Biotechnology - Thirty Years On

They say the modern biotechnology industry was born 30 years ago this year, with the founding of Genentech in April 1976. Now, in its 20th anniversary edition report called Beyond Borders 2006, Ernst & Young sets out an in-depth analysis and key trends for the biotechnology sector with a timeline charting the industrys evolution.

The news is good as biotech is booming across the globe, from the maturing US sector to the emerging Asia-Pacific. Revenues of the world’s publicly traded biotech companies grew 18 percent in 2005, reaching an all-time high of $63.1 billion. In addition, the sector raised $19.7 billion in capital, the sector’s second highest total since 2000.

According to Ernst & Young, the European biotechnology sector has emerged from a lengthy restructuring period with double-digit revenue growth and the second-strongest financing year on record, with €3.2 billion in capital raised. The pipelines of Europe's publicly traded biotech companies increased by 28 per cent. While the US biotechnology sector is still strong with 32 new product approvals, the Asia-Pacific biotechnology sector showed 46 per cent increase in revenues.

There is also tremendous growth in biotech crops despite the EU's chronic incapacity to lift national bans on GMO products. There is increasing pressure by the WTO to allow such crops. Other countries have asserted that the EU had been in violation of international trade rules since 1998 by imposing a moratorium on GM crops, contrary to scientific advice that they presented no health or safety risk. They complained that the EU has set no deadline to lift the moratorium.

Between 1997 and 2000, Austria, France, Germany, Greece, and Luxembourg imposed individual bans on GM crops that had secured approval by the European Food Safety Agency (EFSA). The bans were imposed on a temporary basis using a so-called "national safeguard clause" that EU member states can invoke when they have doubts about the products' safety for human health or the environment. The EU commission is responsible for the implementation of EU treaties and decisions but has imposed delays on biotech approvals, preventing the marketing of GM crops.

While oversold in the beginning, the next big thing in biotech may just be biogenerics (if the FDA ever sets out guidellines for their approval). It is predicted that by 2009, the pharmaceutical market will hit $650 billion, with biotech drug sales representing 15 percent to 20 percent of total sales. Furthermore, it is expected that 50 percent of all new drug approvals in 2010 will be for biotech drugs. Already, the top five biotech drugs represent almost $12 billion in sales with most of them already off patent but there are no generics given the regulatory hurdles for biogenerics.

Given the relatively complex nature of biotech products compared with conventional chemical generics, it is clear that when the FDA acts on biogenerics, it will most likely require substantially more data to obtain approval. Unlike small molecules, the data needed for biogenerics may depend on the product itself.