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and next-generation sequencing. The average cost of a molecular diagnostic test in 2025 was still over USD 200, making it unaffordable for those in low- and middle-income nations. As a result, the use of contemporary IVD technologies is declining in Africa and Southeast Asia, which hinders their global dissemination.

Competitive Landscape

The U.S. IVD market is led by global giants including Abbott, Roche, Thermo Fisher, Siemens Healthineers, and Quest Diagnostics, with growing competition from innovative biotech firms and startups entering precision diagnostics. Roche is concentrating on growing its platforms for molecular diagnostics and digital health. Abbott invests in the development of rapid point-of-care tests for infectious diseases. While Thermo Fisher is developing next-generation sequencing diagnostics, Siemens is interested in utilizing AI in lab automation. Partnerships and regional expansions are used by startups to enter new markets and diversify their test offerings. All market sectors experience increased competition as a result.

Major players in the In-Vitro Diagnostics industry include,

F. Hoffmann-La Roche LtdHologic IncAbbott LaboratoriesSiemens Healthcare GmbH (Siemens Healthineers)Exact Sciences CorpbioMérieux SAQuidelOrtho CorpSysmex CorpBio-Rad Laboratories IncThermo Fisher Scientific IncBecton DickinsonDanaher Corporation (Beckman Coulter, Cepheid etc.)IlluminaDiaSorin (Luminex Corporation)Koninklijke Philips NV (Philips Healthcare)Qiagen N.V.Werfen, S.A. (Biokit S.A.)Agilent Technologies IncQuest DiagnosticsRevvity IncMindray

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In-Vitro Diagnostics Market Segmental Analysis

The in-vitro diagnostics market is segmented into product, technology, specimen, site of testing, application, end user, and region.

By product, since reagents & instruments are required for so many different diagnostic tests, reagents and instruments held the largest market share in 2024. They are always needed in hospital and lab settings, so revenue will always be coming in. Better test automation and additional disease screening initiatives contributed to the increase even more.By technology, in 2024, immunoassays were the most widely used technology due to their high accuracy, speed, and widespread use in determining whether a person had a chronic or infectious disease. The testing process was accelerated by their compatibility with automated systems. They were a common diagnostic tool in labs and hospitals because of their ability to handle large volumes of samples.By specimen, due to ease of collection and ability to identify a wide range of diseases, blood continued to be the most common specimen type in 2024. Blood tests are commonly accepted as fundamental diagnostic methods in medical settings. Blood-based diagnostics became even more popular due to their high sensitivity for early illness identification.By site of testing, as centralized laboratories are more accurate, standardized, and scalable, laboratory testing was the most common form of testing in 2024. The majority of complex diagnostic procedures, including molecular and genetic analysis, are carried out in laboratories. Because more extensive panels and batch testing were required, the lead for this area grew stronger.By application, infectious disorders accounted for the largest percentage of applications in 2024, as people still want to test for respiratory pathogens. Additionally, many people in developing nations still required HIV, TB, and hepatitis testing. Spending on infectious disease testing increased as travel and antibiotic resistance increased.By end user, since hospitals & clinics perform the majority of patient diagnostics in both emergency and routine settings, they are the largest end users in 2024. Doing more tests was made easier by instant access to testing supplies and integrated healthcare services. Due to their use in primary care settings, IVD instruments will always be in demand.

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Regional Insights

North America continued to dominate the in-vitro diagnostics market in 2024 Due to its highly developed healthcare system, high healthcare costs, and rapid adoption of new technologies. As it invested heavily in molecular diagnostics and AI-integrated testing systems, the U.S. was the region's leader. Innovation was also stimulated by strategic partnerships between diagnostic companies and hospitals. People still required routine and specialized tests because chronic illnesses are so prevalent.Europe's in-vitro diagnostics market continued to expand rapidly due to effective public health systems and an increasing demand for customized drugs. The nations that used immunoassays and genetic testing the most were Germany, the United Kingdom, and France. Although the EU In Vitro Diagnostic Regulation (IVDR) made it more difficult for companies to comply with the regulations, it also ensured that the products were of higher quality. Population aging and increased initiatives to encourage screening before illness also played a role.The in-vitro diagnostics market is expanding at the fastest rate in Asia-Pacific because more people are becoming middle class, more diagnostic networks are being established in countries like China, India, and Japan, and more people are becoming aware of healthcare issues. More tests were conducted as a result of government efforts to enhance digital health and early illness detection. Additionally, there was an increased need in the region for point-of-care and home-based diagnostics. Local production and foreign investment strengthened regional capacities.The market in LAMEA is gradually expanding as a result of improved healthcare infrastructure and easier test-taking. Particularly in infectious disease testing, South Africa and Brazil are significant players. However, factors like unequal compensation and a shortage of skilled workers reduce the market's potential for expansion. People in underdeveloped areas are finding it easier to access care thanks to international collaborations and mobile diagnostic units.

Explore Extensive ongoing Coverage on Healthcare Sector:

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About SkyQuest Technology Consulting

SkyQuest Technology Consulting is a leading Strategy Consulting and Market Research firm, provides syndicated as well as customized research reports and growth consulting services, trusted by CXOs from Fortune 500 Companies, Start-ups, and MSMEs. The company comprises a team of expert research analysts and consultants, adding more than 1200 market research reports in our database each year. These reports offer in-depth analysis on 40+ industries & sub industries across 25 major countries worldwide, serving global clients across diverse industries. The company specializes in delivering customized intelligence, data-driven insights, and strategic advisory services that enable businesses to stay competitive and make informed decisions in rapidly evolving industries.

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