Global Trastuzumab Biosimilar Market 2027: Top Key Players Amgen Inc., Biocon Limited, Mylan Inc., BioXpress Therapeutics SA, Celltrion, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Samsung Bioepis Co., Ltd., and Merck & Co.

Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that binds to human epidermal growth factor receptor 2 (HER2). HER2 is over expressed in some types breast cancer cells hence, trastuzumab is mainly indicated for the treatment of HER2 positive breast cancer as well as it is also approved for the treatment of metastatic breast cancer and gastric cancer. It is marketed under the trade name of Herceptin by Roche. It is approved by U.S. Food and Drug Administration (FDA) in 1998 and by European Medicines Agency in 2000. Trastuzumab was Roche’s first targeted anticancer drug which accounts more than 90% of HER2 positive cancer market. Trastuzumab is world’s second monoclonal antibody which has resulted in a better prognosis for breast cancer (HER2 positive) and improved survival rates. Some of the market players leading the global trastuzumab biosimilar market include Amgen Inc., Biocon Limited, Mylan Inc., BioXpress Therapeutics SA, Celltrion, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Samsung Bioepis Co., Ltd., and Merck & Co.

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As a cost of Herceptin is so high therefore there is great demand for affordable medicines so that it can fulfil the need of low-income patients as well as expand its coverage. Biosimilar is defined as a type of biological products that are approved by respective regulatory bodies because of its clinical similarity to already approved biological products. Patent of Herceptin expired in Europe in 2014, in Asia in 2017, and in the U.S. the patent will expire in 2019. Thus many of biosimilar of trastuzumab have entered into the market and several companies are developing trastuzumab biosimilar and are expected to come into the market in forecast period. Introduction to biosimilars, increase in incidence and prevalence rate of breast cancer and gastric cancer, rising demand for targeted therapy, and price cuts have boosted the growth of trastuzumab biosimilar market. The price of trastuzumab biosimilar is predicted to be 80% of that of Herceptin thus making it more affordable and accessible in low and medium income developing countries. However, stringent regulatory process for the approval of trastuzumab biosimilar is major restrain for the growth of the trastuzumab biosimilar market.

Based on application, the global trastuzumab biosimilar market is segmented in breast cancer, gastric cancer and others. Breast cancer segment is expected to grow at higher pace during the forecast period owing to increasing incidence and prevalence rate. Based on distribution channel the global trastuzumab biosimilar market is segmented as hospital pharmacy, online pharmacy and others. Hospital pharmacy segment is expected to grow during forecast period due to increase in number of hospital visit and hospital stays.

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At regional level, the global trastuzumab biosimilar market has been segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. In terms of revenue, Europe is major contributor for the global trastuzumab biosimilar market. This is partly because of a trastuzumab patent has been expired in 2014 and on Nov 2017, Samsung Bioepis launched trastuzumab biosimilar in Europe. Europe is followed by North America which is second major revenue generator owing to factors such as strong clinical pipeline, increasing research and drug development activities propels market growth in the region. Asia Pacific is third promising revenue contributor which is expected to grow at rapid pace in upcoming year. Countries such as Japan, India and China are major contributors for this market. Emerging and huge population base countries such as China and India offers tremendous market opportunities.

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