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Fc Protein and Glyco-engineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics (3rd edition), 2021-2030

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    Report

  • 290 Pages
  • July 2021
  • Region: Global
  • Roots Analysis
  • ID: 5441010

Overview

With close to 100 approved monoclonal antibodies, and over 550 molecules in the clinical pipeline, antibody based pharmacological interventions have become one of the fast growing segment of the biopharmaceutical industry. In fact, these interventions are anticipated to generate a cumulative sales of USD 300 billion by 2025. Further, within the antibody therapeutics industry, engineered antibodies, developed by modifying the fragment crystallizable (Fc) region, have garnered significant interest over the past few years. The modifications (such as glycoengineering, protein engineering or isotype chimerism) in the Fc region of an antibody have shown to augment the various effector functions, such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) activity and / or the half-life of the molecule. Moreover, several Fc engineering technologies enable the suppression of the effector functions in certain pathways, and are being actively exploited for development of anti-cancer antibodies. 

Over time, a substantial body of evidence has validated the therapeutic applications of Fc engineering platforms, which, in turn, has led to the establishment of numerous strategic partnerships (focused on therapy development and clinical research) and significant investment into the innovator companies. The consistent research efforts in this domain have translated into the emergence of two blockbuster drugs, namely Gazyva® (for Chronic Lymphocytic Leukemia) and POTELEGIO® (for Sézary syndrome) and several other Fc engineered antibody products, including Margenza™, MONJUVI® and SKYRIZI™ that received approval in the past few years. More recently, in 2021, two Fc engineered antibodies, namely Sotrovimab and Etesevimab, got approved for the treatment of COVID-19. Further, there are several drugs in the development pipeline, which are being investigated by various small and established pharmaceutical companies. The promising clinical results, and ongoing technical developments, coupled to the growing interest of biopharmaceutical developers, are anticipated to give the required impetus to the push pipeline products to higher stages of development, and commercialization. We believe that the market is likely to evolve at a commendable pace over the next decade.


Scope of the Report

The ‘Fc Protein and Glyco-engineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics (3rd edition), 2021-2030’ report features an extensive study on the current and future potential of Fc engineered antibodies. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. 


Amongst other elements, the report includes:

  • A detailed review of the Fc protein and glyco-engineered antibodies that are currently marketed and are in different stages of development. It features a detailed analysis of marketed / development programs, based on several relevant parameters, such as phase of development (marketed, clinical and preclinical), target disease indication (atopic dermatitis, gastric cancer, head and neck cancer, non-small cell lung cancer, psoriasis, solid tumors and others), target therapeutic area (autoimmune disorders, infectious diseases, oncological disorders and others), target gene (CD20, CD30, PD-L1 and others), type of antibody (IgG1, IgG2, IgG2/4 and others), type of Fc engineering, and impact of Fc engineering (enhanced effector function, reduced effector function and enhanced serum half-life), route of administration (intravenous, subcutaneous and others) and type of therapy (monotherapy and combination therapy).
  • A detailed review of the companies developing Fc engineered antibodies, along with information on their year of establishment, company size, and location of headquarters.
  • Elaborate profiles of the key players engaged in the development of Fc engineered antibodies. Each profile includes a brief overview of the company, its financial information (if available), information on product portfolio, recent developments and an informed future outlook.
  • An analysis of the partnerships that have been established in this domain, since 2016, covering research agreements, product / technology licensing agreements, mergers and acquisitions, asset purchase agreements, R&D agreements, clinical trial agreements, product development and commercialization agreements, and other relevant type of deals.
  • An in-depth analysis of completed, ongoing, and planned clinical studies for evaluating different Fc engineered antibodies, based on several relevant parameters, such as trial registration year, current trial status, phase of development, enrolled patient population, study design, leading industry and non-industry players (in terms of number of trials conducted), study focus, type of drug molecule, target disease indication, therapeutic area and key geographical regions.
  • An in-depth analysis of the grants awarded to various research institutes for projects related to Fc protein and glyco-engineered antibodies, in the period between 2016-2021, based on parameters, such as year of award, amount awarded, administering institute center, support period, type of grant application, purpose of grant award, activity code, emerging focus areas of the grants, popular NIH departments, type of recipient organization, popular recipient organizations, popular program officers and regional distribution of recipient organizations.
  • An in-depth analysis of around 6,500 patents related to Fc engineering that have been filed / granted, since 2016, highlighting the key trends associated with these patents, across parameters, such as type of patent, publication year and application year, regional applicability, IPCR symbols, emerging focus areas, inventor information, leading patent assignees (in terms of number of patents filed / granted), and patent valuation.

One of the key objectives of the report was to estimate the existing and future growth potential of Fc protein and glyco-engineered antibodies market, over the coming decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2021-2030. The report features the likely distribution of the current and forecasted opportunity across [A] type of Fc engineering (Fc protein and glyco-engineered) [B] type of therapy (monotherapy and combination therapy) [C] therapeutic area (autoimmune disorders, oncological disorders, infectious diseases and others), [D] route of administration (intravenous, subcutaneous and others), and [E] 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, portraying the conservative, base and optimistic tracks of the anticipated industry’s growth. 

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.


Key Questions Answered

  • Who are the leading industry and non-industry players engaged in the development of Fc protein and glyco-engineered antibodies?
  • Which are the key disease indications being targeted by Fc engineered antibodies?
  • Which partnership models are commonly adopted by stakeholders engaged in this domain?
  • Which geographies are the most active in conducting clinical trials on Fc protein and glyco-engineered antibodies? 
  • Which are the leading administering institutes supporting the research related to Fc protein and glyco-engineered antibodies? 
  • How has the intellectual property landscape in this market evolved over the years?
  • Which key factors are likely to influence the evolution of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

 


Please note: This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

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, 2021-2030
10.3.1. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2030: Distribution by Type of Fc Engineering
10.3.1.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Fc Protein Engineered Antibodies, 2021-2030
10.3.1.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Fc Glycoengineered Antibodies, 2021-2030
10.3.2. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2030: Distribution by Type of Therapy
10.3.2.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Monotherapy, 2021-2030
10.3.2.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Combination therapy, 2021-2030
10.3.3. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2030: Distribution by Therapeutic Area
10.3.3.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Oncological Disorders, 2021-2030
10.3.3.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Rare Disorders, 2021-2030
10.3.3.3. Fc Protein Engineered and Glycoengineered Antibodies Market for Dermatological Disorders, 2021-2030
10.3.3.4. Fc Protein Engineered and Glycoengineered Antibodies Market for Autoimmune Disorders, 2021-2030
10.3.3.5. Fc Protein Engineered and Glycoengineered Antibodies Market for Infectious Diseases, 2021-2030
10.3.3.6. Fc Protein Engineered and Glycoengineered Antibodies Market for Gastrointestinal Disorders, 2021-2030
10.3.3.7. Fc Protein Engineered and Glycoengineered Antibodies Market for Neurological Disorders, 2021-2030
10.3.3.8. Fc Protein Engineered and Glycoengineered Antibodies Market for Pulmonary Disorders, 2021-2030
10.3.4. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2030: Distribution by Route of Administration
10.3.4.1. Fc Protein Engineered and Glycoengineered Antibodies Market for Intravenous Route, 2021-2030
10.3.4.2. Fc Protein Engineered and Glycoengineered Antibodies Market for Subcutaneous Route, 2021-2030
10.3.4.3. Fc Protein Engineered and Glycoengineered Antibodies Market for Other Routes of Administration, 2021-2030
10.3.5. Fc Protein Engineered and Glycoengineered Antibodies Market, 2021-2030: Distribution by Geography
10.3.5.1. Fc Protein Engineered and Glycoengineered Antibodies Market in North America, 2021-2030
10.3.5.2. Fc Protein Engineered and Glycoengineered Antibodies Market in Europe, 2021-2030
10.3.5.3. Fc Protein Engineered and Glycoengineered Antibodies Market in North America, 2021-2030
10.3.5.4. Fc Protein Engineered and Glycoengineered Antibodies Market in Asia-Pacific, 2021-2030
10.3.6. Global Fc Protein and Glycoengineered Antibodies Market (For Clinical Late-Stage Products), 2021-2030
10.3.7. Global Fc Protein and Glycoengineered Antibodies Market (For Commercialized Products), 2021-2030

11. CONCLUDING REMARKS12. APPENDIX 1: TABULATED DATA13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AbbVie
  • Academia Sinica
  • AGC Biologics 
  • Agenus
  • Airway Therapeutics
  • Akesobio
  • Albert Einstein College of Medicine
  • Alexion Pharmaceuticals
  • Amgen
  • argenx
  • AstraZeneca
  • BeiGene
  • BIOCAD
  • Biogen
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Canadian Cancer Trials Group
  • Cantargia
  • CATO SMS
  • Celgene
  • Celldex Therapeutics
  • Chia Tai Tianqing Pharmaceutical 
  • Chinese Academy of Sciences
  • Chugai Pharmaceuticals
  • CSL Behring
  • Daiichi Sankyo
  • Dana-Farber Cancer Institute
  • Duke University
  • Eli Lilly
  • Emory University
  • EVERSANA
  • Five Prime Therapeutics
  • Fountain Biopharma
  • Genentech
  • Genmab
  • German CLL Study Group
  • Gilead Sciences
  • Glycotope
  • GlaxoSmithKline
  • Guangzhou Development District
  • Hoosier Cancer Research Network
  • Horizon Therapeutics
  • Humanigen
  • I-Mab Biopharma
  • Immunicum
  • Incyte
  • Janssen
  • Junshi Biosciences
  • Kolltan Pharmaceuticals 
  • Kyowa Kirin
  • Leland Stanford Junior University
  • LEO Pharma
  • Ludwig Institute for Cancer Research
  • MD Anderson Cancer Center
  • MacroGenics
  • Memorial Sloan Kettering Cancer Center
  • Menarini
  • MorphoSys
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health Clinical Center
  • NGM Biopharmaceuticals
  • Novartis
  • Oneness Biotech
  • ONK Therapeutics
  • PAREXEL
  • Patheon
  • Provention Bio
  • Roche
  • Samsung Biologics
  • Sanofi
  • Seagen
  • Seoul National University Hospital
  • Sino Biopharmaceutical
  • SYNIMMUNE
  • TG Therapeutics
  • The Rockefeller University
  • Tillotts Pharma 
  • Tiziana Life Sciences
  • TRIANNI
  • United BioPharma
  • University of California, Los Angeles (UCLA)
  • University of Leicester
  • University of Maryland
  • University of Pennsylvania
  • University of Texas
  • University of Virginia
  • Viela Bio
  • Vir Biotechnology
  • Visterra
  • Vitaeris
  • Washington University
  • WuXi Biologics
  • Xencor
  • Zai Lab
  • Zymeworks

Methodology

 

 

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