Jeremiah Kelly published, “For U.S. Market Entry, Don’t Overlook Abbreviated Applications to FDA for Drugs, Biologics, and Devices” in the May/June issue of American Pharmaceutical Review. The following is an excerpt:
The U.S. biopharma and medical device markets remain the largest and most robust in the world. The statistics on the size and potential growth of these markets are staggering: the pharmaceutical market size is currently $527 billion and expected to increase to $902 billion by 2030; the biologics market size is currently sitting at $264 billion, with growth expected to reach $719 billion by 2030; and the “medtech” device market size is currently $191 billion and anticipated to grow to $291 billion by 2030. The United States spent $717 billion in research and development in 2021, and this number continues to grow. The sheer size of these markets presents opportunities for firms to introduce breakthrough technology to compete with products that are already approved by the U.S. Food and Drug Administration. This competition can come in the form of innovations, but it can also be manifested by “me too” products that are the same as or similar to the FDA-approved, -licensed, or -cleared medical product.
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