Owing to the fact that a number of ADC developers are outsourcing various aspects of their business processes, CMOs engaged in this domain have undertaken several expansion initiatives to become one-stop-shops to cater to the diverse needs of ADC developers. 

Roots Analysis has announced the addition of “ADC Contract Manufacturing Market (5th Edition), 2022-2035” report to its list of offerings.

In order to mitigate the challenges associated with ADC manufacturing, around 70-80% of the therapeutics developers prefer to outsource their operations to contract manufacturing organizations (CMOs), which claim to have the required expertise and experience to leverage their capabilities and yield cost savings opportunities   

Key Market Insights

Presently, more than 30 players claim to offer ADC contract manufacturing services

This segment of the industry is dominated by the presence of large (more than 501 employees) and mid-sized (51-500 employees) players, which collectively represent more than 80% of the total contract manufacturers in this domain. In addition, around15% firms were established post 2010.

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More than 84 expansions were reported in this industry, during 2012-2021

Of the total, 57% instances were focused on enhancing dedicated capabilities and capacities, followed by those carried out for the expansion / establishment of manufacturing facilities (42%).

Partnership activity in this domain has increased at a CAGR of over 16%, during 2016- 2021

Manufacturing agreements emerged as the most popular type of partnership model adopted by industry stakeholders (18%), followed by product development agreements (16%) and research agreements (15%). Further, most of the deals were inked by players based in Europe (46%).

Global, installed ADC contract manufacturing capacity is currently estimated to be close to 33 Kilograms

The maximum share of the current installed capacity is expected to be captured by large players. Moreover, close to 37% of the installed manufacturing capacity is available in the Asia-Pacific region.

140,200+ patients have been enrolled in over 714 clinical trials, worldwide

Clinical research activity, in terms of number of trials registered, is reported to have increased at a CAGR of 21%, in the past three years. Of the total number of trials, close to 47% of the studies are recruiting patients, while 30% have been completed.

Global demand for ADC contract manufacturing is anticipated to grow at a CAGR of 13%, during 2022-2035

The commercial demand for ADC therapeutics is projected to increase at a CAGR of 22%. Further, the clinical demand for ADC therapeutics in phase III trials is projected to increase at a CAGR of 10%.

The market is anticipated to grow at a CAGR of nearly 13%, during the period 2022-2035

In terms of type of cancer, ADC therapeutics targeting solid tumors (48%) are anticipated to capture the highest share; this trend is unlikely to change in the foreseen future. Further, based on type of antibody isotype, majority of the revenue share (90%) of the overall market is likely to be driven by IgG1 antibodies.

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Key Questions Answered

·        Who are the key players engaged in providing ADC contract manufacturing services?

·        Which regions represent the current contract hub for ADC manufacturing?

·        What percentage of ADC manufacturing operations are currently outsourced?

·        Which are key hubs for the expansion activity of ADC contract manufacturers?

·        What kind of partnership models are commonly adopted by stakeholders in this industry?

·        What is the industry attractiveness and competitive strength in the ADC contract manufacturing domain?

·        What factors should be taken into consideration while deciding whether the manufacturing operations for ADCs should be kept in-house or outsourced?

·        Which therapy developers are likely to partner with ADC contract manufacturers?

·        What is the overall cost distribution across various steps of the ADC manufacturing process?

·        What is overall ADC manufacturing / bioconjugation capacity (in kilograms) of contract manufacturers?

·        Which are the key clinical trial hubs for studies focused on ADC therapeutics?

·        What is the current, global demand for ADC products and how is it expected to evolve in the foreseen future?

·        How is the current and future market opportunity likely to be distributed across key market segments?

The financial opportunity within the ADC contract market has been analyzed across the following segments:

Scale of Operation

·        Commercial

·        Clinical

Phase of Development

·        Phase III

·        Phase II

·        Phase I

Type of Component Manufacturing

·        Antibody manufacturing

·        HPAPI / Cytotoxic Payload and Linker Manufacturing

·        Conjugation

·        Fill / Finish

Target Indication  

·        Solid Tumors

·        Hematological Malignancies

·        Others

Type of Payload Used

·        Maytansinoid

·        Auristatin

·        Camptothecin

·        PBD

·        Others

Type of Linker Used

·        SMCC

·        VC

·        Malemide

·        Peptide Linker

·        Others

Type of Antibody Origin

·        Humanized

·        Chimeric

·        Murine

·        Human

·        Others

Type of Antibody Isotype

·        IgG1

·        Others

Key Geographical Regions

·        North America

·        Europe

·        Asia-Pacific

·        Rest of the World

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information

The opinions and insights presented in the report were also influenced by discussions held with key stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

·        Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals)

·        Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics)

·        John Burt (ex-Chief Executive Officer, Abzena)

·        Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia)

·        Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma)

·        Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics)

·        Takashi Owa (Chief Innovation Officer, Eisai) and Toshimitsu Uenaka (Executive Director, Eisai)

·        Anthony DeBoer (Director, Business Development, Synaffix)

·        Christian Bailly (ex-Director of CDMO, Pierre Fabre)

·        Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (ex-Group Product Manager, Catalent Pharma Solutions)

·        Vitor Sousa (Business Development Manager, Cerbios-Pharma)

·        David Cunningham (Director Corporate Development, Goodwin Biotechnology)

·        Laurent Ducry (ex-Head of Bioconjugates Commercial Development, Lonza)

·        Mark Wright (ex-Site Head, Piramal Pharma Solutions)

·        Zhala Tawfiq (Associate Scientist, Ajinomoto Bio-Pharma Services)

·        Anonymous (Director, Business Development, Leading CMO)

·        Anonymous (Chief Executive Officer, Leading CMO)

The research also includes detailed profiles of key ADC contract manufacturers (listed below); each profile features an overview of the company, its financial information (if available), details on product portfolio, recent developments, and an informed future outlook

·        MabPlex

·        AbbVie Contract Manufacturing

·        Lonza

·        Catalent Pharma Solutions

·        Goodwin Biotechnology

·        MilliporeSigma

·        Piramal Pharma Solutions

·        Wuxi Biologics

·        Abzena

·        CARBOGEN AMCIS

·        Cerbios-Pharma

·        Formosa Laboratories

·        Creative Biolabs

·        Novasep

·        Sterling Pharma Solutions

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