Why legislation, big data, and rising demands form crucial issues for pharmacovigilance – a new analysis explains

Monday 2 June 2014, Amsterdam

A new report, now available on ASDReports, predicts global spending on pharmacovigilance will reach $8.67 billion in 2014, with strong growth to 2024. That forecast and others appear in Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024, published in April 2014.

After drug safety concerns, the past five years have shown changes in safety monitoring of pharmaceuticals. That trend is set to continue, with new drug-approval legislation in the EU and US demanding more-rigorous and wide-ranging evaluation of benefit-risk balances. Also the emerging national markets have increasingly robust pharmacovigilance programmes that demand more resources from pharmaceutical companies. These factors will increase workloads and lead to a sustained growth in pharmacovigilance spending over the short, medium and long term. There will also be benefits to providers of equipment and services for pharmacovigilance, especially contract research organisations (CROs).

Jonathan Weymer, a healthcare industry analyst, said: “Pharmacovigilance is a process that is constantly evolving to deal with data companies and regulators collect on marketed drugs. New EU and US legislation changes that market and industry. With market authorisation holders managing and mitigating risk during all phases of a medicine’s lifecycle, we believe pharmacovigilance strategies are becoming more wide-ranging and robust, leading to increased spending on those operations.

“However, it isn’t just regulations that change pharmacovigilance. New technology and the ability to analyse huge datasets causes a structural shift in how regulators and pharma companies assess product safety. Informatics analysis of electronic health records will push the industry toward a “live model” of assessing drug safety. This approach will also help eliminate the under-reporting bias that exists for the current paradigm of sporadic report analysis. Data mining tools will also help companies navigate the landscape of social media to identify emerging drug safety issues. However, the currently uncertain guidance from regulators leaves that channel closed to many firms.

“Our research evaluates prospects for pharmacovigilance spending worldwide. In the established national markets a shift towards dynamic live monitoring will lead to increased spending. Also, emerging national markets are increasingly demanding robust drug safety monitoring in exchange for market access. We believe those advances will stimulate growth in pharmacovigilance spending worldwide through to 2024.”

The new study assesses pharmacovigilance spending forecasts to 2024 at overall world, regional, and national level. That investigation analyses pharmacovigilance markets, safety case volumes and regulations. It also forecasts that spending in the United States (US), the European Union (especially Germany, France, United Kingdom, Spain, and Italy), Japan, South Korea, the BRIC countries (Brazil, Russia, India and China), and the rest of the world (as a group).

Driving and restraining factors for pharmacovigilance spending are discussed, along with opportunities and threats to industry participants. The leading business process outsourcing firms, contract research organisations (CROs), and software providers are also profiled and analysed. Those companies include Accenture, Tata Consultancy Services, Quintiles and Cognizant. That work also shows interviews with three companies.

Pharmacovigilance and Related Developments: Industry and Market Analysis 2014-2024 adds to the reports on markets in the healthcare industries.