Cancer prevalence is increasing worldwide and often it is diagnosed in late stage, which affects the medical decision significantly. As cancer may be potentially cured if diagnosed in early stages, the importance of rapid point of care diagnostic tests is increasing in medical sector. Currently, cancer diagnosis is done by invasive techniques such as biopsy. Rapid biomarker identification tests are not present in extensive number. The U.S. Food & Drug Administration has approved breast cancer test in March 2018, offered by the company 23andMe. This cancer test is capable of diagnosing three of the 1000 mutations in the BRCA1 and BRCA2 genes associated with increased risk of breast, ovarian, and prostate cancer. Cancer point of care diagnostic/biomarker testing holds huge potential for market growth, as there is no significant competition in this sector.
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Demand for point of care testing is increasing, owing to factors such as lack of access to centralized laboratories in emerging economies such as Asia Pacific, independence from centralized laboratories as the testing can be done on the spot without the need of laboratory facilities, and rapid diagnosis, which is expected to create significant demand for point of care diagnostics market. The market is expected to gain significant growth, owing to further developments in point-of-care diagnostics aimed towards impacting medical outcomes, increased adoption of rapid medical diagnostic devices, and rising prevalence of chronic diseases such as HIV, infectious diseases, and diabetes. Development of innovative point of care tests for wide number of applications is expected to fuel growth of the market. Product recalls in point of care diagnostics market and supply chain related issues in remote areas are expected to hinder the market growth.
Increasing launch and approval of novel product is supporting growth of the market
High product and test volumes are driving growth of the Point of care diagnostics market. Furthermore, leading market players are focused on launching novel products to expand their product portfolio for treatment of several diseases using advanced technologies. For instance, in February 2018, Siemens Healthineers received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) point-of-care tests, which is intended for use in the diagnosis of renal diseases and metabolic imbalances. Furthermore, in 2017, Beckman Coulter Diagnostics received CE Mark clearance for new high-sensitivity troponin assay, which aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms. Moreover, Alere, Inc. launched first-ever rapid diagnostic test, Malaria Ag P.f, for detection of asymptomatic malaria infection in May 2017. Furthermore, Alere, Inc. along with its partner company GenPrime, Inc., launched point of care testing device, the xReader for work-place drug testing in 2016.
Increasing prevalence of chronic diseases is expected to propel demand for diagnostic tests providing rapid results
Prevalence of infectious diseases such as HIV, tuberculosis (TB), and malaria is increasing in emerging economies such as Africa and Asia Pacific. For instance, according to the World Health Organization (WHO), in 2016, an estimated 36.7 million people were suffering from HIV worldwide. According to the World Health Organization (WHO), in 2015, around 3, 23,000 new cases of TB and an estimated 32,000 deaths from tuberculosis were reported in the European region. Moreover, out of around 3, 23,000 people with TB cases in this region, 27,000 people were reported to be suffering from HIV co-infection. Incidences of chronic diseases such as cancer, diabetes, and cardiovascular conditions is increasing, which is expected to positively impact growth of the point of care diagnostics market. This is due to increasing demand from patients for rapid diagnosis and treatment. For instance, according to the World Health Organization (WHO), cancer was responsible for 8.8 million deaths in 2015, worldwide. Furthermore, according to American Diabetes Association (ADA), in 2015, around 30.3 million people in the U.S. were suffering from diabetes and around 1.5 million people are diagnosed with the disease annually. POC diagnostic tests aid in quick diagnosis and treatment initiation, therefore, the market is projected to witness high growth over the forecast period.
Point of care diagnostic products are often subjected to recalls due to product issues, which may be technical or any other malfunctioning. For instance, Abbott Point of Care, Inc.’s product i-Stat PT/INR was recalled in 2015, due to result associated problems. Furthermore, Alere voluntarily recalled Class I products INRatio and INRatio2 PT/INR monitoring systems and INRatio test strips were recalled in 2016 due to possibility of generation of incorrect results by the products. These factors are expected to hinder growth of the market.
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Major players operating in the point of care diagnostics market include Danaher Corporation, Abbott Laboratories, Acon Laboratories, Inc., Hoffman-La Roche Ltd., Becton, Dickinson, and Company, Johnson & Johnson, Trinity Biotech Plc., and Siemens Healthineers.