By application, oncology is the largest and fastest-growing segment and accounts for a share of 25% of the global Biosimilars Market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyle.
Europe dominates the global Biosimilars Market with around 40% share in 2013. The factors driving the European market are its well-defined regulatory guidelines; presence of various Biosimilar drugs such as omnitrope, tevagrastim, and binocrits; numerous pipeline products; and more than 15 biologics going off-patent in the coming years. Although the penetration of Biosimilars varies by country, it also depends on various other factors, including local pricing and reimbursement policies, stakeholder influence, and attitudes towards the adoption and use of Biosimilars. Currently, Germany commands the highest share in the European market due to the presence of a reference pricing system.
The U.S., on the other hand, has a very restricted Biosimilars Market owing to the stringent regulatory environment in North America. The Asia-Pacific market is estimated to be the fastest-growing market. Asia-Pacific accounts for an overall share of 29% of the global Biosimilars Market. This large share of the market is mainly due to the semi-regulatory environment of the region that easily approves similar biologics in the market. In addition, low manufacturing costs and the presence of highly skilled expertise at low costs are also factors that make Asia-Pacific a lucrative destination for the Biosimilars Market.
The factors restricting the growth of the market are high manufacturing complexities and costs, stringent regulatory environment in the U.S. and Europe, innovative strategies used by biologic drug manufacturers to protect th
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