading companies striving to maintain their positions and expand their consumer bases. Key players such as Becton, Dickinson and Company (BD), bioMérieux SA, and Thermo Fisher Scientific Inc. are adopting various strategies to achieve these objectives.

One key strategy is continuous innovation in product development, with a focus on introducing advanced diagnostic technologies and solutions that offer greater accuracy, efficiency, and ease of use. In addition, strategic collaborations and partnerships with healthcare institutions, research organizations, and other industry players enable companies to broaden their market reach and access new customer segments. In addition, mergers and acquisitions are being employed to strengthen market presence, enhance product portfolios, and capitalize on synergies to drive growth. Overall, these strategies help leading companies in the infectious disease diagnostics market to stay competitive and meet the evolving needs of healthcare providers and consumers worldwide.

These companies include:

• Roche Diagnostics
• Abbott Laboratories
• bioMérieux
• Danaher Corporation (Cepheid)
• Thermo Fisher Scientific
• Becton, Dickinson and Company (BD)
• Hologic, Inc.
• Qiagen N.V.
• Siemens Healthineers
• Bio-Rad Laboratories
• DiaSorin S.p.A
• Quidel Corporation
• Luminex Corporation
• Ortho Clinical Diagnostics
• GenMark Diagnostics

Recent Development:

• January 2024: QIAGEN announced the introduction of two syndromic testing panels for its QIAstat-Dx instruments in India: the Gastrointestinal Panel 2 and Meningitis/Encephalitis Panel. These join the Respiratory SARS-CoV-2 Panel, authorized for emergency use in 2020. Regulatory approval from the Central Drugs Standard Control Organization (CDSCO) enables healthcare providers in India to diagnose patients accurately, faster, and more easily. The QIAstat-Dx system, designed for laboratory use, utilizes cost-efficient, single-use cartridges with all reagents onboard and built-in sample processing. Using multiplex real-time PCR, it detects and differentiates between multiple pathogens. QIAstat-Dx also provides easy-to-view cycle threshold (Ct) values and amplification curves, offering additional insights not available with endpoint PCR or other techniques.
• October 2023: Abbott Laboratories and artus GmbH announced the launch of three nucleic acid-based tests for detecting infectious diseases, including the virus linked to Severe Acute Respiratory Syndrome (SARS). One of these tests, the RealArt HPA Coronavirus PCR Kit, utilizes highly sensitive real-time Polymerase Chain Reaction (PCR) technology to directly detect the virus in patient samples for early diagnosis. This test was developed for the Applied Biosystems ABI PRISM 7000 Sequence Detection System by artus, in collaboration with the Bernhard-Nocht Institute for Tropical Medicine in Hamburg, Germany. The ABI PRISM 7000 is a comprehensive real-time PCR system for detecting and quantifying nucleic acid sequences. Also introduced was real-time PCR tests for Chlamydia trachomatis and Mycobacterium tuberculosis for use on the ABI PRISM 7000 system - the RealArt C. trachomatis TM PCR Kit, and the RealArt M. tuberculosis TM PCR Reagents.
• February 2023: Thermo Fisher Scientific announced launch of its Applied Biosystems TaqPath PCR kits for infectious diseases, including multi-drug-resistant tuberculosis (MTB MDR), M. tuberculosis complex (MTB), hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus (HIV), as well as for genetic analysis (HLA B27). The kits have been licensed by the Central Drugs Standard Control Organisation (CDSCO), and will be manufactured in India in collaboration with Mylab Discovery Solutions. Thermo Fisher Scientific stated that the TaqPath PCR kits have been analytically and clinically validated for patient care, including disease screening, diagnosis, monitoring therapeutic response, disease progression, and identifying genetic risk factors.
• October 2021: Roche introduced its first infectious disease tests on the Cobas 5800 System, which is a new molecular laboratory instrument, in countries that accept the CE mark. The Cobas 5800 System is a real-time PCR molecular testing solution that offers high performance and added utility in a compact design. It provides automation, consolidation, integration, and standardization, making it a scalable and cost-efficient choice for smaller labs aiming for high-level performance or larger labs seeking agility. The tests include those for HIV-1, HBV, HCV, HIV-1/HIV-2 Qualitative, and the omni Utility Channel kit. These additions enhance the Roche Molecular portfolio by delivering standardized performance and efficiencies for molecular laboratory testing across low, medium, and high-volume needs.

Infectious Disease Diagnostics Market Research Scope

Report Metric	Report Details
Infectious Disease Diagnostics Market Size available for the years	2021-2023
Base Year	2023
Forecast Period	2024-2032
Compound Annual Growth Rate (CAGR)	7.7%
Segment covered	Product Type, Technology, Indication, End User
Regions Covered	North America:  The U.S. & Canada Latin America: Brazil, Mexico, Argentina, & Rest of Latin America Asia Pacific: China, India, Japan, Australia & New Zealand, ASEAN, & Rest of Asia Pacific Europe: Germany, The U.K., France, Spain, Italy, Russia, Poland, BENELUX, NORDIC, & Rest of Europe The Middle East & Africa:  Saudi Arabia, United Arab Emirates, South Africa, Egypt, Israel, and Rest of MEA
Fastest Growing Country in Europe	The U.K.
Largest Market	North America
Key Players	Roche Diagnostics, Abbott Laboratories, bioMérieux, Danaher Corporation (Cepheid), Thermo Fisher Scientific, Becton, Dickinson and Company (BD), Hologic, Inc., Qiagen N.V., Siemens Healthineers, Bio-Rad Laboratories, DiaSorin S.p.A, Quidel Corporation, Luminex Corporation, Ortho Clinical Diagnostics, GenMark Diagnostics