Monoclonal antibodies were first used to treat cancer in 1997, a landmark achievement in the field of cancer treatment. This innovation has considerably reduced side effects of chemotherapy, and the monoclonal antibody’s ability to bind to specific cells or proteins was one of the main reasons for the reduction in side effects.
Today, monoclonal antibodies help treat various cancers including breast cancer, non-small cell lung cancer, melanoma, gastric cancer, Hodgkin’s lymphoma and colorectal cancer. Other cancers include non-Hodgkin’s lymphoma, brain tumor, lymphocyte leukemia, ovarian cancer and colorectal cancer. Moreover, monoclonal antibodies are in trials for treatment approval for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, metastatic kidney cancer (mRCC), advanced cervical cancer (CC).
The global Cancer Monoclonal Antibodies market is slated to experience a decent growth rate of 5.16% during the forecast period 2016-2022. The United States monoclonal antibodies industry dominates the global market, followed by European countries such as Germany and the United Kingdom. North America accounts for nearly 50% of the market share. The Asia-Pacific market is also growing rapidly.
Factors Driving the Market
The prevalence of cancer, the elongated periods of therapy, the side effects of the condition and the chronic nature of the disease are factors that drive the market for cancer monoclonal antibodies. Other reasons like the adverse effects of existing drugs and the increasing number of patient assistance programs run by organizations also contribute to this continuously growing market.
Many organizations are spending on research and development of cancer monoclonal antibodies. Their research is also focused on existing cancer monoclonal antibodies to address different types of cancer. There are many drugs, currently undergoing and slated to be, in clinical trials. The advent of these new drugs is expected to boost this market’s growth further.
Major products like Kadcyla, Perjeta, Yervoy, Adcetris and Xgeva contribute to the current development of the market. However, the market share is dominated by Avastin, Rituxan, Herceptin, and Erbitux. However, Rituxan went off-patent in 2013, and this led to the development of biosimilars across the world. Hence, the market value of the drug is not expected to rise. According to Roche Holding, though, Rituxan remains the most widely used drug for treatment of common forms of blood cancer.
Many pharmaceutical and biotech companies are carrying out clinical trials on the drugs for different indications. The National Institute of Allergy and Infectious Disease is currently recruiting for Phase 2 of testing Rituxan in Lupus Nephritis. GSK is testing Rituxan for its safety and efficacy in patients with Primary Sjogren’s Syndrome. The National Cancer Institute recently completed its Phase 2 clinical trial study on patients with AIDS-associated lymphoma. Hoffmann La Roche and Genentech are carrying out clinical trials for the treatment of Pemphigus Vulgaris. Dana Farber Cancer Institute has collaborated with Novartis and Millennium Pharmaceuticals for conducting clinical trials with Rituximab to treat relapsed/refractory Waldenstrom’s Macroglobulinemia (WM).
Keytruda from Merck & Co. is expected to be launched in India by the end of December 2016. The drug has already got approval from Drug Controller General of India. The drug has already been initiated in Japan, Australia, and New Zealand within Asia-Pacific. Keytruda was also approved by the European Commission for the treatment of advanced or metastatic PD-L1 positive non-small cell lung cancer. These favorable reimbursement policies are expected to boost the sales of the drug in the region. However, limited national reimbursement for essential medicines, a dominance of generic players and compulsory license applications did not go down to well with big pharma giants.
Adcetris – a cancer monoclonal antibody from Seattle Genetics – was in clinical trial for the treatment of cutaneous T-cell lymphoma. The drug demonstrated better efficacy than standard therapy for cutaneous T-cell lymphoma.
Advances in genetic engineering techniques have also contributed to the growth of cancer monoclonal antibodies market. The fully humanized monoclonal antibodies are considered as highly safe, as they are not antigenic in humans. Unlike murine mAbs, the production of humanized monoclonal antibodies by hybridoma technology is a complicated process, as the immortalized cell lines and human hybridomas do not produce stable levels of the antibody. Thus, fusion partner method and phage display methods become the commonly used technologies.
The new product launches and approval for more cancer indications are set to drive the growth of the cancer monoclonal antibodies market. The efficacious therapy and proper patient information are crucial to the success of these treatments.
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