COVID-19 Underscores Need for Drug Manufacturing to Return to U.S. Shores

Written by Annette Kreuger - VP Pharma-Bio Group (Sugar Land, Texas)--As the globe struggles to understand and combat the COVID-19 coronavirus, it is sometimes difficult to discern fact from rumor. Yet one fact is becoming quite clear. Entirely too much of the U.S.' drug supply relies on the production of active pharmaceutical ingredients (APIs) and generic drug products from distant countries like China or India. This has occurred for a number of reasons, but mainly financial ones. Drug companies could save money on production, as well as focus on advanced drug products that are still under patent protection. The bulk of what is manufactured overseas are pharmaceuticals (e.g. antibiotics), not the complex biologics such as cellular and genetic therapies.

There is a wide range of statistics flying around regarding just how much is offshored -- 90-97% -- but the truth is there is no hard-and-fast number or percentage. Even the U.S. Food & Drug Administration (FDA) has no true accounting, but suffice to say, it is a lot. COVID-19 has brought home the fact that having the bulk of the domestic drug supply manufactured over 7,000 miles away is not a wise decision.

A rush of new plant construction and retooling of those idled by the industry reorganization of a decade ago will not happen overnight. Virtually every drug company is focusing on either detecting, preventing or curing COVID-19 at this point. Not to mention, simple logistics. Companies across all industry sectors are doing their best to accommodate a crisis that impacts everyone and every business. It is an environment that changes on a daily basis, if not hourly.

Industrial Info is following 277 API (bulk, excipients, etc.) production plants in the U.S. Click on the graph below to see the breakdown by U.S. market region, and click here for a list of plants.



But, it will happen. On the other side of this hard-learned lesson, the industry and indeed, the federal government, will do everything to make sure we avoid being in this situation again. Even with no true numbers of current drug shortages, the fear of it happening, coupled with the likelihood of it occurring, is enough to eventually begin an impetuous series of planning.

Interestingly, the largest current pharma-bio capital project in the U.S. is the $2 billion Novo Nordisk diabetes APIs plant in Clayton, North Carolina. Built to support future demand for diabetes therapeutics for the U.S. market, construction of the nearly 1 million-square-foot facility, known as DAPI, began in 2016 next to the company's existing manufacturing site, a fill-and-finish facility (DFPF). See map below.

Novo Nordisk has invested, and will continue to invest, millions into expanding a sister plant in Kalundborg, Denmark, to serve the European market.

Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn. For more information on our coverage, send inquiries to info@industrialinfo.com or visit us online at http://www.industrialinfo.com.