Major players in the point–of–care diagnostic devices and equipment market are Abbott, F. Hoffmann-La Roche, Siemens Healthineers, Danaher, Beckman Coulter, Becton Dickinson and Company, QIAGEN N.V., Johnson & Johnson, Alere Inc, and BioMerieux.
The global point-of-care diagnostics devices and equipment market is expected to grow from $24.44 billion in 2021 to $28.74 billion in 2022 at a compound annual growth rate (CAGR) of 17.6%. The market is expected to grow to $51.73 billion in 2026 at a compound annual growth rate (CAGR) of 15.8%.
The point-of-care diagnostics devices and equipment market consists of sales of point-of-care (POC) diagnostics devices and equipment and related services. Point-of-care diagnostics devices and equipment are designed to aid physicians in performing medical diagnostic testing at or near the point of care, for immediate knowledge on diseases or conditions.
The main types in point-of-care diagnostic devices and equipment are infectious disease testing kits, cardiometabolic monitoring kits, cholesterol testing kits, pregnancy and fertility tests kits, tumor/cancer markers, urinalysis testing kits, hematology testing kits, drugs of abuse testing kits, fecal occult testing kits, and others.Pregnancy and fertility tests kits in point-of-care diagnostic devices are the devices that are used to test the pregnancy and fertility in advance before going to the doctor.
The various prescription mode includes prescription-based testing devices, and over-the-counter (OTC) testing devices. These are used by end-users such as professional diagnostic centers, hospitals/critical care centers, outpatient healthcare settings, ambulatory care settings, research laboratories, and homes.
North America was the largest region in the point–of–care diagnostic devices and equipment market in 2021.Asia Pacific was the second-largest region in the point–of–care diagnostic devices and equipment market.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
An increase in the incidence of target diseases is driving the POC devices and equipment market globally.The rising incidence of chronic diseases, like diabetes, rheumatism, or cancer is increasing steadily worldwide due to poor lifestyle choices and increasing obesity, thus driving the growth of the POC devices and equipment market.
For example, according to the Centers for Disease Control and Prevention, 2019, Heart disease is the leading cause of death in the U.S. as well, causing approximately 647,000 deaths per year.
The POC diagnostics devices and equipment market is expected to slow down due to stringent regulatory policies, which increase the gestational period before the product enters the market.POC devices and equipment manufacturers are required to obtain multiple FDA clearances before launching their product into the market.
The entire process of approval consumes a lot of time, thereby restraining the market growth.
Over-the-Counter (OTC) testing is being termed as an important trend driving the growth of the point of care diagnostics market.FDA has approved OTC test kits for cholesterol, fecal occult blood, pregnancy, and HIV/HCV.
This method would improve the access to testing and early detection of the disease. These testing kits may generate more revenue than prescription tests over the forecast period due to ease of using the kits, increased home care and self-testing, and a rise in availability and adoption rate.
Point of care devices is regulated by the U.S. Food and Drug Administration (FDA) and all the diagnostic laboratory tests are regulated by the clinical laboratory improvement amendments of 1988 (CLIA) that are administered by the Centers for Medicare & Medicaid Services (CMS). As these devices measure the biomarker levels in the body they are classified as class II (requiring 510[k] approval), or III devices (requiring the more tedious premarket approval). On the contrary, to the stringent approvals by FDA, China has a moderately lenient approval mechanism. Therefore, the top companies are using a partnership approach with local vendors and distributors to expand their market share.
The countries covered in the point–of–care diagnostic devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and USA.
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