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Fc Protein and Glyco-engineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics, 2021-2030

Fc Protein and Glyco-engineered Antibodies Market: Focus on Type of Fc Engineering and Therapeutics, 2021-2030

  • June 2021
  • 290 pages
  • ID: 6154596
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
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?

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary research. This information helps us to draw out our opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated 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 till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market trends 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 market for Fc protein and glyco-engineered antibodies and its likely evolution in the short-mid-term and long term.

Chapter 3 provides a general introduction to antibodies, including information on structure of antibodies, history of antibody discovery, antibody isotypes, mechanism of action of antibodies. Further, the chapter features a brief overview of the Fc region and effector functions, type of Fc receptors, engineering of the region along with details on glycoengineering, protein engineering and isotype chimerism. Furthermore, the chapter provides an overview of the upcoming future trends, which, we believe, are likely to influence the growth of the Fc engineered antibodies market.

Chapter 4 provides information on over 125 marketed / development programs that are designed for the treatment of various indications, including autoimmune disorders, oncological disorders and others. It features a detailed analysis of Fc protein and glyco-engineered antibodies, based on several relevant parameters, such as phase of development (marketed, clinical and preclinical), target therapeutic area (autoimmune disorders, infectious diseases, oncological disorders and others), target gene (CD20, CD30, PD-L1 and others), type of therapy (monotherapy and combination therapy), route of administration (intravenous, subcutaneous 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).

Chapter 5 includes tabulated profiles of prominent players engaged in the development of Fc engineered antibodies. 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.

Chapter 6 provides a detailed analysis of the recent collaborations (established since 2016) focused on Fc engineered antibodies, based on relevant parameters, such as the year of agreement, type of agreement, therapeutic area, type of Fc engineering, and regional distribution of partnerships.

Chapter 7 provides an in-depth analysis of completed, ongoing, and planned clinical studies of Fc engineered antibodies, based on several relevant parameters, such as current trial status, trial registration year, drug molecule, phase of development, enrolled patient population, study design, leading industry and non-industry players (in terms of number of trials conducted), study focus, target disease indication, therapeutic area and key geographical regions.

Chapter 8 features an in-depth analysis of grants awarded to various research institutes for projects related to Fc protein and glyco-engineered antibodies, in the period between 2016- 2021, based on several 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.

Chapter 9 features an elaborate 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.

Chapter 10 presents an insightful market forecast analysis, highlighting the likely growth of Fc protein and glyco-engineered antibodies till the year 2030. For this purpose, we have segmented the future opportunity across [A] type of Fc engineering (Fc protein and glyco-engineering) [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) [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.

Chapter 11 is a summary of the overall report, which presents insights on the contemporary market trends and the likely evolution of the Fc protein and glyco-engineered antibodies market.

Chapter 12 is an appendix, that contains tabulated data and numbers for all the figures included in the report.

Chapter 13 is an appendix, which contains the list of companies and organizations mentioned in the report.

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