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
The projected value of Fc fusion protein market is expected to be valued at USD 15,500 million in 2022 and is anticipated to grow at a CAGR of 10% during the forecast period.
Since the approval of Enbrel® in 1998, marking a significant milestone in the treatment of rheumatoid arthritis, the landscape of therapeutic interventions has evolved with the emergence of Fc fusion therapies. This category, exemplified by a recombinant human tumor necrosis factor (TNF) receptor-Fc fusion protein, has grown substantially. Presently, there are 13 commercially available Fc fusion drugs, and the developmental pipeline boasts approximately 50 molecules addressing a diverse range of disease indications. Noteworthy recent approvals, including Arcalyst® (for recurrent pericarditis in March 2021), Reblozyl® (for beta-thalassemia in September 2020), and Eylea® (for diabetic retinopathy in May 2019), underscore the expanding therapeutic relevance of Fc fusion therapies.
These innovative Fc fusion molecules harness the advantageous pharmacological properties of biologically active ligands in tandem with the crystallizable fragment (Fc) domain of immunoglobulin G (IgG). A distinctive feature of these advanced immunoglobulin-derived therapeutics is their protection from lysosomal degradation upon endothelial cell uptake. The Fc-fragment engages with FcRn receptors in endosomes, facilitating the release of molecules back into the bloodstream. This unique mechanism extends the exposure of pharmacologically active moieties to target tissues, thereby augmenting therapeutic efficacy.
The capacity of Fc fusion therapies to prolong the serum half-life of biologically active proteins has found applications across diverse therapeutic areas, encompassing oncology, neurology, respiratory disorders, and rare genetic disorders. Ongoing research endeavors in this field concentrate on refining the stability and solubility of pharmacologically active moieties to enhance therapeutic potential.
The development of novel Fc fusion therapies has garnered active participation from numerous drug developers, including major pharmaceutical entities that are allocating significant time and capital to advance in the Fc fusion protein market. The sector's vibrancy has attracted attention from both private and public sector investors, as well as investment funds, providing substantial financial support to proficient developer companies. Furthermore, the industry's dynamism is underscored by considerable partnership activity in recent years. With continuous efforts and promising clinical trial outcomes, the Fc fusion therapies market is poised for robust growth as more drug candidates receive approval and enter the market over the forecast period.
Research Coverage
Since the approval of Enbrel® in 1998, marking a significant milestone in the treatment of rheumatoid arthritis, the landscape of therapeutic interventions has evolved with the emergence of Fc fusion therapies. This category, exemplified by a recombinant human tumor necrosis factor (TNF) receptor-Fc fusion protein, has grown substantially. Presently, there are 13 commercially available Fc fusion drugs, and the developmental pipeline boasts approximately 50 molecules addressing a diverse range of disease indications. Noteworthy recent approvals, including Arcalyst® (for recurrent pericarditis in March 2021), Reblozyl® (for beta-thalassemia in September 2020), and Eylea® (for diabetic retinopathy in May 2019), underscore the expanding therapeutic relevance of Fc fusion therapies.
These innovative Fc fusion molecules harness the advantageous pharmacological properties of biologically active ligands in tandem with the crystallizable fragment (Fc) domain of immunoglobulin G (IgG). A distinctive feature of these advanced immunoglobulin-derived therapeutics is their protection from lysosomal degradation upon endothelial cell uptake. The Fc-fragment engages with FcRn receptors in endosomes, facilitating the release of molecules back into the bloodstream. This unique mechanism extends the exposure of pharmacologically active moieties to target tissues, thereby augmenting therapeutic efficacy.
The capacity of Fc fusion therapies to prolong the serum half-life of biologically active proteins has found applications across diverse therapeutic areas, encompassing oncology, neurology, respiratory disorders, and rare genetic disorders. Ongoing research endeavors in this field concentrate on refining the stability and solubility of pharmacologically active moieties to enhance therapeutic potential.
The development of novel Fc fusion therapies has garnered active participation from numerous drug developers, including major pharmaceutical entities that are allocating significant time and capital to advance in the Fc fusion protein market. The sector's vibrancy has attracted attention from both private and public sector investors, as well as investment funds, providing substantial financial support to proficient developer companies. Furthermore, the industry's dynamism is underscored by considerable partnership activity in recent years. With continuous efforts and promising clinical trial outcomes, the Fc fusion therapies market is poised for robust growth as more drug candidates receive approval and enter the market over the forecast period.
Research Coverage
- An introduction to Fc fusion therapeutics is presented, covering components, mechanisms of action, and types. Emphasis is placed on applications, emerging trends, and the anticipated evolution of this research field.
- Details on over 110 Fc fusion therapeutic programs, analyzing their development stages, molecule types, target genes, therapeutic areas, and more. Information on drug developers is also provided.
- Detailed profiles of stakeholders involved in Fc fusion therapeutic development, including overviews, financial information, product portfolios, recent developments, and future outlooks.
- A comprehensive analysis of completed, ongoing, and planned clinical studies is presented, considering various parameters such as trial phase, study design, and regional distribution.
- An analysis of more than 200 grants awarded to research institutes engaged in Fc fusion therapeutics projects, highlighting key parameters and influential entities.
- Over 1,100 research articles related to Fc fusion therapeutics, considering parameters like publication year, focus areas, authors, and key journals.
- An overview of patents filed/granted related to Fc fusion therapeutics since 2018, including information on publication year, patent type, geographic location, and leading players.
- An analysis of collaborations and partnerships within the Fc fusion therapeutics domain, covering parameters such as partnership type, leading players, and regional distribution.
- A detailed market forecast analysis for Fc fusion therapeutics until 2035, considering target indications, molecule types, route of administration, and geographical regions.
- A case study on Fc protein engineered and glycoengineered antibodies, detailing development parameters, impact, and key players.
- Alphamab Oncology
- Amgen
- Acceleron Pharmaceuticals
- Bristol Myers Squibb
- Sanofi
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Overview of Fc Fusion Therapeutics
3.2. Components of Fc Fusion Therapeutics
3.3. Mechanism of Action
3.4. Types of Fc Fusion Therapeutics
3.4.1. Antibody-based Fc Fusion Therapeutics
3.4.2. Cytokine-based Fc Fusion Therapeutics
3.4.3. Enzyme-based Fc Fusion Therapeutics
3.4.4. Peptide-based Fc Fusion Therapeutics
3.4.5. Receptor ECD-based Fc Fusion Therapeutics
3.5. Applications of Fc Fusion Therapeutics
3.6. Advantages of Fc Fusion Therapeutics over Other Biological Moieties
3.7. Future Perspectives
4. PIPELINE REVIEW: MARKETED AND CLINICAL DRUGS
4.1. Analysis Methodology and Key Parameters
4.2. Fc Fusion Therapeutics: Drug Pipeline
4.3. Fc Fusion Therapeutics: Pipeline Analysis
4.3.1. Analysis by Phase of Development
4.3.2. Analysis by Type of Fusion Molecule
4.3.3. Analysis by Target Gene
4.3.4. Analysis by Therapeutic Area(s)
4.3.5. Analysis by Target Disease Indication(s)
4.3.6. Analysis by Type of Therapy
4.3.7. Analysis by Route of Administration
4.3.8. Analysis by Dosing Frequency
4.4. Fc Fusion Therapeutics: List of Drug Developers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Leading Developers
4.4.5. Grid Analysis: Distribution by Phase of Development, Company Size and Location of Headquarters
5. COMPANY PROFILES
5.1. Chapter Overview
5.2. Alphamab Oncology
5.2.1. Company Overview
5.2.2. Financial Information
5.2.3. Product Portfolio
5.2.4. Recent Developments and Future Outlook
5.3. Amgen
5.3.1. Company Overview
5.3.2. Financial Information
5.3.3. Product Portfolio
5.3.4. Recent Developments and Future Outlook
5.4. Acceleron Pharmaceuticals
5.4.1. Company Overview
5.4.2. Financial Information
5.4.3. Product Portfolio
5.4.4. Recent Developments and Future Outlook
5.5. Bristol Myers Squibb
5.5.1. Company Overview
5.5.2. Financial Information
5.5.3. Product Portfolio
5.5.4. Recent Developments and Future Outlook
5.6. Sanofi
5.6.1. Company Overview
5.6.2. Financial Information
5.6.3. Product Portfolio
5.6.4. Recent Developments and Future Outlook
6. CLINICAL TRIAL ANALYSIS
6.1. Analysis Methodology and Key Parameters
6.2. Fc Fusion Therapeutics: List of Clinical Trials
6.3.1. Analysis by Trial Registration Year
6.3.4. Analysis by Trial Phase
6.3.3. Analysis by Study Design
6.3.2. Analysis by Type of Masking
6.3.3. Analysis by Type of Intervention Model
6.3.9. World Cloud: Emerging Focus Areas
6.3.8. Analysis by Trial Registration Year and Geography
6.3.5. Analysis by Type of Sponsor
6.3.6. Leading Industry Players: Analysis by Number of Trials Registered
6.3.7. Leading Non-Industry Players: Analysis by Number of Trials Registered
6.3.10. Popular Indications: Analysis by Number of Registered Trials
6.3.11. Popular Interventions: Analysis by Number of Registered Trials
6.3.12. Geographical Analysis by Number of Registered Trials
6.3.13. Geographical Analysis by Number of Patients Enrolled
7. ACADEMIC GRANT ANALYSIS
7.1. Analysis Methodology and Key Parameters
7.2. Fc Fusion Therapeutics: Analysis of Academic Grants
7.2.1. Analysis by Year of Grant Award
7.2.2. Analysis by Amount Awarded
7.2.3. Analysis by Administering Institute Center
7.2.4. Analysis by Support Period
7.2.5. Analysis by Type of Grant Application
7.2.6. Analysis by Purpose of Grant Award
7.2.7. Analysis by Activity Code
7.2.8. Word Cloud Analysis: Emerging Focus Areas
7.2.9. Popular NIH Departments: Analysis by Number of Grants
7.2.10. Prominent Program Officers: Analysis by Number of Grants
7.2.11. Popular Recipient Organizations: Analysis by Number of Grants
8. PUBLICATION ANALYSIS
8.1. Analysis Methodology and Key Parameters
8.2. Fc Fusion Therapeutics: Recent Publications
8.3. Analysis by Year of Publication
8.4. Word Cloud Analysis: Emerging Focus Areas
8.5. Analysis by Target Therapeutic Area
8.6. Leading Authors: Analysis by Number of Publications
8.7. Key Journals: Analysis by Number of Publications
9. PATENT ANALYSIS
9.1. Analysis Methodology and Key Parameters
9.2. Fc Fusion Therapeutics: Patent Analysis
9.2.1. Analysis by Publication Year
9.2.2. Analysis by Type of Patent
9.2.3. Analysis by Geographical Location
9.2.4. Analysis by Patent Age
9.2.5. Analysis by CPC Symbols
9.2.6. Word Cloud Analysis: Emerging Focus Areas
9.2.7. Leading Patent Assignees: Analysis by Number of Patents
9.2.8. Leading Industry Players: Analysis by Number of Patents
9.2.9. Leading Non-Industry Players: Analysis by Number of Patents
9.2.10. Fc Fusion Therapeutics: Patent Benchmarking Analysis
9.2.10. Fc Fusion Therapeutics: Patent Valuation Analysis
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Analysis Methodology and Key Parameters
10.2. Partnership Models
10.3. Fc Fusion Therapeutics: List of Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Type of Partnership and Type of Fusion molecule
10.3.4. Analysis by Year of Partnership and Type of Partner
10.3.5. Analysis by Type of Partnership and Type of Partner
10.3.6. Most Active Players: Analysis by Number of Partnerships
10.3.7. Regional Analysis
10.3.7.1. Intercontinental and Intracontinental Agreements
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Forecast Methodology and Key Assumptions
11.2. Global Fc Fusion Therapeutics Market, 2021-2031
11.3. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Target Indication
11.4. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Type of Fusion Molecule
11.5. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Type of Therapy
11.6. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Route of Administration
11.7. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Geography
11.8. Fc Fusion Therapeutics: Individual Product Sales Forecasts
11.8.1. ABP 938 (Amgen)
11.8.2. Alprolix® (Sanofi)
11.8.3. AnBaiNuo® (Hisun Pharmaceuticals)
11.8.4. Arcalyst® (Kiniska Pharmaceuticals)
11.8.5. BIVV001 (Sanofi)
11.8.6. CD24Fc (Merck)
11.8.7. Eloctate® (Biogen)
11.8.8. Eylea™ (Regeneron Pharmaceuticals)
11.8.9. FRSW107 (Zhengzhou Gensciences)
11.8.10. KN035 (Alphamab Oncology)
11.8.11. KN046 (Alphamab Oncology)
11.8.12. Lumitin® (Chengdu Kanghong Biotech)
11.8.13. Reblozyl® (Bristol-Myers Squibb)
11.8.14. RyzneutaTM (Evive Biotech)
11.8.15. Strensiq® (AstraZeneca)
11.8.16. Telitacicept (RemeGen)
12. CASE STUDY: FC PROTEIN ENGINEERED AND GLYCOENGINEERED ANTIBODIES
12.1. Fc Protein Engineered and Glycoengineered Antibodies: Drug Pipeline
12.1.1. Analysis by Phase of Development
12.1.2. Analysis by Target Disease Indication
12.1.3. Analysis by Therapeutic Area
12.1.4. Analysis by Type of Fc Engineering
12.1.5. Analysis by Impact of Fc Engineering
12.1.6. Analysis by Route of Administration
12.1.7. Analysis by Type of Therapy
12.2. Fc Protein Engineered and Glycoengineered Antibodies: List of Developers
12.2.1 Analysis by Year of Establishment
12.2.2 Analysis by Company Size
12.2.3 Analysis by Location of Headquarters
13. CONCLUSION
14. APPENDIX 1: TABULATED DATA
15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Overview of Fc Fusion Therapeutics
3.2. Components of Fc Fusion Therapeutics
3.3. Mechanism of Action
3.4. Types of Fc Fusion Therapeutics
3.4.1. Antibody-based Fc Fusion Therapeutics
3.4.2. Cytokine-based Fc Fusion Therapeutics
3.4.3. Enzyme-based Fc Fusion Therapeutics
3.4.4. Peptide-based Fc Fusion Therapeutics
3.4.5. Receptor ECD-based Fc Fusion Therapeutics
3.5. Applications of Fc Fusion Therapeutics
3.6. Advantages of Fc Fusion Therapeutics over Other Biological Moieties
3.7. Future Perspectives
4. PIPELINE REVIEW: MARKETED AND CLINICAL DRUGS
4.1. Analysis Methodology and Key Parameters
4.2. Fc Fusion Therapeutics: Drug Pipeline
4.3. Fc Fusion Therapeutics: Pipeline Analysis
4.3.1. Analysis by Phase of Development
4.3.2. Analysis by Type of Fusion Molecule
4.3.3. Analysis by Target Gene
4.3.4. Analysis by Therapeutic Area(s)
4.3.5. Analysis by Target Disease Indication(s)
4.3.6. Analysis by Type of Therapy
4.3.7. Analysis by Route of Administration
4.3.8. Analysis by Dosing Frequency
4.4. Fc Fusion Therapeutics: List of Drug Developers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Leading Developers
4.4.5. Grid Analysis: Distribution by Phase of Development, Company Size and Location of Headquarters
5. COMPANY PROFILES
5.1. Chapter Overview
5.2. Alphamab Oncology
5.2.1. Company Overview
5.2.2. Financial Information
5.2.3. Product Portfolio
5.2.4. Recent Developments and Future Outlook
5.3. Amgen
5.3.1. Company Overview
5.3.2. Financial Information
5.3.3. Product Portfolio
5.3.4. Recent Developments and Future Outlook
5.4. Acceleron Pharmaceuticals
5.4.1. Company Overview
5.4.2. Financial Information
5.4.3. Product Portfolio
5.4.4. Recent Developments and Future Outlook
5.5. Bristol Myers Squibb
5.5.1. Company Overview
5.5.2. Financial Information
5.5.3. Product Portfolio
5.5.4. Recent Developments and Future Outlook
5.6. Sanofi
5.6.1. Company Overview
5.6.2. Financial Information
5.6.3. Product Portfolio
5.6.4. Recent Developments and Future Outlook
6. CLINICAL TRIAL ANALYSIS
6.1. Analysis Methodology and Key Parameters
6.2. Fc Fusion Therapeutics: List of Clinical Trials
6.3.1. Analysis by Trial Registration Year
6.3.4. Analysis by Trial Phase
6.3.3. Analysis by Study Design
6.3.2. Analysis by Type of Masking
6.3.3. Analysis by Type of Intervention Model
6.3.9. World Cloud: Emerging Focus Areas
6.3.8. Analysis by Trial Registration Year and Geography
6.3.5. Analysis by Type of Sponsor
6.3.6. Leading Industry Players: Analysis by Number of Trials Registered
6.3.7. Leading Non-Industry Players: Analysis by Number of Trials Registered
6.3.10. Popular Indications: Analysis by Number of Registered Trials
6.3.11. Popular Interventions: Analysis by Number of Registered Trials
6.3.12. Geographical Analysis by Number of Registered Trials
6.3.13. Geographical Analysis by Number of Patients Enrolled
7. ACADEMIC GRANT ANALYSIS
7.1. Analysis Methodology and Key Parameters
7.2. Fc Fusion Therapeutics: Analysis of Academic Grants
7.2.1. Analysis by Year of Grant Award
7.2.2. Analysis by Amount Awarded
7.2.3. Analysis by Administering Institute Center
7.2.4. Analysis by Support Period
7.2.5. Analysis by Type of Grant Application
7.2.6. Analysis by Purpose of Grant Award
7.2.7. Analysis by Activity Code
7.2.8. Word Cloud Analysis: Emerging Focus Areas
7.2.9. Popular NIH Departments: Analysis by Number of Grants
7.2.10. Prominent Program Officers: Analysis by Number of Grants
7.2.11. Popular Recipient Organizations: Analysis by Number of Grants
8. PUBLICATION ANALYSIS
8.1. Analysis Methodology and Key Parameters
8.2. Fc Fusion Therapeutics: Recent Publications
8.3. Analysis by Year of Publication
8.4. Word Cloud Analysis: Emerging Focus Areas
8.5. Analysis by Target Therapeutic Area
8.6. Leading Authors: Analysis by Number of Publications
8.7. Key Journals: Analysis by Number of Publications
9. PATENT ANALYSIS
9.1. Analysis Methodology and Key Parameters
9.2. Fc Fusion Therapeutics: Patent Analysis
9.2.1. Analysis by Publication Year
9.2.2. Analysis by Type of Patent
9.2.3. Analysis by Geographical Location
9.2.4. Analysis by Patent Age
9.2.5. Analysis by CPC Symbols
9.2.6. Word Cloud Analysis: Emerging Focus Areas
9.2.7. Leading Patent Assignees: Analysis by Number of Patents
9.2.8. Leading Industry Players: Analysis by Number of Patents
9.2.9. Leading Non-Industry Players: Analysis by Number of Patents
9.2.10. Fc Fusion Therapeutics: Patent Benchmarking Analysis
9.2.10. Fc Fusion Therapeutics: Patent Valuation Analysis
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Analysis Methodology and Key Parameters
10.2. Partnership Models
10.3. Fc Fusion Therapeutics: List of Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Type of Partnership and Type of Fusion molecule
10.3.4. Analysis by Year of Partnership and Type of Partner
10.3.5. Analysis by Type of Partnership and Type of Partner
10.3.6. Most Active Players: Analysis by Number of Partnerships
10.3.7. Regional Analysis
10.3.7.1. Intercontinental and Intracontinental Agreements
11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Forecast Methodology and Key Assumptions
11.2. Global Fc Fusion Therapeutics Market, 2021-2031
11.3. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Target Indication
11.4. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Type of Fusion Molecule
11.5. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Type of Therapy
11.6. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Route of Administration
11.7. Global Fc Fusion Therapeutics Market, 2021-2031: Distribution by Geography
11.8. Fc Fusion Therapeutics: Individual Product Sales Forecasts
11.8.1. ABP 938 (Amgen)
11.8.2. Alprolix® (Sanofi)
11.8.3. AnBaiNuo® (Hisun Pharmaceuticals)
11.8.4. Arcalyst® (Kiniska Pharmaceuticals)
11.8.5. BIVV001 (Sanofi)
11.8.6. CD24Fc (Merck)
11.8.7. Eloctate® (Biogen)
11.8.8. Eylea™ (Regeneron Pharmaceuticals)
11.8.9. FRSW107 (Zhengzhou Gensciences)
11.8.10. KN035 (Alphamab Oncology)
11.8.11. KN046 (Alphamab Oncology)
11.8.12. Lumitin® (Chengdu Kanghong Biotech)
11.8.13. Reblozyl® (Bristol-Myers Squibb)
11.8.14. RyzneutaTM (Evive Biotech)
11.8.15. Strensiq® (AstraZeneca)
11.8.16. Telitacicept (RemeGen)
12. CASE STUDY: FC PROTEIN ENGINEERED AND GLYCOENGINEERED ANTIBODIES
12.1. Fc Protein Engineered and Glycoengineered Antibodies: Drug Pipeline
12.1.1. Analysis by Phase of Development
12.1.2. Analysis by Target Disease Indication
12.1.3. Analysis by Therapeutic Area
12.1.4. Analysis by Type of Fc Engineering
12.1.5. Analysis by Impact of Fc Engineering
12.1.6. Analysis by Route of Administration
12.1.7. Analysis by Type of Therapy
12.2. Fc Protein Engineered and Glycoengineered Antibodies: List of Developers
12.2.1 Analysis by Year of Establishment
12.2.2 Analysis by Company Size
12.2.3 Analysis by Location of Headquarters
13. CONCLUSION
14. APPENDIX 1: TABULATED DATA
15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
