September 11, 2018

ADC Manufacturing: Current Landscape, Growth Opportunities and Future Market Outlook

By Arun Gupta Antibodies, Biologics 0 Comments

Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along with the required expertise and manufacturing acumen related to both biologics and highly potent chemical substances. The production of the cytotoxic payloads that are used in ADCs requires specialized manufacturing facilities and equipment, highly contained production environments and experts in advanced synthetic chemistry and purification techniques. Although some big pharma companies carry out in-house manufacturing of their ADC products, the trend of outsourcing such operations is likely to flourish in the coming years.

Owing to complex development / production process requirements, industry stakeholders concur on the opinion that outsourcing is a beneficial business strategy for ADC products

The contract services market is niche with limited number of players having manufacturing / conjugation capabilities; however, over 10 companies claim to be one-stop-shops

The US and EU, with relatively more manufacturing facilities dedicated to the production of ADCs and their components, are the key manufacturing hubs

Majority of ADC developers are dependent on contract manufacturers for the supply of their late-stage product candidates and their components

Case Study: Presently, there are over 400 registered clinical trials with 70,000+ enrolled patients, evaluating the therapeutic potential of ADCs in multiple centers across the globe

In order to keep pace with the growing demand for ADC therapeutics, several contract manufacturers have invested or entered into strategic alliances to expand existing capabilities

The global capacity for bioconjugation is driven by mid to large-sized CMOs; most of this capacity is installed in facilities based in Europe

As more pipeline candidates gain approval, the commercial ADC therapeutics are anticipated to drive over 90% of the demand by 2030

The installed capacity is sufficient to meet the current overall annual demand; however, as the demand rises, CMOs will be required to invest in installing incremental capacity

With over 70% of the ADC manufacturing operations currently being outsourced, we expect the market to grow at an annualized rate of over 10% during the next decade

The market is likely to be distributed across various linker and payload types; mytansinoid and auristatin based candidates are expected to account for relatively higher market shares