Summary
Ongoing consolidation of the generics industry and entry of major pharma companies in the generics space is changing the competitive landscape. This highlights the need for effective strategies for the introduction of new generics products.
Generics Launch Strategies in the EU: The impact of IP variations and national market acceptance
This report analyzes the key issues that influence the options for successfully launching new generics products in Europe, including the constraints on the freedom to operate in seeking approval of new generics, and the markedly different reimbursement and market environments. It also assesses the major players, and identifies opportunities for generics and biosimilars products.
Scope of this research
- Compare and assess different strategic options to enter specific markets or therapy areas.
- Understand the impact of recent legislative and reimbursment changes on the approval process for generics.
- Identify market opportunities by assessing the size of European generic markets and their potential for new generic products.
- Evaluate the difference between generics and biosimilars and the opportunities that each presents.
- Identify impending product specific generic opportunities in Europe over the medium term.
Research and analysis highlights
There are sustained opportunities for generics producers to launch generics in Europe in the period 2010 to 2020, although in the medium term there may be a slight hiatus, in 2014-2015, where the opportunities for new generics are rather more limited than in most other years. These opportunities include many top selling drugs, such as clopidogrel.
It is clearly preferable to develop generic formulations of mass market drugs for marketing across Europe, as patent and market exclusivities expire, such a strategy is less appropriate for smaller companies. Their commercial interests are likely to be better served by trying to target selected markets.
Minimizing costs, and especially the cost of goods (i.e. the API and finished formulations) is critical in Europe. While it only impacts upon profitability in markets such as France, where there is no price competition, it is critical to success in key markets where tendering is significant (e.g. Germany and the Netherlands).
Key reasons to purchase this research
- Which markets offer the best prospects for generic launches in Europe?
- What major generic opportunities are available?
- How high are the entry barriers to the launch of biosimilars?
- Is it better to seek national or central (EU) approval for a new generic?
- Are there good opportunities for new market entrants?
