ADC Opportunity: Big Risk Vs. Big Payoff for CMO Industry
PharmSource report addresses how the opportunity for Antibody Drug Conjugates measures up to the bio/pharma industry’s expectations
Fairfax, VA, USA (February 8, 2016) – Bio/pharmaceutical contract manufacturers (CMOs) are placing big bets on antibody drug conjugates (ADCs) but the technology has yet to prove itself in the commercial market. While CMOs can currently profit by serving the need for clinical trial materials, the commercial payoff is still years away.
That’s the conclusion of a new report from PharmSource, ADC Market Opportunity for CMOs. The report analyzes the ADC pipeline, technology developments and service provider network, and assesses the adequacy of the supply base to serve projected industry demand. It also takes a frank look at the risks facing CMOs addressing the ADC market.
ADCs are complex products that require a combination of high-value processing steps, including mammalian cell culture, cytotoxic API manufacture and fill/finish and conjugation, a process unique to ADCs. Few biopharmaceutical companies have the extensive capabilities needed to manufacture ADCs, so the industry is dependent on CMOs to produce them.
A handful of select CMOs have jumped at the ADC opportunity and more are entering the market even as the early players expand their capacity. But PharmSource’s expert researchers, making extensive use of industry data, found that only one of the 51 ADC candidates in the clinical pipeline has made it to Phase 3 and eight to Phase 2.
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,” he said. “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.”
The report includes rich data for those interested in evaluating the ADC market opportunity. It explains the dilemmas faced by the CMO industry: on one hand, there is an opportunity to ascend the value chain, yet ADC technology and business challenges create uncertainties that must be understood. PharmSource’s expert analysis brings data-driven deep insight to these important issues.
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