CMOs to benefit from double-digit approvals for ADCs

MADRID—The global antibody-drug conjugate (ADC) therapeutics market is expected to grow to $4 billion by 2023, with double-digit approvals within three years, according to a new analysis in the CPhI Annual Report. The complete findings of the report were released live at the CPhI Worldwide conference held in Spain in October.

CPhI Annual Report expert Vivek Sharma, the CEO of Piramal Pharma Solutions, expects the global market for ADCs to grow at around a 19-percent compound annual growth rate between 2017 and 2030 and reach the estimated value of $4 billion in the next five years, with 17 drugs that are either approved or in late stages of clinical development catalyzing that growth.

“The last few years have seen a progressive evolution of targets from first- to second- and third-generation antibody-drug conjugates, which is now accelerating growth as new compounds are more targeted, more druggable and potentially have a better chance for approval,” Sharma said.

The understanding of site-specificity and homogenously conjugated ADCs has accelerated the U.S. Food and Drug Administration approval rate and has led to a dramatic increase in the number of clinical trials for ADCs, especially in solid tumors. In total, there are now 600 clinical trials being conducted worldwide on ADCs, with 202 ADCs entering clinical trials—out of which 116 are actively progressing, according to CPhI. Most encouragingly, there has been an increase of 30 percent in the last 12 months, with 23 new ADCs entering clinical trials.

The report outlines that contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are particularly well set to capitalize on this growing therapeutic product class, and may even lead to new business models such as co-development partnerships, particularly among small and medium-sized biotechs.

Due to technical challenges associated with ADC manufacturing and the substantial investment involved on safety and hazardous material equipment, Vivek estimates that around 70 percent of ADC manufacturing is outsourced to CMOs. This is expected to rise, particularly for horizontally integrated CDMOs, along with co-development business models, driven by biotechs and smaller companies that need specialist development expertise and facilities.

The full findings of the CPhI Annual Report are available for free at www.cphi.com/europe/cphi-annual-report.