“Safety does not come with luck. It must be prepared” – Pharmacovigilance Report
Our latest industry analytics report features analysis on the drug safety sector within the life sciences industry.
Clinical Professionals Group CEO, Yvette Cleland comments:
“The global pharmacovigilance (PV) market size was estimated at $4.87 billion in 2019, according to a Global Market Insights report, by 2024 the market is predicted to exceed US$8 billion . Key drivers to the continued growth in PV is primarily based on increasing drug consumption and drug development rates, growing incidence rates of adverse drug reactions and drug toxicity, and increasing trend of outsourcing pharmacovigilance services.
In this area of life sciences, we see the presence of a competitive environment for introducing new molecules in the market. In turn this has led to an escalating demand for improved manufacturing operations, pharmacovigilance, clinical data management, streamlined R&D, and medical writing. Manufacturers now show a rapid and growing trend in outsourcing to curtail costs. Key to outsourcing is the internal resource flexibility with the potential to improve timelines and gain better outcomes in the short- and long-term. It can in addition impact better pharmacovigilance practices as it impacts regulatory compliance, higher quality, better productivity, and improved strategic decisions.
Our current report looks at the PV/drug safety “open vacancy” volume across Europe. Big pharma accounts for circa 69% of all PV vacancies across Europe, and 2018 versus 2019 data shows a growth of 18% in total in new live roles. If we look more deeply into the data, we find a significant increase in volume of vacancies in Biotech showing an 81% increase in requirements for PV/drug safety professionals over the same period (18/19). We believe this is simply based on the number of drugs moving from R&D to trial phases and we are seeing a continued impact with the greater analysis through AI within PV.
Potentially, ee are now in a scenario where AI could fill some of the gaps within PV services in terms of a greater ability to assimilate vast volumes of cloud-based data. The mapping of this data could effectively predict ADR’s. Real-world patient data and genetic information also feeding into this more streamlined approach could start the journey of PV being a more predictable science. In the continued industry drive to enhance operational efficiencies, quality and regulatory compliance integrated IT and technological; expertise becomes pivotal.
As the PV landscape continues to evolve, we are seeing regulatory authorities using more sophisticated tools to collect, characterise and evaluate data on AEs. There is an ever-growing need for Biopharma to implement ground-breaking PV programs and more efficiently manage the safety of drugs. As populations increase and we see the continued highly specialised therapies for unmet medical needs expand there is an expectation that the life sciences industry continues to drive the technology revolution. As expected, costs to drug development drive the requirement for automation to challenge the costs and complexities of clinical trials and minimise increasing expenditure whilst also allowing greater stakeholder collaboration in real-time. Robotic automation and AI technologies will open opportunities in reducing manual effort and the cost of safety case processing. Automation is vital if the costs and complexities of clinical trials are to be minimised.
Pharmacovigilance and Patient Safety ultimately aims to promote and protect the health and well-being of patients. The main focus for PV professionals and life science companies is to collect, assess and report adverse events (ADR’s) and to ensure the continual monitoring, interpretation and communication of product benefit-risk profiles to enable Signal Detection and Benefit-Risk Management. Artificial intelligence and upcoming technology offer great promise to address key challenges and in turn provide new opportunities relevant to the core aspects of Pharmacovigilance.”
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