PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI
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The European clinical trials market in 2008 is estimated to be around €20.3 billion ($32 billion). If the forecasted revenue
growth of CROs is a good indicator, we can expect the market to grow by 10.6% annually, reaching €30.38 billion ($47 billion)
in 2012, with growth notably coming from the Eastern part of Europe (see Figure 1). A key driving force behind this strong
growth is the increasing number of drugs that need to be tested, as pharma companies are complimenting the traditional model
of developing blockbusters with greater emphasis on niche drugs.1 Our interviews also validated an estimate that in value terms, some 65% of clinical trials are directly managed by pharmaceutical
companies, whilst CROs account for most of the remaining 35%.
Figure 1. A breakdown of the European market for clinical trials by key players in 2008 and a growth forecast for the years
2008 to 2012 for Western and Eastern Europe.
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A cursory inspection of the pipeline of five major pharmaceutical companies reveals that more than half of all drugs under
development are in Phases II and III of clinical trials (see Figure 2). This suggests that there will be continued growth
in the size of the Phase III market, in which the trials are often the largest and have a greater demand for service provision.
It also seems likely that at least one third of these will be for trials of new molecular entities.2
Figure 2. Number of drugs in the pipeline according to phase for five leading pharmaceutical companies as of early 2008: AstraZeneca,
GlaxoSmithKline, Pfizer, Roche, and Sanofi-Aventis.
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We also assessed the cost of clinical trials. It is obvious that such breakdowns vary greatly from one trial to another. But
from our interviews with the different players in the market, we have established that the most expensive category of the
clinical trial is salaries and wages to doctors, nurses, and technicians at the investigational sites (see Table 1). Next
come the CROs (or their activities), which account for a quarter to one third of the cost. Trial and comparator drugs make
up of for some 10% to 20% of the total cost, while another 10% to 20% goes to shipping and handling of drugs and trial kits
(usually when cold-chain is required, the proportion of logistics will increase to 30% of the cost). Furthermore, we found
that the cost of comparator drugs and placebos (including packaging, recapsulation, and labeling) cost half as much as the
drugs to be trialed. These categories are not mutually exclusive, but offer a broadly validated basis for estimation.
Regulatory harmonization
Table 1: Breakdown of clinical trial costs.
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In 2001, the EU published the EU Clinical Trials Directive, which aims at harmonizing national regulatory frameworks. The
key impact of the Directive is that every member state became responsible for creating separate regulations that transpose
the Directive into national law. It also saw the establishment of the EudraCT, a database of all interventional clinical trials
of investigational medicinal products in the EU. [At the time of our research, this database had yet to begin operations.]
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