A Clinical Trial is the term used for a study of a drug, therapy, surgical procedure, medical device or of nutrition or behavioral changes in people. Clinical trials assess the safety and efficacies of new therapeutics, drugs, vaccines, devices or other interventions. The overall purpose of a clinical trial is to learn, not treat patients. Before trials are conducted with human participants, they may have previously been studied with laboratory animals like mice or rats, to draw preliminary conclusions and to judge the safety of the protocol for human patients.
Contract Research Organizations serving the pharmaceutical industry generated a revenue of about $7 billion in the year 2010 globally. North American revenues are expected to reach $10.6 billion by 2015 and to exceed $19.5 billion by 2021. Off shoring to emerging markets and demand for late-stage development services will help to fuel cumulative growth of more than 50% in the worldwide market for clinical trials over the next five years.
The major market drivers for this industry are the entry of new emerging markets where there is a lot of scope to perform R&D studies, the cost competitiveness factor where the cost involved in performing a clinical trial in emerging nations is very less compared to US, lenient regulatory affairs at other markets, wide range of diseases in the market and the number of patients getting affected by them is another major market driver. The main constraints are the shrinking clinical research workforce and certain complications in the regulatory affairs of certain markets and high R&D costs in several markets.
The emerging markets share the highest market share in phase (II/III) trials with focus hugely on Oncology, Alzheimers, metabolic and cardiovascular diseases. The main reason for this high market share is the continuous support provided by the respective Governments and the minimum R&D costs involved when compared to other markets.
US and Canada have the highest market share in the North American market.
The major companies involved in this sector are Quintiles, Paraxel, Pfizer, CenterWatch, Charles River.