In Vitro Diagnostics Market | USD 165.74 Billion by 2034
The in vitro diagnostics market size was exhibited at USD 86.17 billion in 2024 and is projected to hit around USD 165.74 billion by 2034, growing at a CAGR of 6.76% during the forecast period 2025 to 2034.
The growth can be attributed to the increasing adoption of in vitro diagnostics (IVD) owing to rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel the growth. The rising number of IVD products launched by key players is also fueling the growth of the market.
The U.S. in vitro diagnostics market size is evaluated at USD 27.79 billion in 2024 and is projected to be worth around USD 53.45 billion by 2034, growing at a CAGR of 6.12% from 2025 to 2034.
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North America In Vitro Diagnostics market dominated the global market and accounted for a 42.28% share in 2024. The region is estimated to retain its leading market position throughout the forecast period. The market in this region is collectively driven by factors such as the rising incidence of chronic diseases, the presence of strong market players, the increasing launch of novel tests, and supportive government funding. For instance, in January 2023, BD and CerTest Biotec received EUA from the U.S. FDA for a PCR test for Mpox virus detection in the U.S. Moreover, the increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to further drive the market growth in North America.
U.S. In Vitro Diagnostics Market Trends
In vitro diagnostics market in the U.S. is growing steadily, driven by trends like personalized medicine, point-of-care testing, and advanced molecular diagnostics. Personalized medicine, which tailors treatments to individual genetic profiles, is gaining ground with IVD innovations like Roche's LightCycler PRO System. Point-of-care testing is also rising, enabling quicker diagnostics in settings outside traditional labs, as seen with Abbott's rapid COVID-19 tests. Additionally, molecular diagnostics, especially for cancer and infectious diseases, is expanding with tests like bioMérieux's VIDAS TBI, which aids in assessing traumatic brain injury.
Europe In Vitro Diagnostics Market Trends
The Europe in vitro diagnostics market is expanding, propelled by trends in infectious disease testing, molecular diagnostics, and compliance with regulatory standards like CE-IVDR. Demand for infectious disease diagnostics surged post-COVID-19, with companies like Siemens Healthineers advancing platforms like the Atellica CI Analyzer for efficient, compact testing. Molecular diagnostics are also booming, as seen with ELITechGroup’s CE-IVDR certified GI Bacterial PLUS kit, aimed at gastrointestinal infections. The strict IVDR regulation drives innovation, ensuring higher accuracy and safety in diagnostic tests across Europe.
In vitro diagnostics market in the UK is experiencing growth, driven by advancements in point-of-care testing, molecular diagnostics, and AI-powered solutions. Point-of-care testing has gained popularity, particularly in managing chronic diseases, as seen with Abbott’s handheld glucose monitors. Molecular diagnostics, such as Roche’s next-generation LightCycler PRO for precise genetic testing, are expanding to support personalized medicine initiatives. Additionally, AI integration in diagnostics is helping streamline workflows, enabling faster data analysis and interpretation, which is essential for enhancing patient care in both clinical and remote settings.
France IVD market is evolving rapidly, with strong trends in point-of-care testing, molecular diagnostics, and infectious disease assays. Point-of-care solutions, particularly for chronic disease management, are gaining traction in decentralized healthcare settings. The demand for molecular diagnostics, boosted by advancements like CE-IVDR compliance, is also expanding, especially in oncology and genetic testing. Infectious disease diagnostics remain a focal area, driven by heightened public health awareness and investment in rapid testing technologies to enhance outbreak response.
In vitro diagnostics market in Germany is advancing with trends in personalized medicine, molecular diagnostics, and automation in laboratory processes. The focus on personalized healthcare is propelling demand for molecular diagnostics, particularly in cancer genomics and infectious disease detection. Automation is also a key trend, with laboratories adopting advanced systems to streamline workflows, reduce error rates, and manage high sample volumes. Additionally, Germany's regulatory alignment with the EU’s IVDR standards is driving innovation and compliance in diagnostic devices and testing methods.
Asia Pacific In Vitro Diagnostics Market Trends
Asia Pacific in vitro diagnostics market is anticipated to exhibit significant growth at CAGR of 8.59% during the forecast period. The regional market of Asia Pacific is expected to be driven by a number of factors, some of which include the presence of stabilizing economies, a rapidly growing middle-class population, supportive government policies, and rapid urbanization across the region. For instance, in October 2023, Fapon and Halodoc partnered to increase the in vitro diagnostic products sales and services in Indonesia. Moreover, leading players are collaborating with regional players to expand their reach in developing countries in Asia Pacific.
In vitro diagnostics market in China is expanding rapidly, driven by a rising demand for molecular diagnostics, point-of-care testing, and digital health integration. Molecular diagnostics, especially in infectious diseases and oncology, are seeing significant growth due to public health initiatives and increased healthcare spending. Point-of-care testing is gaining momentum in rural and community health settings, providing accessible diagnostic options. Additionally, digital health and AI-driven diagnostics are being integrated to improve patient outcomes, streamline diagnostics, and support the country’s healthcare modernization efforts.
Japan in vitro diagnostics market is experiencing growth spurred by an aging population and advancements in personalized medicine. Key trends include the rising use of molecular diagnostics, particularly for oncology and genetic testing, as these help identify targeted treatments for age-related diseases. Automation and AI integration in diagnostic labs are also enhancing efficiency and accuracy, which is crucial given Japan’s limited healthcare workforce. Furthermore, there’s an increased demand for point-of-care testing, especially in home and community health settings, supporting proactive and preventive healthcare.
Latin America In Vitro Diagnostics Market Trends
In vitro diagnostics market in Latin America is growing due to rising healthcare investments, increased focus on disease prevention, and expanding healthcare access. A key trend is the rising adoption of point-of-care testing for infectious diseases like dengue, Zika, and COVID-19, crucial in remote and underserved areas. Additionally, demand for molecular diagnostics, particularly in oncology, is increasing as awareness of personalized medicine grows. Public-private partnerships and government initiatives are also supporting diagnostics infrastructure, making advanced testing technologies more accessible across the region.
The Brazil in vitro diagnostics market is experiencing significant growth, driven by advancements in technology, an aging population, and increasing prevalence of chronic diseases. Key trends include the rising demand for point-of-care testing, which offers rapid results and enhances patient management. Additionally, there is a growing focus on personalized medicine and molecular diagnostics, supported by government initiatives to improve healthcare infrastructure. The market is also witnessing increased investments in research and development, fostering innovation in diagnostic solutions.
Middle East & Africa In Vitro Diagnostics Market Trends
The In vitro diagnostics market in Middle East and Africa (MEA) is poised for growth, driven by rising healthcare expenditures and an increasing prevalence of infectious diseases. Key trends include the adoption of advanced molecular diagnostics and point-of-care testing, which enhance disease detection and management. Additionally, a growing focus on personalized medicine and government initiatives aimed at improving healthcare infrastructure are supporting market expansion. Collaborations between local and global players are also fostering innovation and enhancing the accessibility of diagnostic solutions in the region.
The Saudi Arabia in vitro diagnostics market is experiencing robust growth, fueled by a rising demand for advanced diagnostic solutions and an expanding healthcare infrastructure. Key trends include the increasing adoption of point-of-care testing and molecular diagnostics, which enhance disease detection and management. Additionally, government initiatives aimed at improving healthcare quality and accessibility are driving investments in the IVD sector. The growing prevalence of chronic and infectious diseases further propels market growth, alongside a focus on personalized medicine and innovative diagnostic technologies.
| Report Coverage | Details |
| Market Size in 2025 | USD 91.99 Billion |
| Market Size by 2034 | USD 165.74 Billion |
| Growth Rate From 2025 to 2034 | CAGR of 6.76% |
| Base Year | 2024 |
| Forecast Period | 2025-2034 |
| Segments Covered | Products, Technology, Application, End-use, Test Location, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional scope | North America; Europe; Asia Pacific; Latin America; MEA |
| Key Companies Profiled | Abbott; bioMérieux SA; QuidelOrtho Corporation; Siemens Healthineers AG; Bio-Rad Laboratories, Inc.; Qiagen; Sysmex Corporation; Charles River Laboratories; Quest Diagnostics Incorporated; Agilent Technologies, Inc.; Danaher Corporation; BD; F. Hoffmann-La Roche Ltd. |
Reagents held the largest revenue share of 68.0% in the market in 2024. The segment is expected to retain its dominance growing at the fastest CAGR during the forecast period owing to the extensive R&D initiatives undertaken by major market players to develop novel reagents and test kits. For instance, in February 2023, BD received the market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test in the U.S. The increasing R&D activities to enable faster cancer detection and precision medicine is allowing companies to focus on niche profitable areas in the IVD business. For instance, in March 2023, QIAGEN partnered up with Servier to develop a companion diagnostic test for TIBSOVO, indicated for treating the blood cancer acute myeloid leukemia. The growth in precision medicine is projected to enhance the overall demand for such novel reagents and consumables.
Instruments held the second-largest revenue share in 2024. Increasing approvals for novel IVD instruments is anticipated to drive the segment growth. For instance, in April 2023, bioMérieux SA submitted 510(k) application to the U.S. FDA for VITEK REVEAL, rapid AST system. Players are aligning their instrument launches with the increasing genetic test requirement globally. For instance, in March 2022, Ion Torrent Genexus Dx Integrated Sequencer was introduced in the market by Thermo Fisher Scientific for research as well as diagnostic purposes.
Immunoassay accounted for the largest revenue share of the market in 2024. The increasing incidence of chronic & communicable diseases and the rising need for early diagnosis are among the key factors leading to an increase in demand for immunological methods, including different Enzyme-Linked Immunosorbent Assays (ELISAs). Moreover, key players are focused on R&D for the development of new immunological diagnostic instruments and tests for IVD applications. For instance, in October 2023, Sysmex Corporation and Fujirebio Holdings, Inc. collaborated to enhance their R&D, production, clinical development, and marketing activities in immunoassay.
Coagulation is expected to grow at the fastest rate from 2025 to 2034. The growth of the segment can be attributed to the increasing prevalence of cardiovascular diseases, blood-related disorders, and autoimmune diseases. Moreover, the instruments are getting updated and handheld coagulation analyzers, such as the Xprecia stride coagulation analyzer, such instruments are anticipated to enhance the overall workflow of detection. Some of the key players offering instruments and coagulation tests are Abbott, Siemens Healthcare GmbH, and Beckman Coulter, Inc.
Hospitals held the largest revenue share of the market in 2024, owing to a rise in hospitalizations that require support from faster diagnostics. Moreover, the ongoing development of healthcare infrastructure and favorable initiatives taken by government bodies are anticipated to enhance the existing hospital facilities. Thus, the demand for hospital-based IVD tests is increasing. Most IVD devices are purchased by hospitals and used in significant volumes. In 2023, there are over 6,129 hospitals in the U.S. that require constant aid from IVD for critical decision-making, as IVD tests provide faster and more accurate results. Moreover, in December 2023, the American Hospital Association wrote a letter to the FDA not to apply device regulations to hospital LDTs.
The homecare segment is expected to grow at a high CAGR from 2025 to 2034 due to the rising geriatric population and increasing demand for home care IVD devices. There is a growing need for novel molecular diagnostic and immunoassay platforms to assist patients in self-testing. For instance, in February 2023, the initial over-the-counter (OTC) home diagnostic test that can distinguish and identify influenza A and B, commonly referred to as the flu, and SARS-CoV-2, the virus causing COVID-19, was given an EUA by the FDA.
The infectious diseases segment dominated the market in 2024. The outbreak of the COVID-19 pandemic has increased the segment share significantly in recent years. Moreover, key players are introducing novel testing products to improve access to high-quality, innovative laboratory services for patients & healthcare providers. For instance, in February 2023, BD received EUA from the U.S. FDA for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV). Such initiatives by key players to strengthen their presence are expected to drive the market.
The oncology segment is anticipated to grow at the fastest rate from 2025 to 2034. The increasing incidence of cancer coupled with a high mortality rate is increasing the demand for cancer biomarker tests at an early stage. Moreover, increasing approval of novel tests, R&D activities, and favorable initiatives undertaken by regulatory bodies are expected to drive growth. For instance, in June 2023, the U.S. FDA announced a pilot program that gives chance to manufacturers to submit validation and performance data for LDTs for cancer. Moreover, in April 2023, Biocartis Group NV & APIS Assay Technologies Ltd. collaborated to manufacture and commercialize a breast cancer subtyping test on Idylla, a molecular diagnostics platform.
Others (lab-based tests) accounted for the largest revenue share of the market in 2024. A large number of test analyses at one time and the higher accuracy of laboratory-based tests make them more reliable compared to PoC and home tests, giving these tests a competitive edge over the other two segments. Moreover, the availability of tests that allow for sample collection at home and sending it to the laboratories for testing makes testing highly convenient for patients.
The homecare segment is expected to grow at a high CAGR from 2025 to 2034 due increasing reliability of these tests and the patient-centric approaches of manufacturers. These tests have been an important source in mitigating the spread of the SARS-CoV-2 pandemic. Significant actions have been taken by government bodies globally to ensure access to affordable and efficient homecare tests. In April 2023, Llusern Scientific, a University of South Wales spinoff, developed the PoC molecular diagnostic platform, Lodestar Dx platform, for panel testing of urinary tract infections.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the in vitro diagnostics market
By Product
By Technology
By Application
By Test Location
By End-use
By Regional
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers