ADC Contract Manufacturing Market (6th Edition): Industry Trends and Global Forecasts, till 2035 - Distribution by Stage of Development (Phase I, Phase II, Phase III and Commercial), Process Component (Antibody, HPAPI / Cytotoxic Payload, Conjugation / Linker and Fill / Finish), Target Indication (Solid Tumors, Hematological Tumors and Others), Antibody Generation (Second, Third, Fourth and Next), Antibody Origin (Humanized, Chimeric, Murine and Others), Antibody Isotype (IgG1, IgG4 and Others), Type of Payload (Auristatin, Camptothecin, DNA Topoisomerase I Inhibitor, Maytansinoid and Others), Type of Linker (Maleimide, SMCC, Tetrapeptide-based linker, Valine-citrulline and Others), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World)
The ADC Contract Manufacturing Market is valued at USD 1.79 billion in 2024 growing at a CAGR of 13% during the forecast period 2024-2035.
In recent years, antibody drug conjugates (ADCs) have emerged as a powerful therapeutic approach for treating a broad spectrum of cancers, encompassing both solid tumors and hematological malignancies. These sophisticated compounds consist of an antibody chemically linked to biologically active cytotoxic agents, offering improved stability, target specificity, tumor selectivity, and pharmacokinetic properties. These attributes have spurred extensive research and development efforts aimed at advancing ADC therapies to market fruition. Presently, the ADC pipeline boasts over 260 candidates undergoing clinical evaluation, alongside 23 ADC therapeutic programs already sanctioned by regulatory bodies. The promise of such therapies in precisely targeting tumor cells while minimizing off-target toxicities has propelled their success and widespread adoption within the healthcare sector.
Nevertheless, the manufacturing process for ADCs is intricately complex, fraught with various challenges such as drug/linker side reactions, toxicity exposure, contamination risks, and scale-up difficulties. Additionally, it demands substantial expertise and cutting-edge technologies, incurring significant costs. Consequently, ADC developers often opt to outsource manufacturing operations to specialized ADC contract manufacturers. By leveraging the expertise, capabilities, and production facilities of these contract manufacturing organizations (CMOs), ADC therapy developers aim to streamline manufacturing operations while reducing costs. Notably, CMOs involved in ADC contract manufacturing are actively striving to evolve into comprehensive solution providers, addressing challenges related to technology transfer and scale-up. With the escalating demand for ADCs and the growing inclination toward outsourcing among drug developers, the ADC contract manufacturing market is poised for substantial growth in the foreseeable future.
Key Market Segments
Stage of Development
- Phase I
- Phase II
- Phase III
- Commercial
Process Component
- Antibody
- HPAPI / Cytotoxic Payload
- Conjugation / Linker
- Fill / Finish
Target Indication
- Solid Tumors
- Hematological Tumors
- Others
Antibody Generation
- Second Generation
- Third Generation
- Fourth Generation
- Next Generation
Antibody Origin
- Humanized
- Chimeric
- Murine
- Others
Antibody Isotype
Type of Payload
- Auristatin
- Camptothecin
- DNA Topoisomerase I Inhibitor
- Maytansinoid
- Others
Type of Linker
SMCC
- Tetrapeptide-based linker
- Valine-citrulline
- Others
Key Geographical Regions
- North America
- Europe
- Asia-Pacific and Rest of the World
Research Coverage:
- Insightful overview on the essential components of ADC therapeutics, the challenges associated with manufacturing of such therapies along with information on the rising trend of contract manufacturing in this segment of biopharmaceutical industry.
- An in-depth analysis of the comprehensive market landscape for ADC contract manufacturers involves evaluating various pertinent factors. These include the establishment year, company size denoted by the number of employees, headquarters location, and the range of ADC manufacturing services provided, encompassing antibody manufacturing, HPAPI and payload synthesis, linker manufacturing, conjugation, and fill/finish services. Additionally, consideration is given to the types of additional services offered, such as proof-of-concept studies, process development and scale-up, and analytical development. The scale of operation, categorized into preclinical, clinical, and commercial phases, is also a crucial aspect. Moreover, the geographic location of manufacturing facilities plays a significant role in assessing the overall landscape of ADC contract manufacturers.
- Comprehensive competitiveness analysis of ADC contract manufacturers, based on manufacturing strength (in terms of scale of operation and number of ADC manufacturing facilities), service strength (in terms of number of ADC services offered, number of additional services offered and location of ADC manufacturing facilities) and 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 (if available), manufacturing services portfolio (specific to antibody drug conjugates), location of production facilities, and an insightful recent development and future outlook.
- A detailed analysis of the various expansion initiatives undertaken by ADC contract manufacturers, during the period 2019-2023, along with information on several relevant parameters, such as year of expansion, type of expansion, purpose of expansion (manufacturing, analytical / development and fill / finish), scale of operation (preclinical, clinical and commercial), location of expanded facility, type of facility and most active players (based on number of expansion initiatives).
- An analysis of the recent partnerships inked between various ADC contract manufacturers, since 2019, based on several parameters, such as year of partnership, type of partnership (acquisitions, joint ventures, licensing agreements, manufacturing agreements, mergers, product development agreements, product development and manufacturing agreements, research agreements, technology integration agreements and others), purpose of agreement, scale of operation and most active players (in terms of number of partnerships). This section also highlights the regional distribution of partnership activity in this market.
- A qualitative analysis highlighting the various factors that need to be considered by ADC developers, while deciding whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.
- 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 stage.
- An estimate of the overall ADC manufacturing / bioconjugation capacity (in kilograms) of ADC 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).
- An overview of the current market landscape of ADCs, along with detailed analysis of the ADCs pipeline, based on several relevant parameters, such as status of development, target disease indication, therapeutic area, line of treatment, dosing frequency, type of therapy, target antigen, antibody isotype, payload / cytotoxin / warhead, type of payload and type of linker.
- An in-depth analysis of completed and ongoing clinical studies of various antibody drug conjugates, based on several relevant parameters, such as trial registration year, trial status, trial phase, enrolled patient population, type of sponsor / collaborator, target population, study design, most active industry players, and non-industry players (in terms of number of trials) and key geographical regions.
- An in-depth analysis of over 140 ADC therapy developers that are likely to partner with ADC contract manufacturers, based on several relevant parameters, such as developer strength (in terms of company size and its experience), pipeline maturity (in terms of number of drugs in pipeline, their stage of development and type of target indication) and manufacturing capabilities.
- An informed estimate of the annual commercial and clinical demand for ADC therapeutics (in kilograms) based on, based on relevant parameters, such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
- A detailed regional capability assessment framework comparing the key geographies, based on a number of parameters, including the number of ADC contract manufacturers, number of ADC manufacturing facilities, number of facility expansions, installed ADC bioconjugation capacity, number of registered clinical trials and demand for ADCs in that particular geographical region.
- A detailed assessment of the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments, plotted on a 2X2 matrix.
- A detailed ADC contract manufacturing market forecast analysis in order to estimate the existing market size and future opportunity for ADC contract manufacturers over the next 12 years. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market size during the forecast period 2024-2035.
- Detailed projections of the current and future opportunity within the ADC contract manufacturing market across different stages of development, such as phase I, phase II, phase III and commercial.
- Detailed projections of the current and future opportunity within antibody drug conjugates contract manufacturing market across different process components, such as antibody, HPAPI / cytotoxic payload, conjugation / linker and fill / finish.
- Detailed projections of the current and future opportunity within the ADC contract manufacturing industry across different target indications, such as solid tumors, hematological tumors and others.
- Detailed projections of the current and future opportunity within the market across different antibody generations, such as second, third, fourth and next generation.
- Detailed projections of the current and future opportunity within the ADC contract manufacturing market across different antibody origins, such as humanized, chimeric, murine and others.
- Detailed projections of the current and future opportunity within the antibody drug conjugates contract manufacturing market across different antibody isotypes, such as IgG1, IgG4 and others.
- Detailed projections of the current and future opportunity within the ADC contract manufacturing market across different types of payloads, such as auristatin, camptothecin, DNA topoisomerase I inhibitor, maytansinoid and others.
- Detailed projections of the current and future opportunity within the market across different types of linkers, such as Maleimide, SMCC, tetrapeptide-based linker, valine-citrulline and others.
- Detailed projections of the current and future opportunity within the ADC contract manufacturing industry across key geographical regions, including North America, Europe, Asia-Pacific and rest of the world.
- Detailed projections of the current and future opportunity within the commercial ADC contract manufacturing market, based on several relevant parameters such as type of component, target indications, type of generation, type of antibody origin, type of antibody isotype, type of payload, type of linker and key geographical regions.
- Detailed projections of the current and future opportunity within the clinical ADC contract manufacturing market, based on several relevant parameters such as phase of development, type of component, target indications, type of antibody origin, type of antibody isotype, type of payload, type of linker and key geographical regions.
- An in-depth analysis of the factors that can impact on the growth of ADC contract manufacturing market. It also features identification of key drivers, potential restraints, emerging opportunities, and existing challenges.
Key Benefits of Buying this Report
- The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
- Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
- The report provides stakeholders with a pulse on the ADC Contract Manufacturing Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
Leading Market Companies
- AbbVie Contract Manufacturing
- Abzena
CARBOGEN AMCIS
- Catalent Pharma Solutions
- Cerbios-Pharma
- Formosa Laboratories
GBI
- Lonza
- MabPlex
- Millipore Sigma
- Piramal Pharma Solutions
- Sterling Pharma Solutions
- WuXi Biologics