Since the approval of Enbrel® in 1998 for the treatment of rheumatoid arthritis, Fc fusion therapies have evolved into a prominent class of therapeutics; currently, several therapies are being developed for a variety of disease indications
With 13 drugs approved in the European Union and the US, Fc fusion therapeutics are considered to be one of the most successful classes of IgG-based products. The success of these biopharmaceutical products can be attributed to their diverse biological and pharmacological properties, including an extended serum half-life, enhanced Fc mediated effector functions, easy expression, increased stability and aggregation resistance, modulated immunogenicity and improved safety profiles, for the treatment of a wide range of disease indications. Since the approval of Enbrel®, a recombinant human tumor necrosis factor (TNF) receptor-Fc fusion protein (for the treatment of rheumatoid arthritis) in 1998, Fc fusion therapies have evolved into a prominent class of therapeutics.
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Key Market Insights
Presently, more than 115 Fc fusion therapeutics are approved / under development
Over 60% of the aforementioned candidates are being evaluated in clinical stages; of these, 50 molecules are in advanced phases (Phase II and above) of clinical trials. This is followed by more than 30% of the Fc fusion therapeutics which are already marketed for various disease indications. It is worth noting that majority of the pipeline therapies (18) are being developed to target PD-L1 for the treatment of oncological disorders.
More than 25 companies claim to be engaged in the development of Fc fusion therapeutics
Post 2001, there has been a significant rise in the number of companies working in this domain. It is worth noting that majority (48%) of the firms engaged in this domain are based in North America, followed by those headquartered in Asia-Pacific (38%) and Europe (3%).
Over 1,450 clinical trials have been registered for the evaluation of Fc fusion therapeutics, globally
Of these, most of the trials were / are being conducted in North America (48%). Within this region, more than 50% of the total patients were enrolled in trials focused on the evaluation of these therapeutics. This was followed by studies being conducted in Europe and Asia Pacific.
Close to 200 grants have been awarded to support research on Fc fusion therapeutics, since 2010
Around USD 68 million have been awarded to various organizations working in this domain, since 2010. Further, almost 80% of the total grants were awarded for a support period of 1-5 years.
Over 10,000 patents have been filed / granted related to Fc fusion therapeutics, since 2018
Of these, majority (45%) of the patents were filed / granted in North America, followed by Asia-Pacific (21%). Moreover, in addition to the industry players, various patents related to Fc fusion therapeutics were filed by academic institutes as well.
Partnership activity within this domain has grown significantly between 2015 and 2021
The maximum number of partnerships for Fc fusion therapeutics were signed in 2020. Further, product development and commercialization (32%) emerged as the most popular type of partnership model adopted by stakeholders in this domain. This was followed by product development agreements (26%), acquisitions (21%), and manufacturing and supply agreements (11%).
Funding and Investments within this domain has shown a significant growth between 2016 and 2021
Around USD 450 million was raised in the Fc fusion therapeutics domain, through various funding rounds. It is worth mentioning that majority of the amount (~USD 550 million) was raised through venture capital financing.
At present, therapies targeting ophthalmological disorders represent majority of the market share (in terms of sales revenue)
We believe that, in the foreseen future the trend is likely to remain the same. The market opportunity within this therapeutic area is likely to be distributed among indications, such as ophthalmological disorders, and hematological diseases. This is followed by genetic disorders which represent over 30% of the market share.
The research includes detailed profiles of key players (listed below); each profile features an overview of the company, its financial information (if available), a description of the services offered, details on recent developments and an informed future outlook.
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