Where do the Growth Opportunities Lie in the Global Apheresis Equipment Market?

Regulators in the U.S. are Proposing to Classify Apheresis Systems as Class 2 Medical Devices

In a recent development on the regulatory front, a panel of advisers to the United States Food and Drug Administration (FDA) have stressed on more regulatory scrutiny for medical devices that use centrifugal force on whole blood so as to separate blood components such as plasma and then pump that blood back into the patient. The FDA, in February 2016, convened the Gastroenterology and Urology Devices Panel, which functions under the aegis of the Medical Devices Advisory Committee, to receive inputs on how such devices should be regulated.

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The fact that this development is occurring in the United States, one of the largest markets worldwide for apheresis equipment will have some impact on the global market too. In the United States, as many as 17 types of centrifuge-based apheresis systems for therapeutic purposes have received a stamp of approval and are on the market, says a report on the Medscape website. However, these devices have not been assigned to any of the classes created by medical device regulatory authorities via a 1976 law.

The American Society for Apheresis terms apheresis as being an effective first-line therapy for a range of diseases such as Guillain-Barré syndrome, severe cryoglobulinemia, myasthenia gravis, and fulminant Wilson disease, among others. In several other illnesses, apheresis is used as a second-line treatment. However, of the 1447 reports that were submitted to the agency between 2010 and 2015, 20 reports of deaths were also included.

The FDA has noted that many of the aforementioned diseases have a high rate of morbidity, which could also be attributable to the many deaths and adverse events associated with its examination of the Manufacturer and User Facility Device Experience database for apheresis equipment.

Going forward, the agency is proposing to classify apheresis systems as class 2 medical devices. This class includes devices that pose an intermediate degree of risk and such devices are required to undergo a 510K premarket clearance. Also on the cards in the United States is more detailed information on the labels of apheresis equipment and systems. However, a final decision on this front is awaited.

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The global market for apheresis equipment is projected to stand at a valuation of US$2.3 bn by 2018, according to Transparency Market Research (TMR). The market intelligence firm also states that the global apheresis equipment market is expected to log a compounded annual growth rate (CAGR) of 11.3% between 2012 and 2013. Although these numbers might seem encouraging, regulators are watching this space more closely than ever before; the market’s growth is certainly not devoid of challenges.

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This release was published on openPR.