1. The global biologics market, which saw a 21% compound annual growth rate between 2003 and 2008, has slowed to 8% but revenue will increase from $110 billion in 2008 to $165 billion in 2013 due largely to rapid growth in monoclonal antibodies.
2. The $20 billion bio- production market is growing at a 7% compound annual growth rate and will likely pass the $25 billion market within three years.
3. A significant number of high-value biologics will lose patent protection starting in 20l2. By 20l3, the value of off patent biologic drugs will exceed $20 billion. or almost 13% of the overall market for biologics.
4. By 2017, biologic therapies with total revenue of $37 billion will have lost patient protection suggesting considerable opportunity for bio similars.
5. Monoclonal antibodies are the fastest growing sub segment of biologics with a 13% compound annual growth rate. The segment will be valued at more than $60 billion by 20l3. Vaccines and cell therapies are a few years away from their peak growth. The vaccines segment valued at $17.5 billion in 2008. is experiencing 9% annual growth which could accelerate due to an increase in R&D investment and an expansion into new indications such as oncology.
6. Innovator drug companies, contract manufacturers and generic drug producers are taking action to add the capacity and scientific expertise needed to play in the bio similars market.
7. Potential hurdles include complex and costly manufacturing technologies; heavy competition; stringent regulatory guidelines in Europe, Middle East, and Africa and the still uncertain regulatory framework in the United States.
Source: http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=340
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