In terms of revenue, the global in vitro diagnostics market size surpassed USD 102.05 billion in 2024 and is expected to attain around USD 132.18 billion by 2034, with a CAGR of 2.62% from 2024 to 2034. The North America in vitro diagnostics market size was estimated at USD 45.48 billion in 2023.
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Market Overview and Industry Potential
In vitro diagnostics is the transformative method in biomedical research and diagnostic laboratories. The in vitro diagnostics market revolutionized the traditional approaches with advanced tools and techniques to diagnose, treat, and cure a vast range of diseases. These diagnostic tests are performed in well-equipped scientific laboratories and are immunoassays like ELISA, RIA, CLIA, FPIA, FIA, etc. Additionally, slide agglutination tests, optical methods, dipstick methods, and point-of-care tests are performed for blood group typing, ABO blood group and Rh factor typing, ALP enzyme detection, blood screening, antibody detection, etc.
The leading industrial players such as Siemens Healthineers, Abbott, BioMerieux, Roche, Mindray, Sysmex, etc. experienced strategic market positioning through their innovations. According to the World Health Organization (WHO), above 1.2 million rapid diagnostic tests against cholera shipped to 14 countries stating the largest global deployment in April 2024. The global cholera diagnostics program was funded and coordinated by the Vaccine Alliance (Gavi), and delivery was led by UNICEF, and undertaken in collaboration with WHO and the Global Task Force on Cholera Control (GTFCC).
In Vitro Diagnostics Market Highlights:
• North America dominated the global in vitro diagnostics (IVD) market with the largest market share of 42% in 2023.
• By product, the reagents segment contributed the biggest market share of 66% in 2023.
• By application, the infectious diseases segment accounted for the biggest market share of 53% in 2023.
• By end-uses, the laboratory segment has held a major market share of 38% in 2023.
• By test location, the point-of-care segment captured the highest market share in 2023.
In Vitro Diagnostics Market Regions and Segments Revenue Analysis
Global In Vitro Diagnostics Market Revenue (USD Million), By Regions
Region | 2023 | 2024 | ||
North America | 45,485.13 | 42,856.34 | ||
Europe | 28,504.19 | 26,937.78 | ||
APAC | 25,200.01 | 24,101.53 | ||
LA | 4,953.16 | 4,709.10 | ||
MEA | 3,624.70 | 3,444.33 |
Global In Vitro Diagnostics Market Revenue (USD Million), By Product
Product | 2023 | 2024 |
Instruments | 26,909.55 | 25,379.75 |
Reagents | 70,996.28 | 67,404.76 |
Services | 9,861.36 | 9,264.58 |
Global In Vitro Diagnostics Market Revenue (USD Million), By Application
Application | 2023 | 2024 |
Infectious Diseases | 56,833.27 | 53,602.44 |
Diabetes | 8,475.36 | 7,969.48 |
Oncology | 8,323.38 | 8,055.14 |
Cardiology | 8,538.03 | 8,125.43 |
Nephrology | 6,127.88 | 5,744.71 |
Autoimmune Diseases | 4,987.83 | 4,718.45 |
Drug Testing | 3,757.30 | 3,593.52 |
Others | 10,724.14 | 10,239.92 |
Immediate Delivery Available | Buy This Premium Research Report@ https://www.precedenceresearch.com/checkout/1130Major Trends in the In Vitro Diagnostics Market
• Next-Generation Sequencing: The new technologies like next-generation sequencing are making it possible to develop rapid, sensitive, accurate, and precise in vitro diagnostic tests. The next-generation sequencing can be used to develop new tests for diagnosing and treating genetic disorders and cancer. NGS is a powerful technology to sequence the entire human genome. Illumina Inc., one of the leading biotechnology companies developed several NGS-based in vitro diagnostic tests. Illumina Inc. developed the TruSight Oncology 500 Test which is ideally used to identify genetic mutations in cancer patients. Bio-Rad Laboratories Inc., Myriad Genetics Inc., NanoString Technologies Inc., PaigeAI, etc. are small and medium-sized in vitro diagnostic companies providing innovative technologies and products.
• The Rise of Precision Medicine: Precision medicine is an innovative approach in healthcare that considers individuals’ environmental, behavioral, genetic, and lifestyle factors to diagnose, prevent, treat, or manage diseased conditions. In vitro diagnostic tests play major roles in precision medicine, enabling clinicians to predict the best treatments for individual patients.
• Point-of-Care Testing: The point-of-care tests are becoming popular and they can be performed outside the laboratories which enables clinicians and patients to access them more conveniently. These POC tests are affordable and POC in vitro diagnostics play major roles in the early detection and diagnosis of diseases. Abbott Laboratories developed several in vitro diagnostic tests which include the i-STAT handheld blood analyzer that can be used to test several diseased conditions.
Role of Artificial Intelligence in the In Vitro Diagnostics Market
Artificial intelligence has immense potential to develop new in vitro diagnostics tests and improve the performance of existing tests. Artificial intelligence is also used to develop new algorithms for data analysis. AI-powered algorithms help clinicians in better decision-making about patient care.
AI plays a prominent role in immune genetics and biomedical research. It helps to analyze the immuno-genetic data, enhance the prediction of the immune system, develop innovative algorithms for epitope discovery, etc. It also helps to optimize immunotherapy strategies and identify novel immunological targets.
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In Vitro Diagnostics Market Regional Analysis
U.S. In Vitro Diagnostics (IVD) Market
The U.S. in vitro diagnostics market size was valued at USD 34.98 billion in 2024 and is expected to achieve USD 42.63 billion by 2034, growing at a CAGR of 2% between 2024 and 2034.
North America dominated the in vitro diagnostics market in 2023 due to the rising healthcare awareness among people and the well-established healthcare system. The ease and convenience in product accessibility, and the extensive use of different healthcare products uphold the market’s reputation in this region. The rising shift of people towards personalized medicine, diabetes, genetic testing, and cancer propels the market’s growth.
The scientific innovations in superior and cost-effective medical solutions drive the market’s progress remarkably. Furthermore, technological advancements like laboratory automation boost the market’s performance. The innovations like POC CE-marked COVID-19 assays developed by BioGX on their Pixl platform and a qPCR detection system called the CFX Opus 384 Dx System and CFX Opus 96 Dx System developed by Bio-Rad Laboratories offered accurate and precise quantification in diagnostic testing which enhances the workflow efficiency.
• In October 2024, AstraZeneca announced that it will share new data across its Vaccines and Immune Therapies portfolio and showcase its efforts in the advancements of novel immunization against infectious diseases at the 13th annual ID week in Los Angeles.
• In October 2024, GlaxoSmithKline and ViiV Healthcare announced that they would share new data from their industry-leading, infectious disease portfolio including data about vaccines and medicines at the Infectious Disease Society of America’s ID week annual meeting in 2024 in Los Angeles.
Asia Pacific is anticipated to be the fastest-growing region in the in vitro diagnostics market during the forecast period due to increasing healthcare expenditure and the rising incidence of diabetes in this region. The presence of a strong customer base, rapid economic growth, and emerging need for improved healthcare solutions are the major rationales behind the growth of this market in the Asia Pacific region.
The expansion of R&D facilities and increasing investments in manufacturing are also major driving factors. The enlarging geriatric population and shift towards advanced diagnostics uplift the market. Several countries like India, Japan, Singapore, and China are prominent players in the market setting a benchmark through their efforts and innovations.
• In May 2024, Serum Institute of India made strategic investment in IntegriMedical, the first needle-free injection system (N-FIS) technology of India by acquiring a 20% stake in the company being the world’s largest vaccine manufacturer.
• In April 2024, the top 3 state-owned enterprises (SOEs) of Singapore namely DBS, Singtel, and Singapore Airlines led with 26.1% of the Singapore Exchange (SGX) market capitalization.
In Vitro Diagnostics Market Scope
Report Coverage | Details |
Market Size in 2024 | USD 102.05 Billion |
Market Size in 2025 | USD 104.01 Billion |
Market Size by 2034 | USD 128.33 Billion |
Growth Rate from 2024 to 2033 | 2.6% |
Base Year | 2023 |
Forecast Period | 2024 to 2033 |
Segments Covered | Product, Technology, Application, and Regions |
Regional Scope | North America, APAC, Europe, Latin America, MEAN, Rest of the World |
Companies Mentioned | Alere, Inc., Hoffmann-La Roche Ltd., Arkray, Beckman Coulter, Becton Disckinson, Bio-Rad laboratories, Danaher, Sysmex Corporation, Abbott Laboratories |
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In Vitro Diagnostics Market Segmentation:
Product Insights
The reagents segment dominated the in vitro diagnostics market in 2023 due to their indispensable role in in vitro diagnostic tests. The rising demand for point-of-care tests and self-care tests with increasing R&D initiatives is expected to accelerate the growth of this segment. The emerging technological advancements by the leading market players contribute to creating opportunities for this segment shortly.
The exciting innovations like the ClearLLbal 10C System launched by Beckman Coulter Inc., for clinical flow cytometry laboratory, and CE-IVD marked AltoStar Molecular Diagnostics Workflow launched by Altona Diagnostics GmbH provide useful features in healthcare. The development of flexible and automatic systems with the insertion of automation in the entire workflow accelerates the growth of this segment significantly.
Technology Insights
By technology, the molecular diagnostics segment dominated the in vitro diagnostics market due to the supportive measures by government regulatory authorities such as Sophia Genetics received CE-IVD marking for solid tumor solution that will allow the characterization and detection of altered genes skin cancer, brain cancer, lung cancer, and colorectal cancer.
The emerging demand for better diagnostic solutions for several purposes like treating autoimmune disorders, cancer, and infectious diseases accelerates the growth of this segment. The potential of multiplex immunoassays in the simultaneous detection of several analytes in a single sample allows the delivery of personalized treatments by understanding disease profiles.
The immunoassay segment is expected to be the fastest-growing in the in vitro diagnostics market over the forecast period due to the growing demand for immunoassay-based rapid testing and point-of-care testing. The popularity of point-of-care testing and the development of new immunochemical approaches propel the growth of this segment. The precise, practical, and rapid diagnostic outcomes offered by POC testing enable clinicians to give efficient clinical results. The speed, accuracy, and potential features of POC testing make the immunoassays ideal for diagnostic purposes.
Application Insights
The infectious disease segment dominated the in vitro diagnostics market due to the rising incidence of infectious diseases like hepatitis, pneumonia, HIV/AIDS, tuberculosis, etc. The emergence of deadly pathogens like malaria, diarrhea, meningitis, etc. raises the high prevalence of severe health disorders. The launch of new diagnostic methods like RT-PCR helps to diagnose these infectious diseases to save lives.
The oncology segment is anticipated to grow at the fastest rate in the in vitro diagnostics market over the forecast period due to the developments of automated in vitro diagnostics assays and the rising prevalence of cancer all over the world. Roche Diagnostics developed an automated in vitro diagnostics immunohistochemistry assay named Ventana pan-TRK (ERP17341) for the detection of tropomyosin receptor kinase proteins in cancer.
Discover Additional Market Trends with Our Related Reports:
• Immunohistochemistry Market: The global immunohistochemistry market size is expected to be valued at USD 2.72 billion in 2024 and is anticipated to reach around USD 5.10 billion by 2034, expanding at a CAGR of 28.2% over the forecast period from 2024 to 2034.
• In-vitro Diagnostics Enzymes Market: The global in-vitro diagnostics enzymes market size was valued at USD 2.20 billion in 2023 and is anticipated to reach around USD 4.10 billion by 2033, growing at a CAGR of 6.42% from 2024 to 2033.
• Cancer IVD Market: The global cancer IVD market size is expected to be worth USD 19.45 billion in 2024 and is anticipated to reach around USD 34.97 billion by 2034, growing at a solid CAGR of 6.04% over the forecast period 2024 to 2034.
• In-Vitro Toxicology Testing Market: The global in-vitro toxicology testing market size accounted for USD 11.92 billion in 2024 and is expected to be worth around USD 30.06 billion by 2033, at a CAGR of 10.82% from 2024 to 2033.
• Cancer Diagnostics Market: The global cancer diagnostics market size accounted for USD 34.21 billion in 2024 and is anticipated to reach around USD 85.13 billion by 2034, growing at a CAGR of 8.62% from 2024 to 2034.
• IVD Contract Manufacturing Market: The global IVD contract manufacturing market size accounted for USD 19.17 billion in 2024 and is expected to be worth around USD 56.94 billion by 2034, at a CAGR of 11.5% from 2024 to 2034.
• Infectious Disease Diagnostics Market: The global infectious disease diagnostics market size was USD 30.74 billion in 2023, accounted for USD 32.99 billion in 2024, and is expected to reach around USD 66.73 billion by 2034, expanding at a CAGR of 7.3% from 2024 to 2034.
• In-vitro Colorectal Cancer Screening Tests Market: The global in-vitro colorectal cancer screening tests market size is projected to be worth around USD 1,310 million by 2034 from USD 970 million in 2024, at a CAGR of 3.06% from 2024 to 2034.
Competitive Landscape and Major Breakthroughs in the In Vitro Diagnostics Market
The in vitro diagnostics market continues to evolve rapidly and showcases remarkable advancements in 2023 and 2024 with a dynamic competitive landscape. Major players such as Beckman Coulter, Becton & Dickinson, Sysmex Corporation, Bio-Rad Laboratories, Abbott Laboratories, etc. hold prominent positions in the in vitro diagnostics market. These industries are setting excellent benchmarks in front of young researchers through their outstanding R&D innovations, trustful product manufacturing, and useful service deliveries globally.
What is Going Around the Globe?
• In April 2024, Abbott achieved global sales for the first quarter of 2024 topped analyst estimates, and achieved $10 billion with a strong performance and robust product pipeline.
• In December 2024, Roche Diagnostics announced that it would continue its significant efforts in the advancements of diagnostics through collaboration, and innovations to deliver impactful and accessible diagnostics services.
The research report categorizes the In Vitro Diagnostics Market into the following segments and subsegments:
By Product
• Reagents
• Instruments
• Services
By Technology
• Immunoassay
o Instruments
o Reagents
o Services
• Hematology
o Instruments
o Reagents
o Services
• Clinical Chemistry
o Instruments
o Reagents
o Services
• Molecular Diagnostics
o Instruments
o Reagents
o Services
• Coagulation
o Instruments
o Reagents
o Services
• Microbiology
o Instruments
o Reagents
o Services
• Others
o Instruments
o Reagents
o Services
By Application
• Diabetes
• Cardiology
• Nephrology
• Infectious Disease
• Oncology
• Drug Testing
• Autoimmune Diseases
• Others
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa
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