The global ADC therapeutics market is expected to grow to US $ 4bn by 2023, with double digit approvals within 3-years. Novel payloads that target tumor-initiating cells on third generation antibody-drug conjugates or ADCs could come to market in the next couple of years. Driven by a healthy late stage pipeline, experts believe that the market for antibody-drug conjugates will expand at around 19%  compounded annual growth rate (CAGR) between 2017 and 2030.

These growth expectations are based on 17 drugs that are either approved or in late stages of clinical development, catalyzing growth.

Furthermore, the expectation is that outsourcing of ADC manufacturing to Contract Manufacturing and Contract Development and Manufacturers will continue, with increased co-development driven by increased needs from biotechnology companies requiring unique, specialist development expertise and facilities.

But the  most exciting aspect of growth predicted is the expansion of antibody-drug conjugates into therapeutic areas other than oncology. With the development of antibody-drug conjugates in infectious disease, experts believe this to be the next (r)evolution.

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Annual Report
These predictions are based on a new analysis published in the 2018 edition of the CPhI Annual Report – the complete findings of which were released earlier this month at CPhI Worldwide in Madrid, Spain, the global pharmaceutical event held October 9 – 11, 2018.

“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,” said Vivek Sharma, Chief Executive Officer of Piramal Pharma Solutions and co-author of the 2018 CPhI Annual Report.

Better understanding
The understanding of site-specificity and homogeneously conjugated antibody-drug conjugates ADCs has accelerated the U.S. Food and Drug Administration’s (FDA) approval rate and has led to dramatic increase in the number of clinical trials, especially in solid tumors. In total there are now more than 600 clinical trials being conducted worldwide with ADCs. And a  staggering 202 antibody-drug conjugates are 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 among smaller and medium sized biotech companies.

“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, biotechnology and pharma companies are increasing their research and product development in biologics” added Sharma.

Technical challenges
Due to technical challenges associated with the manufacturing of antibody-drug conjugates 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.

Other therapeutic areas
In the long term, ADCs are now being utilized in other therapeutic products classes beyond oncology. Specifically, antibody-drug conjugates are projected to provide more targeted therapeutics in infectious diseases (against multi drug resistant bacteria) and chronic conditions such as autoimmune and cardiovascular diseases.[2]

Despite the relatively simple concept, taking antibody-drug conjugates outside the realm of oncology and hematology remains challenging. In contrast, to onclogical indications, non-oncological indications generally require that payloads are delivered to the target cells and modulate biological functions without affecting cell viability. Furthermore, these payloads are non-toxin-based and are largely less potent compared to toxins used in oncology and hematology. As a result, in non-oncological indications, antibody-drug conjugates have a ‘higher standard’ in terms of target selection, antibody carriers, linker chemistry, as well as conjugation approaches to achieve sufficient binding, efficient internalization, and payload release. With a better understanding of antibody-drug conjugates and the applicable chemistries, a number of researchers are currently developing novel, non-oncological ADCs. The expectation is that a larger number of these novel, investigational agents will be included in the ADC-pipeline in the next 3 – 5 years. [2][3]

Small and Large
“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,” said Orhan Caglayan, CPhI Brand Director Europe.

“[This is] clearly extremely promising for CDMOs, and the wider outsourcing industry with over 70% of future manufacturing set to be contracted to specialist providers,” Caglayan concluded.

Note: Download the full findings published in the CPhI Annual Report 2018, which includes 11 in-depth expert contributions as well as the CPhI Manufacturing and Bio leagues tables.


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