SMEs in Europe

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</a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/we-wont-rest/patient-stories/" class="navigation--link no-popup " data-id="12213"> <div class=" navigation__link-container"> <i class="navigation__icon icon-speech"></i> <span>Patient stories</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=11228" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Alzheimer's patient story</span> </div> </a> </li> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=15647" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Blood cancer patient story</span> </div> </a> </li> <li> <a 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<li> <a href="https://efpia.eu/about-medicines/" class="subnavigation__header currentpage"> <i class="navigation__icon icon-loop"></i> <span>About medicines</span> </a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/development-of-medicines/" class="navigation--link no-popup currentpage" data-id="1081"> <div class=" navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Development of medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/animal-use-and-welfare/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Animal Use and Welfare</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/antimicrobial-resistance-amr/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Antimicrobial resistance (AMR)</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/digital-health/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Digital Health</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/intellectual-property/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Intellectual Property</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/precision-medicine/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Precision medicine</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/public-private-partnerships/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Public-private partnerships</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Regulations, safety & supply</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/smes-in-europe/" class="navigation--link currentpage"> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>SMEs in Europe</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/trade/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Trade</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/unmet-medical-need/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Unmet medical need</span> </div> </a> </li> </ul> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/use-of-medicines/" class="navigation--link no-popup " data-id="1082"> <div class=" navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Use of medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/hta-relative-efficacy-assessment/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>HTA & Relative Efficacy Assessment</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Disease-specific groups</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Healthcare Systems</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/value-of-medicines/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Value of medicines</span> </div> </a> </li> </ul> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/access-to-medicines/" class="navigation--link no-popup " data-id="16315"> <div class=" navigation__link-container"> <i class="navigation__icon icon-paper-plane"></i> <span>Access to medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/access-to-medicines/back-innovation-boost-access/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-paper-plane"></i> <span>Back Innovation, Boost Access</span> </div> </a> </li> </ul> </li> </ul> <ul class="subnavigation__list" id="submenu-16790"> <li> <a href="https://efpia.eu/more-than-medicine/" class="subnavigation__header "> <i class="navigation__icon icon-ma-compare"></i> <span>More Than Medicine</span> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/improving-health/" class="navigation--link no-popup " data-id="16650"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Improving Health</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/turning-science-into-new-medicines/" class="navigation--link no-popup " data-id="16651"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Turning science into new medicines</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/responsible-innovation/" class="navigation--link no-popup " data-id="16652"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Responsible Innovation</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/economic-impact/" class="navigation--link no-popup " data-id="16653"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Economic impact</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-17887"> <li> <a href="https://efpia.eu/pharmaceutical-legislation/" class="subnavigation__header "> <i class="navigation__icon icon-book-open"></i> <span>Pharmaceutical Legislation</span> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1077"> <li> <a href="https://efpia.eu/relationships-code/" class="subnavigation__header "> <i class="navigation__icon icon-notebook"></i> <span>Relationships & code</span> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/the-efpia-code/" class="navigation--link no-popup " data-id="13034"> <div class=" navigation__link-container"> <i class="navigation__icon icon-notebook"></i> <span>The EFPIA Code</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/patient-organisations/" class="navigation--link no-popup " data-id="1089"> <div class=" navigation__link-container"> <i class="navigation__icon icon-people"></i> <span>Patient organisations</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/healthcare-professionals-hcps/" class="navigation--link no-popup " data-id="1080"> <div class=" navigation__link-container"> <i class="navigation__icon icon-book-open"></i> <span>Healthcare professionals (HCPs)</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/disclosure-of-payments/" class="navigation--link no-popup " data-id="10735"> <div class=" navigation__link-container"> <i class="navigation__icon icon-user"></i> <span>Disclosure of payments</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/national-codes/" class="navigation--link no-popup " data-id="1093"> <div class=" navigation__link-container"> <i class="navigation__icon icon-globe-alt"></i> <span>National codes</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/eu-institutions/" class="navigation--link no-popup " data-id="1088"> <div class=" navigation__link-container"> <i class="navigation__icon icon-grid"></i> <span>EU institutions</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1076"> <li> <a href="https://efpia.eu/publications/" class="subnavigation__header "> <i class="navigation__icon icon-layers"></i> <span>Publications</span> </a> </li> <li class=""> <a href="https://efpia.eu/publications/data-center/" class="navigation--link no-popup " data-id="1123"> <div class=" navigation__link-container"> <i class="navigation__icon icon-pie-chart"></i> <span>Data center</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/publications/downloads/" class="navigation--link no-popup " data-id="6474"> <div class=" navigation__link-container"> <i class="navigation__icon icon-cloud-download"></i> <span>Downloads</span> </div> </a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/publications/cancer-comparator-report/" class="navigation--link no-popup " data-id="14162"> <div class=" navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Comparator Report</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/about/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>About</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/recommendations/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Recommendations</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-cases/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer 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</div> </div> </header> <div class="searchbar__mobile"> <form action="https://efpia.eu/search-results/"> <i class="material-icons searchbar__close">close</i> <input type="text" placeholder="" name="query" /> <span class="fa fa-search submit-search-mob"></span> </form> </div> <div class="content__section"> <header role="banner" style="background-image: url(/media/580568/biotech-sector.jpg?width=1200&amp;height=490); background-position: 50% 50%; " class=" " id="banner-image"> <div class="text__wrapper"> <div class="header__blurb"> <h2>SMEs in Europe</h2> <p>Biopharmaceutical SMEs and their role in the industry</p> </div> </div> </header>  <div class="video__modal"> <div class="video__modal-cell"> <div class="video__close"> <a href="#" class="icon-close"></a> </div> <div class="videoWrapper">  <iframe id="player" width="420" height="315" frameborder="0" allowfullscreen="allowfullscreen" mozallowfullscreen="mozallowfullscreen" msallowfullscreen="msallowfullscreen" 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href="http://www.linkedin.com/shareArticle?url=https://efpia.eu/about-medicines/development-of-medicines/smes-in-europe/&title=SMEs in Europe&source=https://efpia.eu/about-medicines/development-of-medicines/smes-in-europe/" class="section-navigation__nav-items__links--social" title="Share on LinkedIn" target="_blank"> <i class="fa fa-linkedin-square"></i> </a> </div> </div> </div> </nav> <section class="content__container content__container--no-padding-m"> <div class="umb-grid"> <div class="grid-section"> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-paragraph">Biopharmaceutical small and medium-sized enterprises (SMEs)* are <strong>key drivers of innovation</strong> in Europe. They play a major role in the development of new medicines, particularly in sectors that are under-served due to technological challenges or lower expected market potential, such as biological approaches, potential pandemics, infectious and rare diseases. For example, from all medicines from SMEs that were recommended for marketing authorisation between 2005-2015, 1 in 2 contained a new active substance and 42% of the medicines were for rare diseases[1]. Additionally, 81% of preclinical projects in the antibacterial pipeline are in SMEs. This huge added value that SMEs bring to the industry underlines the importance of their role and the need to create an ecosystem that supports this innovation[2].<br /></span></p> <p><span class="rte-paragraph"><strong>The SME ecosystem</strong></span></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <img src="/media/580563/screenshot-2020-12-10-at-174039.png" alt="SME funding sources"> <p class="caption">SME funding sources</p> </div> </div> <div class="col-md-6 column"> <div > <p><span class="rte-paragraph">SMEs with bright ideas and a strong team have a range of options when looking for early-stage investment. Grants, seed venture capital and loans support companies in their early stages of development. The challenges mount if the preclinical phase goes well. Early success brings a significant increase in the need for funding.<br /><br />The reason is simple: clinical trials are very costly and time-consuming, at a different level than start-ups and fast-growing small IT firms or green-tech companies. <br /></span></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <span class="rte-paragraph">The costs and timeframes for drug development are a turn-off for many investors. Very few European public or private investors are keen on investing more than €100 million in a company that might not have revenue for over a decade – and, like any innovative company, live with the risk of failure.</span> <img src="/media/580564/screenshot-2020-12-10-at-174627.png" alt="Source: DiMasi et al, Journal of Health Economics, January 2016"> <p class="caption">Source: DiMasi et al, Journal of Health Economics, January 2016</p> <p><span class="rte-paragraph">Companies typically look to venture capital or private equity support for this high-risk/high-reward investment. Other solutions – such as public listing, joint ventures and partnerships with larger pharmaceutical companies – are also an option. For European biopharmaceutical SMEs, the final phases of product development usually necessitate either making a deal with an established multinational firm or relocating to the US. Ultimately, few European SMEs bring their products to market alone.<br /><br /></span><span class="rte-paragraph">The gap between the early stages of product development, currently well supported, and reaching the market is often called the ‘valley of death’ – a chasm into which countless innovative firms are lost.</span></p> <p><span class="rte-paragraph"><strong>EFPIA SMEs’ proposal for an innovative funding in Europe</strong></span></p> <p><span class="rte-paragraph">To mitigate this gap, EFPIA SMEs are currently discussing a proposal addressed to the European Commission to develop financial instruments that would create new ways of risk-sharing and boost the size of venture capital funding. There is a need to create large specialised European life science guarantee funds composed of public and private investors such as the European Investment Bank, pension funds, insurance companies and banks. These investors could invest in all phases of the SME development from early stage to market launch. Such an innovative funding mechanism would help retain European innovative SMEs that go to the US to finance their development.<br /></span></p> <iframe src="https://player.acast.com/19-conversations/episodes/how-does-a-pharmaceutical-sme-function" frameborder="0" width="100%" height="110px" allow="autoplay"></iframe> <p><span class="rte-paragraph"><strong>A robust EU industrial and pharmaceutical strategy is important for SMEs</strong></span></p> <p><span class="rte-paragraph">Additionally, a robust EU <a href="/media/413646/eu-industrial-and-pharmaceutical-strategy-an-opportunity-to-drive-europe-s-health-and-growth.pdf" target="_blank">industrial and pharmaceutical strategy</a> must be at the heart of the European landscape that emerges from the pandemic. To make Europe an innovation hub, companies and investors need to see a stable regulatory system, a supportive intellectual property regime, access to market, and a strong research ecosystem.</span> </p> <iframe src="https://player.acast.com/19-conversations/episodes/how-can-we-keep-smes-in-europe" frameborder="0" width="100%" height="110px" allow="autoplay"></iframe> <span class="rte-heading">Why is intellectual property important for SMEs?</span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <div class="video-col-container"> <iframe frameborder="0" src="https://www.youtube.com/embed/kSGrxz0X6uQ"></iframe> </div> </div> </div> <div class="col-md-6 column"> <div > <div class="video-col-container"> <iframe frameborder="0" src="https://www.youtube.com/embed/fZsm87prtWM"></iframe> </div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div class="download-list__container"> <h2 class="section__header">EFPIA SMEs position on the EC SME Strategy</h2> <ul class="download-list__list"> <li class="download-list__item"> <a href="/media/580569/efpia-sme-group-s-position-paper-on-ec-sme-strategy-for-a-sustainable-and-digital-europe.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA SME Group’s position paper on EC SME Strategy - For a sustainable and digital Europe.pdf</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/580572/efpia-smes-position-paper-on-innovative-funding-for-biopharmaceutical-smes.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA SMEs’ position paper on innovative funding for biopharmaceutical SMEs</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> </ul> </div> <div class="article-list__container"> <ul class="article-list__list"> <li class="article-list__item"> <a href="/news-events/the-efpia-view/blog-articles/europe-s-covid-19-response-points-the-way-to-fighting-amr/"> <h4 class="article-list__title">Europe’s COVID-19 response points the way to fighting AMR</h4> <div class="article-list__description">Antimicrobial resistance: Perspectives from a pharmaceutical SME</div> <ul class="article-list__authors"> </ul> <div class="article-list__date">16.07.20</div> <div class="article-list__overlay"></div> <div class="article-list__readmore">Read Article</div> </a> </li> <li class="article-list__item"> <a href="/news-events/the-efpia-view/blog-articles/how-biotech-smes-adapted-to-covid-19-an-interview-with-minoryx-therapeutics/"> <h4 class="article-list__title">How biotech SMEs adapted to COVID-19: An interview with Minoryx Therapeutics</h4> <div class="article-list__description">As the pandemic threatened to disrupt key clinical trials, a small company responded swiftly to protect patients and keep rare diseases research on track</div> <ul class="article-list__authors"> </ul> <div class="article-list__date">16.07.20</div> <div class="article-list__overlay"></div> <div class="article-list__readmore">Read Article</div> </a> </li> </ul> </div> <p><span class="rte-paragraph">*Biopharmaceutical SMEs are enterprises focussed on the discovery and development of biopharmaceutical products for human healthcare, based on tools and approaches from modern biotechnology. They have a turnover of less than €50 million, and up to 250 employees. To find out more about the EFPIA SME members, click <a data-id="2376" href="/about-us/membership/" target="_blank" title="Membership">here</a>.</span></p> <p><span class="rte-paragraph Subheading"><br />Additional Resources</span></p> <ul> <li><span class="rte-paragraph"><a href="https://www.ema.europa.eu/en/documents/report/report-10th-anniversary-sme-initiative_en.pdf" target="_blank">EMA report on the 10<sup>th</sup> anniversary of the SME initiative</a></span></li> <li><span class="rte-paragraph"><a href="https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/biotech-in-europe-a-strong-foundation-for-growth-and-innovation" target="_blank">McKinsey 2019 report on Biotech in Europe: A strong foundation for growth and innovation</a></span></li> <li><span class="rte-paragraph"><a href="/media/24995/access-to-finance-and-barriers-to-growth-in-the-innovative-biopharmaceuticals-sector-may-2015.pdf" target="_blank">EFPIA study on the access to finance and barriers to growth in the innovative biopharmaceuticals sector</a></span></li> <li><span class="rte-paragraph"><a href="https://www.eib.org/attachments/pj/access_to_finance_conditions_for_life_sciences_r_d_en.pdf" target="_blank">European Investment Bank study on Financing the next wave of medical breakthroughs – What works and what needs fixing? </a></span></li> <li><span class="rte-paragraph"><a href="https://ec.europa.eu/growth/smes/sme-strategy/performance-review_en" target="_blank">EC annual report on European SMEs</a></span></li> <li><span class="rte-paragraph"><a href="https://ec.europa.eu/info/sites/info/files/communication-sme-strategy-march-2020_en.pdf" target="_blank">EC SME Strategy</a></span></li> </ul> <br />[1] <span>EMA, </span><span>REPORT ON THE 10TH ANNIVERSARY OF THE SME INITIATIVE, 2016<br />[2] THEURETZBACHER, U. 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