Engineered antibodies are antibody based therapeutics, which are gaining increasing attention from both large and small pharmaceutical companies. Developed through introduction of modifications in monoclonal antibodies, the aim is to develop antibodies with improved efficacy.
Research done in the last decade to develop engineered antibodies has yielded a rich knowledge base on how to develop and market these next generation antibodies. These therapeutic antibodies seem to be more promising, with improved properties when compared to their ancestors. There are several molecules in phase II / III clinical trials and a few waiting for approvals. In addition, a large number of molecules are also in pre-clinical trials and are expected to progress through various stages of drug development over the next ten years.
The “Fc Protein and Glycoengineered Antibody Market, 2013-2023” report was commissioned to examine the various aspects of engineering an antibody to develop novel drugs and address several oncology specific diseases. With the market being fairly new, the report examines several elements of developing these next generation antibodies including technologies used for their production, site of engineering in an antibody and molecules in pipeline.
For the purposes of this report, engineered antibodies are defined as antibodies which have been modified in their Fc region. The two types of modification considered are:
• Fc Glycoengineering (referred to as ‘Glycoengineering’ in the report)
• Fc Protein engineering
SCOPE OF THE REPORT
The base year for the report is 2012, with estimated sales data presented for the single engineered antibody - Mogamulizumab - marketed so far. One of the primary objectives of this report is to understand the current and future status of the engineered antibody therapeutics market. This is done by analysing:
• Molecules in pipeline and drugs approved for marketing across various markets
• Research programs, focused on engineered antibody therapeutics, of global pharmaceutical companies and recently established start-ups
• Technologies to produce engineered antibodies
• Likely adoption rate of the new drugs, some of which are expected to be used for lifecycle management of existing drugs
The report provides short-mid term and long term market forecasts for the periods 2013 - 2018 and 2018 - 2023, 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 forecasted sales of
• Seven marketed and pipeline glycoengineered antibodies and
• Three pipeline Fc protein engineered antibodies
Owing to niche nature of the market, with most products in the pipeline, we provide three scenarios for our market forecast to add robustness to our model. The conservative, base and optimistic scenarios are considered for the forecasting of each of the analysed drugs. The figures mentioned in this report are in USD, unless otherwise specified.
1. Oncology dominates the field of engineered antibodies. Many drugs are in Phase II and III clinical trials while one drug, mogamulizumab (KW-0761 / POTELIGEO / AMG761), has already received approval for marketing.
2. By 2023, the overall market is estimated to be in the range of USD 4.3 billion to USD 6.6 billion. The true picture over the forecast period will be determined by the success or failure of the pipeline drugs. We expect the market to be heavily dominated by glycoengineered antibodies.
3. The growth in this market will continue to be aided by major developments with respect to the technology platforms, which are being designed by various companies.
4. Although there are several engineered antibodies under development, the number of target antigens which has been explored to date is limited. Most research to date has focused on CD20, CD19 and HER2 as the target antigens.
5. The market is likely to face competition from other innovative antibody based therapeutics technologies. Antibody drug conjugate (ADC) is one such approach which is attracting the interest of pharmaceutical companies. Two high profile ADCs, namely Adcetris and Kadcyla, have already reached the market.
6. In addition to the current development focus, there are other emerging opportunities for engineered antibodies. For instance, they can be used as a potent life cycle management tool for companies with marketed monoclonal antibody drugs. Companies with successful antibody drugs nearing patent expiry can explore development of an engineered antibody using mAb.