Biosimilars is a biological medical product which are identical copy of the original medical product manufacture by different companies. Biosimilars product is the fastest growing market in the United States owing to increasing interest of manufacturer for in this market.
Biosimilars Market is expected to register a CAGR of 7.5% during the forecast period of 2019 to 2025, It is an approved process and normally manufactured when the original product's patent expires. According to Food and Drug Administration, in 2015, FDA approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
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Global Biosimilars Market –Major Key Players
Pfizer Inc. (U.S.), Teva Pharmaceuticals Industries Ltd. (Israel), Sandoz International GmbH (Germany), Celltrion, Inc. (South Korea), Astra Zeneca (UK), Amgen Inc. (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Biocon Ltd. (India), Dr. Reddy’s Laboratories Ltd. (India), Novartis (Switzerland), Accord Healthcare (UK), Eli Lilly (US) and Samsung Bioepis (South Korea) are some of the leading players at the cutting edge of the competition in the market of biosimilars, globally.
Global Biosimilars Market – Overview
The global biosimilars market is rising with a swift phase; mainly owing to enhanced productivity and clinical trial activities for biosimilars and increasing demand for the cheap medical products. There are many recently development due to the expiry of patient of original drugs. In 2015, The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998 and in 2016, FDA approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Companies are continuously invent new products to capture the market globally. Thus major players invest more in research and development activity, in order to lead the global market. In this regards, Pfizer Inc., in 2016 announced that it has acquired Bamboo Therapeutics, Inc., in order to lead the market. This acquisition combines the technology and research & development and enhance potentially life-changing therapies. PF-05280014, PF-05280586 and PF-06410293 are under biosimilars clinical trials. It is third largest contributor for biosimilars market. Also In 2016, Teva and Celltrion announce exclusive biosimilar commercial partnership. Teva Pharmaceutical share around 20 % of total global biosimilars market.
Sandoz International GmbH, is the global leader in biosimilars. This company shares 11 % of total global biosimilars market. Increasing need of the better treatment and rising investment and funds for research and development have driven the global market. Moreover companies from developed region are majorly focus in export the drugs to emerging market of Asia Pacific region, As countries from these region have more focus to avail effective treatment at reasonable rate.
Global Biosimilars Market - Regional Analysis
Europe has dominating market for the biosimilars market owing to presence of huge patient population and also major player of Germany, France who have more focused in exporting the drugs to developing region of Asia Pacific. Furthermore Increasing prevalence of diseases and rising geriatric population has led to grow this market in Europe.
Recently in 2017, The U.S. Food and Drug Administration approved first biosimilar for the treatment of cancer, Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer.
The Americas has second leading market for biosimilars players, owing to present of huge population affected with disease. According to Centers for Disease Control and Prevention (CDC), in 2014, seven of the top ten causes of death were chronic diseases that are heart disease and cancer. The main causes for these diseases are smoking and alcohol, whereas report published by Centers for Disease Control and Prevention (CDC) suggest, around 36.5 million adults in the United States said they currently smoked cigarettes, cigarette smoking accounts for more than 480,000 deaths each year.
Asia Pacific and the Middle East and Africa region are considering the huge market. Whereas country like India and china of Asia Pacific region are considering fastest growing region due to presence of huge population effected with chronic disease, additionally they are open to adopt drugs at lower cost. Japan is well developed country and have well established healthcare system and technology, whereas developing countries are still focusing on biosimilars drugs for the treatment, this gap between the developed and developing countries will present significant growth and opportunity for the biosimilars market players to enhance the revenue and market share in the coming years.
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