It is always said that ‘”Nothing worth having comes easy”. A very suitable case in point would be pharmaceutical development because having access to safe and advanced pharmaceutical drugs does not come ‘easy’.
It involves high costs and a lot of time. The path of a marketed drug includes a long and exhaustive journey through basic research, the discovery of the medicine, pre-clinical development tests, complicated clinical trials, and regulatory approval by the Food and Drug Administration (FDA).
In the early stages of development, the major challenge is the designing of the drug product, drug product formulations, and manufacturing methods of drug chemical or biological compounds that are suitable for an early start of non-clinical studies.
It takes several years (sometimes more than a decade) and hundreds of millions of dollars later, under the best of circumstances for a new drug to be approved for marketing. This intricacy makes drug discovery and development, one of the most financially risky endeavors in all of science and a major challenge for the biomedical industry.
Cost from failures accounts for a large part of the total research and development costs. Although they are disappointing and costly, they still contribute to the body of knowledge on disease processes. The process of drug development, though tedious and risky, help respond to unmet medical needs. Also, the revenue generated from the sale of a drug further helps fuel more research and develop newer drugs. This cycle of drug development caters to much-needed medical treatments and helps pharma companies grow as well.
Since the pressure keeps mounting on pharma companies to deliver more drugs to market in a short span of time and effectively manage costs, many innovator companies are now outsourcing their various needs. It is not just data or technology that is pursued, but they also seek partnerships in sharing of knowledge and experience that is much needed throughout the process of drug development. Pharma companies rely on these companies to provide innovative solutions during the tricky phases of drug development.
Outsourcing has become the current trend and an answer to overcome a major challenge in the pharmaceutical industry. It is a strategic decision that is made keeping in mind the benefits like cost and manufacturing efficiencies, smoother regulatory processes, and the ability to focus resources on core competencies eg. Marketing.