CMOs to Benefit from Double-Digit Approvals for ADCs, CPhI Reports

The global therapeutic antibody drug conjugates (ADC) 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.

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

“The last few years have seen a progressive evolution of targets from first to second and third generation ADCs, which is now accelerating growth as new compounds are more targeted, more druggable, and potentially have a better chance for approval,” commented Sharma in an Oct. 9, 2018 press release issued by CPhI.

The understanding of site-specificity and homogenously conjugated ADCs has accelerated the FDA approval rate and has led to dramatic increase in the number of clinical trials, 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, CPhI reports. There has been an increase of 30% clinical trials 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 positioned to capitalize on this growing therapeutic product class, and may even lead to new business models, such as co-development partnerships, particularly amongst smaller- and medium-sized biotechs.

“The global market for ADCs is expected to be driven by the advancement in medical technology, rising incidence of cancer, and an increasing demand for biologic therapies, Sharma added. “In the quest for more targeted therapies and potentially more clinically efficacious drugs, bio/pharma companies are increasing their research and product development in biologics.”

Due to technical challenges associated with ADC manufacturing and the substantial investment involved on safety and hazardous material equipment, Vivek estimates that around 70% 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, as stated by CPhI.

The annual report also highlights that ADCs are now being used in other therapeutic products classes beyond oncology. Specifically, ADCs are projected to provide more targeted therapeutics in infectious diseases (against multi-drug resistant bacteria) and chronic conditions such as autoimmune and cardiovascular diseases.

“The findings in the full CPhI annual report further reinforces that there is a clear bridge now forming between small- and large-molecule industries, with the cross-sharing of knowledge in the ADC market leading to less clinical attrition and greater approvals,” added Orhan Caglayan, CPhI Europe brand director, in the press release. “So whilst it is clearly good news for CPhI and bioLIVE-as we combine small- and large-molecule exhibitions in 2018-the market also looks extremely promising for CDMOs, and the wider outsourcing industry with over 70% of future manufacturing set to be contracted to specialist providers.”

The complete findings of the report, which include 11 in-depth expert contributions as well as the CPhI Manufacturing and Bio leagues tables, were released live at CPhI Worldwide 2018 in Madrid, Spain on Oct. 9–11, 2018.

Source: CPhI