Infectious Disease in Vitro Diagnostics Global Market Report 2025

The infectious disease in vitro diagnostics market size has grown strongly in recent years. It will grow from $14.14 billion in 2024 to $15.1 billion in 2025 at a compound annual growth rate (CAGR) of 6.7%. The growth during the historic period is attributed to antibiotic resistance, globalization and travel, an aging population, the emergence of novel pathogens, and bioterrorism threats.

The infectious disease in vitro diagnostics market size is expected to see strong growth in the next few years. It will grow to $19.83 billion in 2029 at a compound annual growth rate (CAGR) of 7%. The growth in the forecast period can be attributed to increasing demand for point-of-care testing, rising prevalence of infectious diseases, growing adoption of personalized medicine, and expansion of healthcare infrastructure in emerging markets. Key trends in the forecast period include next-generation sequencing, microfluidics-based platforms, lab-on-a-chip technology, multiplex polymerase chain reaction (PCR) assays, and digital immunoassays.

The rise in global infectious diseases drove the growth of the infectious disease in vitro diagnostics market during the historic period. Infectious diseases encompass bacterial, viral, fungal, or parasitic infections affecting populations worldwide at a given time, reflecting the overall disease burden. Changes in climate have expanded the habitats of vectors such as mosquitoes, increasing the global prevalence of infectious diseases. Infectious disease in vitro diagnostics support this trend by offering precise and timely diagnostic tools that allow healthcare providers to detect pathogens, initiate appropriate treatment, and control outbreaks efficiently. For example, in October 2024, the World Health Organization reported that approximately 10.8 million people worldwide contracted tuberculosis, with 55 percent men, 33 percent women, 12 percent children and adolescents, and 6.1 percent of cases among individuals living with HIV. Therefore, the rising global prevalence of infectious diseases contributed to the growth of the infectious disease in vitro diagnostics market during the historic period.

Major companies in the infectious disease in vitro diagnostics market are developing innovative products such as rapid detection of multiple gastrointestinal pathogens to enable timely diagnosis, improve patient outcomes, and expand point-of-care testing. Rapid detection of multiple gastrointestinal pathogens involves diagnostic tests that quickly identify several disease-causing microorganisms in the gastrointestinal tract from a single sample. In June 2024, MP Biomedicals, a US-based provider of products, chemicals, and diagnostics, launched immunochromatographic rapid diagnostic kits for gastrointestinal infectious diseases. These kits allow fast and accurate detection of Helicobacter pylori, Salmonella typhi, and Vibrio cholerae serogroups O1 and O139. They support rapid, point-of-care qualitative detection, versatile sample use including stool, blood, plasma, serum, water, and food, and are suitable for both clinical and research settings. Using immunochromatographic technology, they support early diagnosis, treatment monitoring, and confirmation of pathogen eradication, offering a combination of speed, precision, and broad pathogen coverage.

In January 2025, Fremman Capital, a UK-based private equity firm focused on healthcare and life sciences investments, acquired a majority stake in DIESSE Diagnostica Senese for an undisclosed sum. Fremman Capital intends to accelerate DIESSE’s international growth and reinforce its position in the specialty in vitro diagnostics market by supporting innovation, expanding the product range for autoimmune and infectious disease diagnostics, and increasing production capacity at DIESSE’s biotech campus, driving long-term sustainable growth. DIESSE Diagnostica Senese is an Italy-based developer of innovative in vitro diagnostics and reagents for autoimmunity, infectious diseases, and hematological testing, serving clinical laboratories worldwide.

Major companies operating in the infectious disease in vitro diagnostics market are F. Hoffmann-La Roche AG, Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific Inc., Siemens Healthcare AG, BioMérieux SA, Qiagen N.V., Becton, Dickinson and Company, Hologic, Inc., Labcorp Holdings Inc., DiaSorin S.p.A., Meridian Bioscience, Quidel Corporation, Quest Diagnostics, Revvity Inc. (Formerly PerkinElmer, Inc.), OraSure Technologies, Inc., Transasia Bio-Medicals Ltd., Randox Laboratories, Luminex Corporation, Wako Pure Chemical Industries, Bio-Rad Laboratories Inc., Trivitron Healthcare, and InBios International Inc.

North America was the largest region in the infectious disease in vitro diagnostics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the infectious disease in vitro diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the infectious disease in vitro diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

The infectious disease in vitro diagnostics market research report is one of a series of new reports that provides infectious disease in vitro diagnostics market statistics, including infectious disease in vitro diagnostics industry global market size, regional shares, competitors with an infectious disease in vitro diagnostics market share, detailed infectious disease in vitro diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the infectious disease in vitro diagnostics industry. This infectious disease in vitro diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Infectious disease in vitro diagnostics are laboratory tests performed on samples such as blood, urine, or swabs to detect, identify, and monitor infectious pathogens including bacteria, viruses, fungi, and parasites. These diagnostics enable accurate and timely diagnosis, guide treatment decisions, and support disease surveillance and infection control.

The main product types in infectious disease in vitro diagnostics are instruments, reagents, and software and services. Instruments are tools or devices used to measure and monitor environmental conditions including air, water, soil, and noise. They utilize technologies such as molecular diagnostics, immunoassay, microbiology, hematology, urinalysis, and others. Applications include methicillin-resistant Staphylococcus aureus, Clostridium difficile, respiratory viruses, tuberculosis and drug-resistant tuberculosis, gonorrhea, human papillomavirus, human immunodeficiency virus, hepatitis C, hepatitis B, and more. End-users include hospitals, clinics, diagnostic laboratories, academic research institutes, and other organizations.

The infectious disease in vitro diagnostics market consists of revenues earned by entities by providing services such as serology testing, rapid diagnostic testing, disease surveillance and monitoring, sample collection and processing, and consulting and training services. The market value includes the value of related goods sold by the service provider or included within the service offering. The infectious disease in vitro diagnostics market also includes sales of rapid test kits, culture media, controls and calibrators, molecular sequencing kits, flow cytometry reagents, and point-of-care diagnostic devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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