As mergers and acquisitions continue the need for outsourcing will increase. Another factor for the increase is the continued movement into emerging countries placing a higher demand for global clinical trial services networks.
It is possible that because of growth in the CRO space, with mergers and acquisitions etc., we will see greater placement of pharma work at a single supplier. Instead of shopping around and having distinct parts of a study with different providers, the placement of work at a single supplier will likely increase as companies seek to leverage the benefits, such as cost and ease of contracting, of multi-service CROs.
Pipeline size increase, biotech proliferation, on-going big pharma ‘virtualization’ processes.
Internal resources at pharmas are already significantly reduced, especially for development support. The question is no longer which type of studies we need to outsource – the single most important factor which can influence the outsourced work is the discovery/development portfolios.
The programs in various pipelines will enable more outsourced work. On the other hand, pharmas are more willing to terminate programs at earlier stages. In other words, CROs may see increased work on preclinical development and fewer late phase clinical studies.
We all know preclinical work takes more method development and validation work and fewer real samples. Those who are sufficiently staffed with method development scientists may have the edge in attracting more business.
The complexity and the fiscal challenges in obtaining marketing authorizations for new therapies is apparent in what is perceived as a resultant downward trend in the industries productivity is surely going to have an impact on outsourcing trends. The aim of many organizations will still continue to be to control research and development costs, particularly in managing capital expenditure.
Undoubtedly it still remains that a prime motive for any organization to outsource is to maintain productivity where internal resource gaps occur. This may be in personnel, expertise, technology or demands caused by local geographical regulatory and business factors. The model of drug development organizations having all technologies and the concomitant resources and expertise they may require at sometime within their ’in house‘ establishment has gone and are very unlikely to reinstated. These two factors alone will surely drive an increase in amount of outsourcing.
CROs are already responding to this by becoming more innovative, offering services in areas such as discovery support, widening their technology platforms and looking to deliver added value in offerings that stretch wider than traditional bioanalytical support models. Obviously, they will need to remain focused on quality, productivity and cost factors but innovative opportunities clearly exist.
The range of therapeutic agents being developed and researched is clearly much more diverse than in the past. Thus, bioanalytical requirements are now much less predictable. It is no longer the case that the only bioanalytical requirement is to quantify an exogenously dosed small molecule from fixed time point samples. Bioanalysis is now expected and required to cover a range of types of therapeutic agents which are much more diverse than have even been previously. Thus, to meet this diversity, new technology developments are currently and will continue to be made available. However, access to these new technologies and the expert resource required to manage and operate them are as likely to be held in contract organizations as in innovator organizations. Experienced resource with appropriate attributes and expertise is in significant demand.
I think mainly the cost. I think the CROs usually have a more efficient operation and we can sometimes do projects for different clients to save the cost. We are more efficient. I think that’s what will drive outsourcing for the pharma and even small start-up companies.
Current trends for the industry include expansion into new therapeutic areas, new biological targets to address high unmet medical need, as well as complex biologics and gene therapies. Outsourcing support will grow to fit these key areas of growth in the biopharma industry.