At the Conference on Pharmaceutical Ingredients (CPhI) opened its doors yesterday, In-PharmaTechnologist.com spoke with Nick Hyde, global business director at leading contract manufacturer Dowpharma, to hear his views on the state of the industry.
And on the surface, it makes grim reading. The combination of surplus capacity and dwindling demand - a consequence of shrinking pharmaceutical pipelines and a shift towards higher-potency compounds - and competition from new players in Asia have taken their toll on the sector in recent years, and the situation looks unlikely to improve going forward.
But while the overall picture for the CMO sector may look bleak, companies that can differentiate themselves in the marketplace can still do well, and Hyde believes Dowpharma has the ingredients in place to buck the trend.
"As you walk around the show, it is clear that 90 per cent of the reactions shown on the booths can be carried out by any company, so the rise in competition for undifferentiated products is unsurprising," he said.
Dowpharma is protected from this development by virtue of its willingness to embrace new technologies, and by offering a breadth of services that smaller players cannot match, according to Hyde. The company has invested strongly in chiral technology, is an established player in biologics production and also has a portfolio of development and product lifecycle offerings, including its recently-launched BioAqueous solubilisation service.
It is also building a leading position in manufacturing using plants, and is already using this approach for some compounds in clinical trials.
But other CMOs are suffering and he expects continued rationalisation and consolidation in the sector. "In general, the intermediates business in Europe is generic, and looks likely to be under pressure for the foreseeable future," continued Hyde.
And he is skeptical of the current axiom that the answer lies in expanding into sectors such as biologics and high-potency compounds. The former has a high barrier to entry for most companies and still makes up only a minority portion of the overall drugs market, and the latter market is very restricted.
"The global drugs market has passed the $500 billion mark for the first time, but small molecules still account for more than 80 per cent of the total - and high-potency only a tiny fraction of that," noted Hyde.
Dowpharma recently elected not to go ahead with plans to build a mammalian cell production facility at its Smithfield site in the US, a decision which now seems sensible given recent market research from Frost & Sullivan which is predicting an overcapacity in biologics manufacturing out to 2011.
Instead the company is focusing on new technologies such as its new strain of the bacterium Pseudomonas fluorescens - called Pfenex - which drives up the yields in biotherapeutics production compared to existing systems such as Escherichia coli.
This provides Dowpharma with a competitive advantage in the contract biopharmaceutical manufacturing sector, as it can produce more protein per reactor and should reduce costs.
Pfenex also extends the use of microbial fermentation and can be used to make biotherapeutics that would otherwise require mammalian cell culture. The expense of the latter - typically around twice the cost of microbial fermentation - means that mammalian systems tend only to be used if no microbial approach can be found.
Dowpharma also recently expanded into peptides, including expression and purification strategies, and has signed a series of technology acquisition deals in the plant biomanufacturing sector. More on the company's efforts in plant-based systems will be reported in a forthcoming edition of In-PharmaTechnologist.com.