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 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%

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.

Metric	Value
Market Size (2025E)	USD 90,400 million
Market Value (2035F)	USD 146,500 million
CAGR (2025 to 2035)	4.8%

Country-wise Outlook

Country	CAGR (2025 to 2035)
United States	4.5%

Country	CAGR (2025 to 2035)
United Kingdom	4.2%

Region	CAGR (2025 to 2035)
European Union	4.3%

Country	CAGR (2025 to 2035)
Japan	4.4%

Country	CAGR (2025 to 2035)
South Korea	4.6%

Competitive Outlook

Company Name	Estimated Market Share (%)
Roche Diagnostics	20-24%
Abbott Laboratories	15-19%
Siemens Healthineers	12-16%
Danaher Corporation	10-14%
Other Companies (Combined)	30-40%

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

Global in vitro diagnostics market to hit $232.69B by 2029 at 11.8% CAGR, driven by rising demand for self-administered tests and rapid diagnostic solutions.

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.

In Vitro Diagnostic market is segmented into Test Type, Application, End User. Market is expected to witness a significant CAGR of 5.06% during the forecast period 2020-2030. IVD market report by BIS Research provides deep market insight that will help your business to grow. testing

Snapshot img

In-Vitro Diagnostics Market Size 2025-2029

The in-vitro diagnostics (IVD) market size is forecast to increase by USD 28.8 billion, at a CAGR of 4.6% between 2024 and 2029. The market is experiencing significant growth, driven by the increasing geriatric population and the global adoption of advanced treatment solutions.

Major Market Trends & Insights

North America dominated the market and accounted for a 44% share in 2023. The market is expected to grow significantly in Europe region as well over the forecast period. Based on the Product Type, the reagents and kits segment led the market and was valued at USD 76.00 billion of the global revenue in 2023. Based on the Technology, the immunoassay segment accounted for the largest market revenue share in 2023.

Market Size & Forecast

Market Opportunities: USD 113.40 Billion Future Opportunities: USD 28.8 Billion CAGR (2024-2029): 4.6% North America: Largest market in 2023

The market continues to evolve, driven by advancements in technology and increasing demand for accurate and rapid diagnostic solutions across various sectors. Point-of-care testing (POCT) is a prime example of this trend, with real-time Polymerase Chain Reaction (PCR) technology enabling quick and precise results for infectious diseases and genetic disorders. Diagnostic test validation remains a critical aspect of the IVD market, with sample preparation methods and patient sample handling gaining significant attention. Hematology analyzers and clinical chemistry analyzers are essential tools in this regard, providing accurate measurements for blood components and clinical chemistry parameters. Chromatography techniques, mass spectrometry, and biosensors development are also transforming the IVD landscape, offering improved limits of detection and enhanced diagnostic test accuracy.

What will be the Size of the In-Vitro Diagnostics (IVD) Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2019-2023 and forecasts 2025-2029 - in the full report.
Request Free Sample

Microbiology systems, molecular diagnostics, and next-generation sequencing are revolutionizing infectious disease diagnosis, while regulatory compliance and data management systems ensure the reliability and security of test results. For instance, the use of digital PCR technology in blood gas analyzers has led to a 20% increase in sales for one major IVD manufacturer. The global IVD market is projected to grow by 7% annually, underpinned by ongoing research and development efforts and the continuous unfolding of market activities. Immunofluorescence assays, immunoassay technology, serology testing, and ELISA techniques are further expanding the diagnostic capabilities of the IVD industry. Coagulation analyzers and electrochemistry sensors are essential for monitoring coagulation and electrolyte levels, respectively. The instruments segment is the second largest segment of the product type and was valued at USD 22.00 billion in 2023.

The assay validation process, IVD instrument calibration, and test result interpretation are crucial components of the IVD value chain, ensuring the accuracy and reliability of diagnostic tests. Spectrophotometry methods and microfluidic devices are advancing these processes, enabling more efficient and cost-effective diagnostic solutions. In summary, the IVD market is characterized by continuous innovation and growth, with various technologies and applications shaping its future trajectory.

The aging demographic is leading to a surge in chronic and infectious diseases, necessitating frequent diagnostic testing. In response, IVD manufacturers are innovating to meet this demand, developing more accurate and efficient diagnostic tools. However, this market is not without challenges. Stringent regulatory bodies are guiding IVD manufacturers, ensuring the production of safe and effective diagnostic solutions. These regulatory requirements add to the development and production costs, making it essential for companies to navigate this complex regulatory landscape effectively.

Additionally, the high competition in the market necessitates continuous innovation and improvement to maintain market share. Companies must balance the need for regulatory compliance with the pressure to deliver cost-effective and efficient solutions to meet the growing demand for IVDs.

How is this In-Vitro Diagnostics (IVD) Industry segmented?

The in-vitro diagnostics (IVD) industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

Product Type

Reagents and kits Instruments Others

Technology

Immunoassay Molecular diagnostics Clinical chemistry Hematology Others

Application

Oncology Cardiology Autoimmune diseases Neurolog

The In Vitro Diagnostics Market size will exceed a valuation of USD 152.62 billion by 2034, to grow at a CAGR of 6.7% during the forecast period.

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.

The in-vitro diagnostics kit market is estimated to advance at a CAGR of 4.40%, reaching US$ 18.8 billion through the forecasted period. The estimated market size of the market by 2024 is US$ 12.2 billion. Various market forces influence the market.

Attributes	Key Insights
Estimated Market Size in 2024	US$ 12.2 billion
Projected Market Value in 2034	US$ 18.8 billion
Value-based CAGR from 2024 to 2034	4.40%

Demand Analysis of In-vitro Diagnostics Kit Market from 2019 to 2023 vs. Outlook from 2024 to 2034

Historical CAGR from 2019 to 2023	5.00%
Forecast CAGR from 2024 to 2034	4.40%

Country-wise Analysis

Countries	Forecasted CAGR
The United States	2.7%
France	1.6%
Spain	3.3%
China	5.6%
India	6.7%

Category-wise Insights

Category	Application - Infectious Diseases
Market Share in 2024	28.1%
Market Segment Drivers	The prevalence of infectious diseases has been increasing, which surges the demand for testing units to arrest pathogens. Epidemics create more demand for testing kits, another market driver. Rapid testing is required in the case of infectious disease, which requires an in-vitro diagnostics kit. Hence, it is another critical driver.

Category	End Use - Hospital Laboratories
Market Share in 2024	43.2%
Market Segment Drivers	The number of patients reaching hospital laboratories has increased as their physician prescribes them. Hence, this is a primary market segment driver. Hospital laboratories produce accurate test results with the help of in-vitro diagnostics test kits. Hence, this is a key segment driver.

Report Scope

Attributes	Details
Estimated Market Size in 2024	US$ 12.2 billion
Projected Market Valuation in 2034	US$ 18.8 billion
Value-based CAGR 2024 to 2034	4.40%
Forecast Period	2024 to 2034
Historical Data Available for	2019 to 2023
Market Analysis	Value in US$ billion
Key Regions Covered	North America Latin America Western Europe Eastern Europe South Asia and Pacific East Asia The Middle East and Africa
Key Market Segments Covered	Kits Format Application End Use Region
Key Countries Profiled	The United States Canada Brazil Mexico Germany The United Kingdom France Spain Italy Poland Russia Czech Republic Romania India Bangladesh Australia New Zealand China Japan South Korea GCC Countries South Africa Israel
Key Companies Profiled	Bio-Rad Laboratories Inc. Corning Incorporated DWK Life Sciences. Greiner Bio-One International GmbH Narang Medical Limited Thermo Fisher Scientific Inc. Sarstedt AG & Co. KG Aptar Group Incorporated West Pharmaceutical Services Cardinal Health Atlas Medical CareDx Inc. Altona Diagnostics GmbH Mylab Discovery Solutions Pvt. Ltd. Becton, Dickinson and Company Amcor Limited GBF Inc. Co-Diagnostics Inc. Epitope Diagnostics Inc. Integrated DNA Technologies Inc. AusDiagnostics

In Vitro Diagnostics Market Outlook

The global In Vitro Diagnostics (IVD) market size was valued at approximately $82 billion in 2023 and is projected to reach around $110 billion by 2032, growing at a compound annual growth rate (CAGR) of 3.2%. The market's growth is primarily driven by the rising prevalence of chronic diseases, increasing geriatric population, and advancements in diagnostic technologies.

The rising prevalence of chronic and infectious diseases globally is one of the key growth factors for the IVD market. Chronic conditions such as diabetes, cardiovascular diseases, and cancer require frequent diagnostic testing, which drives the demand for IVD products. Additionally, the recent COVID-19 pandemic underscored the importance of diagnostics in managing public health, further boosting the market. The increasing incidence of infectious diseases, including emerging and re-emerging infections, has also led to higher demand for rapid and accurate diagnostic tests.

Another significant growth factor is the growing geriatric population worldwide, which is more susceptible to various diseases. As the global population ages, the demand for diagnostic tests that can identify and manage age-related diseases is expected to rise. This demographic shift, coupled with an increase in healthcare expenditure, particularly in developed economies, supports the expansion of the IVD market. The elderly population often requires more frequent diagnostic testing, contributing to the market's sustained growth over the forecast period.

Technological advancements in the field of diagnostics have also played a crucial role in driving the market. Innovations such as next-generation sequencing, digital pathology, and AI-powered diagnostic tools have significantly enhanced the accuracy and efficiency of diagnostic tests. The integration of these advanced technologies in IVD products has led to improved disease detection and patient outcomes. Additionally, the development of point-of-care (POC) diagnostics has made it possible to conduct tests outside traditional laboratory settings, further boosting market growth.

In Vitro Diagnostics Devices have become a cornerstone in the healthcare industry, providing essential tools for disease detection and management. These devices encompass a wide range of equipment used to perform tests on samples such as blood, urine, and tissue. The evolution of these devices has been marked by significant technological advancements, enabling more precise and rapid diagnostics. As healthcare systems worldwide strive for efficiency and accuracy, the demand for state-of-the-art In Vitro Diagnostics Devices continues to rise. These devices not only improve patient outcomes by facilitating early detection but also support healthcare providers in making informed treatment decisions. The integration of digital technologies and automation in these devices further enhances their capabilities, making them indispensable in modern medical practice.

Regionally, North America holds the largest share of the IVD market, driven by high healthcare expenditure, well-established healthcare infrastructure, and the presence of major market players. Europe follows closely due to similar factors. However, the Asia Pacific region is expected to witness the fastest growth during the forecast period, supported by increasing healthcare investments, rising awareness about early disease diagnosis, and a growing patient population. The region's large population base and improving healthcare infrastructure present significant opportunities for market expansion.

Product Type Analysis

The IVD market by product type is segmented into instruments, reagents, software, and services. Instruments constitute a significant segment due to their essential role in conducting diagnostic tests. These include analyzers, automation systems, and point-of-care devices, which are critical for various diagnostic applications. The continuous advancements in instrumentation technology, such as the development of high-throughput systems and integrated platforms, are driving the growth of this segment. Moreover, the increasing adoption of automation in laboratories to enhance efficiency and reduce turnaround times is further propelling the demand for diagnostic instruments.

Reagents are another crucial segment within the IVD market, encompassing a wide range of chemical, biological, and immunological substances used in

In Vitro Diagnostics (IVD) Market Size, Share, Forecast, & Trends Analysis by Offering (Kits) Technology (Immunoassay, Molecular Diagnostics [PCR, NGS] Rapid Test) Application (Infectious Diseases, Oncology) Diagnostic Approach (Lab, POC) - Global Forecast to 2032

The Asia Pacific 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, and Reusable IVD Devices), Application (Infectious Diseases, Diabetes, and More), End User (Diagnostic Laboratories, and More), and Country (China, Japan, and More). The Market Forecasts are Provided in Terms of Value (USD).

Vietnam In-Vitro Diagnostics Market was valued at USD 336.07 Million in 2024 and is expected to reach USD 441.23 Million by 2030 with a CAGR of 4.60% during the forecast period.

Pages	84
Market Size	2023: USD 336.07 Million
Forecast Market Size	2029: USD 441.23 Million
CAGR	2024-2029: 4.60%
Fastest Growing Segment	Immunodiagnostics
Largest Market	Southern Vietnam
Key Players	1. F. Hoffmann-La Roche Ltd 2. Abbott Laboratories GmbH 3. Siemens Vietnam 4. Thermo Fisher Scientific Inc 5. Natera, Inc. 6. Agilent Technologies, Inc 7. BD Vietnam Co. Ltd.

The Latin America in-vitro diagnostics market grew a CAGR of 17.90% during the period 2025-2034. Analysis of human samples offers physicians with vital information to properly diagnose, treat, and prevent illnesses. Several leading companies offer in-vitro diagnostic (IVD) solutions that deliver rapid, sensitive results while minimizing cost and complexity. Modern in-vitro diagnostics (IVDs) enable better diagnosis for prevention and management of infectious and chronic diseases. In-vitro diagnostics can help identify early warning signs and individual risk factors, generating new openings for prevention and early intervention. Some in-vitro diagnostics range beyond the laboratory, hospital or doctor’s office, enabling patients with chronic illnesses to self-monitor and manage their own conditions. These factors are expected to drive market growth.

Europe in vitro diagnostics market size is expected to grow from USD 32 billion in 2024 to USD 34 billion in 2025 and USD 57 billion by 2035, at a CAGR of 5.4%

The In Vitro Diagnostics (IVD) market is projected to grow at a CAGR of 5-6%, driven by factors such as the increasing prevalence of chronic and infectious diseases, rising demand for personalised medicine, technological advancements enhancing diagnostic accuracy and efficiency, growing investments in healthcare infrastructure, and the shift towards non-invasive and rapid testing methods improving […]

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.

Introduction

The global In Vitro Diagnostics (IVD) market is set to grow from USD 95.3 billion in 2022 to USD 149.4 billion by 2032, at a CAGR of 4.7%. Key growth drivers include the rising demand for personalized medicine, where IVD tests are crucial. These tests help tailor treatments to individual patients by identifying genetic variations that influence drug responses. This capability enhances treatment outcomes, making personalized medicine an integral component of modern healthcare. Next-generation sequencing tests are especially important in this context, as they offer precise genetic analysis​.

Technological advancements are significantly boosting the IVD market. Innovations such as point-of-care and home testing kits have made diagnostics more accessible and convenient. These technologies enable quicker diagnosis and treatment, which is particularly beneficial in remote or resource-limited areas. As a result, the use of IVDs is expanding beyond traditional laboratories, providing a broader reach and facilitating timely medical interventions. This trend is vital in ensuring healthcare delivery is efficient and effective across various settings​.

Regulatory support also plays a crucial role in the growth of the IVD market. Agencies like the FDA have streamlined approval processes for IVD devices, especially during public health emergencies. The introduction of Emergency Use Authorizations (EUAs) during the COVID-19 pandemic allowed for rapid test deployment. Such regulatory flexibility highlights the importance of a supportive framework in fostering market growth. These measures have significantly contributed to the timely availability of essential diagnostic tools, crucial in managing health crises​.

The global focus on disease prevention and management has further increased the adoption of IVDs. These diagnostics are vital in the early detection of infectious diseases, enabling timely intervention and reducing healthcare costs. The World Health Organization emphasizes the importance of IVDs in achieving universal health coverage by ensuring access to essential diagnostic services. This global emphasis on healthcare accessibility and disease management is driving market expansion, with IVDs playing a central role in modern healthcare strategies​​.

Recent developments in the IVD market include significant innovations and strategic partnerships. Thermo Fisher Scientific and Sysmex Corporation are leading in these advancements. In November 2022, Thermo Fisher Scientific launched the Accula Flu A/Flu B test, a rapid RT-PCR test that differentiates influenza A and B in about 30 minutes. In October 2022, Thermo Fisher acquired The Binding Site Group to enhance its capabilities in specialty diagnostics. Meanwhile, Sysmex introduced the UF-1500 Fully Automated Urine Particle Analyzer, reflecting the increasing demand for automated and precise diagnostic instruments​​.