A clinical trial is a process carried out to ascertain the effectiveness and safety of a pharmaceutical preparation. It is done in five phases. A preclinical phase precedes all others and is done in laboratory settings. Phase 1 and 2 are carried out on animal subjects and together with the preclinical phase are called early phase trials, as they help scientists establish drug safety and delineate a safe pharmacological dose to give to human subjects in upcoming trials. Phases 3 and 4 are then done on actual human subjects, with Phase 4 actually being a post marketing feedback on efficacy and long term effects of the preparation.
Early phase trials are often expensive to carry out given the advanced laboratory infrastructure required and keeping healthy animal subjects ready for testing. Outsourcing these trials helps recycle resources among different pharmaceutical manufacturers and keep development costs low. Given the steady growth the pharmaceutical industry is seeing owing to the current COVID-19 pandemic and an increasing base of chronic diseases globally, early phase outsourcing market will continue to grow over the period of 2020 to 2030, states Transparency Market Research.
A number of outsourcing agencies are looking to cash-in on the increased requirements for clinical trials. This makes the market scenario fragmented. Key players in the outsourcing market include:
By acquiring smaller laboratories and trial facilities, these players are expected to expand infrastructure required for early phase trials and attract pharmaceutical companies to invest in their operations.
North America and Europe are currently global leaders in the early phase clinical trial outsourcing market. An existing pharmaceutical infrastructure coupled with innovations in regional laboratories should is set to bring steady growth in this market.
The Asia Pacific region (APAC) is expected to register the fastest growth in this market in the future owing to a rising awareness about trial outsourcing among an already robust pharmaceutical industry. South Korea is due to be a leader in this region given the government's favorable laws over clinical trials. China and Australia too are expected to show impressive growth in this market.