The global molecular infectious disease testing market is witnessing significant expansion driven by rising infectious disease burdens, advancements in diagnostic technologies, and increasing global focus on early disease detection. Valued at US$8.49 billion in 2023, the market increased to US$9.37 billion in 2024 and is projected to reach US$17.78 billion by 2029, registering an impressive CAGR of 13.7% during the forecast period. The acceleration of molecular diagnostics adoption worldwide, particularly in response to emerging pathogens and antimicrobial resistance, continues to shape the market’s growth trajectory.
Rising Infectious Disease Burden Accelerates Market Adoption
One of the primary forces driving growth in the molecular infectious disease testing market is the rising global prevalence of infectious diseases. Conditions such as HIV, hepatitis, influenza, and various respiratory and gastrointestinal infections continue to impose a substantial healthcare burden. Additionally, the emergence of novel pathogens and variants—exemplified by outbreaks such as COVID-19, Monkeypox, RSV, and re-emerging diseases—has reinforced the need for highly sensitive, rapid, and accurate diagnostic tools.
Antibiotic-resistant infections pose another significant challenge, increasing the demand for molecular testing platforms that enable precise pathogen identification and antimicrobial resistance profiling. Healthcare systems are increasingly relying on advanced molecular diagnostics due to their superior ability to detect low levels of pathogens with high specificity, ultimately enabling earlier intervention and improved patient outcomes.
Technological Advancements Fueling Diagnostic Innovation
Rapid technological progress in molecular diagnostics is another key contributor to the market’s growth. Modern techniques such as Polymerase Chain Reaction (PCR), multiplex assays, and next-generation sequencing (NGS) have significantly enhanced diagnostic efficiency and accuracy. These advancements offer several critical advantages:
- High Sensitivity and Faster Turnaround Times
New molecular platforms deliver results in a matter of hours rather than days. This speed is critical for effective outbreak management, timely therapeutic decisions, and infection control.
- Multiplex Pathogen Identification
Advancements in multiplex testing enable simultaneous detection of multiple pathogens in a single sample, which is essential for diagnosing co-infections and managing complex disease presentations.
- Enhanced Workflow Automation
Modern PCR and NGS systems incorporate advanced automation, reducing manual handling and improving reproducibility. Automated extraction, amplification, and analysis workflows enhance laboratory efficiency, especially in high-volume diagnostic settings.
- Improved Accessibility of Molecular Testing
The evolution of portable, point-of-care (POC) molecular platforms has expanded testing beyond traditional laboratories, enabling rapid diagnosis even in resource-limited settings.
Growing investment in R&D, supported by public health agencies, biotech companies, and academic institutions, continues to accelerate innovation in molecular diagnostics. As a result, newly developed assays are becoming increasingly precise, cost-effective, and scalable.
PCR Remains the Dominant Technology Segment
In 2023, Polymerase Chain Reaction (PCR) held the largest market share within the molecular infectious disease testing market. PCR remains the gold standard due to its unmatched sensitivity, reliability, and versatility across a wide range of pathogens. Several factors contribute to PCR’s continued dominance:
- Well-established protocols and standardization
- Wide availability of commercial kits and reagents
- High compatibility across laboratory settings
- Advancements in automated PCR systems
- Increased demand for rapid and accurate testing during outbreaks
PCR’s ability to amplify minute quantities of pathogen nucleic acids makes it invaluable in early detection and outbreak response. Technologies such as real-time PCR (qPCR) and digital PCR (dPCR) provide quantification capability, driving their continuous adoption in clinical diagnostics, surveillance programs, and research laboratories.
While emerging technologies such as NGS and isothermal amplification are growing, PCR remains the preferred method due to its cost-effectiveness, scalability, and established regulatory acceptance.
Diagnostic Laboratories: Fastest-Growing End User Segment
Among end users—diagnostic laboratories, hospitals & clinics, and other testing facilities—the diagnostic laboratory segment is projected to grow at the fastest pace. This growth is largely attributed to:
- Increasing global testing volumes
- Rising demand for high-throughput and accurate molecular assays
- Strong emphasis on early disease detection
- Integration of advanced platforms such as multiplex PCR and NGS
- Increased frequency of outbreak-related testing
Diagnostic laboratories remain at the forefront of infectious disease detection due to their capability to process large sample volumes and deliver highly accurate results. The surge in molecular testing during global health crises has further strengthened their role. As healthcare systems prioritize advanced pathogen detection and surveillance, diagnostic laboratories are expected to expand their capacities and adopt next-generation molecular testing technologies.
North America Leads the Global Market
In 2023, North America emerged as the largest regional market for molecular infectious disease testing. Several factors contribute to the region’s leading position:
- Highly developed healthcare infrastructure
- Early adoption of advanced molecular diagnostic technologies
- Strong presence of key industry players
- Supportive regulatory frameworks from agencies like FDA & CDC
- Robust disease surveillance systems
- High investments in research, innovation, and public health preparedness
The region’s strong focus on outbreak detection, antimicrobial resistance management, and personalized medicine continues to drive the adoption of molecular infectious disease testing solutions. The increasing prevalence of infectious diseases and heightened awareness of rapid diagnostics further support market expansion in the U.S. and Canada.
Key Companies Operating in the Molecular Infectious Disease Testing Market
Prominent players driving innovation, product development, and market expansion include:
- Danaher (US)
- F. Hoffmann-La Roche Ltd (Switzerland)
- bioMérieux (France)
- Hologic, Inc. (US)
- Abbott (US)
- Thermo Fisher Scientific Inc. (US)
- QIAGEN (Netherlands/Germany)
- Revvity (US)
- Siemens Healthineers AG (Germany)
- BD (US)
- Grifols, S.A. (Spain)
- QuidelOrtho Corporation (US)
- DiaSorin S.p.A. (Italy)
- Bruker (US)
- Seegene Inc. (South Korea)
- Genetic Signatures (Australia)
- Co-Diagnostics, Inc. (US)
- Savyon Diagnostics (Israel)
- Vela Diagnostics (Singapore)
- Molbio Diagnostics Pvt. Ltd. (India)
- Uniogen OY (Finland)
- geneOmbio Technologies (India)
- Advanced Molecular Diagnostics (UK)
- GeneFirst Limited (UK)
- altona Diagnostics GmbH (Germany)
These organizations are actively investing in assay development, multiplex panels, automated molecular platforms, and global testing solutions to meet rising clinical demands.