To mitigate the challenges associated with ADC manufacturing, around 70–80% of then therapeutics developers prefer to outsource their operations to contract manufacturing organizations (CMOs), which claim to have the required expertise and experience to leverage their capabilities and yield cost savings opportunities.
The report features 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.
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.
Key Features of Report
· 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 based on 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 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 stage.
· 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), considering 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 (based on company size and its experience), pipeline strength and maturity (based on 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 several 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 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.
· A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Scale of Operation
· Commercial
· Clinical
Phase of Development
· Phase III
· Phase II
· Phase I
Type of Component Manufacturing
· Antibody manufacturing
· HPAPI / Cytotoxic Payload and Linker Manufacturing
· Conjugation
· Fill / Finish
Target Indication
· Solid Tumors
· Hematological Malignancies
· Others
Type of Payload Used
· Maytansinoid
· Auristatin
· Camptothecin
· PBD
Key Market Insights
Presently, more than 30 players claim to offer ADC contract manufacturing services
This segment of the industry is dominated by the presence of large (more than 501 employees) and mid-
sized (51–500 employees) players, which collectively represent more than 80% of the total contract
manufacturers in this domain. In addition, around15% firms were established post 2010.
More than 84 expansions were reported in this industry, during 2012–2021
Of the total, 57% instances were focused on enhancing dedicated capabilities and capacities, followed by
those carried out for the expansion / establishment of manufacturing facilities (42%).
Partnership activity in this domain has increased at a CAGR of over 16%, during 2016- 2021
Manufacturing agreements emerged as the most popular type of partnership model adopted by industry stakeholders (18%), followed by product development agreements (16%) and research agreements (15%). Further, most of the deals were inked by players based in Europe (46%).
Global, installed ADC contract manufacturing capacity is currently estimated to be close to 33 Kilograms
The maximum share of the current installed capacity is expected to be captured by large players. Moreover, close to 37% of the installed manufacturing capacity is available in the Asia-Pacific region.
140,200+ patients have been enrolled in over 714 clinical trials, worldwide
Clinical research activity, in terms of number of trials registered, is reported to have increased at a CAGR
of 21%, in the past three years. Of the total number of trials, close to 47% of the studies are recruiting patients, while 30% have been completed.
Global demand for ADC contract manufacturing is anticipated to grow at a CAGR of 13%, during 2022–2035
The commercial demand for ADC therapeutics is projected to increase at a CAGR of 22%. Further, the clinical demand for ADC therapeutics in phase III trials is projected to increase at a CAGR of 10%. The market is anticipated to grow at a CAGR of nearly 13%, during the period 2022–2035 In terms of type of cancer, ADC therapeutics targeting solid tumors (48%) are anticipated to capture the highest share. this trend is unlikely to change in the foreseen future. Further, based on type of antibody isotype, majority of the revenue share (90%) of the overall market is likely to be driven by IgG1 antibodies.
The research also includes detailed profiles of key ADC contract manufacturers (listed below); each profile features an overview of the company, its financial information (if available), details on product portfolio, recent developments, and an informed outlook.
1. MabPlex
2. AbbVie Contract Manufacturing
3. Lonza
4. Catalent Pharma Solutions
5. Goodwin Biotechnology
6. MilliporeSigma
7. Piramal Pharma Solutions
8. Wuxi Biologics
9. Abzena
10. CARBOGEN AMCIS
11. Cerbios-Pharma
12. Formosa Laboratories
13. Creative Biolabs
14. Novasep
15. Sterling Pharma Solutions
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 currently outsourced?
· Which are key hubs for the expansion activity of ADC contract manufacturers?
· 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?
· Which are the key clinical trial hubs for studies focused on ADC therapeutics?
· What is the current, global demand for ADC products and how is it expected to evolve in the foreseen future?
· How is the current and future market opportunity likely to be distributed across key market segments?
