According to Vision Research Reports, the U.S. in vitro diagnostics market was valued at USD 55.3 billion in 2021 and it is predicted to surpass around USD 36.7 billion by 2030 with a CAGR of -4.45% from 2022 to 2030.
According to Vision Research Reports, the U.S. in vitro diagnostics market was valued at USD 55.3 billion in 2021 and it is predicted to surpass around USD 36.7 billion by 2030 with a CAGR of -4.45% from 2022 to 2030.
Report Highlights
- The reagent segment held the highest market share of 65.34% in 2021.
- In 2021, the instruments accounted for 25.42% of the revenue share.
- Molecular diagnostics held the largest share of 49.13% in 2021.
- Coagulation is expected to be the fastest-growing segment over the forecast period.
- In 2021, the infectious diseases segment held the highest revenue share of 69.21%.
- The oncology segment is anticipated to experience the fastest CAGR over the forecast period.
- The hospitals segment dominated the U.S. in vitro diagnostics market in 2021 with a revenue share of 45.32%.
- Home care segment is expected to exhibit the fastest CAGR of 3.52% during the forecast period.
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Medical instruments that perform diagnostic tests on bio-fluids including blood, urine, and tissues are known as in vitro diagnostics (IVD). The IVD tests are used to study pharmacological therapy and to identify and evaluate infectious diseases, autoimmune disorders, and a variety of medical ailments.
The rising prevalence of chronic and pathogenic diseases, the aging population, the increasing popularity of point-of-care testing, and personalized medicine are anticipated to increase the demand for IVD testing in the country. Moreover, with developments in genomics & proteomics, this industry is seeing new prospects as molecular diagnostics expands its reach and introduces a new variety of condition-specific indicators and tests.
Several ailments, such as genetic, cardiovascular, and neurological disorders, are becoming more common. Cardiovascular diseases (CVDs) are the major cause of death in the U.S., killing an estimated 659,000 people each year, as per the Centers for Disease Control and Prevention (CDC). This has resulted in a significant public awareness about early diagnosis and a rise in routine diagnosis, both of which support the market's overall development.
The launch of new advanced IVD products is assisting the market's rapid expansion. Moreover, market players and research institutes are actively involved in the development of novel products to reduce the overall disease burden in the country. For instance, in May 2021, the University of California developed an ultrasensitive molecular test. This test is based on a chip technology that can detect the presence of influenza A and SARS-CoV-2 antigens. The test is under further study for conversion into a Point-of-Care (PoC) test.
The adoption of IVD testing at the point-of-care testing facilities is increasing rapidly. As several players are focusing on launching tests for home care facilities, there has been a shift in the industry dynamics. Moreover, in 2021, FDA also prioritized home-based molecular diagnostics tests. In March 2021, BATM Advanced Communications Limited announced the launch of its molecular diagnostics self-test kit for the detection of COVID-19.
The market is gaining strength as diagnostic laboratories increasingly employ fully automated tools. Automated instruments, as opposed to manual and semi-automated equipment, are more expandable, meet high level of performance, reduce technologists' hands-on time, eliminate batch testing, and provide faster results to physicians. Market participants are increasingly working on building automated instruments as a result of these benefits.
Furthermore, laboratory automation facilitates, expedites, and improves the efficiency and efficacy of diagnostic tests. From loading specimen tubes to providing findings for all major laboratory disciplines, a total lab automated system can handle all parts of the testing process. As more manufacturers enter the market with broader automation choices, the evolution of lab automation in the clinical diagnostics business is continuing to accelerate.
Since it is utilized to detect the SARS-CoV-2 virus, the COVID-19 pandemic has increased the demand for molecular diagnostics tools. Additionally, among hospitalized patients suffering from COVID-19, there was a surge in demand for test kits and consumables for measuring blood glucose levels, troponin levels, and a variety of other parameters. As a result, the usage of IVD devices increased during the pandemic and propelled the market growth.
Scope of The Report
|
Report Coverage |
Details |
|
Market Size in 2021 |
USD 55.3 billion |
|
Revenue Forecast by 2030 |
USD 36.7 billion |
|
Growth rate from 2022 to 2030 |
CAGR of -4.45% |
|
Base Year |
2021 |
|
Forecast Period |
2022 to 2030 |
|
Segmentation |
Technology, application, product, Region |
|
Companies Covered |
Abbott; bioMérieux; Bio-Rad Laboratories, Inc.; Siemens Healthcare GmbH; Qiagen; Quidel Corporation; F. Hoffmann-La Roche Ltd.; BD (Becton Dickinson and Company); Thermo Fisher Scientific, Inc.; Ortho Clinical Diagnostics; Danaher Corporation |
Product Insights
The reagent segment held the highest market share of 65.34% in 2021, owing to the increasing demand for genetic testing and the availability of advanced cancer diagnostic tests. The high demand for testing for SARS-CoV-2 infection significantly increased the growth during the pandemic.
Increasing approval of COVID-19 tests for emergency use by regulatory authorities is anticipated to drive the market. For instance, in April 2020, the U.S. FDA approved the EUA for the VITROS Anti-SARS-CoV-2 Total reagent pack and calibrators of Ortho Clinical Diagnostics.
In 2021, the instruments accounted for 25.42% of the revenue share. Increasing technological advancements, such as the introduction of portable instruments like cobas 4800 developed by Roche Diagnostics and GeneXpert by Cepheid, and others are increasing market penetration of IVD instruments in the country.
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Technology Insights
Molecular diagnostics held the largest share of 49.13% in 2021, attributed to the increasing adoption of point-of-care testing and rapid testing. The increasing product launches due to Emergency Use Authorization for various COVID-19 diagnostic tests have also contributed to the growth.
For instance, in March 2020, Abbott received EUA from the U.S. FDA for its molecular test, RealTime SARS-CoV-2 for COVID-19. Moreover, in November 2021, Roche announced the launch of the cobas 5800 System for molecular testing in infectious diseases such as sexually transmitted diseases and respiratory infections.
Coagulation is expected to be the fastest-growing segment over the forecast period, driven by an increase in the adoption of IVD assays and a rise in the demand for point-of-care diagnostics. The rising prevalence of cardiovascular diseases, blood-related disorders, and autoimmune diseases is expected to boost the demand for coagulation testing.
Application Insights
In 2021, the infectious diseases segment held the highest revenue share of 69.21%, and this is expected to maintain its dominance throughout the projection period. The increased testing rate for COVID-19 is one of the major factors for the dominance of this segment. Moreover, the introduction of new products and an increase in the prevalence of infectious diseases have increased segment share in the market.
Prominent market participants are collaborating to promote patient and healthcare provider access to high-quality, innovative laboratory services. For instance, in January 2020, Quest Diagnostics partnered with Memorial Hermann Health System to provide 21 hospital laboratories in Houston with better, cost-effective, high-quality, and creative diagnostic services.
The oncology segment is anticipated to experience the fastest CAGR over the forecast period. Increasing prevalence of cancer, increasing awareness about early diagnosis of cancer, and government initiatives are anticipated to increase the segment growth over the forecast period.
For instance, in February 2022, Cancer Moonshot was initiated by the U.S. government to enhance the screening rate for cancer for identifying the missed cases due to the COVID-19 pandemic. In the next 25 years, the government aims to reduce the cancer death rate by 50% with early diagnosis and treatment.
End-use Insights
The hospitals segment dominated the U.S. in vitro diagnostics market in 2021 with a revenue share of 45.32%, due to huge & extensive infrastructure, and an increase in hospitalization. In addition, an increase in hospital-acquired infections among hospitalized patients has increased the segment share.
As per the CDC, around 5% of hospitalized individuals are infected with MRSA and carry germs. As a result, the FDA approved the Cobas vivoDx MRSA screening test in December 2019, which can screen patients for bacterial colonization faster than traditional culture-based procedures. The FDA's measures to allow diagnostic tests with technological advances and improved accuracy are expected to maintain their dominance throughout the forecast period.
Home care segment is expected to exhibit the fastest CAGR of 3.52% during the forecast period due to the rising geriatric population and increasing demand for home care IVD devices. A few of the home diagnostics tests are the Home Access Hepatitis C Test (Home Access Health Corp), ADEXUSDx HIV 1/2 Test, and Home Access Express HIV-1 Test (Home Access Health Corp).
Moreover, regulatory authorities rigorously evaluate the performance of diagnostic tests to meet standards of safety, performance, and quality. For instance, in July 2019, Mylan N.V. and Atomo Diagnostics received prequalification approval from WHO for Mylan HIV Self-Test.
Key Players
- 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)
Market Segmentation
- By Product Outlook
- Instruments
- Reagents
- Services
- By Technology Outlook
- 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
- Immunoassays
- By Application Outlook
- 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
- Infectious Diseases
- By End-use Outlook
- 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
- Hospitals
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