Industry Trend Analysis - Regional Themes - FEB 2018
BMI View : Drugmakers in Europe will need to continue to assess their business strategies, R&D focus and product portfolios. Despite the growing demand for and consumption of high-value medicines in the region, drugmakers will face significant challenges in 2018 due to the relocalisation of the EMA. This may result in approvals delays and regulatory uncertainty; however , drugmakers will seek to attenuate these risks through greater collaborations with other industry stakeholders.
Despite the increasingly tough regulatory challenges facing drugmakers in Western Europe, the region will remain integral to the commercial prospects of multinational pharmaceutical firms. The predominant driver of increasing pharmaceutical and healthcare expenditure is the region's growing pensionable population. In particular, the rising incidence of chronic conditions amongst a population with a strong bias towards branded drugs will continue to boost healthcare spending. Nevertheless, cost containment remains high on the agenda of all governments and efficiency measures will weigh on market growth - particularly within Western Europe. In 2018, concerns over the business continuity of the European Medicines Agency (EMA) will come to the fore, creating significant challenges for drugmakers.
In 2017, one of the biggest issues facing the European pharmaceutical industry following the UK's decision to leave the EU was the future location of the EMA. In early November 2017, after months of consultations, it was announced that the EMA will relocate to Amsterdam in the Netherlands. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. It is our view that in 2018, there will be increased dialogue between the EMA and different stakeholders, including drugmakers, patient groups and national regulatory bodies, to ensure that the Agency can continue to deliver on its mission and protect public and animal health after the UK leaves the EU.
|2018: Increased Scrutiny On EMA Operations|
|The EMA's Mission|
|Source: EMA, BMI|