Since the approval of human insulin and the first monoclonal antibody (mAb), there has been a surge in the discovery and development of biologics, leading to the approval of hundreds of large molecules spanning diverse therapeutic areas. They have accounted for approximately one-third of the FDA-approved drugs over the past decade with no end in sight. As a result, the biologics market is expected to reach over $800 billion by 2033.
New treatment modalities – mRNA vaccines, multi-specific antibodies, ADCs, gene therapies and CAR-T cells, and others – are positively transforming the treatment landscape for cancer, rare diseases, and emerging pathogens through novel MOAs.
Despite the thousands of biologics undergoing preclinical and clinical investigation globally, the track from discovery to market approval is expensive and risky, made even more uncertain by the historically high rate of translational failure. Each type of biologic has unique challenges. Their biological complexity introduces many difficulties with characterization and analytical assessment, consistent manufacturing and scale-up, stability, and formulation.
Eurofins is your trusted partner for every step in biotherapeutics discovery. Our seasoned experts can help you navigate early target validation and antigen generation through manufacturability assessment, immunogenicity testing, and preclinical development across various treatment modalities, including mAbs, peptides, proteins, viral vectors and more.
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