With over 100 therapeutic monoclonal antibodies and antibody-based products in the market, the demand for developing and manufacturing of such products is anticipated to increase beyond the capabilities of innovator companies alone
Although biopharmaceuticals offer significant profit margins and have been proven to be effective in treating a myriad of diseases, they are generally associated with high costs of development and complex manufacturing protocols; this is true for antibody-based products as well. Presently, there are a number of companies that claim to offer end-to-end solutions, ranging from antibody development to commercial production. Further, prevalent trends suggest that sponsor companies are likely to continue relying on contract service providers for various aspects of antibody-based product development and manufacturing.
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Key Market Insights
Over 100 CMOs presently claim to offer manufacturing services for antibodies
The antibody contract manufacturing market is currently dominated by the presence of small and mid-sized companies, which represent 70% of the industry stakeholders. It is also worth highlighting that more than 55% of CMOs claim to have the capabilities to manufacture antibodies across all scales of operation (preclinical, clinical and commercial).
More than 90% service providers are focused on the production of monoclonal antibodies
However, players based in Asia are now increasingly focusing on the development of bispecific antibodies for therapeutic use. It worth highlighting that close to 20% of the CMOs engaged in this domain claim to offer manufacturing services for both bispecific antibodies and antibody fragments.
Europe has emerged as a key manufacturing hub for antibody-based products
More than 120 manufacturing facilities have been established by various players, worldwide; of these, 40% are in Europe. Additionally, 40% of the total installed capacity is in Europe, followed by Asia. Some of the prominent regions in Asia include (in decreasing order of number of manufacturing facilities) China, South Korea, India, Japan and Taiwan.
More than 90 partnership agreements have been inked between 2013 and 2019
Majority of these agreements were focused on manufacturing of various types of antibodies. Other popular types of collaboration models include process development and manufacturing agreements (22%), product development and manufacturing agreements (10%) and licensing agreements (7%).
Multiple expansion initiatives were undertaken by CMOs between 2017 and 2019
More than 50% of such initiatives were reported to be focused on the expansion of manufacturing facilities, followed by building new facilities (38%). It is worth noting that close to 50% of the total number of expansion initiatives were undertaken in Europe, of which, 25% were in the UK.
Demand for therapeutic antibodies is anticipated to grow at a CAGR of 10%, during 2020-2025
Given the fact that there are a number of antibody-based products in the market, the commercial demand for antibodies is significantly higher than the clinical demand. Across the three major global regions, North America represent over half of the overall global manufacturing demand for antibodies.
North America and Europe are anticipated to capture over 70% of the market share by 2030
However, the market in the Asia is anticipated to grow at a relatively faster rate. Further, presently, more than 90% of the antibodies are being developed using mammalian expression systems, and this trend is unlikely to change significantly in short to mid-term.
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Key Questions Answered
§ Who are the leading CMOs engaged in the production of antibody-based therapeutics?
§ What kind of partnership models are commonly adopted by stakeholders in this industry?
§ What is the annual clinical and commercial demand for antibody-based products?
§ What is the current installed capacity for manufacturing of antibodies?
§ What are the various expansion initiatives undertaken by antibody CMOs?
§ How is the current and future market opportunity likely to be distributed across key market segments?
The USD 17 billion (by 2030) financial opportunity within the antibody contract manufacturing market has been analyzed across the following segments:
§ Type of Antibodies
§ Monoclonal Antibodies
§ Bispecific Antibodies
§ Company Size
§ Large / Very Large
§ Scale of Operation
§ Preclinical / Clinical
§ Type of expression system used
§ Key geographical regions
§ North America
§ Asia and RoW
The report features inputs from eminent industry stakeholders, according to whom antibody therapeutics developers are increasingly outsourcing their manufacturing operations owing to complex nature of the overall process, as well as the high investments associated with setting-up in-house expertise. The report includes detailed transcripts of discussions held with the following experts:
§ Dietmar Katinger (Chief Executive Officer, Polymun Scientific)
§ David C Cunningham (Director, Corporate Development, Goodwin Biotechnology)
§ Claire Otjes (Marketing Manager, Batavia Biosciences)
The research covers profiles of key players that offer manufacturing services for antibodies, featuring a company overview, information on their respective service portfolios, manufacturing facilities and capabilities, and an informed future outlook.
§ AGC Biologics
§ Boehringer Ingelheim BioXcellence
§ Emergent BioSolutions
§ Eurofins CDMO
§ FUJIFILM Diosynth Biotechnologies
§ KBI Biopharma
§ Nitto Avecia Pharma Services
§ Pierre Fabre
§ Samsung BioLogics
§ Thermo Fisher Scientific
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