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Global Infectious Disease Diagnostic Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

By Product;

Reagents, Kits, Consumables, and Instruments

By Type of Testing;

Laboratory Testing and POC Testing

By Sample Type;

Blood, Serum, Plasma, and Urine

By Disease Type;

Hepatitis, Human Immunodeficiency Virus, Chlamydia Trachomatis Genital Infection & Gonorrhea, Hospital Acquired Infections, Human Papillomavirus, Tuberculosis, Influenza, and Others

By End-Use;

Hospital/Clinical laboratories, Reference laboratories, and Others

By Geography;

North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)

Report ID: Rn922205911 Published Date: May, 2025 Updated Date: June, 2025

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Infectious Disease Diagnostic Market Overview

Infectious Disease Diagnostic Market (USD Million)

Infectious Disease Diagnostic Market was valued at USD 33,639.11 million in the year 2024. The size of this market is expected to increase to USD 54,371.43 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 7.1%.

Global Infectious Disease Diagnostic Market Growth, Share, Size, Trends and Forecast

*Market size in USD million

CAGR 7.1 %

Study Period	2025 - 2031
Base Year	2024
CAGR (%)	7.1 %
Market Size (2024)	USD 33,639.11 Million
Market Size (2031)	USD 54,371.43 Million
Market Concentration	Medium
Report Pages	394

33,639.11

2024

54,371.43

2031

Major Players

Thermo Fisher Scientific Inc.
Becton, Dickinson and Company (BD)
Siemens Healthineers AG
QIAGEN N.V.
Hologic, Inc.

Market Concentration

Consolidated - Market dominated by 1 - 5 major players

Global Infectious Disease Diagnostic Market

Fragmented - Highly competitive market without dominant players

The infectious disease diagnostic market is expanding rapidly, fueled by an urgent need for fast and precise testing solutions. As healthcare systems focus more on early intervention and containment, the adoption of efficient diagnostic tools has grown substantially across both clinical and laboratory environments.

Technological Advancements Fueling Market Growth
Cutting-edge innovations like molecular diagnostics, point-of-care testing, and automation are playing a pivotal role in transforming disease detection. Notably, molecular diagnostics account for over 35% of the market, reflecting their strong reliability and quick turnaround times in pathogen identification.

Rising Disease Burden Amplifies Testing Needs
The increasing prevalence of infectious diseases continues to elevate the demand for timely diagnostic testing. Their role in enabling early treatment and outbreak management remains crucial to healthcare outcomes. Key industry stakeholders are actively engaging in R&D and strategic partnerships to enhance diagnostic performance and expand test offerings. Over 40% of companies are channeling investments into innovations that improve test sensitivity and range, contributing to a highly dynamic and competitive market landscape.

Infectious Disease Diagnostic Market Recent Developments

In July 2022, F. Hoffmann-La Roche Ltd launched the Elecsys HCV Duo, a pioneering diagnostic test for hepatitis C. This advanced immunoassay is among the first commercially available tests that can simultaneously and independently detect both antigens and antibodies of the hepatitis C virus from a single human plasma or serum sample. By offering enhanced accuracy and faster results, the Elecsys HCV Duo significantly improves the early detection and management of HCV infections.
In February 2022, SEEGENE received the CE-IVD mark from the EU regulatory authority for its Allplex SARS-CoV-2 rapid MDx Assay. This advanced diagnostic tool is ideal for use in airports, schools, and other large-scale institutions, thanks to its ability to deliver accurate COVID-19 results in under 30 minutes. The rapid assay enhances large-scale testing capabilities, making it a crucial asset in public health screening initiatives.

Segment Analysis

In this report, the Infectious Disease Diagnostic Market has been segmented by Product, Type of Testing, Sample Type, Disease Type, End-use and Geography.

Infectious Disease Diagnostic Market, Segmentation by Product

The Infectious Disease Diagnostic Market has been segmented by Product into Reagents, Kits, And Consumables, and Instruments.

Reagents
Reagents play an essential role in infectious disease diagnostics by facilitating the chemical reactions required to detect pathogens accurately. These substances are integral to testing technologies such as PCR, immunoassays, and molecular diagnostics. With around 47% of the market share, reagents dominate the segment, driven by the growing need for precise, reliable, and rapid testing tools across clinical laboratories and research institutions.

Kits and Consumables
Kits and consumables consist of ready-to-use diagnostic sets and disposable items that simplify the testing process and ensure consistency. These products are widely used in hospitals, laboratories, and point-of-care settings due to their ease of use and fast turnaround times. This segment holds approximately 38% of the market and continues to grow, particularly with the increasing adoption of home-based testing and decentralized healthcare services.

Instruments
Instruments such as PCR analyzers, immunoassay systems, and lab automation equipment are pivotal for conducting large-scale diagnostic tests. Though their initial cost is higher, these systems offer enhanced efficiency and throughput. Currently accounting for about 15% of the market, instruments are gaining traction in both developed and developing regions as labs scale up their capabilities to meet rising diagnostic demands.

Infectious Disease Diagnostic Market, Segmentation by Type of Testing

The Infectious Disease Diagnostic Market has been segmented by Type of Testing into Laboratory Testing, and POC Testing.

Laboratory Testing
Laboratory-based testing holds the largest share in the infectious disease diagnostic market, owing to its superior accuracy and ability to handle high volumes of samples. These tests are typically conducted in hospital and reference labs using advanced technologies such as PCR, culture methods, and immunoassays. With approximately 63% of the market share, this segment is critical for accurate diagnosis, especially during disease outbreaks or for complex case analysis. Its dominance continues due to robust infrastructure and trusted diagnostic protocols.

Point-of-Care (POC) Testing
Point-of-Care (POC) testing offers rapid, convenient, and accessible diagnostics outside traditional laboratory environments. It plays a significant role in community health programs, emergency care, and at-home disease monitoring. Currently comprising about 37% of the market, POC testing is rapidly gaining popularity due to its ability to deliver immediate results, particularly in infectious diseases such as COVID-19, HIV, and influenza. Its portability and scalability make it ideal for developing countries and underserved regions.

This segmentation highlights the evolving landscape of infectious disease diagnostics, emphasizing the importance of tailored testing approaches to meet diverse global healthcare challenges.

Infectious Disease Diagnostic Market, Segmentation by Sample Type

The Infectious Disease Diagnostic Market has been segmented by Sample Type into Blood, Serum, and Plasma, and Urine.

Blood Samples
Blood-based diagnostics remain the most widely utilized approach in infectious disease testing due to their high sensitivity and comprehensive detection capabilities. Blood samples support various technologies such as PCR, ELISA, and rapid tests that detect pathogens, antibodies, and genetic material. With approximately 54% of the market share, this segment leads due to its versatility and diagnostic accuracy across a wide range of infectious diseases.

Serum and Plasma
Serum and plasma testing are essential components of infectious disease diagnostics, particularly for monitoring viral loads, antibody presence, and inflammatory markers. Derived from blood, these components are highly effective in precision-based assays. They contribute around 34% to the market, favored for their use in high-throughput laboratories and diagnostic platforms focused on viruses like HIV and hepatitis.

Urine Samples
Urine-based diagnostics offer a non-invasive and convenient sample collection method, making them increasingly popular in point-of-care and home-testing scenarios. Though traditionally limited in scope, innovations in molecular testing are broadening their application to include respiratory and systemic infections. Currently making up about 12% of the market, urine testing is on the rise, especially in STI detection and screening for viral infections.

Infectious Disease Diagnostic Market, Segmentation by Disease Type

The Infectious Disease Diagnostic Market has been segmented by Disease Type into Hepatitis, Human Immunodeficiency Virus, Chlamydia Trachomatis Genital Infection & Gonorrhea, Hospital Acquired Infections, Human Papillomavirus, Tuberculosis, Influenza, and Others.

Hepatitis
The Hepatitis diagnostics segment is witnessing strong growth due to the global prevalence of chronic Hepatitis B and Hepatitis C infections. Approximately 3.5% of the global population is infected with Hepatitis B, while nearly 1% are affected by Hepatitis C. Early and accurate diagnostic tools are essential to prevent severe liver-related complications and support timely treatment.

Human Immunodeficiency Virus (HIV)
The market for HIV diagnostics is expanding rapidly, driven by advancements in testing technologies and large-scale awareness programs. Around 0.7% of the adult population globally lives with HIV. Continued public health initiatives and funding are enhancing diagnostic outreach, especially in underserved regions.

Chlamydia Trachomatis Genital Infection & Gonorrhea
Chlamydia and Gonorrhea diagnostics are critical for controlling the spread of these common STIs. Chlamydia affects about 4.2% and Gonorrhea 0.9% of women aged 15 to 49 worldwide. The adoption of advanced NAATs has significantly improved detection rates, boosting the diagnostic segment's growth.

Hospital Acquired Infections (HAIs)
The HAIs diagnostics segment addresses infections contracted within healthcare facilities, impacting up to 7% of hospitalized patients in developed countries. Rising concerns over antimicrobial resistance and hospital safety protocols are accelerating the demand for efficient diagnostic solutions.

Human Papillomavirus (HPV)
HPV diagnostic tools are gaining traction due to their role in cervical cancer prevention. High-risk HPV strains affect nearly 11% of women worldwide. Accurate molecular diagnostics and DNA-based screening tests are becoming standard in preventive healthcare.

Tuberculosis (TB)
The TB diagnostics market plays a pivotal role in detecting active and latent TB cases. With around 10% of the global population carrying latent TB infection, molecular and point-of-care testing options are essential for early detection and containment of the disease.

Influenza
Influenza diagnostic testing sees high demand due to its widespread seasonal impact. Annual flu infection rates range from 5–10% in adults and up to 30% in children. Rapid testing enables faster clinical decisions and helps control outbreaks more effectively.

Infectious Disease Diagnostic Market, Segmentation by End-use

The Infectious Disease Diagnostic Market has been segmented by End-use into Hospital/Clinical laboratories, Reference laboratories and Others.

Hospital/Clinical Laboratories
Hospital and clinical laboratories dominate the infectious disease diagnostics market due to their ability to perform a wide variety of tests essential for patient care. With access to a steady flow of patient samples and on-site diagnostic capabilities, these labs are critical for immediate diagnosis and treatment initiation. Holding around 58% of the total market, this segment is essential for emergency care, surgical cases, and general clinical diagnostics.

Reference Laboratories
Reference laboratories provide specialized diagnostic services that support both public and private healthcare facilities. Known for their high-throughput processing and access to sophisticated testing platforms, these labs handle complex and large-scale testing needs. Comprising roughly 29% of the market, their significance has grown during public health emergencies, where centralized testing plays a key role in disease surveillance and response.

Infectious Disease Diagnostic Market, Segmentation by Geography

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

Regions and Countries Analyzed in this Report

Legend

North America

Rest of North America

Europe

Rest of Europe

Asia Pacific

Rest of Asia Pacific

Middle East and Africa

Rest of Middle East and Africa

Latin America

Rest of Latin America

Rest of the World

Infectious Disease Diagnostic Market Share (%), by Geographical Region, 2024

North America
North America remains at the forefront of the infectious disease diagnostic market, driven by advanced healthcare systems, ongoing R&D efforts, and widespread implementation of rapid and molecular diagnostic technologies. The region benefits from established reimbursement policies and strong public health initiatives. Currently holding approximately 41% of the total market, North America continues to lead in both innovation and adoption rates.

Europe
Europe plays a significant role in shaping the diagnostic landscape through its centralized healthcare structure and strong disease surveillance networks. The region's growth is supported by a rising focus on early diagnosis and coordinated healthcare delivery. With a market share of around 27%, Europe maintains momentum through collaborative R&D and widespread availability of testing services.

Asia Pacific
Asia Pacific represents a high-growth opportunity in the infectious disease diagnostics sector. Increasing healthcare funding, a growing middle-class population, and frequent disease outbreaks are prompting rapid investments in diagnostic infrastructure. With about 22% of global share, this region is advancing through technological adoption, especially in decentralized and point-of-care diagnostics.

Middle East & Africa and Latin America
Middle East & Africa and Latin America are steadily expanding markets with untapped potential. While their combined market share stands at around 10%, both regions are gaining traction due to increased attention on epidemic preparedness, expanding laboratory networks, and improving healthcare access in remote areas.

Infectious Disease Diagnostic Market Trends

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.

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

Increasing Prevalence of Infectious Diseases
Emergence of New Pathogens and Disease Outbreaks
Demand for Rapid and Accurate Diagnostic Solutions
Technological Advancements in Diagnostic Technologies
Growing Awareness and Focus on Public Health - The rising public awareness of infectious diseases has become a crucial driver in the expansion of the infectious disease diagnostic market. Increased health literacy among populations, fueled by widespread educational campaigns and digital media, has led to a greater emphasis on early disease detection and preventive healthcare. People are now more aware of the risks posed by viral, bacterial, and parasitic infections, and this has translated into a growing demand for accurate and rapid diagnostic tools. The heightened perception of personal and community health risks has created a favorable environment for the widespread adoption of diagnostic solutions.

In parallel, initiatives by governments and global health organizations are further strengthening diagnostic frameworks. Strategic investments in healthcare infrastructure, infectious disease surveillance, and laboratory networks have significantly improved access to diagnostics, particularly in developing regions. The COVID-19 pandemic underscored the necessity for robust testing systems, further accelerating innovations and scaling up of diagnostic services. As public health continues to be a global priority, the market for infectious disease diagnostics is expected to see sustained growth, driven by the combined momentum of informed communities and institutional support.

Restraints

Limited Access to Diagnostic Facilities in Developing Regions
High Cost Associated with Advanced Diagnostic Technologies
Stringent Regulatory Requirements for Diagnostic Tests
Challenges in Differentiating Between Similar Infectious Agents
Risk of False Positive or False Negative Results - A significant restraint in the growth of the infectious disease diagnostic market is the persistent risk of false positive and false negative results. These inaccuracies can lead to serious implications for patient care and public health. A false negative result may prevent an infected individual from receiving timely treatment and increase the likelihood of disease transmission. Conversely, a false positive result can cause unnecessary anxiety, lead to unwarranted treatment, and strain healthcare resources. Such diagnostic errors undermine trust in testing systems and hinder effective disease surveillance, especially during major outbreaks.

Several factors contribute to these challenges, including sample contamination, technological limitations of diagnostic assays, and operator-related errors. In under-resourced settings, the lack of advanced laboratory infrastructure and trained personnel further elevates the likelihood of inaccurate outcomes. Even with high-sensitivity

Opportunities

Expansion into Emerging Markets
Development of Multiplex Diagnostic Assays
Integration of Artificial Intelligence (AI) and Machine Learning (ML) in Diagnostic Platforms
Point-of-Care Testing (POCT) in Resource-Limited Settings
Collaboration with Public Health Agencies and Research Institutions - Collaboration with public health agencies and research institutions offers a significant opportunity to accelerate the growth of the infectious disease diagnostic market. These partnerships support the advancement of innovative diagnostic technologies by enabling access to valuable epidemiological data and funding resources. Organizations such as the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) play a crucial role in guiding industry priorities, while also fostering an ecosystem that encourages faster development and deployment of diagnostics for both new and existing infectious threats.

Research institutions bring scientific depth and technical expertise that complement the commercialization capabilities of diagnostic manufacturers. Collaborating with universities and research centers allows companies to leverage cutting-edge developments in fields like genomics, molecular biology, and microbiology. These alliances help streamline the transition from laboratory research to real-world applications, ensuring that new diagnostics are not only effective but also responsive to the specific needs of different regions and healthcare systems.

Such collaborations also enhance access to real-time disease surveillance data, enabling companies to anticipate outbreaks and scale production to meet rising demand. During health crises such as the COVID-19 pandemic, these joint efforts proved essential in accelerating diagnostic availability through fast-track approvals and public health initiatives. Governments and global health organizations often back these initiatives with regulatory support and financial incentives, reducing time-to-market

Infectious Disease Diagnostic Market Competitive Landscape Analysis

Key players in Infectious Disease Diagnostic Market include,

Roche Diagnostics
Abbott Laboratories
Siemens Healthineers
Thermo Fisher Scientific
BioMérieux SA
Becton, Dickinson and Company
Cepheid
Hologic, Inc.
QIAGEN N.V.
Bio-Rad Laboratories, Inc.
Luminex Corporation
Ortho Clinical Diagnostics
DiaSorin S.p.A.
Meridian Bioscience, Inc.
GenMark Diagnostics, Inc.

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

Introduction
1. Research Objectives and Assumptions
2. Research Methodology
3. Abbreviations
Market Definition & Study Scope
Executive Summary
1. Market Snapshot, By Product
2. Market Snapshot, By Type of Testing
3. Market Snapshot, By SampleType
4. Market Snapshot, By Disease Type
5. Market Snapshot, By End-use
6. Market Snapshot, By Region
Infectious Disease Diagnostic Market Dynamics
1. Drivers, Restraints and OpportunitiesPEST Analysis
  1. Drivers
    1. Increasing Prevalence of Infectious Diseases
    2. Emergence of New Pathogens and Disease Outbreaks
    3. Demand for Rapid and Accurate Diagnostic Solutions
    4. Technological Advancements in Diagnostic Technologies
    5. Growing Awareness and Focus on Public Health
  2. Restraints
    1. Limited Access to Diagnostic Facilities in Developing Regions
    2. High Cost Associated with Advanced Diagnostic Technologies
    3. Stringent Regulatory Requirements for Diagnostic Tests
    4. Challenges in Differentiating Between Similar Infectious Agents
    5. Risk of False Positive or False Negative Results
  3. Opportunities
    1. Expansion into Emerging Markets
    2. Development of Multiplex Diagnostic Assays
    3. Integration of Artificial Intelligence (AI) and Machine Learning (ML) in Diagnostic Platforms
    4. Point-of-Care Testing (POCT) in Resource-Limited Settings
    5. Collaboration with Public Health Agencies and Research Institutions
2. Political Analysis
  1. Economic Analysis
  2. Social Analysis
  3. Technological Analysis
3. Porter's Analysis
  1. Bargaining Power of Suppliers
  2. Bargaining Power of Buyers
  3. Threat of Substitutes
  4. Threat of New Entrants
  5. Competitive Rivalry
Market Segmentation
1. Infectious Disease Diagnostic Market, By Product, 2021 - 2031 (USD Million)
  1. Reagents
  2. Kits
  3. Consumables
  4. Instruments
2. Infectious Disease Diagnostic Market, By Type of Testing, 2021 - 2031 (USD Million)
  1. Laboratory Testing
  2. POC Testing
3. Infectious Disease Diagnostic Market, By Sample Type, 2021 - 2031 (USD Million)
  1. Blood
  2. Serum
  3. Plasma
  4. Urine
4. Infectious Disease Diagnostic Market, By Disease Type, 2021 - 2031 (USD Million)
  1. Hepatitis
  2. Human Immunodeficiency Virus
  3. Chlamydia Trachomatis Genital Infection and Gonorrhea
  4. Hospital acquired infections
  5. Human Papillomavirus
  6. Tuberculosis
  7. Influenza
  8. Others
5. Infectious Disease Diagnostic Market, By End-use, 2021 - 2031 (USD Million)
  1. Hospital/Clinical laboratories
  2. Reference laboratories
  3. Others
6. Infectious Disease Diagnostic Market, By Geography, 2021 - 2031 (USD Million)
  1. North America
    1. United States
    2. Canada
  2. Europe
    1. Germany
    2. United Kingdom
    3. France
    4. Italy
    5. Spain
    6. Nordic
    7. Benelux
    8. Rest of Europe
  3. Asia Pacific
    1. Japan
    2. China
    3. India
    4. Australia & New Zealand
    5. South Korea
    6. ASEAN(Association of South East Asian Countries)
    7. Rest of Asia Pacific
  4. Middle East & Africa
    1. GCC
    2. Israel
    3. South Africa
    4. Rest of Middle East & Africa
  5. Latin America
    1. Brazil
    2. Mexico
    3. Argentina
    4. Rest of Latin America
Competitive Landscape
1. Company Profiles
  1. Roche Diagnostics
  2. Abbott Laboratories
  3. Siemens Healthineers
  4. Thermo Fisher Scientific
  5. BioMérieux SA
  6. Becton, Dickinson and Company
  7. Cepheid
  8. Hologic, Inc.
  9. QIAGEN N.V.
  10. Bio-Rad Laboratories, Inc.
  11. Luminex Corporation
  12. Ortho Clinical Diagnostics
  13. DiaSorin S.p.A.
  14. Meridian Bioscience, Inc.
  15. GenMark Diagnostics, Inc.
Analyst Views
Future Outlook of the Market