Pharmacovigilance Services

Global Market Outlook on Pharmacovigilance Services

• CAGR growth rate: 11.5-13 percent between 2018 to 2023
• 2020 (E) Market Value: ~ $5.3 Billion

The major driver for case processing is stringent regulations and rising incidence rates of adverse drug reactions. Adverse drug reactions are causing over 100,000 death globally and awareness among public and demand for safe medication is on the rise

• Demand for case processing is increasing as the cost of the service in-house is relatively greater and also there has been a steady rise in the number of adverse events being reported

• Companies are outsourcing most of phase IV and post-marketing case processing segments to capture adverse events from various sources

• Regulations vary from region to region and the current trend is harmonization of these across the globe. Hence, local sourcing in areas where the company focuses is a must

Current Trends

Increased emphasis on drug safety and faster submissions for regulatory approval are among the key drivers for the need for innovation in the pharmacovigilance space. Greater dependency is seen on pharmacovigilance tools and software to improve process and drive value for better vigilance.

Global Pharmacovigilance Market: Drivers and Constraints

Drivers 

Rising Inclination Toward Outsourcing

Pharmacovigilance service providers are rapidly turning to outsourcing as a feasible cost-cutting technique. Outsourcing helps improve timelines, boost internal resource fluidity, and ensure enhanced outcomes in the short and long haul. Also, it helps accomplish better pharmacovigilance via regulatory adherence, better efficacy, enhanced quality, and improved decision-making.

Supportive Government Efforts

Governments across the globe are rigorously working toward improving the management of pharmacovigilance approaches. Case in point, DIA has organized a conference highlighting the drug safety and risk tactics involved in pharmacovigilance. 

Moreover, the European Medicines Agency (EMA) has taken the initiative for patient registries to promote the setup of new registries and ensure better usage of the current ones. Such initiatives are expected to drive the pharmacovigilance market revenue over the projection time frame. 

Constraints

Lack of worldwide regulatory harmonization, high risks related to data privacy and security, and insufficient data standardization for adverse events are hampering the growth of the global pharmacovigilance market.

Global Harmonization

Regulatory bodies, including FDA, EMA and PMDA are adopting ICH E2B R3 standards for electronic reporting to allow easy and reliable transmission of safety data across borders. Various challenges involved are meeting patient privacy requisites, and rules required to enable data sharing

Innovation

Automated tools are being developed, which include artificial intelligence (AI), machine learning (ML), and others, to examine closely online networks, social media, literature, and other data sources to signal potential adverse events.

Integration- Services Providers and Clients

Increased outsourcing in terms of pharmacovigilance requires constant overview from the buyers. Currently, with the increased adoption of automated platforms, it is best to integrate with the vendors to have transparency and efficiencies.

End-to-End Tracking

Such tracking will help in data standardization (through analytics) to obtain overall signal management with data integration and rationalization from multiple sources.

Acquisitions to expand capability

Acquisition of Chiltren by Labcorp, Shin Nippon Biomedical Laboratories Ltd. by PPD are examples to prove that, major service vendors are expanding their services to cater to the developing need across geographies

Supportive Technologies Adopted by Suppliers

Buyers usually enjoy the privilege of the technology developed and adopted by the suppliers. So choosing the right vendor to engage is essential to obtain cost savings and timeliness in case reporting

Big players in PV case processing have already adapted to automation, meanwhile smaller players have either not adopted or are in process of making this shift

Outsourcing Models Followed by Peers

Pharma companies should prefer engaging with local suppliers with large research centers to develop and monitor trials to gain regulatory approval in those geographies. In the absence of a local office in certain countries, pharmaceutical companies typically engage with large western CROs to manage regulatory services in these regions.

Why You Should Buy This Report

The report on the pharmacovigilance market trends provides the industry overview of different geographies, including North America, Latin America, APAC, Europe, and the Middle East. The research study underlines the key drivers and constraints that affect the global pharmacovigilance market forecast and offers Porter's Five Force Analysis for developed and emerging regions. It discusses the best acquisition and innovation practices and the primary factors for successful sourcing. Furthermore, it elucidates the key performance indicators (KPI) with pricing structure assessment in the global pharmacovigilance market.

Methodology for Writing This Report

Beroe gathers intelligence through primary sources that include industry experts, researchers, and consultants, as well as current suppliers, producers, and distributors. Secondary sources can include business journals, newsletters, magazines, market research data, company sources, and industry associations. Following data collation, analysis, and strategic review, the Final Research Report is published on Beroe LiVE.

FAQs

• What is the global pharmacovigilance market outlook as mentioned by Beroe?
  The global pharmacovigilance market generated revenue of around $5.3 Bn in 2020. As per the industry report, the market value is anticipated to grow at a CAGR of 11.5-13% during 2018-2023.
• What are the key technologies that are used in the global pharmacovigilance market?
  Pharmacovigilance providers are leveraging automated tools based on machine learning (ML), artificial intelligence (AI), and others, to closely analyze social media, online networks, literatures, and other information sources to indicate possible adverse occurrences. In addition, they are using end-to-end tracking in data standardization (via analytics) to gather comprehensive signal management with data rationalization and integration from several sources.
• What are the key drivers behind the growth of the pharmacovigilance market? 
  The major driver for the pharmacovigilance market is the uptight regulatory framework and increasing cases of severe drug reactions. Moreover, a greater focus on drug safety and faster submissions for regulatory authorizations are fueling the need for innovation. 
• What outsourcing models are players in the pharmacovigilance market following?
  Pharmacovigilance service providers are engaging with domestic suppliers with large-scale research centers to set up and track trials to obtain regulatory approval in those regions. Amid the absence of a domestic branch in certain regions, market players generally engage with established western CROs to handle regulatory services in these countries.