Blood glucose or blood sugar refers to the sugar passed through the blood stream that is responsible for ensuring the energy supply to all the cells in the body. The regulation of blood glucose levels is essential in order to maintain the normal levels thereby maintaining hemostasis (maintaining a stable or equilibrium condition in the blood’s internal environment). The state of hemostasis is necessary for our bodies to ensure proper functionality.
There exist different types of blood glucose measurement tests performed such as fasting blood sugar test, postprandial blood sugar, oral glucose tolerance test, glycohemoglobin A1c testing and random blood sugar testing. Deviation in blood glucose levels from the normal range results in the development of disorders such as hyperglycemia and hypoglycemia. Hyperglycemia refers to a condition characterized by high levels of blood sugar than normal range whereas hypoglycemia refers to a condition characterized by lower blood glucose levels than normal range. Research studies have proved that higher levels of blood glucose levels lead to increased risk of developing cardiovascular diseases both in diabetic and non-diabetic population.
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Blood glucose monitoring is referred to the regular testing of glycemia (testing the levels of glucose). Usually the blood glucose levels are monitored by either using a glucose meter comprising lancets, test strips and logbooks. In January 2014, the U.S. Food and Drug Administration (FDA) proposed the new draft guidance for blood glucose test strips. The FDA has issued for the first time two separate guidance drafts for blood glucose test strips of which one is focused on point of care prescription meters (used in hospitals) and the other for over-the-counter (OTC) products.
The scope for allowable range of errors has been tightened from plus or minus 20% to plus or minus 15%. Similarly, the range of errors in case of point of care meters is also tightened. The other requirements would be the disinfection requirements and the packaged maters would contain the information about the accuracy results of the products. This would help the buyers to select the appropriate test strips. Another major requirement that FDA had added is that it would review the manufacturers test strips release lot that means there would be more stringent scrutiny for the clearance of test strips. Hence, these guidelines would ensure safety along with high reliability and accuracy and also reduce the probability of product recalls by the respective companies.
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The market for blood glucose test strips can be segmented based on the test strips available for hospital use and over the counter products. Also, a detailed geographical landscape elucidating the market trends for four major geographies can be provided. The major factors favoring the growth of the blood glucose test strips market is consistent increase in the prevalence of diabetes along with increasing obesity and increased physical inactivity. As per the data enumerated by the International Diabetes Federation, in the year 2013 there are around 382 million people suffering from diabetes worldwide of which 37 million are Americans, 72 million people in South East Asian countries and around 56 million in European countries and others. In addition, rise in technological advances and increased awareness about diabetes is leading to increased diagnosis rates both at hospitals and at individual level.
These factors would in turn enhance the adoption of blood glucose test strips and drive the market growth. On the other hand, lack of accuracy, reliability, and increasing product recalls by several manufacturers would impede the market growth. Some of the key market players competing in this market are Abbott Laboratories, Bayer Healthcare AG, LifeScan, Inc., and F.Hoffmann-La Roche Ltd.