Pharmaceutical manufacturing faces challenges and opportunities, with M&A, biosimilars, and AI innovations reshaping drug discovery and production processes.
By Benedette Cuffari, M.Sc.Reviewed by Lily Ramsey, LLM Key Trends Shaping Pharmaceutical Manufacturing Pharmaceutical manufacturing encompasses all processes involved in the manufacturing and production of biological and medical products, botanical drugs, and herbs, as well as other pharmaceutical products used for internal consumption, such as tablets and capsules, as well as those used for external applications, like ointments.
Biosimilars on the Rise Of the 50 different drugs approved by the U.S. Food and Drug Administration in 2024, 18 of these agents were biosimilars, eight of which target reference products with no previous biosimilar competition. The most recent biosimilar to receive approval by the FDA is Steqeyma, a biosimilar for Stelara , which is an antibody therapy used in the treatment of several inflammatory conditions, including plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease .
Some of the key advantages associated with CDMOs include reduced costs, as many CDMOs are equipped with laboratory and manufacturing infrastructure that is ready for use. CDMOs also employ highly experienced professionals, many of whom can offer their expertise in navigating the highly complex aspects of the pharmaceutical manufacturing process.
As technology continues to advance, the integration of AI into various aspects of the pharmaceutical industry will undeniably drive innovation, improve patient outcomes, and reshape the future of healthcare.6”Sustainability in Manufacturing In 2018, the pharmaceutical industry produced over 52 million metric tons of carbon dioxide equivalents, with these emissions directly contributed by research, transportation, and manufacturing processes.
AM also offers a more sustainable approach to drug manufacturing, as it can significantly reduce the amount of materials used, as well as the amount of energy and time needed to complete the print.
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