CMOs to benefit from double digit approvals for ADCs in the next 3 years

Therapeutic ADC market expected to reach $4 billion by 2023.

CPHI Annual Report expert Vivek Sharma, CEO of Piramal Pharma Solutions, expects the global market for ADCs to grow at around 19% CAGR between 2017 and 2030 and reach an estimated value of $4 billion in the next 5 years, with 17 drugs that are either approved or in late stages of clinical development, catalysing such growth.

“The last few years have seen a progressive evolution of targets from first to second and third generation Antibody Drug Conjugates (ADCs), which is now accelerating growth as new compounds are more targeted, more druggable and potentially have a better chance for approval.” commented Vivek Sharma.

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 tumours. 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. Most encouragingly, there has been an increase of 30% in the last 12 months with 23 new ADCs entering clinical trials.

The report outlines that CMO’s and CDMO's are particularly well set to capitalise 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. 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” added Sharma.

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.

In the long term, the Annual Report also highlights that ADCs are now being utilized in other therapeutic products classes beyond oncology. Specifically, ADCs are projected to provide more targeted therapeutics in infectious diseases (against multidrug-resistant bacteria) and chronic conditions such as autoimmune and cardiovascular diseases.

CPHI Brand Director Europe, Orhan Caglayan added: “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. 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. So I encourage all of our attendees at CPHI Worldwide to engage both these findings and with the wider industry this week – by establishing new partnerships we will help accelerate development of the global market."