Table of Contents
The concept of bispecific antibodies is increasingly gaining traction in the pharma industry owing to several therapeutic advantages and their potential to address challenges known with the monoclonal antibody based therapies.Bispecific antibodies are artificial antibodies created by joining together two monoclonal antibodies (or parts) that target different epitopes. The resulting antibody has binding affinities for two or three different epitopes concurrently.
The market is still in its infancy. With the EMA approval for Removab in 2009, a great deal of interest has been generated in the bispecific antibody market. The pipeline, which is rich and diverse, has drugs being developed for both oncological and non-oncological indications. These drugs are based on about 50 different technological platforms developed by companies such as Trion Pharma, Amgen, AbbVie, Ablynx, Affimedand MacroGenics amongst others. The platforms are based on the concepts of chemical crosslinking, hybrid hybridomas, with the latest being recombinant techniques. Different binding sites can be exploited to produce bispecific systems with different mechanisms, such as the T cell engager system.
During the course of our research, we came across 37 molecules currently in different stages of clinical development. Over 75% of these molecules are industry sponsored and we expect around 8-9of them to be launched by the end of this decade, providing the much needed push to this market. in addition to the clinical pipeline, we have identified over 70 molecules which are currently in preclinical / discovery phase. Technological advancements, especially in the purification of bispecific antibodies will ensure the development of products with improved safety, potency and efficacy profile. As more products move from pipeline to the market, we expect to see an increase in the investment in this area from various quarters.
SCOPE OF THE REPORT
The 2nd edition of the “Bispecific Antibody Therapeutics Market, 2014-2024” report extensively studies the current and upcoming market of the bispecific antibodies for therapeutic use. This new class of antibody based therapeutics are likely to help target and combat multifactorial diseases through their potential to bind two antigens simultaneously.
The report covers bispecific antibody drugs currently available in the market as well as in various stages of clinical trials. These drugs are being developed for both oncological as well as non-oncological indications. The report highlights various companies which are active in the market and discusses, in detail, the underlying technologies which form the basis of many of the pipeline drugs.
Expecting more FDA and EMA approvals of bispecific antibodies in the coming years, one of the key objectives of this report has been to forecast the bispecific antibody market, currently at a nascent stage, over the course of next ten years. This is done by analysing
- Molecules in pipeline and drugs approved for marketing across various geographical regions
- Research programs, focused on bispecific antibody therapeutics, of global pharmaceutical companies and recently established start-ups
- Technologies to produce bispecific antibodies
- Development and sales potential based on target consumer segments, expected pricing and the likely adoption rate of the new drugs, some of which are expected to be used for lifecycle management of existing drugs
- Competitive landscape and inherent threats to growth in the short term and long term
The report provides short-mid term and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. We have discussed, in detail, the key drivers behind the growth of this market. The research, analysis and insights presented in this report include the sales of 11 marketed and pipeline bispecific antibodies.Owing to the niche nature of this market, with most products in the pipeline, we have provided three scenarios for our market forecast to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of market evolution. The figures mentioned in this report are in USD, unless otherwise specified.
1. About 50 different technology platforms have paved the way for the current pipeline of molecules. Triomab (Trion Pharma), BiTE (Amgen), DVD-Ig (AbbVie), Nanobody (Ablynx), DART (MacroGenics) and TandAb (Affimed) are some of the well-known technologies.
2. Oncology currently dominates the field. About 68% of the industry sponsored molecules are being directed against oncological diseases; with almost two-thirdof them targeting solid tumors.Non oncological drug indications include rheumatoid arthritis, dry age-related macular degeneration, respiratory diseases and autoimmune diseases.
3. Drugs are being tested for several indications. This one drug- multiple applications prospect is extremely appealing to drug manufactures as it reduces their development costs and increases chances of creation of drugs for many diseases at once.
4. Interest of the large and small pharma companies is evident from the fact that about 42 instances of partnership deals have taken place in the last five years (14 in 2014 itself).There are opportunities for the large pharmaceutical companies to either in-license the technology or the product. Companies can develop innovative molecules in-house using in-licensed technology or collaborate on the development of a product already in clinical development to expand their portfolio of drugs.
5. By 2024, we expect the overall market to be valued at USD 5.8 billionannually. The ongoing evolution of technology platforms and increased venture capital interest will act as strong enablers to support this rapid growth.
6. Owing to the complexity of the structure of bispecific antibodies, there are abundant opportunities for contract manufacturers in this area. In particular, the purification of bispecific antibodies is a challenging task, making this field attractive for contract manufacturers and purification technology providers.
Most of the data presented in this report has been gathered by secondary research. We have also conducted 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 shape up across different regions and drug 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
- Other analysts’ opinion reports
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and 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.
Chapter 2 presents an executive summary of the report. It offers a high level view on where the bispecific antibody therapeutics market is headed in the mid-long term.
Chapter 3 provides a general introduction to the concept of bispecific antibodies, covering basics such as antibody technology, the conventional monoclonal antibody and its comparison with bispecific antibody. The chapter also highlights the historic evolution of the industry since the launch of first anti-CD3 antibody, Orthoclone Okt3, in 1986.
Chapter 4 provides a detailed overview and background of the bispecific antibodies market. This chapter covers a detailed pipeline analysis of various molecules under preclinical and clinical trials. We have segmented the drugs on the basis of respective technologies and indications.
Chapter 5 analyses the commercial potential of the global bispecific antibody market, with a special emphasis on the future growth over the next ten years. The market forecast is based on the evolution of the current marketed drug (Removab) and the likely adoption of various drugs which are in advanced clinical trial stages.
Chapter 6 focuses on the various technology platforms currently available or being developed for bispecific antibody production. The chapter highlights many companies which are active in the bispecific antibody market either as drug developers and / or technology providers. We have profiled, in detail, the most promising technologies which form the basis of upcoming pipeline drugs. In addition, this chapter also provides details on the recent partnerships which have emerged in this field.
Chapter 7 provides insight to the recent developments in the field of bispecific antibodies. It includes a comprehensive list of partnerships, including the details of agreements, which have taken place between various pharmaceutical companies over the last few years.
Chapter 8 provides profiles of the key companies in the bispecific antibody market. Each company profile includes information such as financial performance, geographical presence, marketed / pipeline drugs and recent developments.
Chapter 9 analyses the various factors impacting the global bispecific antibody market under the SWOT framework. We examine the various technological, commercial and regulatory trends which have shaped the industry till date.
Chapter 10 is a collection of interview transcripts; these discussions have helped us in forming a better understanding of the key market dynamics, competitive landscape and the likely future trends.
Chapter 11 concludes 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 the appendix, which lists all the companies and organisations mentioned in this report.
Chapter 13 is the appendix, which provides tabulated data and numbers for all the figures provided in the report.
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