The report analyzes the ADC pipeline, technology developments and service provider network, and assesses the adequacy of the supply base to serve projected demand. It also looks at the risks CMOs face in the ADC market.
ADC products are complex and require a combination of high-value processing steps, including mammalian cell culture, cytotoxic API manufacture and fill/finish and conjugation. Biopharma companies that lack the extensive capabilities needed to manufacture ADCs are dependent on CMOs to produce them.
Several CMOs have taken on ADCs and are expanding capacity with more entering the market. However, PharmSource’s researchers, using extensive industry data, found that only one of the 51 ADC candidates in the clinical pipeline has made it to Phase III and eight to Phase II.
The outlook for new ADC approvals is clouded by the limited clinical and commercial track record of ADCs, the early nature of the clinical development pipeline and the relative immaturity of the technology, said Jim Miller, president of PharmSource and co-author of the report. “Nearly all companies developing ADCs will depend on CMOs for the cytotoxic payload, conjugation and cytotoxic fill/finish. Given the immaturity of ADC technology and uncertainty of clinical and commercial success, it is not surprising that the only two approved ADCs are manufactured with heavy dependence on CMOs.”