Infectious Disease Diagnostics Market Size & Forecast 2033

The Infectious Disease Diagnostics Market, estimated at USD 1,926.1 Mn in 2026, is expected to exhibit a CAGR of 10.0% and reach USD 3,755.7 Mn by 2033.

The market growth is driven by rising demand for accurate and early disease detection, supported by advances in molecular diagnostics, imaging, and point-of-care testing. Growing focus on personalized medicine, supportive healthcare policies, and ongoing R&D investments are creating new opportunities for industry players.

Initiatives to address diagnostic challenges in emerging economies is expected to propel growth of the global infectious disease diagnostics market over the forecast period. For instance, In Aug 2025, Australian researchers at the Kirby Institute at UNSW Sydney, Burnet Institute, and Doherty Institute, along with international organizations, the Clinton Health Access Initiative and Foundation for Innovative New Diagnostics, have received US $5.2 million to improve laboratory capacity for testing and diagnosis of HIV, malaria, and tuberculosis in the Indo-Pacific region

Market Driver

Continuous Product Innovation and Multiplex Assay Launches

Manufacturers are introducing automated, high-throughput systems that reduce turnaround time and laboratory workload. For instance, in March 2026, Roche launched the cobas MPX-E assay, a four-in-one donor-screening test that detects HIV, hepatitis B, hepatitis C, and hepatitis E in a single workflow. In July 2026, the company also received CE Mark approval for its Elecsys IGRA TB blood test, which provides results within 24 hours and reduces processing time to 19 minutes per patient. (Source: F. Hoffmann-La Roche Ltd )

Increasing Focus on Antimicrobial Resistance

The growing prevalence of drug-resistant infections is creating demand for tests that rapidly identify pathogens and determine antimicrobial susceptibility. For instance, in May 2026, the World Health Assembly adopted the Global Action Plan on Antimicrobial Resistance for 2026–2036, emphasizing stronger surveillance, innovation, infection prevention, and responsible antimicrobial use. This policy direction is expected to support demand for rapid culture, molecular, and resistance-detection assays. (Source: WHO)

Growing Adoption of Multiplex Molecular Diagnostics

Healthcare providers are increasingly adopting multiplex assays that identify several pathogens from a single patient sample. For instance, in April 2026, the U.S. Centers for Disease Control and Prevention highlighted that multiplex tests can distinguish influenza, SARS-CoV-2, and respiratory syncytial virus infections and support antiviral treatment and other clinical-management decisions. This is strengthening demand for PCR, nucleic acid amplification, and syndromic-testing platforms. (Source: CDC)

Market Opportunity

Expansion of Near-Point-of-Care Testing in Emerging Economies

The limited availability of centralized laboratories in low- and middle-income countries creates significant opportunities for portable, affordable, and battery-operated diagnostic systems. For instance, in March 2026, the World Health Organization issued its first recommendations for near-point-of-care molecular tuberculosis tests, tongue-swab sampling, and sputum-pooling strategies. WHO stated that these portable tests could be available at less than half the cost of many existing molecular diagnostic systems. Manufacturers can capitalize on this opportunity by developing simple platforms suitable for primary healthcare centres, mobile clinics, pharmacies, and community-testing programmes.

Diagnostics for Emerging Pathogens and Disease Outbreaks

Recurring outbreaks create opportunities for companies capable of rapidly developing pathogen-specific molecular tests. For instance, in July 2026, WHO added the first molecular diagnostic test for Bundibugyo Ebola virus to its Emergency Use Listing. The test detects viral genetic material in blood samples and supports rapid confirmation of infection. The development demonstrates the commercial and public-health opportunity for adaptable PCR platforms, emergency-use assays, portable testing systems, and partnerships with governments and international procurement agencies. (Source: WHO)

Market Trends

Automation and Digital Interpretation of Diagnostic Results

Clinical laboratories are integrating automated sample handling, result interpretation, reporting, and traceability tools to address workforce shortages and rising test volumes. In July 2026, Roche received CE Mark approval for its Elecsys IGRA TB blood test. The assay includes a digital tool that automates result calculation, interpretation, and reporting. It can also be integrated with third-party automated liquid handlers for front-end laboratory processes. Such systems are reducing manual intervention and enabling laboratories to manage higher infectious disease testing volumes with greater consistency. (Source: F. Hoffmann-La Roche Ltd)

Increasing Use of Multiplex and Syndromic Testing

Laboratories are increasingly adopting assays capable of detecting multiple pathogens from a single patient or donor sample. These tests help reduce sample requirements, turnaround time, instrument usage, and operational costs. In March 2026, Roche launched the cobas MPX-E assay, which simultaneously detects and differentiates HIV, hepatitis B virus, hepatitis C virus, and hepatitis E virus. The assay operates on automated cobas x800 systems and provides laboratories with up to eight hours of unattended processing. This development reflects the increasing transition toward consolidated respiratory, gastrointestinal, blood-screening, and sexually transmitted infection panels.

Expansion of Pathogen Genomic Surveillance

Genomic sequencing is becoming an important component of infectious disease diagnosis and surveillance. It enables public health agencies to identify emerging variants, understand transmission patterns, and support outbreak and vaccination strategies. In April 2026, WHO’s South-East Asia Regional Office and India’s CSIR-Institute of Genomics and Integrative Biology conducted an initiative focused on dengue genomic surveillance. WHO emphasized that genomic surveillance extends beyond basic case detection by helping identify emerging variants and supporting evidence-based outbreak responses. This trend is strengthening demand for sequencing instruments, bioinformatics platforms, reagents, and integrated diagnostic-surveillance systems.

Global Infectious Disease Diagnostics Market: Key Developments

In July 2026, Cepheid, molecular diagnostics company announced plans to unveil its third-generation GeneXpert system at ADLM 2026. The platform is designed to support high-plex panel testing, faster time-to-result, random-access processing, and future sample-to-answer applications, strengthening automated molecular testing capabilities for infectious diseases across laboratories and near-patient healthcare settings. (Source: Cepheid)
In May 2026, Biotia launched BIOTIA-DX Resistance, integrating clinically approved antimicrobial-resistance reporting into its New York State CLEP-approved BIOTIA-ID Urine Test. The solution detects pathogens and predicts resistance directly from urine samples, supporting more precise antibiotic selection for recurrent or complicated urinary tract infections. Biotia stated that the platform achieved the highest prediction accuracy in the 2026 CAMDA Antimicrobial Resistance Challenge for the second consecutive year, advancing data-driven infection care. (Source: Biotia)
In April 2026, Bruker Corporation, manufacturer of high-performance scientific instruments and analytical solutions launched MyGenius PRO at ESCMID Global 2026 in Munich. The fully automated, high-throughput PCR system manages the complete workflow from patient sample to diagnostic result, while supporting continuous loading and random-access operation. Its initial IVDR assay menu covers cytomegalovirus, Epstein-Barr virus, and BK virus. Bruker plans to add HIV-1, hepatitis B, hepatitis C, and human herpesvirus 6 assays during 2026 to broaden infectious disease testing capacity. (Source: Bruker Corporation)
On December 15th, 2025; Roche announced the launch of the first infectious disease tests on the cobas 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. These include cobas HIV-1, cobas HBV, cobas HCV, cobas HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit. These launches expand the Roche Molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs.
On October 11th, 2025; Aegis Sciences Corporation expanded its molecular testing capabilities to rapidly identify pathogens in the respiratory and urogenital health spaces. With Aegis Infectious Disease Testing, providers will have access to: Clinically relevant tests for a wide variety of pathogens and condition, diversity in specimen collection options, 24-hour turnaround time, semi-quantitative reporting available where clinically appropriate and clear, reliable, and actionable results. The testing menu includes customizable order options for the most common pathogens that cause respiratory tract infections (RTIs), genital health/sexually transmitted infections (STIs), gastrointestinal infections (GIs) and urinary tract infections (UTIs).
In March 2025, Chembio Diagnostics, Inc., a point-of-care Diagnostics Company focused on infectious diseases, completed the technical feasibility phase for a potential companion/compatible diagnostic test being developed in collaboration with Shire Human Genetic Therapies, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
On March 27th, 2025, Abbott announced that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

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Key Takeaways of the Global Infectious Disease Diagnostics Market

The cell cultures segment is expected to dominate the market during the forecast period. Several types of infections can be diagnosed using cell culture, as microbes can be grown in a laboratory setting
The STDs segment held dominant position in the global infectious disease diagnostics market followed by Central Nervous System infection, and respiratory infections, respectively. Increasing sexually transmitted disease burden is fueling growth of the segment. Among 20 STDs, the most common are Gonorrhea, Chlamydia, Syphilis, Herpes, Hepatitis (HBV), and Human Immunodeficiency Virus (HIV). For Instance, in June 2025, WHO, WHO estimated 374 million new infections with 1 of 4 STIs: chlamydia (129 million), gonorrhoea (82 million), syphilis (7.1 million) and trichomoniasis (156 million).
Clinics segment in the global infectious disease. In 2025, diagnostics market is accounted for share during the forecast period. Central diagnostic laboratories are well equipped with latest diagnostic instruments and have large resources to carry out multiple tests. Large number of tests are carried out on a daily basis in these centers which supports growth of the hospital segment and healthcare infrastructure for treatment.