The U.S. IVD market was valued at USD 28.63 Billion in 2022 and grew at a CAGR of 4.95% from 2023 to 2032. The market is expected to reach USD 46.41 Billion by 2032. It is projected that over the forecast period, there will be an exponential decline in the demand for in vitro diagnostics (IVD) to diagnose SARS-CoV-2 infection. However, IVD is a cutting-edge method that offers fresh approaches to detecting and treating diseases. It is projected that IVD testing methods will grow due to the rising incidence of chronic and infectious diseases in the United States.
To offer data for diagnostic, monitoring, and therapeutic reasons, in vitro diagnostics (IVD) is designed for the in vitro analysis of samples produced from the human body. They are employed in diagnosing numerous illnesses, including cancer, cardiovascular, and infectious diseases. The market is primarily driven by the rise in the geriatric population and the incidence of chronic and infectious diseases like diabetes, T.B., and lifestyle diseases. The Affordable Care Act (ACA)'s implementation and a rise in automated lab equipment that enables precise and quick test results have also contributed to the expansion of the IVD market. Additionally, the promotion of point-of-care diagnostics and personalised medicine is projected to promote market expansion. However, the absence of helpful reimbursement policies and strict governmental rules regulating product approval, production, and IVD sales are anticipated to restrain market expansion. The market is anticipated to witness new opportunities due to ongoing R&D efforts connected to IVD. In-vitro diagnostics is a cutting-edge technique that offers new resources for disease detection and therapy. The market for in-vitro diagnostics (IVD) has grown due to the rising incidence of infectious and chronic diseases in the United States. In the U.S., in-vitro diagnostics (IVDs) include much more than simple assays in test tubes and close examination of glass plates. These devices are used to examine patient-provided tissue samples and bodily fluid samples.
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Worldwide occurrence of chronic diseases and technological advances– In low- and middle-income nations, about 70% of cancer-related deaths occur. The Coronavirus (COVID-19) Pandemic has increased the demand for rapid tests, and the rising incidence of cancer cases and other chronic illnesses is driving demand for self-care tools and Point of Care (POC) diagnostics in the United States for the treatment of persistent illnesses. This is driving demand for oncology-based diagnostics tests and driving the growth of the U.S. IVD Market during the forecast period. Technological advancements are driving the expansion of the U.S. IVD market. A group of methods used for investigating genome and proteome biomarkers are known as molecular diagnostics (Dx). These tests look at specific nucleic acid sequences and how cells express genes as proteins. Rapid molecular tests are innovative diagnostic tests to identify influenza viral RNA or nucleic acids in upper respiratory tract specimens in less than 15 to 30 minutes.
Premarket approval and IVD labelling requirements as specified under the sections of the United States FDA– Premarket Approval (PMA) is a method used by the FDA to evaluate the safety and effectiveness of Class III medical devices through scientific and regulatory evaluation. Since the security of the instrument is rarely linked to contact between the instrument and the patient, IVDs have a unique connection between security and efficiency. For IVD products, the instrument's security is related to the device's function and, more specifically, to the impact of false negative and false positive results on patient health. It is essential to secure Premarket Approval. The 21 CFR 809, Subpart B, In Vitro Diagnostic Products for Human Use, specifies additional labelling standards for in vitro diagnostic products. Manufacturers of IVD products must label their products by labelling requirements before receiving marketing authorisation. These problems are hampering the expansion of the U.S. market for In Vitro Diagnostics.
The technology segment is divided into hematology, molecular diagnostics, microbiology, immunoassays, coagulation, clinical chemistry, and others. The molecular diagnostics segment dominated the market, with a share of around 16.38% in 2022. It is due to the point of care and rapid testing's rising popularity. Growing product launches due to Emergency Use Authorization for several COVID-19 diagnostic procedures have also contributed to the rise.
The application segment is divided into diabetes, cardiology, autoimmune diseases, hematologic diseases, infectious diseases, nephrology, oncology, drug testing, and others. The infectious diseases segment dominated the market, with a share of around 14.77% in 2022. One of the main drivers of this segment's dominance involves the rising COVID-19 testing rate. Additionally, a rise in the prevalence of infectious diseases and the launch of new products have raised segment share in the market.
Leading business organisations are working together to enhance the availability of top-notch, cutting-edge laboratory services for patients and healthcare providers. For instance, in January 2020, Quest Diagnostics and Memorial Hermann Health System teamed up to offer better, more affordable, higher-quality, and more innovative diagnostic services to 21 hospital laboratories in Houston.
Report Description:
Attribute | Description |
---|---|
Market Size | Revenue (USD Billion) |
Market size value in 2022 | USD 28.63 Billion |
Market size value in 2032 | USD 46.41 Billion |
CAGR (2023 to 2032) | 4.95% |
Historical data | 2019-2021 |
Base Year | 2022 |
Forecast | 2023-2032 |
Segments | Technology, Application |
As per The Brainy Insights, the size of the U.S. IVD market was valued USD 28.63 Billion in 2022 to USD 46.41 Billion by 2032.
U.S. IVD market is growing at a CAGR of 4.95% during the forecast period 2023-2032.
The market's growth will be influenced by worldwide occurrence of chronic diseases and technological advances.
Premarket approval and IVD labelling requirements as specified under the sections of the United States FDA could challenge the market growth.
Key players are F. Hoffmann-La Roche Ltd., Siemens Healthcare GmbH, Qiagen, Quidel Corporation, Abbott, Agilent Technologies, Inc., Becton Dickinson and Company, Bio-Rad Laboratories, Inc., bioMérieux, among others.
1. Introduction
1.1. Objectives of the Study
1.2. Market Definition
1.3. Research Scope
1.4. Currency
1.5. Key Target Audience
2. Research Methodology and Assumptions
3. Executive Summary
4. Premium Insights
4.1. Porter’s Five Forces Analysis
4.2. Value Chain Analysis
4.3. Top Investment Pockets
4.3.1. Market Attractiveness Analysis By Technology
4.3.2. Market Attractiveness Analysis By Application
4.4. Industry Trends
5. Market Dynamics
5.1. Market Evaluation
5.2. Drivers
5.2.1. Worldwide occurrence of chronic diseases and technological advances
5.3. Challenges
5.3.1. Premarket approval and IVD labelling requirements as specified under the sections of the United States FDA
6. U.S. IVD Market Analysis and Forecast, By Technology
6.1. Segment Overview
6.2. Hematology
6.3. Molecular Diagnostics
6.4. Microbiology
6.5. Immunoassays
6.6. Coagulation
6.7. Clinical Chemistry
6.8. Others
7. U.S. IVD Market Analysis and Forecast, By Application
7.1. Segment Overview
7.2. Diabetes
7.3. Cardiology
7.4. Autoimmune Diseases
7.5. Hematologic Diseases
7.6. Infectious Diseases
7.7. Nephrology
7.8. Oncology
7.9. Drug Testing
7.10. Others
8. U.S. IVD Market-Competitive Landscape
8.1. Overview
8.2. Market Share of Key Players in the IVD Market
8.2.1. U.S. Company Market Share
8.3. Competitive Situations and Trends
8.3.1. Product Launches and Developments
8.3.2. Partnerships, Collaborations, and Agreements
8.3.3. Mergers & Acquisitions
8.3.4. Expansions
9. Company Profiles
9.1. F. Hoffmann-La Roche Ltd.
9.1.1. Business Overview
9.1.2. Company Snapshot
9.1.3. Company Market Share Analysis
9.1.4. Company Product Portfolio
9.1.5. Recent Developments
9.1.6. SWOT Analysis
9.2. Siemens Healthcare GmbH
9.2.1. Business Overview
9.2.2. Company Snapshot
9.2.3. Company Market Share Analysis
9.2.4. Company Product Portfolio
9.2.5. Recent Developments
9.2.6. SWOT Analysis
9.3. Qiagen
9.3.1. Business Overview
9.3.2. Company Snapshot
9.3.3. Company Market Share Analysis
9.3.4. Company Product Portfolio
9.3.5. Recent Developments
9.3.6. SWOT Analysis
9.4. Quidel Corporation
9.4.1. Business Overview
9.4.2. Company Snapshot
9.4.3. Company Market Share Analysis
9.4.4. Company Product Portfolio
9.4.5. Recent Developments
9.4.6. SWOT Analysis
9.5. Abbott
9.5.1. Business Overview
9.5.2. Company Snapshot
9.5.3. Company Market Share Analysis
9.5.4. Company Product Portfolio
9.5.5. Recent Developments
9.5.6. SWOT Analysis
9.6. Agilent Technologies, Inc.
9.6.1. Business Overview
9.6.2. Company Snapshot
9.6.3. Company Market Share Analysis
9.6.4. Company Product Portfolio
9.6.5. Recent Developments
9.6.6. SWOT Analysis
9.7. Becton Dickinson and Company
9.7.1. Business Overview
9.7.2. Company Snapshot
9.7.3. Company Market Share Analysis
9.7.4. Company Product Portfolio
9.7.5. Recent Developments
9.7.6. SWOT Analysis
9.8. Bio-Rad Laboratories, Inc.
1.1.1. Business Overview
1.1.2. Company Snapshot
1.1.3. Company Market Share Analysis
1.1.4. Company Product Portfolio
1.1.5. Recent Developments
1.1.6. SWOT Analysis
9.9. bioMérieux
9.9.1. Business Overview
9.9.2. Company Snapshot
9.9.3. Company Market Share Analysis
9.9.4. Company Product Portfolio
9.9.5. Recent Developments
9.9.6. SWOT Analysis
List of Table
1. U.S. IVD Market, By Technology, 2019-2032 (USD Billion)
2. U.S. Hematology, IVD Market, 2019-2032 (USD Billion)
3. U.S. Molecular Diagnostics, IVD Market, 2019-2032 (USD Billion)
4. U.S. Microbiology, 2019-2032 (USD Billion)
5. U.S. Immunoassays, 2019-2032 (USD Billion)
6. U.S. Coagulation, IVD Market, 2019-2032 (USD Billion)
7. U.S. Clinical Chemistry, 2019-2032 (USD Billion)
8. U.S. Others, 2019-2032 (USD Billion)
9. U.S. IVD Market, By Application, 2019-2032 (USD Billion)
10. U.S. Diabetes, IVD Market, 2019-2032 (USD Billion)
11. U.S. Cardiology, IVD Market, 2019-2032 (USD Billion)
12. U.S. Autoimmune Diseases, IVD Market, 2019-2032 (USD Billion)
13. U.S. Hematologic Diseases, IVD Market, 2019-2032 (USD Billion)
14. U.S. Infectious Diseases, IVD Market, 2019-2032 (USD Billion)
15. U.S. Nephrology, IVD Market, 2019-2032 (USD Billion)
16. U.S. Oncology, IVD Market, 2019-2032 (USD Billion)
17. U.S. Drug Testing, IVD Market, 2019-2032 (USD Billion)
18. U.S. Others, IVD Market, 2019-2032 (USD Billion)
List of Figures
1. U.S. IVD Market Segmentation
2. IVD Market: Research Methodology
3. Market Size Estimation Methodology: Bottom-Up Approach
4. Market Size Estimation Methodology: Top-Down Approach
5. Data Triangulation
6. Porter’s Five Forces Analysis
7. Value Chain Analysis
8. U.S. IVD Market Attractiveness Analysis By Technology
9. U.S. IVD Market Attractiveness Analysis By Application
10. U.S. IVD Market: Dynamics
11. U.S. IVD Market Share By Technology (2023 & 2032)
12. U.S. IVD Market Share by Application (2023 & 2032)
13. U.S. IVD Market Share by Company (2022)
This study forecasts revenue at the country level from 2019 to 2032. The Brainy Insights has segmented the U.S. IVD market based on below mentioned segments:
U.S. IVD Market by Technology:
U.S. IVD Market by Application:
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