Need for Rapid and Accurate Results are increasing The Technological Advancements in POCD Market
In laboratory diagnostics, the field of Point of Care Testing/Diagnostics (POCT/POCD) is growing significantly. POCD is performed outside the clinical laboratory at or near the site of patient care in order to improve the Therapeutic Turnaround Time (TTAT) with the effectiveness of lab testing. The driving concept in support of POCT is to bring the test conveniently and to obtain the results quickly that enables clinicians to support the early diagnosis, monitoring and helps in deciding further treatment. Some of the major point of care diagnostic test includes glucose monitoring, infectious disease tests, coagulation monitoring, cardiometabolic disease tests, urinalysis tests, Pregnancy and fertility tests, etc., In addition to these applications, the POCD field is expanding to include rapid molecular diagnostics in autoimmune diseases and cancer diagnostics and all these POCT can be performed in hospitals, home, clinics, emergency department, ambulances, military, etc.
The speed factor is the major key characteristic of POCD as, rapid diagnosis facilitates faster patient management and another important factor is that it generally requires less sample volume than tests performed in the central laboratory. However, these benefits come with a monetary cost, as POCT is usually more expensive than tests performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements. Also, the accuracy and sensitivity issues are the main factors restraining the wide adoption of point of care diagnostics. Hence, the long-term use of POCT will only be a viable option if all the requirements of accuracy, reliability, and timeliness for all test results are met. It is especially much needed in the present medico-legal environment that each testing site re-evaluates their POCT program for accuracy and reliability based on patient care outcomes.
The Recent advancements in technologies include microfluidics, miniaturised sensors, Smart-phone based apps, wearable devices and also digitalized wrist type portable glucose meters for monitoring glucose levels are collectively contributing to the growth of POCD technologies. For Instance, In March 2016, Dexcom, Inc., a leader in continuous glucose monitoring (CGM) for people with diabetes, announced that the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System will support the Apple Watch enabling users to monitor their G5 Mobile glucose data using the app with one glance of their wrist. Microfluidic technologies enable the ultra-small volume of body fluid to be manipulated on disposable plastic cartridges. Recently, there has been an increase in interest to incorporate POC biosensors with microfluidics, which has permitted the miniaturisation of conventional techniques to enable high-throughput and low-cost measurements through lab-on-a-chip systems and these instruments can combine multiple analytical functions into self-contained, portable devices that can be used by non-specialists to detect and diagnose disease, and enables the decision of further therapies. Recent advancements in Smartphone technologies equipped with a computer-like platform and various types of sensors have several properties promoting their uses in POC diagnostics.
Also, Non-invasive point of care tests for glucose monitoring is under development stage which uses a smartphone-based technology. For instance, Mediwise Ltd. is developing GlucoWise product, an affordable, non-invasive, wireless, glucose-sensing product. This revolutionary technology enables diabetic patients to accurately monitor their blood glucose levels for better management of their condition. Smart contact lenses are another example of a novel point of care technology. Recently in March 2016, USFDA has cleared Sensimed`s Triggerfish smart contact lenses that helps in detecting the changes in ocular dimension for monitoring the patterns of intraocular pressure fluctuations in order to improve the management of glaucoma. Due to all these advancements in technology, utilisation of POCT and the extensiveness of its applications in the healthcare system have expanded tremendously. POCT can be an effective means of improving efficiency and outcomes and responding to essential health care needs among large populations especially in rural areas as they lack the infrastructure of modern laboratories with fully automated instruments. Hence, Point of care technologies quickly becoming part of the transformation of the healthcare landscape. In the right situations, if implemented properly and thoughtfully, Point Of Care Testing can have a positive impact on operational efficiency and patient care.
The advancements in Point of care diagnostic technologies such as microfluidic/lab-on-a-chip, PCR, lateral flow and sensor technologies has led to the tremendous increase in both public and private funding for the companies and research organizations. The increase in funding is boosting many smaller firms to come-up with new technologies in new therapeutic applications of POC such as Cancer, infectious diseases, etc. For instance, POC Medical Systems Inc, received $21 million funding in January 2017 from Bio Ventures Investors along with Sirius America Insurance Company, IFG Healthcare and MIA Investment Limited to provide Clinical beta testing and initial commercialization of a rapid, portable breast cancer screening test, MammoAlert based on its Pandora CDx Microfluidics-based platform.
According to IQ4I analysis, Point of care diagnostics global market is expected to grow at a CAGR of 6.2% to reach $26,331.1 million by 2023. The rapid rise in aging population, high prevalence of infectious and lifestyle related diseases, lack of skilled central laboratory technicians in emerging countries, rising number of CLIA-Waived POC tests, rising awareness about point of care diagnostics in developing countries and advancements of technologies are driving the growth of point of care diagnostics global market. However, the Inconsistent reimbursement and high cost of devices, stringent regulatory requirements, accuracy issues and rising incidence of product recalls are some of the factors restraining the growth of point of care diagnostics global market. Geographically, developed regions of North America followed by Europe dominates in revenue, however, Asia-Pacific region is propelling with fast growth due to increase in healthcare spending and advancements in healthcare facilities.
Some of the major companies operating in point of care diagnostics market are Abbott Laboratories, Inc. (U.S.), Becton Dickinson and company (U.S.), Biomerieux (France), Danaher Corporation (U.S.), Johnson & Johnson (J&J), (U.S.), Medtronic plc (Ireland), Nova Biomedical (U.S.), F. Hoffmann-La Roche AG (Switzerland), Siemens AG (Germany), ThermoFisher Scientific, Inc. (U.S.), Ascensia diabetes care holdings AG (Switzerland) and Dexcom Inc. (U.S.) are considered to be the leaders in this space with their market products and strong pipelines. Some of the emerging players in Point of care diagnostics are PTS Diagnostics (U.S.), EKF Diagnostics (U.K.), Orasure technologies Inc., (U.S.), BTNX Inc., (U.S.), Medmira Inc., (U.S.), Chembio diagnostic systems Inc., (U.S.), Biolytical laboratories Inc.,(U.S.), Omega diagnostics (U.K.), Senseionics (U.S.), Fannin (U.K.), Arkray Inc.,(U.S.), Sentinel diagnostics (Italy), etc.