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SMEs – the driving force of pharma industry in European Union

SMEs – the driving force of pharma industry in European Union

Publish date: 2013-03-08

Recently, European Medicines Agency (EMA) has presented annual report from the SME office 2012 summering outcomes of 7 years of Small and Medium-Sized Enterprises (SMEs). According to it, in 2012, the number of companies assigned as SME status increased by 62% compared to previous year proving rapid development of this sector and as so are recognized as major driving force if innovation in the pharmaceutical industry.

Tags: pharma , europe , SMEs , EMA

What are SMEs?

First of all, it has to be noticed that definition of SMEs are different from country to country. European Commission unified the definition for EU member states defining three broad parameters:

  • Micro- entities with up to 10 employees,
  • Small companies employing up to 50 workers,
  • Medium-sized companies with up to 250 staff members.

Another criteria is the annual turnover not exceeding 50 million euro and an annual balance sheet total not exceeding 43 million euro. Anything larger than 250 employees or not
fulfilling above conditions is regarded to be a large enterprise.

What is the impact of SMEs in pharmaceutical industry?

The majority of registered companies are devoted to medicinal products for human use (over 75 %), around 5% of total share is represented by veterinary  companies, over 5% corresponds to enterprises developing in both products and remaining and remaining 15% are service providers. The size of 41% of registered companies in pharmaceutical industry is still micro-sized with less than 10 employees. The majority of SMEs in this sector are devoted to R&D stage. Second most abundant are academic spin-offs (13%).

How SMEs benefit from registration at EMA?

The main goal is to facilitate communication between SMEs to efficiently monitor their needs and organise workshops and training for them since their size is often limiting factor for rapid development by their own.

Among incentives offered to SMEs in pharmaceutical sectors several are of high importance. Especially administrative and procedural assistance is appreciated. Moreover, fee reductions for e.g. scientific advice, scientific services and inspections and inclusion in the public SME register are also crucial.


Even though, pharmaceutical industry is still recognized as dominated by enormous enterprises often referred as big-pharma the role of SMEs is finally appreciated and supported with number of government programmes. According to the annual report the tendency is growing, therefore, fuelling the innovative market of products in this sector.


By Jacek Plewka


Annual Report from the SME Office 2012



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