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Fc Region and Glycoengineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics (3rd edition), 2021-2035

July 2023 | 290 pages | ID: F725D842E87EEN
Roots Analysis

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The projected value of Fc region and glycoengineered antibodies market is expected to be valued at USD 21,600 million in 2021 and is anticipated to grow at a CAGR of 5% during the forecast period 2021-2035.

With nearly 100 monoclonal Fc antibodies receiving approval and a robust clinical pipeline comprising over 550 molecules, the domain of antibody-based pharmacological interventions stands as a rapidly advancing sector within the biopharmaceutical industry. Projections indicate that these interventions are poised to contribute substantially, with an estimated cumulative sales figure of USD 300 billion by the year 2025.

Within the specific realm of antibody therapeutics, there has been a noteworthy surge in interest surrounding engineered antibodies, particularly those developed through modifications to the fragment crystallizable (Fc) region. Various modifications, such as glycoengineering, protein engineering, or isotype chimerism, implemented in the Fc region, have demonstrated the capacity to enhance diverse effector functions. These functions include antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) activity, and/or the extension of the molecule's half-life. Notably, numerous Fc engineering technologies also facilitate the selective suppression of effector functions in specific pathways, actively contributing to the development of anti-cancer antibodies.

The robust body of evidence validating the therapeutic applications of Fc engineering platforms has resulted in the establishment of numerous strategic partnerships focused on therapy development and clinical research. Substantial investments have followed, directed towards innovator companies engaged in this field. This sustained research effort has yielded significant milestones, exemplified by the emergence of blockbuster drugs such as Gazyva® (for Chronic Lymphocytic Leukemia) and POTELEGIO® (for Sйzary syndrome). Additionally, recent years have witnessed regulatory approvals for several Fc-engineered antibody products, including Margenza™, MONJUVI®, and SKYRIZI™. The year 2021 marked the approval of two Fc-engineered antibodies, namely Sotrovimab and Etesevimab, for the treatment of COVID-19.

The momentum in Fc-engineered antibody development continues, with numerous drugs in the development pipeline under investigation by both small and established pharmaceutical companies. The promising clinical results and ongoing technical advancements, coupled with the growing interest among biopharmaceutical developers, are expected to drive pipeline products to higher stages of development and eventual commercialization. Consequently, a commendable market growth trajectory is anticipated during the forecast period.

Research Coverage
  • A comprehensive introduction to antibodies, covering their structure, history, isotypes, and mechanisms, along with insights into the Fc region, effector functions, Fc receptors, and trends shaping the market's future.
  • Details of over 125 programs for treating various conditions, offering a thorough analysis of Fc protein and glyco-engineered antibodies based on parameters like development phase, therapeutic area, target gene, and more.
  • Profiles of major players in Fc engineered antibodies development, encompassing company overviews, financial information, product portfolios, recent developments, and future outlooks.
  • Detailed collaborations since 2016 related to Fc engineered antibodies, considering factors like the year of agreement, therapeutic focus, and regional distribution.
  • A detail analysis into completed, ongoing, and planned clinical studies of Fc engineered antibodies, examining parameters such as trial status, patient population, and geographical regions.
  • A detailed analysis of grants awarded for Fc protein and glyco-engineered antibodies research between 2016-2021, considering factors like award amount, administering institutes, and regional distribution.
  • Examined around 6,500 patents related to Fc engineering filed/granted since 2016, highlighting trends across parameters like patent type, publication year, and inventor information.
  • A market forecast analysis until 2035, segmented by Fc engineering type, therapy type, therapeutic area, administration route, and geographical regions, with three forecast scenarios.
Key Market Companies
  • AbbVie
  • Alexion Pharmaceuticals
  • AstraZeneca
  • Genentech
  • MacroGenics
  • Kyowa Kirin
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. Chapter Overview
3.2. Structure of Antibodies
3.3. History of Antibody Discovery
3.4. Antibody Isotypes
3.5. Mechanism of Action of Antibodies
3.6. Fc Region and Effector Functions
  3.6.1. Types of Fc Receptors
  3.6.2. Engineering of the Fc Region
    3.6.2.1. Glycoengineering
    3.6.2.2. Protein Engineering
    3.6.2.3. Isotype Chimerism
3.7. Future of Engineered Antibodies

4. MARKET OVERVIEW

4.1. Chapter Overview
4.2. Fc Protein Engineered and Glycoengineered Antibodies: Pipeline Review
  4.2.1. Analysis by Phase of Development
  4.2.2. Analysis by Target Disease Indication
  4.2.3. Analysis by Therapeutic Area
  4.2.4. Analysis by Target Gene
  4.2.5. Analysis by Type of Antibody
  4.2.6. Analysis by Type of Fc Engineering
  4.2.7. Analysis by Impact of Fc Engineering
  4.2.8. Analysis by Route of Administration
  4.2.9. Analysis by Type of Therapy
  4.2.10. Popular Fc Engineering Technologies: Analysis by Number of Development Programs
4.3. Fc Protein Engineered and Glycoengineered Antibodies: List of Developers
  4.3.1 Analysis by Year of Establishment
  4.3.2 Analysis by Company Size
  4.3.3 Analysis by Location of Headquarters

5. COMPANY PROFILES

5.1. Chapter Overview
5.2. AbbVie
  5.2.1. Company Overview
  5.2.2. Financial Information
  5.2.3. Drug Portfolio
    5.2.3.1 Drug Profile: Skyrizi
  5.2.4 Recent Developments and Future Outlook
5.3. Alexion Pharmaceuticals
  5.3.1. Company Overview
  5.3.2. Financial Information
  5.3.3. Drug Portfolio
    5.3.3.1. Drug Profile: Soliris
    5.3.3.2. Drug Profile: Ultomiris
  5.3.4. Recent Developments and Future Outlook
5.4. AstraZeneca
  5.4.1. Company Overview
  5.4.2. Financial Performance
  5.4.3. Drug Portfolio
    5.4.3.1. Drug Profile: Imfinzi
    5.4.3.2. Drug Profile: Fasenra
    5.4.3.3. Drug Profile: Anifrolumab
    5.4.3.4. Drug Profile: Nirsevimab
  5.4.3 Recent Developments and Future Outlook
5.5. Genentech
  5.5.1. Company Overview
  5.5.2. Financial Information
  5.5.3. Drug Portfolio
    5.5.3.1. Drug Profile: Gazyva
    5.5.3.2. Drug Profile: Tecentriq
    5.5.3.3. Drug Profile: Ocrevus
  5.5.4 Recent Developments and Future Outlook
5.6. MacroGenics
  5.6.1. Company Overview
  5.6.2. Financial Information
  5.6.3. Drug Portfolio
    5.6.3.1. Drug Profile: Margenza
    5.6.3.2. Drug Profile: Enoblituzumab
  5.6.4. Recent Developments and Future Outlook
5.7. Kyowa Kirin
  5.7.1. Company Overview
  5.7.2. Financial Portfolio
  5.7.3. Drug Portfolio
    5.7.3.1. Drug Profile: POTELIGEO
  5.7.4. Recent Developments and Future Outlook

6. PARTNERSHIPS AND COLLABORATIONS

6.1. Chapter Overview
6.2. Partnership Models
6.3. Fc Protein Engineered and Glycoengineered Antibodies: List of Partnerships and Collaborations
  6.3.1. Analysis by Year of Partnership
  6.3.2. Analysis by Type of Partnership
  6.3.3. Analysis by Year of Partnership and Type of Partner
  6.3.4. Analysis by Type of Partnership and Type of Partner
  6.3.5. Most Active Players: Analysis by Number of Partnerships
  6.3.6. Analysis by Therapeutic Area
  6.3.7. Analysis by Type of Fc Engineering
  6.3.8. Analysis by Type of Partnership, Therapeutic Area and Type of Fc Engineering
  6.3.9. Regional Analysis
  6.3.10. International and Intracontinental Agreements

7. CLINICAL TRIAL ANALYSIS

7.1. Chapter Overview
7.2. Scope and Methodology
7.3. Fc Protein Engineered and Glycoengineered Antibodies: Clinical Trials
  7.3.1. Analysis by Trial Registration Year
  7.3.2. Analysis by Trial Registration Year and Trial Status
  7.3.3. Analysis by Trial Registration Year and Enrolled Patient Population
  7.3.4. Analysis by Trial Phase
  7.3.5. Analysis by Trial Phase and Enrolled Patient Population
  7.3.6. Analysis by Study Design
  7.3.7. Analysis by Type of Sponsor / Collaborator
  7.3.8. Most Active Industry Players: Analysis by Number of Registered Trials
  7.3.9. Most Active Non-Industry Players: Analysis by Number of Registered Trials
  7.3.10. Analysis by Trial Focus
  7.3.11. Analysis by Type of Drug Molecule
  7.3.12. Analysis by Key Indications
  7.3.13. Analysis by Therapeutic Area
  7.3.14. Geographical Analysis by Number of Clinical Trials
  7.3.15. Geographical Analysis by Number of Clinical Trials and Trial Status
  7.3.16. Geographical Analysis by Enrolled Patient Population
  7.3.17. Geographical Analysis by Enrolled Patient Population and Trial Status

8. ACADEMIC GRANTS ANALYSIS

8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Fc Protein Engineered and Glycoengineered Antibodies: Academic Grants Analysis
  8.3.1. Analysis by Year of Grant Award
  8.3.2. Analysis by Amount Awarded
  8.3.3. Analysis by Administering Institute Center
  8.3.4. Analysis by Funding Institute Center
  8.3.5. Analysis by Support Period
  8.3.6. Analysis by Funding Institute Center and Support Period
  8.3.7. Analysis by Type of Grant Application
  8.3.8. Analysis by Purpose of Grant Award
  8.3.9. Analysis by Activity Code
  8.3.10. Word Cloud Analysis: Emerging Focus Areas
  8.3.11. Analysis by Study Section Involved
  8.3.12. Popular NIH Departments: Analysis by Number of Grants
  8.3.13. Prominent Program Officers: Analysis by Number of Grants
  8.3.14. Analysis by Type of Recipient Organization
  8.3.15. Popular Recipient Organizations: Analysis by Number of Grants
  8.3.16. Regional Distribution of Recipient Organizations

9. PATENT ANALYSIS

9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Fc Protein Engineered and Glycoengineered Antibodies: Patent Analysis
  9.3.1. Analysis by Publication Year
  9.3.2. Analysis by Issuing Authority / Patent Offices Involved
  9.3.3. Analysis by CPC Symbols
  9.3.4. Word Cloud: Emerging Focus Areas
  9.3.5. Analysis by Type of Organization
  9.3.6. Leading Players: Analysis by Number of Patents
  9.3.7. Analysis by Patent Valuation
  9.3.8. Leading Patents by Number of Citations

10. MARKET FORECAST AND OPPORTUNITY ANALYSIS

10.1. Chapter Overview
10.2. Key Assumptions and Forecast Methodology
10.3. Global Fc Protein and Glycoengineered Antibodies Market, 2021-2035
  10.3.1. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2035: Distribution by Type of Fc Engineering
    10.3.1.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Fc Protein Engineered Antibodies, 2021-2035
    10.3.1.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Fc Glycoengineered Antibodies, 2021-2035
  10.3.2. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2035: Distribution by Type of Therapy
    10.3.2.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Monotherapy, 2021-2035
    10.3.2.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Combination therapy, 2021-2035
  10.3.3. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2035: Distribution by Therapeutic Area
    10.3.3.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Oncological Disorders, 2021-2035
    10.3.3.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Rare Disorders, 2021-2035
    10.3.3.3. Fc Protein Engineered and Glycoengineered Antibodies Market for Dermatological Disorders, 2021-2035
    10.3.3.4. Fc Protein Engineered and Glycoengineered Antibodies Market for Autoimmune Disorders, 2021-2035
    10.3.3.5. Fc Protein Engineered and Glycoengineered Antibodies Market for Infectious Diseases, 2021-2035
    10.3.3.6. Fc Protein Engineered and Glycoengineered Antibodies Market for Gastrointestinal Disorders, 2021-2035
    10.3.3.7. Fc Protein Engineered and Glycoengineered Antibodies Market for Neurological Disorders, 2021-2035
    10.3.3.8. Fc Protein Engineered and Glycoengineered Antibodies Market for Pulmonary Disorders, 2021-2035
  10.3.4. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2035: Distribution by Route of Administration
    10.3.4.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Intravenous Route, 2021-2035
    10.3.4.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Subcutaneous Route, 2021-2035
    10.3.4.3. Fc Protein Engineered and Glycoengineered Antibodies Market for Other Routes of Administration, 2021-2035
  10.3.5. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2035: Distribution by Geography
    10.3.5.1. Fc Protein Engineered and Glycoengineered Antibodies Market in North America, 2021-2035
    10.3.5.2. Fc Protein Engineered and Glycoengineered Antibodies Market in Europe, 2021-2035
    10.3.5.3. Fc Protein Engineered and Glycoengineered Antibodies Market in North America, 2021-2035
    10.3.5.4. Fc Protein Engineered and Glycoengineered Antibodies Market in Asia-Pacific, 2021-2035
  10.3.6. Global Fc Protein and Glycoengineered Antibodies Market (For Clinical Late-Stage Products), 2021-2035
  10.3.7. Global Fc Protein and Glycoengineered Antibodies Market (For Commercialized Products), 2021-2035

11. CONCLUDING REMARKS

12. APPENDIX 1: TABULATED DATA

13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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