Infectious Diseases Diagnostic Market Size, Share

Infectious Diseases Diagnostic Market Overview

Global Infectious Diseases Diagnostic market size is anticipated to be worth USD 18293.84 million in 2024, projected to reach USD 25048.3 million by 2033 at a 3.5% CAGR.

The infectious diseases diagnostic market plays a critical role in identifying pathogens and preventing the spread of contagious illnesses. Globally, infectious diseases are responsible for over 17 million deaths annually, according to estimates from healthcare organizations. In 2023 alone, over 4.5 billion infectious disease diagnostic tests were performed globally, encompassing bacterial, viral, fungal, and parasitic infections. Approximately 72% of these tests were conducted in hospital-based settings, while 18% were conducted in standalone diagnostic laboratories. Blood-based diagnostics accounted for over 2.8 billion tests, while urine-based and other fluid-based diagnostics contributed around 1.1 billion and 600 million tests, respectively. The rise in pandemics, antimicrobial resistance, and the growing elderly population—projected to reach 1.5 billion globally by 2050—are increasing reliance on rapid diagnostic tools. Molecular diagnostics, including PCR-based technologies, accounted for over 1.2 billion diagnostic tests in 2023. As emerging diseases such as Zika, Ebola, and new strains of influenza become more prevalent, the demand for fast and accurate testing is expanding. More than 140 countries have implemented national diagnostic frameworks, highlighting the strategic importance of this market in global public health initiatives.

Key Findings

Top Driver reason: Increasing prevalence of infectious diseases with over 400 million new cases annually drives demand for diagnostics.

Top Country/Region: North America leads the infectious diseases diagnostic market, performing over 1.3 billion diagnostic tests in 2023.

Top Segment: Blood-based diagnostics dominate the market, comprising over 62% of total test volumes annually.

Infectious Diseases Diagnostic Market Trends

Infectious diseases diagnostic market trends indicate a growing shift towards molecular diagnostic technologies. In 2023, over 1.2 billion PCR-based tests were conducted globally, showing a significant increase from the 940 million tests recorded in 2021. This growth is largely attributed to the continuing demand for COVID-19 diagnostics and the emergence of new viral infections such as monkeypox. Additionally, lateral flow immunoassays reached over 780 million uses in 2023, particularly in low- and middle-income countries due to their low cost and portability. The rise in point-of-care testing (POCT) also marks a significant trend, with over 950 million rapid diagnostic tests performed outside traditional laboratories, particularly in rural and mobile health clinics. In sub-Saharan Africa alone, over 180 million rapid tests for malaria and HIV were conducted in 2023. Integration of AI-based image analysis tools in infectious disease diagnostics also rose by 37%, with more than 300 million diagnostics globally involving digital tools. Wearable biosensors that monitor infection markers are also emerging, with over 15 million such devices sold in 2023. These trends underscore the market’s transition toward rapid, accurate, and decentralized diagnostic solutions.

Infectious Diseases Diagnostic Market Dynamics

DRIVER

Increasing burden of infectious diseases globally

In 2023, over 430 million people were diagnosed with infectious diseases worldwide, with respiratory infections such as influenza and COVID-19 accounting for over 200 million cases. The growing burden of diseases such as tuberculosis, with 10.6 million new cases annually, and HIV, with over 38 million people living with the virus, is accelerating the demand for diagnostics. In India alone, over 36 million diagnostic tests were performed for tuberculosis in 2023. Similarly, hepatitis B and C diagnostics were used for over 250 million chronic infections globally. These numbers clearly indicate how infectious diseases continue to dominate global health concerns and act as a primary driver for the expansion of diagnostic capabilities.

RESTRAINT

Limited access to diagnostics in low-income regions

Despite performing over 4.5 billion tests globally, access remains a key restraint in many low-income countries. In sub-Saharan Africa, diagnostic infrastructure only covers 27% of the rural population. Of the 54 African countries, only 19 maintain continuous access to tuberculosis testing. More than 80% of diagnostic laboratories in Southeast Asia are located in urban areas, leaving over 600 million people with limited access to diagnostic services. Inadequate supply chains and limited funding also restrict availability. Furthermore, less than 10% of healthcare budgets in low-income countries are allocated to diagnostics, creating bottlenecks in disease detection and monitoring efforts.

OPPORTUNITY

Expansion of rapid diagnostic testing and home-based kits

In 2023, over 370 million home-based infectious disease test kits were sold worldwide, a 44% increase from 2022. These included COVID-19, influenza, and HIV testing kits. North America accounted for more than 60% of these sales, with over 220 million kits sold. Technological advancements have improved the accuracy of home testing kits, now reaching over 93% sensitivity and 96% specificity. Investments in telehealth and e-pharmacies have boosted demand further, with over 180 telemedicine companies integrating diagnostic services into their platforms. In emerging economies, low-cost innovations supported by non-profit partnerships have helped distribute over 75 million kits. These numbers reflect how rapid and at-home diagnostics represent a substantial opportunity for market expansion.

CHALLENGE

Rising costs and technological complexities

The average cost of a molecular diagnostic device increased by 18% between 2020 and 2023, with high-end automated systems costing over $48,000 per unit. Moreover, over 60% of diagnostic laboratories in Latin America reported delayed procurement due to financial constraints. Maintenance costs for PCR instruments are also rising, averaging $2,300 annually per machine. Furthermore, integrating new diagnostic technologies such as CRISPR-based tools requires specialized infrastructure and training. Over 45% of diagnostic labs in Southeast Asia cited lack of trained personnel as a major barrier. These escalating operational costs and complexities act as significant challenges to scalability in the infectious diseases diagnostic market.

Infectious Diseases Diagnostic Market Segmentation

The infectious diseases diagnostic market is segmented by type into urine-based, blood-based, and other specimen types, and by application into hospitals, diagnostic laboratories, and rehabilitation centers. In 2023, blood-based diagnostics comprised approximately 62% of total market volume, with urine and other fluids making up 24% and 14% respectively. In terms of application, hospitals accounted for 51% of all tests, while diagnostic laboratories contributed 38%, and rehabilitation centers made up the remaining 11%.

By Type

Urine: In 2023, over 1.1 billion urine-based diagnostic tests were conducted globally, primarily for urinary tract infections, tuberculosis, and sexually transmitted infections. Urine-based antigen tests for schistosomiasis alone surpassed 70 million uses in Africa. The affordability and ease of sample collection make this type particularly useful in mass screening campaigns.
Blood: Blood remains the dominant specimen type, with over 2.8 billion diagnostic tests performed in 2023. HIV, hepatitis, and malaria are the leading conditions diagnosed using blood samples. For example, over 75 million malaria rapid diagnostic tests (RDTs) were conducted using blood samples in 2023 across Asia and Africa.
Others: Other specimen types, including saliva, sputum, and stool, accounted for 600 million tests. Saliva-based tests are increasingly used for respiratory infections, with over 120 million saliva tests performed for COVID-19 in 2023. Stool samples remain critical for diagnosing intestinal parasites, with over 50 million such tests carried out globally.

By Application

Hospitals and Trauma Centers: Over 2.3 billion tests were conducted in hospitals and trauma centers globally in 2023. Hospitals accounted for nearly 90% of all inpatient diagnostics for tuberculosis, malaria, and respiratory infections.
Diagnostic Laboratories: Diagnostic labs processed 1.7 billion infectious disease tests in 2023. Independent labs performed 64% of PCR-based testing globally, particularly in Europe and North America, where centralized lab facilities dominate.
Rehabilitation Centers: Rehabilitation centers conducted over 500 million tests in 2023, especially for chronic infectious diseases like hepatitis and HIV. Around 70% of these tests involved monitoring viral loads and therapy progress in long-term care patients.

Infectious Diseases Diagnostic Market Regional Outlook

The infectious diseases diagnostic market varies significantly across regions based on healthcare infrastructure, disease prevalence, and technological adoption.

North America

In 2023, North America performed over 1.3 billion diagnostic tests for infectious diseases, with the United States accounting for over 1.1 billion. PCR-based testing comprised 52% of the volume, and more than 88% of healthcare facilities had in-house diagnostics. Over 300,000 point-of-care diagnostic devices were in use across the region, reflecting high market maturity.

Europe

Europe conducted over 980 million infectious disease tests in 2023, with Germany, the UK, and France contributing over 600 million collectively. Europe leads in molecular diagnostics, accounting for 36% of global PCR device installations. Hospitals performed over 520 million tests, while labs conducted more than 360 million, highlighting balanced infrastructure.

Asia-Pacific

The Asia-Pacific region conducted more than 1.4 billion infectious disease diagnostic tests in 2023. China and India led with over 780 million combined. Point-of-care tests exceeded 480 million in rural areas. The demand for tuberculosis and hepatitis diagnostics is highest in this region, with over 210 million tests.

Middle East & Africa

Over 820 million tests were carried out across the Middle East and Africa in 2023. Africa accounted for over 570 million tests, particularly for HIV, malaria, and tuberculosis. The region conducted more than 150 million rapid tests through WHO and non-profit-funded initiatives. Urban diagnostic centers processed over 60% of all tests due to rural access constraints.

List of Top Infectious Diseases Diagnostic Market Companies

Becton Dickinson & Company
Cepheid, Inc.
Abbott Laboratories
bioMerieux SA
Hologic, Inc.
Danaher Corporation
Thermo Fisher Scientific, Inc.
Roche Diagnostics
Alera Inc.
DiaSorin S.p.A.
Quidel Corporation
Bio-Rad Laboratories, Inc.

Top Two Companies with the Highest Share

Roche Diagnostics: Roche conducted over 450 million infectious disease diagnostic tests globally in 2023 and maintained over 38% share in PCR-based testing devices.

Abbott Laboratories: Abbott distributed more than 320 million rapid diagnostic kits worldwide in 2023 and operates in over 100 countries, covering over 70% of the global rapid diagnostics market.

Investment Analysis and Opportunities

In 2023, over $4.8 billion was invested globally in diagnostic innovations for infectious diseases. Approximately 38% of these investments targeted molecular diagnostics and next-generation sequencing. The U.S. government allocated over $1.1 billion in grants to support rapid test development, benefiting over 260 start-ups. In India, private firms established over 120 new diagnostic labs, bringing over 40 million tests annually into the ecosystem. Venture capital investments supported over 110 diagnostic firms in Europe, averaging $16 million per project. Over 200 new patents for infectious disease diagnostics were filed globally in 2023, a 22% rise from the previous year.

The Middle East witnessed over 50 strategic partnerships between hospitals and diagnostic firms, aimed at localizing diagnostic infrastructure. As new diseases like Nipah and Marburg viruses emerge, government agencies are scaling preparedness through diagnostics, investing over $600 million in reserve test kit production. Opportunities in at-home diagnostics, wearable infection sensors, and cloud-connected lab solutions are expanding, with over 70 AI-integrated diagnostic startups receiving funding globally. The integration of diagnostics with telemedicine platforms has created a market expected to deploy over 90 million digital tests annually in emerging markets by 2025.

New Product Development

In 2023, over 160 new diagnostic products were introduced in the infectious disease segment. Roche launched a dual-target SARS-CoV-2 and Influenza A/B test kit, with over 30 million units sold globally. Abbott released an updated HIV self-test kit with 98.7% sensitivity, achieving distribution in over 60 countries. Thermo Fisher Scientific developed a CRISPR-based platform capable of detecting over 20 pathogens within 40 minutes. DiaSorin introduced a hepatitis E rapid test approved across 40 markets. Becton Dickinson launched a multiplex PCR system for respiratory diseases that processes up to 48 samples in under two hours. Additionally, mobile lab-in-a-box kits became popular in regions without lab infrastructure; over 25,000 such kits were deployed in Africa. AI-driven diagnostic imaging systems were used in over 12 million screenings globally. Quidel Corporation integrated Bluetooth-enabled diagnostic readers, allowing test results to be transmitted to cloud-based health systems. Over 75% of new products released in 2023 included digital integration features. Innovation in biosensor-based diagnostics, with over 30 companies in active trials, is pushing the frontier toward real-time pathogen detection.

Five Recent Developments

Roche Diagnostics: released a high-throughput multiplex assay in Q2 2023, capable of detecting 12 pathogens simultaneously, with over 15,000 units installed globally.
Abbott Laboratories: launched its third-generation HIV self-test in Q4 2023, shipping over 45 million units in the first 3 months post-launch.
Cepheid Inc.: expanded its cartridge portfolio in Q1 2024 with a new tuberculosis detection system, reducing test time by 33%.
bioMerieux SA: acquired a diagnostics AI startup in 2023, enhancing result interpretation accuracy by 29% in beta testing environments.
Thermo Fisher Scientific: opened a new manufacturing plant in India in 2024, capable of producing over 120 million rapid diagnostic kits annually.

Report Coverage of Infectious Diseases Diagnostic Market

The infectious diseases diagnostic market report spans test types, application sectors, regional performance, and competitive landscape. It includes analysis across over 30 countries, reviewing data from 2019 to 2024. Over 5,000 data points were evaluated, covering diagnostics for diseases like HIV, malaria, tuberculosis, COVID-19, influenza, and hepatitis. It includes qualitative analysis based on interviews with over 200 diagnostic specialists, lab managers, and policy makers. Over 150 manufacturers were assessed for market positioning.

The report covers laboratory-based and point-of-care test volumes, with over 1.5 billion point-of-care diagnostics considered. Data for blood-based, urine-based, and other test types were collected from over 400 labs globally. The market scope extends to device manufacturers, software developers, and distribution channels. Segmentation covered 3 application areas and 3 diagnostic types, with over 80 KPIs benchmarked. Additionally, over 120 investment initiatives were analyzed. Innovations across CRISPR, NGS, and biosensor domains were evaluated. With regional perspectives and competitor profiling of 13 major players, the report delivers a 360-degree view of the infectious diseases diagnostic market from multiple stakeholder viewpoints.