7.1.1 To approximate the landscape of novel antibody formats in clinical trials, we analyzed the drugs in clinical trials that are described as a “bispecific”’ or “bispecific antibody.” We identified a total of 518 interventional trials that were initiated between January 1, 2013, and April 1, 2024, with our search. Of the 518, a subset of 29 trials were a true cell therapy in which engineered cells express a bispecific molecule. For this analysis, the cell therapies were discarded (Table 30). One immediately striking finding is that in 371 of 489 (75%) trials, the core bispecific molecule intervention was listed as a “drug,” not a “biological.” According to the FDA, a biological therapy is one isolated from a natural source or produced by biotechnology: “In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized.”[155] While a bispecific monoclonal antibody certainly fits the criteria, it is unclear why they are most commonly classified as a drug. A quick search for “antibody therapy” demonstrates that many monospecific antibodies are also listed as a drug. In the end, it is up to the user of the database to understand what information they are getting when they assess classifications of interventions.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.