With close to 100 approved monoclonal antibodies, and over 550 molecules in the clinical pipeline, antibody based pharmacological interventions have become one of the fast growing segment of the biopharmaceutical industry. In fact, these interventions are anticipated to generate a cumulative sales of USD 300 billion by 2025. Further, within the antibody therapeutics industry, engineered antibodies, developed by modifying the fragment crystallizable (Fc) region, have garnered significant interest over the past few years. The modifications (such as Glycoengineered Antibodies, protein engineering or isotype chimerism) in the Fc region of an antibody have shown to augment the various 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. Moreover, several Fc engineering technologies enable the suppression of the effector functions in certain pathways, and are being actively exploited for development of anti-cancer antibodies.
Over time, a substantial body of evidence has validated the therapeutic applications of Fc engineering platforms, which, in turn, has led to the establishment of numerous strategic partnerships (focused on therapy development and clinical research) and significant investment into the innovator companies. The consistent research efforts in this domain have translated into the emergence of two blockbuster drugs, namely Gazyva (for Chronic Lymphocytic Leukemia) and POTELEGIO (for Sézary syndrome) and several other Fc engineered antibody products, including Margenza, MONJUVI and SKYRIZI that received approval in the past few years. More recently, in 2021, two Fc engineered antibodies, namely Sotrovimab and Etesevimab, got approved for the treatment of COVID-19. Further, there are several drugs in the development pipeline, which are being investigated by various small and established pharmaceutical companies. The promising clinical results, and ongoing technical developments, coupled to the growing interest of biopharmaceutical developers, are anticipated to give the required impetus to the push pipeline products to higher stages of development, and commercialization. We believe that the market is likely to evolve at a commendable pace over the next decade.
Fc Protein and Glycoengineered Antibodies – Marketed Drugs and Drug Development Programs
Presently, more than 125 Fc protein or glycoengineered antibodies are developed by various developers for number of disease indications.
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Fc protein and glycoengineered antibodies have enhanced effector functions in comparison to conventional antibodies, targeting oncological disorders
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Broad Clinical Trial Landscape
Multiple clinical studies, evaluating various types of immune cytokines, and involving nearly half a million patients across different centers / hospitals, have been initiated worldwide
A significant rise in number of patents related to Fc protein and glycoengineered antibodies have been seen in recent years, attributing the growing demand of antibodies with better tolerability and lesser off-target toxicity.
Increased Partnership Activity
The increasing interest in this field is reflected in recent partnership activity; majority of deals were inked for oncological disorders and infectious diseases, featuring the participation of both international and indigenous stakeholders.
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Likely Growth of the Fc Protein and Glycoengineered Antibodies Market
During our research, we estimated the market under conservative, base, and optimistic scenarios. As per the base case forecast scenario, the market for Fc protein and glycoengineered antibodies, under clinical evaluation is estimated to be grow at an annualized rate of 27% between 2025 and 2030.
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