U.S. In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents, Instruments, Services), By Technology (Immunoassay, Molecular Diagnostics), By Application, By End-use, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The U.S. in vitro diagnostics market size was estimated at USD 29.86 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 3.70% from 2024 to 2030. The market growth is declining due to a decrease in demand for COVID-19 tests during the forecast period. However, the development of automated in vitro diagnostic (IVD) systems for laboratories & hospitals to provide error-free, efficient, and accurate diagnosis is anticipated to drive the market over the study period. In addition, growing prevalence of infectious and chronic diseases is projected to boost adoption of in vitro diagnostic testing techniques in the U.S. For instance, according to the American Cancer Society, in 2023, about 1.96 million new cancer cases were reported and around 609,820 individuals died due to cancer.

Geriatric population in the U.S. is gradually increasing. According to America’s Health Rankings senior report, more than 54 million adults aged 65 & above are living in the U.S., accounting for 16.5% of the country’s population. By 2050, this number is estimated to surpass 85.7 million. Moreover, with rising age, immune system is affected, which surges susceptibility to numerous diseases. Thus, a large geriatric population needs improved healthcare, especially for diagnosis of chronic diseases. In addition, the geriatric population is more likely to suffer from COVID-19 due to decreased immune function, multimorbidity, and physiological changes associated with aging. According to the CDC data published in May 2023, the mortality rate due to COVID-19 is much higher in the geriatric population. The risk of death in COVID-19 patients aged 65 and above increases more than 60 times compared to the age group of 18 to 29.

Technological advancements in terms of accuracy, cost-effectiveness, and portability are anticipated to be among high-impact rendering drivers for in vitro diagnostics market. Leading market participants are updating their range of testing options for qPCR instruments by undertaking research and development (R&D) initiatives for development of kits that target life-threatening conditions or by entering into collaborations with other kit manufacturers. For instance, in March 2023, Atila Biosystems and Stilla Technologies agreed to market co-labeled digital PCR kits. The kits and assays are manufactured by Atila and would be used on naica systems, Stilla’s lead PCR instrument.In January 2023, QIAGEN launched EZ2 Connect MDx platform to propel its capabilities of automation in sample processing. The advancement would be compatible with PCR, dPCR, and other downstream applications.

Moreover, growing efforts from government and nongovernment organizations to promote development of rapid diagnostics solutions are anticipated to offer lucrative growth opportunities in U.S. market. For instance, in October 2022, a leader in infectious disease diagnostics, Day Zero Diagnostics, Inc., announced that it has been awarded additional funding of USD 8.2 million from CARB-X for development of precise and cutting-edge diagnostic solutions for infectious diseases. In addition, active government support to develop rapid diagnostics solutions is another factor contributing to the market growth. For instance, in October 2021, the NIH granted funding of USD 78 million to develop novel rapid diagnostics solutions for COVID-19. Ultimate aim of this funding was to develop PoC solutions for detecting multiple respiratory infections.

Market Dynamics

Growing demand for personalized IVD instruments to achieve the best diagnostic standards is pressurizing the supply chain. Supply chain of diagnostic equipment and parts has received high attention following the turmoil in Chinese and Asian regions due to the pandemic. Increased freight prices and competition to acquire superior quality materials have intensified competitive rivalry among players. However, a rise in number of vaccinated individuals is projected to reduce the burden on IVD tests.

PCR capacity of the country has significantly escalated owing to increased installations of PCR machines during the pandemic. To utilize this newly acquired capacity, owners are trying to push alternative diagnostic tests to consumers. Regulatory framework for IVD has changed in the past year, and number of emergency approvals has increased to help companies address the pandemic. However, this may impact industry adversely once regulatory flexibility is removed in the post-pandemic era.

Stringent precision and calibration quality control mechanisms ensure the utmost quality of devices and analyzers. Outsourcing is also becoming a significant trend in the market, ensuring profitability and quality. For instance, the usual outsourcing destinations of U.S.-based companies are Asian nations such as China, Singapore, and India.

When compared to diagnostic equipment, the value chain is more complicated and highly impacted by fluctuations in the market due to its high demand. Hence, any changes in marketing environment may lead to a sudden surge or drop in demand, making inventory management difficult for companies. For instance, during the first wave of SARS-CoV-2 infection in the U.S., the sudden increase in demand for reagents led to shortage.

Product Insights

Reagent segment dominated the market in 2023 with a significant revenue share of 65.71%, owing to extensive R&D initiatives being undertaken by major market players for the development of novel biomarker kits. Furthermore, the introduction and commercialization of new reagents are anticipated to drive market growth. For instance, in October 2022, Thermo Fisher Scientific launched TaqPath enteric bacterial select panel test to detect gastrointestinal bacterial infections within two hours. In addition, rising approval of in vitro diagnostics for emergency use by regulatory authorities is expected to fuel segment growth. For instance, in March 2021, the U.S. FDA granted 510(k) clearance for the BioFire Respiratory Panel 2.1 to identify multiple respiratory infections, including COVID-19.

In 2023, instruments held for second largest revenue share of the market. Increasing technological advancements, including the introduction of portable instruments such as cobas 4800 developed by GeneXpert by Cepheid and Roche Diagnostics and may boost market growth during the projected timeframe. Furthermore, key players are also focused on developing new technologies with higher efficiency & accuracy, such as Ortho Vitros XT 7600 integrated system—digital chemistry technology which was intended to perform two separate laboratory tests simultaneously. Moreover, leading market participants are entering into partnerships to strengthen their product portfolios and offer precise diagnostic solutions. For instance, in September 2022, bioMérieux and Brightsight, Inc. announced a partnership to develop clinical digital solutions for diagnostic testing.

Technology Insights

Molecular diagnostics held the largest share in 2023, attributed to the increasing adoption of rapid testing and point-of-care testing. Moreover, the launch of initiatives and programs is further propelling the demand for molecular diagnostics. For instance, in March 2022, Molecular Characterization Initiative was launched by the National Cancer Institute to provide childhood cancer molecular characterization. Additionally, major players are focused on new product developments, and partnerships to expand their businesses in the U.S. market. For instance, in February 2023, Thermo Fisher Scientific, Inc. announced the release of QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR Suite, a new digital PCR research tool. These PCR are the only digital PCR in the market that allows lab automation, lowers administrative costs, and maintains consistency, flexibility, & usability.

Hematology is anticipated to be fastest-growing segment over the forecast period. Hematology tests play a significant role in health monitoring, and the adoption of these tests is rising owing to increased awareness about the importance of regular health checkups. In July 2022, Sysmex presented the XN-Series of automated hematology analyzers with new complimentary products, including the XN-9100 automated hematology analyzer. Moreover, in March 2022, Mindray launched its new BC-700 series of hematology analyzers, which incorporate complete blood count and erythrocyte sedimentation rate tests. This approval is anticipated to reduce the waiting time to get CBC results, thereby facilitating faster decision-making in critical cases

Application Insights

In 2023, infectious diseases segment held highest revenue share, and is expected to maintain its dominance throughout the projection period. Leading market participants are engaged in commercializing precise testing solutions for infectious diseases. For instance, in December 2021, Roche launched new tests for infectious diseases on the Cobas 5800 system in countries accepting CE marking. This launch expanded the company’s molecular diagnostics portfolio. Moreover, 57% of patients were reported to have colonized MDR bacteria during post-acute care admission. Prolonged hospitalization is also a source of MDR bacterial infections. The rate of getting a novel resistant gram-negative bacillus was 13.6% per 1,000 patient days of hospitalization. Hence, continuous monitoring and molecular tests for early detection are crucial for limiting the spread of hospital-acquired infections such as HABP/VABP, bloodstream infections, and UTIs.

Oncology segment is anticipated to witness fastest CAGR over the forecast period. Cancer is estimated to be the second most common cause of death in U.S. Genomic and genetic variation molecular tests have become a crucial part in management of breast cancer. These tests can help predict breast cancer in patients with a family history of this condition. Furthermore, technological advancements in cancer diagnostics and rising interventions of AI in cancer diagnosis are facilitating segment expansion. For instance, in September 2022, Ibex Medical Analytics launched the Galen 3.0, a transformative solution for diagnosis of multiple tissue types across digital pathology workflows. This product is expected to transform the diagnosis of breast, gastric, and prostate cancers.

End-use Insights

Hospitals segment dominated the U.S. in vitro diagnostics market in 2023. Due to rising hospitalization rates, doctors rely on diagnostic interpretation for treatment decisions. Diagnostic centers often collaborate with hospitals, which already have their diagnostics setups. Continuous development of healthcare infrastructure is anticipated to improve existing hospital facilities, driving demand for hospital-based in vitro diagnostic tests. Hospitals purchase and use in vitro diagnostic devices in large volumes. In 2022, U.S. had over 6,093 hospitals dependent on in vitro diagnostic tests for prompt and precise decision-making due to their ability to provide fast and accurate results.

Home care segment is anticipated to exhibit the fastest CAGR during the forecast period. Due to the growing geriatric population and rising demand for home care in vitro diagnostic devices. With the increasing demand for molecular diagnosis, there is a growing need for molecular diagnostics platform that can assist patients in conducting self-tests. ADEXUSDx HIV 1/2 Test, Home Access Express HIV-1 Test (Home Access Health Corp), and Home Access Hepatitis C Test (Home Access Health Corp) are few available home diagnostic tests. Regulatory authorities rigorously evaluate performance of diagnostic tests to meet standards of performance, quality, and safety. For instance, as of January 2023, the U.S. FDA has approved around 30 at-home COVID-19 tests, which are available without a prescription at retail stores and online platforms. Most of the authorized OTC COVID-19 tests are antigen tests.

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 Report Scope

U.S. In Vitro Diagnostics Market Report Segmentation

This report forecasts the volume and revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. in vitro diagnostics market report based on product, technology, application, and end-use.

• Product Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Reagents

  • Services

• Technology Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)

  • 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

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • 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

• End-use Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)

  • 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