Molecular Infectious Disease Testing Market Research Report, Size, Share, Analysis, Growth by Forecast to 2031
Global Molecular Infectious Disease Testing Market Overview
The global molecular infectious disease testing market is projected to grow at a compound annual growth rate (CAGR) of approximately 13% over the next five years. This expansion is driven by the increasing global burden of infectious diseases, rising demand for rapid and accurate diagnostic results, technological advancements in molecular diagnostics, and growing investments in research & development (R&D) and public health infrastructure.
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Molecular infectious disease testing encompasses advanced diagnostic techniques used to detect and characterize pathogens—including viruses, bacteria, and other microorganisms—based on their genetic material. These methods commonly utilize polymerase chain reaction (PCR), isothermal amplification technologies, and next-generation sequencing (NGS), among others, to deliver high sensitivity and specificity.
By leveraging these molecular approaches, clinicians can accurately identify causative pathogens, differentiate between viral and bacterial infections, detect co-infections, and guide appropriate antimicrobial therapy. Molecular diagnostics also enable early disease detection—often before severe symptoms develop—supporting timely clinical intervention and improved patient outcomes.
Rising Burden of Infectious Diseases Driving Market Growth
A primary factor fueling market expansion is the escalating global prevalence of infectious diseases. Healthcare systems worldwide are under increasing pressure to detect, manage, and contain infections rapidly and accurately.
Infectious diseases remain a leading cause of global morbidity and mortality. In 2024:
- Tuberculosis accounted for 10.7 million cases and 1.23 million deaths.
- Malaria recorded 282 million cases (a 3% increase from 2023) and 610,000 deaths.
- Dengue cases surged dramatically from 505,430 in 2000 to 14.6 million in 2024.
(Source: WHO)
Multiple structural factors—including urbanization, globalization, climate change, antimicrobial resistance (AMR), and aging populations—are contributing to rising incidences of respiratory infections, sexually transmitted infections (STIs), gastrointestinal diseases, tuberculosis, hepatitis, HIV, and vector-borne diseases. Furthermore, the emergence and re-emergence of novel pathogens continue to increase the frequency and complexity of outbreaks.
Molecular diagnostics directly address these challenges by enabling early, precise detection of pathogens—even at low concentrations and prior to widespread transmission. As disease complexity increases, clinicians and public health authorities increasingly rely on molecular tests for accurate differentiation of pathogens, identification of co-infections, and selection of targeted therapies.
Delayed or inaccurate diagnosis significantly increases healthcare costs due to prolonged hospital stays and inappropriate treatment. Molecular testing helps reduce this financial burden by enabling faster treatment decisions, improving antimicrobial stewardship, and shortening hospitalization durations.
From a public health perspective, molecular testing also enhances disease surveillance. These tests support rapid outbreak detection, large-scale screening programs, and tracking of pathogen mutations and transmission patterns. Consequently, governments and global health organizations continue to invest in strengthening molecular diagnostic capabilities as a core component of outbreak preparedness.
As post-pandemic awareness grows, demand for routine screening and expectations for fast, laboratory-grade accuracy are expected to further accelerate long-term market growth.
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Growth in Point-of-Care (POC) Molecular Solutions: A Key Opportunity
Point-of-care (POC) molecular diagnostics represent one of the most significant growth opportunities in the market. Unlike traditional centralized laboratory testing, POC molecular platforms deliver laboratory-level sensitivity and specificity at or near the site of patient care.
Healthcare settings such as emergency departments, outpatient clinics, and primary care facilities increasingly require rapid diagnostic solutions. POC molecular tests provide actionable results within minutes to an hour, enabling same-visit treatment decisions. This capability is particularly valuable for respiratory infections, sexually transmitted infections, and hospital-acquired infections, where delays in diagnosis can worsen outcomes and increase transmission risk.
POC molecular systems also expand access to high-quality diagnostics in decentralized and resource-limited settings, including rural clinics and community health programs. Compact, automated platforms with minimal sample preparation requirements allow reliable testing even where centralized laboratories are unavailable.
From a public health standpoint, rapid on-site testing enhances outbreak control by enabling early case identification, timely isolation decisions, and prompt treatment initiation. As a result, governments and health agencies are promoting POC molecular diagnostics as essential tools for epidemic preparedness and routine surveillance.
For manufacturers, POC platforms create recurring revenue opportunities through consumables and cartridge-based systems. Ongoing technological advancements are reducing costs, improving ease of use, and expanding multiplex capabilities—positioning POC molecular testing as a major growth engine in the global market.
Strategic Growth Initiatives by Market Players
Market participants are adopting various strategies—including product launches, strategic alliances, and acquisitions—to strengthen their competitive positions.
- In October 2025, Sysmex entered a strategic alliance with QIAGEN for the exclusive distribution of molecular diagnostic instruments and reagents for infectious diseases and oncology in Japan, expanding access to tuberculosis diagnostics and other molecular tests.
- In June 2025, bioMérieux acquired the assets of Day Zero Diagnostics to enhance its next-generation sequencing (NGS) capabilities in infectious disease diagnostics and antimicrobial resistance detection.
- In February 2023, Thermo Fisher Scientific launched Applied Biosystems TaqPath real-time PCR kits in India for the detection of TB, HIV, HBV, and HCV, strengthening the country’s molecular diagnostics ecosystem.
These initiatives reflect a broader industry trend toward innovation, portfolio expansion, and geographic penetration.
Product and Service Segment Outlook
Reagents and kits represent the largest revenue segment in the molecular infectious disease testing market. Their dominance stems from routine, high-volume testing requirements across hospitals and diagnostic laboratories. Unlike instruments—which typically involve one-time capital purchases—reagents, primer sets, probes, and assay kits generate recurring revenue based on testing volume.
Services and software are the fastest-growing segments, driven by increasing adoption of advanced data analytics, bioinformatics solutions, laboratory automation, and connectivity platforms. Growth is further supported by the rising use of multiplex assays, NGS technologies, and the need for integrated workflow management and regulatory-compliant reporting systems.
Regional Outlook
North America is expected to maintain the largest share of the molecular infectious disease testing market. The region benefits from:
- Advanced healthcare infrastructure
- Strong reimbursement frameworks
- High testing volumes
- Robust public health programs
- Significant R&D investments
- Presence of leading molecular diagnostic companies
Asia Pacific (APAC) is projected to be the fastest-growing region. Market growth in APAC is driven by a large patient population, increasing infectious disease burden, expanding healthcare infrastructure, rising government investment in diagnostics, rapid urbanization, and growing local manufacturing initiatives.
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Competitive Landscape
The global molecular infectious disease testing market includes both established leaders and emerging players, such as:
- Danaher Corporation
- F. Hoffmann-La Roche Ltd
- bioMérieux
- Abbott
- Thermo Fisher Scientific Inc.
- QIAGEN
- Hologic, Inc.
- Becton, Dickinson and Company (BD)
- Siemens Healthineers AG
- Seegene Inc.
Global Molecular Infectious Disease Testing Market Segmentation
This report by Medi-Tech Insights provides the size of the global molecular infectious disease testing market at the regional- and country-level from 2024 to 2031. The report further segments the market based on product and service, type, technology, application, and end user.
Market Size & Forecast (2024-2031), By Product and Service, USD Billion
- Reagents and Kits
- Instruments
- Services and Software
Market Size & Forecast (2024-2031), By Type, USD Billion
- Singleplex Testing
- Multiplex Testing
Market Size & Forecast (2024-2031), By Technology, USD Billion
- Polymerase Chain Reaction (PCR)
- Isothermal Nucleic Acid Amplification
- DNA Sequencing and Next-generation Sequencing (NGS)
- In Situ Hybridization
- DNA Microarrays
- Other Technologies
Market Size & Forecast (2024-2031), By Application, USD Billion
- Respiratory Infectious Diseases
- Gastrointestinal Infectious Diseases
- Sexually Transmitted Infections (STIs)
- Vector-borne Diseases
- Hospital-acquired Infections
- Other Applications
Market Size & Forecast (2024-2031), By End User, USD Billion
- Diagnostic Laboratories
- Hospitals and Clinics
- Other End Users
Market Size & Forecast (2024-2031), By Region, USD Billion
- North America
- US
- Canada
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Rest of Asia Pacific
- Latin America
- Middle East & Africa
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