The in Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, and More), Product (Instruments, Reagents and More), Usability (Disposable IVD Devices, Reusable Equipment), Application (Infectious Diseases, Oncology, Cardiology, and More), End User (Stand-Alone Laboratories, and More), Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

In 2020, the in vitro-diagnostics market is expected to be dominated by consumable products with a share of 70 percent. The statistic shows the estimated distribution of the global in-vitro diagnostics market in 2020 and a forecast for 2030, by type of product.

The market was valued at USD 90,400 million in 2025 and is anticipated to reach USD 146,500 million by 2035, expanding at a compound annual growth rate (CAGR) of 4.8% over the forecast period.

Country-wise Outlook

Competitive Outlook

In vitro diagnostics market size is expected to grow from USD 108 billion in 2024 to USD 113 billion in 2025 and USD 190 billion by 2035, at a CAGR of 5.3%

This statistic describes the top 10 medical technology companies for in vitro diagnostics in 2017 and 2024, based on market share. In 2017, Sysmex accounted for 4.4 percent of the global market for in vitro diagnostics. By 2024, this share is expected to increase slightly to 4.5 percent. In vitro diagnostics allows for medical professionals to detect diseases, conditions, and infections. These tests can be conducted within a laboratory and sometimes at within a patient's home.

The Europe In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, and More), Product & Service (Instrument, and More), Usability (Disposable IVD Devices, and More), Specimen Type (Blood, and More), Site of Testing (Central Laboratories and More), Application (Infectious Diseases and More), End User (Diagnostic Laboratories and More) and Country. The Market Forecasts are Provided in Terms of Value (USD).

In Vitro Diagnostics Ivd Market is estimated to be valued at USD 126.73 Bn in 2025 and is expected to expand at CAGR of 6.5% reachingUSD 197.06 Bn by 2032

The global in vitro diagnostics market size reached USD 116.7 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 181.5 Billion by 2033, exhibiting a growth rate (CAGR) of 5.0% during 2025-2033. The rising prevalence of infectious diseases globally, the continuous technological advancements, the shifting consumer preferences towards personalized medicine, and the increasing geriatric population are among the primary factors driving the in vitro diagnostics market growth.

IMARC Group provides an analysis of the key trends in each segment of the global in vitro diagnostics market report, along with forecasts at the global, regional, and country levels from 2025-2033. Our report has categorized the market based on test type, product, usability, application, and end user.

As of 2022, Roche Diagnostics accounted for the largest share of the IVD market in Europe, taking up just over a ***** of the market. Abbott Laboratories followed with a market share of ** percent. The Statista Market Insights cover a broad range of additional markets.

In 2023, the In-Vitro Diagnostics (IVD) Market reached a value of USD 83.63 billion, and it is projected to surge to USD 114.02 billion by 2030.

The global in vitro diagnostics market was valued at USD 81.78 Billion in 2024, driven by the increasing demand for advanced diagnostic facilities across the globe. The market is anticipated to grow at a CAGR of 6.20% during the forecast period of 2025-2034 to achieve a value of USD 149.24 Billion by 2034.

In-vitro Diagnostics Market Outlook

According to our latest research, the global in-vitro diagnostics (IVD) market size reached USD 102.6 billion in 2024. The market is currently experiencing robust expansion, supported by a CAGR of 5.4% during the forecast period. By 2033, the in-vitro diagnostics market is projected to attain a value of USD 163.4 billion. This growth is primarily driven by the increasing prevalence of chronic and infectious diseases worldwide, ongoing technological advancements in diagnostic tools, and the rising emphasis on early disease detection and personalized medicine.

One of the most significant growth drivers for the in-vitro diagnostics market is the rising global burden of chronic and infectious diseases. The increasing incidence of conditions such as diabetes, cancer, cardiovascular diseases, and infectious diseases like tuberculosis and HIV has heightened the demand for early and accurate diagnostic solutions. Early diagnosis is crucial for effective disease management, leading to improved patient outcomes and reduced healthcare costs. Additionally, the emergence of new infectious threats and pandemics, as witnessed during the COVID-19 crisis, has further underscored the vital role of IVD in rapid screening and disease surveillance, prompting both public and private sectors to invest heavily in diagnostic infrastructure and innovation.

Technological advancements are another key factor propelling the growth of the in-vitro diagnostics market. The integration of cutting-edge technologies such as next-generation sequencing, digital PCR, microfluidics, and artificial intelligence has revolutionized the field of diagnostics. These innovations have enabled higher sensitivity, specificity, and automation in testing, thereby enhancing laboratory efficiency and accuracy. Moreover, the increasing adoption of point-of-care testing (POCT) devices and home-based diagnostic solutions is making healthcare more accessible and patient-centric. The development of multiplex assays and companion diagnostics is also supporting the trend towards personalized medicine, allowing for tailored treatment regimens based on individual patient profiles.

Another important growth factor is the supportive regulatory landscape and increasing healthcare expenditure globally. Governments and regulatory bodies are streamlining approval processes for novel diagnostic products, ensuring faster access to advanced testing solutions. Furthermore, rising investments by public and private entities in healthcare infrastructure, particularly in emerging economies, are expanding the reach of IVD technologies. Initiatives aimed at strengthening laboratory networks, improving disease surveillance, and enhancing quality assurance are fostering market growth. The growing awareness among patients and healthcare professionals about the benefits of early detection and preventive care is also contributing to the increased adoption of IVD products.

From a regional perspective, North America continues to dominate the in-vitro diagnostics market, accounting for the largest share in 2024, followed by Europe and Asia Pacific. The region’s leadership is attributed to the presence of advanced healthcare systems, high adoption rates of innovative diagnostic technologies, and significant investments in research and development. However, Asia Pacific is expected to exhibit the fastest growth rate during the forecast period, driven by rising healthcare awareness, expanding patient population, and increasing government initiatives to improve diagnostic infrastructure. Latin America and the Middle East & Africa are also witnessing steady growth, supported by improving healthcare access and rising investments in laboratory services.

Product Type Analysis

The in-vitro diagnostics market by product type is segmented into Instruments, Reagents & Kits, and Software & Services. Among these, reagents & kits represent the largest revenue contributor in 2024, owing to their recurring usage in a wide range of diagnostic tests across var

The Mexico In-Vitro Diagnostics Market Report is Segmented by Technique (Clinical Chemistry, Molecular Diagnostics, and More), Product & Service (Instruments/Analysers, Reagents and More), Usability (Disposable IVD Devices and Reusable Systems), Application (Infectious Disease, Oncology, and More), and End Users (Independent Diagnostic Laboratories, Hospitals and More). The Market Forecasts are Provided in Terms of Value (USD).

The Japan In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, and More), Product (Instruments and Analyzers, and More), Usability (Disposable IVD Devices and Re-Usable IVD Devices), Test Setting (Central-Laboratory Testing and Point-Of-Care Testing), Application (Infectious Diseases, and More), End-User (Hospital-Based Laboratories, and More). The Market Forecasts are Provided in Terms of Value (USD).

In 2029, the global in vitro diagnostics market is forecast to have revenue of over ***** billion U.S. dollars. Between 2020 and 2021, the IVD market size increased significantly, going from around ** billion U.S. dollars to just under 100 billion U.S. dollars. Market leaders and regional distribution Swiss-based pharmaceutical company Roche has maintained its position as the global leader in the IVD market, with projected revenues exceeding ** billion U.S. dollars by 2024. Other major players include Abbott Laboratories and Danaher from the United States. In Europe, Germany dominates the IVD market with a ** percent share, more than double that of France, the next largest market at **** percent. Market composition The IVD market comprises various product categories, including reagents, instruments, and software services. Consumable products accounted for the largest share of the IVD market globally, representing around ** percent of the total market.

Stay Updated on IVD(In-Vitro Diagnostics) Market - Analysis and Forecast 2017-2023 from BIS Research Focuses on Region, key player, Total revenue, challenges, and growth opportunities.

As of 2023, Abbott Laboratories had the largest market share in the IVD market in the United States, at just over ** percent. Following in second place was Danaher with a market share of **** percent.Find more statistics on other topics: a comparison of the value share by brand in Belgium and a comparison of the value share by brand in the United States.The Statista Market Insights cover a broad range of additional markets.

Global in vitro diagnostics (IVD) market was valued at US$ 79.89 Billion in 2024 and is set to reach around US$ 137.29 Billion by 2034 at a CAGR of about 6.2% from 2025 to 2034.

The size of the India In-Vitro Diagnostics Market market was valued at USD 1.71 Million in 2023 and is projected to reach USD 2.67 Million by 2032, with an expected CAGR of 6.58% during the forecast period. The India in-vitro diagnostics (IVD) market is confined to medical devices that are employed to perform tests on samples derived from or on parts of the human body, for the most part for diagnostic purposes. Some of these tests include a blood test, urine test and test on tissues in a bid to diagnose diseases, keep track of the goings-on in a patient’s health and to average the impact of treatment. Most of the relevant uses pertain to the actual identification of diseases for example diabetes or cancer screening and measurement of ongoing conditions, and early screening for illnesses. Key factors that are pushing this market are improving healthcare consciousness among people, technological progress, and a new focus on early diagnostics and individual treatment. Some current trends observed are, point of care testing, the use of artificial intelligence to enhance test accuracy and, an increasing variety of tests for chronic and diseases caused by infections. Recent developments include: In June 2022, Genes2Me Pvt. Ltd launched the CoviEasy Self-test Rapid Antigen kit for COVID-19, which is supported by an AI-driven mobile app., In February 2022, Mylab Discovery Solutions launched CoviSwift, a point-of-care (POC) testing solution comprising the CoviSwift assay and Compact-Q machines and process 16 samples within 40 minutes, four times faster than the typical RT-PCR testing procedure.. Key drivers for this market are: High Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics; Rising Awareness and Acceptance of Personalized Medicine and Companion Diagnostics. Potential restraints include: Stringent Regulations, Cumbersome Reimbursement Procedures. Notable trends are: Molecular Diagnostics Segment is Expected to Grow in the India In-Vitro Diagnostics Market Over the Forecast Period.

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The IVD market share in the US is expected to increase to USD 7.39 billion from 2020 to 2025, at a CAGR of 6.41%. This report provides valuable insights on the post COVID-19 impact on the market, which will help companies evaluate their business approaches.

This IVD market in the US research report extensively covers market segmentation in the US by technology (immunochemistry, molecular diagnostics, tissue diagnostics, hematology, and others) and component (consumables, instruments, and services).

The IVD market in the US report also offers information on several market vendors, including Abbott Laboratories, Becton Dickinson and Co., Bio Rad Laboratories Inc., bioMerieux SA, Danaher Corp., DiaSorin SpA, F. Hoffmann-La Roche Ltd., Siemens Healthineers AG, Sysmex Corp., and Thermo Fisher Scientific Inc. among others.

What will the IVD Market Size in the US be During the Forecast Period?

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IVD Market in the US: Key Drivers, Trends, and Challenges

The increasing geriatric population, chronic, and infectious diseases is notably driving the IVD market growth in the US, although factors such as stringent regulatory bodies guiding IVD manufacturers may impede the market growth. Our research analysts have studied the historical data and deduced the key market drivers and the COVID-19 pandemic impact on the IVD industry in the US. The holistic analysis of the drivers will help in deducing end goals and refining marketing strategies to gain a competitive edge.

Key IVD Market Driver in the US

The increasing geriatric population, chronic, and infectious diseases is one of the key drivers supporting the IVD market growth in the US. Viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and others cause infectious diseases which require the need for IVD tests. The rising incidence rates of diseases such as diabetes and cancer are increasing the need to diagnose diseases at an early stage to ensure regular monitoring of patients to identify, treat, control, and limit the prevalence of diseases. Molecular diagnostic techniques like enzyme-linked immunoassay (ELISA) help in the early detection of infections through antigen and antibody interactions to mitigate diseases. Thus, changing demographics in the US, primarily including the aging population and incidence rates of diseases, will contribute to the growth of the IVD market during the forecast period.

Key IVD Market Trend in the US

Technological advances in IVD is another factor supporting the IVD market growth in the US. Advanced cutting-edge technologies like POCT, next-generation sequencing, near-patient testing, and others have revolutionized the IVD sector by providing an accurate and precise diagnosis at rapid rates. Furthermore, vendors focus on providing customized solutions through advancements in genomic technologies, contributing to the growth of personalized treatment care. Diagnostic companies collaborate with pharmaceutical companies to develop and provide targeted therapy solutions. For instance, bioMerieux provides personalized care diagnostic solutions. Thus, the increasing focus on personalized medicines will lead to the IVD market growth during the forecast period

Key IVD Market Challenge in the US

The stringent regulatory bodies guiding IVD manufacturers is hindering the IVD market growth in the US. IVD are tests conducted to examine blood, tissue, or fluid samples to monitor health conditions and to treat or prevent diseases. The design of devices, malfunctioning, and technical errors are some of the issues associated with the usage of these devices. Such issues can lead to misdiagnosis and improper patient management and treatment of several blood conditions and diseases. Hence, stringent government regulations are imposed on these devices. Also, during the submission for pre-market approval, the company must pay a minimum of USD 62,000 to the FDA, and the approval procedure is time-consuming. Even after the submission, there might be chances for devices to get approved or disapproved. Sometimes, the products may be recalled after approval due to malfunctioning issues. Hence fulfilling stringent government guidelines pose a threat to the growth of the IVD market in the US.

This IVD market in the US analysis report also provides detailed information on other upcoming trends and challenges that will have a far-reaching effect on the market growth. The actionable insights on the trends and challenges will help companies evaluate and develop growth strategies for 2021-2025.

Parent Market Analysis

Technavio categorizes the IVD market in the US as a part of the global healthcare equipment market. Our research report has extensively covered external factors influencing the parent market growth potential in the coming years, which will determine the lev