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).

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.

Country-wise Outlook

Competitive Outlook

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%

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

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

• The global industry was valued at US$ 91.2 Bn in 2022
• It is projected to grow at a CAGR of 5.3% from 2023 to 2031 and reach more than US$ 119.7 Bn by the end of 2031

Market Introduction

Regional Outlook of In Vitro diagnostics Industry

Global In Vitro Diagnostics Market Snapshot

Introduction

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

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

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

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

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

The revenue in the 'In Vitro Diagnostics' segment of the medical technology market in Poland was modeled to stand at ************** U.S. dollars in 2024. Between 2016 and 2024, the revenue rose by ************** U.S. dollars, though the increase followed an uneven trajectory rather than a consistent upward trend. The revenue will steadily rise by ************** U.S. dollars over the period from 2024 to 2030, reflecting a clear upward trend.Further information about the methodology, more market segments, and metrics can be found on the dedicated Market Insights page on In Vitro Diagnostics.

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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?

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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

Global in vitro diagnostics (IVD) market was valued at US$ 79.89 Billion in 2024 and is set to reach around US$ 137.29 Billion by 2034 at a CAGR of about 6.2% from 2025 to 2034.

The United Kingdom In-Vitro Diagnostics Market Report is Segmented by Technique (Clinical Chemistry, Molecular Diagnostics, Immunodiagnostics, and More), Product (Instruments, Reagents, and More), Usability (Disposable IVD Devices and Re-Usable IVD Devices), Application (Infectious Disease, Diabetes, Oncology, and More), and End-User (Hospital & Reference Labs, and More). The Market Forecasts are Provided in Terms of Value (USD).

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

Global in vitro cancer diagnostics (IVD) market worth at $77.07 Billion in 2024, surpass $144.96 Billion by 2034, with a CAGR of 6.5% from 2025 to 2034.

The size of the Italy In Vitro Diagnostics Industry market was valued at USD 129 Million in 2023 and is projected to reach USD 145 Million by 2032, with an expected CAGR of 7.50% during the forecast period. Recent developments include: In April 2023, Biovica International signed a commercial partnership with IT Health Fusion with an aim to commercialize the DiviTum TKa assay in Italy. This is an in-vitro-diagnostic device that is used for semi-quantitative measurement of thymidine kinase activity (TKa) in human serum., In May 2022, the new EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) became effective in Italy with effect from May 26, 2022. Whereas certain legacy devices will benefit from transition periods, all new IVDs and certain low-risk IVDs already on the market are now subject to the IVDR requirements.. Key drivers for this market are: Rising Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics. Potential restraints include: Stringent Regulations. Notable trends are: Molecular Diagnostics Segment is Expected to Hold a Major Share in the Market Over the Forecast Period.

The revenue in the 'In Vitro Diagnostics' segment of the medical technology market in Canada was modeled to be 1.78 billion U.S. dollars in 2024. Between 2016 and 2024, the revenue rose by 781.05 million U.S. dollars, though the increase followed an uneven trajectory rather than a consistent upward trend. The revenue will steadily rise by 369.66 million U.S. dollars over the period from 2024 to 2030, reflecting a clear upward trend.Further information about the methodology, more market segments, and metrics can be found on the dedicated Market Insights page on In Vitro Diagnostics.

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

The Brazil In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immunodiagnostics, and More), Product (Instruments, Reagents, and More), Usability (Disposable IVD Devices, and Reusable IVD Devices), Application (Infectious Disease, Diabetes, and More), and End Users (Diagnostic Laboratories, Hospitals & Clinics, and More). The Market Forecasts are Provided in Terms of Value (USD).

The size of the Argentina In Vitro Diagnostic Industry market was valued at USD 132.5 Million in 2023 and is projected to reach USD 138.4 Million by 2032, with an expected CAGR of 5.40% during the forecast period. Recent developments include: In October 2020, Siemens Healthineers AG launched a rapid antigen test for the detection of SARS-CoV-2 virus infection., In August 2020, the Schep SARS-CoV-2 RT-PCR Duo, a novel kit for the identification of the SARS-CoV-2 virus, was approved by the Argentinian National Administration of Drugs, Food, and Medical Technology (ANMAT). Key drivers for this market are: High Prevalence of Chronic Diseases, Increasing Use of Point-of-care (POC) Diagnostics; Advanced Technologies; Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics. Potential restraints include: Stringent Regulations, Cumbersome Reimbursement Procedures. Notable trends are: Oncology Segment is Expected to Hold a Significant Market Share Over the Forecast Period.

The Sweden In-Vitro Diagnostics Market valued USD 629.43 Mn in 2023, and it is projected to hit USD 910.96 Mn by 2030.