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.

Latin America IVD by Product & Solution, Technology (Immunoassay, Point of Care, Molecular Diagnostics), Application (Infectious Diseases, Diabetes, Oncology), Diagnostic Approach (Lab, OTC, PoC), End User - Forecast to 2030

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 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).

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...

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).

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.

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

Product Market size is rising upward in the past few years And it is estimated that the market will grow significantly in the forecasted period

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.

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 at-home in-vitro diagnostics (IVD) market is experiencing robust growth, driven by several key factors. The increasing prevalence of chronic diseases like diabetes and infectious illnesses, coupled with a rising demand for convenient and accessible healthcare solutions, is fueling market expansion. Technological advancements in point-of-care diagnostics, offering rapid and accurate results within the home setting, are further accelerating this trend. Consumers are increasingly seeking self-management tools for health monitoring, reducing reliance on traditional clinical settings and empowering proactive healthcare decisions. The market is segmented by test type (glucose, infectious disease, other), target user (adult, children), and geography, reflecting diverse needs and adoption rates across regions. While regulatory hurdles and potential concerns about test accuracy remain restraints, the overall market outlook remains positive, with significant growth projected over the next decade. The rising adoption of telehealth and remote patient monitoring programs further complements the at-home IVD market's expansion, creating a synergistic effect. The competitive landscape includes established players like Roche, Abbott, and Siemens, alongside innovative smaller companies specializing in specific at-home diagnostic solutions. Strategic partnerships and acquisitions are expected to continue shaping the market dynamics. North America and Europe currently hold a significant share of the market, driven by high healthcare expenditure and technological infrastructure. However, emerging economies in Asia Pacific and Latin America are showing promising growth potential, as healthcare access improves and awareness of at-home testing increases. Future growth will depend on successful navigation of regulatory landscapes, ensuring reliable test accuracy and affordability while addressing patient education and data security concerns. Continued innovation in technology, including improved user interfaces and connectivity, will be essential for broader market adoption and sustained growth.

The global In Vitro Diagnostic (IVD) Test market is projected to reach a value of $97,070 million by 2033, exhibiting a CAGR of 5% during the forecast period (2025-2033). Factors driving the market growth include the increasing prevalence of chronic diseases, the growing demand for personalized medicine, and the technological advancements in IVD testing. Additionally, favorable government initiatives and the rising adoption of IVD tests in emerging markets are expected to contribute to the market's growth. The market is segmented based on application, type, and region. By application, the market is segmented into hospitals, laboratories, and other settings. By type, the market is segmented into immuno diagnostics, chemistry diagnostics, molecular diagnostics, POCT, and other types. Geographically, the market is segmented into North America, Europe, Asia Pacific, South America, and the Middle East & Africa. North America is the largest market, followed by Europe and Asia Pacific. The Asia Pacific region is expected to witness the highest growth rate during the forecast period due to the increasing healthcare expenditure and the growing demand for IVD tests in emerging economies.

The size and share of the market is categorized based on Type (Reagents and kits, Instruments, Services, Data management software) and Application (Diabetes, Infectious diseases, Oncology or cancer, Cardiology, Nephrology, Autoimmune diseases, Drug testing, HIV or Aids) and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa).

product market has been steadily increasing over recent years, and forecasts suggest a substantial growth trajectory in the upcoming period.

The size and share of the market is categorized based on Application (Diabetes, Infectious Diseases, Oncology, Cardiology, Hiv) and Product (Tissue Diagnostics, Professional Diagnostic, Molecular Diagnostic, Diabetes Monitoring) and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa).

According to Future Market Insights (FMI) analysis in a recent market survey, the global celiac disease diagnostics market was valued at US$ 271.3 Million in 2022 and is expected to reach US$ 647.3 Million by 2033.

Market Outlook:

Scope of the Celiac Disease Diagnostics Report

The global IVD antibodies market is projected to grow at a healthy CAGR of around 3.8% during the forecast period between 2022 and 2032, reaching a valuation of nearly US$ 1.38 Billion by 2022. Demand for IVD antibodies is driven by the rising prevalence of chronic and infectious diseases worldwide and the increasing need for early diagnosis of chronic diseases to initiate proper treatment.

Report Scope