ADC Contract Manufacturing Market

ADC Contract Manufacturing Market Overview

The ADC contract manufacturing market is estimated to be worth $2.8 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 11.8% during the forecast period. 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 ADC contract manufacturing market, a total of USD 14.8 billion (since 2014) has been the investment in ADCs 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 ADC contract manufacturing market 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 ADC contract manufacturing market 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 market growth during the forecast period.

Key Companies in ADC Contract Manufacturing Market

Examples of key companies engaged in ADC contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie Contract Manufacturing, Abzena, CARBOGEN AMCIS, Catalent Pharma Solutions, Cerbios-Pharma, Creative Biolabs, Formosa Laboratories, Goodwin Biotechnology, Lonza, MabPlex, Millipore Sigma, Novasep, Piramal Pharma Solutions, Sterling Pharma Solutions and WuXi Biologics. This market report includes an easily searchable excel database of all the companies providing ADC contract manufacturing, worldwide.

Recent Developments in ADC Contract Manufacturing Market:

Several recent developments have taken place in the field of ADC contract manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In July 2023, BeiGene signed an agreement with DualityBio with an aim to acquire an exclusive option for the international clinical and commercial licensing of DualityBio’s antibody-drug conjugate (ADC) therapy for the treatment of patients suffering from solid tumors. 
• In May 2023, Olon announced the expansion by adding a new facility at its Rodano site (Milan, Italy) dedicated to managing and producing Ultra-Potent compounds including payloads and payload-linkers for antibody-drug conjugates (ADCs). 
• Simris Alg entered into a strategic agreement with Lonza with an aim to commercialize Simris’ novel Antibody-Drug Conjugate (ADC) payload platform.

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” market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities associated with the ADC contract manufacturing market, during the forecast period. The market research report includes an in-depth analysis, highlighting the capabilities of contract services providers engaged in ADC contract manufacturing market. The table below highlights various market segmentations done in the market report.

Market Segmentations

Report Attribute	Details
Forecast Period	2022 – 2035
Scale of Operation	Clinical, commercial
Phase of Development	Phase 1, Phase 2, Phase 3
Component Manufactured	Antibody, HPAPI / cytotoxic payload, linker and conjugation manufacturing, fill / finish
Target Indication	Solid tumours, hematological malignancies, others
Type of Payload	Maytansinoid, autistatin, camptothecin, PBD, others
Type of Linker	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

 

Amongst other elements, the market research 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 ADC manufacturers, HPAPI / cytotoxic payload contract manufacturers and biologics fill / finish service providers engaged in ADC contract manufacturing market.
• A detailed competitiveness analysis of ADC 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 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 ADC contract manufacturing market, 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 ADC contract manufacturing market. 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 ADC contract manufacturing market.
• 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 ADC 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 ADC contract manufacturing market, 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 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.

The key objective of ADC contract manufacturing market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for ADC contract manufacturing market during the forecast period. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, over the forecast period 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are antibody drug conjugates?

Answer: Antibody drug conjugates (ADCs) are a type of targeted cancer therapy that combines an antibody, which specifically targets cancer cells, with a cytotoxic (cell-killing) drug.

Question 2: What is the ADC contract manufacturing market size?

Answer: The ADC contract manufacturing market size is estimated to be worth $2.8 billion in 2022.

Question 3: What is the projected market growth of the ADC contract manufacturing market?

Answer: The ADC contract manufacturing market is expected to grow at compounded annual growth rate (CAGR) of 11.8% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the ADC contract manufacturing market?

Answer: Examples of key companies engaged in ADC contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie Contract Manufacturing, Abzena, CARBOGEN AMCIS, Catalent Pharma Solutions, Cerbios-Pharma, Creative Biolabs, Formosa Laboratories, Goodwin Biotechnology, Lonza, MabPlex, Millipore Sigma, Novasep, Piramal Pharma Solutions, Sterling Pharma Solutions and WuXi Biologics.

Question 5: How many ADC manufacturers are operating in the ADC contract manufacturing market?

Answer: Presently, over 30 companies claim to offer ADC contract manufacturing services, globally.

Question 6: Which region is the hub for companies engaged in the ADC contract manufacturing market?

Answer: North America presently harbors the majority of the companies engaged in the ADC contract manufacturing market, with close to 45% of the companies being established in this region.

Question 7: How much investment has been made by the stakeholders in the ADC contract manufacturing market?

Answer: Till date, over USD 14 billion has been invested by both, public and private investors in the ADC contract manufacturing market.

Question 8: What are the market drivers for the ADC contract manufacturing market?

Answer: The rising demand for ADCs, increasing number of clinical trials and complexity associated with ADC manufacturing will drive the outsourcing of ADC manufacturing to contract manufacturers.