U.S. IVD market reaches $53 billion

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The United States is not only the largest geographic market for healthcare products in the world, but also the largest market for in vitro diagnostic products.

According to Kalorama Information, a LabPulse sister brand, in a newly released IVD Market Atlas, the U.S. IVD market reached $53 billion in 2022, or approximately 40% to 45% of the global market. Projected growth is 2.4% annually on average through 2027.

Factors that may dampen IVD market growth include economic downturns; frequent government targeting of clinical testing for overall Medicare and Medicaid cost savings; related private payer insistence on test payment rates in line with or lower than government reimbursement rates; the vulnerability of U.S. economic growth in an increasingly globalized economy; and the extensive approval processes (both for marketing and coverage) applied to new IVD technologies and tests.

However, as growth rates in international markets shrink from the double digits of a decade ago, the U.S. is back on the table for many IVD business planners seeking growth opportunities.

Kalorama Information's IVD market report notes that the US is a "growth stage" geographic region. Where there is a novel market or a new testing technology, the technology is often launched in a developed market such as the U.S. Tests that do not treat core diseases may not be funded everywhere, but they will get a hearing in developed nations.

Kalorama Information’s conservative projection of a $53 billion U.S. IVD market in 2022 acknowledges recently demonstrated vulnerabilities created by the volatile COVID-19 testing market. However, the U.S. IVD market is highly developed and, in some segments, dominated by a handful of leading market players.

In addition to fecal occult blood diagnostics, diabetes testing and cancer are key areas of the growth for which the report provides specific projections.

This article is part of a series of articles based on Kalorama Information's 30-Country IVD Market Atlas, which includes the U.S., China, Germany, U.K., Saudi Arabia, India, United Arab Emirates, France, Vietnam, Turkey, and 20 other countries. For more information on the atlas, please visit Kalorama's page.

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