In-vitro Diagnostics Market Overview 2025: Industry Analysis, Growth Trends & Forecast

The global in-vitro diagnostics market was valued at USD 74.92 billion in 2023 and is projected to grow from USD 73.99 billion in 2024 to USD 117.60 billion by 2032, reflecting a compound annual growth rate (CAGR) of 6.0% over the forecast period (2024-2032). In 2023, North America led the market, accounting for 37.21% of the total share.

In-vitro diagnostics encompass medical devices used to conduct diagnostic tests on biological samples such as blood, urine, and tissues. These tests play a crucial role in detecting and monitoring infectious diseases, autoimmune disorders, and other medical conditions, as well as assessing drug therapy modifications. According to the British In-Vitro Diagnostic Association, IVD tests influence approximately 70% of clinical decisions.

Market Segmentation:

The in-vitro diagnostics market is segmented into instruments and reagents & consumables, with the latter dominating in 2023 due to increased use of self-testing kits, POC tests, and advanced diagnostic products. Rising R&D activities for chronic disease diagnosis and a growing focus on early detection are driving demand for reagents & consumables. For example, in February 2021, Thermo Fisher Scientific launched the CE-IVD marked TaqPath COVID-19 HT kit for high-throughput testing. While the instruments segment is expected to grow at a slower pace, advancements like Sysmex Corporation’s UD-1500 Fully Automated Urine Particle Analyzer, launched in September 2022, are supporting its expansion. It is also segmented by technique into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others. The molecular diagnostics segment led in 2023, driven by high demand for infectious disease testing, particularly during the COVID-19 pandemic, where qRT-PCR was widely used. Growing R&D efforts are fueling innovation, such as ELITech Group’s launch of a high-throughput molecular diagnostics instrument in April 2023. The segment is expected to see strong growth due to the rising prevalence of chronic diseases, with WHO reporting 10.6 million tuberculosis cases globally in 2021.

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List Of Top IVD Market Companies:

·         F. Hoffmann-La Roche Ltd. (Switzerland)

·         Abbott (U.S.)

·         Thermo Fisher Scientific Inc.  (U.S.)

·         Sysmex Corporation (Japan)

·         Siemens Healthineers AG (Germany)

·         BD (U.S.)

·         Seegene Inc. (Republic of Korea)

·         DiaSorin S.p.A. (Italy)

·         Quest Diagnostics Incorporated (U.S.)

·         Bio-Rad Laboratories, Inc. (U.S.)

in-vitro diagnostics Market Growth Factors:

The rising prevalence of diseases such as genetic, cardiovascular, and neurological disorders is straining healthcare systems, highlighting the need for early detection through in-vitro diagnostics. According to WHO, Non-Communicable Diseases (NCDs) account for 74% of global deaths, with cardiovascular diseases leading at 17.9 million deaths annually. Raising awareness and optimizing IVD use can help manage this burden, especially with the growing geriatric population, projected to reach 1.3 billion by 2050. Government support and funding are further driving market growth, with initiatives like WHO’s Essential In-Vitro Diagnostics list and the European Commission’s USD 203 million AGLYC Project, which focuses on early ischemia detection. Such advancements and investments are expected to propel the in-vitro diagnostics market in the coming years.

Restraining Factors:

In-vitro diagnostics products offer numerous benefits, but their high costs and maintenance requirements pose challenges to widespread adoption. Additionally, these instruments require skilled professionals for operation, further increasing maintenance expenses and restricting market growth. For example, RT-PCR systems range in price from USD 15,000 to over USD 90,000, making them less accessible in many countries.

Regional Insights:

North America led the in-vitro market in 2023, valued at USD 27.88 billion, and is expected to maintain dominance due to major companies like Abbott and Thermo Fisher, favorable regulations, and advanced diagnostic infrastructure. In January 2022, Sight Diagnostics received Health Canada’s approval for its Sight OLO analyzers for point-of-care settings. Europe holds the second-largest market share, driven by high healthcare expenditure and increasing point-of-care device launches, such as Sysmex Corporation’s antimicrobial testing system in June 2023. The Asia Pacific region is projected to record the highest CAGR, fueled by improving approval policies and rising healthcare spending in countries like India, South Korea, and China. In April 2021, South Korea’s Seegene Inc. secured an export permit for its COVID-19 variant tests, boosting its global market presence. While Latin America and the Middle East & Africa have a smaller market share, rising healthcare investments and point-of-care adoption are expected to drive future growth.

Key Industry Developments:

December 2023 : Thermo Fisher Scientific Inc. introduced the Thermo Scientific KingFisher Apex Dx and Applied Biosystems MagMAX Dx Viral/Pathogen NA Isolation Kit for efficient isolation and purification of viral and bacterial pathogens.

October 2023 : Sysmex Corporation partnered with Fujirebio Holdings, Inc. to launch advanced immunoassay products for patients.

August 2023 : Qiagen received U.S. FDA approval for its therascreen PDGFRA RGQ PCR kit to address the increasing demand for infectious disease diagnostics.