Rising Production of New-Generation Biologics

Published By: IndustryARC Published On : 17-Mar-2025

Pharmaceutical manufacturers and biotechnology companies are producing more new-generation biologics. Biopharmaceutical companies are experiencing extraordinary growth due to the rising demand for biologics. For instance, Exa-cel, also known as Casgevy, obtained its first regulatory approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) in November 2023 to treat two severe blood disorders: sickle-cell disease and transfusion-dependent beta-thalassemia. The therapy was later authorized by the United States FDA. In terms of new medication approvals in the US, novel modalities such as antibody-drug conjugates, bispecific proteins, and cell and gene treatments contributed to over one-third of all approvals in 2022, enabling biologics approvals to surpass small molecules for the first time.

International partnerships facilitate the global expansion of precision medicine, allowing companies to reach new markets and patient populations. For example, Bayer and Thermo Fisher Scientific joined together in March 2024 to expand patient access to precision cancer medications. In March 2024, AstraZeneca entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The growing production capacity of biotechnology and pharmaceutical businesses to produce next-generation biologics is driving the industry and creating a need for highly efficient biological safety testing instruments. For example, Aragen Life Sciences committed $30 million to establish a new biologics production plant in Bangalore, India. The laboratory will be operational by the third quarter of 2024, with the first production suite projected to be operational in the third quarter of 2025.  In March 2023, Sandoz, a Novartis business, signed a Memorandum of Understanding (MoU) to build a new biologics production factory in Lendava, Slovenia, to meet the rising global demand for biosimilar medicines. Sandoz expects to invest at least $400 million in the new factory.

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