Despite burgeoning demand for biopharmaceutical drugs, little progress is being made toward the improving efficiency and reducing costs in conventional biomanufacturing processes using microbial or mammalian fermentation systems.
This is the verdict of a new market report from Frost & Sullivan, which predicts that the biopharmaceutical market will more than double from a value of $45.0 billion in 2004 to $98.2 billion by 2011.
One possible answer to the lack of progress in biomanufacturing is to use transgenic plants as a production method, says the report. This has the potential to improve scaleability and yield, which should allow a dramatic reduction in costs.
"Using plants as factories to produce recombinant protein products is emerging as a cost-effective, high capability solution to the issue of production capacity," said F&S research analyst Phil Webster.
While several companies are investigating the potential of what the report describes as plant molecular farming, at present the market consists predominantly of small start-ups working independently, and large multinationals offering third-party services, he said.
But several major challenges must be overcome before plant molecular farming can take a significant share of the biopharmaceutical manufacturing industry. Not least of these is public perception, which is particularly unfavourable in Europe where transgenic crops cannot currently be grown for commercial purposes.
This is affecting the ability of small companies to obtain venture capital funding, a major challenge for an industry dominated by start-ups.However, the unofficial moratorium on transgenic crops in Europe is beginning to wane, as more transgenic products are granted approval for market.
No products produced by plant molecular farming are currently available in this emerging market, but as the first ones approach launch around 2006, the regulatory climate is expected to ease as case studies are presented for approval.
Webster told In-PharmaTechnologist.com that the closest product to market is LT-B, an oral vaccine made in corn that is designed to treat traveller's diarrhoea. It is being developed by Prodigene, which has outsourced its production to a company in Texas. Another near-term candidate for commercialisation is Plant Biotechnology's CaroRx, a monoclonal antibody designed to inhibit the bacteria that cause tooth decay.
And with production platforms and enabling technologies already available, high initial market growth is possible, according to Webster.
"There is currently a shortfall in biopharmaceutical manufacturing facilities, which leaves great market potential for biopharmaceuticals produced from plants," he noted.
Webster acknowledged that the current undercapacity in biomanufacturing could change as new facilities come on-line over the next couple of years - as forecast in another recent report . But he also suggested that in a more competitive environment, the benefits of plant molecular farming in terms of scaleability and ease of downstream processing would lend a potent competitive edge.