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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Bispecific antibody (BsAb) is an artificial protein that is composed of fragments of two different monoclonal antibodies and has ability to bind to two different types of antigen. Cancer immunotherapy is the most widely explored application of bispecific antibody. Lung, breast and colon cancer are the wider applications of BsAb. Bispecific antibody simultaneously binds to a cytotoxic cell and target tumor cell and destroys it. Bispecific antibodies are emerging a technologically advanced solution for dual targeting strategies within same molecule.

Due to its dual specificity, bispecific antibody can aid in redirecting T cells to tumor cells, blocking two different signaling pathways simultaneously, dual targeting of different disease mediators, and delivering payloads to targeted sites.  Catumaxomab and blinatumomab are the two U.S. FDA approved bispecific antibody products, which would fuel growth of the bispecific antibodies market. Bispecific antibodies can be divided into three main classes namely, fragment, symmetric, and asymmetric antibodies. Fragment bispecific antibodies such as a nanobody DART and BiTE are currently undergoing clinical trials. Likewise, tetravalent BsAb - DVD and DAF symmetric antibodies are under research. Companies such as Sanofi S.A., Merck & Co., Inc. and Genentech, Inc. are conducting research on symmetric bispecific antibodies. BEAT, duobody, and crossmab are examples of asymmetric bispecific antibodies, which are currently being researched by Glenmark Pharmaceuticals, Eli Lilly and Company, and Genmab A/S.

Catumaxomab – the first Bispecific antibody boost growth of the bispecific antibodies market

As of 2015, over 60 different BsAb formats have been developed, with some making their way into the clinical trials. Bispecific antibodies market growth is increasing due to the limitation of monoclonal antibodies in drug resistance and failure to respond in treatment. Hence, the bispecific antibodies market is projected to gain significant growth traction in the near future.

Catumaxomab is a rat – mouse hybrid monoclonal bispecific trifunctional antibody used to treat malignant ascites. It was developed by Fresenius Biotech and Trion Pharma. Catumaxomab was approved in Europe in 2009 and is undergoing clinical trials in the U.S. Sold under the brand name Removab, Catumaxomab is administered to patients with EpCAM-poisitve carcinoma.

North America and Europe are major regions for Bispecific antibodies market

In Europe and North America, incidence of diseases such as lung cancer, cervical cancer, breast cancer, and prostate cancer is increasing, with the regions accounting for the highest incidence rate for these diseases worldwide. Moreover, with these regions being home to major players, these are the largest bispecific antibodies market. Supportive government initiatives are further fueling growth of bispecific antibody treatment markets in North America and Europe.  Increasing healthcare access and awareness in developing regions such as Asia Pacific, Latin America, and Middle East are projected to propel demand for BsAb owing to fuel growth of the bispecific antibodies market in the near future.

Increasing investments to harness the potential of highly effective BsAb Drug Therapy

Various pharmaceutical companies are actively involved in development and manufacture of bispecific antibodies. MedImmune, LLC and Abpro, collaborated in December 2016 to develop novel bispecific antibody, Ang2-VEGF, which targets angiopoietin-2 and vascular endothelial growth factor. Government funding is projected to further encourage research and development in this field.

Key players involved in the bispecific antibodies market include

Some of the key players in Bispecific antibodies market are Amgen, Inc., Bayer AG, Dow Pharmaceutical Solutions, ImmunGene, Inc., Immunocore Limited, Merck & Co., Inc., Novartis AG, Pfizer, Inc., and F. Hoffmann-La Roche AG.

Key Developments in the bispecific antibodies market

The global bispecific antibodies market is expected to witness significant growth, owing to increasing research and development of novel bispecific antibodies. For instance, in January 2019, the Chinese Academy of Medical Sciences & Peking Union Medical College developed a new bispecific aptamer that enhances immune cytotoxicity against MUC1-positive tumor cells.

Moreover, in September 2018, researchers from China Pharmaceutical University constructed and expressed a fully human, bispecific, single-chain diabody that can bind to vascular endothelial growth factor 165 (VEGF165) and programmed death-1 in Pichia pastoris.

In August 2018, UCB Pharma, a scientific research company based in Belgium, conducted research on the molecular factors in bispecific antibody multimerisation and revealed that the monomer level of single-chain variable fragment-containing bispecific antibody formats can be increased by conversion of the single-chain variable fragment to a disulfide-stabilized single-chain variable fragment.

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Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users