PUBLISHER: The Business Research Company | PRODUCT CODE: 1945428
PUBLISHER: The Business Research Company | PRODUCT CODE: 1945428
In-vitro diagnostic instruments are medical devices used to analyze biological samples, such as blood, urine, or tissue, outside the human body. Their primary function is to detect, diagnose, monitor, and manage diseases or medical conditions by providing accurate and timely laboratory test results. These instruments aid clinical decision-making and support personalized patient care.
The primary product types of in-vitro diagnostic instruments include clinical chemistry, immunoassay, molecular diagnostics, hematology, microbiology, coagulation, and others. Clinical chemistry instruments are digital tools, often leveraging AI, to analyze blood, urine, and other body fluids, helping identify biochemical abnormalities, improve diagnostic accuracy, and guide treatment planning. These instruments are applied across multiple areas, including infectious diseases, cancer, cardiology, nephrology, and autoimmune disorders. They serve a diverse range of end users, including hospitals, diagnostic laboratories, academic and research institutes, point-of-care facilities, blood banks, and pharmaceutical and biotechnology companies.
Tariffs are impacting the in-vitro diagnostics instruments market by increasing costs of imported reagents, analyzers, and precision components, particularly affecting molecular diagnostics and clinical chemistry segments. Asia-Pacific manufacturing hubs such as China and India are most impacted, causing supply chain disruptions and higher device prices. However, tariffs are encouraging local manufacturing investments, which could improve domestic production capabilities and reduce long-term dependency on imports.
The in-vitro diagnostics instruments market research report is one of a series of new reports from The Business Research Company that provides in-vitro diagnostics instruments market statistics, including in-vitro diagnostics instruments industry global market size, regional shares, competitors with a in-vitro diagnostics instruments market share, detailed in-vitro diagnostics instruments market segments, market trends and opportunities, and any further data you may need to thrive in the in-vitro diagnostics instruments industry. This in-vitro diagnostics instruments market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The in-vitro diagnostics instruments market size has grown strongly in recent years. It will grow from $61.09 billion in 2025 to $67.18 billion in 2026 at a compound annual growth rate (CAGR) of 10.0%. The growth in the historic period can be attributed to rising prevalence of chronic diseases, increasing hospital lab infrastructure, advances in diagnostic reagents, growing awareness for early disease detection, government healthcare initiatives.
The in-vitro diagnostics instruments market size is expected to see rapid growth in the next few years. It will grow to $99.44 billion in 2030 at a compound annual growth rate (CAGR) of 10.3%. The growth in the forecast period can be attributed to technological advancements in molecular diagnostics, growth of personalized medicine, integration of AI in diagnostics, expansion of emerging markets healthcare, demand for home-based diagnostic devices. Major trends in the forecast period include point-of-care testing expansion, personalized diagnostics, rapid molecular testing adoption, remote patient monitoring integration, miniaturized lab instruments.
The rising prevalence of chronic and lifestyle related diseases is expected to enhance the growth of the in vitro diagnostics instruments market in the coming years. Chronic and lifestyle related diseases refer to long term health conditions primarily influenced by daily habits, behaviors, and environmental factors, such as heart disease, diabetes, obesity, and certain cancers. The incidence of these diseases is increasing due to sedentary lifestyles and unhealthy dietary habits. In vitro diagnostics instruments are experiencing higher demand as the growing burden of chronic and lifestyle related diseases encourages companies to adopt early detection and monitoring tools for improved disease management. For example, in 2024, according to the American Action Forum, a U.S. based non profit, center right think tank, chronic diseases remain a major public health concern in the United States, with nearly 60 percent of adults living with at least one condition, 40 percent managing multiple conditions, and prevalence expected to nearly double by 2050. Furthermore, the chronic disease treatment market is projected to reach approximately 38.02 billion dollars by 2034, up from 9.74 billion dollars in 2025. Therefore, the rising prevalence of chronic and lifestyle related diseases is enhancing the growth of the in vitro diagnostics instruments market.
Prominent companies operating in the in-vitro diagnostics instruments market are focusing on developing advanced technologies, such as digital polymerase chain reaction (dPCR) systems, to achieve highly precise and sensitive nucleic acid quantification for next-generation diagnostics. Digital polymerase chain reaction (dPCR) systems are sophisticated diagnostic instruments that quantify DNA or RNA molecules by dividing samples into thousands of individual reactions, allowing for exceptional accuracy and sensitivity in detection. For example, in September 2024, QIAGEN N.V., a Netherlands-based biotechnology company, introduced the QIAcuityDx Digital PCR System, expanding its dPCR portfolio into clinical diagnostics with a primary focus on oncology testing. This fully integrated and automated system is specifically designed for clinical use, featuring a cartridge-based workflow that minimizes manual handling. Equipped with automated analysis and reporting software, the QIAcuityDx enables rapid and precise detection of genetic biomarkers for cancer diagnosis and therapy monitoring, reducing operator involvement while ensuring reliable and reproducible results.
In January 2025, Fremman Ltd., a UK-based investment company, acquired a majority stake in DIESSE Diagnostica Senese S.p.A. for an undisclosed amount. Through this acquisition, Fremman Ltd aims to expand DIESSE Diagnostica Senese's international presence, strengthen its leadership in specialty in vitro diagnostics, and support ongoing innovation to advance global diagnostic capabilities and improve patient outcomes. DIESSE Diagnostica Senese S.p.A. is an Italy-based medical equipment company that provides in vitro diagnostic instruments.
Major companies operating in the in-vitro diagnostics instruments market are F. Hoffmann-La Roche Ltd, Danaher Corporation, Abbott Laboratories, Thermo Fisher Scientific, Siemens Healthineers AG, Becton Dickinson and Company, Sysmex Corporation, Bio-Rad Laboratories Inc, Agilent Technologies, Hologic Inc, Qiagen N.V., Illumina Inc, Ortho Clinical Diagnostics, Beckman Coulter Inc, Mindray Medical International Limited, Horiba Ltd, Randox Laboratories Ltd, DiaSorin S.p.A., Werfen S.A., Trinity Biotech plc
North America was the largest region in the in-vitro diagnostics instruments market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the in-vitro diagnostics instruments market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the in-vitro diagnostics instruments market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The in-vitro diagnostics instruments market consists of sales of point-of-care testing devices, flow cytometry instruments, histopathology and cytology instruments, and molecular point-of-care systems. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
In-Vitro Diagnostics Instruments Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses in-vitro diagnostics instruments market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for in-vitro diagnostics instruments ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The in-vitro diagnostics instruments market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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