U.S. In-Vitro Diagnostics Market by Type (Reagents, Instruments, and Software & Services), by Technique (Immunodiagnostics, Hematology, Molecular Diagnostics, Tissue Diagnostics, Clinical Chemistry, and Other IVD Techniques), by Application (Infectious Diseases, Cancer, Cardiac Diseases, Immune System Disorders, Nephrological Diseases, Gastrointestinal Diseases, and Others), and by End User (Stand Alone, Laboratory, Hospitals, Academics and Medical Schools, Point of Care Testing, and Other End Users) – Opportunity Analysis and Industry Forecast, 2024–2030
Industry: Healthcare | Publish Date: 06-Jul-2024 | No of Pages: 139 | No. of Tables: 104 | No. of Figures: 69 | Format: PDF | Report Code : HC2347
U.S. In-Vitro Diagnostics Market Overview
The U.S. In-Vitro Diagnostics Market size was valued at USD 25.54 billion in 2023, and is predicted to reach USD 32 billion by 2030, at a CAGR of 2.9% from 2024 to 2030. In-vitro diagnostics (IVD) refers to a wide range of medical tests conducted on samples of bodily fluids, tissues, or cells outside of the body to diagnose diseases, monitor therapy, and assess overall health conditions. These tests are performed in laboratory settings using various techniques and technologies, including immunoassays, molecular diagnostics, clinical chemistry, hematology, and microbiology.
IVD tests enable early detection of diseases, allowing for timely intervention and treatment initiation. By providing rapid and accurate results, IVD tests facilitate personalized medicine, guiding tailored treatment approaches based on individual patient characteristics. Also, immunoassay experiments provide valuable insights into biological systems, enabling scientists and researchers to make significant contributions to fields such as medicine, biotechnology, and pharmacology. They serve as essential tools for understanding fundamental biological processes and developing innovative solutions to address health challenges.
Rising Chronic Disease Prevalence Drives the U.S. In-Vitro Diagnostics Market Growth
The prevalence of chronic diseases serves as a significant growth driver for the in-vitro diagnostics market in the U.S. Chronic conditions such as diabetes, cardiovascular diseases, and cancer are increasingly common among the population, leading to a heightened demand for diagnostic tests.
Early detection and ongoing monitoring of these diseases are crucial for effective management and treatment. The National association of Chronic Disease Directors reported that cardiovascular diseases accounts for one out of every three deaths in the U.S., totalling 859,000 deaths every year. In response to this, the demand for IVD is rising, facilitating diagnosis, monitoring, and management of chronic diseases in this country.
Presence of Leading Companies Drive the Expansion of the Market
The presence of prominent companies including Bio-Rad Laboratories Inc, Becton, Dickinson and Company, Abbott Laboratories, Quest Diagnostics, and others are involved in innovation, R&D activities, and collaborations which in turn foster the U.S. in-vitro diagnostics market growth.
For instance, in January 2023, Bio-Rad Laboratories Inc recently introduced the CFX Opus 96 Dx Real-Time PCR System, marking its entry into the In-Vitro diagnostic testing arena. The product is approved by the U.S. Food and Drug Administration (FDA) for In-Vitro diagnostic testing and compliant with European Union regulations for In-Vitro diagnostic medical devices.
Bio-Rad's CFX Opus 96 Dx PCR System boasts a user-friendly interface and intuitive software, facilitating seamless operation and minimizing training requirements for lab staff. Its adaptable nature, accommodating various assay formats, offers laboratories the flexibility to employ their preferred testing protocols, provides precise and prompt diagnostic outcomes, thereby enhancing patient care and overall outcomes.
High Research, Development, and Regulatory Approval Costs Hinder the Market Growth
High costs associated with research, development, and regulatory approval are significant factors restraining the U.S. in-vitro diagnostics market expansion. Operating within this sector necessitates significant financial investment for companies to navigate the complex landscape of research and development.
This investment often encompasses extensive clinical trials, laboratory testing, and product refinement to guarantee accuracy and reliability. Additionally, obtaining regulatory approvals from agencies such as the FDA requires strict adherence to stringent standards, further compounding the financial burden. This financial constraint can discourage potential adopters from market expansion.
Introduction of Point-of-Care Testing Solutions in IVD Creates Market Opportunities
Point-of-care testing (POCT) is poised to be a significant driver of in the U.S. IVD market demand, in the forthcoming years. POCT serves as a valuable complement to laboratory testing, especially in situations where immediate results are crucial, such as emergency departments, ambulances, and remote healthcare settings.
With POCT technologies offering rapid tests for infectious diseases, cardiac markers, glucose monitoring, pregnancy testing, and more, healthcare providers can quickly assess patients' conditions and make timely treatment decisions.
By integrating POCT with traditional IVD, healthcare providers can enhance their diagnostic capabilities, delivering more efficient and patient-centered care. This integration streamlines workflows, allowing for faster diagnosis and treatment initiation, ultimately leading to improved patient outcomes.
Competitive Landscape
The promising players operating in the U.S. in-vitro diagnostics industry include Roche Holding AG, Abbott Laboratories, Thermo Fisher Scientific Inc, Danaher Corporation, Becton, Dickinson and Company, Siemens Healthineers AG, bioMérieux SA, Sysmex Corporation, QIAGEN N.V., and Bio-Rad Laboratories, Inc., and others.
U.S. In-Vitro Diagnostics Market Key Segments
By Type
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Reagents
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Instruments
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Software & Services
By Technique
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Immunodiagnostics
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Enzyme-Linked Immunosorbent Assay (ELISA)
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Rapid Tests
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Chemiluminescence Immunoassay (CLIA)
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Enzyme-linked Immunosorbent spot (ELISpot)
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Radioimmunoassay (RIA)
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Western Blot
-
-
Hematology
-
Molecular Diagnostics
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PCR
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INAAT
-
Hybridization
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DNA diagnostics
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Microarray
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Other Molecular Diagnostics
-
-
Tissue Diagnostics
-
Clinical Chemistry
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Basic Metabolic Panel
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Liver Panel
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Renal Profile
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Lipid Profile
-
Thyroid Function Panel
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Electrolyte Panel
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Speciality Chemicals
-
-
Other IVD Techniques
By Application
-
Infectious Diseases
-
Cancer
-
Cardiac Diseases
-
Immune System Disorders
-
Nephrological Diseases
-
Gastrointestinal Diseases
-
Others
By End User
-
Stand Alone Laboratory
-
Hospitals
-
Academics and Medical Schools
-
Point of Care Testing
-
Other End Users
REPORT SCOPE AND SEGMENTATION:
|
Parameters |
Details |
|
Market Size Value in 2023 |
USD 25.54 billion |
|
Revenue Forecast in 2030 |
USD 32 billion |
|
Value Growth Rate |
CAGR of 2.9% from 2024 to 2030 |
|
Analysis Period |
2023–2030 |
|
Base Year Considered |
2023 |
|
Forecast Period |
2024–2030 |
|
Market Size Estimation |
Billion (USD) |
|
Growth Factors |
|
|
Companies Profiled |
10 |
|
Customization Scope |
Free customization (equivalent up to 80 working hours of analysts) after purchase. Addition or alteration to country, regional, and segment scope. |
|
Pricing and Purchase Options |
Avail customized purchase options to meet your exact research needs. |
KEY PLAYERS
-
Roche Holding AG
-
Abbott Laboratories
-
Thermo Fisher Scientific Inc.
-
Danaher Corporation
-
Becton, Dickinson and Company
-
Siemens Healthineers AG
-
bioMérieux SA
-
Sysmex Corporation
-
QIAGEN N.V.
-
Bio-Rad Laboratories, Inc.
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