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In recent years, the healthcare industry has witnessed immense growth in the screening and diagnostics segment. The incorporation of new-age technologies is bringing several life-saving revolutions to the market and improving the overall health outcomes for the patient. Digitization, innovation, newer hybrid business models, and the use of real-time health data and metrics are providing new insight and addressing various critical problems impacting the healthcare market. Similarly, point-of-care diagnostics (POCD) or point-of-care testing (POCT) is an evolving concept in healthcare and is gaining tremendous momentum and growth in demand. As compared to traditional laboratory testing, point-of-care testing has a rapid turnaround time and can provide a better disease diagnosis, monitoring, and management option. Moreover, it holds the potential to deliver higher-quality care as the diseases can be diagnosed at a very early stage, thereby enabling the early start of treatment.
What is Point-of-Care Diagnostics (POCD)?
Point-of-care testing, also known as near-patient testing (NPT), is a type of testing in which the analysis is performed where healthcare is provided close to or near the patient or outside the laboratory. Point-of-care testing is often called by other terms, such as physician’s office testing (POL), off-site testing, bedside testing, and alternative site testing, among others. Preparing the samples and then sending them safely to be tested in medical laboratories is a long and tiring process. It can further lead to wastage of time in critical situations, majorly when the patient is being treated without the actual diagnostic results. Therefore, point-of-care testing has enabled an easy way to test without any hassle and fast and reliable results. With the help of diagnostic results, the medical practitioner can easily make necessary informed decisions about the patient’s treatment and care. POCT can be conducted anywhere, like a pharmacy, ambulance, primary care, nursing home, aged care center, sports clinic, or critical care facility in a major hospital, hospital ward, or hospital clinic. Moreover, Point-of-care testing can be done at home using self-testing devices. The most common point-of-care tests are blood glucose monitoring and home pregnancy tests.
POCT can produce test results within minutes and are generally portable. In recent years, the advancement in technology and a growing need to expand access to testing for diverse test settings have led to the growth of the point-of-care testing market. Point-of-care testing improves patient outcomes with a higher quality of care by providing immediate information to the physicians about the patient’s condition and has led to the decentralization trend in in-vitro diagnostics (IVD) testing. Continuous developments in biosensors, microfluidic, bioanalytical platforms, assay formats, lab-on-a-chip technologies, and complementary technologies are driving the Point-of-care diagnostics (POCD) market.
The devices or kits for point-of-care testing come in several variants and different forms. The test may include basic dipsticks as used during urinalysis, handheld device forms like glucometers, or molecular analyzers for detecting infectious ailments. A healthcare practitioner can also additionally use a handheld tool to carry out the checkup process on the patient. Alternatively, the practitioner can also accumulate a blood pattern from the affected person and take the sample straight to the laboratory, where the pattern is processed and examined on instrumentation.
Currently, several types of point-of-care diagnostics products are available in the market, such as instruments, reagents, and kits. Similarly, these point-of-care diagnostics have immense application for the detection and diagnosis of various diseases and disorders such as blood glucose monitoring, drug of abuse (DOA) testing, urinalysis/nephrology, Hb1Ac testing, coagulation testing, pregnancy & infertility testing, cardiac markers, thyroid stimulating hormone, hematology, feces, lipid testing, cancer marker, blood gas/electrolytes, and others.
In the application segment of the point-of-care diagnostics market, the infectious disease category is anticipated to hold a significant market revenue share in the coming years. Some of the key factors, such as rising product approvals pertaining to infectious diseases and growth in research and development associated with POC kits that help diagnose infectious diseases, will stimulate the market for the infectious diseases category of point-of-care diagnostics.
Who Can Perform Point-Of-Care Testing?
Most of the staff members who perform point-of-care tests are usually not trained or do not have the right knowledge to carry out the process involved in testing. Most tasks unknown to most staff members include patient preparation, collecting samples, calibration of instruments, maintenance of instruments, and quality control. Therefore, the person performing the test should have proper knowledge and training to ensure competency assessment for better and more accurate results. Furthermore, laboratory staff may take complete responsibility for certain point-of-care test activities, including instrument maintenance and ensuring accurate results. The qualifications are necessary for a staff member to perform tests, including verifying state or national authority requirements and accreditation agencies. Each practitioner performing point-of-care testing should complete the initial training and orientation on every test type before practicing or making any changes in the update of instruments
Is Point-Of-Care Testing Accurate?
Point-of-care testing has downsides, despite its vital contribution to medical diagnostic strategies. It may not always be the best option, as point-of-care testing is not always as precise and accurate as conventional lab-based techniques and falls short of sensitivity and specificity associated with laboratory analyzers. Therefore, considering it, laboratory and other medical professionals try to balance the results obtained by the point-of-care testing method’s rapid turnaround and positive effect on patient care with the more robust results available through lab-based testing. Moreover, it is quite important to understand the intensity of fluctuations in the results of the point-of-care testing instruments.
Advantages of POC Testing
Point-of-care testing has several benefits. Some of these include:
- Reduced duration for diagnostic testing and rapid results availability.
- Reduction in time for availability of data.
- Reduction in pre- and post-analytic errors and fluctuations.
- POC testing can include several samples like the patient’s saliva, blood, or urine on the same patient.
Disadvantages of POC Testing
Despite several benefits associated with point-of-care testing, there are some limitations to it, which are as follows:
- Lack of precision and accuracy in the results.
- Lack of trained practitioners to carry out the test in the appropriate manner.
- Lack of quality control and quality assurance.
- Technical issues like the interconnectivity of devices, machines, and readers, may hamper the result, which needs to be addressed appropriately.
Point of Care Diagnostics Market Dynamics
Globally, the demand for point-of-care diagnostics products is growing significantly as it is faster than laboratory testing and provides quick results. Alternatively, it can result in faster implementation of therapy if required. Recently, the rising prevalence of COVID-19 globally has attributed to increased demand for POC kits for COVID-19 detection. Despite the deceased in Covid-19 cases and the high vaccination rate, the point-of-care diagnostics Market will continue to grow in the upcoming years. As per DelveInsight’s assessment, the point-of-care diagnostics market is anticipated to register growth owing to a rise in the number of patients suffering from chronic disorders (such as diabetes, cardiovascular disorders, infectious diseases, and others), rising prevalence of geriatric population susceptible to developing chronic diseases, an increase in technological advancements & innovation, and active participation of MedTech and HealthTech giants in product development. The lack of adequate healthcare infrastructure is a major challenge in developing countries. Adopting point-of-care diagnostics can overcome several challenges and fulfill diagnostic needs in these countries. However, some of the critical aspects, such as stringent regulatory policies pertaining to the approval and commercialization of new point-of-care diagnostics devices, may restrict the market growth.
Key Companies in the Point-of-Care Diagnostics Market
Globally, several leading MedTech and HealthTech companies are actively working in the point-of-care diagnostics market, which includes Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Becton Dickinson and Company, Abbott Laboratories, Quidel Diagnostics, Chembio Diagnostics, EKF Diagnostics, Trinity Biotech, and Fluxergy, Qiagen, Mesa Biotech, Cepheid, Thermo Fisher Scientific Inc., Quest Diagnostics Incorporated, Quidel Corporation, and others. Some of the companies have established their dominance in particular markets and product segments, leaving limited opportunities for new entrants.
Similarly, companies are now focussing on adopting and implementing advanced technologies, such as wearable technology, smartphone-based technology, artificial intelligence, and cloud-based deep learning, to manufacture more efficient and effective point-of-care diagnostics and maintain competitive dominance. Similarly, companies are actively investing and exploring opportunities such as miniaturization in chip technology, microfluidics, and new biosensors.
Recent Developments and Breakthroughs in the Point-of-Care Diagnostics Market
Over the past few years, several key developments have been registered in the point-of-care diagnostics market regarding product approval and launches. Globally, several key companies are active in the point-of-care diagnostics market, and many have entered the segment recently with new and innovative solutions to cater to different needs and grab the market share. Due to high demand from the consumer side, the point-of-care diagnostics market anticipates higher returns and revenue.
Some of the recent clinical, commercial, and regulatory developments in the point-of-care diagnostics market include:
- On November 28, 2022, Chembio Diagnostics, Inc. announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System. Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples.
- On November 12, 2022, iHealth Labs received the FDA Emergency Use Authorization for the over-the-counter sale of the COVID-19 Antigen Rapid Test.
- On October 11, 2022, Takara Bio Europe received CE-IVD Mark for COVID-19 Diagnostic kit, SARS-CoV-2 Direct polymerase-chain-reaction (PCR) diagnostic detection kit.
- On August 24, 2022, NanoDx announced the first commercially ready nano biosensor to yield a protein response. The unique size and electrical properties of nanosensors allow the detection of biomarkers and infections never before possible in a simple, portable point-of-care system. This milestone enables NanoDx to prepare and submit the product for FDA review and eventual commercialization.
Future Perspective and Analysis – Point-of-Care Diagnostics Market
With each passing day, the role of point-of-care diagnostics is growing at an unprecedented rate due to its wide range of applications and benefits in patient health management. Point-of Care Diagnostics has a critical role in reducing the time to treatment, enabling the classification and identification of symptoms, and detecting the disease. In recent years, several prospective Points of Care Diagnostics devices have been developed and launched by major MedTech giants in the market. The biosensor is the most critical element of POCD, used for the bioanalytical performance of an assay. Several prospective label-free biosensors, such as electrochemical, surface plasmon resonance (SPR), white light reflectance spectroscopy (WLRS), etc., have been developed and are being used for improved POCD. Similarly, the growth in the Complementary technologies such as microfluidics, lab-on-a-chip technologies, system integration, device automation, and signal readout is also providing valuable stimulus to and continuous improvements in point-of-care diagnostics.
With the growing technological advancements, the POCD is increasingly moving toward smart devices equipped with mobile healthcare, which is expected to lead to more personalized healthcare monitoring and management system, thereby paving the way for next-generation POCT. Moreover, several mobile health technologies have already been developed and available in the market that can provide the most promising point-of-care diagnostics benefits. The rise in cellphone users is expected to contribute significantly to the growth of point-of-care diagnostics. In the coming years, the growth and development of next-generation POCT devices with advanced features and applications are expected to resolve the existing gaps and make better decisions. As per DelveInsight’s analysis, the global point-of-care diagnostics market was valued at USD 1.85 billion in 2021 and growing at a CAGR of 7.99% during the forecast period (2022 to 2027); it is expected to reach USD 2.93 billion by 2027. The demand for point-of-care diagnostics is growing owing to the rising number of patients suffering from various infectious diseases, the rising prevalence of diabetes, the increasing frequency of both chronic and acute diseases, and the increasing technological advancements, and rising awareness associated with self-testing and rising demand of home care testing.