Biologics and vaccines
The biopharmaceuticals industry develops vaccines and medicines based on proteins such as monoclonal antibodies (MAbs), often referred to as ‘large molecules’ in comparison to chemical compounds that are usually much smaller. In 2007, biological products contributed to about 24% of the sales of the top 100 drugs worldwide (20% in 2006) and some forecasters predict that this proportion could grow to about 37% by 2012. The rate of growth for biological products together with vaccines has been faster than the small molecule segment during the last few years and this trend has been forecast to continue in the immediate future. Some forecasters predict that the compound annual growth rate for the biopharmaceutical market could be 13% in the period up to 2010.
Biological products are, in general, more complex to manufacture compared to small molecule drugs because they are effectively made by generating biological material from cells or other living tissue, rather than through the process of chemical synthesis used for small molecule pharmaceuticals. Essential for this biological manufacturing is a high degree of fermentation, purification and formulation expertise, which biotechnology companies have typically developed as a result of their work and investment over a number of years. The regulatory regimes for ‘biosimilars’ or ‘follow-on biological products’ (similar versions of existing biological products) are also far less developed than those for generic pharmaceutical drugs, although in Europe and increasingly in the US, formal paths leading to the approval of biosimilars are being evaluated by regulatory authorities. These factors can help produce longer product life cycles for biological drugs compared to traditional pharmaceutical products. Biopharmaceuticals typically have a higher success rate from when a biological drug is tested in man for the first time until it is approved for marketing. This is particularly the case up to the end of phase I development when biological drugs often have a more predictable pharmacokinetic and toxicity profile compared with small molecule pharmaceuticals at the same stage of development.
