United States Point-of-Care Diagnostics Market Assessment, By Product, By Prescription By End-user, By Region, Opportunities and Forecast, 2017-2031F

United States point-of-care diagnostics market is projected to witness a CAGR of 5.00% during the forecast period 2024-2031, growing from USD 17.47 billion in 2023 to USD 25.81 billion in 2031. The market growth is supported by influenced by the rising number of infectious cases in the country, increasing awareness for early detection, increasing preference for compact and portable diagnostic devices, growing private and government funding, increased research and development investments, and technological advancements.

The point-of-care diagnostics (PCOD) market is witnessing significant growth post-COVID-19 pandemic as the need for reliable, rapid, and accessible testing becomes more apparent. Challenges in the healthcare system during the pandemic have revealed the need for adequate quality care, particularly for all those in more remote areas. Healthcare priorities are changing, and there is a growing need for continuous patient access and trusted diagnostic tools. Innovations such as artificial intelligence, biosensors, nanotechnology, and smartphone platforms improve the capabilities of the accuracy and speed of diagnostics at the point-of-care. Integrating these advanced technologies with electronic health records (EHR) and the growth of CLIA-waived tests are also a significant transition to patient care. Increased funding for research and development in the United States also accelerates the market toward affordability and accessibility, improving health outcomes across the country.

Moreover, companies are investing in innovations and streamlining the approval process to boost testing access, ultimately driving improved patient outcomes. For instance, in June 2024, Co-Diagnostics, Inc. submitted its pre-market approval (PMA)application for the Co-Dx PCR Pro device that will eventually migrate the gold-standard PCR test from the large, complex laboratories to which it has been confined to this point and make infectious disease diagnostics more accessible in the developing world. The company created miniaturized, smartphone-controllable devices and is pursuing FDA 510(k) clearance through patented Co-Dx Co-Primers technology.

Technological Advancements Drive Market Growth

Technological advancements in the United States Point-of-Care Diagnostics (POCD) market improve the accuracy and efficiency of tests conducted in the Point-of-Care Diagnostics environment. Mobile equipment, such as handheld analyzers, portable ultrasound machines, and mobile labs, enable healthcare providers to make quicker assessments outside traditional settings and, therefore, has improved access in other underserved areas. For example, in June 2024, Cepheid Inc. received FDA marketing authorization for its Xpert HCV test, and GeneXpert Xpress System, the first in the family of hepatitis C virus testing solutions that will be used in the approved point-of-care setting for diagnosing individuals at risk for hepatitis C. Lastly, artificial intelligence is also reshaping diagnostics as it assists in interpreting outcome results, detecting trends, and forecasting outcomes.

For instance, in October 2024, HueDx, Inc. (HueDx) published a study demonstrating the utility of its smartphone-based, paper-driven quantitative diagnostic platform, HueTools and HueLab. Such innovation finally overcomes earlier limitations of demonstrating reliable point-of-care clinical chemistry colorimetric results without additional hardware. These innovations make the diagnosis process easier and provide a healthy boost for the whole market due to portable solutions for testing, improved patient care, and accessibility throughout the country.

Rising Prevalence of Infectious Diseases

Several factors have led to an upsurge of infectious diseases in the United States, including increased international traveling, urbanization, antibiotic resistance, and climatic changes that affect the disease vectors. Other factors include the aged population and increased vulnerability to disease. According to the U.S. Centers for Disease Control and Prevention, new HIV infections occurred in the United States in the year 2022. The country aims to reduce this figure from 32,800 in 2022 to 9,300 in the year 2025 and even lower to 3000 in 2030. As these infections increase, the need for Point-of-Care Diagnostics (POCD) also rises, mainly because of the urgent demand for quick access to testing and rapid therapy. POCD facilitates early detection and treatment, which are fundamental to controlling epidemics and better patient care. Therefore, such increasing demand propels the point-of-care diagnostic market in the United States.

Given the surging demand, companies and governments are working. For example, in April 2024, Cepheid Inc., a subsidiary of Danaher Corporation, received WHO prequalification for its Xpert HIV-1 Qual XC-an in vitro test that is available for the detection of HIV-1 in blood samples.

Increasing Funding or Investments Promote Market Growth

Increasing funding from the government and the private sector is a major driver in point-of-care diagnostics market growth in the United States. Such funding improves more advanced and reliable diagnostic technologies, thus furthering the capabilities and accessibility of tests. Funding for research and innovation results in the development of portable devices and efficient testing schemes that can be fitted into many healthcare settings. Therefore, the market is rapidly advancing in response to the growing requirements for more timely and accurate diagnostics. For instance, in April 2024, Binx Health Inc. raised USD 65 million in Series F funding toward further company growth. They plan to expand their point-of-care diagnostics growth by focusing on speeding up the time between diagnosis and treatment of sexually transmitted diseases. Binx io is the FDA-cleared platform by which Binx aims to accelerate the speed of diagnosis and treatment for sexually transmitted infections. Results from tests for chlamydia and gonorrhea return within 30 minutes.

Product Segment Accounts for Significant Market Share

The glucose monitoring segment is the most dominant in the Point-of-Care Diagnostics market, as diabetes prevails highly in the United States and constantly forces the demand for better self-monitoring products that are easy to use. The advancement of technologies, such as continuous glucose monitors and smart devices, which can be connected to a mobile application, drive this segment that gives the user real-time data and insights. Further, health initiatives that are coming up in the form of diabetes management and education are pushing for the adoption of these tools. Glucose monitoring is thus gaining dominance through the enormous investment it brings into market growth while improving patient engagement and outcomes, thus becoming an important area in the healthcare sector.

For instance, in August 2024, DexCom, Inc. introduced the Stelo, the first over-the-counter glucose biosensor in the U.S. This small device is used to be worn on the upper arm, uses advanced sensing technology to provide personalized glucose insights to the 125 million Americans who suffer from Type 2 diabetes and prediabetes.

Future Market Scenario (2024-2031F)

The integration of artificial intelligence and machine learning in diagnostic devices will ensure accurate and more efficient test results. A significant expansion of telehealth services would also occur since consultation through remote platforms often requires rapid turnaround solutions to ensure the timely treatment of patients. As the trends evolve, the scope for a point-of-care diagnostics market will flourish with a holistic transformation in healthcare delivery.

Increasing investments along with enhanced awareness are promising signs of further expansion of the point-of-care diagnostics market. For example, in April 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) funded USD 1 million to Scout Health Inc. (previously known as Uh-Oh Labs, Inc.), a diagnostics and health-tech company, to develop the STI Scout test, which can differentiate Neisseria gonorrhoeae from Chlamydia trachomatis in just 30 minutes, quickly and affordably.

Key Players Landscape and Outlook

The major players for point-of-care diagnostics in the United States focus on strategic alliances, product innovation, and expanding their channel network distribution to enhance market positions. Investments in research and development will be utilized to introduce new diagnostic solutions at the cutting edge of healthcare demand.

In September 2024, Cepheid Inc. (Cepheid) collaborated with the Fleming Initiative and committed itself to combat global antimicrobial resistance, a global collaboration being spearheaded by Imperial College Healthcare NHS Trust and Imperial College London. Cepheid has become the first diagnostics company to join this endeavor as it applauds its new partnership at an event in New York to coincide with the UN General Assembly High-Level Meeting on AMR.

In June 2022, Visby Medical, Inc. added USD 35 million to its already existing funding round, Series E financing round, taking the total amount to over USD 135 million. Supported by Lightrock LLP, the new capital will help Visby Medical grow its production capacity, increase product lines with advanced respiratory health tests and antimicrobial resistance panels, and provide at-home PCR diagnostics.