The Report Covers United States In Vitro Diagnostics Market Companies and is segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Haematology, and Other Test Types), Product (Instruments, Reagents, and Other Products), Usability (Disposable IVD and Reusable IVD), Application (Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Diseases, Nephrology, and Other Applications), and End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users). The Market Size and Forecast are Provided in Terms of Value (In USD Million) for the Above Segments.

North America in vitro diagnostics market is estimated to reach USD 75 billion by 2035, at a CAGR of 5.4% during the forecast period 2024-2035.

The Global In-Vitro Diagnostics (IVD) Industry Analysis Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immunodiagnostics, Hematology, and Other Test Types), Product (Instruments, Reagents, and Other Products), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, and Other Applications), End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Report Offers the Market Size, Market Forecast, and Market Outlook for Each Segment in Terms of Value (USD).

In 2024, the global in-vitro diagnostics market had a revenue of almost 99 billion U.S. dollars. Between 2020 and 2021, the IVD market size increased significantly, going from around 76 billion U.S. dollars to just under 100 billion U.S. dollars.

The revenue change in the 'In Vitro Diagnostics' segment of the medical technology market in the United States was forecast to continuously increase between 2024 and 2029 by in total 4.2 percentage points. According to this forecast, in 2029, the revenue change will have increased for the sixth consecutive year to 3.36 percent. Find further information regarding revenue in Canada and revenue growth in Canada. The Statista Market Insights cover a broad range of additional markets.

The global in-vitro diagnostics market size is predicted to rise from USD 97.36 billion to USD 201.17 billion, exhibiting a CAGR of over 6.1% during the forecast timeline, from 2025 through 2037. North America industry is projected to account for largest revenue share by 2037, driven by the increasing requirement of genetic testing for personalized health care, diabetes, and cancer in the region.

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.

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

Country-wise Analysis

Category-wise Insights

Report Scope

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In-Vitro Diagnostics Instruments Market Size 2024-2028

The in-vitro diagnostics instruments market size is forecast to increase by USD 52.9 billion at a CAGR of 9.29% between 2023 and 2028.

The market is experiencing significant growth due to various trends and challenges. The aging population in North America is a key factor driving market growth, as the need for preventive healthcare and early disease detection increases. This demographic shift presents potential opportunities for physician office laboratories (POLs), allowing them to expand their diagnostic capabilities and improve patient care. 
However, strained laboratory budgets and decreasing reimbursements pose challenges for instrument sales. To mitigate these issues, market participants are focusing on developing cost-effective and efficient solutions, such as automated systems and point-of-care diagnostics. Additionally, the increasing prevalence of chronic diseases and the growing demand for precision medicine are further fueling market growth.

What will be the Size of the In-Vitro Diagnostics Instruments Market During the Forecast Period?

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Clinical laboratories rely on advanced in vitro diagnostic instruments to ensure accurate and timely results, enabling healthcare professionals to make informed decisions and provide effective treatment plans for their patients. The market is expected to witness continuous growth due to the increasing prevalence of chronic diseases and the rising demand for early and accurate disease detection.

How is this In-Vitro Diagnostics Instruments Industry segmented?

The in-vitro diagnostics instruments industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

Product

  Immunochemistry
  Clinical microbiology
  Molecular diagnostics
  Others


End-user

  Hospitals and diagnostic laboratories
  Academic and research institutes
  Home care


Geography

  North America

    Canada
    US
    Mexico


  Europe

    Germany
    UK
    France
    Italy


  Asia

    China
    India
    Japan


  Rest of World (ROW)

By Product Insights

The immunochemistry segment is estimated to witness significant growth during the forecast period. In vitro diagnostics instruments play a crucial role in medical testing by analyzing samples from bodily fluids, tissues, and specimens in a laboratory environment. These diagnostic technologies include immunodiagnostics, hematology, tissue diagnostics, clinical chemistry, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and infectious diseases such as Norovirus, HIV, Lyme disease, and Shigellosis. The market encompasses IVD equipment, reagents and kits, software and services, and molecular diagnostics like next-generation sequencing (NGS) and liquid biopsy. Personalized medicine, genetic, molecular, and clinical profiles, companion diagnostics, and various chronic conditions like diabetes, oncology, sexually transmitted diseases, and geriatric population-associated diseases are significant areas of focus.

Hospitals, healthcare facilities, pharmacies, drug stores, online providers, standalone laboratories, and manufacturing technology companies are key consumers. Diabetes, cardiovascular diseases, cancer, Alzheimer's disease, and other non-communicable diseases are major applications. The aging population and advancements in diagnostic technologies continue to drive market growth.

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The immunochemistry segment was valued at USD 27.40 billion in 2018 and showed a gradual increase during the forecast period.

Regional Analysis

North America is estimated to contribute 33% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The In Vitro Diagnostics (IVD) instruments market in North America is experiencing notable expansion due to the increasing prevalence of chronic and infectious diseases, such as cardiovascular diseases, cancer, infectious diseases like HIV, Lyme disease, and Shigellosis, and age-associated diseases affecting the aging population. This demographic shift and disease burden necessitate advanced diagnostic technologies, including molecular diagnostics, next-generation sequencing (NGS), and liquid biopsy, to deliver personalized medicine and clinical profiles.

IVD equipment, diagnostic technologies, reagents and kits, software and services, immunodiagnostics, hematology, tissue diagnostics, clinical chemistry, and cardiac diseases are among the key segments in

In-Vitro Diagnostics Quality Control Market is segmented by Products and Services (Quality Control Products, Data Management Solutions, and Quality Assurance Services), Applications (Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, and Other Applications), End Users (Hospitals, Clinical Laboratories, IVD Manufacturers & CROs and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market provides the value (in USD million) for the above-mentioned segments.

The revenue in the 'In Vitro Diagnostics' segment of the medical technology market in Latin America was forecast to continuously increase between 2024 and 2029 by in total 1.1 billion U.S. dollars (+15.38 percent). After the sixth consecutive increasing year, the revenue is estimated to reach 8.27 billion U.S. dollars and therefore a new peak in 2029. Find further information concerning the revenue in the 'Cardiology Devices' segment of the medical technology market in Singapore and the revenue in the 'Ophthalmic Devices' segment of the medical technology market in Indonesia. The Statista Market Insights cover a broad range of additional markets.

The North America in-vitro diagnostics (IVD) market is growing due to rising chronic diseases, technological advancements, and a shift toward personalized medicine.

The global In vitro diagnostics market size is estimated to grow from $108 billion in 2024 to $190 billion by 2035, growing at a CAGR of 5.2% during the forecast period till 2035.

In 2023, the in-vitro diagnostics market in China generated a revenue of over 9.2 billion U.S. dollars, making it the largest in Asia. Japan followed in this year with a revenue of around 5.4 billion U.S. dollars. By 2028, the IVD market in China was forecast to be worth almost 11 billion U.S. dollars.

As per Cognitive Market Research's latest published report, the Global IVD Reagents market size was $34.28 Billion in 2017 and it is forecasted to reach $69.65 Billion by 2029.IVD Reagents Industry's Compound Annual Growth Rate will be 6.47%from 2023 to 2030.

The North America IVD Reagents market size will be USD 23.95 Billion by 2029

What is Driving Ivd Reagents Market?

Ever-increasing geriatric population results in a swelling demand for in-vitro diagnostic tests.

Population aging is at a faster pace compared to the past few years. Lower rates of birth and increased life expectancy have resulted in this rapid growth of the geriatric population across the world. ? The data from the United States Census Bureau states that the growth of the U.S. population aged 65 and older exceeds that of the total population and the population under age 65. There are several factors that are contributing to the longevity of life such as easy access to healthcare facilities, early detection/diagnosis of diseases and disorders, availability of advanced healthcare systems, and Medicare insurance among others. ? The statistics from the World Health Organization state that the percentage of people over 60 in the world will increase from 12% to 22% between 2015 and 2050. ? The statistics also state that 1 in 6 people in the world will be aged 60 years or over by 2030 and the share of the population aged 60 years and above will increase from 1 billion in 2020 to 1.4 billion which is expected to double (2.1 billion) by 2050.

Aging is associated with several health issues/problems including heart disease, diabetes, depression, arthritis, and other chronic conditions. The estimate states that 90% of the population over 60 years, experience at least one chronic condition which needs specific treatment and medical care.

The increasing aging population is resulting in an ever-changing disease burden, escalating healthcare spending, and also increasing the demand for healthcare products from diagnosis to treatment of diseases. Early diagnosis has significant advantages as it significantly reduces the associated risk and devastating complications improving the life of a person. Any disease or disorder can be cured in a shorter time duration with minimum healthcare expenditure if it is diagnosed at an early stage. Thus, in-vitro diagnostic and screening tests are considered preventive care in order to manage burgeoning healthcare costs which are driving the growth of in vitro diagnostics market. In vitro, diagnostic procedures use IVD reagents for patient diagnosis, monitoring, and treatment.

Thus, with the ever-increasing geriatric population, demand for in-vitro diagnostic tests which simultaneously drives the growth of the IVD reagents market.

Restraints for IVD Reagents Market

High cost associated with IVD products and unfavorable reimbursement scenarios.(Access Detailed Analysis in the Full Report Version)

Opportunities for IVD Reagents Market

Increasing R&D investments in the field of IVD.(Access Detailed Analysis in the Full Report Version)

Definition of Ivd Reagents

In vitro diagnostic (IVD) reagents are referred to as critical components that are used in vitro diagnostic procedures in clinical chemistry and special chemistry testing laboratories. These are the solutions of highly-specific biological or chemical substances that can react with target substances in the samples. Without these reagents, chemistry testing laboratories are unable to generate the information required for patient diagnosis, monitoring, and treatment. It is mostly used in the diagnosis of disease or other medical conditions such as a determination of the state of health to cure, mitigate, treat, or prevent disease. The raw materials of in vitro diagnostic (IVD) reagents include antibodies, antigens, and enzymes.

There are different types of IVD reagents available in the market such as antibodies, oligonucleotides, nucleic acid probes, purified proteins or peptides, and others that are dependent on several different technologies to generate accurate and precise test results. It uses several technologies such as immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular, diagnostics, microbiology, hematology, coagulation/hemostatis, urinalysis, and others.

The IVD reagent is used by s...

North America In Vitro Diagnostic (IVD) Kit comes with extensive industry analysis of development components, patterns, flows, and sizes. The report calculates present and past market values to forecast potential market management during the forecast period between 2025 - 2033.

As of 2017, Swiss-based pharmaceutical company Roche was the global leader in the in vitro diagnostics (IVD) market, generating over 10 billion U.S. dollars in revenues in this segment. According to projections, Roche will maintain the leading position until 2024, exceeding 14 billion dollars. Roche’s major competitors are Abbott Laboratories and Danaher from the United States. Among the top 10 companies, U.S. company Exact Sciences from Wisconsin is expected to have the most impressive growth, increasing its IVD revenues nearly sevenfold between 2017 and 2024.

What are in vitro diagnostics? In vitro diagnostics allow for medical professionals to get information about diseases, conditions, and infections. These tests can be conducted within a laboratory and sometimes within a patient's home. IVDs are a large subgroup of medical devices which can range in size from small handheld devices to large complex laboratory instruments. In general, samples derived from the human body are examined ‘in vitro’ – meaning “in the glass” – for purposes of screening, diagnosis, or monitoring. Today, most medical treatments are based on IVD outcomes. IVDs are also essential for the increasing personalization of medical treatments.

Roche Diagnostics The Roche Group from Switzerland is one of the top global pharmaceutical companies. Nevertheless, the company has also a strong medical device division - Roche Diagnostics – which is mainly represented by in vitro diagnostics. Among the best-known and best-selling diagnostic devices by Roche are devices from the cobas series, used in immunodiagnostics, clinical chemistry, and virology.

Technological advancements in the North America In Vitro Diagnostics Devices industry are shaping the future market landscape. The report evaluates innovation-driven growth and how emerging technologies are transforming industry practices, offering a comprehensive outlook on future opportunities and market potential.

The Lab Automation for In-Vitro Diagnostics Market Report is Segmented by Equipment (Automated Plate Handler, Automated Liquid Handler, Robotic Arm, Automated Storage and Retrieval System, and Analyzer), End User (Academic, Laboratory, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa). The Report Offers Market Sizes in Value Terms (USD) for all the Above-Mentioned Segments.

For the fifth year in a row, the U.S. in-vitro diagnostic substance market recorded growth in sales value, which increased by 44% to $64.3B in 2024. In general, consumption, however, continues to indicate a buoyant expansion. In-vitro diagnostic substance consumption peaked in 2024 and is expected to retain growth in the near future.

The market size of the In Vitro DiagnosticsIVD Market is categorized based on Type (In Vitro Diagnostic Reagents, In Vitro Diagnostic Equipment) and Application (Pet, Livestock and Poultry, other) and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa).

This report provides insights into the market size and forecasts the value of the market, expressed in USD million, across these defined segments.