USA Market Overview

At an estimated US$91.3 billion in 2009, the US medical device market is the world’s largest, accounting for 41% of the global total. Per capita expenditure, at US$298, is the highest in the world. While growth has slowed in recent years, the market is still one of the best-performing in the world, and looks set to break the US$100 billion barrier by 2012.

The USA is home to many of the world’s leading medical device manufacturers, such as Johnson & Johnson, General Electric, Baxter, Tyco and Medtronic. Seven out of the world’s top ten device manufacturers are US companies.

Imports are forming an increasingly significant part of the market, and now account for around 34% of the total. This growth is partly explained by US manufacturers using cheap locations abroad, such as Ireland or Mexico, in order to re-export to the US market.
The market is highly regulated, and can be an expensive one in which to operate. It is, however, transparent and ‘rules-based’. The US is a major site for R&D and clinical trials.

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States.