Biosimilar is a biological product highly similar to a biologic i.e. reference products; however not identical to it. Biosimilars are not generics and are never treated as generics by manufacturing companies and suppliers. Alternatively referred to as bio-pharmaceuticals or follow-on biologics, biosimilars differ from generics in the entire manufacturing process, right from the raw materials used in their manufacturing. Generally derived from plants, bacteria, yeast, animals, and viruses, biosimilars are produced essentially by the two key processes, controlled gene expression and recombinant DNA technology.
Awareness and adoption of biosimilars have been rising since the past few years, resulting in a thriving market for biosimilars. Europe is already a sizeable market for biosimilars; however North America, especially the U.S., has recently taken a notable pace. PMR extensively analyzes the global biosimilars market for the next few years by 2020 and provides important insights to help established manufacturers and new entrants to strategize their businesses.
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FACTS AT A GLANCE
Companies: Pfizer Inc., Eli Lily & Company, Sandoz International GMBH, Hospira Inc., Actavis, Inc., Biocon Ltd., Amgen, Inc., Teva Pharmaceutical Industries Ltd., Cipla Ltd, Dr. Reddy’s Laboratories Ltd., Stada Arzneimittel Ag, Celltrion, Inc., Wockhardt Ltd, and Mylan, Inc. are some of the key players profiled in PMR’s global biosimilars market report.
Coverage: All major geographies and key segments
Segments: Biosimilars Market is Segmented by process Controlled Gene Expression and Recombinant DNA Technology with prevention and treatment for chronic diseases such as diabetes, cancers, CVDs, autoimmune diseases, rheumatoid arthritis, kidney failure, growth hormone deficiency, hematological diseases, and infectious diseases
Geographies: North America (U.S., Canada),Latin America (Mexico, Brazil, Argentina, Chile, Peru),Western Europe (Germany, Italy, France, U.K, Spain, BENELUX, Nordic, Eastern Europe),CIS and Russia,Asia-Pacific (China, India, ASEAN, South Korea),Japan,Middle East and Africa (GCC Countries, South Africa, Turkey, Iran, Israel)
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ABSTRACT-
Global Biosimilars Market: Drivers and Restraints
As biosimilars are widely used in prevention and treatment of a range of chronic diseases, such as diabetes, cancers, CVDs, autoimmune diseases, rheumatoid arthritis, kidney failure, growth hormone deficiency, hematological diseases, and infectious diseases, the demand for biosimilars is likely to gather momentum within the next few years. Growing geriatric population is another major factor identified to primarily drive the market for biosimilars.
Moreover, they are increasingly gaining preference over conventional biologics, attributed to relatively lesser costs compared to that of their parent biological drugs. Various government and private bodies are increasingly promoting the usage of biosimilars over conventional biologics and synthetic drug products. This will remain a major factor propelling the market for biosimilars. High costs of existing biological drugs and rapidly growing pharmaceutical realm will collectively foster the market for biosimilars.
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However, high manufacturing costs and complexity may remain longstanding roadblocks to mainstream production of biosimilars. Moreover, availability of affordable generic drugs in market may also hamper the sales of biosimilars. The most prominent restraint for manufacturers is to establish the biosimilarity through extensive analytical characterization.
Prior to approval, each biosimilar can undergo scrutiny by respective regulatory bodies in order to prove the similarity in terms of safety and efficacy. On the other side, consistent price reductions and the resultant price-competitiveness in the market will be the toughest challenges to the commercialization of biosimilars during the forecast period.
Global Biosimilars Market: Trends and Opportunities
Discounted biosimilar prices will continue to hold a major impact on the overall biosimilar sales, as patients will remain the key beneficiaries. Innovator’s price dropping with heavy discounts is a recent, ongoing trend among the manufacturers based in progressing biosimilar markets. This will be a popular trends throughout the forecast period as well, eventually spurring the global biosimilars market growth.
Furthermore, biosimilar manufacturers are likely to trial multiple production volumes or production on different scales. The potential profitability of manufacturing multiple biosimilar products in the same facility can also be a favorable growth opportunity for biosimilar manufacturing companies during the forecast period. A number of leading manufacturers are focusing on strategic collaborations. In addition, a large number of players are increasingly outsourcing the production of biosimilar products. Both these trends will favor the market over the next few years.
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