ADC Contract Manufacturing Market Industry Trends and Global Forecasts to 2035, by Stage of Development, Process Component, Target Indication, Antibody Generation, Antibody Origin, Antibody Isotype, Type of Payload, Type of Linker and Key Geographical Regions

The global ADC contract manufacturing market is estimated to grow from USD 1.79 billion in the current year to USD 6.88 billion by 2035, at a CAGR of 13% during the forecast period to 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

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

• IgG1
• IgG4
• Others

Type of Payload

• Auristatin
• Camptothecin
• DNA Topoisomerase I Inhibitor
• Maytansinoid
• Others

Type of Linker

• Maleimide
• SMCC
• Tetrapeptide-based linker
• Valine-citrulline
• Others

Key Geographical Regions 

• North America
• Europe
• Asia-Pacific and Rest of the World

ADC CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS

The ADC contract manufacturing market is poised for significant growth, primarily driven by the growing demand for advanced therapeutic modalities, such as antibody drug conjugates. It is worth highlighting that more than 20 ADC therapeutic programs have already been approved by various regulatory agencies. In addition, more than 260 drug therapies targeting a wide range of cancers including solid tumors and hematological tumors are being evaluated in clinical trials. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. However, the challenges associated with ADC manufacturing, including drug / linker side reactions, exposure to toxicity, contamination, scale-up, and high capital investments in manufacturing facilities, have driven drug developers to outsource key operations.  

As drug developers invest more in these innovative therapies, the market for ADC contract manufacturing is anticipated to expand further. Moreover, owing to the healthy early-stage pipeline, growth in this domain is expected to continue in the long-term as well. Given the increasing demand for ADCs and preference for outsourcing operations by drug developers, the ADC contract manufacturing market is likely to witness substantial market growth during the forecast period.

ADC CONTRACT MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the ADC contract manufacturing market and identifies potential growth opportunities within the industry.

Some key findings from the report include:

• Currently, over 30 manufacturers claim to have the required capabilities to offer contract manufacturing and conjugation services for antibody drug conjugates, worldwide.
• Majority of the large contract manufacturers (50%) offer a wide range of ADC manufacturing services across all scales of operation; more than 45% of the ADC conjugation facilities are based in North America.

• In pursuit of building a competitive edge, industry stakeholders are actively upgrading their existing capabilities and augmenting their service portfolios to become one-stop shops for ADC manufacturing.
• Majority of the trials focused on ADC therapeutics were registered in the last two years; 57% of the total clinical trial studies are being conducted across different sites in the US.
• 75% of the manufacturing agreements inked in this domain were focused on clinical and commercial manufacturing of ADCs, across different geographical regions.
• ADC therapeutic developers are anticipated to forge strategic alliances with contract manufacturing service providers in order to outsource complex manufacturing operations.
• Driven by the expanding pipeline of ADC therapeutics and manufacturing expertise available with contract service providers, the ADC contract manufacturing market is poised to witness significant growth in the future.
• Over 80% of the current demand for ADC therapeutics is generated by commercialized therapeutics targeted for solid tumors, 45% of the demand is likely to be generated in North America.
• The global installed contract ADC manufacturing capacity is spread across various geographies; over 90% of the current installed capacity is available with large contract manufacturers.
• With nearly 70% of the ADC manufacturing operations currently being outsourced, we expect the market to grow at an annualized rate of over 13.8% over the next decade.
• With the rise in demand for ADC therapeutics, the opportunity for ADC components including antibody, payload and linker is estimated to increase significantly during the forecast period.

ADC CONTRACT MANUFACTURING MARKET: KEY SEGMENTS

By Stage of Development, Commercial Scale is Likely to Dominate the ADC Contract Manufacturing Market During the Forecast Period

Based on the stage of development, the global ADC contract manufacturing market is segmented into phase I, phase II, phase III and commercial. It is worth highlighting that majority of the current ADC contract manufacturing market is captured by the commercial phase (approved drug therapies) and this trend is likely to remain the same in the forthcoming years.  

Currently, Antibody Segment Occupies the Largest Share in the ADC contract Manufacturing Market 

Based on type of component, the global ADC contract manufacturing market is segmented into antibody, HPAPI / cytotoxic payload, conjugation / linker and fill / finish. It is worth highlighting that the antibody segment is likely to dominate the market in the coming decade.

Solid Tumors Segment is Likely to Capture the Largest Share of the ADC Contract Manufacturing Market During the Forecast Period

Based on the target indications, the global ADC contract manufacturing market is segmented into solid tumors, hematological tumors and others. The anticipated success of late-stage ADC therapeutics intended for the treatment of solid tumors is likely to drive the market in the forthcoming years.

At Present, Third Generation Antibodies Occupies the Largest Share in the ADC contract Manufacturing Market

Based on the antibody generation, the antibody market is segmented into second generation, third, fourth and next generation. It is worth highlighting that the market is primarily driven by revenues generated from the manufacturing of third-generation antibodies, followed by fourth-generation antibodies. This can be attributed to the fact that 40% of the approved ADCs and most clinical-stage ADCs contain third-generation components. This trend is unlikely to change in the near future.

Chimeric Origin ADCs Segment is the Fastest Growing Segment in the ADC contract Manufacturing Market

Based on the antibody origin, the ADC contract manufacturing market is segmented into humanized, chimeric, murine and others. It is worth highlighting that, currently, ADCs utilizing human origin antibodies holds the larger share in the ADC contract manufacturing market.

IgG1 Antibody Isotype Segment is Likely to Dominate the ADC Contract Manufacturing Market During the Forecast Period

Based on the type of antibody isotype, the ADC contract manufacturing market is segmented into IgG1, IgG4 and others. Currently, the market is dominated by IgG1 antibody isotype. This can be attributed to the fact that IgG1 is the most common isotype available in the serum. Additionally, it plays a significant role in triggering an immune response through the Fc-mediated effector function, which is the primary mode of action for tumor targeting therapies.

By Type of Payload, Camptothecin Segment Occupies the Largest Share in the ADC Contract Manufacturing Market among HPAPI / Cytotoxic Payloads 

Based on the type of payload, the HPAPI / payload market is segmented into auristatin, camptothecin, DNA topoisomerase I inhibitor, maytansinoid and others. Whilst the camptothecin as an ADC payload/ warheads will be the primary driver of the overall market, it is worth highlighting that the market share for maytansinoid-based ADCs among HPAPI / cytotoxic payloads is likely to grow at a relatively higher CAGR.

By Type of Linker, Maleimide is Likely to Dominate the ADC Contract Manufacturing Market During the Forecast Period

Based on the type of linker, the conjugation / linker market is segmented into Maleimide, SMCC, tetrapeptide-based linker, valine-citrulline and others. Currently, Maleimide (as an ADC linker) captures the largest share in the market and this trend is unlikely to change in the near future.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that over the years, the market in Europe is expected to grow at a higher CAGR.

Key Players in the ADC Contract Manufacturing Market include:

• 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

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

• Chief Executive Officer, BSP Pharmaceuticals
• Technical Business Development Manager, BSP Pharmaceuticals
• Chief Executive Officer & Founder, Oxford BioTherapeutics
• Ex-Chief Executive Officer, Abzena
• Chief Executive Officer & Co-Founder, Syndivia
• Chief Commercial Officer, Cerbios-Pharma
• Chief Business Officer, NBE-Therapeutics
• Executive Director, Eisai
• Chief Innovation Officer, Eisai
• Director, Business Development, Synaffix
• Ex-Director of CDMO, Pierre Fabre
• Director Corporate Development, Goodwin Biotechnology
• Director, Business Development, Catalent Pharma Solutions
• Ex-Group Product Manager, Catalent Pharma Solutions
• Business Development Manager, Cerbios-Pharma
• Ex-Head of Bioconjugates Commercial Development, Lonza
• Ex-Site Head, Piramal Pharma Solutions
• Associate Scientist, Ajinomoto Bio-Pharma Services

ADC CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE

• The report features an in-depth analysis of the ADC contract manufacturing market, focusing on key market segments, including stage of development, process component, target indication, antibody generation, antibody origin, antibody isotype, type of payload, type of linker and key geographical regions.
• The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting market growth.
• A comprehensive evaluation of companies involved in ADC contract manufacturing, considering various parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of ADC manufacturing service offered (antibody manufacturing, cytotoxic drugs and HPAPI manufacturing and payload synthesis,  linker manufacturing, conjugation and fill / finish services), type of additional service offered (proof-of-concept studies, process development and scale-up and analytical development), scale of operation (Preclinical, clinical and commercial) and location of manufacturing facility.
• A comprehensive competitive analysis of ADC contract manufacturers, examining factors such as manufacturing strength (in terms of scale of operation and number of ADC manufacturing facilities), service strength and supplier strength.
• In-depth profiles of key industry players in ADC contract manufacturing market, focusing on company overviews, financial information (if available), manufacturing services portfolio, location of production facilities, and an insightful recent development and future outlook.
• An examination of the different expansion efforts made by ADC contract manufacturers in this field to enhance their manufacturing capabilities, since 2019. This analysis considers various factors, including the 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 partnerships established in this sector, 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.
• An insightful framework that emphasizes the key indicators and factors that need to be considered by ADC developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.
• A comprehensive overview of the different stages involved in the production of antibody-drug conjugates (ADCs), including antibody manufacturing, payload production, linker creation, conjugation, and fill/finish processes, along with insights into the cost implications at each stage.
• Estimation of global ADC manufacturing / bioconjugation capacity, derived from data provided by various stakeholders in the public domain. This analysis emphasizes the distribution of the available 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).
• An overview of the current market landscape of antibody-drug conjugates (ADCs), along with an in-depth analysis of the ADC pipeline. This analysis considers various relevant parameters, including 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.
• Examination of completed, ongoing, and planned clinical studies of various drug conjugates based on parameters like 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.
• A detailed evaluation of over 140 antibody-drug conjugate (ADC) therapy developers that are most likely to collaborate with ADC contract manufacturers. This analysis considers various relevant parameters, including 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.
• Informed estimates of the annual commercial and clinical demand for ADC therapeutics (in kilograms) based on several relevant parameters, such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
• A comprehensive regional capability assessment framework that evaluates key geographies by various parameters, including 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 2×2 matrix.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What kind of partnership models are commonly adopted by industry stakeholders? 
• What is the current annual demand for ADC therapeutics?
• What are the factors that are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

ADDITIONAL BENEFITS

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 10% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older