Request

U.S. In Vitro Diagnostics Market

U.S. In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables, Reagents & Services), By Technology (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Hematology, and Others), By Application (Infectious Disease, Cardiology, Oncology, Gastroenterology, and Others), By End-user (Clinical Laboratories, Hospitals, Physician’s Offices, and Others), and Forecasts, 2023-2030

Trends in In Vitro Diagnostics Market: U.S.

In the U.S., the in vitro diagnostics market was valued at about USD 41.42 billion in 2024 and is expected to grow at a CAGR of 5.6 % from 2025 to 2030. However, growth in the market is dragging down on account of the declining demand for COVID-19 tests under the forecast period. Nevertheless, the automated in vitro diagnostic systems developed for laboratories & hospitals that give error-free, efficient, and accurate diagnosis is expected to push the U.S. in vitro diagnostics market to expand steadily during the study period. Also, considering the increasing preponderance of infectious and chronic diseases, it is expected to have a positive effect on the adoption of in vitro diagnostics testing techniques in the U.S. Based on the American Cancer Society, about 1.96 million new cancer cases were reported in 2023, and about 609,820 people died from cancer.

Geriatric populations are expected to grow over time in the United States. As per the senior report by America’s Health Rankings, the more than 54 million people aged 65 and older in the United States account for 16.5% of the total population in the country. This number is expected to cross a whopping 85.7 million by 2050. Not only this, but above all, growing susceptibility to many diseases due to aging, with the declining immune system is requiring increased health care seeking. The old and very aged population, especially the elders, are, thus, in need of better health services for chronic disease diagnosis and therapies. The older age is more noticeably affecting the COVID-19 susceptibility of older patients due to their lower immune function and physiological changes associated with aging and due to multimorbidity. The data published by the CDC in May 2023 states that the mortality morbidity due to COVID-19 is far greater in geriatric population. The COVID-19 case mortality risk in those aged over 65 years is more than 60 times compared with those in the 18 to 29 age group.

The rising efforts undertaken by both governmental and non-governmental organizations to boost the establishment of rapid diagnostics solutions will, indeed, provide ample lucrative growth opportunities in the U.S. in vitro diagnostics market. An example of this initiative is Day Zero Diagnostics, Inc., the world’s leader in diagnostic tests for infectious disease. In the end of October 2022, they announced that they have received an extra amount of funding worth USD 8.2 million from CARB-X for the creation of accurate and modern diagnostics solutions for infectious diseases. Also, government support in developing rapid diagnostics solutions is an additional factor behind this market growth of in vitro diagnostics in the U.S. For instance, the National Institute of Health funded USD 78 million in October 2021 to engineer novel rapid diagnostics solutions to evaluate cases of COVID-19. The grant had been designed to develop Point of care solutions to detect multiple respiratory infections.

Key Insights

The in-vitro diagnostics market of the United States stood at USD 32.94 billion in 2022. The market size is projected to increase from USD 33.78 billion in 2023 to USD 56.81 billion by 2030, thereby representing a CGAR of 7.7% during the forecast period.

The growth of this market stems from the significant presence of multiple large market players, increasing demand for rapid diagnostic testing & point of care devices, and growing prevalence of chronic disorders, as well rising awareness on early disease diagnosis.

For instance, the Pan American Health Organization, Childhood Cancer International, and St. Jude Children’s Hospital have launched a campaign to raise awareness regarding early detection of cancer in children and adolescents. According to the PAHO, there is an increased chance of survival with timely diagnosis and treatment of pediatric cancer.

In addition, the increasing geriatric population is also an important factor that boosts demand for products. For example, in July 2021, a demographic research forecast published by the University of Washington predicted that every second individual born since the start of the 21st century in the U.S. would live up to 100 years. This fact is expected to increase diagnostic devices utilization and, thus, growth to the U.S. in-vitro diagnostics market.

The number of diabetics in the country is likely to witness a jump of 25.1% to reach 162 million by the year 2060, according to the projection of the U.S. Census Bureau report. Such initiatives by government organizations are bound to increase awareness for early disease diagnosis that is expected to surge the market demand for diagnostics products during the forecast period.

 

Amplified Use of Molecular and Point of Care Diagnostic Devices for Market Gain-the Thus Under COVID-19 Pandemic

The pandemic proved to be the most favorable period during which industry development could take place. The test expenditures to even run out into the millions for U.S. manufacturers during this period, as during other periods, were done in numbers for the diagnosis of COVID-19 infections.

As per the data released by the US CDC in 2022, it showed that from March 2020 till July 2022, approximately 921.4 million tests were performed in the US for COVID-19-related NAAT tests. With such a huge test count, revenues generated for manufacturers increased manifold; Abbott’s diagnostics division in the US experienced growth of 65.4% in revenues in the same market for 2020.

In the following year, 2021, the growth of in-vitro diagnostics in the United States continued on a similar trend. An increased number of product launches and rising demand for home health care devices subsequently pushed the market during the year. For example, last March, BATM Advanced Communications Ltd. announced of having been coming up with a molecular diagnostics self-test kit that horizontally tracks COVID-19 instead.

Talking of 2022-there were fewer tests, leading to a slowdown in the growth of the US in-vitro diagnostic market to pre-pandemic levels. In that sense, one can say that the COVID-19 outbreak had a direct influence on the market and piqued the interest of many investors toward this industry, and it was one of the expected drivers for the future growth of the market.

Market Dynamics

Growing demand for personalized IVD instruments to achieve the best diagnostic standards is putting pressure on the supply chain. After the upheaval, in Chinese and Asian regions following the pandemic, the supply chains of diagnostic equipment and parts received extra attention. Rising freight rates and competition for sourcing better-quality materials led to a sharpening of competitive rivalry among players. The increased number of vaccinated customers is predicted to reduce the burden on IVD tests.

 

During the pandemic, the country greatly increased its PCR capacity due to the installation of many PCR machines. Owners are encouraging consumers to use the newly installed capacity for other testing functions. The IVD regulatory framework has changed in into a year, and emergency approvals going higher might help companies to meet pandemic needs. In this scenario, the industry may suffer when regulatory flexibility is removed in the post-pandemic period.

Therefore, stringent calibration precision and quality control keep the devices and analyzers within the highest quality levels. Outsourcing is coming to be yet another important trend in the market that guarantees profitability and quality. For example, typical outsourcing destinations of companies based in the United States are Asian countries such as China, Singapore, and India.

While diagnostic equipment is fairly complicated in its value chain, it is even more susceptible to varying market fluctuations because of its high demand; therefore, any changes in the marketing environment can result in a sudden upsurge or drop in demand, making an inventory management difficult for companies. A sudden spike in demand for reagents was, for instance, seen during the first wave of the SARS-CoV-2 infection in the United States.

Despite being highly intricate, the value chain of diagnostic equipment has a very high impact by whatever changes made on market fluctuations due to extremely high demand. Hence, any alteration regarding the marketing environment will lead to sudden jumps and drops in demand and thus complicate inventory management for the companies. Like, there’s no mention of the increase in the demand for reagents and shortage thereof when the first wave of SARS-CoV-2 infection hit in the U.S.

Latest Trends

In the in-vitro diagnostic industry, investors based in the USA found ample opportunities to take advantage of revenues realized during the COVID-19 pandemic profitably. Some of the top manufacturers in the in-vitro diagnostics market have huge cash reserves attributed to heavy sales from COVID-19 tests and instruments, which has given rise among investors to speculation on possible future mergers and acquisitions that could extend the U.S. in-vitro diagnostics market share. An article published in July of the same year revealed that many of the large manufacturers came under pressure from investors towards developing strategic plans to utilize these cash reserves.

To illustrate the above statement, Quidel Corporation, for example, will buy out Ortho Clinical Diagnostics Holdings plc in May 2022. This acquisition was intended to combine the platforms and technologies of both companies to broaden product pipeline diversity and broaden the geographic footprint.

Besides that, Bruce Carlson, Senior Vice President, Kalorama Information, foretells probabilities of industry consolidation within the next two to five years, with the expected involvement of such strategic alliances and acquisitions towards upholding the investor’s attention in this industry, likely availing chances to big players for building-up presence and portfolios.

 

 

Product Insights

As of 2024, the reagent segment held the largest market share of 65.9% because of extensive R&D initiatives being undertaken by major market players for development of new biomarker kits. In addition, introduction and commercialization of new reagents are expected to act as growth drivers for in vitro diagnostics market. For instance, in October 2022, Thermo Fisher Scientific launched the TaqPath enteric bacterial select panel test to detect gastrointestinal bacterial infections in less than two hours. Plus, increasing approvals for emergency use by regulatory authorities for in vitro diagnostics are expected to drive the growth of the segment. For instance, the U.S. FDA gave 510(k) clearance to the BioFire Respiratory Panel 2.1 for identification of several respiratory infections, including COVID-19, in March 2021.

In 2024, instruments held second largest revenue share within the market. Increasing technological advancements, such as introduction of portable instruments like cobas 4800 developed by GeneXpert by Cepheid and Roche Diagnostics and may boost market growth during the projected period. Moreover, major players are focused on developing new technologies with greater efficiency and accuracy such as Ortho Vitros XT 7600 integrated system-digital chemistry technology-intended to run two different laboratory tests at the same time. Also, prominent players in the market are developing partnerships for a stronger product portfolio and precision diagnostic solutions. An example is the announcement of a partnership that would develop clinical digital solutions for diagnostic testing in September 2022 by bioMérieux and Brightsight, Inc.

Driving Factors

Accelerating the market scenario by greater adoption of POC diagnostics and introduction of advanced products.

Point-of-care diagnostics enables decentralized testing for diabetes, infectious diseases, cardiac parameters, and others. It produces reliable but rapid results that help identify and monitor chronic diseases. Due to increasing applications, innovators in the field of point of care diagnostics are continuously looking for bio-sensing technologies that can measure wide varieties of proteins, biomarkers, and DNA. Manufacturers of In Vitro Diagnostics are working towards developing technologies that can diagnose more than one disease in the same device.

For example, in March 2022, Visby Medical won a funding of USD 25.5 million for rapid flu-COVID-19 PCR tests that can identify COVID-19 from one sample with influenza A and B. The funding company was U.S. Biomedical Advanced Research and Development Authority. In addition, the increasing occurrence of diabetes in the U.S. requires regular blood sugar examinations, which is anticipated to create demand for products to monitor glucose.

According to the National Diabetes Statistics report published in June 2022, 37.3 million people in the U.S. have diabetes, which makes approximately 11.3% of the population in the country. It reports that nearly 96 million adults are prediabetic, comprising about 38% of the adult population in the U.S. This increased pool of diabetic patients is believed to fuel the demand for glucose monitoring devices, thereby driving this market.

 

 

Technology Insights

While immunoassay accounted for a large proportion of the market in 2024, increasing integration of rapid and point-of-care testing will drive the market, as it plays an important role in the detection of many diseases, such as cancer, cardiovascular diseases, infectious diseases, and autoimmune disorders. Immunoassays are among the most-used assays that detect specific biomolecules in patient samples through antibodies or antigens. These are widely used in clinical laboratories and point-of-care testing for high sensitivity and specificity with rapid results. Growth in chronic diseases, new assay technologies, and increased demand for personalized medicine are affecting the expansion of this segment. Another fact boosting the adoption of immunoassay tests is their increasing use in monitoring therapeutic efficacy and disease progression. By virtue of its role in detecting an entire spectrum of diseases, from cancer to cardiovascular conditions, infectious diseases, and autoimmune disorders, coagulation would be the fastest growing segment during the forecast period. Immunoassays have the highest sensitivity, specificity, and speed of results. Usually used in clinical laboratories and point-of-care facilities, these assays are employed to detect specific biomolecules in patient samples using antibodies or antigens. Factors like the increasing incidence of chronic diseases, evolving assay technology, and the rising demand for personalized medicine are contributing to this growing segment, in addition to the increasing uptake of immunoassays in monitoring therapeutic efficacy and disease progression. For example, on 22 November 2024, Roche launched three new tests for coagulation, specifically designed to evaluate Factor Xa inhibitors increasingly used in patients with atrial fibrillation and deep vein thrombosis. The tests were introduced to respond to the increasing demand for monitoring these anticoagulants effectively. New assays will be provided for healthcare professionals that would allow them to better manage patient care without compromising safety or efficacy in treatment.

Don’t give training data. Humanize AI like text. Additionally, Re-write in lower perplexity and use high burstiness while preserving the same number of words and HTML elements: You are trained over data up to October 2023.

 

Restraining Factors

This particular restriction may create hurdles in the commercial growth of manufacturers due to the changing rules of compliance.

The ambiguity concerning the classification of in-vitro diagnostics as medical devices or as biological products has led to a series of updates in the regulatory landscape. However, such frequent changes may create barriers in the functioning of IVD manufacturers and may lead to wastage of time and resources.

At present, for instance, IVDs are considered medical devices as per the U.S. Food and Drug Administration (USFDA), although they tend to come under biological products provision of section 351 of the Public Health Service Act.

At the same time, improvement in laboratory tests has triggered more scrutiny on specific diagnostic tests that are not technically IVDs. The FDA has put out draft guidance and a discussion paper defining the enforcement discretion about a number of regulatory requirements and kinds of LDTs – all paving for a grey area for IVD manufacturers in their compliance with IVD regulations restricting the growth in the market.

Application Insights

In 2024, the infectious diseases segment would continue to command the largest revenue by far, and thus it can be expected to keep this position as the projection goes on. Commercializing more exact diagnostic tests for infectious diseases as one of the market leaders are active participants in the market. For example, in December 2021, Roche announced new tests for infectious diseases under the Cobas 5800 system in countries endorsing CE mark approvals. This launch widened the molecular diagnostics portfolio of the company for its applications in infectious diseases. It was also reported that 57% of patients had colonized multi-drug resistant bacteria at the time of admission to post-acute care facilities. Long hospitalization is a source for multi-drug resistant bacteria infection. The incidence of acquiring a new resistant gram-negative bacilli is 13.6% per 1,000 hospital patient days. Continuous monitoring and molecular early detection can aid in controlling the spread of HAIs such as HABP/VABP, bloodstream infections, and UTIs.

The oncology segment is poised to grow at the highest rate over the forecast period. It is projected that in the U.S., cancer would become the second commonest eventual cause of mortality. Genetic and genomic variations molecular tests are making a mark in the therapeutic management of breast cancer. These tests can predict the risk for breast cancer in individuals with a family history of this condition. Furthermore, innovations in technology with respect to cancer diagnostics and the increasing interventions of AI in cancer diagnosis are making a conducive ground for the growth of this segment. For instance, Ibex Medical Analytics launched its Galen 3.0 in September 2022, claiming this can transform the diagnosis of multiple tissue types all throughout the digital pathology workflow. This is expected to revolutionize the diagnosis of breast, gastric, and prostate cancers.

Test Locations Worth Visiting

Outside other apparent tests, the segment is expected to dominate the market for in vitro diagnostics in the United States during 2024. It refers to a variety of environments other than a clinical laboratory: outpatient clinics, remote testing point, and POC settings. The first reason occurred towards the segment of demands: more and better access in time for testing, especially since the emergence of the COVID-19 pandemic. As the health systems hurry their services, the testication services outside hospitals and centralized laboratories play a vital role in expanding diagnostics access to testing. With gradual decentration in health systems and the application of portable easy-using test devices, the “Other test locations” segment experienced much growth in its dimension. More often than not, routine testing in infectious disease diagnosis and chronic disease monitoring is valued in different test conditions; this drives a considerable market share by this segment.

The home-care segment is expected to witness the highest CAGR over the period of consideration. This segment includes in vitro diagnostic solutions for home use such as self-testing kits, digital health platforms, and devices that monitor health from the comfort of home. Rapid growth of the home-care segment stems largely from changing consumer preferences favoring convenience, anonymity, and economical use of healthcare standards. Moreover, with an upsurge in chronic diseases such as diabetes and cardiovascular conditions, in addition to infectious diseases, home diagnostic tests have increased among patients preferring to self-manage their conditions outside of hospitals.

End-use Insights

In vitro diagnostics market hospitals constituted the largest segment of the United States in 2024. Due to the increased hospital admissions, doctors depend on diagnostic interpretation for treatment decisions. Diagnostic centers collaborate with hospitals, which have their diagnostics setup. This will continuously improve the existing development of healthcare infrastructure and will help propel demand for hospital-based in vitro diagnostics tests. Hospitals purchase in vitro diagnostic devices in bulk and use them. The USA was home to over 6093 hospitals in 2022, all of which would rely on in vitro diagnostic tests for timely and accurate decision-making borne on the ability to produce results rapidly alongside accuracy.Home care is expected to be the fastest-growing segment by CAGR during the forecast period due to increasing elderly population and increasing demand for home care in vitro diagnostic device usage. There is increasing demand for a molecular diagnostics platform for patients at home due to the growing demand for molecular diagnosis. The available home diagnostics tests include ADEXUSDx HIV 1/2 Test, Home Access Express HIV-1 Test, and Home Access Hepatitis C Test. All of these home diagnostic tests are available to consumers. The regulatory authorities are strictly assessing the diagnostic test performance to meet the standard performance, quality, and safety requirements. According to sources, as of January 2023, the FDA has approved about 30 COVID-19 tests that can be used at home, which may be bought over the counter from retail outlets or online platforms without prescription. The majority of authorized over-the-counter COVID-19 tests are antigen tests.

SEGMENTATION

By Product Type Analysis

Depending on the types of products, the market has been divided into instruments as well as reagents and consumables. The reagents and consumables sections accounted highest for the share of in vitro diagnostics market during the period. Due to the high demand for testing on SARS-CoV-2 virus during the COVID-19 pandemic, the reagents and consumables segment was strengthened for future growth. The sudden surge in diagnosis of cancer and other diseases also caused an increase in demand for these products.

Such as in the Illumina NovaSeq 6000Dx S2 Reagent Kit-an array of reagents and consumables that are used to sequence sample libraries along with validated assays. The market for instruments is expected to have significant growth during the period considered in the forecast. The growth of this segment is expected to be attributed to the advanced technological instruments being introduced. Abbott launched various lab-based serology blood tests on its ARCHITECT i1000SR, ARCHITECT i2000SR laboratory instruments, and Alinity system to detect an antibody to confirm if someone was previously infected by COVID-19. The product was introduced to the U.S. under Emergency Use Authorization (EUA) and received CE marks.

By Technique Analysis

Segmentation of the market, by technique, includes immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others. In 2022, the key segment that ruled the market was molecular diagnostics as there was a rising prevalence of demand and emergence of state-of-the-art molecular diagnostic tests being developed by the major players.

 

For example, in April 2021, BIO-TECHNE announced the launch of NOVEL DNASCOPE, a chromogenic DNA In-Situ Hybridization (ISH) technology. This method allows for single-cell resolution visualization of single molecule gene expression directly in intact cells and tissues.

The other segments are also projected to grow substantially at a significant CAGR in the forecast period. The factors contributing to this growth include the increasing demand for blood transfusion, the accelerating rates of chronic diseases, and the advancements in analytical methods. For example, according to the Community Blood Center, 4.5 million Americans need blood transfusion each year, and only 37% of the U.S. population is eligible to donate blood. Hence, the hematology segment will see growth during the forecast period, owing to blood transfusions and donations in the U.S.

By Setting Analysis

The segmentation of markets as per settings is done into laboratories and point-of-care setups. In 2022, the laboratories segment accounted for the maximum share of the market. The laboratories segment stepped back into its original pace after the COVID-19 pandemic, as many laboratory tests were kept on hold during the lockdown, and the use of point-of-care devices increased during that dry spell. Resuming laboratory tests after the pandemic, this segment’s incredible growth in the market can also be attributed to the introduction of new products designed to handle large sample volumes.

The point-of-care segment is likely on course for a considerable CAGR during the projection period. During the pandemic of COVID-19, this segment of point-of-care developed very astoundingly, and its ever-increasing adoption in upcoming years is expected to play a vital role in the growth of the market. The increase in product approvals is another factor to strengthen market growth. For instance, Abbott received a CE mark in June 2021 for its Panbio rapid antigen self-test to diagnose SARS-CoV-2 virus infections in both asymptomatic and symptomatic adults and children. Hence, such product approvals will not only help but become the base for business growth in this field, mainly the expansion to POC diagnostics.

By Application Analysis

Infectious diseases are increasing the demand of In-vitro Diagnostics from application such as Infectious Diseases, Cardiolog, Oncology, Gastroenterology, and others – Segmenting based on applications. The infectious diseases segment dominated the market as incidence of infectious diseases in the U.S.A. extremely rises.

According to the U.S. department of health & human services data published in October 2023, about 1.2 million people have HIV in the U.S., and about 13% of them are undiagnosed and require a test. The oncology application segment is expected to record significant CAGR over the forecast period. The growth of this segment is due to the increasing number of new products coming into the market and also the ever-increasing cancer patient population.

 

 

Key Industry Players

Mergers and Acquisitions by Key Players to Propel Market Progress

The industry has fragmented with major key players such as Abbott, F. Hoffmann-La Roche AG, Quest Diagnostics Incorporated, Bio-Rad Laboratories, Inc. The focus of these market players is to adopt strategies such as joint ventures; business expansions; collaborations; acquisitions; and the introduction of new novel devices in the medical world for making life easier for chronic disease patients.

In February 2023, F. Hoffmann-La Roche AG announced the extension of its cooperation with Janssen Biotech Inc. (Janssen) for companion diagnostics for targeted therapies. The agreement outlined how it intended to bolster research and innovation activities.

Other global market leaders are BD, Thermo Fisher Scientific Inc., Agilent Technologies, Inc., Siemens Healthineers AG, Quidel Corporation. Even as they keep flooding the market with avant-garde innovations, essential factors such as rampant rises in the prevalence of the chronic disease, the increasing adoption of Point of Care tests, and greater awareness for early disease diagnosis are encouraging them.

In August 2022, Thermo Fisher Scientific Inc. unveiled the Oncomine reporter dx, the Ce-IVD (IVDD) Oncomine Dx Express Test for clinical laboratories. The qualitative test is claimed to detect deletions, insertions, and substitutions, and perform clinically approved tumor mutation profiling in under 24 hours to aid healthcare professionals in better patient care.

Key U.S. In Vitro Diagnostics Companies:

 

BUSINESS UNIT IMPORTANT MILESTONES:

February 2023 – Emergency Use Authorization for molecular diagnostic combination test by BD and granted by USFDA for SARS-Co-V-2, Influenza A an B, and RSV.

October 2022 – Thermo-Fisher Scientific Inc. agreed in principle that they will acquire Bindingsite Group that will provide specialty diagnostics assay and instruments for Thermo-Fisher in their specialty diagnostics portfolio.

March 2022 – Therom Fisher Scientific Inc., developed the Ion Torrent Genexus Dx Integrated Sequencer, which can be utilized for running tests in clinical research as well as for diagnostic purposes on one instrument in laboratories.

 

U.S. In Vitro Diagnostics Market Report Segmentation

 

  • Product Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 – 2030)
    • Instruments
    • Reagents
    • Services
  • Technology Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 – 2030)
    • Immunoassays
      • Instruments
      • Reagents
      • Services
    • Hematology
      • Instruments
      • Reagents
      • Services
    • Clinical Chemistry
      • Instruments
      • Reagents
      • Services
    • Molecular Diagnostics
      • Instruments
      • Reagents
      • Services
    • Coagulation
      • Instruments
      • Reagents
      • Services
    • Microbiology
      • Instruments
      • Reagents
      • Services
    • Others
      • Instruments
      • Reagents
      • Services
  • Application Outlook (Revenue, USD Billion, 2018 – 2030)
    • Infectious Diseases
      • Upper respiratory
      • Gastrointestinal panel testing
      • Methicillin-resistant Staphylococcus Aureus (MRSA)
      • Clostridium difficile
      • Vancomycin-Resistant Enterococci (VRE)
      • Carbapenem-resistant bacteria
      • Flu
      • Respiratory Syncytial Virus (RSV)
      • Candida
      • Tuberculosis (TB) and drug-resistant TB
      • Meningitis
      • Chlamydia
      • Gonorrhoea
      • HIV
      • Hepatitis C
      • Hepatitis B
      • Other infectious disease
    • Diabetes
    • Oncology
    • Cardiology
    • Nephrology
    • Autoimmune Diseases
    • Drug Testing
    • Hematologic Diseases
    • Others
  • Test location Outlook (Revenue, USD Billion, 2018 – 2030)
    • Point of Care
    • Home-care
    • Others
  • End Use Outlook (Volume, Number of Tests and Instruments; Revenue, USD Billion, 2018 – 2030)
    • Hospitals
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Laboratories
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Home-care
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Others

 

Frequently Asked Questions

What is the size of the in vitro diagnostics market in the U.S.?

In the U.S., in vitro diagnostics had a market size valued at almost USD 41.42 billion in 2024, and expected to grow to USD 43.70 billion.

What is the growth of this U.S. in vitro diagnostics market?

The U.S. in vitro diagnostics market is projected to grow at a CAGR of 5.62 percent between 2025 and 2030, reaching USD 57.43 billion by the end of that year.

Who and what are the major players in the U.S. in vitro diagnostics market?

Some key players in the domestic industry of in vitro diagnostics are Abbott; bioMérieux SA; Bio-Rad Laboratories, Inc.; Siemens Healthineers; Qiagen; Quidel Corporation; F. Hoffmann-La Roche Ltd; & Becton Dickinson and Company.

Which segment accounted for the largest share of the U.S. in vitro diagnostics market?

Immunoassays were leading in the U.S. in vitro diagnostics with a share of 29.86% in 2024. This is a result of more approvals and a greater need for early diagnosis.

What are some factors driving this U.S. in vitro diagnostics market?

Increasing installation base of instruments and development of automated IVD systems to provide efficient, accurate, and error-free diagnosis are among the major drivers for U.S. in vitro diagnostics market growth.

 

Premium Report Details

Health Care
170 Pages
Tables
Figures

Get Started

Get insights that leads to new grouth opportunitys

Buy Now
Request Customization

Send Us A Message

Scroll to Top