Antibody Drug Conjugates (ADCs) known as the 21st Century Magic Bullets, have emerged as a promising class of targeted therapies being developed for the treatment of cancer. Two decades ago, in the year 2000, the domain witnessed the approval of first ADC known as Mylotarg®, by the US FDA. This was followed by the successful approval of ADCETRIS® in 2011. However, due to the complex nature of these pharmacological interventions, the domain witnessed the failure of several clinical trials and till 2018 only three ADCs were approved.
The ADC manufacturing is known to be complex, as it requires elaborate technical capabilities, along with manufacturing expertise related to both biologics and highly potent chemical substances. Moreover, it is estimated by several industry stakeholders that, 70-80% of ADC manufacturing operations are outsourced. They further believe that this likely to persist in the coming years, as well. This is driven by the fact that majority of the small and mid-sized companies are anticipated to continue outsourcing their ADC operations. Hence, given the anticipated growth in demand for ADCs, the contract manufacturing market in this domain is also anticipated to witness substantial growth in the coming years.
Notably, over time with the advancements in the research, scientists have further improved the design and development process for these therapies. Owing to such improvements, the domain has recently seen the approval of four new ADCs, BLENREP® (2020), TRODELVYTM (2020), PadcevTM (2019) and POLIVY® (2019). Additionally, there are now close to 250 ADCs that are under development indicating the rising interest in this domain.
Presently, around 35 players, across the globe, claim to have the required capabilities to offer contract services for ADC manufacturing; of these, over 15 players are one-stop-shops.
To know more about the stakeholders and the respective services offered by them, check out our report ADC Contract Manufacturing report.
Further, the current market landscape for ADC manufacturing features the presence of both well-established and new entrants. Around 50% of these service providers claim to operate at all scales of operation.
Who are the leading contractors for ADC manufacturing, across the world?
In order to develop a competitive edge, companies are putting in significant efforts and capital investments towards expanding their capabilities and, thereby enhancing their respective service portfolios.
Recent Developments that have taken place in the ADC Manufacturing Domain
Several contract manufacturers have made significant investments for the expansion of their respective capabilities and working capacities. Some companies have also established new facilities dedicated to bioconjugation and / or manufacturing of highly potent / cytotoxic compounds. Facilities under occupational exposure limit (OEL) below 50 ng/m3 are required for ADC manufacturing owing to the cytotoxic nature of the ADC payload / warheads. During our research, we identified around 85 such developments which were reported during the period 2012 – H1 2020; of these, 67% were instances of facility expansions.
The field has also witnessed the establishment of several partnerships between drug developers and ADC manufacturing service providers. We were able to identify around 60 collaboration agreements for ADC manufacturing alone, which were inked during the period 2012 – H1 2020.
Several Clinical Trials Focused on the Evaluation of ADCs have been Registered Over the Past Few Years
During our research, we came across ~550 registered clinical trials focused on antibody drug conjugates (both marketed and clinical stage therapeutics), during the period between 1997–2020 (till August). Most of the trials were registered in North America (47%), followed by Europe (32%). The abovementioned studies were conducted on more than 100,000 patients who were recruited across different geographies.
The Demand for Contractual ADC Manufacturing is Anticipated to Increase Rapidly in the Coming Years
The demand for ADC manufacturing is projected to grow at an annualized rate of over 17%. Currently, around 80% of the total demand is driven by commercially available products. As more late stage product candidates are approved, the share of commercial scale demand is expected to increase to 94% by 2030.
The Global Capacity for ADC Manufacturing is Driven by Mid to Large-sized CMOs
A major share (over 60%) of the global capacity is installed in facilities of mid to large sized CMOs. Around 50% of the total capacity is installed in facilities based in Europe, which also has the largest number of bioconjugation facilities in the world.
Likely Growth of ADC Contract Manufacturing Services Market
With over 70% of the ADC manufacturing operations currently, being outsourced, we expect the ADC Contract Manufacturing market to grow at an annualized rate of over 12% during the next decade.
Further, the anticipated opportunity is expected to be segregated across a variety of linkers and antibodies; it is also likely to be well-distributed across key geographical regions