U.S. In Vitro Diagnostics Market To Witness Huge Potential In The Future

U.S. In Vitro Diagnostics Market Summary

The U.S. in vitro diagnostics market size was estimated at USD 41.42 billion in 2024 and is projected to grow at a CAGR of 5.6% from 2025 to 2030. Market growth has been impacted by the declining demand for COVID-19 tests during the forecast period, which created a temporary slowdown. However, technological advancements, such as the development of automated in vitro diagnostic systems for laboratories and hospitals, are expected to support growth. These systems provide faster, error-free, efficient, and accurate diagnoses, which are increasingly required to improve healthcare outcomes. In addition, the rising prevalence of both infectious and chronic diseases continues to drive adoption of in vitro diagnostic testing methods across the U.S. For example, data from the American Cancer Society highlighted that in 2023, nearly 1.96 million new cancer cases were reported, with approximately 609,820 deaths recorded due to cancer, further emphasizing the need for reliable diagnostic testing.

The geriatric population in the U.S. is increasing steadily and represents a significant driver of market expansion. According to America’s Health Rankings senior report, more than 54 million adults aged 65 years and older are living in the U.S., making up 16.5% of the total population. By 2050, this number is projected to rise to over 85.7 million. With advancing age, the immune system becomes weaker, leading to higher vulnerability to various health conditions. This demographic shift is directly linked to increased demand for diagnostic services, especially for chronic diseases such as cancer, diabetes, and cardiovascular disorders. Older adults are also more prone to severe outcomes from COVID-19 due to decreased immune function, multiple co-existing health conditions, and age-related physiological changes. According to CDC data published in May 2023, mortality rates due to COVID-19 are significantly higher among seniors, with the risk of death in patients aged 65 and above more than 60 times greater compared to those aged 18 to 29.

Key Market Trends & Insights

• The reagent segment accounted for the largest market share of 65.9% in 2024. This dominance is primarily due to significant R&D initiatives by leading market participants aimed at developing advanced biomarker kits. The introduction and commercialization of innovative reagents enhance diagnostic accuracy and efficiency, which further supports market growth. As diagnostics play a crucial role in early detection and treatment planning, continuous development of reagents remains central to industry expansion.
• Among technologies, immunoassay emerged as the largest segment in 2024. The segment’s growth is linked to its extensive adoption in both rapid testing and point-of-care diagnostics. Immunoassays are critical in the detection of a wide variety of diseases, ranging from cancer and cardiovascular conditions to infectious and autoimmune disorders. Their utility stems from their ability to utilize antibodies or antigens to identify specific biomolecules within patient samples. High sensitivity, specificity, and quick turnaround time have made immunoassays indispensable in clinical laboratories as well as decentralized testing environments.
• Based on applications, the infectious diseases segment dominated the market in 2024 and is anticipated to maintain this leading position throughout the forecast period. Key companies are focusing on launching highly accurate and advanced testing solutions in this area. For instance, in December 2021, Roche introduced new tests for infectious diseases on the Cobas 5800 system in regions that accept CE marking. Such launches highlight the strong emphasis on improving diagnostic accuracy and accessibility for infectious diseases, which continue to be a major public health concern.
• From the perspective of testing locations, the other test locations segment led the U.S. in vitro diagnostics market in 2024. This segment covers a wide range of facilities outside conventional laboratories, including outpatient clinics, remote testing centers, and point-of-care (POC) facilities. The shift toward these settings can be attributed to the demand for convenient, rapid, and accessible diagnostic options, which became particularly evident during the COVID-19 pandemic when immediate testing was crucial for disease control.
• In terms of end-use, the hospital segment was the largest contributor to the U.S. in vitro diagnostics market in 2024. Hospitals play a critical role in diagnostics, as rising hospitalization rates have increased dependence on precise testing for accurate treatment decisions. Furthermore, hospitals often work closely with diagnostic centers or have in-house diagnostic setups, which adds to their dominant role. Continuous advancements in healthcare infrastructure, coupled with investments in upgrading hospital facilities, are expected to further drive demand for hospital-based diagnostic tests in the coming years.

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Market Size & Forecast

• 2024 Market Size: USD 41.42 billion
• 2030 Projected Market Size: USD 57.43 billion
• CAGR (2025 - 2030): 5.6%

Key Companies & Market Share Insights

Major players are opting for market strategies for strategic collaborations and partnerships through mergers & acquisitions in the country. Established market players are focusing on strategies such as mergers & acquisitions, collaborations, and development of new products. In addition, these companies aim to expand their businesses in developing economies to increase their market share. New entrants face high competition owing to the presence of well-established players.

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)

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Conclusion

The U.S. in vitro diagnostics market is poised for steady growth despite the temporary slowdown caused by the reduced demand for COVID-19 tests. The rising prevalence of chronic and infectious diseases, an expanding elderly population, and technological advancements in diagnostic systems are driving adoption across healthcare settings. The dominance of reagents, immunoassays, and infectious disease testing highlights the growing emphasis on precision, speed, and accessibility in diagnostics. Additionally, the increasing reliance on hospitals and point-of-care facilities for timely and accurate testing reflects the changing healthcare landscape. Overall, the market is expected to expand significantly as innovation, accessibility, and patient-centric approaches continue to shape the sector.