The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.

Most CROs are entering China with expectations that a significant local market opportunity will develop as major pharmaceutical companies establish research development operations there...

Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.

During the past two decades, outsourcing has become increasingly prevalent as the way to gain competitive advantage. This trend has led to a significant increase in the number of services and functions available for outsourcing, and there are emerging opportunities for niche outsourcing to contractors that provide specialized sets of tools and access to cutting-edge technology.

The pharmaceutical industry has experienced a number of difficulties during recent years. Greater competition from generics (more than 60% of prescription drugs are supplied from the generic market) and increased gaps in the drug pipeline that result in acquisitions or strategic alliances has led to a feeling of uncertainty in the bio/pharma marketplace. There have also been changes in the marketplace with a shift from primary care to specialty drugs, the introduction of personalized medicine driving the need for biomarker/diagnostic technology and the introduction of biopharmaceuticals.

As globalization of drug development and manufacturing gathered steam in the early part of this decade, many pharmaceutical companies in the newly-favoured regions of Asia, Eastern Europe and Latin America added contract services as adjuncts to their generic API and dosage form businesses. These new units, which in India are known under the unfortunate acronym of CRAMS (contract research and manufacturing services), were opportunistic responses to the growing outsourcing trends. Unfortunately, in many cases, they were not truly strategic commitments to the services business.

Although overall pharmaceutical industry investment in R&D in Spain is growing at a slower annual level since 2004, investment in clinical trials remains strong.