Biosimilars or follow-on-biologics are the “copied” version of reference biologics, which are protected by intellectual rights that will expire soon. Patent expiration is the major driving factor of the biosimilars market. Most of the blockbuster patents will expire by the end of 2014, which would provide a competitive edge to local pharmaceutical manufacturers over the global players. For instance, patents for insulin glargine will expire by the end of this year, which would give an opportunity for the growth of insulin biosimilars market. Global biosimilars/follow-on-biologics market accounted for $1,358 million in 2013 and it is anticipated to generate $35,032 million by 2020, growing at a CAGR of 60.8% from 2014 to 2020.
Regulations for biosimilars plays a vital role in maintaining the viability and balance between original and biosimilar products. Various regulatory authorities, namely EMA and the U.S. FDA are actively regulating the biosimilars market. Regulations in the European union are considered benchmark around the world, as the guidelines proposed are most stringent for validation and commercialization of biosimilars. High profitability is the attractive aspect that is enticing companies to invest in the biosimilars industry.
Geographically, Biosimilars market is segmented into North America, Europe, Asia-Pacific and LAMEA. Due to favorable regulatory policies designed by the European Medical Association, the European market has been maximizing on the biosimilars market. Asia-Pacific and LAMEA market would witness a substantial rise in the use of biosimilars, as the demand for cost effective treatment is growing due to the prevalence of chronic diseases. Collaboration with local players would be a key opportunity that could be fully explored by the biosimilars manufacturers in developing economies. Many companies such as Amgen and Novartis are collaborating with Asian players to gain a foothold in the biopharmaceutical market.
Europe was the first region to draft guidelines for approval of biosimilars in 2006. Nevertheless, in 2008, the first biosimilars version of Granulocyte colony-stimulating factor (G-CSF) was introduced in the European Union under the regulatory guidance of European Medical Association (EMA). Currently, there are three biosimilar versions of G-CSF available in the European market, namely Ratiograstim/Tevagrastim/Biograstim, Zarzio/Filgrastim Hexal and Nivestim/Pliva/Mayne filgrastim. Adding to the G-CSF biosimilars, the insulin biosimilars also showcase tremendous potential in the future.
Global biosimilars/follow-on-biologics market is categorized into technology, product types, applications, services and geography.
MARKET BY TECHNOLOGY
MARKET BY TYPES
MARKET BY APPLICATIONS
MARKET BY SERVICES
MARKET BY GEOGRAPHY
Global biosimilars/follow-on-biologics market in this report is segmented based on their functional bonding in which they are found such as glycosylated and non-glycosylated. Several pharmaceutical manufacturers are exploiting the lucrative opportunities available in this market. Presently, reference biologics are protected by IP (Intellectual Property) rights; however, the property protections for blockbuster drugs will soon expire, this will open up a platform for biosimilars manufacturers to gain dominance. Growing demand for over-the-counter (OTC) and prescription-based drugs would also cement the growth of the biosimilars industry in developing economies. Biosimilars versions of some monoclonal antibodies and granulocyte colony stimulating factors commercialized in the market have gained substantial foothold in the market in terms of revenue and growth. These medicines have outperformed their reference versions in terms of cost, performance and output. After successful market entry, the players operating in this market are now assured of its potential. This has lead to increase in their interest for the research and development of novel biosimilar versions of the blockbuster drugs, which have soon to expire property protections. The biosimilars market would have a double digit growth rate and garner billions of dollars from the reference biopharmaceutical industry during 2013-2020. Developing economies such as China and India would act as the principle contributors to the growth of the biosimilar industry. This is due to the increase in healthcare expenditure, change in the quality of lifestyle and prevalence of chronic diseases in these regions. Additionally, under-developed economies such as those in Africa are also allowing biosimilars to be commercialized under the guidance of government regulations. Demand for biosimilar drugs in developed economies is still yet to gain popularity, as the consumer base in these countries shows an inclination towards branded drugs instead of biosimilars; hence, the biosimilars market is expecting sluggish growth in developed countries during the analysis period.