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The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.
In 2009, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products. However, biosimilars last year only generated around $89 million in sales, with Sandoz's omnitrope accounting for the vast portion of those sales (33% market share). On a more positive note, growth in sales between June 2008 and June 2009 increased by a remarkable 200%.
Europe is by far the most advanced in terms of biosimilars approvals, but market penetration naturally varies considerably between the EU countries, with Germany accounting for the greatest market share in Europe and, indeed, worldwide (see Table I).
Table I: Market share value for marketed biosimilars by country in Q2 2009.
Sandoz is currently the global market leader in biosimilars sales, but Teva and Hospira are also developing a range of biosimilar products. Meanwhile, some Indian companies are using their experiences within the deregulated markets to produce dossiers and products suited for regulated markets. Certain R&D-based companies are also eyeing biosimilars as an opportunity for future growth; for instance, Merck has launched Merck Bioventures to develop biosimilars. Many companies have embarked on partnering and licensing deals in the area of biosimilars, but it will be those that already have in-house capabilities who will be in the best position. The cost of acquisition in this field is high and with the current limited penetration of biosimilars there is no guarantee of a return on investment in the short-to mid-term.
A SWOT analysis of the biosimilars market (FIGURE COURTESY OF THE AUTHOR)
Forecasting biosimilar sales is complex because of various factors including the imprecise classification of a biosimilar and pricing policies of the originator resulting in the use of the brand in place of the biosimilar. Some estimates show the market growing from $66 million in 2008 to $2.3 billion in 2015. Others see sales exceeding $5.6 billion in 2013. Whatever the forecast, there remains a $50 billion potential for biosimilars.
Based on a contribution by ALAN SHEPPARD, principal of Thought Leadership, Global Generics at IMS Health.