Chronic disease burden, FDA-approved innovations, and demand for precision medicine push U.S. diagnostics market expansion. The global in-vitro diagnostics market growth is due to the growing need for accurate, timely, and personalized diagnostic solutions across the globe.

WESTFORD, Mass., Aug. 20, 2025 /PRNewswire/ -- SkyQuest Technology Consulting published a report, titled, In-Vitro Diagnostics Market - Global Opportunity Analysis and Industry Forecast, 2025-2032", valued at USD 109.6 Billion in 2024. With a projected CAGR of 4.4% from 2025 to 2032, the market is expected to reach USD 153.3 Billion by the end of 2032. The main drivers of the In-Vitro Diagnostic (IVD) market expansion are the rise in the prevalence of infectious and chronic diseases, technological advancements, and growing healthcare awareness.

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Key U.S. IVD Market Drivers

• Chronic Disease Burden: According to the CDC, 6 in 10 U.S. adults live with a chronic disease, while 4 in 10 manage two or more, costing the U.S. healthcare system USD 4.1 trillion annually.
• FDA-Approved Diagnostic Innovations: Recent approvals, including QIAGEN's QIAstat-Dx Gastrointestinal Panel and bioMérieux's BIOFIRE SPOTFIRE panel, demonstrate the FDA's commitment to fast-tracking advanced diagnostics.
• Precision & Personalized Medicine: Demand for molecular diagnostics, next-gen sequencing, and AI-driven tools is accelerating adoption in hospitals, labs, and point-of-care settings.

In-Vitro Diagnostics Market Dynamics

The increase in the prevalence of chronic and infectious diseases, and genetic disorders like Turner syndrome, Alzheimer's disease, and Parkinson's disease, is expected to drive up demand for in-vitro diagnostics over the forecast period. According to the CDC, chronic diseases like diabetes and cancer, as well as respiratory and kidney disorders like asthma, account for seven out of ten deaths in the US. About 60% of adults in the US are probably suffering from a chronic illness. These chronic conditions cost the US healthcare system USD 4.1 trillion annually. With 620,000 cases and 213 fatalities, primarily in the Americas, Brazil, Paraguay, and Argentina reported the highest burdens in 2024.

While Asia saw many cases, particularly in India and Pakistan, Senegal was the only country in Africa affected. Europe reported one locally acquired case in France and 118 cases in La Réunion.

Technological advancements in the fields of accuracy, affordability, and portability are expected to have a significant impact on this market. Leading market participants are increasing their testing options by working with other kit manufacturing companies or initiating research and development projects to create kits that target life-threatening conditions. The market's creative product launches are also aided by the growing number of R&D and partnership initiatives by participants.

Recent Developments in In-Vitro Diagnostics Market

In February 2025, ABL Diagnostics acquired Advanced Biological Laboratories and will manufacture and distribute a full range of UltraGene PCR tests. These tests, which cover over 100 pathogens, aid in the diagnosis of infectious diseases in a range of conditions. By combining PCR with its DeepChek sequencing products, the company hopes to expand its presence in precision medicine.

In February 2025, F. Hoffmann-La Roche Ltd (Switzerland) introduced a new class of next-generation sequencing (NGS) technology, powered by Sequencing by Expansion (SBX). This innovation is designed to deliver faster, more precise, and highly scalable sequencing capabilities.

In January 2025, the U.S. FDA approved the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, a targeted syndromic test for bacterial and viral gastrointestinal infections. The company is preparing a product launch to expand QIAGEN's syndromic testing portfolio and offer comprehensive and targeted options to improve inpatient and outpatient diagnostics.

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Major Challenges in In-Vitro Diagnostics Industry

The complex and constantly shifting regulations in various jurisdictions are causing problems for the IVD market. Launches were slowed in 2024 by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) taking longer to approve new products. The FDA's approval rate increased by over 18% annually. Small businesses have been particularly impacted by the new EU IVDR regulations. Compliance concerns have slowed down product rollouts, according to more than half of EU-based diagnostic manufacturers, which has hindered industry growth.

Examples of contemporary diagnostic technologies that are underutilized due to their high cost include molecular diagnostics and next-generation sequencing. The average cost of a molecular diagnostic test in 2025 was still over USD 200, making it unaffordable for those in low- and middle-income nations. As a result, the use of contemporary IVD technologies is declining in Africa and Southeast Asia, which hinders their global dissemination.

Competitive Landscape

The U.S. IVD market is led by global giants including Abbott, Roche, Thermo Fisher, Siemens Healthineers, and Quest Diagnostics, with growing competition from innovative biotech firms and startups entering precision diagnostics. Roche is concentrating on growing its platforms for molecular diagnostics and digital health. Abbott invests in the development of rapid point-of-care tests for infectious diseases. While Thermo Fisher is developing next-generation sequencing diagnostics, Siemens is interested in utilizing AI in lab automation. Partnerships and regional expansions are used by startups to enter new markets and diversify their test offerings. All market sectors experience increased competition as a result.

Major players in the In-Vitro Diagnostics industry include,

• F. Hoffmann-La Roche Ltd
• Hologic Inc
• Abbott Laboratories
• Siemens Healthcare GmbH (Siemens Healthineers)
• Exact Sciences Corp
• bioMérieux SA
• QuidelOrtho Corp
• Sysmex Corp
• Bio-Rad Laboratories Inc
• Thermo Fisher Scientific Inc
• Becton Dickinson
• Danaher Corporation (Beckman Coulter, Cepheid etc.)
• Illumina
• DiaSorin (Luminex Corporation)
• Koninklijke Philips NV (Philips Healthcare)
• Qiagen N.V.
• Werfen, S.A. (Biokit S.A.)
• Agilent Technologies Inc
• Quest Diagnostics
• Revvity Inc
• Mindray

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In-Vitro Diagnostics Market Segmental Analysis

The in-vitro diagnostics market is segmented into product, technology, specimen, site of testing, application, end user, and region.

• By product, since reagents & instruments are required for so many different diagnostic tests, reagents and instruments held the largest market share in 2024. They are always needed in hospital and lab settings, so revenue will always be coming in. Better test automation and additional disease screening initiatives contributed to the increase even more.
• By technology, in 2024, immunoassays were the most widely used technology due to their high accuracy, speed, and widespread use in determining whether a person had a chronic or infectious disease. The testing process was accelerated by their compatibility with automated systems. They were a common diagnostic tool in labs and hospitals because of their ability to handle large volumes of samples.
• By specimen, due to ease of collection and ability to identify a wide range of diseases, blood continued to be the most common specimen type in 2024. Blood tests are commonly accepted as fundamental diagnostic methods in medical settings. Blood-based diagnostics became even more popular due to their high sensitivity for early illness identification.
• By site of testing, as centralized laboratories are more accurate, standardized, and scalable, laboratory testing was the most common form of testing in 2024. The majority of complex diagnostic procedures, including molecular and genetic analysis, are carried out in laboratories. Because more extensive panels and batch testing were required, the lead for this area grew stronger.
• By application, infectious disorders accounted for the largest percentage of applications in 2024, as people still want to test for respiratory pathogens. Additionally, many people in developing nations still required HIV, TB, and hepatitis testing. Spending on infectious disease testing increased as travel and antibiotic resistance increased.
• By end user, since hospitals & clinics perform the majority of patient diagnostics in both emergency and routine settings, they are the largest end users in 2024. Doing more tests was made easier by instant access to testing supplies and integrated healthcare services. Due to their use in primary care settings, IVD instruments will always be in demand.

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Regional Insights

• North America continued to dominate the in-vitro diagnostics market in 2024 Due to its highly developed healthcare system, high healthcare costs, and rapid adoption of new technologies. As it invested heavily in molecular diagnostics and AI-integrated testing systems, the U.S. was the region's leader. Innovation was also stimulated by strategic partnerships between diagnostic companies and hospitals. People still required routine and specialized tests because chronic illnesses are so prevalent.
• Europe's in-vitro diagnostics market continued to expand rapidly due to effective public health systems and an increasing demand for customized drugs. The nations that used immunoassays and genetic testing the most were Germany, the United Kingdom, and France. Although the EU In Vitro Diagnostic Regulation (IVDR) made it more difficult for companies to comply with the regulations, it also ensured that the products were of higher quality. Population aging and increased initiatives to encourage screening before illness also played a role.
• The in-vitro diagnostics market is expanding at the fastest rate in Asia-Pacific because more people are becoming middle class, more diagnostic networks are being established in countries like China, India, and Japan, and more people are becoming aware of healthcare issues. More tests were conducted as a result of government efforts to enhance digital health and early illness detection. Additionally, there was an increased need in the region for point-of-care and home-based diagnostics. Local production and foreign investment strengthened regional capacities.
• The market in LAMEA is gradually expanding as a result of improved healthcare infrastructure and easier test-taking. Particularly in infectious disease testing, South Africa and Brazil are significant players. However, factors like unequal compensation and a shortage of skilled workers reduce the market's potential for expansion. People in underdeveloped areas are finding it easier to access care thanks to international collaborations and mobile diagnostic units.

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About SkyQuest Technology Consulting

SkyQuest Technology Consulting is a leading Strategy Consulting and Market Research firm, provides syndicated as well as customized research reports and growth consulting services, trusted by CXOs from Fortune 500 Companies, Start-ups, and MSMEs. The company comprises a team of expert research analysts and consultants, adding more than 1200 market research reports in our database each year. These reports offer in-depth analysis on 40+ industries & sub industries across 25 major countries worldwide, serving global clients across diverse industries. The company specializes in delivering customized intelligence, data-driven insights, and strategic advisory services that enable businesses to stay competitive and make informed decisions in rapidly evolving industries.

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