In Vitro Diagnostics Market Size to Exceed USD 132.18 Bn by 2034
According to Precedence Research, the global in vitro diagnostics (IVD) market size is expected to exceed USD 132.07 billion by 2034, increasing from USD 104.01 billion in 2025, with a CAGR of 2.30% between 2025 and 2034. Growth is fueled by rising chronic disease prevalence, demand for early detection, and rapid adoption of advanced molecular testing technologies.
Ottawa, Aug. 12, 2025 (GLOBE NEWSWIRE) -- The worldwide in vitro diagnostics market size accounted for USD 102.05 billion in 2024, and is predicted to grow from USD 104.01 billion in 2025 to approximately USD 132.07 billion by 2034. The growing awareness about the early detection of diseases and the growing prevalence of chronic diseases drive market growth.
Note: This report is readily available for immediate delivery. We can review it with you in a meeting to ensure data reliability and quality for decision-making.
Try Before You Buy – Get the Sample Report@ https://www.precedenceresearch.com/sample/1130
In Vitro Diagnostics Industry – Strategic Insights
- In terms of revenue, the in vitro diagnostics market has been calculated at USD 104.01 billion in 2025.
- It is anticipated to reach over USD 132.07 billion by 2034.
- North America captured a 42% revenue share of the global market in 2024.
- Asia Pacific is expected to grow at a significant CAGR between 2025 and 2034.
- By product, the reagents segment held the major market share of 66.07% in 2024.
- By product, the instruments segment is expanding at a solid CAGR from 2025 to 2034.
- By test location, the point-of-care segment held a significant share in 2024.
- By test location, the home care segment is anticipated to witness considerable growth from 2025 to 2034
- By technology, the molecular diagnostics segment contributed the largest market share of 33.06% in 2024.
- By technology, the immunoassay segment is projected to grow at a considerable CAGR from 2025 to 2034.
- By application, the infectious disease segment accounted for the biggest market share of 52.53% in 2024.
- By application, the oncology segment is growing at a notable CAGR between 2025 and 2034.
- By end user, the hospital segment held the largest market share of 37.89% in 2024.
In Vitro Diagnostics Market Revenue (USD Million) By Product Type 2022-2024
| Product | 2022 | 2023 | 2024 |
| Instruments | 28,950.5 | 26,909.55 | 25,379.75 |
| Reagents | 75,883.9 | 70,996.28 | 67,404.76 |
| Services | 10,654.3 | 9,861.36 | 9,264.58 |
In Vitro Diagnostics Market Revenue (USD Million) By Technology 2022-2024
| Technology | 2022 | 2023 | 2024 |
| Immunoassay | 34,688.2 | 32,433.72 | 30,774.22 |
| Hematology | 6,827.4 | 6,345.41 | 5,984.69 |
| Clinical Chemistry | 20,236.7 | 18,978.14 | 18,061.02 |
| Molecular Diagnosis | 38,255.7 | 35,662.26 | 33,736.25 |
| Coagulation | 4,680.5 | 4,328.27 | 4,061.72 |
| Microbiology | 6,384.9 | 5,916.29 | 5,563.15 |
| Others | 4,415.3 | 4,103.12 | 3,868.03 |
In Vitro Diagnostics Market Revenue (USD Million) By Application 2022-2024
| Application | 2022 | 2023 | 2024 |
| Infectious Diseases | 61,149.9 | 56,833.27 | 53,602.44 |
| Diabetes | 9,146.6 | 8,475.36 | 7,969.48 |
| Oncology | 8,727.7 | 8,323.38 | 8,055.14 |
| Cardiology | 9,104.3 | 8,538.03 | 8,125.43 |
| Nephrology | 6,633.3 | 6,127.88 | 5,744.71 |
| Autoimmune Diseases | 5,350.6 | 4,987.83 | 4,718.45 |
| Drug Testing | 3,986.6 | 3,757.30 | 3,593.52 |
| Others | 11,389.6 | 10,724.14 | 10,239.92 |
Available for Instant Download – Order This Premium Market Study Today@ https://www.precedenceresearch.com/checkout/1130
In Vitro Diagnostics Market Overview
In vitro diagnostics (IVD) are tests conducted on samples retrieved from human bodily tissues and fluids. IVD performs on biological samples like tissue, blood, urine, and others, and tests are performed in the laboratory. Tests help to diagnose various infections, diseases, & other health issues, and monitor patient health. IVD helps in the early detection of diseases, avoids the spreading of diseases, and enhances patient care.
The common IVD tests are COVID-19, HIV tests, pregnancy tests, blood glucose monitoring, and many more. Factors like a rise in personalised medicines, increasing awareness about the early detection of diseases, growing cardiovascular diseases, and technological advancements in IVD contribute to the in vitro diagnostics market.
Top Types of IVD Technologies in 2025:
| Technology | Working Principle | Uses |
| ELISA | Capturing the antigen-antibody reaction |
|
| NGS | DNA fragmentation and parallel sequencing |
|
| CLIA | The binding antibody and the corresponding antigen Chemiluminescence reactions |
|
| PCR/RT-PCR | Amplification of DNA & RNA |
|
| Flow Cytometry | Laser-based techniques for the analysis of cells |
|
| Lateral Flow | Sample amplification and target binding |
|
➤ Get the Full Report @ https://www.precedenceresearch.com/in-vitro-diagnostics-market
In Vitro Diagnostics Market Major Trends:
-
Advanced Lateral Flow Tests (LFTs) Beyond COVID-19
Evolved LFTs are now capable of detecting a wide array of substances—from vitamin D and iron to stroke markers—using novel samples like fingerprint sweat or pet vomit. Their versatility is rapidly expanding across healthcare, environmental, and even animal diagnostics.
-
Integrated Point-of-Care and At-Home Nutritional Diagnostics
Innovations like smartphone-compatible devices (e.g., Cornell’s NutriPhone) can measure iron, vitamin A, D, and B12 from just a finger-prick in minutes—indicating a shift toward compact, multipurpose diagnostics useful in both clinics and homes.
-
Artificial Intelligence–Enhanced Digital Nucleic Acid Amplification (dNAAT)
Cutting-edge techniques such as digital PCR (dPCR) and digital LAMP (dLAMP), combined with AI-powered image analysis, are enhancing diagnostic precision and sensitivity. These advancements pave the way for scalable, faster, and more accurate molecular testing, even at the point of care.
In Vitro Diagnostics Market Opportunity
What is the Opportunity for the In Vitro Diagnostics Market?
The growing prevalence of chronic diseases like cancer, diabetes, and cardiovascular diseases increases demand for in vitro diagnostics for early detection of diseases. The increasing patient demand for early detection of chronic diseases increases demand for IVD tests. The increasing demand for tracking the progression of chronic diseases increases the adoption of IVD for managing disease effectively and adjusting treatment plans. The increasing development of personalised treatment requires IVD technologies.
The availability of point-of-care testing increases adoption of IVD for efficient management of chronic conditions. The increasing awareness of early disease detection and the increasing demand for regular health check-ups increase the adoption of IVD. The growing prevalence of chronic diseases creates an opportunity for the growth of the in vitro diagnostics market.
In Vitro Diagnostics Market Challenges and Limitations and Challenges:
Why High Development Cost Limitation for the In Vitro Diagnostics Market?
Despite several benefits of in vitro diagnostics in various disease diagnoses, the high development cost restricts the market growth. Factors like the need for extensive clinical validation, the complex nature of IVD platforms, stricter regulation, high investment in R&D, and intensive clinical trials are responsible for high development costs. The need for high investment in personnel, equipment, and reagents directly affects the market.
The complexity of IVD technologies and lengthy development cycles increases the production costs. The stricter regulations for the development of IVD tests require a high cost. The need for extensive compliance, documentation, and quality assurance requires a high cost. The requirement of specialized materials and precision manufacturing increases the production cost. The high development cost hampers the growth of the in vitro diagnostics market.
Scope of the In Vitro Diagnostics Market
| Report Attributes | Key Statistics |
| Market Size in 2025 | USD 104.10 Billion |
| Market Size in 2030 | USD 117.18 Billion |
| Market Size in 2032 | USD 124.66 Billion |
| Market Size by 2034 | USD 132.07 Billion |
| Growth Rate 2025-2034 | CAGR of 2.30% |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| Historical Data | 2021 to 2023 |
| Largest Regional Market (2024) | North America – 42% revenue share |
| Fastest Growing Regional Market | Asia Pacific |
| Segments Covered | Product, Technology, Application and Regions |
| Regions Covered | North America, APAC, Europe, Latin America, MEAN, Rest of the World |
| Key Players Covered | Alere, Inc., Hoffmann-La Roche Ltd., Arkray,Beckman Coulter, Becton Disckinson, Bio-Rad laboratories, Danaher, Sysmex Corporation, Abbott Laboratories and other |
➡️ Become a valued research partner with us ☎ https://www.precedenceresearch.com/schedule-meeting
How Big is the U.S. In Vitro Diagnostics (IVD) Market?
According to Precedence Research, the U.S. in vitro diagnostics (IVD) market size was evaluated at USD 34.98 billion in 2024 and is expected to rise from USD 35.43 billion in 2025 to approximately USD 42.55 billion by 2034, at a CAGR of 2.20% from 2025 to 2034.
The Complete Study is Immediately Accessible | Download the Sample Pages of this Report@ https://www.precedenceresearch.com/sample/3712
U.S. In Vitro Diagnostics Market Key Takeaways
- The U.S. in vitro diagnostics market reached USD 34.98 billion in 2024.
- It is projected to hit around USD 42.63 billion by 2034.
- The market is growing at a CAGR of 2% from 2025 to 2034.
- By product, the reagents segment held the highest share of 67% in 2024.
- By test location, the point-of-care segment dominated the market in 2024.
- By technology, the Immunoassay segment is expected to grow at a significant CAGR from 2025 to 2034.
- By application, the infectious diseases segment dominated the market with the biggest market share in 2024.
- By application, the oncology segment is expected to witness the fastest CAGR of growth during the forecast period of 2025-2034.
- By end user, the hospital segment held the dominating share of the market in 2024.
U.S. In Vitro Diagnostics Market Leading Companies
- Alere, Inc.
- Beckman Coulter
- BD
- Bio-Rad laboratories
- Danaher
- Abbott Laboratories
- Thermo Fisher Scientific Inc.
- bioMérieux, Inc
- Quest Diagnostics
- Illumina, Inc.
Get Immediate Access – Secure Your Copy of This Premium Research Report@ https://www.precedenceresearch.com/checkout/3712
Which Region Dominated the In Vitro Diagnostics Market?
North America dominated the in vitro diagnostics market in 2024. The well-established healthcare infrastructure, like research centers, modern clinical laboratories, and hospitals, increases the adoption of IVD. The ongoing technological innovations like digital health integration, high-throughput systems, and lab-on-a-chip equipment in IVD help the market growth. The increasing prevalence of infectious and chronic diseases increases the adoption of IVD. The increasing healthcare spending and focus on personalised medicine increase the adoption of IVD. The presence of major players like BD, Abbott, and Thermo Fisher Scientific drives the market growth.
Why Asia Pacific Experiencing the Fastest Growth in the In Vitro Diagnostics Market?
Asia Pacific is experiencing the fastest growth in the market during the forecast period. The growing prevalence of chronic diseases like cancer, diabetes, and cardiovascular diseases increases the adoption of IVD. The growing government investment in healthcare infrastructure and increasing spending on diagnostics increases demand for IVD, helping the market growth. The increasing awareness about the early detection of diseases and the growing expansion of healthcare facilities like clinics & hospitals increases adoption of IVD, supporting the overall growth of the market.
“The integration of AI with molecular diagnostics will reshape IVD workflows over the next decade, improving test turnaround times and accuracy, particularly in decentralized settings,” said Deepa Pandey, Principal Consultant at Precedence Research.
In Vitro Diagnostics Market Segmentation Analysis:
Product Analysis:
Why did Reagent Segment Dominate the In Vitro Diagnostics Market?
The reagent segment dominated the in vitro diagnostics market in 2024. The compatibility of reagents with various diagnostics platforms, like point-of-care, clinical laboratories, and hospitals, helps the market growth. The growth in personalised medicine increases the adoption of reagents. The growth in diagnostics like oncology, infectious diseases, and chronic diseases increases the adoption of reagents. The growing utilization of molecular diagnostic techniques increases demand for reagents, driving the overall growth of the market.
The instruments segment is the fastest-growing in the market during the forecast period. The growing prevalence of chronic diseases like cardiovascular conditions, diabetes, and cancer increases demand for instruments for early detection. The increasing focus on early detection of diseases and timely treatment increases demand for instruments. The ongoing innovations in diagnostic technologies and the expansion of point-of-care testing support the market growth.
Technology Analysis:
How Immunoassay Segment Held the Largest Share in the In Vitro Diagnostics Market?
The immunoassay segment held the largest revenue share in the in vitro diagnostics market in 2024. The increasing detection of various analytes like proteins, drugs, hormones, and antibodies increases the adoption of immunoassays. The increasing demand for ELISA and CLIA immunoassays helps the market growth. The increasing demand for POC testing and the increasing availability of central labs increase the adoption of immunoassays. The increasing risks of infectious diseases and chronic diseases increase demand for immunoassay-based diagnosis, driving the overall market growth.
The molecular diagnostics segment is experiencing the fastest growth in the market during the forecast period. The growing utilization of techniques like next-generation sequencing & PCR for early disease diagnosis helps the market growth. The increased spread of infectious diseases increases the adoption of molecular diagnostics to control the spread of disease. The increasing development of personalised medicine and growth in at-home testing & point-of-care fuels demand for molecular diagnostics, supporting the overall market growth.
Application Analysis:
Which Application Segment Dominated the In Vitro Diagnostics Market?
The oncology segment dominated the in vitro diagnostics market in 2024. The increasing prevalence of cancer increases demand for IVD for accurate diagnosis and early detection of conditions. The ongoing advancements in molecular diagnostics, like liquid biopsies and next-generation sequencing, help in the market growth. The increasing demand for early detection of cancer and the growth in the development of personalised medicines increases the demand for IVD. The increasing demand for IVD tests for various cancers like lung, prostate cancers, breast cancers, and colorectal drives the market growth.
The infectious disease segment is the fastest-growing in the market during the forecast period. The growth in infectious diseases like viral outbreaks, respiratory infections, and STDs increases demand for IVD. The increasing awareness about the early detection of infectious diseases and focus on reducing transmission increases the adoption of IVD. The increasing prevalence of hepatitis, HIV, and tuberculosis increases demand for IVD, supporting the overall market growth.
Test Location Analysis:
How Point of Care Segment Held the Largest Share in the In Vitro Diagnostics Market?
The point of care segment held the largest revenue share in the in vitro diagnostics market in 2024. The increasing demand for faster test results and focus on reducing turnaround times increases the adoption of point of care. The increasing need for IVD tests in underserved and remote areas increases the adoption of IVD. The focus on the management of chronic conditions like cardiovascular diseases and diabetes increases demand for POC. The increasing suitability of POC in various settings like doctors' offices, hospitals, and clinics drives the market growth.
The home care segment is experiencing the fastest growth in the market during the forecast period. The growing patients' preference for testing at home and the growing expansion of home-based testing help the market growth. The increasing development of automated, user-friendly, and portable IVD devices increases adoption of care. The increasing management of chronic conditions like cardiovascular diseases & diabetes increases demand for home care, supporting the overall growth of the market.
End User Analysis:
Why did the Hospital Segment Dominate the In Vitro Diagnostics Market?
The hospitals segment dominated the in vitro diagnostics market in 2024. The high availability of a wide range of diagnostic tests and the increasing number of patients increase the adoption of hospitals. The growing demand for accurate and early diagnosis of diseases increases the demand for hospitals. The availability of advanced technologies like molecular diagnostic tools, automated analyzers, and others helps the market growth. The presence of trained personnel, well-established infrastructure, and high-quality equipment in hospitals drives the market growth.
Related Topics You May Find Useful:
➢ In-Vitro Inflammatory Bowel Disease Diagnostics Market: Uncover how biomarker innovations are transforming early IBD detection
➢ Infectious Disease In-Vitro Diagnostics Market: Explore rising demand for rapid pathogen testing and accuracy-driven diagnostics
➢ In-Vitro Diagnostics Enzymes Market: See how enzyme-based assays are becoming indispensable in chronic disease detection
➢ Diagnostic Testing Market: Track how expanding cardiology testing and hospital-led diagnostics are reshaping global healthcare
➢ Next-Generation IVD Market: Dive into how AI, genomics, and precision medicine are redefining diagnostic frontiers
➢ Cancer IVD Market: Analyze how early cancer detection and immunoassays are fueling a surge in diagnostic innovation
➢ Cancer Diagnostics Market: Discover how hospital-led screening and consumables-led solutions are doubling market size by 2034
➢ DNA Diagnostics Market: Explore how PCR tech and oncology testing are powering DNA testing’s rapid growth
➢ IVD Contract Manufacturing Market: Understand how outsourcing efficiencies and consumable demand are driving diagnostic scale-up
➢ In-Vitro Colorectal Cancer Screening Tests Market: Track rising demand for non-invasive CRC screening and lab-based diagnostics
In Vitro Diagnostics Market Top Companies
- Alere, Inc.
- Hoffmann-La Roche Ltd.
- Arkray
- Beckman Coulter
- Becton Dickinson
- Bio-Rad Laboratories
- Danaher
- Sysmex Corporation
- Abbott Laboratories
Recent Developments:
- In August 2024, InBios launched an in vitro diagnostic test, a serological ELISA kit for strongyloidiasis. The kit provides results under 75 minutes and is intended for use only in patients with symptoms, clinical history, and signs. (Source: https://www.prweb.com)
- In June 2023, GenWorks Health launched IVD tests for malaria & dengue. The test kits include iScreen Dengue NS1 and iScreen Malaria Card Antigen. The IVD products aim to diagnose, treat, prevent, and cure seasonal diseases. (Source: https://www.biospectrumindia.com)
- In September 2023, NeoDx Biotech launched an IVD kit, the HLA-B27 RT-PCR kit for detecting autoimmune disorders. The kits help to analyze disorders like psoriasis, reactive arthritis, ankylosing spondylitis, and inflammatory bowel syndrome. (Source: https://www.biospectrumindia.com)
Case Study: AI-Powered Molecular Diagnostics at Sunrise Labs Boosts Cancer Detection Rates
Sunrise Labs, a leading diagnostic center network in Southeast Asia, faced challenges in delivering early, accurate cancer diagnoses to patients in semi-urban and rural areas. Traditional lab workflows required samples to be shipped to centralized facilities, causing delays of 3–5 days before results reached clinicians.
Solution Implemented:
In 2023, Sunrise Labs partnered with a global IVD leader to deploy a portable, AI-enhanced molecular diagnostics platform capable of running PCR-based oncology tests on-site. The system integrated with the lab’s electronic health record (EHR) system, enabling seamless data transfer and analysis.
Key Innovations:
- Point-of-Care Molecular Testing: Allowed oncologists to receive results within 90 minutes.
- AI-Driven Image Analysis: Improved detection accuracy for early-stage cancers by 18% compared to conventional lab workflows.
-
Custom Reagent Kits: Designed for tropical climates to maintain stability without cold-chain dependency.
Results Achieved:
- Turnaround Time Reduced: From 3–5 days to under 2 hours.
- Screening Uptake Increased: 35% more patients underwent cancer screening in the first year.
- Cost Efficiency: Operational costs dropped by 22% due to reduced logistics and sample handling.
- Patient Outcomes: Early detection rates for breast and cervical cancer improved, enabling earlier treatment interventions.
Industry Implication:
This case underscores how integrating AI with IVD molecular diagnostics can dramatically improve accessibility and patient outcomes in emerging markets, aligning with broader industry trends toward decentralization and personalized medicine. It also highlights the commercial potential for IVD players to target underserved regions with tailored product designs.
In Vitro Diagnostics Market Segments Covered in the Report
By Product
- Reagents
- Instruments
- Services
By Test Location
- Point of Care
- Home Care
- Others
By Technology
- Immunoassay
- Instruments
- Reagents
- Services
- Hematology
- Instruments
- Reagents
- Services
- Clinical Chemistry
- Instruments
- Reagents
- Services
- Molecular Diagnostics
- Instruments
- Reagents
- Services
- Coagulation
- Instruments
- Reagents
- Services
- Microbiology
- Instruments
- Reagents
- Services
- Others
- Instruments
- Reagents
- Services
By Application
- Diabetes
- Cardiology
- Nephrology
- Infectious Disease
- Oncology
- Drug Testing
- Autoimmune Diseases
- Others
By End User
- Hospitals
- Standalone Laboratories
- Academic & Medical Schools
- Point-of-Care
- Others
By Region
- North America
- U.S.
- Canada
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
- Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
- Latin America
- Brazil
- Mexico
- Argentina
- Middle East & Africa
- South Africa
- UAE
- Saudi Arabia
- Kuwait
Thank you for reading. You can also get individual chapter-wise sections or region-wise report versions, such as North America, Europe, or Asia Pacific.
Immediate Delivery Available | Buy This Premium Research Report@ https://www.precedenceresearch.com/checkout/1130
You can place an order or ask any questions, please feel free to contact at sales@precedenceresearch.com | +1 804 441 9344
Stay Ahead with Precedence Research Subscriptions
Unlock exclusive access to powerful market intelligence, real-time data, and forward-looking insights, tailored to your business. From trend tracking to competitive analysis, our subscription plans keep you informed, agile, and ahead of the curve.
Browse Our Subscription Plans@ https://www.precedenceresearch.com/get-a-subscription
About Us
Precedence Research is a worldwide market research and consulting organization. We give an unmatched nature of offering to our customers present all around the globe across industry verticals. Precedence Research has expertise in giving deep-dive market insight along with market intelligence to our customers spread crosswise over various undertakings. We are obliged to serve our different client base present over the enterprises of medicinal services, healthcare, innovation, next-gen technologies, semi-conductors, chemicals, automotive, and aerospace & defense, among different ventures present globally.
Web: https://www.precedenceresearch.com
Our Trusted Data Partners:
Towards Healthcare | Towards Packaging | Towards Automotive | Towards Chem and Materials | Towards FnB | Towards Consumer Goods | Statifacts | Towards EV Solutions | Towards Dental | Nova One Advisor | Market Stats Insight
Get Recent News:
https://www.precedenceresearch.com/news
For the Latest Update Follow Us:
LinkedIn | Medium | Facebook | Twitter
✚ Explore More Market Intelligence from Precedence Research:
➡️ In-Vitro Fertilization Market: Explore how technological advances and rising infertility treatments are driving global IVF demand
➡️ Artificial Intelligence Diagnostics Market: See how AI-powered tools are revolutionizing accuracy and speed in clinical diagnostics
➡️ Non-Invasive Cancer Diagnostics Market: Discover how liquid biopsies and imaging innovations are reshaping cancer detection
➡️ Home Diagnostics Market: Track how convenience and digital health integration are fueling at-home testing adoption
➡️ Point-of-Care Diagnostics Market: Understand how rapid testing solutions are transforming care delivery in clinics and beyond
➡️ Infectious Respiratory Disease Diagnostics Market: Analyze demand shifts driven by pandemic preparedness and respiratory health awareness
➡️ Breast Cancer Diagnostics Market: Learn how imaging, biopsy, and AI tools are advancing early breast cancer detection
➡️ Point-of-Care Molecular Diagnostics Market: Explore how portable PCR and molecular tools are enhancing real-time diagnosis
➡️ Rapid Diagnostics Market: See how speed, accuracy, and accessibility are redefining modern diagnostics
➡️ Next-Generation Cancer Diagnostics Market: Discover how genomic profiling and precision oncology are shaping next-gen cancer testing
➡️ Tissue Diagnostics Market: Understand how histopathology innovations are improving disease characterization
➡️ Blood Transfusion Diagnostics Market: Track advances in screening technologies ensuring safer transfusion practices
➡️ Infectious Disease Diagnostics Market: Explore how rising disease outbreaks are accelerating global diagnostic capabilities
➡️ Point-of-Care Infectious Disease Diagnostics Market: See how rapid and mobile solutions are revolutionizing infectious disease management
➡️ DNA Diagnostics Market: Learn how genetic testing is unlocking new frontiers in personalized medicine
➡️ Infectious Disease In-Vitro Diagnostics Market: Discover how innovation in IVD is boosting accuracy in pathogen detection
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
