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The Fc fusion therapeutics 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 this 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.
Examples of key companies engaged in Fc fusion therapeutics 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 therapeutics, worldwide.
| Company | Headquarters | Key Fc Fusion Products | Therapeutic Areas | Notable Developments |
| Amgen | Thousand Oaks, CA, USA | Enbrel (etanercept) – TNFR-Fc fusion | Autoimmune Disorders and Rheumatological Disorders | Established blockbuster with biosimilar competition; strong revenue contributor |
| Acceleron Pharmaceuticals (acquired by Merck) | Cambridge, MA, USA | Reblozyl (luspatercept-aamt) – ActRIIB-Fc fusion | Hematological Disorders | FDA approved; joint development/marketing with BMS; significant growth in rare diseases |
| Bristol Myers Squibb | New York, NY, USA | Nulojix (belatacept) – CTLA-4-Fc fusion; Reblozyl (via Acceleron partnership) | Immunological Disorders and Hematological Disorders | Nulojix for kidney transplant rejection prevention; IL-12 Fc fusion collaborations in oncology |
| Sanofi | Paris, France | Eloctate (efmoroctocog alfa) – Factor VIII-Fc; Alprolix (eftrenonacog alfa) – Factor IX-Fc | Hematological Disorders | Strong portfolio in rare blood disorders; improved patient convenience and prophylaxis |
| Alphamab Oncology | Suzhou, China | Envafolimab (KN035) – PD-L1 single-domain Ab Fc fusion | Oncological Disorders | Approved in China; expanding global trials and bispecific/ADC Fc fusion candidates |
Several recent developments have taken place in the field of Fc fusion therapeutics 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.
The “Fc Fusion Therapeutics 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 therapeutics market. The market research report underlines an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in Fc fusion therapeutics market. Amongst other elements, the market research report includes:
The key objective of Fc fusion therapeutics 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 therapeutics 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 biologics, 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.