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Global Biosimilars: Identifying 2nd Generation Opportunities
Espicom Business Intelligence Ltd, Jan 2011, Pages: 194
With a US regulatory pathway in place, albeit untried and untested, the path is clear for serious consideration of the opportunities in biosimilars as a global business.
The future of the pharmaceutical industry lies with biotechnology. Biotech drugs account for around 10-15% of the current pharmaceutical market, and the sector is outperforming the market as a whole in terms of growth.
The need for a settled market environment is essential if the growing number of products losing patent protection in the next 5 years is to be exploited. However, progress is painfully slow and the focus is now on three critical issues:
- 2nd generation products will drive growth and interest:
The biosimilar industry can launch itself on half a dozen older products, but it is not going to thrive on them alone. In order to grow, it will need to look ahead to developing similar versions of newer biologic products. Initially, this effort will probably concentrate on improving versions of the first generation products, with techniques such as glycolysation or pegylation. Beyond that, there is a large and growing number of biologics, principally in the oncology and CNS fields, which are appearing on the market. These tend to be expensive, causing funding difficulties for governments and health payers. Some have been on the market for a decade, and patent expiry is looming.
- US regulatory deal unlikely to unlock the floodgates:
President Obama signed the health reform bill (H.R. 3590) into law on 23rd March 2010 which allows for the application of a biological product as a biosimilar and brings to a conclusion a long and hard-fought debate. So it's all good? According to the FDA it “immediately” formed a working group to consider the implementation, the first public hearing taking place 8 months after the Act was signed and against a background of wide consultation. Is this caution or ambivalence? There is a mounting cost saving argument as the Congressional Budget Office estimates the US could save US$25 billion. This remains a key issue: more biologics are prescribed in the US than anywhere else.
- Emerging markets – a better bet?:
One consequence of rapid economic growth in emerging markets has been a reduction of deaths from infectious disease in childhood, and longer life expectancy as a result. This has brought with it a rise in the incidence of more 'western' diseases, such as diabetes or cancer, and is the reason that countries such as India are keen to develop affordable versions of biologic drugs in order to be able to treat more people in their home markets and ultimately overseas – is it any wonder that the Indian biosimilar industry is so progressive?
What is the biosimilar market worth?:
Establishing a reliable value of the biosimilar market is problematical, and estimates have varied widely.
This report forecasts that for EPO, G-CSF and HGH, total biosimilar product sales by 2015 are estimated at US$342 million, of which US$159 million is in the USA and US$183 million outside it. EPO is the largest product category, at US$230 million in total. Beyond 2015, new products will appear which will significantly increase these estimates.
Global Biosimilars: Identifying 2nd generation opportunities is a new, critical 190+ page management report, published in January 2011 by leading generic industry publisher Espicom Business Intelligence. This strategic report addresses the key issues of concern and provides insights into how the sector may practically develop.
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