Fc Fusion Therapeutics Market, 2021-2030 Distribution 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, 2021-2030
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 Alprolix® (haemophilia B, May 2016) 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 domain. 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 growth as more drug candidates get approved and marketed over the coming decade.
SCOPE OF THE REPORT
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, 2021-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapies till 2030. The study underlines an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. Amongst other elements, the 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 this domain).
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 this domain, 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.
One of the key objectives of the report was to estimate the existing market size and the future growth opportunities for Fc fusion therapeutics, over the next few years. 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 period 2021-2030. The 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 report are in USD, unless otherwise specified.
KEY QUESTIONS ANSWERED
Who are the leading industry players involved in the development of Fc fusion therapeutics?
Which geographies are the most active in conducting clinical trials on Fc fusion therapeutics?
Which are the leading funding organizations providing grants for Fc fusion therapeutics?
Which partnership models are commonly adopted by industry stakeholders in the development of Fc fusion therapeutics?
How is the current and future market opportunity likely to be distributed across key market segments?
RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views
While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the Fc fusion therapeutics market and its likely evolution in the short-mid term and long term.
Chapter 3 provides a general introduction to Fc fusion therapeutics, components of Fc fusion along with their mechanism of action and types. Additionally, it also highlights the applications of Fc fusion therapeutics, laying emphasis on the emerging trends and how this field of research is likely to evolve over the coming decade.
Chapter 4 includes information on over 110 programs for Fc fusion therapeutics that are either approved or being developed across different stages (commercial, clinical, and preclinical) for the treatment of various indications. It features a comprehensive analysis of pipeline molecules, highlighting the 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 drug developer(s), highlighting their year of their establishment, company size, and location of headquarters.
Chapter 5 provides detailed profiles of the stakeholders involved in the development of Fc fusion therapeutics. Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio, and recent developments and an informed future outlook.
Chapter 6 provides a detailed 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.
Chapter 7 provides an analysis of more than 200 grants that have been awarded to research institutes engaged in projects related to Fc fusion therapeutics, between 2010 and 2021 (till May), on the basis of important 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).
Chapter 8 provides a detailed analysis of over 1,100 research articles related to Fc fusion therapeutics, published between 2010 and 2021 (till August). The analysis takes into consideration several 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 this domain).
Chapter 9 provides an overview of the various 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.
Chapter 10 features an analysis of the various collaborations and partnerships that have been established amongst various stakeholders in this domain. It includes information on various parameters, such as year of partnerships, type of partnerships, leading players (in terms of collaborations inked) and regional distribution. We have discussed different partnership models (including product development and commercialization, R&D agreements, mergers / acquisitions and clinical trial agreements) that have been established till 2021 (till August).
Chapter 11 features a detailed market forecast analysis, highlighting the likely growth of Fc fusion therapeutics till the year 2030. We have provided inputs on the likely distribution of the market opportunity based on different 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). 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.
Chapter 12 features 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 provides details on the players involved in the development of these Fc protein and glycoengineered antibodies
Chapter 13 is a summary of the overall report, presenting the insights on the contemporary market trends and the likely evolution of the Fc fusion therapeutics market.
Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 15 is an appendix, which contains the list of companies and organizations mentioned in the report.
LIST OF COMPANIES AND ORGANIZATIONS
1. 3SBio
2. AbbVie
3. Acceleron Pharma
4. AdAlta
5. Agenus
6. Akeso
7. Alexion Pharmaceuticals
8. Alphamab Oncology
9. Amgen
10. Anthera Pharmaceuticals
11. Apogenix
12. argenx
13. AstraZeneca
14. Bayer
15. BeiGene
16. BIOCAD
17. Biogen
18. Boehringer Ingelheim
19. Brigham and Women's Hospital (BWH)
20. Bristol Myers Squibb
21. CANbridge Pharmaceuticals
22. Cantargia
23. Celgene
24. Celldex Therapeutics
25. Chengdu Kanghong Pharmaceutical
26. Chia Tai Tianqing Pharmaceutical
27. Chiesi Farmaceutici
28. CSL Behring
29. Daiichi Sankyo
30. Dana-Farber Cancer Institute
31. Eli Lilly
32. Evive Biotech
33. Forbius
34. Genentech
35. Gilead Sciences
36. GlaxoSmithKline
37. Haimen Gensciences
38. Harvard College
39. Horizon Therapeutics
40. Huabo Biopharm
41. Humanigen
42. Incyte
43. Inhibrx
44. National Institute of Health and Medical Research (Inserm)
45. Jiangsu Gensciences
46. Johnson & Johnson
47. Junshi Biosciences
48. KBI Biopharma
49. Kiniksa Pharmaceuticals
50. Kyowa Kirin
51. LEO Pharma
52. MacroGenics
53. Memorial Sloan Kettering Cancer Center
54. Menarini
55. Merck
56. MorphoSys
57. National Cancer Institute (NCI)
58. National Institute of Allergy and Infectious Diseases (NIAID)
59. NGM Biopharmaceuticals
60. Novartis
61. OncoImmune (acquired by Merck)
62. Pfizer
63. Protalix Biotherapeutics
64. Provention Bio
65. Regeneron Pharmaceuticals
66. RemeGen
67. Resolve Therapeutics
68. Roche
69. Sanofi
70. Seagen
71. Shandong TheraWisdom Biopharma
72. Shanghai Henlius Biotech
73. Swedish Orphan Biovitrum (Sobi)
74. SYNIMMUNE
75. SystImmune
76. Takeda Pharmaceutical
77. TG Therapeutics
78. Tiziana Life Sciences
79. United BioPharma (UBP)
80. United States Department of Health and Human Services (HHS)
81. University of California
82. University of Pennsylvania
83. USHEALTH
84. Vir Biotechnology
85. Visterra
86. Xencor
87. Zhejiang Hisun Pharmaceutical
88. Zhengzhou Gensciences
89. Zymeworks
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