Published: September 2021
With the emergence of blockbuster drugs, such as Gazyva® (for Chronic Lymphocytic Leukemia) and POTELEGIO® (for Sézary syndrome), Fc engineered antibodies have garnered significant interest in the medical community, for various clinical conditions
Over time, a substantial body of evidence has validated the therapeutic applications of Fc engineering platforms; Fc modified antibodies have shown to augment the various immune effector functions, such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) activity and / or the half-life of the molecule
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The Fc engineered antibodies pipeline features more than 125 marketed drugs / drug development programs
Around 15% Fc protein and glyco-engineered antibodies are marketed, while close to 75% are being evaluated in different phases of clinical trials and 10% in preclinical studies. Examples of marketed Fc engineered antibodies include Gazvya®, Imfinzi®, MONJUVI® and Skyrizi®.
Around 30 companies claim to be engaged in the development of Fc protein and glyco-engineered antibodies
Around 55% of the aforementioned players are large companies (with more than 5000 employees). It is worth highlighting that, majority of the developers engaged in this domain (54%) are based in North America, followed by Europe (26%) and Asia-Pacific (20%).
Over 1,800 clinical trials are currently evaluating the therapeutic effects of Fc protein and glyco-engineered antibodies, worldwide
It is worth mentioning that most of the trials were / are being conducted in North America (35%) region;
however, more than 91% of the patients enrolled in trials conducted in North America were enrolled in different sites in the United States. Further, 43% of the trials are being sponsored by non-industry players.
Close to 140 grants have been awarded to support research on Fc protein and glyco-engineered antibodies, since 2019
An estimated USD 63 million in grants have been awarded to various companies / organizations working in this domain, during time period between 2019 and 2021. Almost 50% of the total grant amount was funded by the National Institute of Allergy and Infectious Diseases.
Close to 6,500 patents have been filed / granted for Fc protein and glyco-engineered antibodies, since 2016
Around 30% of these intellectual property documents were filed / granted in the Asia-Pacific; with maximum number of patents filed in Australia. This is followed by North America (32%) and Europe (23%). Leading industry players (in terms of the size of intellectual property portfolio) include Roche, Janssen, Novartis, Genentech, Amgen, MacroGenics and Genmab.
Partnership activity within this domain has grown at a CAGR of 48%, between 2016 and 2020
More than 50% of the total deals have been inked post 2019. Licensing (36%) emerged as the most popular type of partnership model adopted by stakeholders in this domain, followed by clinical trial agreements (16%) and acquisitions / mergers (14%).
The market is anticipated to grow at a CAGR of over 30%, during the period 2021-2030
Growth in this domain is anticipated to be driven by the drugs that are being developed for the treatment of oncological disorders. North America (primarily the US) and Europe are expected to capture major share of the Fc protein and glyco-engineered antibodies market by 2030, in terms of the sales-based revenues.
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The financial opportunity within the Fc protein and glyco-engineered antibodies market has been analyzed across the following segments:
The research includes profiles of key players (listed below); each profile features an overview of the company, its financial information (if available), brief description of its drug(s), recent developments, and an informed future outlook.
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