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Role of SMEs in the health sector Numerous start-up and small companies are concentrating their development on niche markets, in the health sector; with many of them being involved in early drug discovery (often funded by public third party money) or aiming for medical device products. A large proportion of these companies seem to be predominantly research laboratories spin-offs. Some data indicate that SMEs struggle to reach a certain critical mass for e.g. pre-clinical proof of concept and first clinical studies, making them less attractive for investment by large established companies of their sector. However, many SMEs are active in other sectors but feed an internal preclinical pipeline by the income from the other sectors. This income may be described in terms of money, but includes technical development as well. These parallel pipelines will be described in more detail in the final report. Businesses may access financial sources through various national funds in Europe at the initial stage. Especially SMEs benefit from such funding. Products and services offered currently and their future prospects The global marine pharmaceutical pipeline consisted of a limited number of substances. Seven marine drugs (Table 0.10 ) are on the market, however, only two of them are marketed by European companies: PharmaMar, Spain and Jazz Pharmaceuticals, Ireland. Prialt was the first European marine drug, approved in 2004. Pharmaceutical demand will be driven by an increasing ageing population, with age-related conditions to be treated: cancer, neurodegenerative disorders, and osteoporosis. Pain relief and antibiotic resistance are also two areas where marine molecules may be relevant151. Marine active molecules have already been identified for major conditions but they have to be adapted before entering the validation process to reach the pharmaceutical market. Medical applications can also been derived from marine polymers: they can be exploited as a new generation of degradable prosthesis allowing bones reconstruction but also as a new type of drug encapsulation. Driver and Barriers in the health sector The lack of interest by industry in natural products from all sources can be attributed to a number of common problems, some of which are perceived to present insurmountable obstacles. Some of these problems (taxonomy, variability, supply) are particularly acute for marine-derived compounds. Taking into account that marine biodiversity is still nearly unknown, the “pure” discovery part of the value chains remains large and depends on access to all kinds of marine resources including deep sea. In the same momentum, the sustainable supply of the raw material for further development after the initial discovery arises as an issue. Harvest of large amounts of marine organisms very often results in harm to the marine environment. Avoiding these impacts will be one of the premises for further development. 151 Schr der, T., 2010, World ocean review: Living with the oceans. Maribus: Hamburg, 232p Study in support of Impact Assessment work on Blue Biotechnology 123

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