2023 September Life Sciences Update

Onshoring of Biomanufacturing Can Be a Catalyst for Growth in the U.S.

Most Biologics and APIs are Developed in the U.S. but Manufactured Abroad

› Pandemic-related drug shortages highlighted vulnerabilities in the supply chain. Recent drug shortages have greatly impacted patients across the country and underscore the need for increased biomanufacturing capacity in the U.S. › According to a 2019 FDA report, only 28% of active pharmaceutical ingredients (API) manufactured for the U.S. market were made in the U.S. Incentivizing domestic production of APIs is a goal of the FDA. › In September 2022, the U.S. government launched a National Biotechnology and Biomanufacturing* Initiative aimed at ensuring that biotechnology products invented in the U.S. are manufactured in the country. Unless existing hurdles are mitigated, onshoring will be challenging. These hurdles include labor availability and costs; raw materials availability and costs; and operational costs and infrastructure. › Nearshoring can be an answer to costly onshoring, bringing the supply chain closer to home. However, challenges include transparency, skilled labor and infrastructure. Key Takeaway: Onshoring biomanufacturing presents growth opportunities and increases supply chain resiliency, but hurdles need to be addressed.

Number of New Chemical or Biological Entities Developed

API Manufacturing Facilities for All Drugs

100%

100%

Canada, 2%

Rest of World, 35

Rest of World, 17

Rest of World, 39

Rest of World, 13%

90%

90%

Japan, 46

Japan, 26

China, 13%

80%

80%

Japan, 30

China, 50

70%

70%

India, 18%

60%

60%

Europe, 55

Europe, 77

Europe, 74

50%

50%

Europe, 26%

40%

40%

30%

30%

United States, 159

United States, 100

United States, 65

20%

20%

United States, 28%

10%

10%

0%

0%

2008-2012

2013-2017

2018-2022

VIEW OUR U.S. MANUFACTURING RESURGENCE REPORT

Source: Federal Drug Administration (FDA), Statista

*Biomanufacturing includes biologicals, APIs, industrials

6 / CUSHMAN & WAKEFIELD

LIFE SCIENCES SEPTEMBER 2023