Antibody drug conjugates are defined as the monoclonal antibodies attached with biologically active drugs by chemical linkers through labile bonds. By combining the targeting ability of molecular antibodies with cancer ability of cytotoxic drugs, antibody drug conjugates allows targeted therapy for the treatment of cancer patients. They allow sensitive discrimination between healthy and cancerous tissues.
The market for antibody drug conjugate is in infancy stage. So far, only three antibody drug conjugates have received market approval from the U.S. Food and Drug Administration (FDA). However, the first among them, Mylotarg was withdrawn from the market by its manufacturer Wyeth, Inc., group company of Pfizer, Inc. in June 2010. Myotarg was used to treat acute myelogenous leukemia but a clinical trial showed that the drug has accelerated the mortality rate among the myelogenous leukemia patients and had added no benefits over conventional cancer therapies. Therefore, the market for antibody drug conjugates can be segmented on the basis of other two approved drugs which include: Adcertis, Kadcyla
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Adcertis (Brentuximab vedotin) is an antibody drug conjugate directed to the protein CD30 which is expressed in Hodgkin lymphoma and systemic anaplastic large cell lymphoma. In February 2011, Seattle Genetics submitted Biologics License Application (BLA) to the U.S. FDA for use in relapsed or refractory Hodgkin’s lymphoma and refractory or relapsed anaplastic large cell lymphoma. The drug was granted accelerated approval by the U.S. FDA in August 2011. Adcertis dominated the antibody drug conjugate market as only approved drug from August 2011 till February 2013. The drug also received marketing authorization from the European Medicines Agency in October 2012.
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Kadcyla (Trastuzumab emtansine) is an antibody drug conjugate consisting of the monoclonal antibody trastuzumab linked to cytotoxic agent mertansine DM1. In the Emilia (Italy) clinical trials of women suffering from HER2 positive breast cancer who were only resistant to trastuzumab alone, kadcyla improved survival by 5.8 months. Based on this trial, the drug received approval from U.S. FDA in February 2013. Kadcyla was developed by Genentech, Inc., a subsidiary of F. Hoffmann-La Roche AG and is manufactured by Lonza group. The introduction of kadcyla assisted the antibody drug conjugate market in its steep growth from 2012 to 2013.
Extensive research and development is the major factor which is driving the antibody drug conjugate market. Majority of the antibody drug conjugates under development are for oncological indications propelled by the availability of monoclonal antibodies targeting different types of cancer. Some market players are also looking outside the oncology domain to develop antibody drug conjugate, though, such drugs are limited in number are in preclinical stage of development. As the large number of large pharmaceutical companies are now involved in antibody drug conjugates market, therefore it is expected that this market will grow rapidly during the forecast period.
More than thirty antibody drug conjugates are under pipeline currently, among which Inotuzumab Ozogamicin by Pfizer, Inc., Glembatumumab Vedotin by Celldex Therapeutics, Lorvotuzumab Mertansine by ImmunoGen, Inc., SAR3419 by Sanofi S.A. and PSMA-ADC by Progenics Pharmaceuticals are currently under phase II clinical trials. However, the high cost associated with research activities and sunk cost involved in R&D activities restrains the antibody drug conjugates market. Other players which are involved in research activities of antibody drug conjugates development include Biotest Pharmaceuticals Corporation, Bayer AG, Synthon BV and Immunomedics, Inc.