The Medical Device Market: USA

With a population of more than 300 million, the United States is the third largest country in the world, behind China and India. The largest state is California, with a population of 37 million.

At an estimated $105.8 billion in 2011, the U.S. medical device market is the world's largest. Per capita expenditure, at $339, is the third highest in the world.

Much of the market is in private hands; there is no single health system. Public healthcare systems, known as Medicaid, for those on low incomes, are operated by each State. Since 1960, the Medicare system has provided hospital care for the elderly; this has also provided prescription drug coverage since 2006.

President Obama succeeded in signing his healthcare reform bill into law on March 23, 2010. The bill, formally called the Patient Protection and Affordable Care Act HR 3590, will eventually extend health insurance cover to an estimated 32 million Americans who do not have any form of health insurance.

In January 2012, the Obama administration said the bill is on track to being implemented, despite opposition from some States. The law requires all States to create new health insurance markets called exchanges, so that people who do not have insurance can buy tax-payer subsidized private cover. The law also expands eligibility for Medicaid so low-income adults who have no dependent children can get government insurance. Putting the two approaches together, more than 30 million Americans are expected to gain coverage by January 2014. Over 20 States are planning to overturn requirements of the law, and have made little progress in planning or creating these exchanges. If State plans are not approved by January 2013, one year before the exchanges are to be up and running, the Federal government can intervene and manage the process.

The United States  is home to many of the world's leading medical device manufacturers, such as Johnson & Johnson, General Electric, Baxter, Covidien, and Medtronic. Seven out of the world's top ten medical device manufacturers are U.S. companies.

Imports are forming an increasingly significant part of the market, and now account for around 32% of the total. This growth is partly explained by U.S. manufacturers using cheap locations abroad, such as Ireland or Mexico, in order to re-export to the U.S. market.

The market is highly regulated, and can be an expensive one in which to operate. It is, however, transparent and 'rules-based'. The U.S. is a major site for R&D and clinical trials.

Imports grew by 8.9% to reach $35.3 billion in 2011. All categories posted positive growth, with consumables recording the strongest rate of 12.1% for the period, reaching $5.3 billion. The largest category, diagnostic imaging, rose by 7.4% during the period to reach $8.3 million.

Includes 3 quarterly updated outlook reports!