FC PROTEIN AND GLYCOENGINEERED ANTIBODIES MARKET – MARKET LANDSCAPE (MARKETED AND DEVELOPMENT PIPELINE)
Currently more than 24 Fc protein and glycoengineered antibodies have been commercialized till date, which constitute more than 15% of the total number of therapies. Examples of marketed products include (in alphabetical order) Fasenra (AstraZeneca), Gazvya (Genentech), Imfinzi (AstraZeneca), Monjuvi (MorphoSys), Skyrizi (Abbvie), and Uplinza (Horizon).
Fc Protein market : 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.
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More than 40% of the players were established pre-2001 which signifies the significant share of established players. Examples of the companies that were established in the recent years (post-2010) include (in alphabetical order) BeiGene (2010), Akesobio (2012), and Tiziana Life Sciences (2013). In addition, examples of players established post-2015 include (in alphabetical order) Vir Biotechnology (2016) and Provention Bio (2017).
Glycoengineered antibodies market : The ‘Fc Protein and Glyco-engineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics (3rd edition), 2021-2030’ report features an extensive study on the current and future potential of Fc engineered antibodies.
Further, more than 70% antibodies are in clinical stages of development; of these 85 are in the development programs in advanced stages (phase II and above). For instance, Anifrolumab (AstraZeneca) is being evaluated in phase II for the treatment of Systemic Lupus Erythematosus. Similarly, BGB-A317 (BeiGene) is being evaluated in phase III trials for the treatment of Non-Small Cell Lung Cancer. These are followed by 10% development programs in discovery / preclinical stage. Examples of such antibodies include AMG 509 (Amgen), which is being evaluated in phase I for the treatment of prostate cancer and XmAb14045 (Xencor), which is being evaluated for the treatment of acute myeloid leukemia. This can be attributed to the initiatives being taken by several industry and non-industry players that are actively engaged in evaluating the efficacy of Fc protein engineered and glycoengineered antibodies for a wide range of indications.
Over 85 programs have been designed for the treatment of oncological disorders. Examples of such therapeutics include (in alphabetical order) AGEN1181 (Agenus), ARGX-110 (Argenx), Enoblituzumab (MacroGenics), and Tecentriq (Genentech). This is followed by programs focused on the treatment of rare disorders (14) and dermatological disorders (13). Examples of therapeutics targeting rare disorders include (in alphabetical order) Fasenra (AstraZeneca), Soliris (atypical Hemolytic Uremic Syndrome), and VIS649 (Visterra).
Majority (77%) of the development programs are based on Fc protein engineering. These antibodies are modified by mutating certain amino acids present in the Fc region. Notable examples of such antibodies include (in alphabetical order) Forteca (BIOCAD), Imfinzi (AstraZeneca), Margenza (MacroGenics), Soliris (Alexion Pharmaceuticals), and Skyrizi (AbbVie).
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