U.S. In Vitro Diagnostics Market - Forecast(2022 - 2027)

Report Code: HCR 0554 Report Format: PDF + Excel

U.S. In Vitro Diagnostics (IVD) Market Overview

The U.S. In Vitro Diagnostics (IVD) Market size is estimated to reach $27.1 billion by 2026, growing at a CAGR of 4.5% during the forecast period 2021-2026. As per U.S. Food and Drug Administration (FDA), “ In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae and such products are intended for use in the collection, preparation, and examination of specimens taken from the human body”. The U.S. Invitrio Diagnostics (IVD) Market is characterized by the advantageous handling of incessant conditions like heart ailments in conjunction with Novel Coronavirus (COVID-19) in 2020. Clinical Chemistry and Molecular Diagnostics are segments of the U.S. Invitrio Diagnostics (IVD) Market based on Test Type. Rapid diagnostics have been fuelled by rapid tests during the Novel Coronavirus (COVID-19) Pandemic in the U.S. Invitrio Diagnostics (IVD) Market. Drug Testing may be considered to be a segment of the U.S. Invitrio Diagnostics (IVD) Market on the basis of application.

The enormous surge in demand for rapid tests owing to the Novel CoronaVirus (COVID-19) Pandemic is fuelling the growth of the U.S. Invitrio Diagnostics Market characterized by the increased utilization of primary assays for COVID-19 discovery applying the Reverse Transcription – Polymerase Chain Reaction (RT-PCR). The increasing population of the elderly and advancement of public and personal diagnostic centers and point of care testing centers for rapid tests is set to propel the growth of the U.S. In Vitro Diagnostics (IVD) Market during the forecast period 2021-2026. This represents the U.S. In Vitro Diagnostics (IVD) Industry Outlook. 

Report Coverage

The report: “U.S. In Vitro Diagnostics (IVD) Market Forecast (2021-2026)”, by Industry ARC, covers an in-depth analysis of the following segments of the U.S. In Vitro Diagnostics (IVD) Market.
By Test Type: Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Haematology, Others.
By Product: Instruments, Reagents, Others.
By Usability: Disposable IVD, Reusable IVD.
By Application: Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, Drug Testing, Others.
By End User: Diagnostic Laboratories, Hospitals and Clinics, Others.

Key Takeaways

  • U.S. In Vitro Diagnostics (IVD) Market growth is being driven by the great predominance of incessant ailments, boost in the utilization of POC (Point-of-care) diagnostics, progressive technologies for rapid tests, heightening awareness, and adoption of personalized medications. However, the dearth of efficient reimbursement regulations and a lack of experienced laboratory technicians are some of the major factors hampering the growth of U.S. In Vitro Diagnostics (IVD) Market. 
  • U.S. In Vitro Diagnostics (IVD) Market Detailed Analysis on the Strength, Weakness, and Opportunities of the prominent players operating in the market will be provided in the U.S. In Vitro Diagnostics (IVD) Market report.

U.S. In Vitro Diagnostics (IVD) Market Share, By Application, 2020(%)

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U.S. In Vitro Diagnostics (IVD) Market Segment Analysis – By Application:

The U.S. In Vitro Diagnostics (IVD) Market based on the application can be further segmented into Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, Drug Testing, and Others. The Infectious Diseases Segment held the largest market share in 2020. This growth is owing to the great predominance of ailments like pneumonia and tuberculosis, resulting in increased utilization of in vitrio diagnostic tools. Rapid tests for tuberculosis have been developed. The Xpert MTB/RIF assay is a novel test that is transforming tuberculosis (TB) regulation by contributing to the accelerated diagnosis of Tuberculosis (TB) ailment and drug resistance. The test concurrently identifies Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in fewer than 2 hours. These kinds of advancements are driving the growth of the Infectious Diseases segment.

Furthermore, the Cancer/Oncology segment is estimated to grow with the fastest CAGR of 4.9% during the forecast period 2021-2026 owing to the increased cases of cancer worldwide. Rapid tests in Oncology have been developed. Seralite® – FLC is an accelerated lateral flow test for the quantitative evaluation of kappa (K) and lambda (?) immunoglobulin free light chains (FLCs) in serum. The plan of this accelerated test allows a free light chain service to be offered in all clinical laboratories. This authorizes the supply of FLC outcomes in ~10 minutes instead of days or weeks. With this simple to utilize, compact, rapid test, clinicians are capable of supervising patients in “real time” backing quicker decision making. The surge in the count of rapid tests for Oncology is propelling the growth of this segment during the forecast period 2021-2026.

U.S. In Vitro Diagnostics (IVD) Market Segment Analysis – By End Use:

The U.S. In Vitro Diagnostics (IVD) Market based on End Use can be further segmented into Diagnostic Laboratories, Hospitals and Clinics and Others. The Hospitals and Clinics Segment held the largest market share in 2020. This growth is owing to the enormous volume of diagnostic tests and rapid tests performed in hospitals and clinics and the increasing volumes of Class II and Class III IVD medical devices that are accessible for diagnostic testing. The healthcare professionals in hospitals use in vitro diagnostics for discovery of ailments and to obtain the best outcomes for every patient. These determinants are fuelling the growth of the Hospitals and Clinics segment.

Furthermore, the Diagnostic Laboratories segment is estimated to grow with the fastest CAGR of 5.1% during the forecast period 2021-2026 owing to the heightening count of rapid tests performed in completely licensed and equipped, preferably CLIA (Clinical Laboratory Improvement Amendments) -certified, clinical diagnostic laboratories in the wake of the Novel Coronavirus (COVID-19) pandemic.

U.S. In Vitro Diagnostics (IVD) Market Drivers

Global Prevalence Of Incessant Ailments Is Projected To Drive The Growth Of U.S. In Vitro Diagnostics (IVD) Market: 

As per World Health Organization (WHO), nearly 70% of demises from cancer, happen in low- and middle-income countries. Furthermore, WHO figures indicate that the total yearly cost of cancer in 2010 was approximated at US $1.16 trillion. Just as the Novel Coronavirus (COVID-19) Pandemic is propelling the demand of rapid tests, the increasing count of cancer cases and other chronic ailments is resulting in greater demand for self-care instruments and Point Of Care (POC) Diagnostics in the U.S. for the treatment of incessant ailments leading to increased demand for oncology-based diagnostics tests which is fuelling the growth of the U.S. In Vitro Diagnostics (IVD) Market during the forecast period 2021-2026.

Technological Innovations Are Expected To Boost The Demand Of U.S. In Vitro Diagnostics (IVDs): 

Technological innovations are driving the growth of the U.S. In Vitro Diagnostics (IVD) market. Molecular diagnostics (Dx) indicates a set of techniques utilized to investigate biomarkers in the genome and proteome. These tests examine particular sequences in nucleic acids, and how cells express genes as proteins. Rapid molecular assays are a novel kind of molecular influenza diagnostic test to discover influenza viral RNA or nucleic acids in upper respiratory tract specimens in nearly 15-30 minutes. In January 2021, Bruker launched MBT Sepsityper® Kit US IVD for accelerated and economical recognition of above 400 microorganisms from positive blood cultures. MBT Sepsityper Kit US IVD allows accelerated, particular discovery of a large number of cases of bacteremia-induced sepsis to help infectious disease specialists in possibly life-saving decisions. It is utilized for MALDI Biotyper® (MBT) recognition straight from Positive Blood Cultures (PBC) with short time-to-result (TTR) of lower than 30 minutes. U.S. Food and Drug Administration (FDA) clearance has been acquired in late December for diagnostic application on MALDI Biotyper CA System with the library of 425 organisms, covering gram-positive and gram-negative bacteria, and yeasts, for example, Candida auris. These kinds of technological innovations are driving the growth of the U.S. In Vitro Diagnostics (IVDs) during the forecast period 2021-2026.

U.S. In Vitro Diagnostics (IVD) Market Challenges

Premarket Approval (PMA) and IVD labelling Requirements As Specified Under The Specific Sections of the U.S. Food And Drug Administration (FDA) Are Challenging:

Premarket Approval (PMA) is the FDA procedure of scientific and regulatory review to assess the security and efficiency of Class III medical devices. For IVDs, there is a rare connection between security and efficiency since the security of the instrument is not normally connected to contact between the instrument and patient. For IVD products, the security of the instrument is connected to the effect of the device's performance, and specifically on the influence of false negative and false positive results, on patient health. Premarket Approval is vital and needs to be obtained. In Vitro Diagnostic Products have more labeling requirements under 21 CFR 809, Subpart B, In Vitro Diagnostic Products for Human Use. Prior to acquiring marketing authorization for an IVD product, makers must label the product as per labeling regulations. These issues are challenging the growth of the U.S. Invitrio Diagnostics Market.

U.S. In Vitro Diagnostics (IVD) Market Landscape:

Product launches, technological advancements, mergers & acquisitions, joint ventures and R&D activities are key strategies adopted by players in the U.S. In Vitro Diagnostics (IVD) Market. Key companies of this market include:
  1. Abbott Laboratories
  2. Becton, Dickinson and Company
  3. F.Hoffmann-La Roche Ltd
  4. BioMerieux SA
  5. Thermo Fischer Scientific Inc
  6. Danaher Corporation
  7. Bio-Rad Laboratories, Inc.
  8. Sysmex Corporation
  9. Quest Diagnostics Incorporated
  10. Siemens Healthineers

Acquisitions/Product Launches:

  • In March 2020, Abbott introduced Novel Coronavirus Test which will be utilized on m2000 RealTime system accessible in hospitals and molecular labs in the U.S. Abbott has acquired emergency use authorization (EUA) from the Food And Drug Administration (FDA) for its molecular test for the recognition of SARS-CoV-2, the virus that brings about COVID-19.
  • In July 2020, BD (Becton, Dickinson and Company), a chief global medical technology firm, declared the accessibility of BD PurPrep™ patient preoperative skin preparation with sterile solution, the earliest and only completely sterile povidone-iodine plus isopropyl alcohol single-use antiseptic skin preparation (PVP-I; 0.83% accessible iodine and 72.5% isopropyl alcohol) commercially accessible in the U.S.

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1. U.S. In Vitro Diagnostics (IVD) Market - Overview
    1.1 Definitions and Scope
2. U.S. In Vitro Diagnostics (IVD) Market - Executive Summary
    2.1 Market Revenue, Market Size and Key Trends
    2.2 Key trends by Product
    2.3 Key trends by Application
    2.4 Key trends by End User
3. U.S. In Vitro Diagnostics (IVD) Market - Comparative Analysis
    3.1 Company Benchmarking – Key Companies
    3.2 Financial Analysis– Key Companies
    3.3 Market Share Analysis– Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis- Average Selling Price
4. U.S. In Vitro Diagnostics (IVD) Market - Startup Companies Scenario Premium
    4.1 Key Startup Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Venture Capital and Funding Scenario
5. U.S. In Vitro Diagnostics (IVD) Market – Industry Market Entry Scenario Premium Premium
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing Business Index
    5.3 Case Studies of Successful Ventures
6. U.S. In Vitro Diagnostics (IVD) Market - Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porters Five Force Model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes
7. U.S. In Vitro Diagnostics (IVD) Market – Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. U.S. In Vitro Diagnostics (IVD) Market – By Test Type (Market Size –$Million/$Billion)
    8.1 Clinical Chemistry
    8.2 Molecular Diagnostics
    8.3 Immuno Diagnostics
    8.4 Haemotology
    8.5 Others
9. U.S. In Vitro Diagnostics (IVD) Market – By Product (Market Size –$Million/$Billion)
    9.1 Instruments
    9.2 Reagents
    9.3 Others
10. U.S. In Vitro Diagnostics (IVD) Market – By Usability (Market Size –$Million/$Billion)
    10.1 Disposable IVD
    10.2 Reusable IVD
11. U.S. In Vitro Diagnostics (IVD) Market – By Application (Market Size –$Million/$Billion)
    11.1 Infectious Diseases
    11.2 Diabetes
    11.3 Cancer/Oncology
    11.4 Cardiology
    11.5 Autoimmune Disease
    11.6 Nephrology
    11.7 Drug Testing
    11.8 Others
12. U.S. In Vitro Diagnostics (IVD) Market – By End User (Market Size –$Million/$Billion)
    12.1 Diagnostic Laboratories
    12.2 Hospitals and Clinics
    12.3 Others
13. U.S. In Vitro Diagnostics (IVD) Market - Entropy
14. U.S. In Vitro Diagnostics (IVD) Market – Industry/Segment Competition Landscape Premium 
    14.1 Market Share Analysis
        14.1.1 Global Market Share – Key Companies
        14.1.2 Market Share by Region – Key companies
        14.1.3 Market Share by Countries – Key Companies
        14.1.4 Competition Matrix
        14.1.5 Best Practices for Companies
15. U.S. In Vitro Diagnostics (IVD) Market – Key Company List by Country Premium Premium
16. U.S. In Vitro Diagnostics (IVD) Market Company Analysis
    16.1 Company 1
    16.2 Company 2
    16.3 Company 3
    16.4 Company 4
    16.5 Company 5
    16.6 Company 6
    16.7 Company 7
    16.8 Company 8
    16.9 Company 9
    16.10 Company 10
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