ADC Contract Manufacturing Market, 2020-2030

ADC Contract Manufacturing Market, 2020-2030

  • November 2020 •
  • 426 pages •
  • Report ID: 3290025 •
  • Format: PDF
INTRODUCTION
Since the success of ADCETRIS® (approved in 2011), antibody drug conjugates (ADCs) are now considered a versatile therapeutic tool and have been accepted into the contemporary portfolio of mainstream healthcare solutions. Over time, clinical researchers have been able to further their understanding of the intricacies of ADC design and have also improved the development process of these complex pharmacological interventions. Some of the recently approved ADC therapeutics include BLENREP® (2020), TRODELVYTM (2020), PadcevTM (2019) and POLIVY® (2019). In addition, there are close to 250 unique ADC product candidates under development. Several big pharma players, including AstraZeneca, GlaxoSmithKline, Pfizer, Roche and Takeda, have also acquired stake in this market. Moreover, the fact that companies involved in the development of ADCs, have received over USD 5 billion in capital investments (since 2011), attests to the therapeutic potential and growing popularity of this novel class of targeted therapeutics. However, the impending growth of the ADC therapeutics market highlights the rising importance of establishing advanced manufacturing capacities in order to meet the anticipated demand. Not all stakeholders in the industry possess end to end capabilities / infrastructure to support the design, development and manufacturing of these complex and highly potent pharmacological entities.

Owing to the fact that ADCs are highly potent, cytotoxic molecules, the manufacturing of such conjugated entities requires elaborate technical capabilities, along with manufacturing acumen related to both biologics and highly potent chemical substances. Specifically, the development of an antibody requires experience in protein engineering, cell line development, bioprocess development and related scale-up techniques. The production of the cytotoxic payloads, which are used in ADCs, requires contained manufacturing facilities, special equipment, and expertise in advanced chemical synthesis and purification techniques. In addition, the process is incomplete without state-of-art linker technologies, which are required for the final bioconjugation step, wherein the antibody component is attached to the cytotoxic payload. Given the aforementioned requirements, industry stakeholders generally do not (entirely) manufacture ADCs in-house. Presently, it is estimated that, 70-80% of ADC manufacturing operations are outsourced. This trend is likely to persist in the coming years, as well. In fact, even some of the leading players in this domain claim to be dependent on contract manufacturers for the supply of one or more components of their respective ADC products / product candidates. All these factors contribute towards increasing the complexity of ADC supply chain. However, as per the recent industry trends, the number of collaborations, strategic alliances and acquisitions have enabled the companies to offer integrated supply chain solutions. Given the anticipated growth in demand for ADCs, the contract manufacturing market in this domain is anticipated to witness substantial growth in the coming years.

SCOPE OF THE REPORT
The “ADC Contract Manufacturing Market (4th Edition) by Phase of Development (Commercial, Phase III, Phase II and Phase I), Type of Component Manufacturing (Antibody Manufacturing, HPAPI / Cytotoxic Payload and Linker Manufacturing, Conjugation and Fill / Finish), Target Indications (Solid Tumors, Hematological Malignancies and Others), Type of Payload Used (Maytansinoid, Auristatin, Pseudomonas Exotoxin, PBD and Others), Type of Linker Used (SMCC, VC, Hydrazone Linker, Peptide Linker, SPDB, and Others), Type of Antibody Origin (Humainzed, Human, Murine and Chimeric), Type of Antibody Isotype (IgG1, IgG2 and IgG4) and Geography (North America (the US, Canada, Mexico and Rest of North America), Europe (the UK, Germany, France, Spain, Italy and Rest of Europe), Asia-Pacific (Japan, China, Korea, Australia, India, Taiwan and Rest of Asia-Pacific), MENA (Israel, Saudi Arabia, UAE, Egypt), Latin America (Brazil, Peru, Argentina and Rest of Latin America) and Rest of the World), 2020-2030” report offers a comprehensive study of the current scenario and future potential of the ADC contract manufacturing market. The study features an in-depth analysis, highlighting the capabilities of contract services providers engaged in this domain. In addition to other elements, the study includes:
An overview of the current market with respect to the players involved in the contract manufacturing of ADCs. It features information on company size, year of establishment, types of services offered (antibody manufacturing / HPAPI or cytotoxic payload manufacturing / linker manufacturing / conjugation / fill-finish), location of headquarters, location of manufacturing facilities, scale of operations (preclinical, clinical and commercial), and additional development services (proof-of-concept studies / process development and scale-up / analytical development). In addition, the chapter includes details on the antibody contract manufacturers and HPAPI / cytotoxic payload contract manufacturers.
Elaborate profiles of contract manufacturers that 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 competitiveness analysis of contract manufacturers across key geographical areas, featuring a four-dimensional bubble representation, taking into consideration supplier strength (company size and its experience in this field), service strength (number of ADC services offered, number of additional services offered and location of ADC manufacturing facilities), manufacturing strength (scale of operation and number of ADC manufacturing facilities) and company size (small-sized, mid-sized and large).
A detailed analysis of the expansions undertaken (since 2012) by various service providers for augmenting their respective ADC service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion and new facility), type of service offered (manufacturing services, analytical / development services and fill / finish), geographical location of facility, scale of operation (preclinical, clinical and commercial) and most active players (in terms of number of instances).
An analysis of the recent partnerships (since 2012) focused on manufacturing of ADCs, based on various parameters, such as year of agreement, type of agreement (manufacturing agreement, research agreement, product development, licensing agreement, service alliance, acquisition and others), key players and the geographical distribution of this activity.
A qualitative analysis highlighting the various factors that need to be taken into consideration by ADC developers, while deciding whether to manufacture their respective products in-house or outsource the manufacturing to a contract service provider.
A detailed discussion on various steps of the manufacturing process, namely antibody manufacturing, payload manufacturing, linker manufacturing, conjugation and fill / finish, of an ADC and the cost requirements across each of the aforementioned stages.
An estimate of the overall ADC manufacturing / bioconjugation capacity (in grams / batch) of contract manufacturers based on information provided on their respective websites (wherever available) and additional data collated via secondary and primary research. The analysis highlights the distribution of global capacity by company size (small-sized, mid-sized and large), geographical location of headquarters, geographical location of ADC manufacturing facilities and key players (in terms of highest bioconjugation capacity).
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 (marketed, clinical and preclinical / discovery stage) of lead candidates, target indication(s), target antigen, antibody origin, antibody isotype, type of payload / warhead, type of linker and key players (in terms of number of preclinical molecules).
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 antibody isotopes, payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, trial phase, trial status, target indication, type of sponsor / collaborator, number of patients enrolled and duration of the trials.
An informed estimate of the annual demand for ADC products (in grams), taking into account commercial, as well as clinical scale requirements, based on parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
A detailed regional capability assessment framework, which compares the key geographies, based on a number of parameters, such as the number of ADC contract manufacturers, number of ADC manufacturing facilities, number of facility expansions, installed ADC capacity, number of registered clinical trials and demand for ADC’s in that particular geographical region.
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.
An insightful discussion on the impact of COVID-19 pandemic on the ADC contract manufacturing market. In addition, it features various strategies that different companies have adopted / may adopt in order to mitigate the challenges affiliated to the current global crisis.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the ADC contract manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] phase of development (commercial, phase III, phase II and phase I), [B] type of component manufacturing (antibody manufacturing, HPAPI / cytotoxic payload and linker manufacturing, conjugation and fill / finish), [C] target indications (solid tumors, hematological malignancies and others), [D] type of payload used (maytansinoid, auristatin, pseudomonas exotoxin, PBD and others), [E] type of linker used (SMCC, VC, hydrazone linker, peptide linker, SPDB, and others), [F] type of antibody origin (humainzed, human, murine and chimeric), [G] type of antibody isotype (IgG1, IgG2 and IgG4) and [H] geography (North America (US, Canada, Mexico and rest of North America), Europe (UK, Germany, France, Spain, Italy and rest of Europe), Asia-Pacific (Japan, China, Korea, Australia, India, Taiwan and rest of Asia-Pacific), MENA (Israel, Saudi Arabia, UAE, Egypt), Latin America (Brazil, Peru, Argentina and rest of Latin America) and rest of the world). To account for the uncertainties associated with the contract manufacturing of ADCs and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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 (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)
Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai)
Anthony DeBoer (Director, Business Development, Synaffix)
Christian Bailly (Director of CDMO, Pierre Fabre)
David Cunningham (Director Corporate Development, Goodwin Biotechnology)
Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)
Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza)
Mark Wright (Site Head, Piramal Pharma Solutions)
Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services)
Anonymous (Director, Business Development, Leading CMO)
Anonymous (Chief Executive Officer, Leading CMO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the period 2020-2030, 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.

KEY QUESTIONS ANSWERED
Who are the leading ADC contract manufacturers, across the world?
In which regions are majority of the ADC manufacturing facilities located?
What percentage of ADC manufacturing operations are outsourced?
What are the key regions targeted by contract manufacturers for expansions or new facility set-up?
Which partnership models are commonly adopted by stakeholders in this industry?
What factors are likely to decide if ADC manufacturing should be done in-house or outsourced?
What is the overall cost distribution across various steps of ADC manufacturing process?
What is overall ADC manufacturing / bioconjugation capacity (in grams / batch) of contract manufacturers?
How many ADCs are under development and approved?
Which geographies are most active in conducting ADC clinical trials?
What is the current, global demand for ADC products?
How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high level view on the likely evolution of the ADC contract manufacturing market in the mid to long term.

Chapter 3 is a general introduction to ADCs and the manufacturing requirements of such therapeutic products. It includes a detailed discussion on the structure of an ADC and its various components, manufacturing steps and associated challenges. The chapter also provides an overview of the growing trend of contract manufacturing, along with the challenges associated with supply chain and the growing demand for one-stop-shops. Further, it features a discussion on the various parameters that a sponsor company needs to consider while selecting a contract manufacturing partner.

Chapter 4 provides a comprehensive overview of contract manufacturers that are actively involved in the production or conjugation of ADCs. The chapter features information on company size, year of establishment, types of services offered (antibody manufacturing / HPAPI or cytotoxic payload manufacturing / linker manufacturing / conjugation / fill-finish), location of headquarters, location of manufacturing facilities, scale of operations (preclinical, clinical and commercial), and additional development services (proof-of-concept studies / process development and scale-up / anaytical development). The chapter also includes a list of various contract manufacturers offering antibody production services along with the information on the location of their headquarters. Further, it provides a list of HPAPI / cytotoxic payload contract manufacturers along with the information on location of facilities dedicated to the manufacturing of such components.

Chapter 5 features profiles of contract manufacturers that 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.

Chapter 6 features a detailed comparative analysis of the ADC contract manufacturers. The companies were compared on the basis of various parameters including supplier strength (company size and its experience in this field), service strength (number of ADC services offered, number of additional services offered and location of ADC manufacturing facilities) and manufacturing strength (scale of operation and number of ADC manufacturing facilities).

Chapter 7 highlights the investments made by CMOs to expand or set up new facilities in order to support their ongoing operations. For each such instance, we have provided information on year of expansion, type of expansion (capacity expansion and new facility), type of service offered (manufacturing services, analytical / development services and fill / finish), geographical location of facility, scale of operation (preclinical, clinical and commercial) and most active players (in terms of number of instances).

Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked between different players in this market since 2012. It includes a brief description of the purpose of the partnership models (including research agreements, manufacturing agreements, technology licensing agreements, product development agreements and acquisitions / mergers). Further, it comprises of analysis based on year of agreement, type of agreement, key players and the geographical distribution of this activity.

Chapter 9 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by ADC developers, while deciding whether to manufacture their respective products in-house or outsource the manufacturing to a contract service provider.

Chapter 10 presents a value chain analysis featuring a detailed discussion on the various steps of the ADC manufacturing process, namely antibody manufacturing, payload, linker manufacturing, conjugation and fill / finish and the cost requirements across each of the aforementioned stages.

Chapter 11 features a comprehensive analysis of the overall installed manufacturing / bioconjugation capacity of contract manufacturers and an estimate of the quantity of ADCs that can be produced per batch. The analysis highlights the distribution of global capacity by company size (small-sized, mid-sized and large), geographical location of headquarters, geographical location of ADC manufacturing facilities and key players (in terms of highest bioconjugation capacity).

Chapter 12 provides a comprehensive overview of the market landscape of ADCs that are already approved and those that are under development (clinical and preclinical). This chapter includes information related to their current phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, target indication(s), target antigen, antibody origin, antibody isotype, type of payload / warhead, type of linker and key players (in terms of number of preclinical molecules).

Chapter 13 features an elaborate discussion and competitive analysis of the various ADC conjugation approaches. This chapter also features an overview of the evolution of these technologies, highlighting the competition between contemporary technology platforms.

Chapter 14 features a comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). The analysis provides details related to the types of antibody isotopes, payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, trial phase, trial status, target indication, type of sponsor / collaborator, number of patients enrolled and duration of the trials.

Chapter 15 features a comprehensive analysis of the annual demand of ADCs (in grams) taking into account commercial, as well as clinical scale requirements. This was based on the parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.

Chapter 16 presents a detailed regional capability assessment framework which compares the key geographies, based on a number of parameters, such as the number of ADC contract manufacturers, number of ADC manufacturing facilities, number of facility expansions, installed ADC capacity, number of registered clinical trials and demand for ADC’s in that particular geographical region.

Chapter 17 presents a comprehensive market forecast analysis, highlighting the likely growth of the contract manufacturing market of ADCs, till 2030. The chapter provides likely distribution of the projected future opportunity based on phase of development (commercial, phase III, phase II and phase I), type of component manufacturing (antibody manufacturing, HPAPI / cytotoxic payload and linker manufacturing, conjugation and fill / finish), target indications (solid tumors, hematological malignancies and others), type of payload used (maytansinoid, auristatin, pseudomonas exotoxin, PBD and others), type of linker used (SMCC, VC, hydrazone linker, peptide linker, SPDB, and others), type of antibody origin (humainzed, human, murine and chimeric), type of antibody isotype (IgG1, IgG2 and IgG4) and geography (North America (US, Canada, Mexico and rest of North America), Europe (UK, Germany, France, Spain, Italy and rest of Europe), Asia-Pacific (Japan, China, Korea, Australia, India, Taiwan and rest of Asia-Pacific), MENA (Israel, Saudi Arabia, UAE, Egypt), Latin America (Brazil, Peru, Argentina and rest of Latin America) and rest of the world(Malia and Chad)).

Chapter 18 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of ADC contract manufacturing market, under a comprehensive SWOT framework.

Chapter 19 highlights the effect of coronavirus outbreak on the ADC contract manufacturing market. It includes a brief discussion on the short-term and long-term impact of COVID-19 on the supply chain and market opportunity for drug developers and contract manufacturers. In addition, it includes a brief section on strategies and action plans that pharma companies are likely to adopt in order to prepare for supply chain disruptions in future.

Chapter 20 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 21 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciar ini (Technical Business Development Manager, BSP Pharmaceuticals), Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics), John Burt (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), Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (Director of CDMO, Pierre Fabre), David Cunningham (Director Corporate Development, Goodwin Biotechnology), Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions), Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza), Mark Wright (Site Head, Piramal Pharma Solutions), Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services), Anonymous (Director, Business Development, Leading CMO) and Anonymous (Chief Executive Officer, Leading CMO).

Chapter 22 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 23 is an appendix, which provides the list of companies and organizations mentioned in the report.