Vast majority of ADC manufacturing outsourced, report finds

By Zachary Brennan contact

- Last updated on GMT

Related tags: Clinical trial, Lonza

CMOs dominate the manufacturing of ADCs though there are only a limited number that can develop linkers and cytotoxins.
CMOs dominate the manufacturing of ADCs though there are only a limited number that can develop linkers and cytotoxins.
Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report.

In addition to the high concentration of outsourcing, there are a limited number of CMOs with the ability to develop linkers and cytotoxins. And even fewer CMOs can provide conjugation services for ADCs, according to the report released last week.

CMOs cited in the report include SAFC, Piramal Healthcare, Lonza, Albany Molecular Research Institute, BSP Pharmaceuticals, Pierre Fabre Medicament Production and Catalent.

Among those, Lonza has recently expanded its investment in single-use technology​ to meet the needs of growing client pipelines. SAFC also recently announced its intentions in a quarterly report to invest further in ADC​ manufacturing tech.

Growth Potential

Overall, the ADC market is still in its infancy and driven by sales of Seattle Genetics’ Adcetris and Genentech’s Kadcyla, which are likely to earn a combined $600m this year.

Several technological developments in the recent past, however, are likely to drive more stable linkers and potent cytotoxins to improve the safety and efficacy of ADCs, the report finds.

The most commonly used cytotoxins for ADCs under clinical development include auristatin, calicheamicin, maytansine and duocarmycin, though auristatin “dominates the market and accounts for over 50% of ADCs in clinical development​,” the report says.

Pipelines

As far as company pipelines are concerned, Seattle Genetics and ImmunoGen are amongst the pioneers in the field of ADCs, with most ADCs in companies’ pipelines using their technology. Roche, with 10 ADCs in various stages of development, is seen as having the most developed pipeline of ADCs, though new entrants to the market, such as Oxford BioTherapeutics, Mersana Therapeutics and Abzena

Most development to date has been carried under technology license agreements. However, we expect to see more co-development agreements in the future​,” the report says.

Still, only seven to ten new ADC commercial launches are expected to occur in the next decade, and the overall market will be worth about $10bn annually by 2024.

Questions Remain

Drug developers / venture capital firms are investing huge amount of money in biologics and it remains to be seen what proportion of this will be directed towards ADCs. The current market landscape will gradually evolve as large pharmaceutical companies look to gain competitive advantage in the ADC market​,” the report concludes.

About 45 molecules are currently in clinical development, with about 25% in Phase II or Phase III trials. 

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