1.1 Definition and scope of study
The antibodies are a biological molecules involved in immunity, mainly used in prevention in the context of vaccination. An antibody is thus a protein (globulin) directly produced by the the immunological system of an organism which is intended to react in the presence of an antigen (a substance foreign to the human immunological system).
There are two main categories of antibodies:
- Monoclonal antibodies that recognize only one type of epitope on a given antigen;
- Polyclonal antibodies which are a mixture of several antibodies recognizing different epitopes on a given antigen.
The antibody production market is dominated by 5 large laboratories (including Novartis, Roche and Biogen) who share 80% of the world market . The major names in the pharmaceutical industry are engaged in a partnership approach to produce antibodies at the lowest cost.
According to the Echoes the French market for monoclonal antibodies is estimated at more than $7 billion and france is one of the first users of monoclonal antibodies in the world. However, only 2% of monoclonal antibody clinical trials are conducted in France, compared to 59% in the United States.
The progress of the medical research are a growth driver for the antibody production market, which now focuses on serious and difficult to treat infections Herpes, hepatitis, HIV, etc. Over the past two decades, hundreds of monoclonal antibodies, including therapeutic antibodies, fusion proteins, conjugated antibodies, antibody fragments, etc., have been approved in major markets such as the United States, Europe and Japan. The approval rate for products in the antibody market has increased significantly - more than 74 therapeutic antibodies were approved in the United States and Europe, representing 10.2% of the global pharmaceutical market in 2015.
New-generation therapeutic antibodies, such as biosimilar antibodies represent a high growth potential for the antibody market. For example, Inflectra, a biosimilar to Remicade, was approved by the EU in 2013 and is now available worldwide. Novartis AG, one of the leading prescription drug companies, has recently received EU approval for two biosimilar antibodies for rheumatoid arthritis.
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