Driven by the rapidly evolving pipeline of ADC therapeutics, the ADC contract manufacturing market is anticipated to grow at an annualized rate of around 11.9% during the period 2018-2030, predicts Roots Analysis

Published: September 2018

Roots Analysis has announced the addition of “ADC Contract Manufacturing Market (3rd Edition), 2018-2030” report to its list of offerings.

Tanya Bhardwaj, the principal analyst, stated, “Owing to the fact that ADC therapeutics 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. Due to the aforementioned challenges, stakeholders are dependent on contract manufacturers for the supply of one or more components of their ADC product candidates.”

The report presents opinions on several key aspects of the market. Among other elements, it includes:

  • An overview of the current status of the market with respect to the players involved in the manufacturing of ADCs. It is worth highlighting that, of the total number of stakeholders, close to 15 players claim to be one-stop-shops, providing end-to-end services for all the steps of ADC manufacturing. Further, over 80% of ADC contract manufacturers are based in either North America or Europe with facilities dedicated to ADC manufacturing / conjugation located in one or multiple regions.
  • Elaborate profiles of the contract service providers that are either one-stop-shops (offering services from antibody manufacturing to fill/ finish operations) or offer conjugation services at the commercial scale. Each profile provides a brief overview of the company, its financial information, details on ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.
  • A comparative analysis of the key contract manufacturers based on various parameters, including company size, year of establishment, number of ADC manufacturing services offered, annual revenues, scale of operation, number of ADC development services offered and number of facilities for conjugation services.
  • An analysis of the recent investments (since 2012) made in this domain, the proceeds of which were intended to be used for the expansion or establishment of new facilities dedicated to offering ADC related services. Over 60 of such developments were reported during the period 2012-H1 2018; of these, 65% of the instances were facility expansion project.
  • An analysis of the recent collaborations focused on manufacturing of ADCs on the basis of year in which the agreement was signed, type of agreement, key players and the geographical distribution of this activity.
  • An estimate of the overall ADC manufacturing / bioconjugation capacity (in grams / batch) of contract service providers highlighting the distribution of global capacity by size of the company / organization (small-sized, mid-sized and large-sized) and geography (North America, Europe and Asia Pacific). A major share (over 90%) of the capacity is installed in facilities of mid-large CMOs. Further, around 55% of the global ADC manufacturing capacity is installed in facilities based in Europe. This is attributed to the large number of bioconjugation facilities that are presently situated in this region.
  • An overview of the ADCs that are already approved and those that are under development (clinical and preclinical), featuring information related to their current phase of development (wherever applicable), key target indications, developer company / organization, affiliated technology provider(s) and the type(s) of cytotoxin(s) and linker(s) used. It is worth mentioning that close to 80 ADCs are currently in the clinical stages of development.
  • A review of the evolution of ADC conjugation technologies, highlighting the various types pf approaches that have been adopted in the past, and the different generations of linkers. It also highlights the competition between contemporary technology platforms.
  • A comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). It provides details related to the different types of payloads and linkers investigated / being investigated across various geographies, based on various parameters, such as the number of trials registered, phase of development and number of patients enrolled. During our research, we came across more than 400 clinical studies, with over 70,000 patients across the globe.
  • An informed estimate of the annual demand for ADC products (in grams), taking into account commercial, as well as clinical scale requirements. Currently, products being evaluated in clinical trials are estimated to contribute around 35% of the annual demand. Further, our projections indicate that, by 2030, commercialized products are likely to contribute to 90% of the demand for ADC manufacturing services.
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall ADC contract manufacturing market.

The report features inputs from a number of eminent industry stakeholders. Bhardwaj remarked, “Most of the experts we spoke to concurred on the opinion that the trend of outsourcing is likely to persist in the future. Approximately 70-80% of ADC manufacturing services are presently being outsourced to contract service providers.” The report features detailed transcripts of discussions held with the following experts:

  • Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals)
  • Anthony DeBoer (Director, Business Development, Synaffix)
  • Christian Bailly (Director of CDMO, Pierre Fabre)
  • Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics)             
  • Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma)
  • Jennifer L Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)
  • John Burt (Chief Executive Officer, Abzena)
  • Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza)
  • Mark Wright (Site Head, Piramal Healthcare)
  • Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia)
  • Anonymous (Director, Business Development, Leading CMO)
  • Anonymous (Chief Executive Officer, Leading CMO)

The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no selection criteria):

  • Abzena
  • Ajinomoto Althea
  • BSP Pharmaceuticals
  • Catalent Pharma Solutions
  • Cerbios-Pharma
  • Creative Biolabs
  • Goodwin Biotechnology
  • Levena Biopharma
  • Lonza
  • MabPlex
  • Merck (SAFC)
  • Novasep
  • Pierre Fabre
  • Piramal Pharma Solutions
  • Syngene
  • WuXi Biologics

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Gaurav Chaudhary
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