Article | August 19, 2021

Helping Non-U.S. Based Biotechs Navigate Entry Into The U.S. Clinical Development Market

By Lauren Valentine, Director of Oncology Strategy, IQVIA Biotech


The United States (U.S.) represents the largest pharmaceutical market in the world. Thanks to its global market size ($105.3bn in 20211), strong protection of intellectual property rights, transparent regulatory framework that encourages innovation, as well as a mature clinical development industry, it is no surprise that many companies based outside of the U.S. are setting sights on this lucrative market.

Like the U.S., many countries have been increasing investments in biotechnology research and development over the past few decades, laying the foundation for potential clinical applications. For example, the number of biotech patents granted in China rose from over 1,600 (12% of global total) to more than 9,000 (24% of global total) from 2009 to 20192. Consequently, an ever-increasing number of non-US based companies are looking to bring their innovative investigational products to the U.S. for clinical development. Clearing the high bar set by the U.S. Food and Drug Administration (FDA) not only ensures access to the largest market, but also may provide a smoother path to marketing approval in other countries and markets.

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