U.S. In Vitro Diagnostics Market, Industry Report, 2033
The U.S. In vitro diagnostics market size was valued at USD 37.19 billion in 2023 and is projected to surpass around USD 45.78 billion by 2033, registering a CAGR of 2.1% over the forecast period of 2024 to 2033.
The U.S. in vitro diagnostics market is experiencing significant growth and evolution. This market primarily involves diagnostic tests performed on biological specimens such as blood, urine, and tissue outside the body. It plays a crucial role in disease diagnosis, monitoring, and treatment decisions. The market is driven by various factors, including the increasing prevalence of chronic and infectious diseases, technological advancements in diagnostic technologies, rising healthcare expenditure, favorable government initiatives, and the aging population. Additionally, the shift towards personalized medicine and the growing awareness of preventive healthcare measures are contributing to market growth. These factors collectively indicate a promising outlook for the U.S. in vitro diagnostics market, with ongoing innovation and expansion anticipated in the coming years.
| Report Attribute | Details |
| Market Size in 2024 | USD 37.97 Billion |
| Market Size by 2033 | USD 45.78 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 2.1% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Technology, application, product, end-use |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | 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). |
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.
Reagent segment dominated the market in 2023 with a significant revenue share of 65.79%, 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.
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
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.
Hospitals segment dominated the U.S. in vitro diagnostics market 45.11%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.
Major players are opting for market strategies for strategic collaborations and partnerships through mergers & acquisitions in the country.
U.S. In Vitro Diagnostics Market Top Key Companies:
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.
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