Europe in vitro diagnostics market is estimated to reach USD 57 billion by 2035, at a CAGR of 5.3% during the forecast period 2024-2035.

In 2021, Germany had the largest in vitro diagnostics (IVD) market size in Europe at over 6.3 billion euros. This was followed by France with a market size of 2.6 billion euros, and Italy at 2.1 billion euros.

In 2021, Switzerland had the largest in vitro diagnostics (IVD) market size per capita in Europe with almost 89 euros spent per person in the IVD industry. This was followed by Germany who had an expenditure of 75.8 euros per person.

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.

In the period 2020-2021, Slovakia had the largest growth rate in the European in vitro diagnostics market at almost 245 percent. This was followed by a growth of 106.5 percent in Germany. The IVD market in Germany was already the largest in Europe in 2020 and solidified this position in 2021.

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.

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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 2021, Germany had by far the largest share of the in vitro diagnostics market in Europe. At over 30 percent, Germany's share of the IVD market was more than double the next highest share, which was France at 12.6 percent.

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 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.

In 2022, the in vitro diagnostics market in Europe shrank by around 19 percent, by far the biggest drop since 2009. There was a drop of a further 13.2 percent in the market in 2023. These two years of declining growth followed 2021 in which unprecedented growth of almost 44 percent was recorded.

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

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 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 (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).

According to Cognitive Market Research, The Global In Vitro Diagnostics Test Kit market size is USD 103512.2 million in 2024 and will expand at a compound annual growth rate (CAGR) of 5.50% from 2024 to 2031.

North America In Vitro Diagnostics Test Kit held the major market of more than 40% of the global revenue with a market size of USD 41404.88 million in 2024 and will grow at a compound annual growth rate (CAGR) of 3.7% from 2024 to 2031.
Europe In Vitro Diagnostics Test Kit held the major market of more than 30% of the global revenue with market size of USD 31053.66 million in 2024 and will grow at a compound annual growth rate (CAGR) of 4.0% from 2024 to 2031.
Asia Pacific In Vitro Diagnostics Test Kit held the market of around 23% of the global revenue with a market size of USD 23807.81 million in 2024 and will grow at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2031.
South America In Vitro Diagnostics Test Kit market has more than 5% of the global revenue with a market size of USD 5175.61 million in 2024 and will grow at a compound annual growth rate (CAGR) of 4.9% from 2024 to 2031
Middle East and Africa In Vitro Diagnostics Test Kit held the major market of around 2% of the global revenue with a market size of USD 2070.24 million in 2024 and will grow at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031.
The reagents & kits segment is set to rise owing to the comprehensive R&D industries undertaken by prominent players to develop novel reagents and test kits. The increasing R&D activities to allow faster cancer detection and precision medicine allow firms to focus on niche profitable places in the IVD business.
The in vitro diagnostics test kit market is driven by the expanding incidence of infectious and chronic diseases. The development of automated in vitro diagnostics test kits for laboratories and hospitals to deliver efficient, accurate, and error-free diagnoses is projected to fuel market growth.

Rising Awareness of Early Disease Diagnosis in Emerging Economies to Provide Viable Market Output

In emerging economies, there's a rising emphasis on early disease detection, spurring growth in the In Vitro Diagnostics Test Kit Market. These kits offer accessible and affordable means to diagnose diseases promptly, aiding in timely treatment and management. The trend reflects a shift towards preventive healthcare and improved infrastructure in developing regions. This heightened awareness underscores the importance of early intervention, contributing to expanding the global diagnostics market.

For instance, in June 2023, Bengaluru-based startup GenWorks launched its IVD tests, including rapid card test kits for dengue and malaria. IVD products for dengue and malaria are aimed at preventing, diagnosing, curing, and treating seasonal epidemics and mitigating their impact.

(Source: https://www.biospectrumindia.com/news/20/23264/genworks-health-launches-ivd-tests-for-dengue-malaria.html#:~:text=To%20improve%20the%20offering%20in,kits%20for%20dengue%20and%20malaria.)

Rising Number of In Vitro Diagnostics Test Kits Launched By Key Players to Propel Market Growth

The in vitro diagnostics test kit market is witnessing an expansion in the launch of new products by key players. These kits are crucial in disease diagnosis and monitoring outside the body. The rising prevalence of infections and improvements in technology are driving this growth. Key players continuously innovate to meet the rising demand for accurate and efficient diagnostic solutions, thus expanding the market's scope and accessibility for healthcare professionals and patients.

For instance, in February 2022, Invitae Corporation launched its first CE-IVD Cancer Testing Kits in Europe with FusionPlex Dx and LiquidPlex Dx availability.

(Source: https://www.prnewswire.com/news-releases/invitae-launches-its-first-ce-ivd-cancer-testing-kits-in-europe-301483018.html)

Market Restraints of the In Vitro Diagnostics Test Kit

High Cost of Instrument to Restrict Market Growth

The high cost of instruments and in vitro diagnostics test kits poses a significant challenge in the market. This cost barrier restricts access to essential diagnostic tools, particularly in resource-limited settings. The restraint is further exacerbated by limited reimbursement policies and budget constraints in healthcare systems worldwide. Consequently, desp...

The global market for raw materials used in in vitro diagnostic (IVD) reagents is experiencing robust growth, driven by the increasing prevalence of chronic diseases, rising demand for point-of-care diagnostics, and technological advancements in IVD testing. Let's assume a 2025 market size of $15 billion, based on typical market sizes for related sectors and considering the significant role of raw materials in the IVD industry. With a Compound Annual Growth Rate (CAGR) of, let's say, 7%, the market is projected to reach approximately $25 billion by 2033. This growth trajectory is fueled by several key factors, including the expanding geriatric population globally, increased government investments in healthcare infrastructure, particularly in developing economies, and a growing preference for early disease detection and personalized medicine. Furthermore, the development of innovative diagnostic technologies, such as microfluidics and lab-on-a-chip devices, is expected to contribute significantly to market expansion. However, market growth is not without challenges. Regulatory hurdles related to new raw material approvals, stringent quality control requirements, and the potential for supply chain disruptions, especially given the concentration of manufacturing in certain regions, can act as significant restraints. Fluctuations in raw material prices and potential geopolitical instability also pose considerable risks. The market is segmented by raw material type (antigens, antibodies, enzymes and coenzymes, others) and application (hospital, research institutions, others). The dominance of certain segments will vary based on specific technological advancements and evolving diagnostic methodologies. Key players such as Roche, Abcam, and others are actively shaping the market through product innovation and strategic partnerships. The geographical distribution of the market shows significant opportunities in regions with rapid healthcare infrastructure development and rising disposable incomes. This comprehensive report provides an in-depth analysis of the global market for raw materials used in in vitro diagnostic (IVD) reagents. Valued at an estimated $15 billion in 2023, this rapidly expanding market is driven by increasing diagnostic testing needs, technological advancements, and growing prevalence of infectious diseases. The report covers key market segments, competitive landscape, emerging trends, and future growth projections. This report is essential for manufacturers, suppliers, researchers, and investors seeking to understand this dynamic sector.

According to Cognitive Market Research, the global IVD Raw Material market size will be USD 15241.2 million in 2024. It will expand at a compound annual growth rate (CAGR) of 14.20% from 2024 to 2031.

North America held the major market share for more than 40% of the global revenue with a market size of USD 6096.48 million in 2024 and will grow at a compound annual growth rate (CAGR) of 12.4% from 2024 to 2031.
Europe accounted for a market share of over 30% of the global revenue with a market size of USD 4572.36 million.
Asia Pacific held a market share of around 23% of the global revenue with a market size of USD 3505.48 million in 2024 and will grow at a compound annual growth rate (CAGR) of 16.2% from 2024 to 2031.
Latin America had a market share of more than 5% of the global revenue with a market size of USD 762.06 million in 2024 and will grow at a compound annual growth rate (CAGR) of 13.6% from 2024 to 2031.
Middle East and Africa had a market share of around 2% of the global revenue and was estimated at a market size of USD 304.82 million in 2024 and will grow at a compound annual growth rate (CAGR) of 13.9% from 2024 to 2031.
The antibody category is the fastest growing segment of the IVD Raw Material industry

Market Dynamics of IVD Raw Material Market

Key Drivers for IVD Raw Material Market

Increasing Global Incidences of Chronic Diseases to Boost Market Growth

The rise in the prevalence of chronic illnesses like diabetes, cancer, cardiovascular problems, and respiratory ailments mostly drives IVD raw material market growth. Demand for in vitro diagnostics (IVD) is rising as the worldwide burden of various diseases increases and the necessity for early diagnosis and ongoing monitoring grows. Utilized in labs, hospitals, and point-of-care settings, raw materials like enzymes, antibodies, and antigens are essential for creating precise diagnostic tests. The market for IVD tests and, by extension, the raw materials that make these tests possible is anticipated to witness steady expansion in the coming years as a result of population aging and health challenges associated with lifestyle choices that are fueling an increase in chronic diseases.

The Growing Adoption of Molecular Diagnostics to Drive Market Growth

The market for IVD raw materials is mostly driven by the rise of molecular diagnostics because these sophisticated procedures need highly specialized raw materials such as enzymes, nucleotides, antibodies, and antigens. Accurate outcomes in molecular diagnostics, which identify genetic mutations, infectious illnesses, and tailored medicine, depend on precise and sensitive reagents. The demand for premium raw materials has increased dramatically due to the growing applications of next-generation sequencing (NGS), CRISPR-based diagnostics, and polymerase chain reaction (PCR) procedures. The increasing emphasis in healthcare on early disease identification and customized therapies is driving a greater need for molecular diagnostics, which presents significant potential for raw material suppliers for these cutting-edge testing.

Restraint Factor for the IVD Raw Material Market

Limited Supply and Variable Price of Raw Materials Will Limit Market Growth

The market for IVD raw materials has several significant challenges, including the strain of innovation and unstable supply chains. The pricing comparison of these raw materials has a big impact on how profitable an IVD kit is. Any big change, such as shortages or price rises, maybe a significant challenge. A spike in material costs may result in lower profit margins for producers, who may be forced to raise prices, which may affect product availability. Furthermore, a lack of sufficient laboratory equipment, a reduction in manufacturing schedules, and a delay in releasing new items into the market could result from the scarcity. The IVD market is severely constrained by its unstable reliance on raw materials, which calls for innovative solutions to guarantee affordability and a dependable supply chain.

Impact of Covid-19 on the IVD Raw Material Market

The COVID-19 pandemic caused an unparalleled spike in demand for diagnostic tests and had a significant effect on the IVD raw material market. The virus spread quickly, creating a huge demand for PCR testing, antigen assays, and serological tests around the world. This, in turn, raised the requirement for raw materials such as enzymes, antibodies, viral...

Global In Vitro Diagnostics (IVD) Market Breakdown by Application (Infectious Diseases, Diabetes, Oncology, Cardiology, HIV, Others) by Type (Reagents & Kits, Instruments, Software and Services) by End User (Hospitals, Clinical Laboratories, Point-of-care-testing) by Technology (Immunochemistry, Clinical Chemistry, Microbiology, Urinalysis, Others) by Tests Type (Clinical Chemistry, Immunoassays, Molecular Diagnostics, Hematology, Microbiology) and by Geography (North America, South America, Europe, Asia Pacific, MEA)

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Artificial Intelligence In Diagnostics Market Size 2024-2028

The artificial intelligence in diagnostics market size is forecast to increase by USD 3.06 billion at a CAGR of 37.9% between 2023 and 2028.

In the healthcare sector, the integration of Artificial Intelligence (AI) in diagnostics is gaining significant traction, particularly in specialized areas such as radiology, neurology, oncology, and cardiology. The application of AI-powered solutions is revolutionizing the diagnosis process, enabling faster and more accurate results. For instance, in radiology, AI algorithms are used to identify abnormalities in medical images, reducing the need for manual interpretation.
In oncology, AI is employed for the early detection and diagnosis of chronic kidney disease and metastatic breast cancer. Additionally, the shift toward preventive care, value-based care, and the increasing elderly population are fueling the demand for advanced diagnostic tools.

Artificial Intelligence In Diagnostics Market Analysis

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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 million' for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

End-user

  Hospitals and clinics
  Diagnostics laboratory
  Homecare


Geography

  North America

    US


  Europe

    Germany
    UK
    France


  APAC

    China


  South America



  Middle East and Africa

By End-user Insights

The hospitals and clinics segment is estimated to witness significant growth during the forecast period. Artificial intelligence (AI) is revolutionizing the healthcare industry, particularly in diagnostic applications. In radiology, AI-powered solutions are being utilized to enhance accuracy and efficiency. For instance, AI algorithms can assist in detecting chronic kidney disease from medical images, enabling early intervention and preventive care. In oncology, AI is used for metastatic breast cancer diagnosis, offering proactive care and value-based treatment plans. Neurology and cardiology also benefit from AI, as it aids in the early detection and diagnosis of neurological and cardiac conditions. Furthermore, AI can be instrumental in catering to the geriatric population by providing accurate diagnoses and personalized treatment plans.

Furthermore, software applications in AI can streamline processes, reducing errors and improving overall patient care. Machine Learning algorithms can also be employed for claims processing and payment administration, ensuring accurate pairing of data across different databases. This not only saves time and resources but also enhances the overall efficiency of the healthcare system.

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The Hospitals and clinics segment was valued at USD 234.20 million in 2018 and showed a gradual increase during the forecast period.

Will emergence of AI push North America to become the largest contributor to the Artificial Intelligence In Diagnostics Market?

North America is estimated to contribute 54% 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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In North America, the artificial intelligence (AI) in diagnostics market held a significant market share in 2023. The US led the regional market's growth due to several factors, including increased healthcare coverage, rising research and development expenditure, a growing geriatric population with chronic diseases, and high healthcare spending. According to the Centers for Disease Control and Prevention (CDC), approximately 60% of adults in the US have chronic diseases, making them the leading cause of death and disability. The presence of numerous AI in diagnostics solution providers in the US is also fueling market growth. In healthcare, AI is increasingly being utilized for image recognition in medical imaging, such as computed tomography (CT) scans and X-rays, to aid in the early detection and diagnosis of various conditions, including cancer.

Additionally, AI is being employed in both in vivo and in vitro diagnostics, particularly in obstetrics and gynecology, ophthalmology, and other medical specialties. The adoption of AI in diagnostics is expected to continue growing due to its potential to improve patient care and reduce healthcare costs by streamlining the diagnostic process and enabling more accurate and timely diagnoses. The use of AI in diagnostics is also expected to lead to earlier detection and intervention for various diseases, ultimately improving pa