As of late 2025, the rise of Advanced Therapy Medicinal Products (ATMPs) has necessitated a shift in the bioanalytical capabilities of preclinical CROs. Unlike traditional small molecules, cell and gene therapies require specialized assays to monitor Vector Shedding, Biodistribution, and Transgene Expression. CROs have integrated droplet digital PCR (ddPCR) and next-generation sequencing (NGS)...

As drug development becomes more complex, the rise of "Specialty CROs" has become a defining feature of the preclinical market. These organizations focus on specific therapeutic areas, such as Central Nervous System (CNS) disorders, ophthalmology, or infectious diseases. Niche CROs often possess specialized equipment—such as high-field MRI for neuroimaging or BSL-3 labs for pathogen...