Driving Next-Gen Biomanufacturing with Digital Transformation

In an era of rapid technological advancement and growing demand for innovative therapies, digital transformation is a strategic necessity to stay competitive, ensure compliance, and meet patient needs effectively. Key technologies in biomanufacturing include artificial intelligence and machine learning (AI/ML), digital twins, Internet of Things (IoT), and predictive modeling, are changing the way companies develop, produce, and deliver biopharmaceuticals. Digital technologies bring enhanced efficiency and flexibility to help manufacturers meet evolving market demands.

The U.S. biologics market is growing rapidly compared to the overall pharmaceutical market. In 2023, it was valued at approximately $419.07 billion USD and is projected to grow at a compound annual growth rate (CAGR) of 7.6 percent (1). In contrast, the U.S. pharmaceutical market was valued at around $574.37 billion, with a CAGR of 5.48 percent expected from 2024 to 2030 (2). Of the 55 novel drugs approved by FDA in 2023, 34 were small molecule drugs, and 21 were biologics (3). As FDA and the U.S. congress have taken steps to simplify the categorization of biosimilars in the US (4) by eliminating the interchangeability testing requirements, biologic drug sponsors may face steep competition as downward pricing pressures increase.