Abstract
Biotherapeutics have experienced significant growth in recent years, primarily due to advancements in molecular biology [1], nanotechnology [2], and immunotherapy [3]. The field includes biologies, such as monoclonal antibodies, cell and gene therapies, and innovative drug delivery systems, which address diseases, including cancer and chronic conditions [4-12]. In 2024, the approval of CASGEVY®, the first cell-based gene therapy for transfusion-dependent beta thalassemia (TDT) in patients 12 years and older, demonstrated the transformative potential of gene editing technologies such as CRISPR [13, 14]. The sector is projected to maintain this momentum into 2025, supported by increased revenue and ongoing innovation in personalized medicine [15, 16]. However, persistent challenges exist in regulatory frameworks, manufacturing processes, and cost management. Notable trends include the expansion of Chimeric Antigen Receptor T (CAR-T) cell therapies, Antibody-Drug Conjugates (ADCs), and the integration of artificial intelligence to expedite drug discovery, which has reduced preclinical development timelines by up to 50 percent. Emerging modalities, including multi-specific antibodies, small interfering RNA (siRNA), and organ-on-a-chip models, are further advancing research and enabling the targeting of previously intractable disease sites [17].
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Bentham Science Publ Ltd