According to Nova One Advisor, the U.S. In vitro diagnostics market size was exhibited at USD 37.19 billion in 2023
According to Nova One Advisor, the U.S. In vitro diagnostics market size was exhibited at USD 37.19 billion in 2023 and is projected to hit around USD 45.78 billion by 2033, growing at a CAGR of 2.1% during the forecast period 2024 to 2033.
The growth of the U.S. in vitro diagnostic market is drive by the expanding use of in vitro diagnostics (IVD) in detecting diseases, monitoring overall health, and enabling precision medicine. IVD tests, conducted on samples like blood or tissue, play a crucial role in diagnosing, treating, and preventing diseases.
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U.S. In Vitro Diagnostics Market Overview
The U.S. in vitro diagnostic market is experiencing rapid expansion, largely driven by the increasing adoption of molecular diagnostics. This technology allows for the detection and analysis of genetic markers and biomarkers, facilitating more precise and personalized diagnostics. With a growing understanding of the genetic basis of diseases and advancements in molecular diagnostic techniques, targeted therapies and personalized medicine have become increasingly prevalent. Consequently, there is a rising demand for molecular diagnostic tests in the United States.
Diagnostic tests, influencing an estimated 70% of healthcare decisions, play a pivotal role in disease management globally. They provide essential information to health systems, aiding in the management of various diseases, infectious or otherwise. Recognized by the World Health Organization (WHO) as increasingly vital, in vitro diagnostic techniques encompass a range of methods such as biochemical, pathology, or microbiology tests. These tests are conducted in clinical settings, laboratories, healthcare facilities, and even at home, contributing to the comprehensive landscape of healthcare diagnostics in the United States.
Key Takeaways:
- Reagent segment dominated the market in 2023 with a significant revenue share of 65.79%.
- In 2023, instruments held for second largest revenue share of the market.
- Molecular diagnostics held the largest share in 2023.
- Haematology is anticipated to be fastest-growing segment over the forecast period.
- In 2023, infectious diseases segment held highest revenue share, and is expected to maintain its dominance throughout the projection period.
- Oncology segment is anticipated to witness fastest CAGR over the forecast period.
- Hospitals segment dominated the U.S. in vitro diagnostics market 45.11%in 2023.
- Home care segment is anticipated to exhibit the fastest CAGR during the forecast period.
In Vitro Diagnostics (IVD) Market Size in the global 2024 to 2033
The global in vitro diagnostics (IVD) market size was valued at USD 78.19 billion in 2023 and is anticipated to reach around USD 121.43 billion by 2033, growing at a CAGR of 4.5% from 2024 to 2033.
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Report Highlights
By Product
In the U.S. in vitro diagnostics (IVD), the reagent segment asserts significant dominance, capturing a substantial share of the market. Reagents produced by the IVD industry serve as essential components for conducting diagnostic laboratory tests. These reagents consist of highly-specific biological or chemical solutions designed to react with target substances within samples. The outcome of this interaction yields a measurable or visible product crucial for diagnostic accuracy. Achieving precise diagnostics is the utilization of IVD-grade reagents sourced from reputable suppliers. Primary and secondary antibodies, integral components of many diagnostic assays, undergo rigorous validation processes to ensure quality and consistency. Similarly, proteins and antigens employed in IVD manufacturing must exhibit consistent high purity levels to mitigate unwanted background signals that could potentially lead to false-positive results. Therefore, the reliability and quality assurance of reagents play a pivotal role in enhancing the accuracy and efficacy of diagnostic testing procedures within the IVD industry.
Within the U.S. in vitro diagnostic (IVD) market, instruments second largest share, underscoring their crucial role in clinical laboratory environments. Designed to meet the demands of the clinical setting, IVD instruments offer streamlined workflows and integrated software, facilitating accurate and reliable screening and diagnostic testing results. Illumina’s IVD instruments exemplify this, providing clinical labs with versatile capabilities for various applications. These instruments, including the MiSeqDx Instrument, NextSeq 550Dx Instrument, and NovaSeq 6000Dx Instrument, empower clinical labs to conduct their own next-generation sequencing (NGS) tests, run predefined gene panels, or pursue diverse clinical research applications. They are applicable across a spectrum of diagnostic areas, including cystic fibrosis testing, IVD assay development, target enrichment, cancer companion diagnostics, noninvasive prenatal testing (NIPT), and comprehensive genomic profiling (CGP). By offering flexibility and precision, IVD instruments play a pivotal role in advancing diagnostic capabilities and enhancing patient care within clinical laboratory settings.
By Technology
The molecular diagnostics emerged as the leading segment, driven by the growing adoption of rapid testing and point-of-care testing. This technology utilizes advanced in vitro biological assays to detect nucleic acids or proteins, even in low concentrations across samples. Such capabilities enable the identification of biomarkers, monitoring the disease’s progression over time, and guiding the selection of appropriate therapies. The focus on developing and early application of various molecular tools holds immense promise in both research and clinical settings. These tools are anticipated to provide significant value in diagnostic endeavours. Molecular diagnostic technologies have undergone continuous development, modification, and commercialization for the analysis of nucleic acids and proteins, both in situ and in solution. By offering precise and sensitive detection capabilities, molecular diagnostics contribute significantly to the advancement of personalized medicine and the optimization of patient care pathways.
The hematology segment emerges as the fastest-growing segment in the forecast period within in-vitro diagnostics (IVD). These diagnostics encompass tests conducted on blood or tissue samples extracted from the human body. They serve the vital role of disease detection, monitoring overall health, and aiding in the treatment, cure, or prevention of various conditions. IVD hematology parameters play a pivotal role in disease monitoring and treatment guidance. From anemias to leukemias to sepsis, clinicians rely on these parameters to ensure optimal patient care. By providing comprehensive insights into blood-related disorders and conditions, IVD hematology parameters enable healthcare professionals to make informed decisions regarding treatment strategies, ultimately improving patient outcomes. The anticipated rapid growth of hematology within IVD underscores its critical importance in clinical practice. As advancements continue in this field, hematology diagnostics will further enhance their utility in disease management, contributing to the ongoing evolution of personalized medicine and healthcare delivery.
Application Insights
The infectious diseases segment commands the highest share, underscoring the growing significance of in vitro diagnostics in this field. In healthcare, the identification of infectious agents is paramount for determining appropriate treatments for patients. Physicians heavily rely on diagnostic tools to accurately detect infectious agents, enabling tailored therapeutic interventions. Monitoring chronic infections necessitates highly sensitive diagnostic methods capable of providing quantitative information to guide therapy adjustments. For instance, viral load monitoring is crucial for individuals living with HIV to ensure optimal treatment outcomes.
Furthermore, diagnostics play a pivotal role in the detection and surveillance of healthcare-associated infections and emerging diseases. In vitro diagnostics serve as indispensable tools in the battle against infectious diseases, providing healthcare professionals with critical insights to inform treatment decisions and mitigate the spread of infections. As advancements continue in this field, the role of diagnostics in infectious disease management will only become more pronounced, further emphasizing their importance in improving patient outcomes and public health.
The oncology segment is poised to witness the fastest Compound Annual Growth Rate (CAGR) over the forecast period, reflecting the increasing importance of in-vitro diagnostics (IVD) in cancer care. IVD tests are rapidly evolving into integral components of determining the most suitable therapy for cancer patients. Companion diagnostics, often utilizing IVD techniques, play a pivotal role in oncology by elucidating the nature and expression of a patient’s tumor. These diagnostics assist clinicians in understanding the likelihood of a specific patient benefiting from a particular treatment regimen. By providing insights into tumor characteristics, companion diagnostics empower healthcare professionals to make more informed treatment decisions, thereby optimizing patient outcomes.
By End-use
The hospitals segment emerges as the dominant player in the U.S. in vitro diagnostics market, highlighting the pivotal role of in vitro diagnostics (IVD) in revolutionizing the healthcare landscape. IVD technologies have significantly transformed the healthcare industry by delivering accurate, precise, and timely diagnostic results, thereby enhancing patient care and treatment outcomes. IVD tests encompass a diverse range of types, including clinical chemistry, immunochemistry, hematology, microbiology, and molecular diagnostics. These tests offer several advantages over traditional diagnostic methods, such as rapidity, accuracy, and cost-effectiveness, making them indispensable tools in clinical practice. the comprehensive nature of healthcare services provided by hospitals, they serve as primary hubs for conducting IVD tests and implementing diagnostic solutions. As healthcare institutions strive to improve patient care through enhanced diagnostics, the demand for IVD tests continues to surge within hospital settings. Therefore, hospitals play a pivotal role in driving the adoption and utilization of in vitro diagnostics, ultimately contributing to the advancement of healthcare delivery in the United States.
The home care segment is anticipated to exhibit the fastest CAGR during the forecast period. IVD medical devices have been designed exclusively for use in a healthcare setting and by a healthcare professional. Due to the advancement of technology in recent years, more and more home-use IVD medical devices are available on the market, such as home-use blood glucose meters and their test strips, urine test strips and pregnancy test kits.
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U.S. In Vitro Diagnostics Market Dynamics
Driver
Early Interventions and Cost Savings
In vitro diagnostic (IVD) investigations play a pivotal role in routine patient management, enabling timely interventions and reducing late-stage healthcare expenditure (HCE). By assessing the potential risk of developing diseases or disorders and guiding patient management, IVD aids in achieving high-quality medical outcomes. Tests conducted on body specimens, including blood and tissue biopsies, either alone or in conjunction with clinical investigations, are perceived as indispensable tools for improving patient care. IVD testing facilitates early-stage and cost-effective interventions, mitigating the need for advanced-stage therapies associated with worse prognoses and higher utilization of healthcare resources. This emphasis on early intervention not only enhances patient outcomes but also contributes to the growth of the U.S. in vitro diagnostic market, as healthcare providers recognize the value of IVD in driving efficient healthcare delivery and cost savings.
Restraint
Regulatory Hurdles Constrain U.S.
Developers and manufacturers of in vitro diagnostic devices encounter significant hurdles in obtaining regulatory approval to market their products in the US. A comprehensive understanding of medical device regulation and early planning of clinical and regulatory strategies are crucial for successful and timely product launches. Establishing a collaborative partnership with the Food and Drug Administration (FDA) is essential to expedite new product applications. The increased time and effort required to navigate regulatory processes in the US market compel some domestic manufacturers to initially market their devices overseas or relocate manufacturing operations offshore. There are indications of FDA efforts to streamline product approvals, manufacturers must still invest in regulatory expertise, strategic planning, and FDA collaboration to achieve regulatory success. These regulatory challenges serve as constraints on the growth of the U.S. in vitro diagnostic market, hindering the timely introduction of innovative diagnostic solutions and impeding market expansion opportunities.
Opportunity
AI Integration
The continuous evolution of in vitro diagnostic testing has significantly enhanced patient outcomes and healthcare provider productivity worldwide. A future is envisioned where artificial intelligence (AI) is seamlessly integrated throughout the lab, and this future is rapidly approaching. According to survey respondents, 69% anticipate AI implementation in in vitro diagnostics (IVD) labs. The integration of AI throughout diagnostic processes is poised to become crucial for labs, enabling them to efficiently handle increased workloads with fewer staff. While AI holds immense potential for analysis and diagnosis, a substantiab/e cnl portion of lab time and effort is dedicated to pre- and postanalytical processes. AI has the capability to bring significant improvements to workflow and operations, offering efficiencies that save time, labor, and costs. This presents a compelling opportunity for the U.S. in vitro diagnostic market to leverage AI technologies, driving innovation, enhancing productivity, and ultimately improving patient care outcomes.
Recent Developments
- In November 2023, Roche introduced a next-generation qPCR system aimed at advancing clinical requirements in molecular diagnostics and tackling public health challenges.
- In July 2023, the U.S. FDA announced plans for Laboratory-Developed Test Rulemaking and initiated a pilot program.
Key Companies & Market Share Insights
Major players are opting for market strategies for strategic collaborations and partnerships through mergers & acquisitions in the country.
- In March 2023, F. Hoffmann-La Roche Ltd., collaborated with Eli Lily and Company to support the development of Roche’s Elecsys Amyloid Plasma Panel (EAPP).
- In February 2023, bioMérieux received CLIA waiver and 510(k) clearance and for BIOFIRE SPOTFIRE system and its BIOFIRE SPOTFIRE respiratory panel. Such initiatives are contributing to the market in the U.S.
U.S. In Vitro Diagnostics Market Top Key Companies:
- Abbott
- F. Hoffmann-La Roche Ltd.
- Bio-Rad Laboratories, Inc.
- Siemens Healthcare GmbH
- Agilent Technologies, Inc.
- Qiagen
- bioMérieux
- Quidel Corporation
- BD (Becton Dickinson and Company)
U.S. In Vitro Diagnostics Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. In Vitro Diagnostics market.
By Product
- Instruments
- Reagents
- Services
By Technology
- Immunoassays
- 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
- Infectious Diseases
- Upper respiratory
- Gastrointestinal panel testing
- Methicillin-resistant Staphylococcus Aureus (MRSA)
- Clostridium difficile
- Vancomycin-Resistant Enterococci (VRE)
- Carbapenem-resistant bacteria
- Flu
- Respiratory Syncytial Virus (RSV)
- Candida
- Tuberculosis (TB) and drug-resistant TB
- Meningitis
- Chlamydia
- Gonorrhoea
- HIV
- Hepatitis C
- Hepatitis B
- Other infectious disease
- Diabetes
- Oncology
- Cardiology
- Nephrology
- Autoimmune Diseases
- Drug Testing
- Hematologic Diseases
- Others
By End-use
- Hospitals
- Immunoassays
- 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
- Immunoassays
- Laboratories
- Immunoassays
- 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
- Immunoassays
- Home-care
- Immunoassays
- 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
- Immunoassays
- Others
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