Asia and Latin America will drive biosimilars growth in next decade, says Visiongain

Established players will focus on monoclonal antibodies and licensing deals

Many of the top 25 biosimilar manufacturers have an established base in the market, but many will see their position challenged in the coming decade by players in emerging markets, finds a new report by Visiongain.

To retain market share, estalbished companies will focus on monoclonal antibodies (mAbs) and form licensing deals to extend their product pipelines.

The report, Top 25 Biosimilar Drug Manufacturers 2012-2022, found that in 2011 the top ten biosimilar drug manufacturers accounted for 54.8% of the market.

Global generics manufacturers occupied three of the top four places in the ranking. Leading manufacturers based in India, China and South Korea were also in the top ten.

According to the report, the top 25 companies will all experience revenue growth in the coming decade, although most will see their market share fall.

Sandoz was the world’s leading biosimilar manufacturer in 2011, with revenue of US$261m and a market share of around 15%. Its revenue is expected to reach $308m this year. While the company markets its biosimilars in many countries worldwide, at present it is focused on the developed markets of the EU. Other prominent biosimilar manufacturers in this region include Teva, which has a global market share of just under 10%, and Hospira.

These three companies are expected to remain among the leading biosimilar manufacturers in developed markets and globally in the coming decade. In the future, Visiongain says they will benefit from their early experiences of launching biosimilars, as well as the fact that their monoclonal antibody development programmes are ahead of other market entrants to the US and EU.

China is currently the world’s largest national biosimilars market. Leading companies here include 3SBio, whose biosimilar erythropoietin, EPAIO, holds a market share of more than 40%, and biosimilar insulin producers Shanghai Fosun Pharmaceutical and Tonghua Dongbao, which together account for more than 15% of the Chinese insulin market, by volume.

In India, a number of major companies offer a similar range of products and achieve similar revenue. Market leaders such as BioCon and Wockhardt are focused on biosimilar insulin, while others have broader portfolios covering more niche market sectors. Most, however, are focusing future biosimilar development on monoclonal antibodies.

The Latin American market for biosimilars, although smaller than China and India and supplied by manufacturers from these two Asian countries, is witnessing the growth of domestic biosimilar producers, with four ranked among the world’s top 25 companies in this sector. The report predicts strong growth for these markets and companies in the coming 10 years.

Market leaders in Central and Eastern Europe (CEE) and Russia include local generics manufacturers and specialist biopharmaceutical developers. Bioton was the leading player in this market in 2011 and is among the world’s largest manufacturers of biosimilar insulin.

In South Korea the biosimilar market is growing at a rapid rate, led by LG Life Sciences, which is also among the world’s top five biosimilar companies. Visiongain forecasts that the make-up of the South Korean market will change significantly in the near future, with the approval of biosimilar monoclonal antibodies developed by companies such as Celltrion.

According to the report, the global biosimilars market will grow rapidly in the next decade, driven by patent expiries for leading biologics, as well as increased demand for low-cost healthcare worldwide.

Richard Lang, a pharmaceutical industry analyst for Visiongain, said: ‘Many of the top 25 biosimilar manufacturers have an established base in the market, having marketed products for the past five to ten years. However, many will see their position challenged in the coming decade. Rapid growth forecast for the biosimilars market has made it an attractive prospect and many new companies are looking to enter.’

Lang says to retain market share, current leaders will launch new biosimilars in the next few years, focusing particularly on monoclonal antibodies (mAbs). Licensing deals will extend the pipelines of established players and new market entrants. Eight of Hospira’s eleven pipeline biosimilars are from its licensing agreement with Celltrion, for example. More deals are expected in this sector in the near future as companies look for a foothold in this fast-growing market.

Visiongain says two established market players will achieve biosimilar revenue of more than $2bn by 2022. Dr. Reddy’s will experience the fastest revenue growth in the period, with a CAGR of over 30%. The launch of seven new biosimilars between 2012 and 2018 will help stimulate this growth.

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