In-vitro Diagnostics Market to Grow by USD 22.17 Billion (2024-2028), Rising Geriatric Population and Disease Prevalence, Report on AI-Driven Market Trends - Technavio

NEW YORK, Nov. 26, 2024 /PRNewswire/ -- Report with market evolution powered by AI - The global in-vitro diagnostics market size is estimated to grow by USD 22.17 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 4.21% during the forecast period. Increasing geriatric population, chronic, and infectious diseases is driving market growth, with a trend towards global adoption of advanced treatment solutions. However, stringent regulatory bodies guiding in-vitro diagnostics manufacturers poses a challenge. Key market players include Abbott Laboratories, Agilent Technologies Inc., ARKRAY Inc., Becton Dickinson and Co., BGI Genomics Co. Ltd., Bio Rad Laboratories Inc., bioMerieux SA, Charles River Laboratories International Inc., Danaher Corp., DiaSorin SpA, F. Hoffmann La Roche Ltd., Grifols SA, Illumina Inc., Merck KGaA, QIAGEN NV, Quest Diagnostics Inc., QuidelOrtho Corp., Siemens Healthineers AG, Sysmex Corp., and Thermo Fisher Scientific Inc..

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Market Driver

The In-vitro Diagnostics (IVD) market is experiencing significant growth, driven by trends like liquid biopsy, point-of-care devices, and rapid diagnostic testing. Chronic diseases and preventive care testing are key applications, with a focus on disease diagnosis in emerging markets and healthcare infrastructure development in emerging economies. Reimbursement scenarios, disease diagnosis, and infectious diseases are major concerns. Personalized medicines and oncology are emerging areas, with rapid tests and next-generation sequencing leading the way. Budget constraints, economic downturns, and recession are challenges, but reagents & kits, instruments, software & services, immunodiagnostics, hematology, tissue diagnostics, clinical chemistry, and molecular diagnostics offer opportunities. Product approval, including companion diagnostic (CDx), is crucial in this competitive landscape. IVD market includes medical tests using bodily fluids and tissues in a laboratory environment with specialized equipment and techniques. 

The in-vitro diagnostics market is experiencing growth in the areas of cancer, cardiovascular diseases (CVD), and infectious kidney diseases, driven by the availability of advanced treatment options. Immunoassay and molecular diagnostic devices are key technologies fueling this growth. For instance, Siemens' Xprecia Stride Coagulation Analyzer performs PT/INR tests with high accuracy, making it a preferred choice for healthcare providers. While routine diagnostic testing dominates the market, specialty testing in esoteric, pathology, and genetic areas is forecasted to grow at a faster rate. As laboratories focus on cost savings, they are increasingly opting for bulk purchases from trusted partners instead of individual analyzers. 

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Market Challenges

• The In-vitro Diagnostics (IVD) market faces several challenges in the current business landscape. Liquid biopsy, a new diagnostic technique using bodily fluids, requires specialized equipment and techniques, posing budget constraints for both emerging markets and healthcare systems. Emerging economies with limited healthcare infrastructure struggle to adopt advanced technologies like molecular diagnostics and next-generation sequencing. Point-of-care devices and rapid diagnostic testing are essential for chronic diseases and preventive care testing, but their high cost and reimbursement scenario remain significant hurdles. Infectious diseases, especially in low-income regions, necessitate affordable, rapid tests. Economic downturns and recession impact healthcare spending, affecting the sales of reagents & kits, instruments, software & services, and immunodiagnostics in clinical and reference laboratories. Product approval processes and budget constraints further complicate market entry for new technologies like Companion diagnostic (CDx) and oncology tests. Healthcare spending trends, disease diagnosis, and healthcare infrastructure development in emerging markets will significantly influence the IVD market's growth trajectory. Supermarkets, hypermarkets, pharmacies, and drug stores are increasingly becoming important channels for IVD sales, while standalone laboratories continue to dominate the market landscape.
• In-vitro diagnostics refer to tests conducted on blood, tissue, or fluid samples to monitor health conditions and diagnose diseases. These tests are crucial for effective patient management and treatment. However, challenges such as device malfunctions and technical errors can lead to misdiagnosis and improper treatment. To mitigate these risks, regulatory bodies like the FDA and EU authorities impose stringent regulations on in-vitro diagnostic manufacturers and marketers. Their approval is necessary to bring these devices to market, and the approval process includes rigorous requirements and regulations. These authorities ensure the safety, efficacy, and quality of in-vitro diagnostic devices and components. Compliance with these regulations is essential to protect patient health and maintain trust in the healthcare industry.

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Segment Overview 

This in-vitro diagnostics market report extensively covers market segmentation by

1. Product Type
• 1.1 Reagents and kits
• 1.2 Instruments
• 1.3 Others
2. Technology 
• 2.1 Immunoassay
• 2.2 Molecular diagnostics
• 2.3 Clinical chemistry
• 2.4 Hematology
• 2.5 Others
3. Geography 
• 3.1 North America
• 3.2 Europe
• 3.3 Asia
• 3.4 Rest of World (ROW)

1.1 Reagents and kits- In the In-vitro Diagnostics (IVD) market, reagents and diagnostic kits play essential roles in facilitating the detection and measurement of various analytes in patient samples. Reagents are chemical substances that react with specific biological markers, while diagnostic kits offer complete solutions for specific diagnostic tests, including reagents, calibrators, controls, and sometimes instruments. In the clinical chemistry segment, reagents are utilized to detect and measure substances like glucose, cholesterol, and enzymes in blood samples, aiding in the diagnosis of medical conditions such as diabetes and cardiovascular diseases. Immunoassay kits, which employ antibodies and antigens, support the diagnosis of infectious diseases, hormonal disorders, and autoimmune conditions. The growth of the reagents and kits segment can be attributed to the increasing incidence of infectious diseases worldwide and the rising number of research trials by pharmaceutical companies. Moreover, the growing use of proteins and reagents by biotechnology and pharmaceutical companies, increasing genome projects, and the expanding application of molecular biology kits for diagnostic procedures will further contribute to market growth. However, challenges such as a lack of a skilled workforce for molecular diagnostic techniques, high costs, and insufficient reimbursement policies for genetic testing can negatively impact market growth. Despite these challenges, the demand for diagnostic test kits during the COVID-19 pandemic from end-users like hospitals and diagnostic centers.

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Research Analysis

The In-vitro Diagnostics (IVD) market encompasses a range of medical tests utilizing bodily fluids and tissues, performed outside the body, to aid in disease diagnosis, monitor treatment progress, and facilitate personalized medicines. IVDs include techniques such as molecular diagnostics, rapid tests, and point-of-care devices. The market is driven by the rise in chronic diseases, healthcare spending, and the need for preventive care testing. Rapid diagnostic testing and liquid biopsy are emerging trends, particularly in oncology and infectious diseases. Economic factors like budget constraints, economic downturns, and recession can impact market growth. Regulatory guidelines ensure safety and efficacy, while reimbursement scenarios vary across regions. Emerging economies present significant opportunities due to increasing healthcare infrastructure and disease burden. Specialized equipment and techniques are crucial for accurate results in the laboratory environment.

Market Research Overview

The In-vitro Diagnostics (IVD) market encompasses a broad range of medical tests that are performed on bodily fluids and tissues outside of the body. This market is witnessing significant growth due to the rising prevalence of chronic diseases, increasing focus on preventive care testing, and the emergence of emerging markets. Liquid biopsy, a promising technology in cancer diagnosis, is gaining traction due to its non-invasive nature. Point-of-care devices and rapid diagnostic testing are becoming increasingly popular in healthcare settings, especially in emerging economies, due to their convenience and affordability. The reimbursement scenario and healthcare infrastructure are critical factors influencing the growth of the IVD market in emerging economies. The market is segmented into various categories, including immunodiagnostics, molecular diagnostics, hematology, tissue diagnostics, clinical chemistry, and next-generation sequencing. Techniques such as PCR, ELISA, and immunofluorescence are commonly used in IVD. Budget constraints, economic downturns, and recession can impact the growth of the IVD market, particularly in developing countries. However, the increasing demand for personalized medicines and the growing number of product approvals for Companion diagnostic (CDx) tests are expected to drive market growth. The market is characterized by the presence of various players offering reagents & kits, instruments, software & services, and specialized equipment. Supermarkets & hypermarkets, pharmacies & drug stores, standalone laboratories, and clinical and reference laboratories are key distribution channels for IVD products. Infectious diseases and oncology are major application areas for IVD, with the latter expected to dominate the market due to the increasing incidence of cancer worldwide.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Product Type
• Reagents And Kits
• Instruments
• Others
• Technology
• Immunoassay
• Molecular Diagnostics
• Clinical Chemistry
• Hematology
• Others
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

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SOURCE Technavio