Point of Care Diagnostics Market Analysis and Forecast to 2031: By Product (Glucose Monitoring, Cardiometabolic Testing, Infectious Disease Testing, Blood Gas/Electrolytes Testing, Pregnancy & Fertility Testing, Tumor/Cancer Marker Testing), By Technology (Lateral Flow Assays, Dipsticks, Microfluidics, Molecular Diagnostics, Immunoassays), By Application (Cardio Metabolic Testing, Infectious Disease Testing, Nephrology Testing, Drug-of-Abuse (DoA) Testing), By End-use (Hospitals, Diagnostic Centers, Research Laboratories, Home-Care Settings), and Region
The global point of care diagnostics market was valued at USD 32.2 billion in 2021 and it is anticipated to grow up to USD 76.4 billion by 2031, at a CAGR of 9.0% during the forecast period.
Point of care diagnostics allows medical staff and physicians to accurately achieve real-time lab-quality diagnostic results within minutes. Point of care testing devices utilize principles of lateral flow chromatography and immunoassays to analyze the whole blood. POCT includes blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, pregnancy testing and fecal occult blood analysis among others.
Market Trends and Drivers
POC tests can greatly improve the management of infectious diseases, especially in developing countries where access to timely medical care is a challenge and the healthcare infrastructure is antiquated and sparse. For instance, according to UNAIDS, around 20.6 million people were living with HIV in East and Southern Africa in 2018. Similarly, in 2019, 20,000 new HIV cases were registered in the Middle East and North Africa as per the UNAIDS Data 2020). In the Asia Pacific, an estimated 5.8 million people were suffering from HIV in 2019, led by India and China. According to UNAIDS, in 2019, approximately 2.1 million people in India were infected with HIV. The high prevalence of HIV is likely to boost the demand for point-of-care diagnostics, further accelerating the treatment of HIV infection. Hence, high prevalence of infectious diseases, coupled with the inadequate healthcare infrastructural facilities in developing countries, is expected to drive the adoption of POC testing.
Market Restraints and Challenges
The pricing pressure due to reimbursement cuts and lack of sufficient budgets affects the growth of the global POC diagnostics market. In 2013, the US government passed a healthcare reform bill, according to which manufacturers must pay a heavy 2.3% annual excise tax on medical devices. Similarly, France has focused on medical devices for cost containment to recover from the recession. The 2013 French budget included price cuts of a total of USD 157.6 million (EUR 115 million) in the medical sector, which comprises savings worth USD 102.8 million (EUR 75 million) from the ambulatory care sector and USD 54.8 million (EUR 40 million) from hospitals. In France, all the cost of patient care is rolled out into one prospective payment under the Diagnosis Related Group (DRG) system, making reimbursement a negligible factor. For instance, in the country, the reimbursement for diabetes technologies in outpatient settings is based on a tariff system. Reimbursable products and services, along with their respective tariffs, are added to the list of reimbursed products and services (LPPR). Blood glucose monitoring strips are reimbursed based on a single “generic” tariff, as French payers do not see the relevant difference in the various prices of BGM.
Global Point of Care Diagnostics Market Segmental Overview
The report analyses the global point of care diagnostics market based on product, technology, application, end use, and region.
Global Point of Care Diagnostics Market by Product
Based on product, it is segmented into glucose monitoring, cardiometabolic testing, blood gas/electrolytes testing, infectious disease testing, pregnancy and fertility testing, tumor/cancer marker testing and others. The Among these, glucose monitoring segment accounted for the largest share of the global Point of Care market, by product type, in 2021. Glucose monitoring products are used to continuously monitor and track glucose levels in the body, which also provides information regarding the amount of insulin being released. The use of such monitoring devices offers better glucose control and enables accurate treatment decisions. POC glucose monitoring kits make use of small amounts of blood (usually through a finger prick) for analyzing results, making them less invasive as compared to lab tests. These kits can also be easily used by elderly patients. Glucose monitoring kits also help patients with type I and type II diabetes to monitor their glucose levels and prevent complications. Moreover, growing prevalence of diabetes globally, ongoing technological advancements in blood glucose self-monitoring devices, and growing patient awareness about POC testing will propel the market growth.
Global Point of Care Diagnostics Market by Technology
Based on technology, it is segmented into lateral flow assays, dipsticks, microfluidics, molecular diagnostics, immunoassays and others. Among these, the Lateral flow assays segment, by platform type, accounted for the largest share of the global Point of Care market in 2021. Lateral flow assays (LFA) or lateral flow immunochromatographic assays are simple devices used to detect the presence or absence of target analytes in samples. These assays help in detecting and quantifying analytes in complex mixtures and provide results within 30 minutes after the sample is placed on the device. Lateral flow assay-based POC tests are increasingly being adopted as a replacement for lengthy, conventional laboratory procedures. POC diagnostic tests require less complex infrastructure and training, owing to which the cost of these tests is lower as compared to conventional laboratory diagnostic procedures. However, regulatory bodies often need the confirmation of results by using an independent method, which makes LFA tests suitable for only primary screening at the point of care. However, technological improvements may affect the apparatus cost and analysis duration of the test, which can hamper the adoption of this platform in the coming years.
Global Point of Care Diagnostics Market by Application
Based on application, it is segmented into cardio metabolic testing, infectious disease testing, nephrology testing, drug-of-abuse (DoA) testing and Others. Among them, the infectious disease segment segment accounted significant share in 2021 owing to the Rising demand for novel products regarding early and cost-effective detection of infectious diseases will influence the product demand. Rising laboratory capacity for the diagnosis of infectious diseases and early detection of emerging pandemic strains will spur the industry expansion. Growing prevalence of infectious disease in elderly people, new-born babies, and people with certain chronic illnesses coupled will impel the growth during analysis period. Additionally, increasing availability of rapid tests resulting in rising applications in faster disease diagnosis will impact the product demand in future. Flu segment will showcase robust growth during forecast period. As per WHO, the average worldwide burden of seasonal influenza is approximately 600 million cases, with 250,000-500,000 deaths and 3 million cases of severe sickness per year. According to CDC estimates, in the U.S. about 200,000 individuals are hospitalized and around 36,000 people die from flu and its complications every year. Thus, growing disease pervasiveness and innovation in diagnostic tools will drive the segment revenue.
Global Point of Care Diagnostics Market by End-use
Based on end-use, it is segmented into hospitals, clinics and others. The hospitals segment accounted for significant revenue size in 2021 owing to the Easy availability of the diagnostic products and presence of skilled workforce in hospitals. Moreover, sophisticated infrastructure, presence of skilled workforce and increasing number of hospital admissions will strengthen the segment growth. Furthermore, requirement of faster diagnostic kits in hospitals for better treatment option will further enhance the segment demand during the forecast period
Geographical Analysis of Global Point of Care Diagnostics Market
Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America therapeutic respiratory devices market captured significant market share in 2021 and is expected to grow significantly during the forecast years. Rising prevalence of infectious diseases and growing application of POC tests for safe and early diagnosis will increase the demand for such rapid tests. Also, high research and development investment by governments and major market players for development of POC molecular diagnostic tests will foster the market revenue during the forecast timeline. Increasing cases of COVID-19 in the region will boost the usage of point of care molecular diagnostic kits to manage the disease efficiently. Moreover, surmounting use of PCR-based procedures for diagnosis and commercialization of real-time PCR products will further influence the regional demand
Major Players in the Global Point of Care Diagnostics Market COVID-19 Impact
The COVID-19 pandemic negatively affected the overall sales of most of the companies but had an positive impact on the point-of-care molecular diagnostics market because of the use of molecular diagnostic methods for COVID-19 testing. Lockdowns resulting from the COVID-19 pandemic caused people to delay undergoing health checkups, thus affecting the number of tests being performed and sales of reagents. However, a resurgence in testing numbers is seen as countries gradually ease restrictions on movement. With the COVID-19 pandemic, responding to infectious disease has become a pressing medical issue worldwide. In addition to the development of vaccines and therapeutic drugs, there is a growing call for the development of more precise and simple testing technologies and the expansion of testing structures. COVID-19 has also impacted the regulatory environment and practices, as governments and healthcare providers face unprecedented challenges. Regulatory authorities utilized methods to speed approval of diagnostic products. Companies have taken strategic developments to introduce COVID-19 rapid tests, sustain their revenues, and nullify the impact of COVID-19 on their operational capabilities.
Recent Developments
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