Table of Contents
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth. The upcoming patent expiration for blockbuster drugs has revolutionized the aspect of commercialization whilst triggering a large scale adoption of biosimilars. Biosimilars industry is facing problems relating to production efficiency and quantity. The lack of economies of scale for small scale manufacturers and absence of regulatory guidelines in lucrative regions such as China, US are hindering the growth of biosimilars market. However, strong government initiatives pertaining to production and approval is a key factor that would eventually reduce the impact of these restraints over the forecast period. Global biosimilars/follow-on-biologics market accounted for an overall revenue of $2,552.0 million in 2014 and it is estimated to generate an approximate revenue of $26,551.3 million by 2020, registering a CAGR of 49.1% from 2015 to 2020. The product segment in the biosimilars market comprises of Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Colony Stimulating Factors and others. Biosimilars erythropoietin is the highest revenue generating biosimilars drug candidate owing to its high approval rate for commercialization. Interferon biosimilars are the fastest growing drugs in the biosimilars market. This growth is supplemented by the use of interferon biosimilars across a wide range of applications.The biosimilars applications market is segmented into blood disorders, oncology diseases, chronic and autoimmune diseases and growth hormone deficiency. The application of biosimilars in blood disease treatment is the highest revenue generating segment owing to the high-priced reference biologics and frequent application. However, biosimilars applications in autoimmune and chronic diseases exhibit the highest potential due to the changing off patent scenario.Based on geography, the biosimilars market is segmented across North America, Europe, Asia-Pacific and LAMEA. Asia Pacific and LAMEA exhibit a large scale demand for biosimilars due to the growing prevalence of chronic diseases in these regions. Collaboration with local players is a key opportunity for biosimilars in developing economies. Many companies such as, Amgen and Novartis are collaborating with Asian players to reach to the depth of the biopharmaceutical market. The absence of effective regulatory guidelines for product approval and commercialization limit the growth of the biosimilars market in North America. However, recent draft published by US FDA has approved first biosimilar in United States. This would eventually standardized the procedure of approval and commercialization of biosimilars in United States.This report provides a comprehensive market share analysis of leading companies and highlights the competition in the market. Product launch is the key strategy adopted by the leading player of biosimilars industry. The key companies profiled in this report are Novartis (Sandoz), Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen idec, Inc., and Genentech (Roche Group). Key BenefitsThis report provides a detailed analysis of drivers and factors that limit the market expansionThe report provides a financial market forecast for the next eight years by considering the 2014 as the base year for evaluation. Comprehensive and quantitative data about changing market trends, competition and opportunities in biosimilars market are provided in the reportUse of Porters Five Forces model and SWOT analysis would help stakeholders in making strategic decisionsDeep dive analysis of leading market players and their key strategies, helps in better understanding the market dynamics Identification of key investment pockets in the biosimilars market would help the stakeholders in making informed decisionsKey DeliverablesGlobal biosimilars/follow-on-biologics market is categorized into product types, applications and geography.MARKET BY TYPESHuman growth hormoneErythropoietinMonoclonal antibodiesInsulinInterferonGranulocyte-Colony Stimulating FactorPeptideOthersMARKET BY APPLICATIONSBlood disordersOncology diseasesChronic and autoimmune diseasesGrowth hormone deficienciesOthersMARKET
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