U.S. In Vitro Diagnostics Industry is Rising Rapidly

According to Vision Research Reports, the U.S. in vitro diagnostics market size was estimated at USD 29.88 billion in 2023 and it is expected to surpass around USD 43.05 billion by 2033, poised to grow at a CAGR of 3.72% from 2024 to 2033. The increasing ageing or geriatric population, technological advancements, rising prevalence of chronic and infectious disease and rising demand for the personalized medication is leading to the growth and development of U.S. in vitro diagnostics market.

Introduction to In Vitro Diagnostics

In vitro diagnostics, often abbreviated as IVD, refers to tests conducted on biological samples outside the human body. These tests are crucial in diagnosing diseases and monitoring health conditions. By analyzing blood, urine, tissue, and other bodily fluids, in vitro diagnostics help healthcare professionals make informed decisions about patient care. These tests are fundamental in identifying infections, measuring levels of substances in the body, and detecting abnormalities that may indicate the presence of diseases like cancer or diabetes. In vitro diagnostics play a vital role in preventive medicine, early detection of illnesses, and guiding treatment plans for better patient outcomes.

Full Report is Ready | Get Sample Copy of Report@ https://www.visionresearchreports.com/report/sample/39223

Key Pointers

• U.S. in vitro diagnostics market size is calculated at USD 30.99 billion in 2024 and will hit around USD 41.51 billion by 2032.
• By Technology, the reagent segment held the largest revenue share of 66% in 2023.
• By Technology, the molecular diagnostics claimed the largest share in 2023.
• By Application, the infectious diseases segment had the largest market share in 2023.
• By Application, the oncology segment is expected to expand at the highest CAGR from 2024 to 2033.
• By End-use, the hospitals segment generated the maximum market share in 2023.
• By End-use, the home care segment is anticipated to exhibit the fastest compound annual growth rate (CAGR) from 2024 to 2033.

Immediate Delivery Available, Get Full Access@ https://www.visionresearchreports.com/report/checkout/39223

Importance of IVD in Healthcare

• Early Detection of Diseases: IVD tests enable the early identification of diseases, often before symptoms manifest. Early detection allows for prompt intervention and treatment, significantly improving patient outcomes and reducing the burden of advanced-stage illnesses.
• Precision Medicine: With advancements in technology, IVD has facilitated the era of precision medicine. By analyzing genetic, molecular, and cellular markers, these tests enable tailored treatment approaches that are personalized to each patient’s unique biological makeup.
• Monitoring Disease Progression: For individuals with chronic conditions such as diabetes, cardiovascular diseases, or cancer, regular monitoring is crucial to track disease progression and treatment efficacy. IVD tests provide healthcare professionals with real-time data to adjust treatment plans accordingly.
• Guiding Therapeutic Decisions: In the field of oncology, for example, IVD tests play a pivotal role in determining the most effective treatment strategies, such as targeted therapies or immunotherapies. By analyzing tumor biomarkers, these tests help oncologists choose the most appropriate course of action for each patient.
• Screening Programs: IVD tests are integral to public health screening programs aimed at identifying individuals at risk of certain diseases, such as HIV, hepatitis, or genetic disorders. Early detection through screening can lead to timely interventions and prevent the spread of infectious diseases within communities.
• Management of Infectious Diseases: Particularly relevant in the context of the COVID-19 pandemic, IVD tests are vital for diagnosing infectious diseases and implementing infection control measures. Rapid diagnostic tests enable quick identification of pathogens, facilitating timely treatment and containment efforts.
• Improving Healthcare Efficiency: By providing accurate and timely diagnostic information, IVD tests help streamline healthcare delivery, reduce unnecessary procedures, minimize hospital stays, and optimize resource allocation.

Some Related Reports:

• In Vitro Diagnostics (IVD) Market: https://www.visionresearchreports.com/in-vitro-diagnostics-ivd-market/41147
• Europe In Vitro Diagnostics Market: https://www.visionresearchreports.com/europe-in-vitro-diagnostics-market/40997

Market Dynamics:

Market Driver: Increasing prevalence of chronic diseases

• The U.S. in vitro diagnostic market is driven by the increasing prevalence of chronic and infectious diseases and an aging population, which requires early detection, observing, and management of health conditions. The rising aged population is the key factor driving the growth of US In Vitro Diagnostic market as aged population requires early access to medication and diagnosis especially the geriatric patient with chronic disease needs improved healthcare. Technological advancements in diagnostic innovations, such as molecular diagnostics drive advancement in the market, leading to precise, sensitive, and fast diagnostic tests.
• The improvement in personalized medication and focused on treatments also drives demand for companion diagnostics and molecular profiling tests, which direct treatment decisions and progress patient outcomes. Rising healthcare use, healthcare access improvement, and reimbursement policies improvement advancements support the development of the IVD market. Regulatory activities like the FDA’s Breakthrough Devices Program cultivate advancement and market expansion

Market Restraint: Regulatory challenges

• The U.S. in vitro diagnostic market presents significant opportunities, but several challenges may hinder its growth and development. Regulatory challenges, such as stringent FDA requirements, intellectual property issues, high development costs, and market access challenges, can hinder advancement.
• Intellectual property protection is significant in the IVD segment, but complex laws, patent disputes, and infringement challenges can constrain companies’ capacity to monetize their resources. High development costs, coupled with long advancement timelines and uncertain clinical results, pose monetary risks for IVD companies, especially startups and small firms with limited assets.
• Market access challenges include complex pricing and repayment processes, formulary limitations, and payer negotiations, which can limit reimbursement scope and hinder commercial success. Ethical and societal concerns encompassing IVD technologies, such as genetic testing and direct-to-consumer testing, can affect public acceptance and regulatory approval. Market competition from established IVD firms, pharmaceutical companies, and emerging startups can constrain market opportunities.

Market Opportunity: Personalized medicine emergence

• The U.S. in vitro diagnostic market offers adequate opportunities for growth and development due to personalized medication advancements, technological advancements, and the COVID-19 pandemic has highlighted the significance of In Vitro Diagnostic tests in pandemic readiness and response efforts. The demand for companion diagnostics and molecular profiling tests is driven by personalized medication, allowing producers to create tests that guide treatment choices and improve patient results.
• Technological advancements like next-generation sequencing and digital pathology are empowering the advancement of diagnostic tests with improved accuracy and affectability, upgrading patient care. The expansion of point-of-care testing (POCT) presents opportunities for IVD producers to create rapid testing devices with decentralized capabilities, enabling faster decision-making and improved patient results.

Recent Developments:

• In January 2023, for detection of covid-19 several companies introduced a new rapid antigen test and point of care molecular test. These innovation aims to enhance the testing capacity and improve accessibility and accuracy to test.
• In July 2023, Siemens Healthineers announced the launch of Atellica CI Analyser after the approval of US FDA the analyser enables both standalone labs and satellite labs for clinical chemistry and immunoassay testing.

Product Insights

In 2023, the reagent sector emerged as the leading force in the market, securing a substantial revenue share of 66%. This dominance is credited to major market players making significant investments in extensive research and development efforts, primarily focusing on creating innovative biomarker kits. The market’s expansion is further driven by the continuous introduction and commercialization of new reagents. A notable instance is Thermo Fisher Scientific’s launch in October 2022 of the TaqPath enteric bacterial select panel test, designed to rapidly detect gastrointestinal bacterial infections within a two-hour timeframe.

During the same period, the instruments segment captured the second-largest share of the market’s revenue. The growth of this segment is fueled by ongoing technological advancements, such as the introduction of portable instruments like the cobas 4800 developed by GeneXpert (Cepheid and Roche Diagnostics), expected to bolster market growth. Key industry players are actively involved in developing new technologies characterized by higher efficiency and accuracy. An example is the Ortho Vitros XT 7600 integrated system, which utilizes digital chemistry technology to conduct two separate laboratory tests simultaneously.

Technology Insights

In 2023, molecular diagnostics took the lead, claiming the largest market share, driven by the increasing adoption of rapid testing and point-of-care diagnostics. The demand for molecular diagnostics is further boosted by the introduction of various initiatives and programs. For example, the Molecular Characterization Initiative launched by the National Cancer Institute in March 2022 aims to provide molecular characterization specifically for childhood cancer. Major industry players are actively pursuing new product developments and partnerships to expand their presence in the U.S. market. For instance, in February 2023, Thermo Fisher Scientific, Inc. introduced the QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR Suite, a state-of-the-art digital PCR research tool. Notably, these PCR tools are the only digital PCR solutions in the market enabling lab automation, reducing administrative costs, and ensuring consistency, flexibility, and usability.

The hematology segment is forecasted to be the fastest-growing over the coming years. This growth is driven by increasing awareness of the importance of regular health checkups, with hematology tests playing a crucial role in health monitoring. In July 2022, Sysmex introduced the XN-Series of automated hematology analyzers, including the XN-9100 automated hematology analyzer. Furthermore, in March 2022, Mindray launched the BC-700 series of hematology analyzers, which integrate complete blood count and erythrocyte sedimentation rate tests. This introduction is expected to reduce waiting times for obtaining complete blood count (CBC) results, facilitating faster decision-making in critical cases.

Application Insights

In 2023, the infectious diseases segment captured the highest revenue share and is expected to maintain its dominance throughout the forecast period. Key market players are actively engaged in commercializing precise testing solutions specifically tailored for infectious diseases. For instance, in December 2021, Roche introduced new tests for infectious diseases on the Cobas 5800 system in countries that accept CE marking. This strategic launch significantly broadened the company’s molecular diagnostics portfolio. Additionally, alarming statistics reveal that 57% of patients were found to be colonized with multidrug-resistant (MDR) bacteria during post-acute care admission.

The oncology segment is set to experience the fastest compound annual growth rate (CAGR) over the forecast period. Cancer stands as the second most common cause of death in the U.S., highlighting the critical necessity for effective diagnostic solutions. Genomic and genetic variation molecular tests have become essential in managing breast cancer, assisting in predicting this condition, particularly in patients with a family history. Furthermore, technological advancements in cancer diagnostics and the increasing integration of artificial intelligence (AI) in cancer diagnosis are facilitating the expansion of this segment.

End-use Insights

In 2023, the hospitals segment emerged as the leading force in the U.S. in vitro diagnostics market. This dominance is attributed to the rising rates of hospitalization, where physicians heavily rely on diagnostic interpretations to make informed treatment decisions. Diagnostic centers often collaborate with hospitals that already have their diagnostic setups. The ongoing development of healthcare infrastructure is expected to enhance existing hospital facilities, thereby driving the demand for in vitro diagnostic tests within the hospital setting. Hospitals, as major consumers, purchase and utilize in vitro diagnostic devices in significant volumes. In 2022, the U.S. was home to over 6,093 hospitals, highlighting the widespread dependence on in vitro diagnostic tests for prompt and precise decision-making due to their ability to deliver fast and accurate results.

The home care segment is expected to demonstrate the fastest compound annual growth rate (CAGR) during the forecast period. This projection is fueled by the increasing geriatric population and a growing demand for home care in vitro diagnostic devices. The surge in demand for molecular diagnosis has underscored the need for molecular diagnostics platforms that enable patients to conduct self-tests.

Impact of COVID-19 on U.S. IVD

The COVID-19 pandemic has had a profound impact on the U.S. IVD market, leading to unprecedented demand for diagnostic tests and accelerating the adoption of telehealth and remote monitoring solutions. The pandemic has underscored the importance of resilient healthcare systems and preparedness for future public health crises.

U.S. In Vitro Diagnostics Market 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 Segmentations:

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
• 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
• 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
• Others

Immediate Delivery Available, Get Full Access@ https://www.visionresearchreports.com/report/checkout/39223

Ask here for more details sales@visionresearchreports.com OR USA: +1 650 460 3308 | IND: +91 87933 22019 | Europe: +44 2080772818