US Point-Of-Care Testing (POCT) Market Size 2024-2028
The US point-of-care testing (POCT) market size is forecast to increase by USD 10.22 billion at a CAGR of 9.45% between 2023 and 2028. The Point-Of-Care Testing (POCT) market in the US is experiencing significant growth due to several key drivers. The rising prevalence of chronic diseases necessitates frequent and timely diagnostic testing, leading to increased demand for POCT devices. Technological advancements in POCT devices, such as lateral flow assays, immunoassays, microfluidics, dipsticks, and molecular diagnostics, are improving test accuracy and convenience. Additionally, stringent regulation policies ensure the quality and safety of POCT devices, instilling confidence in healthcare providers and patients. Urinalysis testing products and drug-of-abuse testing products are particularly popular in this market due to their ease of use and quick results. Overall, the POCT market in the US is poised for continued growth as it provides cost-effective, efficient, and accessible diagnostic solutions.
What will be the Size of the Market During the Forecast Period?
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The Point-of-Care Testing (POCT) market in the US is witnessing significant growth due to the increasing prevalence of chronic ailments, cardiovascular diseases, and infectious illnesses. POCT devices enable healthcare professionals to make accurate treatment decisions at the patient's bedside, reducing the need for lengthy laboratory tests and minimizing the turnaround time for results. The growing burden of infectious diseases such as influenza, tuberculosis, malaria, and Ebola virus disease drives the US POCT market. According to the Centers for Disease Control and Prevention (CDC), influenza affects millions of Americans each year, leading to hospitalizations and deaths.
Moreover, POCT devices can provide quick and accurate results for influenza diagnosis, enabling timely treatment and reducing the spread of the disease. Moreover, the decentralization of healthcare and reimbursement cuts have led to the adoption of POCT devices in both government and private institutions. POCT devices are particularly useful in resource-limited settings, such as emergency departments, clinics, and remote locations, where access to central laboratories is limited. The US POCT market is witnessing innovation in mobile diagnostic devices, which are becoming increasingly popular due to their portability and ease of use. These devices are particularly useful in infectious disease diagnosis, genetic disorders, and congenital heart defects.
For instance, Cepheid's GeneXpert system is a POCT device that can diagnose tuberculosis, influenza, and other infectious diseases in under an hour. The cancer segment is another growing area for POCT devices, with personalized medicine becoming increasingly important in cancer treatment. POCT devices can provide accurate and timely results for cancer biomarkers, enabling personalized treatment plans and improving patient outcomes. However, the US POCT market faces challenges such as regulatory requirements, high costs, and the need for skilled personnel to operate the devices. To overcome these challenges, POCT device manufacturers are focusing on developing user-friendly devices, reducing costs, and partnering with healthcare providers to offer training and support.
In conclusion, the US POCT market is witnessing significant growth due to the increasing burden of chronic diseases, the need for quick and accurate diagnosis, and the decentralization of healthcare. POCT devices are particularly useful in infectious disease diagnosis, cancer treatment, and emergency settings. However, challenges such as regulatory requirements, high costs, and the need for skilled personnel need to be addressed to fully realize the potential of POCT devices in the US healthcare system.
Market Segmentation
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.
- Type
- OTC testing
- Prescription-based testing
- Application
- Blood glucose testing
- Infectious diseases testing
- Cardiac markers testing
- Pregnancy and fertility testing
- Others
- Geography
- US
By Type Insights
The OTC testing segment is estimated to witness significant growth during the forecast period. Point-of-Care Testing (POCT) has witnessed significant growth in the US healthcare sector due to its ability to provide quick and accurate results for various medical conditions. This testing is performed at or near the site of patient care, allowing for timely diagnosis and treatment of multiple medical diseases, including cancer markers and infectious illnesses. The clinic end-use segment holds a prominent position in the POCT market due to the high volume of patients requiring regular testing for chronic ailments such as cardiovascular diseases.
Moreover, POCT has proven to be instrumental in the diagnosis of critical conditions like Ebola virus disease. The convenience and affordability of POCT have made it an essential tool for patient management, particularly for individuals with limited access to healthcare facilities. OTC testing, a segment of POCT, has gained popularity due to its ease of use and availability for conditions such as pregnancy and diabetes. With the increasing prevalence of various medical conditions, the demand for POCT is expected to continue its upward trend in the US market.
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The OTC testing segment was valued at USD 8.08 billion in 2018 and showed a gradual increase during the forecast period.
Market Dynamics
Our market researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
US Point-Of-Care Testing (POCT) Market Driver
The growing prevalence of chronic diseases is the key driver of the market. Point-of-care testing (POCT) has gained significant importance in the US healthcare landscape due to the increasing prevalence of chronic diseases and the need for faster and more convenient testing options. Diabetes, a chronic condition affecting approximately 37.3 million Americans and 28.5 million adults with prediabetes, puts immense pressure on the healthcare system. POCT devices, such as blood glucose monitors, have become indispensable for diabetes management due to their ease of use and quick results. Beyond diabetes, POCT plays a crucial role in managing multiple medical diseases, including infectious illnesses like influenza, tuberculosis, and malaria, and chronic ailments like cardiovascular diseases.
Additionally, POCT is particularly valuable in resource-limited settings and emergency situations, where timely diagnosis and treatment decisions are essential. The POCT market in the US comprises various product segments, including glucose monitoring products, cardiometabolic monitoring products, coagulation monitoring products, hematology testing products, urinalysis testing products, drug-of-abuse testing products, cholesterol testing products, lateral flow assays, immunoassays, microfluidics, dipsticks, molecular diagnostics, mobile diagnostic devices, and more. Despite the benefits, POCT faces challenges such as pre-analytical and post-analytical errors, reimbursement cuts, and limited resources in healthcare facilities. Reimbursement rates for POCT services vary, and government and private institutions play a significant role in setting these rates.
Innovative technologies like biosensors, nephrology testing segment for kidney failures, and personalized medicine through cancer segment and cancer markers are driving the growth of the POCT market. Companies like Sensible Diagnostics, Cepheid GeneXpert, and mobile healthcare solutions such as the Cobas pulse system are leading the way in POCT technology advancements. In conclusion, POCT is a vital component of the US healthcare system, providing faster and more convenient testing options for various medical conditions. With the increasing prevalence of chronic diseases and the need for efficient and accessible testing, POCT will continue to be a growing market in the US.
US Point-Of-Care Testing (POCT) Market Trends
The technological advancements in POCT devices are the upcoming trends in the market. Point-of-Care Testing (POCT) market in the US has witnessed significant growth due to the integration of advanced technologies, enabling faster and more accurate diagnostic results at healthcare facilities and remote locations. One such innovation is the implementation of wireless connectivity in POCT devices, allowing real-time data transmission to electronic health records, minimizing manual data entry, and reducing pre- and post-analytical errors. For example, wireless glucose meters facilitate effective diabetes management by automatically sending blood sugar levels to patients' smartphones or healthcare providers. In the context of infectious diseases, POCT devices play a crucial role in diagnosing and managing conditions such as influenza, tuberculosis, malaria, and Ebola virus disease in emergency settings.
Similarly, POCT devices are also instrumental in diagnosing and monitoring chronic ailments like cardiovascular diseases, congenital heart defects, and genetic disorders, as well as multiple medical diseases and infectious illnesses. The US POCT market encompasses various product segments, including glucose monitoring products, cardiometabolic monitoring products, coagulation monitoring products, hematology testing products, urinalysis testing products, drug-of-abuse testing products, cholesterol testing products, lateral flow assays, immunoassays, microfluidics, dipsticks, molecular diagnostics, and mobile diagnostic devices. Notable brands include Sensible Diagnostics, Cepheid GeneXpert, and Cobas pulse system. Healthcare decentralization and resource-limited settings have driven the demand for POCT devices, particularly in middle-income countries and among government and private institutions.
Despite the benefits, reimbursement cuts and limited resources pose challenges to the market's growth. Regardless, POCT devices' role in personalized medicine and patient management continues to expand, making them an essential component of the US healthcare landscape.
US Point-Of-Care Testing (POCT) Market Challenge
Stringent regulation policies on POCT devices is a key challenge affecting the market growth. In the US healthcare landscape, Point-of-Care Testing (POCT) plays a pivotal role in enabling quick treatment decisions for various medical conditions, including influenza, tuberculosis, and malaria, among others. POCT devices are essential in healthcare decentralization, particularly in resource-limited settings and emergency situations. However, reimbursement cuts pose a challenge to the POCT market's growth. The US reimbursement rates for POCT devices are often lower than those for laboratory tests, which can limit the adoption of these devices in healthcare facilities. Pre-analytical and post-analytical errors are potential concerns in POCT, affecting the accuracy of test results. To mitigate these errors, various POCT technologies, such as lateral flow assays, immunoassays, microfluidics, dipsticks, molecular diagnostics, and mobile diagnostic devices, are being utilized.
However, these technologies offer advantages like portability, ease of use, and rapid turnaround time. The US POCT market comprises various segments, including glucose monitoring products, cardiometabolic monitoring products, coagulation monitoring products, hematology testing products, urinalysis testing products, drug-of-abuse testing products, cholesterol testing products, and cancer markers. The cancer segment is a significant contributor to the market's growth. The clinic end-use segment is also gaining traction due to the increasing prevalence of multiple medical diseases, infectious illnesses, chronic ailments, cardiovascular diseases, and Ebola virus disease. The US POCT market is regulated by stringent policies to ensure the safety, accuracy, and effectiveness of these devices.
In conclusion, the US Food and Drug Administration (FDA) is the primary regulatory body that requires manufacturers to obtain clearance or approval before marketing their POCT devices. The FDA evaluates these devices based on their intended use, performance, and potential risks to patients. The FDA classifies certain POCT devices into different risk categories, such as class I, II, or III, based on their potential harm to patients. In conclusion, POCT devices play a crucial role in the US healthcare system by enabling quick treatment decisions in various medical conditions. The market's growth is driven by the increasing prevalence of multiple medical diseases, infectious illnesses, chronic ailments, and cardiovascular diseases.
However, challenges like reimbursement cuts and potential errors in POCT devices necessitate continuous innovation and regulatory oversight to ensure the safety, accuracy, and effectiveness of these devices.
Exclusive Customer Landscape
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
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Customer Landscape
Key Companies & Market Insights
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Abbott Laboratories - The company offers POCT such as Alinity I System.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
- ACON Laboratories Inc.
- Becton Dickinson and Co.
- Bio Rad Laboratories Inc.
- Boditech Med Inc.
- Cardinal Health Inc.
- Chembio Diagnostics Inc.
- Danaher Corp.
- ELITechGroup SAS
- F. Hoffmann La Roche Ltd.
- Heska Corp.
- iAssay Inc.
- Johnson and Johnson Services Inc.
- Nova Biomedical Corp.
- OraSure Technologies Inc.
- Phamatech Inc.
- Princeton BioMeditech Corp.
- Quest Diagnostics Inc.
- QuidelOrtho Corp.
- Sekisui Chemical Co. Ltd.
- Trivida Health Inc.
- Zoetis Inc.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
Research Analyst Overview
Point-of-Care Testing (POCT) in the US market is transforming healthcare by enabling treatment decisions at the frontlines. POCT devices are particularly crucial in managing infectious diseases like influenza, tuberculosis, malaria, and Ebola virus disease. Healthcare decentralization and resource-limited settings benefit significantly from POCT, reducing pre- and post-analytical errors and relying less on central laboratories. Reimbursement cuts pose challenges for healthcare facilities, but POCT's cost-effectiveness and efficiency make it a valuable investment. POCT caters to various medical needs, including glucose monitoring products, cardiometabolic monitoring products, coagulation monitoring products, hematology testing products, urinalysis testing products, and drug-of-abuse testing products. Middle-income countries and both government and private institutions increasingly adopt POCT for genetic disorders, congenital heart defects, infectious diseases, and chronic ailments like cancer and cardiovascular diseases.
In summary, POCT's role extends to emergency settings, personalized medicine, and mobile healthcare, with technologies like lateral flow assays, immunoassays, microfluidics, dipsticks, molecular diagnostics, and mobile diagnostic devices. POCT's segments include cancer, clinic end-use, and nephrology testing, catering to multiple medical diseases and infectious illnesses. Biosensors technology and Cepheid Genexpert are leading POCT innovations, while Cobas Pulse System and mobile healthcare solutions further expand its reach. POCT's role in patient management is indispensable, offering accurate, timely results and improving overall healthcare efficiency.
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Market Scope |
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Report Coverage |
Details |
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Page number |
146 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 9.45% |
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Market growth 2024-2028 |
USD 10.22 billion |
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Market structure |
Fragmented |
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YoY growth 2023-2024(%) |
8.42 |
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Key companies profiled |
Abbott Laboratories, ACON Laboratories Inc., Becton Dickinson and Co., Bio Rad Laboratories Inc., Boditech Med Inc., Cardinal Health Inc., Chembio Diagnostics Inc., Danaher Corp., ELITechGroup SAS, F. Hoffmann La Roche Ltd., Heska Corp., iAssay Inc., Johnson and Johnson Services Inc., Nova Biomedical Corp., OraSure Technologies Inc., Phamatech Inc., Princeton BioMeditech Corp., Quest Diagnostics Inc., QuidelOrtho Corp., Sekisui Chemical Co. Ltd., Trivida Health Inc., and Zoetis Inc. |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast , fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the market forecast period |
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Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
What are the Key Data Covered in this Market Research Report?
- CAGR of the market during the forecast period
- Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
- Precise estimation of the size of the market and its contribution of the market in focus to the parent market
- Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
- Growth of the market across US
- Thorough analysis of the market's competitive landscape and detailed information about companies
- Comprehensive analysis of factors that will challenge the growth of market companies
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