Biosimilars market expected to grow to US$1.95bn by 2018

Monoclonal antibodies segment is the fastest-growing with an estimated CAGR of more than 40% from 2013 to 2018

The recombinant glycosylated proteins segment (erythropoietin, monoclonal antibodies, and follitropin) is the largest segment of the biosimilars market, accounting for 40% in 2013 at an estimated $314.2m. It is expected to grow at a CAGR of 17.5% over the next five years to 2018, says MarketsandMarkets in its latest report.

According to the market researcher's Biosimilars Market report, the biggest factor behind the growth of this segment is the increasing demand for second-wave biosimilar products, such as insulin and interferon, for the treatment of diabetes and infectious disorders.

Of all segments under the product category, the monoclonal antibodies segment is the fastest-growing, at an estimated CAGR of more than 40% from 2013 to 2018.

By product, the market is segmented into recombinant non-glycosylated proteins (insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone), recombinant glycosylated proteins (erythropoietin, monoclonal antibodies, and follitropin), and recombinant peptides (glucagon and calcitonin).

By application, oncology is the largest and fastest-growing segment accounting for 25% of the market. This is attributed to the increasing prevalence of different types of cancer along with ageing populations and changing lifestyles.

Europe dominates the global biosimilars market with approximately a 40% share in 2013

Europe dominates the global biosimilars market with approximately a 40% share in 2013. The factors driving the market in this region are its well-defined regulatory guidelines; the 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 their adoption and use. Germany currently commands the highest share in the European market due to the presence of a reference pricing system. The US, on the other hand, has a very restricted biosimilars market owing to the stringent regulatory environment in North America.

Asia-Pacific is estimated to be the fastest-growing market, accounting for an overall share of 29%. This large share is mainly due to the semi-regulatory environment of the region that easily approves similar biologics in the market. Low manufacturing costs and the presence of highly skilled expertise at low costs are also factors that make this region a lucrative destination for the biosimilars market.

Factors restricting growth include high manufacturing complexities and costs, the stringent regulatory environment in the US and Europe, innovative strategies used by biologic drug manufacturers to protect their intellectual property, costly purification process, the arrival of biobetters, and the presence of low-priced biogenerics.

Key market players are Sandoz (Germany), Hospira (US), Teva (Israel), Dr. Reddy's Laboratories (India), Biocon (India), Mylan (US), Biopartners (Switzerland), Amgen (US), Intas Biopharmaceultical (India), and Innovent Biologics (US). In 2013, Sandoz is the highest contributor (50%) to the global market.

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