Insulin Biosimilars Market Analysis

A new race has been initiated between biosimilar and branded drug manufacturers to gain maximum revenue share from insulin market. The upcoming three years are very crucial for insulin manufacturers, as most of the branded insulin are going to be off patent which would results into the loss of around US$53 Bn revenue for branded manufacturers in 2016. Generic manufacturers are expected to take smaller chunk of this amount owing to their local presence which would restrain them take share from other markets. In such dynamic situation, the original drug manufacturers are seeking for plan B to sustain their hold in the market. As a result, these companies are now integrated with biosimilar manufacturers through agreement, alliance. Moreover, legal troubles pertaining patent infringement is hampering the development insulin Biosimilars. In order to overcome such infringement issues, the companies are now collaborating with each other to develop biosimilars versions of insulin. Recent example of global collaboration agreement between Mylan N.V. and Momenta Pharmaceuticals, Inc. has provided a competitive advantage to Mylan by increasing the number of insulin biosimlars under development. This collaboration will capitalized Mylan’s existing portfolio of biologics and insulin analog development.

Increasing prevalence of Type I diabetes, higher cost of existing insulin drugs are expected to drive growth of insulin biosimilars market. Government authorities are also focusing on the approval of insulin biosimilars owing to substantial financial burden in terms of reimbursements. Recently, the U.S. FDA has approved new insulin glargine Basaglar, for type 1 and type 2 diabetes which is Biosimilar version of Sanofi’s basal insulin Lantus (insulin glargine). Additionally, Lilly and Boehringer Ingelheim's biosimilar insulin glargine has got approval through European Medicines Agency's (EMA's) Biosimilar pathway. Such ongoing approvals by the respective authorities are expected to drive the growth of insulin Biosimilar market. However, Insulin patent protection rights and strong retaliation from the branded manufactures has restricted the growth of insulin biosimilar development.

The global market for insulin Biosimilar is segmented on the basis of disease indication and geography.             

On the basis of disease indication, the global insulin Biosimilar market is segmented as,

• Type I Diabetes

• Type II Diabetes

Insulin Biosimilars Market: Overview

Development of clinically proven insulin Biosimilar will pave the road for new entrants. The upcoming patent expiration of blockbuster insulin drugs will open a new avenue and unprecedented opportunities for biosimilar development and manufacturing companies. The cost of insulin biosimilar is currently high owing to stringent adherence requirements in terms of complex regulations and manufacturing and operations. Prices of biosimilar drugs are expected decreased by an average of 20% as compared to branded drugs.

Insulin Biosimilars Market: Region-wise Outlook

Geographically, the global insulin biosimilar market is segmented into regions namely, North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific Excluding Japan, Japan, Middle East and Africa. Among all the regions, North America will continue to lead the global market for insulin biosimilars market due to high demand for insulin. Europe insulin market is expected to account for second largest share in global market primarily due to early approval for biosimilar which is expected to fuel the market growth. Asian companies are competing on the basis of price and has patient pool suffering diabetes. Hence, the Asia Pacific insulin biosimilar market is expected to witness fastest growth in overall market over the forecast period.

Insulin Biosimilars Market: Key Players

Key players operating in the global insulin biosimilar market are Eli Lilly & Co., Boehringer Ingelheim, Merck & Co., Pfizer Inc., Biocon, Mylan N.V. and others

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Regional analysis includes

• North America (U.S., Canada)

• Latin America (Mexico. Brazil)

• Western Europe (Germany, Italy, France, U.K, Spain, Nordic countries, Belgium, Netherlands)

• Eastern Europe (Poland, Russia)

• Asia Pacific (China, India, ASEAN, Australia & New Zealand)

• Japan

• Middle East and Africa (GCC, S. Africa, N. Africa)

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