• Market Growth The global infectious disease diagnostics market was valued at approximately USD 25.01 billion in 2024 and is projected to reach USD 62.95 billion by 2034, growing at a CAGR of 9.67% from 2025 to 2034.

• Product Segmentation Reagents, kits, and consumables dominated the market in 2024, while the instruments segment is expected to grow at the fastest CAGR during the forecast period.

• Technology Trends Immunodiagnostics led the market in 2024, with molecular diagnostics anticipated to experience the highest growth rate from 2025 to 2034.

• Regional Dynamics North America held the largest market share in 2024, driven by advanced healthcare infrastructure and high adoption of diagnostic technologies. The Asia Pacific region is expected to grow at the fastest CAGR during the forecast period.

• End-User Applications Diagnostic laboratories accounted for the largest share in 2024, with hospitals and clinics projected to experience significant growth due to increasing healthcare access.

• Clinical Applications Diagnostic testing is fueled by the need to confirm infections, guide treatment decisions, and monitor disease progression. Screening demand is increasing due to preventive healthcare initiatives, population-wide surveillance, and early detection programs aimed at controlling infectious disease spread.

• Market Outlook The market is witnessing accelerated growth, driven by the global resurgence of communicable diseases and the rising demand for timely, accurate diagnostic solutions.

• In July 2022, F. Hoffmann-La Roche Ltd launched the Elecsys HCV Duo, a pioneering diagnostic test for hepatitis C that simultaneously detects both antigens and antibodies, improving early detection and management of HCV infections.

• In February 2022, SEEGENE received CE-IVD certification for its Allplex SARS-CoV-2 rapid MDx Assay, enabling accurate COVID-19 testing in under 30 minutes for large-scale public health screening in airports, schools, and institutions.

In this report, the Infectious Disease Diagnostics market has been segmented by Product, Type of Testing, Sample, Disease, End-Use, and Geography.

Infectious Disease Diagnostics, Segmentation by Product

The market is segmented into four primary product categories, each playing a vital role in the diagnostics process. The demand for these products is heavily influenced by the need for more accurate and efficient diagnostic solutions in detecting infectious diseases. The market is experiencing growth in both reagent sales and instrument adoption, with reagents being the dominant segment due to their critical role in diagnostics.

• Reagents

  Reagents hold the largest market share, as they are essential in preparing samples for testing. The increasing need for accurate results in a variety of diagnostic settings drives this segment's growth.

• Kits

  Kits are essential for providing all the necessary components for testing in a single package. This segment is experiencing a surge in demand due to their convenience and versatility in both clinical and point-of-care settings.

• Consumables

  The consumables segment, which includes materials such as swabs, test strips, and buffers, plays a crucial role in diagnostic workflows. Rising volumes of testing, especially in infectious disease outbreaks, drive the demand for consumables.

• Instruments

  Instruments used in diagnostics, such as PCR machines and analyzers, are becoming increasingly sophisticated. Technological advancements are improving accuracy and speed, propelling growth in this segment.

Infectious Disease Diagnostics, Segmentation by Type of Testing

This market is segmented by testing types, primarily focusing on laboratory and point-of-care (POC) testing. The shift towards faster results in emergency settings is boosting the POC testing segment, while laboratory testing remains dominant due to its accuracy and comprehensive analysis capabilities.

• Laboratory Testing

  Laboratory testing remains the primary method for diagnosing infectious diseases due to its high accuracy and ability to handle complex samples. The need for precise diagnostic results in hospitals and large clinics sustains this segment's growth.

• POC Testing

  Point-of-care testing is gaining traction due to its speed and convenience, offering rapid results at the site of patient care. This segment is expected to grow rapidly, driven by the need for quick diagnostics in urgent care environments.

Infectious Disease Diagnostics, Segmentation by Sample

The market is also segmented by the type of sample used in diagnostics. Blood, serum, plasma, and urine are the most common samples utilized, with blood and serum testing being the most prevalent due to their ease of collection and rich diagnostic information.

• Blood

  Blood samples are commonly used for diagnosing a wide range of infectious diseases due to their ability to provide comprehensive insights into the patient’s condition. This segment holds the largest share in the sample category.

• Serum

  Serum samples are frequently used in immunoassays to detect specific markers of infection. Their high sensitivity makes them essential in diagnosing diseases like hepatitis and HIV.

• Plasma

  Plasma is often used in molecular diagnostics, offering a reliable medium for testing viral loads. The rise in demand for precision medicine is boosting the plasma segment's market share.

• Urine

  Urine testing is gaining traction due to its non-invasive nature. It's especially useful for diagnosing urinary tract infections and is expanding in diagnostic kits used in home care settings.

Infectious Disease Diagnostics, Segmentation by Disease

The market for infectious disease diagnostics is segmented by the type of diseases being targeted. Diseases such as hepatitis, HIV, and tuberculosis remain top priorities in diagnostics, while emerging diseases, such as influenza and hospital-acquired infections, are seeing an increase in diagnostic efforts due to global health concerns.

• Hepatitis

  Hepatitis diagnostics have a strong market presence due to the global prevalence of the disease. With new technologies enhancing testing methods, this segment continues to grow.

• Human Immunodeficiency Virus (HIV)

  HIV diagnostics, particularly for viral load monitoring, remain crucial in managing the epidemic. Demand for rapid testing and early detection continues to drive this segment’s growth.

• Chlamydia Trachomatis Genital Infection & Gonorrhea

  The diagnostics for sexually transmitted infections like chlamydia and gonorrhea are seeing growth, driven by increasing awareness and the shift towards more accessible testing methods.

• Hospital Acquired Infections

  With the rise in hospital-acquired infections, particularly in intensive care units, demand for rapid diagnostic tests in hospital settings is on the rise. This segment is expanding as part of broader infection control initiatives.

• Human Papillomavirus (HPV)

  HPV testing is gaining momentum, particularly for cervical cancer screening. Increasing awareness and prevention initiatives drive this segment’s growth.

• Tuberculosis

  Due to global efforts to eliminate tuberculosis, diagnostics for TB are a major area of focus, with innovations in molecular tests providing faster and more accurate results.

• Influenza

  Flu diagnostics are experiencing significant demand, particularly in the wake of annual outbreaks and global pandemics. Testing innovations are making flu diagnostics quicker and more reliable.

• Others

  Other infectious diseases, including malaria, dengue, and Zika, continue to see diagnostic efforts grow as emerging health concerns arise in specific regions.

Infectious Disease Diagnostics, Segmentation by End-Use

This segment focuses on the end-users of diagnostics, primarily hospitals, reference laboratories, and others. Hospitals and clinical laboratories continue to dominate the market due to the necessity of accurate, high-throughput diagnostics in healthcare settings.

• Hospital & Clinical Laboratories

  Hospitals and clinical laboratories are the largest end-users of infectious disease diagnostics due to the need for accurate and rapid diagnostic results in patient care. This segment is expected to grow steadily as healthcare demands rise globally.

• Reference Laboratories

  Reference laboratories, which offer specialized testing services, are seeing increased demand as healthcare systems expand and require more detailed diagnostic testing.

• Others

  Other end-users, such as home testing kits and point-of-care settings, are also gaining market share, driven by increasing demand for accessible, convenient testing options.

Infectious Disease Diagnostics, Segmentation by Geography

In this report, the Infectious Disease Diagnostics market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

North America

North America dominates the infectious disease diagnostics market due to advanced healthcare infrastructure and high demand for accurate diagnostics. The presence of major diagnostic companies further accelerates market growth in this region.

Europe

Europe is another leading market, supported by strong public health systems and increased focus on infectious disease prevention. The demand for precision diagnostics in the region is expected to continue to grow steadily.

Asia Pacific

The Asia Pacific region is witnessing rapid growth in the infectious disease diagnostics market, driven by population growth, expanding healthcare access, and the increasing burden of infectious diseases.

Middle East and Africa

The Middle East and Africa are emerging markets for diagnostic testing, fueled by increasing healthcare investments and rising awareness of infectious diseases. However, challenges such as limited healthcare access may slow growth in some regions.

Latin America

Latin America is expanding its market presence as healthcare improvements and diagnostic accessibility increase. The rise of infectious disease outbreaks is also contributing to the growing demand for diagnostic testing.

This report provides an in depth analysis of various factors that impact the dynamics of Infectious Disease Diagnostic Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Infectious Disease Diagnostics Market is witnessing rising competition as companies focus on strengthening their positions through strategic partnerships and mergers. With over 45% of the market share concentrated among leading players, collaboration and innovation remain central to driving growth. Firms are increasingly investing in technological advancements to meet evolving diagnostic needs and secure long-term expansion strategies.

Market Structure and Concentration
The market shows a moderately consolidated structure where top players command around 50% share. This concentration encourages mergers and partnerships, shaping competitive intensity. Smaller firms emphasize niche strategies, while established players pursue expansion into specialized testing areas. The balance of collaboration and competition supports overall industry growth and enhances diagnostic innovation.

Brand and Channel Strategies
Key companies implement robust branding strategies, ensuring visibility across multiple diagnostic segments. Distribution channels are being diversified, with around 40% growth in direct-to-lab partnerships. Firms also strengthen collaboration with healthcare networks, enhancing reliability and accessibility. These branding efforts position leading players for sustainable growth while reinforcing trust among clinical stakeholders.

Innovation Drivers and Technological Advancements
The industry invests heavily in innovation, with nearly 55% of companies prioritizing advanced molecular diagnostics. Technological advancements in rapid testing, automation, and AI integration redefine competitive advantages. Partnerships with research institutions fuel progress, allowing firms to introduce novel solutions that accelerate diagnostics. Innovation-driven strategies reinforce leadership and improve diagnostic accuracy.

Regional Momentum and Expansion
Regional expansion is a defining factor, with over 35% of growth driven by emerging markets. Companies invest in collaboration with local laboratories to strengthen accessibility and build resilience. Expansion strategies focus on adapting diagnostic portfolios to regional needs, enabling faster adoption. This momentum highlights the importance of regional strategies in shaping competitive market dynamics.

Future Outlook
The market’s future outlook reflects strong potential, with around 60% of stakeholders planning further investments in partnerships and innovation. Companies aim to enhance technological capabilities while expanding global reach. Strategic collaboration and merger initiatives are expected to reshape competition, ensuring continued growth. This trajectory underscores the sector’s resilience and adaptability in infectious disease diagnostics.

Key players in Infectious Disease Diagnostic Market include:

• Roche (incl. GenMark; Roche Diagnostics)
• Abbott (incl. Alere)
• Danaher (Cepheid)
• bioMérieux (incl. BioFire)
• Thermo Fisher Scientific
• Becton, Dickinson and Company (BD)
• Hologic
• QIAGEN
• Siemens Healthineers
• QuidelOrtho
• DiaSorin (incl. Luminex)
• Bio-Rad Laboratories
• Revvity (formerly PerkinElmer)
• Seegene
• SD Biosensor (incl. Meridian Bioscience)

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis