Infectious Disease In-Vitro Diagnostics Market by Product (PCR-Based Diagnostics, Immunoassays, Microbial Culture Systems, Enzyme-Linked Immunosorbent Assay (ELISA)); Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunofluorescence); Application (Respiratory Infections, Bloodstream Infections, Sexually Transmitted Infections (STIs), Gastrointestinal Infections); End-Use Industry (Hospitals and Diagnostic Laboratories, Point-of-Care Testing) and by Region; Insights & Forecast (2024 – 2030)

As per Intent Market Research, the Infectious Disease In-Vitro Diagnostics Market was valued at USD 5.2 Billion in 2024-e and will surpass USD 14.4 Billion by 2030; growing at a CAGR of 18.6% during 2025 - 2030.

The Infectious Disease In-Vitro Diagnostics (IVD) market is experiencing significant growth driven by the increasing need for accurate, rapid, and reliable diagnostic solutions for infectious diseases. With the growing burden of infectious diseases globally, particularly emerging pathogens and antibiotic-resistant infections, the need for effective diagnostic tools in both clinical and point-of-care settings is more critical than ever. In-vitro diagnostics play an essential role in detecting pathogens, determining disease severity, and guiding treatment decisions. The market is characterized by advancements in technologies such as PCR-based diagnostics, Next-Generation Sequencing (NGS), and immunoassays, which are transforming the way infections are diagnosed and managed.

The shift towards more personalized and precise medicine has spurred the demand for advanced diagnostics that can provide faster and more accurate results. As hospitals, diagnostic laboratories, and healthcare providers increasingly rely on in-vitro diagnostics to enhance patient outcomes and reduce healthcare costs, the demand for innovative and efficient testing solutions is expected to rise. With the growing focus on preventive healthcare and infectious disease control, in-vitro diagnostic tools are becoming indispensable in combating both common and rare infections. The continued development and application of these technologies are expected to further drive market growth, improving global healthcare outcomes.

PCR-Based Diagnostics Are Largest Segment Owing to High Sensitivity and Precision

PCR-based diagnostics dominate the infectious disease in-vitro diagnostics market, owing to their high sensitivity and precision in detecting genetic material from pathogens. Polymerase Chain Reaction (PCR) technologies allow for the amplification of minute amounts of pathogen DNA or RNA, making it possible to identify infectious agents even at early stages of infection. PCR-based diagnostics are particularly valuable in detecting respiratory infections, sexually transmitted infections (STIs), gastrointestinal infections, and bloodstream infections, among others. Their ability to provide rapid and highly accurate results has cemented PCR as the go-to diagnostic tool for infectious disease detection in clinical and hospital settings.

The widespread adoption of PCR-based diagnostics is also driven by its versatility in detecting a wide array of pathogens, including bacteria, viruses, and fungi. With the increasing global prevalence of diseases like COVID-19, HIV, tuberculosis, and influenza, PCR has become a critical tool in both routine and emergency diagnostics. As healthcare providers and diagnostic laboratories seek faster, more reliable, and scalable solutions to meet growing demand, PCR-based diagnostics continue to lead the market, offering significant advantages in terms of speed, accuracy, and reliability.

Next-Generation Sequencing (NGS) Is Fastest Growing Technology Segment Owing to Advanced Pathogen Detection

Next-generation sequencing (NGS) is the fastest-growing technology segment in the infectious disease in-vitro diagnostics market, fueled by its ability to provide comprehensive, high-throughput pathogen detection. NGS enables the sequencing of entire genomes, allowing for the identification of multiple pathogens simultaneously in a single test. This technology has revolutionized the field of infectious disease diagnostics by enabling more detailed and accurate pathogen profiling, including the detection of rare and novel pathogens. NGS also plays a critical role in the identification of mutations and antibiotic resistance genes, which is crucial in the fight against multidrug-resistant organisms.

The adoption of NGS is expected to increase rapidly, particularly in research and diagnostic laboratories, as it allows for more precise and comprehensive disease monitoring, epidemiological surveillance, and outbreak management. NGS also enables the identification of genetic variations in pathogens, providing valuable insights into the emergence of new strains and helping to shape public health responses. As the cost of sequencing continues to decrease and the technology becomes more accessible, NGS is poised to become a mainstream tool in clinical diagnostics, further driving market growth in the coming years.

Hospitals and Diagnostic Laboratories Are Largest End-Use Industry Due to High Testing Volume

Hospitals and diagnostic laboratories are the largest end-use industry for infectious disease in-vitro diagnostics, driven by their critical role in the detection, diagnosis, and management of infectious diseases. Hospitals and diagnostic laboratories conduct a high volume of diagnostic tests, particularly for common and complex infections, such as respiratory infections, gastrointestinal infections, and sexually transmitted infections (STIs). These settings rely heavily on in-vitro diagnostic technologies like PCR, immunoassays, and NGS to provide accurate and timely results, which are essential for initiating appropriate treatment plans.

The growing demand for early and accurate diagnosis, combined with the need to detect emerging infectious diseases, has made hospitals and diagnostic laboratories the primary consumers of in-vitro diagnostic products. As the healthcare landscape becomes more focused on improving patient outcomes, the volume of diagnostic testing in these settings is expected to continue to rise, further solidifying their position as the largest end-user segment. Additionally, hospitals and diagnostic laboratories are increasingly adopting integrated diagnostic platforms that streamline testing processes and improve operational efficiency, contributing to market expansion.

North America Is Largest Region Owing to Advanced Healthcare Infrastructure

North America is the largest region in the infectious disease in-vitro diagnostics market, owing to its advanced healthcare infrastructure, high adoption of cutting-edge diagnostic technologies, and robust healthcare spending. The United States, in particular, has a well-established healthcare system with a strong emphasis on diagnostic testing for infectious diseases. With a large number of hospitals, diagnostic laboratories, and research institutions, North America is at the forefront of adopting the latest in-vitro diagnostic technologies, including PCR, immunoassays, and NGS.

The region's dominance is also attributed to its high rate of infectious disease testing, driven by factors such as the growing prevalence of infectious diseases, a high level of public awareness, and government initiatives aimed at improving disease surveillance and response. North America is home to leading players in the diagnostics industry, with major companies driving innovation in diagnostic products and technologies. As the region continues to lead in healthcare advancements, North America is expected to maintain its dominant position in the infectious disease in-vitro diagnostics market.

Leading Companies and Competitive Landscape

The infectious disease in-vitro diagnostics market is highly competitive, with several global players providing a range of diagnostic solutions to meet the growing demand for infectious disease testing. Key players in the market include Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Siemens Healthineers, BD (Becton, Dickinson and Company), and Cepheid, among others. These companies are actively involved in the development, manufacturing, and distribution of diagnostic products, ranging from PCR-based assays and immunoassays to next-generation sequencing platforms.

The competitive landscape is characterized by continuous innovation, strategic partnerships, and mergers and acquisitions aimed at expanding product portfolios and strengthening market position. Companies are investing heavily in research and development to introduce new diagnostic technologies that offer faster, more accurate, and cost-effective solutions. Additionally, collaborations with healthcare providers, academic institutions, and government health agencies play a significant role in advancing the capabilities of infectious disease diagnostics. As the market continues to evolve, these leading companies are expected to drive growth and shape the future of infectious disease diagnosis globally.

Recent Developments:

• Thermo Fisher Scientific launched a new next-generation sequencing-based diagnostic platform for infectious diseases, enhancing detection capabilities for various pathogens.
• Abbott Laboratories received FDA approval for a new PCR test that detects respiratory infections, improving rapid diagnosis and treatment.
• BioMérieux SA announced the expansion of its molecular diagnostics portfolio with a new product for detecting gastrointestinal pathogens in less than an hour.
• Hologic, Inc. introduced an advanced immunoassay system designed for faster detection of sexually transmitted infections.
• Cepheid launched a new point-of-care diagnostic test for bloodstream infections, reducing time-to-result and improving patient outcomes in emergency settings.

List of Leading Companies:

• Roche Diagnostics
• Abbott Laboratories
• Thermo Fisher Scientific
• Siemens Healthineers
• Danaher Corporation
• BioMérieux SA
• Becton, Dickinson and Company
• Hologic, Inc.
• QIAGEN N.V.
• Cepheid
• Grifols, S.A.
• Illumina, Inc.
• PerkinElmer, Inc.
• GE Healthcare
• Baxter International Inc.

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