A health analysis that is carried out near the patient and does not require a laboratory environment is known as point of care diagnostics/testing. Near-patient testing, bedside testing, mobile testing, remote testing, and quick diagnosis are all terms used to describe point of care (POC) testing. Point of care diagnostics/testing market is expected to reach USD 36,740.3 million by 2027 at a CAGR of 11.6%. In areas with little healthcare infrastructure, the method is used to diagnose infectious infections.
A point-of-care (POC) diagnostic gadget is a device that collects specific clinical data from patients in clinical and resource-constrained situations. The traditional clinical diagnostic technique necessitates high-end and expensive tools, a skilled technician for operation and result interpretation, more time, all of which exhausts and costs money. Although medical facilities in various regions’ healthcare systems have improved significantly, the usage of POC diagnostic equipment is still in its infancy.
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Market Drivers:
The need for self-diagnosing kits and devices has increased as the number of coronavirus cases has increased around the world. Due to limited mobility, the demand for POCs for diagnosing various coronavirus strains has increased. Furthermore, international healthcare organizations like the World Health Organization (WHO) have shared guidelines connected to COVID-POCs to enhance disease self-diagnosis and prevent the spread of the disease.
Market Restraints:
One of the key issues device manufacturers face is deploying their devices in compliance with regional authorities, which is one of the major challenges they confront. These obstacles are stifling the global market for point-of-care diagnostics and testing.
Regional Analysis
North America is estimated to dominate the point of care diagnostics/testing market, owing to the increasing demand for virtual and convenient diagnostic solutions, enhancement in healthcare regulations, and growing awareness about wellness and healthcare among the young population. Furthermore, the involvement/adoption of strategies like mergers & acquisitions by key players, government partnerships, and the development of new products are also propelling the market growth.
Europe embraces the second-largest position in the point of care diagnostics/testing market due to the increasing number of IVD testing, molecular diagnostics, and the prevalence of respiratory diseases across the region. The industry players are involved in various business activities such as product launches, mergers and acquisitions, partnerships, and other commercial approaches. For instance, in May 2020, ProciseDx (US) launched 510k filing for CRP test in Europe for gastrointestinal disorders. The product launch aims to offer high lab-quality results to the patients. In addition, in July 2021, QuantuMDx (Singapore) launched Q-POC, a point-of-care diagnostics to detect SARS-CoV-2. The product is easy to use, affordable, and offers results in 30 minutes. Such business parameters are expected to propel the point of care diagnostic market in the forecast period.
Asia-Pacific is projected to be the fastest-growing regional market during the study period due to increasing demand for diagnostic tests such as blood gas tests, rapid blood coagulation tests, pregnancy tests, drug abuse screening, rapid diagnosis of cardiac markers, blood glucose testing, electrolyte analysis, urine analysis, and dry biochemical tests across the region. In addition, the increasing demand for multiple diagnostic devices coupled with the rising demand for accurate and efficient diagnostic and testing devices is driving the Asia-Pacific point of care diagnostics market.
The growth of the market in the Rest of the World is gaining importance over the last few years due to the increasing diagnosis of HbA1c and growing demand for glycated hemoglobin analysis. Moreover, the rising number of COVID-19 cases across the region is supporting the demand for POCs diagnosis. In addition, increasing investment in healthcare device manufacturing facilities is strengthening the product portfolio of the regional and global healthcare providers. The escalating demand for in-vitro diagnostics in South America is fueling the sales of POCs across the region. Such factors are expected to augment the market growth over the assessment period.
Segmentation
The global point of care diagnostics/testing market is categorized into product, end user, mode of purchase, and platform. Based on the product category, the market has been segregated into glucose monitoring, pregnancy & fertility testing, infectious disease testing, drug abuse testing, coagulation monitoring, cardiometabolic monitoring, cancer/tumor marker testing, hematology testing, urinalysis testing, cholesterol, and others. The glucose monitoring segment is expected to hold a considerable share of the market in 2020. Increasing POC urine hCG (Human Chorionic Gonadotropin) tests to diagnose pregnancy is fueling the market growth. Companies such as Abbott (US) are offering total β-hCG for the early detection of pregnancy. In addition, rising POC testing for early tumor detection is strengthening the demand for POC diagnostic products.
Based on end user, the global point of care diagnostics/testing market has been classified as hospitals & clinics, diagnostics centers, homecare/self-testing, and others. Hospitals &clinics held the largest segment share in 2020, owing to easy maneuvering, sample processing, and quick delivery of results. A laboratory information system also manages and stores patient’s test data for further reference, which further drives the market growth. Additionally, the demand for homecare/self-testing is accelerating due to increasing health risks during the pandemic outbreak and rising connectivity between patients and health care providers.
Based on mode of purchase, the global point of care diagnostics/testing market has been classified as over the counter (OTC) testing products and prescription-based testing products. The OTC testing products aim to hold a larger market share in the mode of purchase category. OTC products are sold without the prescription for generic disease-diagnosed patients. They comply with certain parameters that include the highest standards for efficacy and safety, Good Manufacturing Practice (GMP) manufacturing, stability testing, and labeling under 21 CFR 201.66. According to the FDA, over 300,000 marketed OTC drug products are categorized into 80 therapeutic classes. The largevariety and availability of the products are driving the point of care diagnostics/testing market.
Based on the platform, the global point of care diagnostics/testing market has been classified as immunoassays, molecular diagnostics, dipstick, and others. Immunoassays is estimated to hold the largest segment share in 2020, owing to the increasing demand forthe products for testing antibodies or a specific antigen in blood or other body fluids. The immunoassays based POC test is carried out in countries with low resources and facilities. Among the immunoassays, lateral flow immunoassays are highly used for quick diagnosis as they are sensitive to specific antigens and offer quick & accurate results.
Market Competitive Landscape:
The competitors in the trade are always shifting to meet the changing needs of the healthcare industry. These market competitors are employing a variety of business methods to expand their market share. The companies are leveraging new technologies and expanding their R&D capabilities to generate new products, propelling the point-of-care diagnostics/testing industry further. Contractual agreements, acquisitions and mergers, product developments, increased investments, and working with other regional or local companies to grow their worldwide footprint.
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The important companies in the point of care diagnostics market are:
Becton, Dickinson, and Company (US), Instrumentation Laboratory Company (Werfen) (US), Danaher Corporation (US), PTS Diagnostics (US), Nova Biomedical (US), Abbott Laboratories (US), Siemens Healthineers GmbH (Germany), Chembio Diagnostics, Inc.(US), Hoffmann-La Roche Ltd (Switzerland), Johnson & Johnson Services, Inc. (US), QuidelCorporation (US), Sekisui Diagnostics (US), Trinity Biotech (Ireland), EKF Diagnostics Holdings plc (UK)
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