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.
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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.
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.
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.
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.
The global biosimilars market can be segmented on the basis of product type, application, and distribution channel.
Geographical segmentation of the global biosimilars market classified the market as North America, Europe, Asia, and rest of the world. The biosimilars industry was solely concentrated in the European market since 2006 when the first biosimilar was approved in the EU by the EMA (European Medicines Agency). Recently, in 2015, the first FDA approval for a biosimilar in the U.S. marked a promising hit of the biosimilars industry across North America. Europe has been the first and the largest market for biosimilars, now followed by North America.
Owing to ready availability of skilled labor, relatively lower manufacturing costs, and less complicated regulatory measures, the market for biosimilars in Asian countries is expected to witness significant growth in near future. The biosimilars market is currently witnessing active growth in regions, such as China, India, and Korea. The number of biosimilar manufacturers within China is drastically surging, as a result of which the FDA of China recently developed and finalized the biosimilars guidelines confined to the market for biosimilars production, sale, and consumption across China.
Some of the leading Asian manufacturers are already trading approved biosimilar products in the EU. A number of Asian players are likely to get product approvals in Western markets over the forecast period.
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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.
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