The in vitro diagnostics market was valued at $92.5 billion in 2022 and is estimated to reach $138.4 billion by 2032, exhibiting a CAGR of 4.1% from 2023 to 2032. In vitro diagnostics (IVDs) are tests that detect diseases, conditions, and infections. In vitro means these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself. In vitro diagnostics (IVD) includes a wide range of tools and techniques, including reagents, instruments, software, and services utilized for the examination of specimens such as blood, urine, stool, tissues, and various human body fluids. These diagnostic tools are essential for detecting diseases, conditions, and infections. IVD tests are conducted in various settings, including standalone laboratories, hospital-based facilities, and point of care centers.
In addition, in vitro diagnostic techniques encompass a broad array of methodologies, including clinical chemistry, tissue diagnostics, immunodiagnostics, hematology, and more. For instance, a thyroid function test involves the collection of blood from a patient, which is then analyzed to determine the level of thyroid-stimulating hormone (TSH) in the bloodstream. This test serves as a critical tool in assessing thyroid function. Furthermore, techniques such as polymerase chain reaction (PCR) are employed to identify the presence of infectious diseases such as HIV, hepatitis, and various others. The in vitro diagnostics market growth is significantly driven by increase in the prevalence of chronic diseases such as cardiovascular disorders, cancer, and infectious diseases, surge in awareness about importance of early disease diagnosis, and increase in new test launches, thus fueling the demand for IVD tests for early detection, monitoring, and management. For instance, according to American Cancer Society (ACS), about 1.9 million new cancer cases are expected to be diagnosed in the U.S. in 2023. Thus, rise in prevalence of chronic diseases drives the demand for in vitro diagnostic tests.
In addition, surge in awareness about early disease diagnosis among the general population has increased the demand for in vitro diagnostics. Awareness campaigns, educational seminars, and training programs emphasize the importance of early disease diagnosis. For instance, F. Hoffmann-La Roche Ltd., supports local community partners to run screening programs and counselling programs for diseases such as cancers, hepatitis, tuberculosis, HIV, HPV, and cardiovascular disease. Moreover, ongoing innovations in IVD products, service designs, and technology have prompted doctors and researchers to transition their emphasis away from conventional diagnostic approaches toward personalized medicine. This shift reflects a growing recognition of the benefits of tailoring medical treatments and interventions to individual patient needs and characteristics, which support the market growth.
However, lack of skilled laboratory technicians is anticipated to hinder the market growth during the forecast period. However, rise in the number of diagnostic testing and technological advancements in DNA sequencing are expected to create lucrative opportunities for the market growth during the forecast period.
The in vitro diagnostics market is segmented into product & services, technique, application, end user, and region. By product & services, the market is categorized into reagents & kits, instruments, and software & services.
By technique, the market is divided into immunodiagnostics, hematology, molecular diagnostics, tissue diagnostics, clinical chemistry, and others. By application, the market is classified into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and others. By end user, the market is classified into standalone laboratories, hospitals, academic and medical schools, point of care, and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
Major key players that operate in the global in vitro diagnostics market are Freenome Holdings, Inc., Invitae Corporation, Natera, Inc., Agilent Technologies, Inc., Exact Sciences Corporation, Guardant Health, Illumina, Inc., InterVenn Biosciences, NeoGenomics Laboratories, F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific, Inc. Key players operating in the market have adopted product launch, acquisition, partnership, product approval, and expansion as key strategies to expand their market share and product portfolio.
In addition, in vitro diagnostic techniques encompass a broad array of methodologies, including clinical chemistry, tissue diagnostics, immunodiagnostics, hematology, and more. For instance, a thyroid function test involves the collection of blood from a patient, which is then analyzed to determine the level of thyroid-stimulating hormone (TSH) in the bloodstream. This test serves as a critical tool in assessing thyroid function. Furthermore, techniques such as polymerase chain reaction (PCR) are employed to identify the presence of infectious diseases such as HIV, hepatitis, and various others. The in vitro diagnostics market growth is significantly driven by increase in the prevalence of chronic diseases such as cardiovascular disorders, cancer, and infectious diseases, surge in awareness about importance of early disease diagnosis, and increase in new test launches, thus fueling the demand for IVD tests for early detection, monitoring, and management. For instance, according to American Cancer Society (ACS), about 1.9 million new cancer cases are expected to be diagnosed in the U.S. in 2023. Thus, rise in prevalence of chronic diseases drives the demand for in vitro diagnostic tests.
In addition, surge in awareness about early disease diagnosis among the general population has increased the demand for in vitro diagnostics. Awareness campaigns, educational seminars, and training programs emphasize the importance of early disease diagnosis. For instance, F. Hoffmann-La Roche Ltd., supports local community partners to run screening programs and counselling programs for diseases such as cancers, hepatitis, tuberculosis, HIV, HPV, and cardiovascular disease. Moreover, ongoing innovations in IVD products, service designs, and technology have prompted doctors and researchers to transition their emphasis away from conventional diagnostic approaches toward personalized medicine. This shift reflects a growing recognition of the benefits of tailoring medical treatments and interventions to individual patient needs and characteristics, which support the market growth.
However, lack of skilled laboratory technicians is anticipated to hinder the market growth during the forecast period. However, rise in the number of diagnostic testing and technological advancements in DNA sequencing are expected to create lucrative opportunities for the market growth during the forecast period.
The in vitro diagnostics market is segmented into product & services, technique, application, end user, and region. By product & services, the market is categorized into reagents & kits, instruments, and software & services.
By technique, the market is divided into immunodiagnostics, hematology, molecular diagnostics, tissue diagnostics, clinical chemistry, and others. By application, the market is classified into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and others. By end user, the market is classified into standalone laboratories, hospitals, academic and medical schools, point of care, and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
Major key players that operate in the global in vitro diagnostics market are Freenome Holdings, Inc., Invitae Corporation, Natera, Inc., Agilent Technologies, Inc., Exact Sciences Corporation, Guardant Health, Illumina, Inc., InterVenn Biosciences, NeoGenomics Laboratories, F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific, Inc. Key players operating in the market have adopted product launch, acquisition, partnership, product approval, and expansion as key strategies to expand their market share and product portfolio.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the in vitro diagnostics market analysis from 2022 to 2032 to identify the prevailing in vitro diagnostics market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the in vitro diagnostics market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global in vitro diagnostics market trends, key players, market segments, application areas, and market growth strategies.
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Key Market Segments
By End User
- Standalone Laboratories
- Hospitals
- Academic and Medical Schools
- Point of Care
- Others
By Product and Services
- Reagents and Kits
- Instruments
- Software and Services
By Technique
- Molecular Diagnostics
- Tissue Diagnostics
- Clinical Chemistry
- Others
- Immunodiagnostics
- Hematology
By Application
- Infectious Diseases
- Cancer
- Cardiac Diseases
- Immune System Disorders
- Nephrological Diseases
- Gastrointestinal Diseases
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
- Key Market Players
- InterVenn Biosciences
- Agilent Technologies, Inc.
- Illumina, Inc.
- Thermo Fisher Scientific, Inc.
- NeoGenomics Laboratories
- Exact Sciences Corporation
- Freenome Holdings, Inc.
- Natera, Inc.
- F. Hoffmann-La Roche Ltd.
- Guardant Health
- Invitae Corporation
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Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: IN VITRO DIAGNOSTICS MARKET, BY PRODUCT AND SERVICES
CHAPTER 5: IN VITRO DIAGNOSTICS MARKET, BY TECHNIQUE
CHAPTER 6: IN VITRO DIAGNOSTICS MARKET, BY APPLICATION
CHAPTER 7: IN VITRO DIAGNOSTICS MARKET, BY END USER
CHAPTER 8: IN VITRO DIAGNOSTICS MARKET, BY REGION
CHAPTER 9: COMPETITIVE LANDSCAPE
CHAPTER 10: COMPANY PROFILES
List of Tables
List of Figures
Executive Summary
According to the report, the in vitro diagnostics market was valued at $92.5 billion in 2022, and is estimated to reach $138.4 billion by 2032, growing at a CAGR of 4.1% from 2023 to 2032.The In Vitro Diagnostics Market is likely to experience a significant growth rate of 4.1% from 2023-2032 owing to an increase in demand for in vitro diagnostic testing from the medical devices and supplies sector.
In vitro diagnostics (IVD) refers to a category of medical tests and diagnostic techniques that are performed on samples of biological materials, such as blood, urine, tissues, and other bodily fluids, outside the human body. IVD tests are designed to detect, diagnose, monitor, and manage various medical conditions, diseases, infections, and health-related parameters. They play a crucial role in clinical decision-making, allowing healthcare professionals to assess a patient's health status, make informed treatment decisions, and monitor the effectiveness of therapies.
Key factors driving the growth of the in vitro diagnostics market include the increase in prevalence of chronic and infectious diseases and rise in awareness about early disease diagnosis and personalized medicine. For instance, according to the National Center for Biotechnology Information (NCBI) in 2023, around 1,958,310 new cancer cases are estimated to occur in the U.S. Thus, increase in incidence of chronic diseases surges the need for in vitro diagnostic testing such as oncology testing, neurology testing, and immunology testing. In addition, rise in need for different technologies such as RT-PCR, flow cytometry, molecular diagnostics, mass spectrometry, and DNA sequencing for diagnosis of diseases and conducting various research activities also drives the growth of in vitro diagnostics market in the region. Furthermore, increase in healthcare expenditure and technological advancements with respect to screening of cancer are anticipated to act as growth factors for the market during the forecast period. Furthermore, the rise in prevalence of geriatric population, who are more prone to chronic disease due to aging effect and metabolic change, surges the need for in vitro diagnostics testing and boosts the market growth.
The market also offers growth opportunities to the key players in the market. Technological advancements in in vitro diagnostics enhances the diagnostic accuracy and speed and enables the practice of personalized medicine, which expand access to testing through point of care testing, telehealth, and data analytics to improve disease management. These advancements open significant opportunities for the growth of the in vitro diagnostics market. In addition, widespread adoption of point of care (POC) testing, conducted outside traditional laboratory settings, is fueled by its ability to deliver rapid results. Healthcare providers and patients may readily and effortlessly utilize these POC tests, thereby provide lucrative opportunities to market growth.
The in vitro diagnostics market is segmented into product & services, technique, application, end user, and region. On the basis of product & services, the market is categorized into reagents & kits, instruments, and software and services. By technique, the market is classified immunodiagnostics, hematology, molecular diagnostics, tissue diagnostics, clinical chemistry, and others. Depending on application, the market is classified into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and others. The infectious disease segment is further categorized into RSV, Norovirus, HIV, Hepatitis A & C, Lyme disease, COVID-19, Chlamydia, and Shigellosis. On the basis of end user, it is segregated into standalone laboratories, hospitals, academics & medical schools, point of care, and others. Region wise, it is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
The key players profiled in the study include Freenome Holdings, Inc., Invitae Corporation, Natera, Inc., Agilent Technologies, Inc., Exact Sciences Corporation, Guardant Health, Illumina, Inc., InterVenn Biosciences, NeoGenomics Laboratories, F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific, Inc. The players in the market have been actively engaged in the adoption of various strategies such as product launch, acquisition, partnership, product approval, and expansion to remain competitive and gain an advantage over the competitors in the market. For instance, in March 2021, Natera, Inc., a pioneer and global leader in cell-free DNA testing, announced that the U.S. Food and Drug Administration (FDA) granted two Breakthrough Device Designations (BDDs) covering new intended uses of the Signatera molecular residual disease (MRD) test.
Key Market Insights
By product & services, the reagents and kits segment is the largest revenue contributor to the market and is estimated to reach $80.8 billion by 2032. However, the instruments segment is anticipated to grow at the highest CAGR during the forecast period.By technique, the immunodiagnostics segment dominated the global market in 2022. However, the molecular diagnostics segment is anticipated to grow at the highest CAGR of 5.3% during the forecast period.
By application, the infectious diseases segment dominated the global market in 2022. However, the cancer segment is anticipated to grow at the highest CAGR during the forecast period.
Based on end user, the standalone laboratories segment was the largest revenue contributor to the market. However, the point of care segment is anticipated to grow at the highest CAGR of 5.1% during the forecast period.
Based on region, North America garnered the largest revenue share in 2022, whereas Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.
Companies Mentioned
- InterVenn Biosciences
- Agilent Technologies, Inc.
- Illumina, Inc.
- Thermo Fisher Scientific, Inc.
- NeoGenomics Laboratories
- Exact Sciences Corporation
- Freenome Holdings, Inc.
- Natera, Inc.
- F. Hoffmann-La Roche Ltd.
- Guardant Health
- Invitae Corporation
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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