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 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.

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.

Report Attribute	Key Statistics
Base Year	2024
Forecast Years	2025-2033
Historical Years	2019-2024
Market Size in 2024	USD 116.7 Billion
Market Forecast in 2033	USD 181.5 Billion
Market Growth Rate 2025-2033	5.0%

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.

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% reaching USD 197.06 Bn by 2032

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).

The United States in Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Hematology, and More), Product (Instruments, Reagents & Kits, and More), Usability (Disposable IVD and Reusable IVD), Application (Infectious Diseases, Diabetes, Oncology, and More), and End User (Diagnostic Laboratories, Hospitals & Clinics, and More). The Market Forecasts are Provided in Terms of Value (USD).

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.

The global in-vitro diagnostics market size was valued at USD 102.16 billion in 2024 and is set to expand at over 6.8% CAGR from 2025 to 2034, fueled by the increasing need for genetic testing related to diabetes and cancer.

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).

Snapshot img

In-Vitro Diagnostics (IVD) Market Size 2025-2029

The in-vitro diagnostics market size is valued to increase USD 28.8 billion, at a CAGR of 4.6% from 2024 to 2029. Increasing geriatric population, chronic and infectious diseases will drive the in-vitro diagnostics (ivd) market.

Major Market Trends & Insights

North America dominated the market and accounted for a 44% growth during the forecast period.
By Product Type - Reagents and kits segment was valued at USD 70.30 billion in 2023
By Technology - Immunoassay segment accounted for the largest market revenue share in 2023

Market Size & Forecast

Market Opportunities: USD 41.35 billion
Market Future Opportunities: USD 28.80 billion
CAGR : 4.6%
North America: Largest market in 2023

Market Summary

The market represents a significant and continually evolving sector within the healthcare industry. This market encompasses a range of diagnostic tests conducted outside the body, utilizing various core technologies such as immunoassays, molecular diagnostics, and clinical chemistry. The applications of IVDs span from infectious disease testing to genetic screening and drug monitoring. The global adoption of advanced treatment solutions and the increasing geriatric population are major drivers propelling the growth of this market. 
Stringent regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), guide in-vitro diagnostics manufacturers, ensuring the highest standards for accuracy and safety. However, challenges persist, including the high cost of IVDs and the need for continuous innovation to address emerging diseases and diagnostic demands. Despite these hurdles, opportunities abound, particularly in emerging markets and in the development of point-of-care (POC) diagnostics, which offer increased accessibility and convenience. In summary, the In-Vitro Diagnostics Market is a dynamic and essential component of the healthcare industry, driven by technological advancements, demographic shifts, and regulatory requirements.
With a projected growth rate of approximately 5% per year, this market is poised for continued expansion and innovation.

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

Get Key Insights on Market Forecast (PDF) Request Free Sample

How is the In-Vitro Diagnostics (IVD) Market Segmented and what are the key trends of market segmentation?

The in-vitro diagnostics 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
  Neurology
  Others


End-user

  Hospitals and clinics
  Research institutes
  Diagnostics laboratories
  Others


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    Italy
    UK


  Middle East and Africa

    Egypt
    KSA
    Oman
    UAE


  APAC

    China
    India
    Japan


  South America

    Argentina
    Brazil


  Rest of World (ROW)

By Product Type Insights

The reagents and kits segment is estimated to witness significant growth during the forecast period.

The global IVD market is experiencing significant growth, with reagents and diagnostic kits being key components driving this expansion. Reagents, as chemical substances, play a crucial role in the detection and measurement of target analytes in patient samples. They facilitate various diagnostic tests, ranging from clinical chemistry to molecular diagnostics. Clinical chemistry applications account for a substantial portion of the market, with reagents used to measure substances like glucose, cholesterol, and enzymes in blood samples. These measurements contribute to the assessment of medical conditions such as diabetes and cardiovascular diseases.

Molecular diagnostics, another burgeoning segment, utilizes reagents for techniques like polymerase chain reaction (PCR) and next-generation sequencing. These advanced methods enable the identification of genetic mutations and infectious agents, offering valuable insights for personalized medicine and disease management. Diagnostic kits, which include reagents along with calibrators, controls, and sometimes instruments, provide a complete solution for specific diagnostic tests. They cater to diverse applications, such as urinalysis systems, immunofluorescence assays, microbiology systems, and hematology analyzers. Test performance metrics, such as sensitivity and specificity, are critical in ensuring diagnostic accuracy. Technological advancements, like real-time PCR, digita

The size of the China In-vitro Diagnostics market was valued at USD 10.61 Million in 2023 and is projected to reach USD 16.10 Million by 2032, with an expected CAGR of 6.14% during the forecast period. In-vitro diagnostics are medical devices with the ability to diagnose diseases by processing biological samples outside the human body. They are very key in healthcare since early disease detection, monitoring, and treatment progress can be checked. They also help in preventing the spread of infections since most of them are quite fast. Examples of these IVDs include a blood test, urine tests, and rapid diagnostic tests. As factors include aging elderly, expanding health expenditures, and improved recognition for preventive care, the country has ranked highly for market growth compared with any other place worldwide. Though being led primarily by the top global leaders of this product space, significant numbers are growing inside for areas that fall in categories like clinical chemistry or immunodiagnostics. High demand for rapid diagnostic tests, as well as other COVID-19-related tests during the COVID-19 pandemic, pushed the growth further in the IVD market of China. This has thereby led to increased investment in research and development, along with technology advancement in the IVD sector. The Chinese government supports the development of the IVD industry through supportive policies such as simplification of the regulatory procedure and encouraging innovation. Therefore, with modernization of the Chinese healthcare systems, the IVD markets are bound to expand as it opens up vast future opportunities for both domestic players and international players. Recent developments include: September 2023, Roche Diagnostics China Technical Innovation Center (TIC) was opened in Shanghai's Pudong New Area in Jinqiao. It consists of laboratories and classrooms, covering 7,080 square meters focusing on a comprehensive upgrade of smart diagnostics, service innovation, talent training, and customer experience in diagnostics., March, 2023, Hainan government issued new guidelines regarding the administration of urgently needed imported drugs and medical devices in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port.. Key drivers for this market are: High Burden of Chronic Diseases and Infectious Diseases, Increasing Use of Point-of-Care (POC) Diagnostics Spurring the IVD Market; Increasing Awareness and Acceptance of Personalized Medicine. Potential restraints include: Lack of Proper Reimbursement, Stringent Regulatory Framework. Notable trends are: Molecular Diagnostics Segment Dominates the Chinese In Vitro Diagnostics Market.

The China In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Microbiology, and More), Product (Instrument, Reagents & Consumables, and More), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cardiology, and More), and End-User (Hospitals & Clinics, and More). The Market Forecasts are Provided in Terms of Value (USD).

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.

The Italy In Vitro Diagnostics Market size was valued at USD 4224.01 USD Million in 2023 and is projected to reach USD 6393.41 USD Million by 2032, exhibiting a CAGR of 6.1 % during the forecast period. In vitro diagnostics (IVD) refer to medical tests conducted using bodily samples like blood or tissue in a controlled environment outside the living organism (in vitro). These tests play a critical role in diagnosing diseases, monitoring therapy progress, and predicting health outcomes. They are categorized into clinical chemistry, immunochemistry, molecular diagnostics, and microbiology, each serving distinct diagnostic purposes. Key features include high accuracy, rapid results, and minimal invasiveness compared to traditional diagnostic methods.IVDs find applications across various medical disciplines, including oncology, infectious diseases, and genetic testing, enabling personalized treatment plans and early disease detection. Their benefits include improving patient outcomes through timely intervention, reducing healthcare costs, and supporting evidence-based medicine.

Snapshot img

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?

Download the Free Report Sample to Unlock the IVD Market Size in the US for the Forecast Period and Other Important Statistics

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

As per Cognitive Market Research's latest published report, the Global In Vitro Diagnostics market size will be $87,826.93 Million by 2028.In Vitro Diagnostics Industry's Compound Annual Growth Rate will be 4.48% from 2023 to 2030.

North America In Vitro Diagnostics market size will be USD 30,196.36 Million by 2028.

What is Driving In Vitro Diagnostics Industry Growth?

Rise in the geriatric population

The rise in the adoption of advanced healthcare systems, new diagnostic techniques and adoption of medicines, have led to a significant decline in mortality rates, thereby accelerating the life expectancy.

Moreover, the early detection of the diseases and adoption of advanced diagnostic tools, including the over-the-counter diagnostic products, including glucose monitoring kits, are present in the market. These products are adopted by the elderly to reduce hospital visits.

Moreover, the development in the health care system, and early detection of diseases, and advanced treatment options, are some of the factors, which have extended the life expectancy, thereby leading to the rise in the geriatric population.

According to the World Health Organization (WHO), by 2050, the world’s population aged 60 years and above is expected to reach around 2 billion, that has increased from 900 million in 2015.

Additionally, according to the data published by UN, the global population aged 60 years or over numbered 962 million in 2017, has witnessed a significant rise, as large as in 1980 when there were 382 million geriatric people across the world.

The rise in the life expectancy is associated with the presence of several diseases, including the rise in the cardiovascular disease, diabetes, chronic low back pain is some of the factors, which have an inversely proportional rise in the demand for the invitro diagnostics.

Additionally, the immune system is affected owing to the rise in the age, which increases susceptibility to acquiring various diseases. Therefore, a significantly geriatric population needs access to advanced healthcare systems, especially for chronic diseases.

Therefore, the growth in the geriatric population is expected to increase the prevalence of various diseases across the globe. Thus, it is considered as one of the significant factors driving the growth of the invitro diagnostics market.

Restraints for In Vitro Diagnostics Market

High cost of devices and unfavorable reimbursement scenario’s.(Access Detailed Analysis in the Full Report Version)

Opportunities for In Vitro Diagnostics Market

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

Introduction of In Vitro Diagnostics

A range of tools is used by health care practitioners to diagnose illnesses and guide treatment decisions. In-vitro diagnostics (IVDs), which are clinical tests that examine samples obtained from the human body, are among the most popular and commonly utilized.

In-vitro diagnostics are tests performed on samples obtained from the human body, such as blood or tissue. It can identify illnesses and other disorders, as well as monitor a person's general health to assist in the cure, treatment, or prevention of diseases.

IVDs are used to analyze human samples like blood and saliva, either by measuring the concentration of specific substances, or analytes (like sodium and cholesterol) or by detecting the presence or absence of a specific marker or set of markers, like a genetic mutation or an immune response to infection.

Precision medicine also employs in vitro diagnostics to identify patients who are likely to benefit from certain treatments or therapies. These in vitro diagnostics can involve next-generation sequencing tests, which analyze a person's DNA for genetic changes.

In-vitro diagnostics can be performed in laboratories, hospitals, or even at home. IVD tests are often conducted in a stand-alone laboratory, a hospital-based laboratory, or a point-of-care (POC) center, and typically comprise polymerase chain reaction (PCR), microarray methods, sequencing technologies, and mass spectrometry.

The tests themselves can be carried out on a wide range of tools, from simple portable devices to complicated laboratory equipment. It also made use of reagents that enable doctors to accurately diagnose patients and work to deliver suitable therapies.

Several...

Indonesia In Vitro Diagnostics (IVD) Market is estimated to grow at a CAGR of about 9.35% during the forecast period 2024-30. F. Hoffmann-La Roche AG, Sysmex Corporation, SD Biosensor, and Others, are the top In Vitro Diagnostics companies players in the Indonesia Market.