Infectious Diseases Diagnostic Market Size, Share, Growth, and Industry Analysis, By Types (Urine, Blood, Others) , Applications (Hospitals and Trauma Centers, Diagnostic Laboratories, Rehabilitation Centers, Others) and Regional Insights and Forecast to 2034

Infectious Diseases Diagnostic Market Size

The Global Infectious Diseases Diagnostic Market was valued at USD 26.64 Billion in 2024, is projected to reach USD 28.6 Billion in 2025, and is expected to rise to USD 30.7 Billion by 2026. The market is further estimated to reach approximately USD 54.1 Billion by 2034, expanding at a robust CAGR of 7.34% from 2025 to 2034. The growth of the Infectious Diseases Diagnostic Market is attributed to technological advancements in molecular diagnostics, rapid test kits, and increasing global demand for point-of-care testing solutions that ensure early disease detection and outbreak management.

The U.S. Infectious Diseases Diagnostic Market holds a dominant position globally, supported by advanced healthcare infrastructure, high testing volumes, and continuous innovation in molecular diagnostics. The market is driven by the increasing prevalence of infectious diseases and strong investments in research and development. With widespread adoption of PCR-based assays, rapid antigen kits, and digital diagnostic platforms, the United States accounts for nearly one-third of the total global share. Additionally, the presence of leading manufacturers and government-funded screening programs continues to accelerate domestic demand and product innovation.

Key Findings

• Market Size : Valued at USD 28.6 Billion in 2025 and expected to reach USD 54.1 Billion by 2034 with a CAGR of 7.34 %.
• Growth Drivers : Approximately 42 % increase in molecular testing and 38 % growth in point-of-care adoption fuel market expansion.
• Trends : Nearly 45 % rise in AI-driven diagnostic automation and 31 % increase in home-based test usage shaping future demand.
• Key Players : Roche Diagnostics, Abbott Laboratories, QIAGEN, Thermo Fisher Scientific, bioMérieux.
• Regional Insights : North America 32 %, Europe 27 %, Asia-Pacific 29 %, Middle East & Africa 12 % of global market share.
• Challenges : About 40 % of developing countries face testing cost constraints and limited lab infrastructure.
• Industry Impact : More than 50 % of hospitals worldwide adopted digital infection-monitoring tools to enhance diagnostic efficiency.
• Recent Developments : Over 35 % of new products focus on multiplex testing and portable molecular devices.

The Infectious Diseases Diagnostic Market is evolving rapidly due to growing global health awareness and the urgent need for faster, more reliable diagnostic solutions. More than 65% of infectious disease testing worldwide now incorporates molecular and immunodiagnostic technologies, improving detection accuracy and turnaround time. The demand for multiplex assays capable of identifying multiple pathogens simultaneously has increased by 42% in the last two years. Furthermore, the shift toward decentralized testing, driven by portable and point-of-care devices, is transforming traditional laboratory workflows and expanding accessibility in developing regions. Manufacturers are focusing on integrated diagnostic platforms that combine data analytics with real-time disease surveillance to support global health initiatives.

Infectious Diseases Diagnostic Market Trends

The global Infectious Diseases Diagnostic Market is witnessing strong growth trends due to the rising prevalence of infectious diseases such as tuberculosis, HIV, influenza, and COVID-related infections. An estimated 38% of diagnostic revenue in 2025 will come from molecular diagnostic tests due to their high sensitivity and specificity. The increasing adoption of PCR-based and next-generation sequencing (NGS) technologies is driving accuracy improvements, while the use of artificial intelligence for automated data analysis has increased testing speed by 45% across leading laboratories. Point-of-care diagnostics account for nearly 34% of total test volume worldwide, with demand surging in rural and low-resource healthcare systems.

Additionally, government health initiatives promoting disease control, such as WHO’s Global Health Security Agenda, are propelling diagnostic adoption rates by 28% annually. The surge in antimicrobial resistance (AMR) testing has prompted manufacturers to design rapid detection kits capable of identifying resistant strains within minutes. Moreover, the growing emphasis on personalized medicine and preventive healthcare is creating new opportunities for multiplex diagnostic panels and pathogen detection tools. With digital diagnostic platforms gaining traction, cloud-based test management systems are enabling real-time monitoring and outbreak tracking in hospitals and research centers globally. The combination of automation, IoT, and smart diagnostic connectivity is redefining the landscape of infectious disease management and creating an integrated diagnostic ecosystem that improves both clinical outcomes and operational efficiency.

Infectious Diseases Diagnostic Market Dynamics

OPPORTUNITY

Expanding Adoption of Point-of-Care Diagnostics

The Infectious Diseases Diagnostic Market is experiencing substantial opportunities due to the rapid adoption of point-of-care diagnostic solutions. Around 35% of healthcare institutions globally have deployed portable diagnostic devices, enabling faster infection detection and treatment decisions. The increasing use of compact molecular and immunodiagnostic kits in rural and low-resource settings improves access to essential testing for diseases such as HIV, malaria, and influenza. Technological integration with smartphone-based readers and IoT-enabled connectivity is expected to further enhance diagnostic precision and accessibility.

DRIVERS

Rising Global Disease Burden and Demand for Rapid Testing

The increasing global prevalence of infectious diseases remains a major driver for market growth. Over 28% of the world’s population experiences at least one infectious outbreak each year, leading to a heightened need for diagnostic accuracy and early detection. Continuous government investments in epidemic preparedness and global testing initiatives have led to a 32% increase in annual diagnostic test volumes. The demand for molecular diagnostics and antigen detection kits has strengthened laboratory workflows and driven market competitiveness across healthcare institutions worldwide.

Market Restraints

"Limited Infrastructure in Emerging Economies"

The Infectious Diseases Diagnostic Market faces notable restraints due to the lack of adequate diagnostic infrastructure in developing regions. Approximately 45% of low-income nations do not possess advanced molecular laboratories capable of performing PCR or NGS-based testing. Challenges such as high setup costs, lack of technical workforce, limited reagent supply, and poor reimbursement systems hinder diagnostic capacity expansion. Moreover, the absence of global quality control standards leads to inconsistent test performance, reducing trust in diagnostic accuracy in remote healthcare systems.

Market Challenges

"High Equipment Costs and Regulatory Complexities"

One of the critical challenges affecting the Infectious Diseases Diagnostic Market is the high cost associated with advanced testing systems and reagents. More than 40% of hospitals in emerging markets face affordability issues for automated analyzers and immunodiagnostic equipment. Additionally, differences in regulatory approvals and test validation processes across countries delay market entry for global manufacturers. Complex reimbursement structures and low patient awareness further restrict widespread adoption, creating a need for harmonized global diagnostic policies and affordable pricing strategies.

Segmentation Analysis

The Infectious Diseases Diagnostic Market is segmented based on Type and Application. By Type, it includes Urine, Blood, and Others, with the Blood segment holding the dominant share due to high testing reliability and global use in virology and immunology diagnostics. By Application, the market is classified into Hospitals & Trauma Centers, Diagnostic Laboratories, Rehabilitation Centers, and Others. Hospitals and diagnostic laboratories collectively account for over 70% of global revenue, driven by advancements in molecular diagnostics, automation, and integrated software-based test management systems.

By Type

Urine

Urine-based testing is witnessing rapid growth in the Infectious Diseases Diagnostic Market owing to its non-invasive nature and ease of specimen collection. Around 22% of infectious disease screenings globally rely on urine samples for pathogen identification, particularly in urinary tract infections and sexually transmitted diseases.

The Urine segment held a market size of USD 6.29 Billion in 2025, representing 22% of the total share, and is projected to grow at a CAGR of 6.8% during 2025–2034.

Major Dominant Countries in the Urine Segment

• United States – 34% share, driven by innovation in urinary antigen testing systems.
• Germany – 18% share, supported by strong diagnostic lab infrastructure.
• Japan – 11% share, due to high adoption of portable urine analyzers.

Blood

Blood-based diagnostics dominate the global Infectious Diseases Diagnostic Market, accounting for approximately 52% of total testing volume. Blood assays are crucial for detecting viral infections such as HIV, hepatitis, and influenza, providing the highest accuracy and reliability. Increased automation and molecular assay development have reinforced the dominance of this category.

The Blood segment achieved a market size of USD 14.87 Billion in 2025, holding 52% share, and is expected to expand at a CAGR of 7.5% through 2034.

Major Dominant Countries in the Blood Segment

• United States – 36% share, leading in molecular diagnostic and blood screening technologies.
• China – 22% share, with high-scale testing across infectious disease control programs.
• United Kingdom – 14% share, fueled by early adoption of immunodiagnostic techniques.

Others

The Others segment comprises saliva, sputum, and tissue-based diagnostics used primarily for respiratory and tropical diseases. Continuous improvements in sample processing, biosensors, and sequencing technologies have made non-traditional samples increasingly viable for accurate testing.

This segment accounted for USD 7.44 Billion in 2025, with a 26% market share, growing steadily at a CAGR of 7.1% through the forecast period.

Major Dominant Countries in the Others Segment

• India – 29% share, owing to extensive tuberculosis screening initiatives.
• Brazil – 18% share, driven by respiratory infection diagnostic programs.
• South Korea – 13% share, focusing on saliva-based viral testing innovations.

By Application

Hospitals and Trauma Centers

Hospitals and trauma centers lead the market, accounting for 38% of global diagnostic revenue. High patient inflow, infection control needs, and emergency testing requirements have driven investment in automated testing platforms and integrated infection monitoring systems.

The segment reached a market size of USD 10.87 Billion in 2025 and is projected to grow at a CAGR of 7.2% through 2034.

Major Dominant Countries in the Hospitals and Trauma Centers Segment

• United States – 41% share, due to rapid adoption of automated diagnostic analyzers.
• France – 16% share, supported by advanced infectious disease prevention programs.
• Japan – 11% share, emphasizing precision diagnostics in hospitals.

Diagnostic Laboratories

Diagnostic laboratories represent 32% of total market share, playing a critical role in mass-scale disease detection. Around 60% of global molecular diagnostic tests are performed in centralized laboratories, supported by growing private lab networks and cross-border testing collaborations.

This segment achieved a market size of USD 9.15 Billion in 2025 and is projected to expand at a CAGR of 7.4% over the forecast period.

Major Dominant Countries in the Diagnostic Laboratories Segment

• United States – 35% share, backed by strong molecular diagnostics capability.
• Germany – 21% share, with advanced laboratory infrastructure.
• India – 12% share, driven by private testing chain expansion.

Rehabilitation Centers

Rehabilitation centers contribute 18% to global revenue, focusing on patient recovery and post-treatment infection control. Increasing demand for follow-up diagnostic tests and infection surveillance is strengthening the segment’s adoption rate.

This segment recorded USD 5.15 Billion in 2025 and is forecasted to grow at a CAGR of 6.9%.

Major Dominant Countries in the Rehabilitation Centers Segment

• United Kingdom – 29% share, supported by advanced rehabilitation monitoring programs.
• Canada – 18% share, driven by preventive infection initiatives.
• South Korea – 11% share, implementing smart infection detection in recovery centers.

Others

The Others segment includes mobile clinics, community health centers, and NGOs providing infectious disease testing in underserved areas. This category contributes 12% to global demand and is expected to grow steadily as public health testing initiatives expand.

The segment accounted for USD 3.43 Billion in 2025 and is expected to increase at a CAGR of 7.0%.

Major Dominant Countries in the Others Segment

• China – 31% share, expanding mobile laboratory testing capabilities.
• Nigeria – 19% share, led by malaria and HIV testing outreach.
• Brazil – 12% share, with rising government diagnostic campaigns.

Infectious Diseases Diagnostic Market Regional Outlook

The Global Infectious Diseases Diagnostic Market, valued at USD 26.64 Billion in 2024 and projected to reach USD 28.6 Billion in 2025, is anticipated to surge to USD 54.1 Billion by 2034, exhibiting a CAGR of 7.34%. North America dominates due to advanced healthcare infrastructure, while Asia-Pacific demonstrates the fastest expansion supported by public-health investments and domestic test-kit manufacturing. Regional market shares are distributed as follows — North America 32%, Europe 27%, Asia-Pacific 29%, and Middle East & Africa 12%, collectively accounting for 100 % of global revenue.

North America

North America holds approximately 32% of the total market share, led by high infection surveillance programs and early adoption of molecular testing. Strong R&D activities and growing demand for rapid antigen and PCR-based assays continue to boost growth in both public and private laboratories.

North America accounted for USD 9.15 Billion in 2025, driven by technological integration and government-funded diagnostic initiatives.

North America – Major Dominant Countries in the Market

• United States – 60% regional share due to widespread use of AI-driven molecular testing platforms.
• Canada – 25% share supported by strong hospital diagnostic infrastructure.
• Mexico – 15% share with rising investment in point-of-care testing centers.

Europe

Europe contributes 27% of global revenue, propelled by national infection-control policies, cross-border diagnostic networks, and increased use of immunoassay-based kits. Public-private partnerships enhance large-scale testing capacity across major countries.

Europe reached USD 7.72 Billion in 2025, supported by continuous modernization of laboratory infrastructure.

Europe – Major Dominant Countries in the Market

• Germany – 35% share led by advancements in automated testing systems.
• France – 30% share driven by public screening programs and pandemic preparedness.
• United Kingdom – 20% share supported by rapid adoption of digital diagnostics.

Asia-Pacific

Asia-Pacific represents 29% of the market and shows the highest growth potential due to population density, infectious disease prevalence, and rising healthcare expenditure. Large-scale investments in domestic diagnostic manufacturing and digital health initiatives are accelerating regional demand.

Asia-Pacific stood at USD 8.29 Billion in 2025, driven by expanding hospital networks and improved disease surveillance systems.

Asia-Pacific – Major Dominant Countries in the Market

• China – 38% share with massive expansion of PCR testing facilities.
• India – 28% share supported by national infectious disease control programs.
• Japan – 18% share due to advanced automation and AI integration in laboratories.

Middle East & Africa

The Middle East & Africa segment accounts for 12% of global revenue. Growth is driven by increased government focus on healthcare modernization and international aid for infectious disease testing infrastructure, particularly for tuberculosis, malaria, and HIV programs.

The region’s value was USD 3.44 Billion in 2025, fueled by improved access to affordable diagnostics.

Middle East & Africa – Major Dominant Countries in the Market

• United Arab Emirates – 33% share with rapid adoption of digital lab solutions.
• South Africa – 30% share driven by government disease-control initiatives.
• Saudi Arabia – 20% share due to increasing private-sector investments.

LIST OF KEY Infectious Diseases Diagnostic Market COMPANIES PROFILED

Investment Analysis and Opportunities

Investments in the Infectious Diseases Diagnostic Market have accelerated as governments and private entities focus on pandemic readiness and healthcare resilience. More than 45% of new healthcare funds in 2024–2025 were directed toward expanding molecular diagnostic infrastructure and local manufacturing units. Strategic partnerships between biotech startups and global diagnostic leaders are fueling innovation in sample preparation, reagent formulation, and AI-based data analytics. Venture capital funding in digital diagnostic platforms grew by 38%, signaling strong investor confidence. Emerging economies like India, Brazil, and Indonesia present high-return opportunities owing to increasing public health budgets, rapid test adoption, and diagnostic digitization initiatives.

New Products Development

The market has witnessed consistent new-product launches focusing on automation, multiplex detection, and next-generation molecular platforms. Over 30% of newly introduced infectious-disease test kits in 2025 are multiplexed, capable of detecting multiple pathogens in a single run. Companies like Abbott, Roche, and Thermo Fisher have launched integrated PCR systems with real-time cloud-based data reporting to improve traceability. Development of antigen-based home-testing kits has expanded accessibility across emerging nations, while microfluidic lab-on-chip devices are revolutionizing portable diagnostics. Continuous R&D in biosensors and CRISPR-based detection is expected to redefine accuracy and reduce testing time by over 40% in the coming decade.

Recent Developments

• Roche Diagnostics launched a fully automated multiplex PCR system enhancing pathogen-detection efficiency by 35%.
• Abbott Laboratories introduced a rapid antigen test for respiratory viruses with expanded digital connectivity features.
• Thermo Fisher Scientific announced collaboration with public health agencies to develop AI-based data monitoring tools.
• bioMérieux SA unveiled an enhanced immunoassay platform reducing false positive rates by 28%.
• Danaher Corporation invested in portable molecular diagnostic startup for real-time disease detection.

Report Coverage

This report provides a comprehensive analysis of the Infectious Diseases Diagnostic Market, covering market size, trends, segmentation, competitive landscape, and regional performance from 2024 to 2034. It evaluates technological advancements, product innovations, and strategic initiatives shaping the industry. The coverage includes in-depth examination of key players’ portfolios, R&D investments, distribution networks, and growth strategies. Emphasis is placed on the transition toward decentralized testing, digital connectivity, and data-driven diagnostics. The report also analyzes regulatory frameworks, sustainability factors, and future investment prospects driving long-term industry expansion worldwide.