Number of pages: 1000 | Report Format: PDF | Published date: July 18, 2022
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 40.5 billion |
Revenue Forecast in 2031 |
US$ 75.74 billion |
CAGR |
7.2% |
Base Year for Estimation |
2022 |
Forecast Period |
2023 to 2031 |
Historical Year |
2021 |
Segments Covered |
Product, Materials, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global point-of-care diagnostics market was valued at US$ 40.5 billion in 2022 and is expected to register a revenue CAGR of 7.2% to reach US$ 75.74 billion by 2031.
Point of Care Diagnostics Market Fundamentals
Point of care diagnosis (POC) is a type of medical diagnostic testing that enables doctors and other healthcare professionals to quickly and correctly get lab-quality diagnostic data in real time. Point-of-care testing devices use immunoassays and lateral flow chromatography principles to evaluate whole blood. Among other things, POC covers drug misuse screening, pregnancy testing, fecal occult blood analysis, quick coagulation testing, blood gas and electrolytes analysis, and rapid cardiac markers diagnosis.
Rapid screening and detection of infectious disorders, including bacterial, viral, and parasite infections, are frequently accomplished via POC diagnostics. These tests can aid in the early diagnosis of illnesses, timely treatment of those diseases, stopping the spread of those diseases and enhancing patient outcomes. For instance, quick diagnostic tests for strep throat, HIV, malaria, and influenza are frequently employed in POC settings. Also, POCT diagnostics are essential in managing diabetes, cardiovascular disease, and chronic respiratory problems. Patients can utilize portable gadgets at home or while visiting the clinic to check their blood glucose, cholesterol, and lung function. These tests offer fast feedback, enabling patients and medical professionals to modify treatment approaches promptly.
Furthermore, pregnancy tests frequently employ POC diagnostics, which offer fast findings in only a few minutes. POC fertility testing also aids in family planning and fertility treatments by enabling women to monitor their hormone levels and identify the most fertile times of their menstrual cycles. Handheld ultrasounds and other portable imaging equipment enable medical professionals to do rapid and practical diagnostic imaging at the patient's bedside. These devices are very helpful in emergency scenarios, critical care settings, and distant places with limited access to conventional imaging equipment.
Point of Care Diagnostics Market Dynamics
The market is expected to speed up in the upcoming years due to the growth in funding from various sources, the growing frequency of the target illnesses, and the requirement to deal with the recent coronavirus pandemic. The ongoing COVID-19 pandemic significantly influenced the international industry in 2021, and this effect is predicted to continue throughout the projected duration. For instance, as part of the DiaTrust COVID-19 Ag Rapid Test purchase agreement, the South Korean Department of Defense gave Celltrion USD 626 million in September 2021.
The growth of POC solutions in environments with constrained resources is anticipated to be significantly impacted by incorporating digital technology. Adopting telehealth as the new norm for POC companies requires a crucial go-to-market strategy. According to the U.S. Centers for Disease Control and Prevention, nearly 95% of U.S. health centers offered telehealth services during the pandemic. Therefore, it is anticipated that the proliferation of remote patient monitoring systems like PixCell Medical, a POC technology for CBC testing, would positively impact the market’s growth.
Moreover, the rise in home-based POC device usage, technical advances, and the rising number of regulatory approvals for innovative immunoassay methods are anticipated to support the development of the studied market throughout the forecast period. For instance, BioGX introduced the CE-marked, three-gene multiplex POC COVID-19 test in July 2022. The US Food and Drug Administration (USFDA) has approved BioGX's Xfree COVID-19 Direct RT-PCR assay, which uses the company's exceptionally powerful Xfree direct sample testing chemistry for emergencies. As a result, regulatory approvals for introducing new products help expand the market under study.
Likewise, POC diagnostics, which are frequently distinguished by being independent of laboratory equipment and relatively economical, can significantly increase the accessibility of diagnostics, according to research released by Mylab Discovery Solutions in March 2022. The article also stated that POC tests are expanding as an important tool to increase diagnostic coverage of the population in low- and middle-income countries where healthcare access is quite uneven. As a result, demand for POC is constantly rising, driving the growth of the studied market.
However, the need for more accuracy of quick point-of-care diagnostic tests worldwide and the low number of FDA approvals for rapid testing have hampered the entire industry's growth due to the high cost of viral clearing technology. The field of point-of-care testing is rife with pre-analytical mistakes. Therefore, such situations may limit the introduction of new products, hindering the market’s growth. For example, Siemens Healthcare issued a Class 2 Device Recall for their BGEM analyze Card In-vitro Diagnostic Device in August 2020. This device is used to quantitatively analyze un-anticoagulated arterial, venous, or capillary whole blood in a laboratory setting or at the point of care. The conflicting glucose values on card lot 01-20095-10 were the cause of this. This could delay the diagnosis of diabetes or unnecessary treatment for hypoglycemia.
Point of Care Diagnostics Market Ecosystem
The global point-of-care diagnostics market is analyzed from the following perspectives by product, materials, and region.
Point of Care Diagnostics Market by Products
Based on product, the point-of-care diagnostics market is segmented into glucose monitoring, cardiometabolic monitoring, pregnancy & fertility testing, infectious disease testing, hematology testing, urinalysis testing, drug abuse testing, and other POC products.
The glucose monitoring products segment held the largest share of the point-of-care diagnostics market in 2020. The large share of this segment can be attributed to factors such as a large diabetic population and a high volume of glucose monitoring tests being performed. The uptake of glucose monitoring is also significantly high in-home care and remote settings. Convenience in use, improved precision of POC glucose monitoring products, and improved awareness in the general population facilitate this trend.
Point of Care Diagnostics Market by Materials
Based on the end user, the point-of-care diagnostics market is segmented into hospitals & critical care centers, outpatient & ambulatory care facilities, home care settings, and other end users.
The hospitals & critical care centers segment dominated the point-of-care diagnostics market in 2020. A large number of POC tests being performed at hospitals & critical care is the major factor attributing to the large share of this end-user segment. Additionally, home care is the rapidly growing segment in the global point-of-care diagnostics market. The healthcare system worldwide has been having an increasing burden of reducing hospital costs and rates of readmission. Due to this, several physicians treating patients with chronic diseases are touting and recommending home healthcare solutions and systems to ensure patients’-maintained health and treatment. This has enabled the adoption of point-of-care diagnostic products in home care settings. Some of the most commonly used POC devices in home healthcare are blood glucose monitoring devices and pregnancy & fertility testing solutions.
Regulatory agencies are increasing POC device validation/verification requirements as POCT utilization rises in hospitals. For instance, a Clinical Laboratory News article from January 2022 noted that institutions must assess and verify hospital POC glucose meters use. Although formal validation is not necessary for on-label POCT devices, it is still necessary to confirm the precision, accuracy, and analytical measurement range, among other fundamental characteristics specified by CLIA.
Point of Care Diagnostics Market by Region
The global point-of-care diagnostics market is segmented based on region: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for a significant revenue CAGR during the forecasted period. The countries of the United States, Canada, and Mexico make up North America. Due to the presence of major market participants and the increased prevalence of infectious and chronic illnesses, the area is anticipated to grow considerably during the projected period. The latest product launches and acquisitions have helped the industry under study expand. As an illustration, Heska Corporation, a US-based provider of cutting-edge veterinary diagnostic and specialty products and solutions, purchased MBio Diagnostics, Inc. in January 2023. Instruments for POC testing are among the sophisticated veterinary diagnostic and specialty healthcare items produced, developed, and sold by Heska Corporation. As a result, these purchases fuel the expansion of the region's studied market.
Additionally, in May 2022, the USFDA approved NOWDiagnostic's ADEXUSDx hCG Test, making it available in the US for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma, or serum. In several clinical and critical care settings, healthcare practitioners can use this immunoassay test as an early pregnancy detection assistance. Thus, the approval of novel POC diagnostics by regulatory bodies is assisting in expanding the region's investigated market. The region's increasing incidence of ailments, including diabetes and cancer, is fueling the market's expansion. For instance, according to a report by the Canadian Diabetes Association released in March 2022, the prevalence of diabetes in the nation is rising rapidly. When the report was released, 11.7 million Canadians were estimated to have diabetes or prediabetes, with nearly 5.7 million diagnosed. As the prevalence of diabetes rises, so does the need for POC, fueling the expansion of the market under investigation.
With a CAGR of 7.1% from 2023 to 2031, the Asia Pacific market is predicted to have the highest growth. A growing number of local diagnostic kit and reagent producers in the Asia Pacific are anticipated to drive the point-of-care market in this region by providing various testing options for detecting coronavirus infection. To increase COVID-19 testing, the nations are continually expanding their capabilities. For example, the Malaysian Ministry of Health approved using antigen quick testing kits shipped from South Korea in April 2020 to expand the nation's COVID-19 testing to a daily capacity of 16,500 tests.
Point of Care Diagnostics Market Competitive Landscape
Some of the prominent market players in the global point-of-care diagnostics market include,
Point of Care Diagnostics Market Strategic Development
Point of care diagnosis (POC) is a type of medical diagnostic testing that enables doctors and other healthcare professionals to quickly and correctly get lab-quality diagnostic data in real time.
North America is dominating the global point-of-care diagnostics market.
The estimated market size of the point-of-care diagnostics market in 2031 is US$ 75.74 billion.
The revenue CAGR of the point-of-care diagnostics market during the forecast period is 7.2%
Some prominent global point-of-care diagnostics market players include F. Hoffmann-La Roche Ltd., bioMerieux SA, and Danaher Corporation.
*Insights on financial performance are subject to the availability of information in the public domain