U.S. In Vitro Diagnostics Market Size to Hit Around USD 45.78 Billion by 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.?

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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.

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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.

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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.

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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.

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• Reagent segment dominated the market in 2023 with a significant revenue share of 65.79%.
• In 2023, instruments held for second largest revenue share of the market.
• Molecular diagnostics held the largest share in 2023.
• Hematology is anticipated to be fastest-growing segment over the forecast period.
• In 2023, infectious diseases segment held highest revenue share, and is expected to maintain its dominance throughout the projection period.
• Oncology segment is anticipated to witness fastest CAGR over the forecast period.
• Hospitals segment dominated the U.S. in vitro diagnostics market 45.11%in 2023.
• Home care segment is anticipated to exhibit the fastest CAGR during the forecast period.

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1. Personalized Medicine: The shift towards personalized medicine is influencing the IVD market, with a growing demand for diagnostic tests that provide tailored treatment options based on an individual's genetic makeup, lifestyle, and environment. This trend is driving the development of advanced molecular diagnostic techniques, such as next-generation sequencing (NGS) and companion diagnostics.
2. Point-of-Care Testing (POCT): There's a rising demand for rapid and convenient diagnostic solutions that can deliver results at the point of care, such as in physician offices, clinics, or even at home. POCT devices offer timely diagnosis, enabling prompt treatment decisions and improving patient outcomes. Technologies like handheld analyzers and biosensors are becoming increasingly prevalent in this segment.
3. Digitalization and Connectivity: Integration of digital technologies and connectivity solutions is transforming the landscape of IVD. Innovations such as cloud-based platforms, mobile health apps, and remote monitoring capabilities are enhancing the efficiency of diagnostic processes, enabling real-time data sharing, and facilitating better patient management.
4. Automation and Robotics: Automation and robotics are streamlining laboratory workflows, reducing human error, and enhancing the accuracy and throughput of diagnostic tests. Automated platforms for sample preparation, handling, and analysis are becoming more widespread, allowing laboratories to process a higher volume of samples efficiently.
5. Growing Importance of Infectious Disease Diagnostics: The COVID-19 pandemic has underscored the critical role of infectious disease diagnostics in public health. While the pandemic has led to a surge in demand for COVID-19 testing kits and related products, it has also highlighted the need for robust diagnostic infrastructure to address emerging infectious threats and to monitor and manage outbreaks effectively.
6. Focus on Chronic Disease Management: With the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular disorders, there's a growing emphasis on diagnostic tests for early detection, monitoring, and management of these conditions. This includes the development of novel biomarkers and diagnostic assays aimed at improving disease detection and treatment outcomes.
7. Regulatory Reforms and Compliance: Regulatory reforms, such as the implementation of the new Clinical Laboratory Improvement Amendments (CLIA) regulations and the FDA's efforts to modernize the regulatory framework for diagnostics, are shaping the market landscape. Compliance with regulatory requirements and adherence to quality standards are paramount for market players to ensure the safety and efficacy of diagnostic products.

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• 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)

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