Infectious Disease Diagnostics Market

The global infectious disease diagnostics market in terms of revenue was estimated to be worth $21.4 billion in 2023 and is poised to reach $31.5 billion by 2028, growing at a CAGR of 8.0% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Government initiatives, schemes, or funding that support and promote the innovation and development of the diagnostics market provide growth opportunities in the market. These financial incentives and support systems enable companies/institutes to invest in R&D, infrastructure, and the production of advanced diagnostic technologies. By facilitating access to funds, the manufacturers can push the boundaries of diagnostics, leading to breakthrough innovations in disease detection, monitoring, and personalized medicine.

Infectious Disease Diagnostics Market Market Size, Dynamics & Ecosystem

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Infectious Disease Diagnostics Market Dynamics

DRIVER: Rising prevalence of infectious diseases

Diseases such as tuberculosis, HIV/AIDS, hepatitis, sexually transmitted infections, and respiratory infections require an accurate and timely diagnosis for effective treatment and control. Early diagnosis of these diseases plays a crucial role in the monitoring of these infectious diseases, driving the growth of the market in this area.

RESTRAINT: Unfavorable reimbursement scenario

Inadequate reimbursements are a major factor restraining the growth of the market. According to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This decline and additional budgetary concerns among healthcare systems are major obstacles to implementing novel diagnostic techniques in clinical laboratories.

OPPORTUNITY: Increased growth opportunities in emerging economies

Emerging economies such as India, Brazil, Turkey, Russia, and South Africa are expected to offer potential growth opportunities for major players operating in the market. This can be attributed to the high disease prevalence, large patient population, improved healthcare infrastructure, increased disposable income, and growing medical tourism. In addition to the factors mentioned above, the Asia Pacific region has emerged as an adaptive and business-friendly hub due to relatively less stringent regulations and data requirements.

CHALLENGE: Operational barriers and shortage of skilled laboratory technicians

Clinical laboratories in key markets are undergoing continuous evolution, and technicians encounter operational challenges in guaranteeing the efficient procurement, storage, and transportation of samples. This is particularly true when incorporating innovative technologies like Next-Generation Sequencing (NGS) and lab-on-a-chip PCR devices. Additionally, laboratory spaces must be reconfigured to align with the demands of conducting specific diagnostic tests for infectious diseases, ensuring pathogen detection while preventing cross-contamination and optimizing time efficiency. Therefore, there is a significant increase in costs associated with maintaining and operating advanced infectious disease diagnostic instruments, especially those designed to handle a single sample type.

Infectious Disease Diagnostics Market Segmentation & Geographical Spread

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Reagents, kits, and consumables segment accounted for the largest share of the infectious disease diagnostics industry in 2022, by product & service.

The infectious disease diagnostics market is categorized into reagents, kits, and consumables; instruments; and software & services, based on product & service. The reagents, kits, and consumables segment emerged as the dominant force in the market in 2022. The versatility of reagents and kits in accommodating diverse testing needs contributes to their extensive usage and market demand. Moreover, with the growing prevalence of diseases and the need for accurate and timely diagnoses, the volume of infectious disease diagnostics tests is consistently increasing. Reagents and kits play a critical role in accommodating this rise in test volumes, ensuring an ongoing demand for these consumables. The availability of advanced reagents and kits that offer enhanced performance and reliability fosters their widespread adoption and contributes to the growth of the segment.

Hepatitis segment accounted for the largest share in the infectious disease diagnostics industry in 2022, by disease type.

The global infectious disease diagnostics market is categorized into hepatitis, HIV, hospital-acquired infections, Chlamydia trachomatis, Neisseria gonorrhea, HPV, tuberculosis, influenza, syphilis, mosquito-borne diseases, and other infectious diseases based on disease type. The hepatitis segment accounted for the largest share of the market in 2022. The global impact of hepatitis in terms of morbidity, mortality, and economic burden has contributed to a greater emphasis on developing diagnostic tools for these infections. Many countries have implemented hepatitis B vaccination programs to prevent new infections. As a result, there is a focus on early screening and diagnostics to identify and manage existing cases.

Laboratory testing segment accounted for the largest share in the infectious disease diagnostics industry in 2022, by type of testing.

The infectious disease diagnostics market has been segmented into laboratory testing and PoC testing, based on the type of testing. In 2022, the laboratory testing segment accounted for the largest share of the market. Laboratory tests generally have higher sensitivity and specificity compared to PoC tests. The controlled laboratory environment allows for more accurate and precise measurements, reducing the chances of false-negative or false-positive results. This is particularly crucial in infectious disease diagnostics, where accuracy is paramount for appropriate treatment and containment measures. Another advantage of lab tests is the ability to process a large volume of samples simultaneously. Automated platforms and high-throughput systems in laboratories can handle a high sample throughput, enabling efficient testing for infectious diseases. Such factors are expected to fuel the growth of this segment.

North America accounted for the largest share of the infectious disease diagnostics industry in 2022.

The infectious disease diagnostics market is segmented into five major regions: North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America emerged as the leading contributor, claiming the largest portion of the market share in the infectious disease diagnostics industry. The region has a robust infrastructure for R&D. Also, North America houses several major companies operating in the infectious disease diagnostics sector. These companies have significant expertise, resources, and established distribution networks, which contribute to the region's market dominance. Also, the high burden of infectious diseases on regional healthcare systems is another major driver for market growth.

The major players in infectious disease diagnostics market are F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), bioMérieux (France), Siemens Healthineers AG (Germany), and Danaher (US). These players lead the market because of their extensive product portfolios and wide geographic presence.

Scope of the Infectious Disease Diagnostics Industry

This report categorizes the infectious disease diagnostics market to forecast revenue and analyze trends in each of the following submarkets:

By Product & Service

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

By Type of Testing

• Laboratory Testing
• PoC Testing

By Technology

• Immunodiagnostics
• Polymerase Chain Reaction
• Clinical Microbiology
• Isothermal Nucleic Acid Amplification Technology
• DNA Sequencing & Next-generation Sequencing
• DNA Microarray
• Other Technologies

By Disease Type

• Hepatitis
  • Hepatitis B
  • Hepatitis C
  • Other Hepatitis Diseases
• HIV
• Hospital-acquired Infections
• Mosquito-borne Diseases
• HPV
• Chlamydia trachomatis
• Neisseria gonorrhea
• Tuberculosis
• Influenza
• Syphilis
• Other Infectious Diseases

By Sample Type

• Blood, Serum, and Plasma
• Urine
• Other Sample Types

By End User

• Diagnostic Laboratories
• Hospitals & Clinics
• Academic Research Institutes
• Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Rest of Asia Pacific
• Latin America
• Middle East & Africa
  • GCC Countries
  • Rest of Middle East & Africa

Recent Developments of Infectious Disease Diagnostics Industry

• In January 2023, Thermo Fisher Scientific Inc. (US) launched its CE-IVD marked Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit.
• In July 2022, Roche launched Elecsys HCV Duo, an immunoassay that allows the simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample.
• In September 2022, Siemens Healthineers released its CE-marked FTD SARS-CoV-2/FluA/FluB/HRSV Assay, a PCR test, and the CLINITEST Rapid COVID-19 + Influenza Test.
• In December 2021, Roche completed a purchase agreement with TIB Molbiol (Germany) to expand the PCR-test portfolio in the fight against new infectious diseases.
• In February 2020, Cepheid collaborated with Sherlock Biosciences (US). This collaboration between the two companies aimed to explore the development of new cutting-edge molecular diagnostic tests for infectious diseases leveraging CRISPR technology.

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