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desirable bioactivity; organisms containing novel molecules may not be culturable in the lab; even if culturable organisms may produce different molecules each batch that is grown; molecules may be too complex for chemical synthesis; genes may be isolatable but not expressed on transfer to a common industrial system; successful production of target materials is not replicable when culture is scaled-up. The risks here are cumulative, to the extent that end-users in industry may not see the opportunities in Blue Biotechnology. Small and medium sized enterprises (SMEs), whether facilitators or validators, need to be able to address this to enhance attractiveness for end-user investment. Metagenomic techniques are currently seen as one of the major breakthroughs for screening organisms and biological material and allowing identification of new molecules in this process. Quite often certain organisms are targeted for study if there is reason to believe they will produce the type of molecules that are being searched for, such as:  Pharmaceutical companies tend to target fixed organisms (shellfish, corals, tunicates, sponges etc.) that rely on chemical responses to combat other species to grow on them. Molecules discovered may limit cell multiplication, which could be used to combat cancer and as antibiotics;  Chemical companies looking for antifouling solutions would follow the same approach as pharmaceuticals companies as they are searching for the same type of effect: blocking organisms growth processes;  Bacteria producing biofilms that could be of interest for the pharmaceutical or plastics industry are usually found in extreme environment (extreme temperatures, high salinity etc.). 2.1.2 Closing the marine biotechnology loop: the ‘blue’ application of marine biotechnology' Marine biotechnology is beginning to play an increasingly important role in the protection and management of the marine environment. The use of marine biotechnology products and services in the marine environment can be thought of as ‘closing the loop, in the field of marine biotechnology (as presented in Figure 1.1). There are a range of potential marine biotechnology applications in the marine environment, including biofouling control, environmental monitoring, marine habitat restoration, bioremediation and natural resource and environment management13. While the majority of marine biotechnology applications in the marine environment are in their infancy, and activity is very much in the research and development phase, there is huge potential for products that can be used to improve the environmental health of the oceans thereby supporting marine ecosystem services. 2.2 Overall size and structure of the Blue Biotechnology sector 2.2.1 Size Although the term “Blue Biotechnology” has been on top of political agendas for some years the lack of an official or commonly agreed definition of what the Blue Biotechnology sector is creates challenges in quantifying the extent of the sector. Without a unique entity in national or international statistics, interpretations of its boundaries and overall size vary. This creates difficulties in assessing the size and structure as well as socio-economic performance (as is discussed in Section 3.1.4). Despite this, it is worth trying to look at orders of magnitude of value of Blue Biotechnology as a guide to prioritising future investments and policy initiatives. Annex 2 provides a detailed approach towards valuing the Blue Biotechnology sector in Europe. 13 e.g. Giuliano L, Barbier M Eds. (2012) New Partnerships for Blue biotechnology Development CIESM Marine Policy Series 1 June 2012, CIESM Monaco ISSN 2306-4897 Study in support of Impact Assessment work on Blue Biotechnology 7

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