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ADC Contract Manufacturing Market by Phase of Development, Scale of Operation, Type of Component Manufacturing, Target Indications, Type of Payload, Type of Linker, Type of Antibody Origin, Antibody Isotype and Geography, 2022-2035

ADC Contract Manufacturing Market by Phase of Development, Scale of Operation, Type of Component Manufacturing, Target Indications, Type of Payload, Type of Linker, Type of Antibody Origin, Antibody Isotype and Geography, 2022-2035

  • July 2022
  • 580 pages
  • ID: 6316296
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
In the past two decades, antibody therapeutics have become a key component of the treatment regimens against a range of diseases, specifically cancer. Representing one of the rapidly growing segments of the pharmaceutical industry, a number of technological advancements have been reported in this sector. In this context, a number of researchers are evaluating the potential of antibody drug conjugates (ADCs) for the treatment of a myriad of disease indications. In addition to enabling better efficacy as compared to antibody therapeutics, ADCs exhibit higher stability, reduced toxicity, improved tumor selectivity, increased drug tolerance and less systemic exposure. , It is worth highlighting that, in the last few years, more than 10 ADCs have received the FDA approval. Further, a number of ADCs are being evaluated across 700+ clinical trials for the treatment of a wide array of disorders. To support the ongoing pace of research in this domain, a total of USD 14.8 billion (since 2014) has been invested in this domain by several private / strategic investors and government organizations, indicating the therapeutic potential and growing appeal of this unique class of targeted medicines. However, the production of this therapeutics is associated with several challenges, including generation of antibody aggregates, drug / linker side reactions, containment of highly toxic drug compounds, and lot-to-lot variation in drug-antibody ratio (DAR). Moreover, the manufacturing process often requires the use of cutting-edge linker technologies, which are expensive to acquire.

In order to mitigate the abovementioned challenges associated with ADC manufacturing, around 70-80% players engaged in this domain prefer to outsource their operations to contract manufacturing organizations (CMOs) having the required expertise and experience, in order to leverage their capabilities and yield cost savings opportunities. Currently, the ADC contract manufacturing market landscape is highly fragmented, featuring a mix of start-ups, mid-sized firms and well-established players. Moreover, stakeholders claim to offer a range of services, across different scales of operations; over 35% of such companies have established their facilities across different geographies. 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. Moreover, given the projected increase in demand for ADCs, the associated contract manufacturing market is anticipated to witness substantial growth in the coming years.

SCOPE OF THE REPORT
The “ADC Contract Manufacturing Market (5th Edition) by Phase of Development (Phase I, Phase II and Phase III), Scale of Operation (Clinical and Commercial), Type of Component Manufacturing (Antibody Manufacturing, HPAPI / Cytotoxic Payload, Linker and Conjugation Manufacturing, and Fill / Finish), Target Indications (Solid Tumors, Hematological Malignancies and Others), Type of Payload (Maytansinoid, Auristatin, Camptothecin, PBD and Others), Type of Linker (SMCC, VC, Malemide, Peptide Linker and Others), Type of Antibody Origin (Humanized, Chimeric, Murine, Human and Others), Antibody Isotype (IgG1and Others) and Geography (North America, Europe, Asia-Pacific and Rest of the World), 2022-2035” report features an extensive study of the current market landscape and the likely future potential associated with the ADC contract manufacturing market, over the next decade. The study includes an in-depth analysis, highlighting the capabilities of contract services providers engaged in this domain.

Amongst other elements, the report features:

A detailed overview of the overall market landscape of players engaged in the contract manufacturing of ADCs, based on several relevant parameters, such as company size, year of establishment, location of headquarters, type of service(s) offered (antibody manufacturing, HPAPI and payload synthesis, linker manufacturing, conjugation and fill-finish), other ADC service(s) offered (proof-of-concept studies / process development and scale-up / analytical development), scale of operation (preclinical, clinical and commercial) and location of manufacturing facilities. In addition, it provides details on the antibody contract manufacturers, HPAPI / cytotoxic payload contract manufacturers and biologics fill / finish service providers engaged in this domain.
A detailed competitiveness analysis of ADC contract manufacturers, based on manufacturing strength (on the basis of scale of operation and number of ADC manufacturing facilities), service strength (based on the number of ADC services offered, number of additional services offered and location of ADC manufacturing facilities), supplier strength (in terms of employee count and years of experience in this field).
Elaborate profiles of ADC contract manufacturers (shortlisted on the basis of competitiveness analysis). Each profile provides a brief overview of the company, its financial information, along with details on its ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.
A detailed analysis of the various expansion initiatives undertaken by service providers engaged in this domain, during the period 2012-2022, along with information on several relevant parameters, such as year of expansion, type of expansion (capacity expansion and new facility), type of service(s) offered (manufacturing services, analytical / development services and fill / finish services), location of expanded facility, scale of operation (preclinical, clinical and commercial) and most active players (in terms of number of instances).
An analysis of the recent partnerships inked between various players engaged in this domain. Additionally, it includes a brief description of the various types of partnership models (manufacturing agreements, product development agreements, research agreements, service alliance, acquisitions, product development and manufacturing agreements, licensing agreements, and others) that have been adopted by stakeholders engaged in this domain.
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 (antibody manufacturing, payload manufacturing, linker manufacturing, conjugation and fill / finish) involved in the manufacturing of ADCs, along with information on the cost requirements across each stages.
An estimate of the overall ADC manufacturing / bioconjugation capacity (in kilograms) of contract manufacturers of contract manufacturers based on information provided by various stakeholders in the public domain. The analysis highlights the distribution of global capacity by company size (small, mid-sized and large), key geographical regions (North America, Europe and Asia-Pacific) and key players (in terms of highest bioconjugation capacity).
A detailed overview of the ADCs that are either approved or under development (clinical and preclinical), along with information on their current phase of development (marketed, clinical and preclinical / discovery stage), target indication(s), target antigen, antibody origin, antibody isotype, type of payload and type of linker.
A review of the evolution of ADC conjugation technologies, highlighting the various types of approaches that have been adopted in the past, and the different generations of linkers. It also highlights the competition between contemporary technology platforms.
An analysis of completed, ongoing and planned clinical studies, based on several relevant parameters, such as number of trials registered, trial phase, trial status, target indication, type of sponsor / collaborator and number of patients enrolled.
An informed estimate of the annual demand for ADC products (in kilograms), taking into account commercial, as well as clinical scale requirements, based on relevant parameters, such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
An in-depth analysis of over 80 ADC based therapy developers that are likely to partner with contract service providers engaged in this domain, based on several relevant parameters, such as developer strength (on the basis of company size and its experience), pipeline strength and maturity (on the basis of number of drugs in pipeline, their stage of development and type of target indication) and manufacturing capabilities.
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 ADCs in that particular geographical region.
A proprietary 2×2 representation, highlighting the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.
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.

One of the key objectives of the report was to estimate the current opportunity and future size of the ADC contract manufacturing market. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, over the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] Phase of Development (Phase I, Phase II and Phase III), [B] Scale of Operation (Clinical and Commercial) [C] Type of Component Manufacturing (Antibody Manufacturing, HPAPI / Cytotoxic Payload, Linker and Conjugation Manufacturing, and Fill / Finish), [D] Target Indications (Solid Tumors, Hematological Malignancies and Others), [E] Type of Payload (Maytansinoid, Auristatin, Camptothecin, PBD and Others), [F] Type of Linker (SMCC, VC, Malemide, Peptide Linker and Others), [G] Type of Antibody Origin (Humanized, Chimeric, Murine, Human and Others), [H] Type of Antibody Isotype (IgG1and Others) and [I] Geography (North America, Europe, Asia-Pacific and Rest of World). In order to account for future uncertainties and add robustness to our forecast model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the market’s revolution.

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 have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order 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 will evolve across different regions and technology segments. Where 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 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)
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)
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 outsourced?
In which regions is the expansion activity of ADC contract manufacturers primarily centered?
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?
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 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the ADC contract manufacturing market and its likely evolution in the mid to long term.

Chapter 3 provides 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, along with information on the key manufacturing steps involved. 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 detailed overview of the overall market landscape of players engaged in the contract manufacturing of ADCs, based on several relevant parameters, such as company size, year of establishment, location of headquarters, type of service(s) offered (antibody manufacturing, HPAPI and payload synthesis, linker manufacturing, conjugation and fill-finish), other ADC service(s) offered (proof-of-concept studies / process development and scale-up / analytical development), scale of operation (preclinical, clinical and commercial) and location of manufacturing facilities. In addition, it provides details on the antibody contract manufacturers, HPAPI / cytotoxic payload contract manufacturers and biologics fill / finish service providers engaged in this domain.

Chapter 5 features a detailed competitiveness analysis of ADC contract manufacturers, based on manufacturing strength (on the basis of scale of operation and number of ADC manufacturing facilities), service strength (based on the number of ADC services offered, number of additional services offered and location of ADC manufacturing facilities), supplier strength (in terms of employee count and years of experience in this field).

Chapter 6 Elaborate profiles of ADC contract manufacturers (shortlisted on the basis of competitiveness analysis). Each profile provides a brief overview of the company, its financial information, along with details on its ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.

Chapter 7 provides a detailed analysis of the various expansion initiatives undertaken by service providers engaged in this domain, during the period 2012-2022, along with information on several relevant parameters, such as year of expansion, type of expansion (capacity expansion and new facility), type of service(s) offered (manufacturing services, analytical / development services and fill / finish services), location of expanded facility, scale of operation (preclinical, clinical and commercial) and most active players (in terms of number of instances).

Chapter 8 presents an analysis of the recent partnerships inked between various players engaged in this domain. Additionally, it includes a brief description of the various types of partnership models (manufacturing agreements, product development agreements, research agreements, service alliance, acquisitions, product development and manufacturing agreements, licensing agreements, and others) that have been adopted by stakeholders engaged in this domain.

Chapter 9 presents 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.

Chapter 10 presents a detailed discussion on various steps (antibody manufacturing, payload manufacturing, linker manufacturing, conjugation and fill / finish) involved in the manufacturing of ADCs, along with information on the cost requirements across each stages.

Chapter 11 features an estimate of the overall ADC manufacturing / bioconjugation capacity (in kilograms) of contract manufacturers based on information provided by various industry stakeholders in the public domain. It also features the distribution of global capacity on the basis of company size (small, mid-sized and large), key geographical regions (North America, Europe and Asia-Pacific) and key players (in terms of highest bioconjugation capacity).

Chapter 12 provides an overview of the ADCs that are either approved or under development (clinical and preclinical), along with information on their current phase of development (marketed, clinical and preclinical / discovery stage), target indication(s), target antigen, antibody origin, antibody isotype, type of payload and type of linker.

Chapter 13 features a review of the evolution of ADC conjugation technologies, highlighting the various types of approaches that have been adopted in the past, and the different generations of linkers. It also highlights the competition between contemporary technology platforms.

Chapter 14 features an analysis of completed, ongoing and planned clinical studies, based on several relevant parameters, such as number of trials registered, trial phase, trial status, target indication, type of sponsor / collaborator and number of patients enrolled.

Chapter 15 features an in-depth analysis of over 80 ADC based therapy developers that are likely to partner with contract service providers engaged in this domain, based on several relevant parameters, such as developer strength (on the basis of company size and its experience), pipeline strength and maturity (on the basis of number of drugs in pipeline, their stage of development and type of target indication) and manufacturing capabilities.

Chapter 16 provides an informed estimate of the annual demand for ADC products (in kilograms), taking into account commercial, as well as clinical scale requirements, based on relevant parameters, such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.

Chapter 17 provides 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 ADCs in that particular geographical region.

Chapter 18 features a proprietary 2×2 representation, highlighting the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.

Chapter 19 presents a comprehensive market forecast analysis, highlighting the likely growth of the contract manufacturing market of ADCs, till 2035. The chapter provides likely distribution of the projected future opportunity based on phase of development (phase I, phase II and phase III), scale of operation (clinical and commercial), type of component manufacturing (antibody manufacturing, HPAPI / cytotoxic payload, linker and conjugation manufacturing, and fill / finish), target indications (solid tumors, hematological malignancies and others), type of payload (maytansinoid, auristatin, camptothecin, PBD and others), type of linker (SMCC, VC, malemide, peptide linker and others), type of antibody origin (humanized, chimeric, murine, human and others), type of antibody isotype (IgG1 and others) and geography (North America, Europe, Asia-Pacific, and Rest of the World).

Chapter 20 presents 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.

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 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), Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (ex-Director of CDMO, Pierre Fabre), David Cunningham (Director Corporate Development, Goodwin Biotechnology), Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (ex-Group Product Manager, Catalent Pharma Solutions), 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) and Anonymous (Chief Executive Officer, Leading CMO).

Chapter 22 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the ADC contract manufacturing market.

Chapter 23 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 24 is an appendix, which contains a list of companies and organizations mentioned in this report.

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