Global Clinical Research Industry

The pharmaceutical industry is considered to be a US$ 427 billion industry with the Clinical Trials market being valued at well over US$ 45 billion. Drug companies invest an approximate US$ 200-250 million in conducting clinical trials for each new drug.

Clinical trials are conducted in all major regions of the world which has led to the clinical research industry being spread across America, Europe, Russia, Asia, Africa and Australia. Although in the past clinical trials were restricted to developed nations like the United States and some countries in Europe, the clinical trials market has now over the past few years undergone a paradigm shift. Naïve patient populations, English speaking doctors, low costs and multiple other advantages offered by developing countries have opened up new avenues for the clinical trials market. Favorable regulatory environment and framework coupled with tight R&D budgets in the pharma-biotech industry are also in a way forcing companies to move to east. This industry scenario has resulted in formation of strategic alliances and partnerships between the pharma-biotech companies and the contract research organizations (CRO's).

Today, developing countries conduct the largest chunk of late phase clinical trials (phase II/III) that are being conducted globally. The main therapeutic areas in question are oncology, diabetes, neurology and cardiovascular diseases. Cooperation from local regulatory agencies is an important factor that is leading to the growth of the clinical trials market in developed nations like India. Clinical studies funded by the pharma-biotech companies have a much larger share in the market in comparison to those funded by government organizations.

In 2010 North America (U.S. and Canada together) reported to have conducted the highest number of clinical trials worldwide. In the same year in Europe, Germany conducted 734 clinical trials which was more than any other country in Western Europe. Among the Eastern European Countries, Poland conducted the most number of clinical trials (263) for 2010.

The whole of the Asian region is one of the most rapidly growing markets for global clinical trials. India, China, Taiwan, Korea, and Singapore are leading drug and device development in this region while giving a stiff competition to each other. The main reason for Asia to have immense potential as a clinical trial market is its large, diverse patient population with illnesses that are prevalent in most countries. Thus, different kinds of studies can be efficiently performed in this region. Large patient population helps in faster subject recruitment in clinical trials and also increases retention of subjects enrolled in these trials. This helps drug companies complete the clinical trials on time and saves millions of dollars.

The major players (Contract Research Organizations) in the clinical research business include Quintiles, ICON, PPD, Parexel and Kendle.

In 2008 alone, a total of 10,236 global clinical trials were conducted. This is the highest between 2007 to 2010. In the same year the most widely conducted clinical trials (28.47%) were reported to be in the area of oncology. Asia reported to a steady growth in the number of clinical trials as compared to the other regions.