With six approved drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), and more than 300 candidates in the pipeline (clinical / preclinical stages), antibody drug conjugates (ADCs) have emerged as a promising class of therapeutics for the treatment of various disease indications. Over time, medical researchers have been able to further develop their understanding of the intricacies of ADC design and have also improved the development process of these complex pharmacological interventions. ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Given the fact that ADCs are highly potent cytotoxic molecules, the manufacturing of ADCs requires elaborate technical capabilities and highly potent chemical substances. Specifically, the multi-step process of production of cytotoxic payloads, which are used in ADCs, requires a contained environment, dedicated manufacturing facilities, specialized analytical and purification techniques, and storage facilities. However, several ADC developers do not have the in-house capabilities to manufacture cytotoxic payload on a commercial scale and tend to rely on contract manufacturers. As per the estimates, 70-80% of ADC manufacturing operations are outsourced.
Since 2000, several contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), offering HPAPI and cytotoxic drug related services have been established to cater to the rise in demand of cytotoxic ADCs and other similar therapeutic interventions. In addition, several ADC developers have forged strategic partnerships with payload providers to advance the development of pipeline ADC candidates. Given the growing clinical pipeline of ADCs, coupled to the various technological advancements, the market for ADC payload and warheads is anticipated to witness substantial growth in the coming years.
ADC Payload / Warheads Developers
Presently, around 40 companies across the globe claim to have the required expertise and capabilities to provide ADC payload and warheads for ADCs.
The current market landscape is a mix of both CDMOs and developers; most of them provide microtubule inhibitors and DNA damaging agents as ADC payload.
Rise in Intellectual Property Portfolio
Over time, the intellectual property related to ADC payload / warheads has grown at a significant rate, primarily for ADCs containing auristatin, calicheamicin and maytansinoids as payloads.
Increased Partnership Activity
In the past few years, a steady increase in partnership activity has also been observed; a relatively higher proportion of deals were inked for licensing and development of ADCs.
Significant Rise in Demand
With the success of marketed products and anticipated approval of new antibody drug conjugates, the demand for ADC payload / warheads is expected to steadily increase.
Likely Growth of the ADC Payload / Warheads Market
During our research, we estimated the market under conservative, base, and optimistic scenarios. As per the base case forecast scenario, the market for ADC payload / warheads is anticipated to grow at a CAGR of over 10% during the next decade; the opportunity is likely to be well-distributed across different regions worldwide.