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 market size of the In Vitro Diagnostics IVD Products And Test Market is categorized based on Type (Quality Control Products, Quality Assurance Services, Data Management Solutions) and Application (Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Others) 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.

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

The report on North America In-Vitro Diagnostics covers a summarized study of several factors supporting market growth, such as market size, market type, major regions, and end-user applications. The report enables customers to recognize key drivers that influence and govern the market.

Snapshot img

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?

Request Free Sample

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.

Get a glance at the share of various segments. Request Free Sample

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.

For more insights on the market share of various regions, Request Free Sample

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

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.

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.

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.

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 In Vitro Diagnostics market is projected to grow from $104.6B in 2025 to $198.1B by 2035, with a CAGR of 5.6%.

The North America In Vitro Diagnostics (IVD) Products and Test market report offers a thorough competitive analysis, mapping key players’ strategies, market share, and business models. It provides insights into competitor dynamics, helping companies align their strategies with the current market landscape and future trends.

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

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...

The global clinical diagnostics market is experiencing robust growth, driven by several key factors. The rising prevalence of chronic diseases like diabetes, cardiovascular diseases, and cancer necessitates frequent diagnostic testing, fueling market expansion. Technological advancements, such as the development of point-of-care diagnostics, rapid diagnostic tests, and molecular diagnostics, are improving accuracy, speed, and accessibility of testing. Furthermore, the increasing geriatric population, coupled with rising healthcare expenditure and improving healthcare infrastructure in developing economies, are contributing to market expansion. The market is segmented by type (e.g., in-vitro diagnostics, molecular diagnostics, imaging diagnostics) and application (e.g., infectious disease diagnostics, oncology diagnostics, cardiology diagnostics). The competitive landscape is characterized by the presence of established players like Abbott, Biomerieux, Beckman Coulter Diagnostics, Roche, and Qiagen, who are engaged in product innovation and strategic partnerships to maintain their market share. While regulatory hurdles and reimbursement challenges pose certain constraints, the overall market outlook remains positive. Over the forecast period (2025-2033), the market is projected to witness sustained growth, primarily driven by the continued adoption of advanced diagnostic technologies and the expanding scope of personalized medicine. The increasing focus on preventative healthcare and early disease detection is further enhancing the demand for clinical diagnostics. Geographic expansion, particularly in emerging markets with growing healthcare infrastructure and increased access to diagnostic services, will also significantly contribute to market growth. Regional variations in market penetration will likely persist, with North America and Europe continuing to hold significant market shares due to advanced healthcare systems and high adoption rates. However, the Asia Pacific region is expected to witness substantial growth due to rapid economic development and increasing awareness of disease prevention. Competitive intensity is anticipated to remain high, with companies focusing on research and development, strategic acquisitions, and expansion into new markets.

The size and share of the market is categorized based on Application (Academic, Laboratory, Others) and Product (Automated Plate Handler, Automated Liquid Handler, Robotic Arm, Others) and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa).

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.

The In Vitro Diagnostics (IVD) market, currently experiencing robust growth, is projected to reach a substantial size within the next decade. Driven by factors such as the increasing prevalence of chronic diseases, advancements in diagnostic technologies (including point-of-care testing and molecular diagnostics), and rising healthcare expenditure globally, the market shows significant promise. A Compound Annual Growth Rate (CAGR) of 6.41% from 2019 to 2024 suggests a continuously expanding market, fueled by technological innovation and a growing need for accurate and timely disease diagnosis. The market segmentation, encompassing various diagnostic types and applications, further highlights the diverse opportunities within the sector. Key players like Abbott Laboratories, Roche, and Siemens Healthineers are strategically investing in research and development, focusing on innovative solutions and expanding their global reach. This competitive landscape necessitates continuous adaptation and innovation to maintain market share. The regional distribution demonstrates a significant concentration in North America and Europe, attributed to well-established healthcare infrastructure and higher per capita healthcare spending. However, emerging economies in Asia-Pacific are showing rapid growth, presenting lucrative opportunities for expansion. The IVD market's future trajectory is influenced by several factors. Regulatory changes and reimbursement policies play a crucial role in market accessibility and adoption of new technologies. The integration of artificial intelligence (AI) and big data analytics is transforming diagnostic capabilities, improving accuracy and efficiency. The increasing demand for personalized medicine also contributes to the market's expansion, requiring highly specific and individualized diagnostic tests. However, challenges remain, including high costs associated with advanced diagnostic technologies, stringent regulatory approvals, and the need for skilled professionals to operate and interpret the results. Overcoming these challenges through collaborative efforts between industry stakeholders, healthcare providers, and regulatory bodies is vital to unlock the full potential of this dynamic market. The focus on improving access to affordable and reliable diagnostics in underserved regions presents both an ethical imperative and a significant market opportunity.

Snapshot img

Emerging Molecular Diagnostics Market Size 2025-2029

The emerging molecular diagnostics market size is forecast to increase by USD 3.80 billion at a CAGR of 6.4% between 2024 and 2029.

Molecular diagnostics is a rapidly evolving field in the healthcare industry, driven by the increasing prevalence of chronic diseases and the need for accurate and timely diagnosis. The market is witnessing significant growth due to factors such as the launch of innovative molecular diagnostic devices and the increasing adoption of point-of-care (PoC) testing devices for diagnosing various conditions. However, the high cost associated with these advanced diagnostic tools remains a challenge for both practitioners and patients. Financial incentives, such as reimbursement policies and government funding, are playing a crucial role in driving the adoption of molecular diagnostics. For instance, the IVD Directive in Europe and similar regulations in other regions are encouraging the development and commercialization of in vitro diagnostic (IVD) devices.
Furthermore, investments from both public and private sectors are fueling the growth of market . In the US, the trend towards personalized medicine and the growing demand for accurate and early diagnosis are expected to drive the growth of market. These advancements include liquid biopsy, a minimally invasive diagnostic technique, and point-of-care diagnostics, which enable real-time analysis of patient samples. The adoption of PoC tests and advanced molecular diagnostic devices is expected to increase significantly in the coming years, as they offer faster turnaround times and improved accuracy compared to traditional diagnostic methods. However, the high cost of these advanced diagnostic tools remains a significant challenge, and efforts are being made to make them more affordable and accessible to a wider patient population.

What will be the Size of the Market During the Forecast Period?

Request Free Sample

The market is witnessing significant advancements, driven by the increasing demand for early disease detection, personalized medicine, and disease management in the US healthcare sector. This market encompasses various technologies, including gene sequencing, biomarker discovery, and DNA sequencing technology, which are revolutionizing clinical diagnostics and drug development. One of the most promising trends in molecular diagnostics is the integration of biotechnology advancements into clinical laboratories.
These innovations contribute to improved disease screening, clinical decision support, and disease prevention. Moreover, healthcare technology plays a crucial role in the market. Clinical trials, medical research, and clinical laboratory testing are increasingly relying on digital health solutions, such as software updates, telemedicine, and remote patient monitoring. Home healthcare and wearable technology are also gaining popularity, as they enable continuous patient monitoring and data collection. Regulatory standards are a critical aspect of the market. Compliance with these standards ensures the accuracy and reliability of diagnostic tests, which is essential for effective disease management and patient safety.

How is this market segmented and which is the largest segment?

The market 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.

Technology

  PCR
  NGS
  Microarray technologies
  Others


End-user

  Hospitals and clinics
  Diagnostics laboratories
  Others


Geography

  North America

    Canada
    Mexico
    US


  Europe

    Germany
    UK


  Asia

    China
    India
    Japan
    South Korea


  Rest of World (ROW)

By Technology Insights

The PCR segment is estimated to witness significant growth during the forecast period.

Polymerase chain reaction (PCR) is a crucial laboratory technique that amplifies specific DNA segments, making it an indispensable tool in biomolecular sciences. In the realm of the market, PCR's versatility and precision have positioned it as a cornerstone for various applications. One primary application of PCR is in diagnosing bacterial and viral infections. Its high sensitivity and specificity enable the rapid identification of infectious agents in clinical samples, facilitating timely and accurate diagnoses. This is particularly important in conditions like pneumonia, where early detection and treatment can significantly improve patient outcomes. Another significant application of PCR is in screening for genetic disorders.

By identifying genetic mutations and testing and abnormalities, PCR plays a pivotal role in early intervention and management of hereditary conditions. This not only improves patient care but also reduces healthcare costs by enabling e

The size and share of the market is categorized based on Application (Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Others) and Product (Quality Control Products, Quality Assurance Services) and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa).