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Market Overview

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The global in vitro diagnostics (IVD) market reached a size of over USD 105.23 billion in 2022 and is projected to reach USD 127.56 billion by 2028, growing at a CAGR of 3.26%. The IVD market offers advanced, cost-effective, and rapid tools for precise diagnosis and point-of-care or self-testing. The market has shifted from conventional instruments to advanced analyzers that require small sample volumes and high-throughput screening methods. These advancements, coupled with AI and cloud technology, are revolutionizing the IVD market. Key trends in the market include low-volume sample analysis, automation, high-throughput analysis, rapid analysis times, small footprint, low cost, portability, and disposability.

IVD refers to clinical tests that analyze samples taken from individuals to provide specific disease treatments. The global burden of chronic and infectious diseases is driving the demand for advanced diagnostic services, thereby fueling the growth of the IVD market. In the United States, the market growth is primarily driven by the country’s healthcare expenditure and awareness of chronic and infectious diseases. Access to diagnostic and care services in the US is significantly higher compared to other developed countries. The country’s preference for early detection and diagnosis of chronic and infectious diseases has increased the demand for IVD solutions. Apart from COVID-19 and monkeypox, other infectious diseases such as HIV, HSV, and chlamydia are leading drivers of IVD diagnosis demand in the US.

The healthcare industry has witnessed substantial development and growth in in vitro diagnostics over the past decade. Advancements in molecular diagnostics are significantly improving medical treatment outcomes. Bio-pharmaceutical companies are turning to molecular-level solutions and molecular diagnostics due to drug failures in clinical trials and regulatory barriers. Next-generation sequencing and CRISPR technology have notably enhanced molecular diagnostics for oncology and infectious diseases care. These factors are expected to drive the future growth of the IVD market.

IVD diagnostics is one of the industries experiencing numerous product launches in recent years. The increasing demand for new diagnostic tests is driving the development of innovative solutions. Currently, IVD players operate in a world where they design, develop, manufacture, and sell best-in-class solutions. The COVID-19 pandemic has prompted many companies to develop rapid test kits for detecting the virus.

In the first half of 2021, IVD companies reported significant revenues from COVID-19 testing. However, in the second half of the year, many companies experienced lower demand for COVID-19 testing, leading to decreased revenue from COVID-19 products. During the same period, IVD companies pursued M&A strategies to increase production capacity and expand distribution networks. Major and emerging IVD companies have engaged in M&As to enhance their diagnostic testing portfolios in preparation for future outbreaks. These acquisitions have facilitated market expansion and portfolio diversification in the in vitro diagnostics sector.

Chronic diseases such as cancer, diabetes, cardiovascular diseases, and others are major public health concerns globally, driving the demand for diagnostic services. Additionally, infectious diseases like HIV, COVID-19, influenza, staphylococcus, respiratory syncytial virus, and others create significant demand for diagnostic services and contribute to market growth.

The adoption of advanced technologies in the IVD field enables extensive testing without burdensome time and cost implications. These technologies have increased diagnostic efficiency and accuracy, thereby accelerating market growth. Advancements such as AI-powered IVD products and digital platforms are introducing new dimensions to the global in vitro diagnostics market.

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Market Segmentation

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The market is segmented based on various factors, including product & services, technology, application, end-users, and geography.

Segmentation By Product & Services
Reagents and Consumables
Instruments/ Analyzers & Software
Services

Segmentation By Technology
Immuno and Clinical Chemistry
Molecular Diagnostics
Hematology
Microbiology and Cytology
Others Technology

Segmentation By Application
Infectious Diseases
Diabetes
Cardiology
Oncology
Autoimmune Diseases
Nephrology
Drug Testing
Others

Segmentation By End-Users
Standard Reference Labs
Hospital-Affiliated Labs
Individuals
Clinics
Others

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain, Russia
APAC – China, Japan, India, South Korea, Australia, Indonesia, Malaysia, Singapore
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey

In 2022, the reagent and consumables segments were the largest components of the global in vitro diagnostics market, comprising 66.47% of the total market share. Reagents and consumables play a crucial role in IVD procedures by serving as a medium and transporter for patient specimens used in diagnosis, treatment, and monitoring of medical conditions. The recurring use of reagents and consumables is a key driver of market growth. However, compared to analyzers, there is relatively low innovation in consumables, particularly reagents. Nonetheless, certain companies have introduced new types of reagents for unique products. For example, Sysmex, a Japanese company, has developed concentrated reagents for hematology analyzers. These concentrated reagents are gaining popularity in the market, especially in developed countries, and have helped Sysmex gain market share. End-users are increasingly shifting towards concentrated reagents due to their superior benefits compared to conventional reagents.

The global in vitro diagnostics market is segmented by technology into immuno & clinical chemistry, molecular testing, hematology, microbiology & cytology, point-of-care, and others. In 2022, the immuno & clinical chemistry segment accounted for the largest market share at 45.26%, dominating the other segments. Immunoassay and clinical chemistry technologies are widely used in IVD for diagnosing infectious and chronic diseases, which pose significant burdens on global healthcare services. The patient population affected by chronic and infectious diseases is driving the growth of immunochemistry-based IVD solutions. Additionally, clinical chemistry has diverse applications in the detection of cancer, diabetes, heart disease, renal disease, liver disorders, and other health conditions, contributing to the segment’s growth.

For the application segment, infectious diseases accounted for the largest market share (46.95%) of the global IVD market in 2022. The applications of in vitro diagnostics are categorized into infectious diseases, diabetes, cardiology, oncology, autoimmune diseases, nephrology, drug testing, and others. The COVID-19 pandemic significantly boosted the demand for in vitro diagnostics, with more than 3 to 4 billion tests conducted worldwide. In addition to COVID-19, the prevalence of infectious diseases such as HIV, influenza, and respiratory syncytial virus drives the demand for IVD and stimulates industry growth. As the burden of infectious diseases continues to increase, the demand for diagnosis and treatment rises, thereby driving the demand for IVD solutions. Recent technological advancements and the integration of new technologies for infectious disease diagnosis have resulted in high revenue generation through the infectious diseases segment.

Among end-users, standard reference labs dominated the global in vitro diagnostics market in 2022, with a valuation of USD 36 billion. Standard reference laboratories provide various types of IVD services and have rapidly expanded in low- and middle-income countries (LMICs) to offer a wide range of tests. Their adoption of new technologies and product offerings has contributed to significant market growth. These laboratories establish their presence in specific regions or concentrated areas, providing easy access to diagnostic services at affordable prices. The broad range of diagnostic services increases access to multiple tests, attracting a large consumer base and generating substantial revenue. The standard reference labs segment accounted for 34.21% of the global IVD market in 2022.

In the global IVD market, hospital-affiliated labs were valued at USD 28.54 billion in 2022. Hospitals serve as primary sources and first points of contact for disease diagnosis and treatment, and their associated laboratories contribute to a significant number of IVD practices, driving segmental growth. Factors such as the increasing number of hospitals and associated laboratories, growing infrastructure, and rising healthcare expenditure fuel the demand for IVD practices through hospitals.

North America dominated the global IVD market in 2022, accounting for a 39.90% market share. The region’s large patient population and high healthcare expenditures contribute to its market growth. Furthermore, awareness regarding disease diagnosis, including point-of-care, early detection, and preventive health check-ups, positively impacts industry growth in the region. A significant portion (60% to 80%) of the regional population suffers from chronic conditions that require diagnostic services. Healthcare expenditure in the region exceeded USD 4.3 trillion in 2021, with a 2.7% growth from 2020, indicating a high potential for market growth. Leading companies such as Abbott, BD, Bio-Rad Laboratories, and Biomerieux SA have a strong market presence in North America, particularly in the US. They are expanding access to IVD components and contributing to high revenue generation in the country.

Europe is also a prominent region for the IVD market, experiencing significant demand for IVD solutions. The increasing aging population in the region, coupled with the prevalence of chronic and infectious diseases, drives the demand for IVD solutions. Europe boasts more than 25,000 pathologists, with the UK having 40 pathologists per million population and Germany and France having 20 to 29 pathologists per million population. The in vitro diagnostics market in Europe is projected to reach USD 31.41 billion by 2028.

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Competitive Landscape

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F Hoffmann-La Roche, Abbott, Thermo Fisher Scientific, and Siemens Healthineers are the prominent players in the global in vitro diagnostics market. These companies face competition from rapidly emerging market players. In order to expand their market share, these vendors are utilizing strategies such as inorganic growth and continuous product launches to attract new customers.

Abbott, a leading company in the global in vitro diagnostics market, stands out as a pioneer in point-of-care diagnostics. It boasts a comprehensive portfolio of tests and systems. Within its diagnostic products segment, Abbott offers core laboratory analyzers and biomarkers (clinical chemistry), immunoassay, hematology, and transfusion products. In the year 2021, the company achieved approximately USD 15.6 billion in revenue.

Key companies profiled in this report include Abbott, Danaher, F. Hoffmann-La Roche, Siemens Healthineers, Thermo Fisher Scientific, Atomo Diagnostics, Accelerate Diagnostics, Agilent Technologies, altona Diagnostics, Amoy Diagnostics, ARKRAY, AccuBioTech, Agappe Diagnostics, BD, Bio-Rad Laboratories, Balio diagnostics, B&E BIO-TECHNOLOGY, BIOMÉRIEUX, bioLytical Laboratories, Biosynex, Biocartis, Biocept, Biohit Oyj, Biomerica, Biosystems, Bioway Biological Technology, Boule Diagnostics, Cupid Limited, CareDx, Chembio Diagnostics, CLINDIAG SYSTEMS, CONTEC MEDICAL SYSTEMS, Convergent Technologies, CPC Diagnostics, CPM Scientifica, CellaVision, DIALAB, Dexcom, DiaSorin, Diagon, Diatron, DIRUI, Drucker Diagnostics, EDAN Instruments, EKF Diagnostics Holdings, ELITechGroup, Erba Diagnostics, Genetron Holdings, Genrui Biotech, Hologic, High Technology, HORIBA, Linear Chemicals, Illumina, INTEC, J. Mitra & Co., Kilpest India Limited, Maccura Biotechnology, Medsource Ozone Biomedicals, Meril Life Sciences, MP Biomedicals, Nanjing Synthgene Medical Technology, NIHON KOHDEN, Norma Instruments, NOWDiagnostics, Ortho Clinical Diagnostics, OPKO Health, OraSure Technologies, Perkin Elmer, Prestige Diagnostics, QIAGEN, Quidel, Sysmex, Salofa Oy, SEASUN BIOMATERIALS, Sekisui Diagnostics, SFRI, Shenzhen Dymind Biotechnology, Shenzhen iCubio Biomedical Technology, Shenzhen Mindray Bio-Medical Electronics, SHENZHEN PROKAN ELECTRONICS, Shenzhen Landwind Medical, Sinocare, SPINREACT, SureScreen Diagnostics, The Binding Site Group, Trinity Biotech, Trivitron Healthcare, Xiamen Biotime Biotechnology, Zhejiang Orient Gene Biotech.

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Recent Industry Developments

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In March 2020, Abbott’s rapid diagnostic segment introduced a molecular test solution for detecting COVID-19 using its ID NOW rapid point-of-care (POC) platform in the United States.

Hoffmann-La Roche made significant investments in research and development (R&D) activities to develop innovative in vitro diagnostics (IVD) test solutions. For instance, in the fiscal year 2019, the company invested approximately $12.86 billion in R&D activities.

In July 2019, Siemens Healthineers successfully completed the acquisition of Minicare B.V., a company specializing in the development of technology for point-of-care immunoassay testing. This acquisition has been integrated into the Diagnostics segment of Siemens Healthineers and will enable the company to enhance its portfolio in the rapid diagnostics field.

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Key Questions Answered

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What is the size of the global In Vitro Diagnostics Market?

The global in vitro diagnostics market was valued at USD 105.23 billion in 2022 and is projected to reach USD 127.56 billion by 2028.

What is the growth rate of the in vitro diagnostics market?

The in vitro diagnostics market is growing at a compound annual growth rate (CAGR) of 3.26% from 2022 to 2028.

Who are the major players in the global in vitro diagnostics market?

Abbott, Danaher, F. Hoffmann-La Roche, Siemens Healthineers, and Thermo Fisher Scientific are the key players in the global in vitro diagnostics market.

Which region holds the largest market share in the global in vitro diagnostics market?

North America accounted for the largest market share of 39.90% in the global in vitro diagnostics market in 2022. The region’s awareness of primary care and point-of-care solutions for various diseases has contributed to the acceptance of in vitro diagnostic solutions and services.

What are the emerging trends in the in vitro diagnostics market?

The in vitro diagnostics market is witnessing advances in molecular diagnostics, which are transforming the future of healthcare. There is also an increasing demand for companion diagnostics in the field of in vitro diagnostics, as well as a rise in product launches, mergers, and acquisitions.