POC diagnostics – Coming into its own

Point-of-care testing has long been touted as a revolutionary technology potentially transforming healthcare. The development of POC diagnostic testing accelerated unparalleled during the Covid-19 pandemic.

Point-of-care (POC) technologies moved into the spotlight during the recent pandemic. Empowering both patients and clinicians and delivering swift, accurate results, they transformed medical decision making. They recognized its value in non-hospital settings.

The versatility and challenges of POC testing
POC diagnostics are used across care settings, from consumers’ homes to bedsides in hospital intensive care units. The POC diagnostic industry marks the shift from curative to predictive medicine, with millions spent annually on the market globally. This represents the middle ground between rapid testing performed near a low complexity and the advanced technology that uses clinical molecular diagnostics. To this end, POC diagnostics seek rapid results with an ease-of-use operation.

POC testing involves conducting diagnostic tests outside the laboratory. These tests are utilized for quick and reliable results in detecting chronic diseases and acute infections. However, inaccurate results can reduce demand for POC testing, compared to traditional laboratory testing alternatives. The accuracy of POC devices can be compromised due to factors such as user error, environmental conditions, and limitations in technology.

Additionally, the cost-effectiveness of these devices is often a concern, particularly in resource-limited settings. The regulatory landscape for POC testing is also complex and varies by region, posing challenges for manufacturers and end users. Improvements in POC devices’ sensitivity, specificity, cost, and turnaround time for test results could enhance their utility. Enhancements to a POC device should be considered if they are economically viable and lead to a significant increase in demand.

Global market
The global POC diagnostics market is estimated to reach USD 77.8 billion by 2028, from USD 49.7 billion in 2023, growing at a CAGR of 9.7 percent.

From 2019 to 2021, the demand for POC diagnostics solutions grew by over 15 percent. The market can be understood as infectious disease POC diagnostics and non-infectious disease POC diagnostics. While the market for infectious disease testing is relatively larger, holding over 60 percent of the demand, non-infectious diseases such as HIV, cardiovascular problems, and others are also gradually adopting POC testing.

The increasing prevalence of conditions, such as cardiac disorders, diabetes, and infectious diseases, among others, and owing to several benefits, such as the potential to generate quick results and efficiency, among others, are leading to a growing number of patients undergoing POC testing procedures globally.

Along with this, the rising focus of the market players on developing and introducing products with advanced technology and features in various testing kits, including infectious diseases testing kits, urinalysis testing kits, and hematology testing kits, is another significant factor contributing to the growing demand for these devices in the market.

The increasing demand for novel products, along with the robust efforts of the key players, is leading to the development and introduction of products with advanced technology and features.

Major market players have increased their focus on adopting advanced technologies such as artificial intelligence, Internet of Things (IoT), and machine learning, among others, to manufacture efficient diagnostic tests.

Miniaturization and increased mobility of the POC testing devices are a few more features that are included in these devices owing to technological advancements. These technological advancements enable bioassays, such as microbiological culture, enzyme-linked immunosorbent assays (ELISA), and polymerase chain reaction (PCR), to be used at the point of care.

Therefore, the increasing R&D focus of the market players and rising initiatives by the government bodies and national and international healthcare organizations to create awareness regarding testing for various chronic conditions are expected to fuel the technological advancements in the products.

The increase in POC diagnostic testing has become crucial for patient-centric healthcare due to the rapid diagnosis results required for accurate and quicker treatment decisions. A shift from centralized POC testing to decentralized testing for chronic and infectious diseases has resulted in convenient patient access to these diagnostics.

The increase in the demand for fast turnover testing has allowed many players to develop infectious disease tests for decentralized locations.

Remarkably, the Covid-19 pandemic has increased regulatory agencies’ willingness to expedite the approval of diagnostic products. The US National Institutes of Health (NIH) Point-of-Care Technologies Research Network (POCTRN) introduced the Rapid Acceleration of Diagnostics (RADxSM) initiative in April 2020.

With the development of novel applications in fields like non-invasive prenatal and oncology, the market for POC diagnostic testing through next-generation sequencing (NGS) and other genetic technologies is predicted to expand steadily.

Despite the advantages of POC technology, it has yet to achieve widespread adoption, accounting for less than 15 percent of the IVD market, compared to routine testing. Significant barriers include limited accuracy and high costs. In emerging countries, underdeveloped healthcare infrastructure and poor connectivity result in manual record entry, leading to errors, delays, and increased costs. Additionally, the lack of standardization across devices and tests, high expenses, and the need for proper training of healthcare professionals pose challenges. Clinicians may also be skeptical of results from unaccredited personnel, further hindering adoption.

Segment insights. In 2023, the blood glucose monitoring segment dominated the global POC diagnostics market, by product segment. This is due to the rising prevalence of diabetes among the population and the growing focus of the market players on developing and introducing products with advanced features and technology.

The hospital bedside segment dominated the market in 2023, based on end-users. The rising adoption of advanced POC testing devices and instruments in hospitals in developed countries, improvement in healthcare infrastructure, and rising investments by public and private sectors in emerging countries, owing to rising healthcare expenditures among these countries, are some of the vital factors fueling the growth of the segment in the market.

Regional insights. North America generated revenue of USD 10.92 billion in 2023, and dominates the market. The intense penetration of advanced POC diagnostics to detect various chronic and infectious diseases, the growing funding environment, and the availability of favorable reimbursement policies are likely to boost market growth in the region.

Europe’s market for POC diagnostics captured a notable share in 2023, and is anticipated to grow at a steady CAGR. Key players in Europe are focusing on the launch of rapid diagnostic tests for time-efficient diagnosis of infectious diseases. Moreover, the government has invested in R&D activities to strengthen the diagnostics sector for highly advanced POC diagnostic tests. These factors support the market growth in the region.

Moreover, Asia-Pacific is expected to expand at a significant CAGR. The increasing prevalence of infectious and chronic ailments across the region will likely propel the adoption of POC diagnostic tests.

Innovations and future directions in POC diagnostics
POC technologies are used at the location of patient care, encompassing a spectrum of settings from near-patient laboratories within hospitals and emergency departments to outpatient clinics, community settings, and even patients’ homes. The uncontrolled environments in which these POC technologies are used and the absence of training for the intended users present significant potential for human error. Controlled environments with trained users often include near-patient labs in inpatient settings like intensive care units (ICUs) or emergency departments (EDs). A trained staff member collects specimens, and testing is performed at or near the patient in an optimized environment. Ideally, the temperature and humidity are regulated, and there is adequate space and lighting, as well as limited noise distraction. The user (e.g., medical technician, respiratory therapist, nurse, physician assistant, and the physician) has been trained and follows a standardized protocol. These settings are regulated by hospital policy and external regulatory agencies. Oftentimes, these settings are linked to a centralized clinical laboratory where a gold standard test or follow-up testing can be performed to verify POC results. The results are then interpreted by a medical professional who makes a clinical decision.

There are few, if any, points of human–human interaction. Despite the simplicity of information flow in this setting, there is no regulation of the testing process or environment, and home environments can vary considerably. For example, there may be poor light and increased humidity. Users in a home setting are likely to experience distractions or interruptions. This variability of the home environment may influence the accuracy of testing.

Additionally, self-testing, while a user is ill and therefore not at peak performance, adds another challenge to what might already be a novel experience. In the home setting, interpretation of results and medical decision making may also be challenging. Depending upon a person’s medical literacy, the implications of a test result may not be clear. Without the guidance of a trained medical professional, who can explain the meaning of a result, a person may experience uncertainty and anxiety about what to do with the information they have obtained.

Environmental control and user training are two variables that must be considered in the design and implementation of POC technologies. Knowledge of human factors provides the tools for addressing these and is a needed skill for engineers and clinicians alike.

Rapid deep learning-assisted predictive diagnostics for POC testing are being explored to enhance sensitivity and reduce assay time for diagnostic tests. Prominent techniques, such as real-time polymerase chain reaction (RT-PCR), enzyme-linked immunosorbent assay (ELISA), and rapid kits, are currently being used. Existing commercial molecular methods typically take several hours, while immunoassays can range from several hours to tens of minutes. Rapid diagnostics are crucial in POC testing, an approach that integrates a time-series deep learning architecture and AI-based verification for the enhanced result analysis of lateral flow assays. This approach applies to both infectious diseases and non-infectious biomarkers. In blind tests using clinical samples, the method achieved diagnostic times as short as 2 minutes, exceeding the accuracy of human analysis at 15 minutes.

Furthermore, such a technique significantly reduces assay time to 1–2 minutes in the POC test setting. This advancement has the potential to dramatically enhance POC test diagnostics, enabling both healthcare professionals and non-experts to make rapid, accurate decisions.

The potential areas for growth in the POC testing industry could focus on integrating intelligent technologies into POC testing devices and collaborating with the innovative technology sector to increase revenue. Developing more sensitive and accurate POC testing devices for non-communicable diseases, requiring continuous patient monitoring, could revolutionize medical diagnosis and potentially save many lives, provided they meet clinical standards.

What is on the horizon?
POCT in the horizon will be increasingly adopted for inpatient, outpatient, and non-clinical settings, such as homes and airports.

Diagnostic companies are investing in expanding their rapid testing portfolio by covering more therapy areas – such as rapid testing cancer biomarkers for common cancers to better support patients at home.

Advances in biosensor technology and microfluidics have improved the accuracy and sensitivity of POC testing devices while allowing for multiplexing. The high penetration of smartphones has made it possible to develop POC testing devices that can connect to the internet and transmit data to healthcare providers in real time. This allows healthcare providers to monitor patients’ health conditions more closely and offer timely intervention.

Next technology revolutionizing the POC testing market
Syndromic/multiplex testing in POC molecular diagnostics can significantly enhance primary care by providing simple tests to detect multiple pathogens, leading to faster and more accurate diagnoses. Improving these tests’ accuracy, reliability, and cost could further empower primary care providers. New multiplex tests now include up to 30 assays, with some offering more than 50.

Artificial Intelligence (AI) is the next game changer, with physicians viewing AI as a tool for clinical decision support. Innovative POC solutions that integrate AI with connected health – linking test results to hospital EMRs and aiding in result interpretation – will be particularly appealing in the post-Covid era, amid significant healthcare workforce shortages.

Connectivity has demonstrated the effectiveness of self-testing combined with telemedicine, empowering patients and alleviating healthcare system’s burdens. Supported by telemedicine, home tests help filter patients needing at-home symptom management from those requiring complex treatments. While home tests provide initial screening, they do not replace laboratory testing. Additionally, with widespread smartphone use, data from POC devices can be collected and managed, enhancing patient monitoring by clinicians.

Outlook
Overall, POC testing is a powerful tool with the potential to improve healthcare delivery in several ways. As POC testing technology continues to advance, it will likely play an even greater role.