Fc Fusion Protein Market

Fc Fusion Protein Market Overview

The Fc fusion protein market is estimated to be worth $15.5 billion in 2022 and is expected to grow at CAGR of 10% during the forecast period. 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. Currently, 13 Fc fusion drugs are commercially available, while around 50 molecules are under development for various disease indications. Some of the Fc fusion therapeutics including  Arcalyst® (recurrent pericarditis, March 2021), Reblozyl® (beta-thalassemia, September 2020) and Eylea® (diabetic retinopathy, May 2019) were approved recently. These molecules combine the beneficial pharmacological properties of biologically active ligands with the properties of the crystallizable fragment (Fc) domain of an immunoglobulin G (IgG). It is worth highlighting that these advanced variants of immunoglobulin derived therapeutic candidates are protected from lysosomal degradation once they are taken up by endothelial cells and later released back into the bloodstream by binding of the Fc-fragment to FcRn receptors present in endosomes. This prolongs the exposure of the pharmacologically active moieties to the target tissue thereby, increasing their therapeutic efficacy. Given their ability to extend the serum half-life of biologically active proteins, these disease-modifying interventions find applications across different therapeutic areas (including but not limited to oncological disorders, neurological disorders, respiratory disorders, rare genetic disorders). 

Presently, several drug developers are actively engaged in the development of novel Fc fusion therapies with enhanced efficacy. The research in this field is focused on improving the stability and solubility of pharmacologically active moiety, thereby, improving its therapeutic potential. Further, several big pharma players have demonstrated interest in Fc fusion therapeutics and are investing both time and capital in Fc fusion protein market. The activity in this segment of the industry has also attracted the attention of both private and public sector investors / investment funds, which have extended financial support to the initiatives of capable developer companies. Moreover, the market has witnessed substantial partnership activity over the last few years. Given the ongoing efforts and the encouraging clinical trial results, the Fc fusion therapies market is poised to witness healthy market growth as more drug candidates get approved and marketed over the forecast period.

Key Companies in Fc Fusion Protein Market

Examples of key companies engaged in Fc fusion protein market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Alphamab Oncology, Amgen, Acceleron Pharmaceuticals, Bristol Myers Squibb and Sanofi. This market report includes an easily searchable excel database of all the companies developing Fc fusion protein therapeutics, worldwide.

Recent Developments in Fc Fusion Protein Market:

Several recent developments have taken place in the field of Fc fusion protein market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In June 2023, Akero Therapeutics presented results from its phase IIb expansion cohort of SYMMETRY trial evaluating Efruxifermin in combination with GLP-1. 
• In February 2023, the FDA approved once-weekly ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], a new class of factor VIII therapy for hemophilia A offering significant bleed protection.

Scope of the Report

The “Fc Fusion Protein Market by Target Indications (Neutropenia, Graft Versus Host Disease, Breast Cancer, Rheumatoid Arthritis, Non-Small Cell Lung Cancer, Neovascular (Wet) Age-related Macular Degeneration (AMD), Hemophilia A, Neuromyelitis Optica Spectrum Disorders and Systemic Lupus Erythematosus), Type of Fusion Molecule (Antibody, Cytokine, Growth Factor, Receptor ECD and Others), Route of Administration (Subcutaneous, Intravenous and Intravitreal) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2021-2035” market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the Fc fusion protein market. The market research report underlines an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in Fc fusion protein market. Amongst other elements, the market research report includes:

• A detailed assessment of the current market landscape of Fc fusion therapeutics, providing information on phase of development (marketed, clinical and pre-clinical) of lead candidates, type of fusion molecule (antibody based, cytokine based, enzyme based, growth factor based, peptide based, receptor ECD based and others), target gene, therapeutic area(s), target disease indication(s), type of therapy (combination therapy and monotherapy), route of administration (intravenous, intravitreal, oral and subcutaneous) and dosing frequency. In addition, the chapter includes information on the drug developer(s), highlighting their year of establishment, company size, and location of headquarters.
• Elaborate profiles of key players involved in the development of Fc fusion therapeutics. Each profile features a brief overview of the company, its financial information (if available), information on product portfolio, recent developments and an informed future outlook.
• An in-depth analysis of completed, ongoing and planned clinical studies of various Fc fusion therapeutics, based on several relevant parameters, such as trial registration year, trial phase, study design, type of masking, type of intervention model, emerging focus area, leading industry sponsors / collaborators (in terms of number of trials conducted), popular indications, popular interventions and regional distribution of trials.
• A study of the various grants that have been awarded to research institutes engaged in conducting projects related to Fc fusion therapeutics, between 2010 and 2021 (till May), including analyses based on several relevant parameters, such as year of grant award, amount awarded, administering institute center, support period, type of grant application, purpose of grant award, activity code and emerging focus areas. In addition, it highlights the popular NIH departments, prominent program officers, and popular recipient organizations (in terms of number of grants awarded).  
• A detailed review of close to 1,135 peer-reviewed, scientific articles related to Fc fusion therapeutics, which have been published between 2010 and 2021 (till August). It discusses the trends across parameters, such as year of publication, emerging focus areas, target therapeutic area, leading authors, and key journals (in terms of number of articles published in Fc fusion protein market).
• An in-depth analysis of the patents that have been filed / granted related to Fc fusion therapeutics, since 2018. It includes information on various parameters, such as patent publication year, type of patent, geographical location / patent jurisdiction, patent age, CPC symbols, emerging focus areas, and the leading / academic players (in terms of number of patents filed). In addition, it includes a patent benchmarking analysis and a detailed valuation analysis.
• An analysis of the partnerships established between various stakeholders in Fc fusion protein market, during the period 2016-2021 (till August), covering product development and commercialization, R&D agreements, mergers / acquisitions, clinical trial agreements, and other relevant types of deals. 
• A case study on the Fc protein engineered and glycoengineered antibodies that are either marketed or being developed based on multiple of relevant parameters, such as phase of development, target disease indication, therapeutic area, type of Fc engineering, impact of Fc engineering, route of administration, and type of therapy. It also highlights the players involved in the development of these Fc protein and glycoengineered antibodies.

The key objective of Fc fusion protein market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for Fc fusion protein market during the forecast period. Based on multiple parameters, such as target patient population, likely adoption rate and the annual treatment cost, we have provided informed estimates on the evolution of the market for the forecast period 2021-2035. The market report also features the likely distribution of the current and forecasted opportunity across [A] target indications (neutropenia, graft versus host disease, breast cancer, rheumatoid arthritis, non-small cell lung cancer, neovascular (wet) age-related macular degeneration (AMD), hemophilia A, neuromyelitis optica spectrum disorders and Systemic lupus erythematosus) [B] type of fusion molecule (antibody, cytokine, growth factor, receptor ECD and others) [C] route of administration (subcutaneous, intravenous and intravitreal) and [D] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in the market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is Fc fusion protein?

Answer: Fc fusion protein are biopharmaceutical products where Fc region of an antibody is linked to another moiety.

Question 2: How big is the Fc fusion protein market?

Answer: The Fc fusion therapeutics market size is estimated to be worth $15.5 billion in 2022.

Question 3: What is the projected market growth of the Fc fusion protein market?

Answer: The Fc fusion protein market is expected to grow at compounded annual growth rate (CAGR) of over 10% during the forecast period 2021 - 2030.

Question 4: Who are the leading companies in the Fc fusion protein market?

Answer: Examples of key companies engaged in development of Fc fusion protein based drugs (which have also been profiled in this market report; the complete list of companies is available in the full report) include Alphamab Oncology, Amgen, Acceleron Pharmaceuticals, Bristol Myers Squibb and Sanofi.

Question 5: How many clinical trials have been completed for evaluating different therapeutics by companies engaged in the Fc fusion protein market?

Answer: More than 1,500 clinical trials have been completed for evaluating different therapeutics by companies engaged in the Fc fusion protein market.

Question 6: How many Fc fusion protein product candidates are currently available?

Answer: Over 110 Fc fusion protein product candidates are currently marketed / under development.