In Vitro Diagnostics Market Size, Share, Trends, Industry Analysis, and Forecast (2025 – 2031)

In Vitro Diagnostics Market Size

The global in vitro diagnosticsmarket size was valued at $79.54 billion in 2025 and is projected to reach $122.75 billion by 2031, growing at a CAGR of 7.5% during the forecast period.

In Vitro Diagnostics Market Overview

In Vitro Diagnostics (IVD) refers to medical devices, reagents, and instruments used to analyze samples taken from the human body, such as blood, urine, or tissue, to detect diseases, monitor health conditions, and guide treatment decisions. IVD tests are performed outside the body in a controlled environment, often in laboratories or healthcare facilities. These tests play a crucial role in healthcare, influencing an estimated 70% of medical decisions.

Companies can benefit from the growing IVD market in several ways. Manufacturers of IVD instruments, reagents, and kits can capitalize on the increasing demand for diagnostic tests driven by the rise in chronic and infectious diseases. Point-of-care IVD tests that enable quick diagnoses and treatment decisions can be particularly advantageous for companies targeting underserved areas with limited access to laboratory infrastructure.

In Vitro Diagnostics Market Dynamics

The in vitro diagnosticsmarket is expected to witness significant growth in the future due to the increasing prevalence of chronic and infectious diseases, growing demand for personalized medicine and targeted therapies, and advancements in technology, including molecular diagnostics and point-of-care testing. However, the stringent regulatory and legal frameworks affecting product approvals, unfavorable reimbursement situations for certain diagnostic tests, and high costs associated with advanced diagnostic technologies are restraining the growth of the market.

Furthermore, expansion of telemedicine and remote patient monitoring solutions, growth potential in emerging markets with increasing healthcare investments, development of innovative IVD products and technologies are the key trends propelling the in vitro diagnosticsmarket.

Increasing Prevalence of Chronic and Infectious Diseasesis Driving the In Vitro Diagnostics Market

The increasing prevalence of chronic and infectious diseases is significantly impacting the in vitro diagnostics market, by driving the demand for diagnostic tests to enable early detection, monitoring, and management of these conditions.

• In January 2024, Roche, which launched its new Elecsys Anti-SARS-CoV-2 S test. This test is designed to measure the immune response to COVID-19 vaccines and infections, helping healthcare providers monitor the effectiveness of vaccination efforts and guide treatment decisions.
• Additionally, in April 2024, Qiagen unveiled its new QIAstat-Dx Respiratory Panel, which provides rapid and comprehensive testing for respiratory pathogens, including COVID-19, RSV, and influenza. This product launch demonstrates how IVD companies are developing innovative solutions to address the growing need for infectious disease testing.

Government initiatives are also supporting the growth of the IVD market.

• For instance, the U.S. FDA's Breakthrough Devices Program is cultivating innovation and market expansion by providing a pathway for the expedited development and review of IVD products that demonstrate the potential to address life-threatening or irreversibly debilitating diseases or conditions.
• In March 2024, Agilent introduced its new line of in vitro diagnostic reagents designed to enhance the accuracy and reliability of laboratory testing for chronic conditions.

These examples illustrate how the increasing burden of chronic and infectious diseases is driving innovation and growth in the IVD market, with companies and governments working together to develop and support the adoption of advanced diagnostic solutions.

By End Users, the Hospital and ClinicsSegment is projected to be the Largest Segment in the In Vitro Diagnostics Market

Hospital and clinics is the largest segment in the in vitro diagnosticsmarket, driven by the increasing rates of hospitalization and the essential role diagnostic tests play in clinical decision-making. In 2023, the hospitals segment emerged as the leading force in the U.S. IVD market, largely due to the reliance of healthcare providers on diagnostic interpretations to guide treatment decisions. Hospitals, which numbered over 6,093 in the U.S. as of 2022, are major consumers of IVD products, utilizing them in substantial volumes to ensure prompt and accurate diagnosis.

• For example, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for its rapid Antimicrobial Susceptibility Testing (AST) system, VITEK REVEAL, aimed at improving the speed and accuracy of diagnosing infectious diseases in hospital settings.

Additionally, the ongoing development of healthcare infrastructure, supported by government initiatives, is expected to enhance existing hospital facilities and further drive the demand for IVD testing. The COVID-19 pandemic has also accelerated the adoption of diagnostic tests, underscoring their critical role in managing public health crises, which has led to an unprecedented demand for IVD solutions in hospitals and clinics.

By Geography, North AmericaHolds the Largest Share in the Market Revenue

North America holds the largest share of the in vitro diagnosticsmarket, driven by the increasing prevalence of chronic and infectious diseases, along with the growing emphasis on early diagnosis and personalized medicine. The North American IVD market was valued at approximately USD 21.2 billion in 2022 and is projected to reach around USD 33.2 billion by 2030, reflecting a robust growth trajectory. This expansion is supported by major companies such as Abbott Laboratories and Roche Diagnostics, which are continuously innovating and launching new products.

• For example, Roche launched the Cobas 6800/8800 systems, which streamline laboratory workflows and improve the accuracy of infectious disease testing, in June 2023.

Government initiatives also play a crucial role in fostering growth in this sector.

The U.S. FDA has implemented streamlined approval processes for diagnostic tests, particularly in response to the COVID-19 pandemic, which has led to a surge in the use of rapid testing solutions. Furthermore, the aging population in North America, which is more susceptible to chronic diseases such as diabetes and cardiovascular conditions, is increasing the demand for effective diagnostic tools.

• According to the International Diabetes Federation, in 2021around 32.2 million people in the U.S. were living with diabetes, underscoring the need for advanced IVD solutions.

Overall, the combination of rising disease prevalence, technological advancements, supportive regulatory environments, and a strong focus on patient-centered care are key factors driving the substantial demand for In Vitro Diagnostics in North America.

Key Target Audience:

• IVD Instrument Manufacturers
• Hospitals and Clinics
• Research Institutes
• Distributors of IVD Products
• Regulatory Bodies

List of the Key Players Profiled in the Report Includes:

• Abbott
• bioMérieux SA
• QuidelOrtho Corporation
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Qiagen
• Sysmex Corporation
• Charles River Laboratories
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.
• Danaher Corporation
• BD
• F. Hoffmann-La Roche Ltd.

Recent Developments:

• In July 2024, Abbott announced FDA approvals for new products, including the Esprit below-the-knee system and two over-the-counter continuous glucose monitoring systems, Lingo and Libre Rio.
• In June 2024, Siemens Healthineers launched its latest in vitro diagnostic solution, the Atellica VTLi, which enhances laboratory workflow and efficiency in testing for infectious diseases.
• In April 2024, bioMérieux announced the launch of its new molecular diagnostic platform, BioFire FilmArray 2.0, designed to enhance pathogen detection capabilities in clinical microbiology laboratories.
• In March 2024, QuidelOrtho introduced its new rapid diagnostic test for respiratory viruses, including COVID-19, which aims to improve patient management during the flu season.

Market Segmentation:

The research report includes in-depth coverage of the industry analysis with size, share, and forecast for the below segments:

Market by, Product & Service:

• Instruments
• Data Management Software and Services
• Reagents & Kits

Market by, Technology:

• Chromatography & Mass Spectrometry
• Clinical Chemistry
• Coagulation & Hemostasis
• Hematology
• Immunoassays
• Immunodiagnostics
• Microbiology
• Molecular Diagnostics
• Urinalysis

Market by, Setting:

• Laboratories
• Point-of-Care

Market by, Specimen:

• Blood, Serum, and Plasma
• Saliva
• Urine
• Other Specimens

Market by, Application Split:

• Allergy Diagnostics
• Autoimmune Diseases
• Blood Group Typing
• Blood Screening
• Bone & Mineral Disorder
• Cardiology
• Coagulation Testing
• Drug Monitoring & Testing
• Endocrinology
• Gastroenterology
• Genetic Testing
• Infectious Diseases
• Oncology
• Other Applications

Market by, End Users:

• Academic Institutes
• Blood Banks
• Clinical Laboratories
• Home Care Settings
• Hospital & Clinics
• Pharmaceutical & Biotechnology Companies
• Other End Users

Market by, Geography:

The in vitro diagnosticsmarket report also analyzes the major geographic regions and countries of the market. The regions and countries covered in the study include:

• North America (The United States, Canada, Mexico), Market Estimates, Forecast & Opportunity Analysis
• Europe (Germany, France, UK, Italy, Spain, Rest of Europe), Market Estimates, Forecast & Opportunity Analysis
• Asia Pacific (China, Japan, India, South Korea, Australia, New Zealand, Rest of Asia Pacific), Market Estimates, Forecast & Opportunity Analysis
• South America (Brazil, Argentina, Chile, Rest of South America), Market Estimates, Forecast & Opportunity Analysis
• Middle East & Africa (UAE, Saudi Arabia, Qatar, Iran, South Africa, Rest of Middle East & Africa), Market Estimates, Forecast & Opportunity Analysis

The report offers insights into the following aspects:

• Analysis of major market trends, factors driving, restraining, threatening, and providing opportunities for the market.
• Analysis of the market structure by identifying various segments and sub-segments of the market.
• Understand the revenue forecast of the market for North America, Europe, Asia-Pacific, South America, and Middle East & Africa.
• Analysis of opportunities by identification of high-growth segments/revenue pockets in the market.
• Understand major player profiles in the market and analyze their business strategies.
• Understand competitive developments such as joint ventures, alliances, mergers and acquisitions, and new product launches in the market.