Fc 융합 단백질 시장 : 업계 동향과 세계 예측 - 표적 적응증별, 융합 분자 유형별, 투여 경로별, 주요 지역별

GLOBAL FC FUSION PROTEIN MARKET: OVERVIEW

As per Roots Analysis, the global Fc fusion protein market valued at USD 15.5 billion in the current year is anticipated to grow at a CAGR of 10% during the forecast period.

The market sizing and opportunity analysis has been segmented across the following parameters:

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
• Systemic Lupus Erythematosus

Type of Fusion Molecule

• Antibody
• Cytokine
• Growth Factor
• Receptor ECD
• Others

Route of Administration

• Subcutaneous
• Intravenous
• Intravitreal

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

GLOBAL FC FUSION PROTEIN MARKET: GROWTH AND TRENDS

Since the approval of Enbrel(R) (a CD4-Fc fusion protein for the treatment of rheumatoid arthritis) in 1998, Fc fusion protein therapies have become a prominent class of therapeutics. At present, 13 Fc fusion protein-based drugs are commercially available, and approximately 50 additional molecules are in development for a range of disease indications. These therapies combine the advantageous pharmacological properties of biologically active ligands with the unique characteristics of the crystallizable fragment (Fc) domain of immunoglobulin G (IgG). Moreover, due to their ability to prolong the serum half-life of biologically active proteins, these disease-modifying therapies are utilized in a variety of therapeutic areas. Some of these include oncological, neurological, respiratory, and rare genetic disorders.

Currently, numerous drug developers are actively involved in the development of novel Fc fusion therapies with improved efficacy. In fact, the research efforts by developers in this area are centered on enhancing the stability and solubility of the pharmacologically active component, ultimately aiming to boost its therapeutic potential. Consequently, the Fc fusion therapies market is expected to witness healthy market growth during the forecast period.

GLOBAL FC FUSION PROTEIN MARKET: KEY INSIGHTS

The report delves into the current state of global Fc fusion protein market and identifies potential growth opportunities within industry. Some key findings from the report include:

• Presently, around 40 players from across the world, are engaged in evaluating the potential benefits of Fc fusion therapeutics for the treatment of a wide range of disease indications.
• The pipeline features 115+ drug therapies being evaluated either as monotherapies or in combination with other interventions across different stages of development; most of these are designed for parenteral administration.
• Majority of the approved therapies and late-stage candidates are intended for the treatment of various oncological disorders, genetic disorders, hematological disorders and immunological disorders.
• Given the therapeutic benefits of fc fusion, these interventions are primarily evaluated as monotherapies; examples of late-stage drugs being investigated as monotherapy include ACE-011 and RC18.
• Around 50% of the fc fusion therapeutics are meant for subcutaneous administration; these can be self-administered by the patients using different drug delivery systems.
• Over two million patients have been enrolled in the clinical studies being conducted for the evaluation of close to 120 fc fusion-based therapy candidates, across various geographies.

• Several organizations have extended financial support to aid research efforts in this domain; currently, the focus, in terms of funds disbursed, is primarily in support of investigations of drugs for non-SBIR / STTR purposes.
• The number of grants awarded to stakeholders in this domain have increased in the past few years; more than 60% of the total amount was awarded for research projects.
• The field has witnessed the involvement of various administering institutes of the NIH; of all the institutes, participation of the NCI, NIAID, and NHLBI has been relatively more prominent.
• Over time, the intellectual property related to Fc fusion therapeutics has grown at a commendable pace, with patents being filed by both industry and non-industry players.
• Number of patents filed / granted in this domain have increased at a CAGR of 17% during the given time period, with majority of the patents filed / granted in the past two years.
• In addition to industry players, several academic organizations, such as Stanford University and INSERM have also filed patents related to fc fusion therapeutics.
• The high value patents focus on the modification of Fc region with different fusion molecules, such as receptor ECD, enzyme and peptide.
• Published scientific literature is indicative of the ongoing pace of research in this field; the focus of past and ongoing studies seems to be fixated on the development of anti-cancer therapeutics.
• The past few years have seen a steady rise in the number of publications related to fc fusion therapeutics; these include articles highlighting the type of biological moieties fused with the Fc region of the antibodies.
• Majority (~70%) of the published articles are related to the research studies focused on evaluating the therapeutic potential of Fc fusion proteins across various oncological and blood disorders.
• Articles related to Fc fusion therapeutics have been published in several high impact journals; however, PLoS One and MAbs have emerged as the key journals with over 30 articles.
• With multiple pipeline candidates in the mid to late stages of development, these interventions are primarily targeting oncological disorders; majority of these are Fc protein engineered antibodies.
• A number of marketed drugs, such as Fasenra, Gazyva, Margenza and Skyrizi, are now being evaluated for their efficacy across other oncological indications as well.
• Majority (~60%) of the late-stage candidates are targeting oncological indications, including solid tumors, non-Hodgkin lymphoma, and non-small cell lung cancer.
• Driven by an increasing number of late-stage therapies in the pipeline, the future opportunity, in terms of revenues, is anticipated to grow at an annualized rate of nearly 10%.

• The estimated market opportunity is expected to be well-distributed across different types of therapies, target indications, type of fusion molecules, routes of administration and key geographic regions.

Example Players in the Drug Discovery Platforms Market

• Abzena
• Creative Biolabs
• Distributed Bio (Subsidiary of Charles River)
• ImmunoPrecise Antibodies
• IONTAS
• LakePharma
• Leading Biology
• Sino Biological
• XOMA

GLOBAL FC FUSION PROTEIN MARKET

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global Fc fusion protein market, focusing on key market segments, including [A] target indications, [B] type of fusion molecule, [C] route of administration and [D] key geographical regions.
• Market Landscape: A comprehensive evaluation of Fc fusion therapeutics, considering various parameters, such as [A] phase of development of lead candidates, [B] type of fusion molecule, [C] target gene, [D] therapeutic area(s), [E] target disease indication(s), [F] type of therapy, [G] route of administration and [H] dosing frequency. Additionally, a detailed evaluation of the drug developer(s), based on [A] year of establishment, [B] company size, and [C] location of headquarters.
• Company Profiles: In-depth profiles of companies engaged in the development of Fc fusion therapeutics, focusing on [A] company overview, [B financial information (if available), [C] product portfolio and [D] recent developments and an informed future outlook.
• Clinical Trial Analysis: A detailed analysis of clinical studies of various Fc fusion therapeutics, based on several relevant parameters, such as [A] trial registration year, [B] trial phase, [C] study design, [D] type of masking, [E] type of intervention model, [F] emerging focus area, [G] leading industry sponsors / collaborators, [H] popular indications, [I] popular interventions and [J] regional distribution of trials.
• Grant Analysis: An in-depth analysis of grants that have been awarded to research institutes engaged in conducting projects related to Fc fusion therapeutics, based on various relevant parameters, such as [A] year of grant award, [B] amount awarded, [C] administering institute center, [D] support period, [E] type of grant application, [F] purpose of grant award, [G] activity code and [H] emerging focus areas.
• Publication Analysis: A comprehensive analysis of close to 1,135 peer-reviewed scientific articles related to Fc fusion therapeutics, based on [A] year of publication, [B] emerging focus areas, [C] target therapeutic area, [D] leading authors and [E] key journals.
• Patent Analysis: An in-depth analysis of patents filed / granted related to Fc fusion therapeutics, based on various relevant parameters, such as [A] publication year, [B] geography, [C] CPC symbols, [D] emerging focus areas, [E] type of applicant, [F] leading industry players and [G] patent valuation analysis.
• Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in this domain, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] focus area, [D] type of partner, [E] most active players (in terms of the number of partnerships signed) and [F] geographical distribution of partnership activity.
• Case Study: A detailed discussion on the Fc protein engineered and glycoengineered antibodies that are either marketed or being developed based on multiple of relevant parameters, such as [A] phase of development, [B] target disease indication, [C] therapeutic area, [D] type of Fc engineering, [E] impact of Fc engineering, [F] route of administration and [G] type of therapy.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

• 1.1. Scope of the Report
• 1.2. Research Methodology
  • 1.2.1. Research Assumptions
  • 1.2.2. Project Methodology
  • 1.2.3. Forecast Methodology
  • 1.2.4. Robust Quality Control
  • 1.2.5. Key Considerations
    • 1.2.5.1. Demographics
    • 1.2.5.2. Economic Factors
    • 1.2.5.3. Government Regulations
    • 1.2.5.4. Supply Chain
    • 1.2.5.5. COVID Impact / Related Factors
    • 1.2.5.6. Market Access
    • 1.2.5.7. Healthcare Policies
    • 1.2.5.8. Industry Consolidation
• 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
  • 6.2.1. Analysis by Trial Registration Year
  • 6.2.2. Analysis by Trial Phase
  • 6.2.3. Analysis by Study Design
  • 6.2.4. Analysis by Type of Masking
  • 6.2.5. Analysis by Type of Intervention Model
  • 6.2.6. World Cloud: Emerging Focus Areas
  • 6.2.7. Analysis by Trial Registration Year and Geography
  • 6.2.8. Analysis by Type of Sponsor
  • 6.2.9. Leading Industry Players: Analysis by Number of Trials Registered
  • 6.2.10. Leading Non-Industry Players: Analysis by Number of Trials Registered
  • 6.2.11. Popular Indications: Analysis by Number of Registered Trials
  • 6.2.12. Popular Interventions: Analysis by Number of Registered Trials
  • 6.2.13. Geographical Analysis by Number of Registered Trials
  • 6.2.14. 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
  • 9.2.11. 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, Till 2035
• 11.3. Global Fc Fusion Therapeutics Market, Till 2035: Distribution by Target Indication
• 11.4. Global Fc Fusion Therapeutics Market, Till 2035: Distribution by Type of Fusion Molecule
• 11.5. Global Fc Fusion Therapeutics Market, Till 2035: Distribution by Type of Therapy
• 11.6. Global Fc Fusion Therapeutics Market, Till 2035: Distribution by Route of Administration
• 11.7. Global Fc Fusion Therapeutics Market, Till 2035: Distribution by Geography
• 11.8. Fc Fusion Therapeutics: Individual Product Sales Forecasts
  • 11.8.1. ABP 938 (Amgen)
  • 11.8.2. Alprolix(R) (Sanofi)
  • 11.8.3. AnBaiNuo(R) (Hisun Pharmaceuticals)
  • 11.8.4. Arcalyst(R) (Kiniska Pharmaceuticals)
  • 11.8.5. BIVV001 (Sanofi)
  • 11.8.6. CD24Fc (Merck)
  • 11.8.7. Eloctate(R) (Biogen)
  • 11.8.8. Eylea(TM) (Regeneron Pharmaceuticals)
  • 11.8.9. FRSW107 (Zhengzhou Gensciences)
  • 11.8.10. KN035 (Alphamab Oncology)
  • 11.8.11. KN046 (Alphamab Oncology)
  • 11.8.12. Lumitin(R) (Chengdu Kanghong Biotech)
  • 11.8.13. Reblozyl(R) (Bristol-Myers Squibb)
  • 11.8.14. RyzneutaTM (Evive Biotech)
  • 11.8.15. Strensiq(R) (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