In Vitro Diagnostics Market Size

Global In Vitro Diagnostics Market:

The global in vitro diagnostics market size reached USD 116.7 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 181.5 Billion by 2033, exhibiting a growth rate (CAGR) of 5% during 2025-2033. The rising prevalence of infectious diseases globally, the continuous technological advancements, the shifting consumer preferences towards personalized medicine, and the increasing geriatric population are among the primary factors driving the market growth.

Global In Vitro Diagnostics Market Analysis:

• Major Market Drivers: The extensive utilization of IVD tests for early diagnosis, disease screening, treatment selection, and monitoring therapy progress is mainly augmenting the market growth. Moreover, the escalating demand for these procedures across several medical specialties, including microbiology, clinical chemistry, hematology, molecular diagnostics, immunology, etc., is catalyzing the global market.
• Key Market Trends: The increasing cases of chronic illnesses and the growing geriatric population are bolstering the market for IVD, globally. Besides this, the elevating incidences of diabetes, cancer, and cardiovascular disorders, owing to lifestyle changes and hectic schedules of individuals, are further influencing the market outlook.
• Competitive Landscape: Some of the major in vitro diagnostics market companies comprise of Abbott Laboratories, Agilent Technologies Inc., Biomerieux SA, Bio-Rad Laboratories Inc., F. Hoffmann-La Roche Ltd, Fujifilm Holdings Corporation, Illumina Inc., Qiagen N.V, Quest Diagnostics, Shimadzu Corporation, Siemens Healthcare GmbH, and Sysmex Corporation among others.
• Geographical Trends: North America dominated the market, owing to its well-developed and advanced healthcare infrastructures, such as modern clinical laboratories, hospitals, and research institutions. Furthermore, the robust medical care system and the continuous technological advancements in the IVD industry are catalyzing the expansion of the market. Besides this, the inflating investments by the major companies and institutions in research and development activities for introducing innovative diagnostic techniques are positively influencing the market growth in this region.
• Challenges and Opportunities: One of the major challenges hampering the in vitro diagnostics market growth includes obtaining reimbursement for IVD tests, on account of the changing healthcare policies and the increasing need for demonstrating cost-effectiveness and clinical utility. However, the ongoing technological innovations, including point-of-care testing, lab-on-a-chip, and artificial intelligence (AI), are opening up new possibilities for faster, more accurate, and less invasive diagnostics, which presents substantial opportunities for market expansion in the future.
   

In Vitro Diagnostics Market Trends:

Continuous Technological Advancements

The growing popularity of advanced technologies, including molecular diagnostics, next-generation sequencing, and microfluidics, have enabled more accurate and sensitive testing methods, which is augmenting the in vitro diagnostics market statistics. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.  Additionally, the emerging trend of automation for streamlining diagnostic processes, reducing human errors, and improving efficiency is expected to further support market growth in the near future. For example, Siemens Healthineers introduced the Atellica Solution, a fully automated clinical chemistry and immunoassay system. The system offers high throughput, a broad assay menu, and enhanced efficiency for clinical laboratories. Moreover, in June 2023, Toray Industries, Inc. received marketing approval from the Japan’s Ministry of Health, Labor and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. Also, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S.

Rising Prevalence of Chronic Diseases

The rising prevalence of chronic illnesses, such as diabetes, cardiovascular disorders, and cancer is catalyzing the in vitro diagnostics market recent opportunities. Besides this, the elevating requirement for in vitro diagnostics in the early detection, monitoring, and management of severe diseases is propelling the growth of the market forward. For instance, according to the International Diabetes Federation Diabetes Atlas Tenth edition, a total of 537 million individuals (20-79 years old) worldwide has diabetes. By 2030, there will be around 643 million diabetics globally, and by 2045, the number is expected to reach 783 million individuals. Moreover, the extensive utilization of IVD tests by healthcare professionals for making informed decisions in treatment, as they facilitate early screening and identification of risk factors, allowing timely preventive measures, is positively influencing the market. For example, Abbott Laboratories launched the Panbio COVID-19 Ag Rapid Test Device, a rapid antigen test for COVID-19. The test delivered the results within 15 minutes and was widely used for screening and surveillance purposes during the pandemic. Furthermore, Roche Diagnostics (Switzerland) launched the Cobas pulse system, a blood glucose management solution with mobile digital health capabilities to improve patient care. Also, Roche received the Food and Drug Administration (FDA) approval for VENTANA MMR RxDx Panel to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy. Moreover, in December 2023, ARUP Laboratories and Medicover collaborated to provide diagnostic and healthcare services in Europe. ARUP Laboratories introduced AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe hemophilia A patients.

Increasing Emphasis on Personalized Medicine

The rising focus on personalized medicine, which aims to tailor medical treatment to individual patients based on their genetic makeup, lifestyle, and other factors, is propelling the in vitro diagnostics market demand significantly. In line with this, IVD tests, such as genetic testing and companion diagnostics, provide critical insights into the unique characteristics of patients, enabling targeted therapies and avoiding unnecessary treatments or adverse reactions, which is also augmenting the market dynamics. Moreover, precision diagnostics, enabled by advanced technologies, such as Next-Generation Sequencing (NGS) and companion diagnostics, facilitate the identification of specific disease subtypes and molecular targets. For instance, in August 2023, the Precision Medicine Centre (PMC) formed a partnership with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for the diagnosis of cancer in Northern Ireland. Additionally, in October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that aid scountries in making decisions regarding diagnostic tools. It provides evidence-based recommendations and ensures the accessibility of essential products for target people. Furthermore, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa.

Global In Vitro Diagnostics Market Segmentation

IMARC Group provides an analysis of the key trends in each segment of the global in vitro diagnostics market report, along with forecasts at the global, regional, and country levels from 2025-2033. Our report has categorized the market based on test type, product, usability, application, and end user.

Breakup by Test Type:

• Clinical Chemistry
• Molecular Diagnostics
• Immunodiagnostics
• Hematology
• Others
   

Molecular diagnostics represents the most popular test type

The report has provided a detailed breakup and analysis of the market based on the test type. This includes clinical chemistry, molecular diagnostics, immunodiagnostics, hematology, and others. According to the report, molecular diagnostics represented the largest share in the in vitro diagnostics market recent price.

Molecular diagnostics assist in achieving higher levels of accuracy and sensitivity in disease detection. They can identify even low concentrations of target molecules, enabling early diagnosis and precise monitoring of illnesses. This level of sensitivity is particularly crucial in the detection of infectious diseases, genetic disorders, and certain types of cancer, where early intervention is vital for successful treatment. Moreover, molecular diagnostics plays a key role in the advancement of personalized medicine. For instance, Medix Biochemica acquired 100% shares of myPOLS Biotec GmbH. By acquiring myPOLS Biotec, Medix Biochemica added to its portfolio of IVD raw materials and increased its selection of reagents for molecular diagnostics. This acquisition expanded the company's global presence and offered customers more advanced scientific and technological capabilities in molecular diagnostics.

Breakup by Product:

• Reagents and Kits
• Instruments
   

Reagents and Kits hold the largest share in the industry

The report has provided a detailed breakup and analysis of the market based on the product. This includes reagents and kits and instruments. According to the report, reagents and kits accounted for the largest share in the in vitro diagnostics market forecast.

Reagents and kits are fundamental components of diagnostic tests. They incorporate the necessary substances and chemicals required to perform specific assays and analyze patient samples. Diagnostic laboratories and healthcare facilities rely heavily on reagents and kits to conduct various tests, such as routine screenings and complex molecular diagnostics. Moreover, reagents and kits are designed to be user-friendly and standardized, ensuring consistent and reliable results across several laboratories and testing sites, which is bolstering the in vitro diagnostics market revenue. They simplify the testing process, minimizing the need for extensive manual preparation and minimizing the risk of errors. For example, Bio-Rad Laboratories Inc.'s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit was granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems. Moreover, Roche Ltd. launched the Elecsys Anti-SARS-CoV-2 S antibody test, which measures the level of antibodies against the spike protein of the SARS-CoV-2 virus. The test aids in assessing a person's immune response after COVID-19 vaccination or infection.

Breakup by Usability:

• Disposable IVD Devices
• Reusable IVD Devices
   

The report has provided a detailed breakup and analysis of the market based on the usability. This includes disposable IVD devices and reusable IVD devices.

Disposable IVD devices are created for single-use and are discarded after a single patient interaction or testing procedure. They are pre-sterilized and are available in a ready-to-use format, which eliminates the need for cleaning, disinfection, or reprocessing after each use. Healthcare providers find disposable IVD devices convenient and timesaving, as they eliminate the requirement for complex and time-consuming reprocessing procedures. On the other hand, reusable IVD devices can be utilized at various times after appropriate cleaning, sterilization, and maintenance. They are made of durable materials that can withstand repeated use without compromising their performance. Moreover, reusable IVD devices also offer greater flexibility in terms of test customization and parameter adjustments, making them suitable for research and specialized testing needs.

Breakup by Application:

• Infectious Disease
• Diabetes
• Cancer/Oncology
• Cardiology
• Autoimmune Disease
• Nephrology
• Others
   

Infectious diseases currently dominate the market

The report has provided a detailed breakup and analysis of the market based on the application. This includes infectious disease, diabetes, cancer/oncology, cardiology, autoimmune disease, nephrology, and others. According to the report, infectious diseases accounted for the largest share in the in vitro diagnostics market outlook.

Infectious diseases pose significant global health challenges and outbreaks which can have severe consequences on public health and economies. Besides this, these illnesses have a high incidence and prevalence rate, affecting millions of people globally. Common infectious diseases, such as tuberculosis, influenza, hepatitis, etc., continue to impact communities across the globe. As a result, in vitro diagnostics offer a rapid and convenient way to identify infectious agents, allowing healthcare providers to initiate appropriate therapies, implement infection control measures, and prevent further transmission. For instance, in February 2023, BD received EUA from the U.S. FDA for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV).

Breakup by End User:

• Hospitals Laboratories
• Clinical Laboratories
• Point-of-care Testing Centers
• Academic Institutes
• Patients
• Others
   

A detailed breakup and analysis of the market based on the end user has also been provided in the report. This includes hospitals laboratories, clinical laboratories, point-of-care testing centers, academic institutes, patients, and others.

Hospital laboratories represent an essential part of healthcare facilities, providing diagnostic testing services to inpatients and outpatients. They are equipped with several IVD instruments and reagents to perform various tests, including clinical chemistry, hematology, microbiology, and immunology. Hospitals depend highly on timely and accurate diagnostic results from their in-house laboratories to aid in patient diagnosis, treatment, and disease management. Besides this, clinical laboratories are separate entities that offer diagnostic testing services to healthcare providers, hospitals, clinics, and other medical settings. They handle high-volume and specialized tests that may not be available in all hospital laboratories. For instance, in February 2023, Unilabs announced investing over US$ 200 Million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure. Moreover, point-of-care testing (POCT) centers refer to a rapidly growing segment in the IVD market. They provide diagnostic tests at or near the location where patient care is delivered. Point-of-care testing centers are especially valuable in emergency rooms, ambulances, nursing homes, and remote or resource-limited settings where quick diagnosis is critical. Additionally, academic institutes, including research universities and medical schools, contribute to the market growth through research, development, and education. They play a pivotal role in advancing diagnostic technologies, discovering new biomarkers, and evaluating the effectiveness of diagnostic tests. Furthermore, patients are increasingly involved in their healthcare decisions, including diagnostic testing.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America leads the market, accounting for the largest in vitro diagnostics market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America represents the largest region according to the in vitro diagnostics market overview, owing to its well-developed and advanced healthcare infrastructure, such as modern clinical laboratories, hospitals, and research institutions. Furthermore, the robust medical care system and the continuous technological advancements in the IVD industry are catalyzing the expansion of the market. Besides this, the inflating investments by the major companies and institutions in research and development efforts for introducing innovative diagnostic techniques are positively influencing the market growth in this region. For instance, according to the Centers for Disease Control and Prevention, chronic diseases are the leading cause of death and disability every year in the United States. Moreover, Bio-Rad Laboratories Inc.'s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit was granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems.

Competitive Landscape:

The competitive landscape of the In vitro diagnostics (IVD) market is characterized by a diverse and highly competitive environment, with numerous companies vying for market share. They are developing advanced technologies, novel biomarkers, and point-of-care testing devices to meet the evolving needs of the healthcare industry. They are engaging in mergers and acquisitions (M&As) to expand their product portfolios, gain access to new markets, and enhance their technological capabilities. They are also expanding their market presence by establishing distribution networks in new regions or countries. Moreover, companies are embracing digitalization and investing in digital diagnostic solutions. This includes the development of digital pathology, remote monitoring, and telehealth solutions to enhance diagnostic efficiency and accessibility.

The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided. Some of the major market players in the In Vitro Diagnostics Industry include:

• Abbott Laboratories
• Agilent Technologies Inc.
• Biomerieux SA
• Bio-Rad Laboratories Inc.
• F. Hoffmann-La Roche Ltd
• Fujifilm Holdings Corporation
• Illumina Inc.
• Qiagen N.V
• Quest Diagnostics
• Shimadzu Corporation
• Siemens Healthcare GmbH
• Sysmex Corporation
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

In Vitro Diagnostics Market Recent Developments:

• April 2024: WHO announced ‘The Week of Quality for IVDs 2024’ with the theme of Optimizing IVD Product Development: Principles of Design, Quality and Compliance. It is specifically designed to equip manufacturers and regulatory authorities in low- and middle-income countries (LMICs) with the essential knowledge and guidance needed to promote strategies for product design, development, and production of IVDs.
• April 2024: The European Parliament adopts Measures for Better In Vitro Diagnostics as proposed by the European Commission in January 2024. These measures include granting more time to companies to transition to the new EU rules on IVDs, introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices and allowing for the gradual roll-out of the European Database on Medical Devices - Eudamed.
• April 2024: Revvity's EUROIMMUN business, one of the providers of in-vitro diagnostic products, and ALPCO-GeneProof, a company dealing in molecular diagnostics, jointly announced a strategic partnership to enhance the availability of GeneProof PCR kits throughout the European Union.

In vitro diagnostics Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the in vitro diagnostics market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global in vitro diagnostics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the in vitro diagnostics industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.