Quality assurance is one of the major concerns hampering the growth of the life sciences BPO market. Life sciences BPO dealing with sensitive patient data and performing critical functions like clinical trials and drug discovery require highest level of accuracy and compliance. Any lapse in quality can put patients' health at risk and also invite huge penalties and litigations for companies. This heavy burden of ensuring top notch quality at every stage act as a deterrent for many pharma and biotech companies from outsourcing their core operations.
Maintaining quality standards across different global locations while managing a distributed workforce is challenging for BPO firms in this industry. These need to implement robust QA mechanisms and meticulous documentation practices to clear regular audits. This increases operational costs and reduces profit margins. In 2021, according to the report from United Nations, 50% of outsourced clinical trials from U.S. faced quality issues including protocol deviations, incomplete record maintenance and misreporting of adverse events. This has severely dented client confidence in outsourcing and driven more work back in-house.
The inherent risks associated make companies wary of relinquishing control of critical functions. Even a small error can lead to delays in drug launch, clinical trial failures or product recalls causing huge financial losses running into millions. This risk avoidance behaviour of pharma companies stagnates the reliance on external partners. Unless BPO players find innovative ways to strengthen quality oversight, assuage security concerns and ensure regulatory adherence at low costs, the life sciences BPO market might face suppressed growth rates compared to other sectors. Improving transparency through technological interventions and upskilling workforce on nuanced quality aspects can help allay many reservations holding back broader adoption of distributed manufacturing and R&D models.
Market Opportunities: New drug discovery & development
Global life sciences BPO market focusing on new drug discovery and development can offer growth opportunities. The process of drug development is very long, complex and capital intensive. It takes 10-15 years for a new drug molecule to be developed, tested and brought to market. The average cost of developing a new drug is estimated to be over US$ 2.6 billion, according to a report by Tufts Center for the Study of Drug Development. This has compelled many large pharmaceutical companies to look at outsourcing non-core activities to specialist CROs and CMOs to reduce costs and timelines. Drug discovery and clinical research are two phases where life sciences companies are deriving significant benefits from outsourcing. As per the analytics by the WHO, over 3,000 clinical trials were outsourced globally to CROs in 2021 across different therapeutic areas. CROs offer advantages of specialized expertise, dedicated facilities, flexible staffing models and geographical presence which can accelerate drug trials. Their advanced analytics capabilities also help pharmaceutical sponsors to identify the right drug candidates faster from the initial pool of molecules. On the discovery side, CROs maintain sophisticated libraries of chemical compounds and screening technologies that assist researchers in selecting lead molecules for development.
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