Towards Healthcare
Infectious Disease Diagnostics Market to Surge USD 62.95 Bn by 2034

Infectious Disease Diagnostics Market Evolution 2025 From Laboratory-Based to Point-of-Care Transformation

Market insights predict, the infectious disease diagnostics industry is expected to grow from USD 25.01 billion in 2024 to USD 62.95 billion by 2034, driven by a CAGR of 9.67%.The market is growing due to healthcare providers seeking faster, more reliable detection methods to control outbreaks. Growing awareness, government initiatives, and technological innovations in diagnostic tools are also fueling growth.

Category: Diagnostics Insight Code: 6012 Format: PDF / PPT / Excel

Infectious Disease Diagnostics Market Size, Key Players and Segment Insights

The global infectious disease diagnostics market size was valued at US$ 25.01 billion in 2024 and is projected to grow to US$ 27.43 billion in 2025. Forecasts suggest it will reach approximately US$ 62.95 billion by 2034, registering a CAGR of 9.67% during the period.

Infectious Disease Diagnostics Market Size 2024 to 2034

The infectious disease diagnostics market is witnessing steady growth driven by the rising prevalence of viral and bacterial infections, increasing demand for rapid and accurate testing, and advancements in molecular and point-of-care diagnostic technologies. Growing awareness, supportive government initiatives, and expanding healthcare infrastructure further fuel market adoption. The market encompasses diverse testing methods, including PCR, immunoassays, and next-generation sequencing, catering to hospitals, clinics, and research laboratories worldwide.

Key Takeaways

  • Infectious disease diagnostics industry poised to reach USD 25.01 billion by 2024.
  • Forecasted to grow to USD 62.95 billion by 2034.
  • Expected to maintain a CAGR of 9.67% from 2025 to 2034.
  • North America dominated the infectious disease diagnostics market revenue shares in 2024.
  • Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
  • By product service, the reagents, kits & consumables segments dominated the market.
  • By product service, the instruments segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By technology, the immunodiagnostics segment led the market in 2024.
  • By technology, the molecular diagnostics segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By testing setting, the laboratory-based testing segment held the highest infectious disease diagnostics market share in 2024.
  • By testing settings, the point-of-care (POC) testing segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By disease, the respiratory infections segment dominated the market in 2024 and is expected to grow at the fastest CAGR in the market during the forecast period.
  • By end-user, the hospitals segment held the highest revenue shares in the market in 2024.
  • By end-user, the diagnostic laboratories segment grows significantly in the market during the forecast period.

Quick Facts Table

Table Scope
Market Size in 2025 USD 27.43 Billion
Projected Market Size in 2034 USD 62.95 Billion
CAGR (2025 - 2034) 9.67%
Leading Region North America
Market Segmentation By Product & Service, By Technology / Test Type, By Testing Setting, By Disease Type, By End-User, By Region
Top Key Players Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, bioMérieux, Danaher (e.g. Cepheid, Beckman Coulter), Beckton Dickinson (BD), Siemens Healthineers, Bio-Rad Laboratories, QIAGEN, Hologic, Grifols, Adaptive Biotechnologies, Illumina, Quest Diagnostics, PerkinElmer, Sysmex Corporation, MedMira, Lucira Health, Seegene, Sherlock Biosciences

How Infectious Disease Diagnostics Market Evolving?

The Infectious Disease Diagnostics Market encompasses tests, instruments, reagents, and software for detecting pathogens (viruses, bacteria, fungi, parasites) across clinical, point-of-care (POC), and public health settings. It includes molecular assays, immunodiagnostics (antigen/antibody tests), microbiology culture, sequencing, and rapid diagnostics, helping clinicians manage outbreaks, guide treatment, and monitor epidemiology globally. The market is evolving with the rise of rapid molecular testing, such as PCR and next-generation sequencing, which allows precise and timely pathogen detection. Point-of-care diagnostics, AI-powered data analysis, and digital health integration are improving real-time monitoring and clinical decision-making. Increased emphasis on early detection, outbreak management, and personalized treatment strategies is driving innovation and expanding the market's reach across healthcare and research settings worldwide.

For Instance,

  • In January 2025, bioMérieux acquired Norway-based SpinChip Diagnostics ASA for USD 154.57 million to enhance its point-of-care testing offerings. SpinChip’s benchtop analyzer provides laboratory-quality results from whole blood samples in just 10 minutes, strengthening bioMérieux’s rapid diagnostic capabilities.

Government Initiatives and Funding : Programs targeting disease surveillance, prevention, and control promote diagnostic development and use. 

  • In March 2025, French company bioMérieux received FDA 510(k) clearance for its VITEK COMPACT PRO system. Designed for microorganism identification and antibiotic susceptibility testing, the system aims to assist clinical laboratories in diagnosing infectious diseases and addressing antimicrobial resistance efficiently.

Advancements in Molecular Diagnostics : Techniques like PCR, next-generation sequencing, and CRISPR improve detection sensitivity and speed.

  • In March 2024, SEKISUI Diagnostics received EUA approval for its OSOM Flu SARS-CoV-2 Combo Test, allowing its use in both professional home healthcare and home testing environments.

How Can AI Affect the Market?

AI is transforming the infectious disease diagnostics market by enabling faster and more accurate analysis of complex clinical data. It supports early detection of infections, predictive outbreak modeling, and automated interpretation of molecular and imaging results. Integration of AI with point-of-care and laboratory diagnostics enhances decision-making, reduces human error, and improves patient outcomes, driving efficiency and expanding the adoption of advanced diagnostic solutions across healthcare settings.

Market Dynamics

Driver

Rising Prevalence of Infectious Diseases

The growing incidence of infectious diseases is propelling the infectious disease diagnostics market as healthcare systems require efficient tools to detect and manage infections promptly. Higher disease prevalence increases testing volumes in hospitals, clinics, and laboratories, driving demand for reliable diagnostics. Additionally, frequent outbreaks and emerging pathogens emphasize the need for rapid and accurate detection methods, encouraging the adoption of advanced diagnostic technologies and expanding the market across both developed and developing regions.

Restraint

High Cost of Advanced Diagnostics Test

The elevated cost of modern diagnostic technologies poses a significant challenge for the infectious disease diagnostics market. Many healthcare facilities, particularly in low-and middle-income regions, face budget constraints that limit the adoption of advanced molecular and rapid testing solutions. High expenses for equipment, reagents, and skilled personnel make widespread implementation difficult, slowing the overall market expansion despite the growing need for accurate and timely detection of infectious diseases.

Opportunity

Advancements in Molecular and Point-of-Care Technologies

Innovations in molecular and point-of-care diagnostics offer promising opportunities in the infectious disease market by simplifying and accelerating pathogen detection. These technologies enable immediate testing at clinics or remote locations, minimizing delays in treatment and improving disease management. Enhanced sensitivity and specificity of modern molecular assays, combined with portable POC devices, expand access to critical diagnostics, support outbreak control, and strengthen healthcare response capabilities, making them a major growth avenue for the market in the future.

For Instance,

  • In October 2024, the FDA authorized the Healgen Rapid Check COVID-19/Flu A&B Antigen Test for at-home use. This over-the-counter test delivers results in about 15 minutes from a nasal swab, enabling rapid detection of COVID-19 and influenza A and B without a prescription.

Segmental Insights

How did the Reagents, Kits & Consumables Segment Dominate the Market in 2024?

The reagents, kits & consumables segment leads the infectious disease diagnostics market due to their critical role in enabling consistent and reliable testing. As diagnostic procedures expand across hospitals, clinics, and laboratories, the repeated need for these supplies ensures sustained demand. Moreover, the rise of advanced molecular and rapid testing techniques increased the consumption of specialized reagents and kits, making the segment a key contributor to market growth and a central component of diagnostic workflows.

The instruments segment is anticipated to record the fastest growth in the infectious disease diagnostics market, driven by the rising need for sophisticated testing equipment in clinical and research laboratories. Innovations in automated analyzers, molecular testing platforms, and point-of-care devices enhance testing speed, accuracy, and efficiency. As healthcare providers prioritize rapid diagnosis and outbreak management, investment in advanced instruments increases, making this segment a significant contributor to market expansion during the forecast period.

What made the Immunodiagnostics Segment Dominant in the Market in 2024?

In 2024, the immunodiagnostics segment dominated the infectious disease diagnostics market due to its ease of use, quick turnaround, and dependable results. These methods are widely implemented for detecting immune responses to infections and are suitable for both clinical labs and decentralized testing locations. The growing emphasis on early diagnosis and routine screening has further driven the adoption of immunodiagnostic technologies, securing their leading position in the market.

The molecular diagnostics segment is projected to experience the fastest growth in the infectious disease diagnostics market because of its precision and rapid detection capabilities. Healthcare providers increasingly rely on these techniques for identifying pathogens quickly and accurately, especially during outbreaks. Rising investments in molecular testing infrastructure, coupled with growing awareness of early and reliable disease detection, are accelerating adoption, making this segment a major driver of market expansion over the forecast period.

How did the Laboratory-based Testing Segment Dominate the Market in 2024?

The laboratory-based testing segment dominated the infectious disease diagnostics market because clinical and high-throughput laboratories provide precise, reliable, and large-scale testing solutions. These facilities are equipped with advanced instruments and trained staff capable of handling complex assays, ensuring accurate detection of pathogens. Additionally, increasing requirements for routine screening, epidemiological surveillance, and confirmatory testing drive the continued reliance on laboratory-based diagnostics, making the market the leading contributor to market revenue.

The point-of-care (POC) testing segment is projected to grow rapidly as healthcare providers increasingly seek quick and accessible diagnostic solutions. Rapid antigen and antibody tests allow immediate detection of infectious diseases at clinics, pharmacies, and remote sites, minimizing delays in patient care. Rising awareness of early diagnosis, convenience of on-site testing, and the need to manage outbreaks efficiently are key factors driving the accelerated adoption and growth of POC testing in the market.

How Does the Respiratory Infections Segment Dominate the Market?

The respiratory infections segment led the infectious disease diagnostics market in 204 and is projected to grow rapidly due to the widespread incidence of illnesses like influenza, COVID-19, and respiratory syncytial virus (RSV). Rising awareness of early detection, the necessity for quick treatment, and the implementation of advanced molecular and rapid testing methods in hospitals and clinics are driving adoption. This combination of high disease burden and technological advancement positions respiratory diagnostics as a major growth driver in the market.

Why did the Hospitals Segment hold the Largest Market Share in 2024?

In 2024, the hospitals segment accounted for the largest revenue share in the infectious disease diagnostics market due to its capacity to provide extensive testing services and manage high patient volumes. With access to sophisticated diagnostic equipment and trained staff, hospitals can deliver rapid and accurate detection of infectious pathogens. The increasing focus on patient care, early disease identification, and outbreak management reinforces hospitals' role as key end-users, making them the dominant contributor to the market revenue.

The diagnostic laboratories segment is projected to witness lucrative growth in the infectious disease diagnostics market during the forecast period, driven by the need for accurate, large-scale testing and specialized analyses. These laboratories provide advanced equipment and skilled personnel capable of handling complex assays, making them essential for routine screening and outbreak surveillance. Increasing collaboration with healthcare providers, adoption of automated testing platforms, and rising demand for efficient, reliable diagnostic services are key factors fueling the expansion of the market.

Regional Insights

How is North America Contributing to the Expansion of the Market?

In 2024, North America led the infectious disease diagnostics market because of its robust healthcare system, advanced laboratory infrastructure, and strong focus on technological innovation. High adoption of molecular and rapid diagnostic tools, combined with supportive government policies and funding for infectious disease surveillance, has boosted market growth. The presence of major diagnostic companies and rising awareness for early detection and treatment further contribute to the region’s leading position and substantial revenue share in the market.

U.S. Infectious Disease Diagnostics Market Trends

The U.S. market is growing due to the rising prevalence of infectious diseases, increasing demand for rapid and accurate testing, and widespread adoption of advanced molecular and point-of-care diagnostic technologies. Strong healthcare infrastructure, continuous R&D investment, and government initiatives for disease surveillance and outbreak management further support market expansion. Additionally, growing awareness about early diagnosis and timely treatment is driving the uptake of diagnostic solutions across hospitals and laboratories.

Canadian Infectious Disease Diagnostics Market Trends

The market in Canada is expanding as healthcare providers increasingly focus on the timely and precise detection of infections. Rising use of molecular, immunodiagnostic, and rapid testing technologies, supported by modern laboratory facilities and skilled personnel, is driving growth. Government programs promoting disease surveillance, increased funding for healthcare infrastructure, and heightened public awareness about early diagnosis and preventive measures further contribute to the market’s steady development across the country.

How is Asia-Pacific Accelerating the Market?

Asia-Pacific is expected to grow at a faster pace in the infectious disease diagnostics market during the forecast period due to the rising prevalence of infectious diseases, increasing healthcare expenditure, and expanding access to advanced diagnostic technologies. Rapidly improving healthcare infrastructure, growing awareness about early disease detection, and rising adoption of point-of-care and molecular testing in countries like China, India, and Japan are key growth drivers. Additionally, government initiatives and rising investments in laboratory facilities support market expansion in the region.

China Infectious Disease Diagnostics Market Trends

The market in China is increasing due to the rising prevalence of infectious diseases, growing demand for rapid and accurate testing, and expanding adoption of advanced molecular and immunodiagnostic technologies. Government support through healthcare initiatives, increased funding for disease surveillance, and investments in diagnostic infrastructure are further boosting market growth. Additionally, rising public awareness about early detection and the expansion of hospitals and laboratories contribute to the market’s steady expansion.

India Infectious Disease Diagnostics Market Trends

The market in India is witnessing strong growth due to rising population density and frequent outbreaks of infectious diseases. Expansion of private and public healthcare facilities, increasing availability of advanced diagnostic technologies, and government initiatives promoting health screening are driving demand. Additionally, growing awareness among patients about early detection and timely treatment, along with investments in modern laboratory infrastructure, is further accelerating the market’s development across the country.

How is Europe approaching the Infectious Disease Diagnostics Market?

Europe is approaching the market through significant investment in advanced molecular, immunodiagnostic, and point-of-care technologies to enhance early detection and management of infectious diseases. Strong healthcare infrastructure, stringent regulatory standards, and government-supported disease surveillance programs drive the adoption of innovative diagnostic solutions. Additionally, collaborations between biotech companies, research institutions, and hospitals, along with rising awareness of rapid and accurate testing, are fueling market growth across countries such as Germany, the U.K., and France.

UK Infectious Disease Diagnostics Market Trends

The UK market is expanding as healthcare providers increasingly prioritize early and precise detection of infections. Rising adoption of innovative molecular, immunodiagnostic, and rapid testing technologies, supported by well-established laboratories and healthcare facilities, is fueling growth. Government initiatives for disease monitoring, public health campaigns, and investments in diagnostic infrastructure further enhance market development, while growing awareness among patients and clinicians about timely testing contributes to the sector’s steady advancement.

German Infectious Disease Diagnostics Market Trends

The market in Germany is expanding as the growing use of innovative testing technologies, including PCR, rapid antigen, and immunodiagnostic assays, enhances diagnostic accuracy and efficiency. Supportive government policies, investments in laboratory infrastructure, and increasing awareness about preventive healthcare and early disease identification are also driving market growth, positioning Germany as a leading player in Europe’s infectious disease diagnostics landscape.

Top Companies in the Infectious Disease Diagnostics Market

Infectious Disease Diagnostics Market Companies

Latest Announcement by Industry Leaders

In September 2024, F. Hoffmann-La Roche Ltd. (Switzerland) introduced the cobas Respiratory Flex Test, featuring its innovative TAGS (Temperature-Activated Generation of Signal) technology. This multiplex PCR-based test can detect up to 15 respiratory pathogens in a single run by integrating color, temperature, and data processing. Roche highlighted that many respiratory illnesses share similar symptoms, complicating diagnosis. CEO Matt Sause emphasized that TAGS technology enables faster, accurate identification of viruses, helping clinicians provide timely treatment and reduce transmission.

Recent Developments in the Infectious Disease Diagnostics Market

  • In June 2025, Becton, Dickinson and Company (US) obtained FDA 510(k) clearance for the BD Phoenix M50 and BDXpert System integrated with the BD Synapsys Informatics Solution. These systems utilize rapid identification and antimicrobial susceptibility testing algorithms to simplify the analysis of complex diagnostic data. The technology aims to provide accurate and reliable diagnoses, particularly for antimicrobial resistance (AMR), supporting clinicians in making informed treatment decisions and improving patient care outcomes.
  • In May 2025, Revvity, Inc. (US) introduced the IDS i20 analytical platform from EUROIMMUN, a fully automated, random-access system for chemiluminescence immunoassays (ChLIA). CE-marked and FDA-listed, the IDS i20 supports high-throughput testing for infectious diseases as well as other specialized assays, offering laboratories an efficient and reliable solution for large-scale diagnostic workflows.

Segments Covered in the Report

By Product & Service

  • Reagents, Kits & Consumables
  • Instruments
  • Software & Services

By Technology / Test Type

  • Immunodiagnostics (ELISA, lateral flow, serology)
  • Molecular Diagnostics (PCR, isothermal amplification, NGS)
  • Clinical Microbiology (culture-based, microscopy)
  • Other emerging tech (CRISPR-based, antigen rapid tests)

By Testing Setting

  • Laboratory-based testing (clinical labs, high-throughput)
  • Point-of-Care (POC) Testing (rapid antigen/antibody)

By Disease Type

  • Respiratory Infections (e.g., influenza, COVID-19, TB)
  • HIV, Hepatitis
  • Hospital-Acquired Infections (HAIs)
  • Sexually Transmitted Infections
  • Mosquito-Borne & Other Diseases

By End-User

  • Hospitals
  • Diagnostic Laboratories
  • Clinics / POC Settings  
  • Research Institutes / Public Health Agencies

By Region 

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Last Updated: 19 August 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Deepa Pandey is a focused and detail-oriented market research professional with growing expertise in the healthcare sector, delivering high-quality insights across therapeutic areas, diagnostics, biotechnology and healthcare services.

Learn more about Deepa Pandey

Aditi Shivarkar, with over 14 years of experience in consumer goods, leads research at Towards Consumer Goods, ensuring precise, actionable insights on trends, consumer preferences, and sustainable packaging for businesses.

Learn more about Aditi Shivarkar

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FAQ's

The infectious disease diagnostics market is worth USD 27.43 billion in 2025, and by 2034, it is forecasted to hit USD 62.95 billion, registering a CAGR of 9.67% over the decade.

North America is currently leading the infectious disease diagnostics market due to its robust healthcare system, advanced laboratory infrastructure, and strong focus on technological innovation.

Some key players include Illumina, Quest Diagnostics, PerkinElmer, Sysmex Corporation, MedMira, Lucira Health 

Key trends include the growth due to healthcare providers seeking faster, more reliable detection methods to control outbreaks.

They allow timely and accurate detection, enabling early treatment, outbreak management, and infection control.

India Brand Equity Foundation, Food and Drug Administration, U.S. Environmental Protection Agency, European Medicines Agency, and National Medical Products Administration.