Contract Research Organisations (CROs) provide independent development services for pharma, biotechnology, and medical device markets. Services offered by CROs have evolved from providing basic support, to a wide range of services catering to various needs of the market and the sponsors. The United States is the world’s largest market for drugs and accounts for almost half of the research and development (R&D) spending in pharmaceutical and biotechnology markets. Hence, CROs have a strong presence in this market and have invested in new facilities and technologies to cater to a wide range of sponsors. It is estimated that only 25 percent of the R&D activity is currently being outsourced to these organisations. This is likely to double in the coming years due to mounting pressure on the pharmaceutical companies to increase productivity of the cost intensive drug development process.
In the highly competitive contract manufacturing outsourcing (CMO) market the industry is on the rise with pharmaceutical and biotechnology companies targeting their resources towards marketing, rather than production and drug discovery. Pharmaceutical and biopharmaceutical companies are faced with the need to outsource the manufacture of their products for a variety of reasons.
Research within the pharmaceutical industry has tripled in the past 25 years, with the pipelines of the top companies doubling. Stricter regulations, guidelines, price and reimbursement legislation all result in a changing business environment. The growing market in drug development and increase in research and development (R&D) investment, including that of small service companies; coupled with an increase in development costs; the importance of timely development of new products and the aim of reducing time-to-market are all important financial considerations for achieving business growth.
India and China have been known to be steeped in medicinal tradition from time immemorial. What with the modernisation of their economies, liberalisation of regulations and a human capital that is the envy of the world, it’s not a surprise that they are the cynosure of all eyes. It is widely believed that, in the long run, both these countries have the potential to exceed the return from western markets.
Total global spending on contract clinical services in 2005 exceeded $6.2 billion (US), excluding pass through fees (e.g. central lab costs and investigator grants). This represents an increase of 15 per cent annually since 2001. In fact, spending on contract clinical services is outpacing annual growth in sponsor spending on overall global development activity by four to five percentage points.