NEW YORK, May 11, 2016 /PRNewswire/ --
Developed through introduction of modifications in monoclonal antibodies (mAbs), antibody based therapeutics are gaining increased attention from both large and small pharmaceutical companies. The Y-arm of the antibody is known as Fab, comprising a constant and a variable domain from each light and heavy chain. The variable domain (Fv) within the Fab region is responsible for target specificity and binding affinity whereas the base of the antibody, known as the fragment crystallizable (Fc) region, is responsible for interaction with immune cells. Modifications made in the Fc region can alter its effector functions. The key changes made in the Fc domain to improve the effector functions include glycoengineering, protein engineering or isotype chimerism. This can result in improvement in the ADCC activity, CDC activity, ADCP activity and half-life of the molecule.
The concept of engineered antibodies is widely being used for development for biobetters/biosimilars, addressing the drawbacks of their ancestor drug candidates. Several players have developed and made available their proprietary technologies for production of such engineered antibodies. This has encouraged and opened an opportunity for a large amount of licensing activity in this domain, building a strong collaborative network of small and big pharmaceutical companies.
Currently, two drugs, namely Gazyva® and POTELIGEO®, are commercially available. A number of molecules are being tested primarily for oncological indications; in addition, a limited set of molecules are also being developed for non-oncological indications such as asthma, COPD, neuromyelitis optica, ulcerative colitis and hemolytic disease in the newborn. Such initiatives suggest that the overall market is likely to hold a strong potential in the coming years.
SCOPE OF THE REPORT
The "Fc Protein and Glycoengineered Antibodies Market (2nd Edition), 2016-2026" report was commissioned to examine the various aspects of engineering an antibody to develop novel drugs for addressing several oncology and non-oncological disorders. This market has steadily evolved over the last few years. The report examines several elements of developing these next generation antibodies, such as the technologies used for their production, site of engineering in an antibody and a robust landscape in the form of clinical / preclinical pipeline. For the purposes of this report, engineered antibodies are defined as antibodies that have been modified in their Fc region. The two types of modification considered include:
- Fc Glycoengineering (referred to as 'Glycoengineering' in the report)
- Fc Protein engineering
As pharmaceutical companies continue to initiate and expand their research programs in this area, one of the key objectives outlined for this report was to understand the future potential of the market. This was done by analyzing:
- The Fc protein and glycoengineered antibody pipeline in terms of phase of development, type of therapy (monotherapy or combination therapy) and target indications.
- Technologies established by various players for development of engineered antibody therapeutics including the key mechanism involved, licencing activity, advantages and the molecules being developed using the technology.
- Partnerships that have taken place in the recent past covering technology licensing, product development and commercialization agreements, clinical trial collaborations, product license agreements, acquisitions and other relevant agreements.
- Inherent threats to growth in the short and long term.
- The likely adoption of the Fc protein and glycoengineered antibodies by understanding the competition posed by the current treatment plans and the expected growth rate over the coming few years.
The study provides a detailed market forecast and opportunity analysis for the short-mid term (2016-2021) and long term (2021-2026). The research, analysis and insights presented in this report include potential sales of the approved drugs and the ones in late stages of development (phase III). To add robustness to our model, we have provided three scenarios for our market forecast; these include the conservative, base and optimistic scenarios. Our opinions and insights, presented in this study were influenced by several discussions we conducted with experts in this area. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
1.1. RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy 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 over the coming ten years, 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 gathered from various secondary and primary sources of information.
1.2. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the report. It offers a high level view on where the Fc protein and glycoengineering antibodies market is headed in the mid to long term.
Chapter 3 maps the historical evolution of monoclonal antibodies and provides a general introduction to the underlying concepts of antibody based therapeutics. This covers details about the structure of antibodies and techniques used to optimize/engineer them. In addition to this, we have also briefly discussed advantages of engineered antibodies over traditional therapeutic
Chapter 4 includes information on nearly 70 molecules that are approved and are being evaluated in different stages of development (both clinical and preclinical/discovery). In this chapter, we have identified the companies that are active in this market and conducted a detailed pipeline analysis including information on type of therapy (monotherapy/combination therapy), most commonly targeted indications and the phase of development.
Chapter 5 focuses on the glycoengineered antibodies market. It gives comprehensive profiles of the marketed, phase III and phase II drug candidates with a detailed understanding on the history of development, mechanism of action, clinical development status and key clinical trial results. Furthermore, we have provided a brief overview on the companies developing these molecules.
Chapter 6 provides information on the Fc protein engineered antibodies market. We have profiled phase II drug candidates with a detailed understanding on the history of development, mechanism of action, clinical development status and key clinical trial results. Furthermore, we have provided a brief overview on the companies developing these molecules.
Chapter 7 gives a comprehensive view on the market forecast measuring the opportunity in the short mid-term (2016-2021) and the long term (2021-2026). We have presented the key assumptions, forecast methodology and corresponding sales forecast output for different target indications. In addition, we have highlighted the relative contribution of the approved, phase III and phase II/III Fc protein and glycoengineered molecules individually.
Chapter 8 highlights the key technologies available for the production of engineered antibodies. We aim to review the advantages of each technology in detail and analyze the licensing activity in the recent past.
Chapter 9 features an elaborate discussion on the collaborations and partnerships that have been forged amongst players in this market. We have also discussed the various partnership models in existence and the most common forms of deals/agreements that have evolved over time.
Chapter 10 provides our analysis of the market under the SWOT framework. This section identifies key elements that are likely to influence future growth and/or impede the progress.
Chapter 11 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 12 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market.
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. Overall, we have identified nearly 70 products in marketed, clinical and preclinical stages of development; nearly 60% of the pipeline accounts for molecules in clinical development.
2. The market is characterized by the presence of both small and big pharma players. Notable examples of small to mid-sized firms include (in alphabetical order) arGEN-X, Celldex Therapeutics, Clovis Oncology, Five Prime Therapeutics, Genmab, Immune Design, MorphoSys, TG Therapeutics and Zymeworks. The larger companies in the domain include Amgen, AstraZeneca/MedImmune, Boehringer Ingelheim, Roche/Genentech, Kyowa Hakko Kirin and Merck.
3. Several firms have also developed their proprietary technologies for Fc optimization and glycoengineering monoclonal antibodies. Examples include (in alphabetical order) BioWa with its POTELLIGENT® technology, Glycart with its GlycoMab Technology, Glycotope with its GlycoExpress™, ProBioGen with its GlymaxX® technology and Xencor with its XmAb Fc technology.
4. Encouraging clinical results and prospects in multiple disease areas have yielded an intense framework of collaborative and licensing activity in this field. In fact, between 2005 and February 2016, there have been over 80 collaborations in this space.
5. With two approved drugs, the glycoengineered antibodies are likely to emerge as the forerunner in the short term (84% of the market share by 2021). Subsequently, the Fc protein engineered antibodies are likely to garner a higher proportion (55% by 2026); specifically, Atezolizumab (by Roche) and Durvalumab (by AstraZeneca/MedImmune) are expected to be blockbusters.
6. The overall market is anticipated to grow aggressively at a healthy annual growth rate of over 40% between 2016 and 2026. In the longer term, we expect the market to continue to rise steadily with high adoption rates of marketed drugs and approval of new drugs and indications.
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