According to our new research study on "Infectious Disease In vitro Diagnostics Market Forecast to 2031 - Global Analysis - by Application and End User," the market is expected to grow from US$ 45.69 billion in 2024 to US$ 76.71 billion by 2031; it is estimated to record a CAGR of 7.7% from 2025-2031. Key factors driving the growth of the infectious disease in vitro diagnostics market are the increasing prevalence of infectious diseases and strategic developments by key players. However, the inadequate reimbursement scenario hinders the market's growth.

The scope of the infectious disease in vitro diagnostics market report includes the assessment of the market performance in North America, Europe, Asia Pacific, South and Central America, and the Middle East and Africa. Asia Pacific is anticipated to register the fastest CAGR in the infectious disease in vitro diagnostics market from 2025 to 2031. The market growth in the region is attributed to increasing infectious diseases, growing research activities and technological advancements, and a surging number of startups, biotechnology, and biopharmaceutical companies. Moreover, the presence of associations or organizations enhancing the quality of care in infectious disease management contributes to the infectious disease in vitro diagnostics market growth. According to a blog published by ChinaTown Online, ~1 in 7 people aged 15-49 have been infected with sexually transmitted diseases (STDs) in China. Chlamydia, gonorrhea, genital warts, and syphilis are the most common STDs. This created a demand for In vitro diagnostics products and services in Malaysia, supporting the infectious disease in vitro diagnostics market growth in the Asia Pacific.

China, India, and Japan are three significant contributors to the market growth in this region. China is experiencing a surging prevalence of infections such as HIV, hepatitis, UTI, pneumonia, and respiratory infections, generating the demand for antibiotics and antimycotics. According to the Epidemiology & Infection Journal 2023, ~21.1 million people suffer from community-acquired pneumonia (CAP) every year in China. Also, according to WHO, there are 87 million chronic carriers of the hepatitis B virus in China, which represents one-third of all chronic carriers of the hepatitis B virus globally. It is estimated that there are 7.6 million Chinese individuals with chronic hepatitis C. Adequate comprehension of the epidemiological burden, program delivery status, and policy context for viral hepatitis in China is essential to combating viral hepatitis and realizing global elimination targets.

The increasing number of strategic initiatives by market players, such as product launches, product developments, and product development, is expected to create ample opportunities for the market growth during the forecast period. For instance, in October 2024, Abbott, the world leader in healthcare, launched its locally produced immunoassay module Alinity i and automated GLP line for the localized manufacturing of these smart solutions at Abbott Diagnostics' Hangzhou site. With the encouragement from the Zhejiang provincial government, the project of Alinity i localization took nine months from approval to launch. This project further became the first in-house production effort of imported medical devices in Hangzhou. Further, in March 2024, Shanghai Jiao Tong University and Zhejiang Orient Gene Biotech Co., Ltd. announced the co-development of a multi-index in vitro detection system using quantum dot liquid biochips.

Moreover, Japan is experiencing a rising prevalence of various infectious diseases. Japan recorded the all-time highest number of cases of streptococcal toxic shock syndrome (STSS), a type of bacterial infection, in 2024. According to CNN World, the Japan Health Ministry recorded 977 cases of streptococcal toxic shock syndrome as of June 2024, with a mortality rate of 30%, leading to ~77 deaths between January to March.

Market players are adopting inorganic growth strategies for market expansion. For instance, in June 2025, Fujirebio, a pioneering innovator of In vitro diagnostics, announced a partnership with Stanford Medicine to speed up research and innovation in infectious disease testing. The partnership is intended to promote the use of ultrasensitive immunoassays that utilize single-molecule counting technology developed by Fujirebio's Silicon Valley wholly-owned subsidiary, Fluxus, Inc. Increased sensitivity in testing can more effectively guide treatment at the clinic, as well as speed studies toward therapeutics and preventive measures against infectious disease threats globally. Further, in February 2025, Kaneka Corporation finalized a sales partnership agreement in Japan for the first domestic Trichophyton antigen test kit "DermaQuick1 Onychomycosis2" (In vitro diagnostic agent) produced by Maruho Co., Ltd.

The country is observing an increasing approval for the latest products. For instance, in June 2024, ELITechGroup announced the clearance of its BBV Panel for the Japanese market. ELITechGroup provides a completely automated PCR solution for testing the BBV panel, comprising quantitative assays for monitoring of Human Immunodeficiency Virus (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV). The HBV and HCV assays won approval under Japan's Pharmaceuticals and Medical Devices Act (PMDA) in March, and then the HIV-1 assay in June.

New product launches are aiding the infectious disease in vitro diagnostics market growth in Japan. For instance, in June 2023, Sysmex Corporation launched a testing system in Europe that detects antimicrobial susceptibility quickly. The system identifies the presence or absence of bacteria. It evaluates antimicrobial effectiveness based on urine samples from patients with suspected urinary tract infections (UTIs). Similarly, in July 2024, Shionogi & Co., Ltd. launched an in vitro diagnostic product, Shionogi MIC Dry Plate Cefiderocol, to evaluate sensitivity against the gram-negative bacterial infection treatment Fetroja.

Furthermore, the cases of HIV among Indian adults have increased at an alarming rate. As per UNAIDS, in India, 2.50 million individuals were living with AIDS in the country in 2023. Also, according to an article published in eHealth, India contributes ~27% of TB cases globally. As per the same source, 350-500 million people suffer from TB, and ~2.6 million people develop TB annually in India. Moreover, government authorities in the country are also focusing on extending access to healthcare solutions, which is also expected to have a positive impact on the growth of the infectious disease In vitro diagnostics market in India. For instance, in 2023, under the National Health Mission, the Indian government launched the Free Diagnostics Service Initiative (FDSI) to provide accessible and affordable diagnostics, reducing out-of-pocket expenses on healthcare, supporting the infectious disease in vitro diagnostics market growth.

New product launches are expected to contribute to the infectious disease in vitro diagnostics market growth in India. For instance, in June 2023, GenWorks launched In vitro diagnostic tests to check the monsoon outbreak of dengue and malaria. With the Rapid Card kits for Malaria and Dengue, GenWorks intends to bring healthcare solutions within reach, affordability, and equity. The kits are a step toward increasing awareness of the need for accurate and timely disease diagnosis among the Indian populace. Further, in January 2023, Cipla introduced a point-of-care device for infectious diseases for other health ailments. The device is CE IVD approved, meaning the device has the approval of the European In vitro Diagnostic Device Directive, thereby providing credible testing solutions, the company added in a release.

Similarly, in Feb 2023, Thermo Fisher Scientific declared that its Applied Biosystems TaqPath PCR kits for infectious diseases such as multi-drug-resistant tuberculosis (MTB MDR), hepatitis C virus (HCV), human immunodeficiency virus (HIV), M. tuberculosis complex (MTB), hepatitis B virus (HBV), and for genetic analysis (HLA B27) have been licenced by the Central Drugs Standard Control Organisation (CDSCO) and will be produced in India in partnership with Mylab Discovery Solutions. Therefore, the factors mentioned above are promoting a favorable environment for the infectious disease in vitro diagnostics market in the region.

Abbott Laboratories, F. Hoffmann-La Roche Ltd., Becton Dickinson and Co., Sysmex Corp., bioMerieux SA, Bio-Rad Laboratories Inc., QIAGEN NV, QuidelOrtho Corp., and Bruker Corp are among the leading companies profiled in the infectious disease in vitro diagnostics market report.

Based on application, the infectious disease in vitro diagnostics market is segmented into HIV/AIDS, tuberculosis, hepatitis B & C, malaria, and others. In terms of end user, the infectious disease in vitro diagnostics market is segmented into hospitals and clinics, diagnostics laboratories, blood bank, and others. Geographically, the market is categorized into North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), the Middle East and Africa (Saudi Arabia, South Africa, the UAE, and the Rest of Middle East and Africa), and South and Central America (Brazil, Argentina, and the Rest of South and Central America).

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