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Biotechnology to Germany

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(Last updated: 25 Jan 2008)

Trends and opportunities

The market

With more than 600 companies involved in biotech activities, Germany is one of the leading countries for biotech in Europe. Approximately 350 of these companies are considered core biotech companies. They represent roughly 19 per cent of European core biotechs.

In 2004, these 350 companies achieved combined sales of more than €1 billion which represents roughly 10 per cent of European biotech sales. German investments in R&D were €860 million – 14 per cent of European biotech R&D spending.

More than 80 per cent of all German biotechs are small and medium enterprises and have 50 or fewer employees. Only seven per cent employ more than 100 people. All in all, more than one-third of the European biotech employees are working in Germany (11,500 people).

Most German biotechs are organised in one of the 25 biotech clusters (BioRegios) with the highest biotech concentration in the state of Bavaria, Baden-Württemberg, Nordrhein-Westfalen, and Berlin/Brandenburg.

Key activities of German biotech firms are in the fields of therapeutics, platform technologies, diagnostics, bioinformatics and proteomics. Therapeutics research is heavily dominated by oncology, followed by infectious diseases and cardiovascular.

Funding of biotech companies remains strong – in fact, 40 per cent of all European biotech venture capital is invested in Germany.

Germany ranks second after the US in terms of patents for pharmaceuticals that have a biotech link.

Biotech is rapidly gaining momentum in Germany – in fact, experts believe that 30 per cent of the economy will somehow depend on biotech by 2015.

Leading companies in Germany and Switzerland include:

  • Boehringer Ingelheim
  • Bayer Healthcare
  • Merck KGaA
  • Merz
  • Novartis
  • Roche
  • Sanofi-Aventis

German biotechnology attracts the most venture capital funding in Europe, according to Ernst & Young - 40 per cent, twice as much as the UK, of Europe’s funding is won by German companies. The finance market has reacted positively to the establishments of new biotechnology companies. Money for growing biotechnology companies are also available from strong financing partners, however, there is room for improvements.


On the Frankfurt Stock exchange there is now the possibility for hi-tech knowledge companies to register in a special segment called 'der neuer Markt'. Hard requirements have to be filled in order to be allowed to list a company in this segment which guarantees high quality. Around 20 biotechnology companies are traded on der neuer Markt today.


Germany is a world leader in pharmaceuticals. Many of the companies have research subsidiaries in Australia. German companies in Australia include:

(Sources: Initiative Europe, BNP Paribas Biotech report,  Ernst & Young Lenoir report, OECD Science and Industry Scoreboard.)


In Europe and Australia, R&D collaborations dominate the biotechnology industry. Compare this to the USA, where commercial deals involving late-stage products are the preferred strategy. The European market is still in a development phase and therefore less competitive and more open to international collaborations than the US market. These collaborations would offer the Australian industry access to a critical mass and facilitate access to venture capital.


Germany has a strong pharma industry that needs to expand providing the Australian biotechnology industry with licensing opportunities or selling of research projects. Oncology is the dominant recipient of research and the future looks bright for companies within genomics, proteomics and bioinformatics as these services are in high demand.


Many of the large German biotechnology and pharmaceutical companies have invested in Australia, increasing the potential for further internationalisation. The German Government has been supporting the biotechnology  industry since 1996 with significant funding programs. Programs include Bioprofile, BioRegio, Biofuture, Biochance to name just a few.

Opportunities

Opportunities for Australian exporters exist in the following areas:

  • German companies conducting clinical trials (especially within oncology).
  • Import of marine and plant organisms for pharmaceutical manufacturing.
  • Licensing agreements between German pharma and biotech companies/research institutions.
  • Research collaborations/strategic alliances between biotech companies (focus on Australian cutting-edge areas such as genomics, proteomics and bioinformatics).

(Sources: Ernst & Young, Mergent, Information Secretariat for Biotechnology, Deutsche Bank)

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Tariffs, regulations and customs

Biotechnology cuts across many legislative areas, and there is no single pan-European law covering the sector. It is important to obtain advice at an early stage. Austrade Frankfurt can provide advice and referrals to industry specialists in Germany and across Europe.

Industry standards

All European Union (EU) countries are covered by a harmonised trade system. Common Customs Tariff (CCT) is applicable to goods from non-EU countries, including Australia. Goods travelling between EU member states are free of customs duty. VAT is payable on the duty paid price dependent upon the product concerned.


Import licenses may be required and you may need an export certificate from Australia.


Certain products will need to comply with pan-European and German legislation for medical devices, medicines, foods and ingredients.


There are also local variations in legislation, packaging and labelling that need careful consideration before shipping samples or final products.


German Federal Customs Administration
Customs Information Center
Hansaallee 141
60320 Frankfurt am Main
Germany
Tel: (49 69) 4699 7600
Fax: (49 69) 4699 7699
Email: info@zoll-infocenter.de

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Marketing your products and services

Market entry

The main methods of market entry for biotechnology companies looking at Germany and wider to Europe are:

Supplying a European company

The traditional market entry strategy, and a good option to consider for companies with products that can be easily combined by European end users. Pharmaceutical companies are likely to be a major end-user.  You can develop relationships with these companies via :

  • licensing
  • sales
  • contracting
  • R&D services

Collaboration


Working with European biotechnology/pharma companies and research institutions, often in the development phase. These relationships can take the form of:

  • joint ventures
  • acquisitions
  • in-licensing and out-licensing
  • co-development (platform development through to product pipeline)
  • co-marketing

Investment

In order to gain access to venture capital funding or research collaborations it may be necessary to invest in Europe. This could take the form of setting up a branch of your company overseas, or acquiring a suitable European company.

Clinical trials

It can be advantageous to run clinical trials in Europe, rather than in the USA or Australia.  Some of the benefits are:

  • The Mutual Recognition Procedure means that trials conducted in one EU country using the MRP become approved in all European Union member states.
  • In many European countries trials are cheaper to run than in the USA.
  • Working with European scientists on a trial builds your credibility and network.
  • As the trial process is often quicker in Europe, you can start generating revenue faster.
  • Media coverage is easier to generate if you are in the market.
  • A collaboration partner can help the approvals process with the European authorities.
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Links and industry contacts

Biotechnology–related resources

Association of German Biotechnology Companies (DECHEMA) – www.dechema.de/Biotechnology-lang-en.html
German biotechnology companies – www.biosme.de
German biotechnology clusters – www.bioregio.com
German industry association for biotechnology – www.vci.de
Biotech cluster Bavaria – www.lifescience-bavaria.de
Biotech cluster Munich – www.bio-m.de/web/index.php4?lg=en
European Federation of Biotechnology – www.efb-central.org/

Biotechnology and pharmaceutical companies

Bayer – www.bayer.com.au
Biofrontera – www.biofrontera.com
Boehringer Ingelheim – www.boehringer-ingelheim.com
Degussa – www.degussa.com.au
Eppendorf – www.eppendorf.com.au
GPC Biotech – www.gpc-biotech.com/en/index.html
Lion BioScience – www.lionbioscience.com
Medigene – www.medigene.de
Merck – www.merck.com.au
Mihopharm – www.mihopharm.com.au
Morphosys – www.morphosys.de
Schering – www.schering-plough.com.au

Government, business and trade resources for Germany

Federal Institute for Drugs and Devices – www.bfarm.de/en/index.php
German Ministry of Economics and Technology (BMWi) – www.bmwa.bund.de/Navigation/Service/english.html
German Commission for Foreign Investment – www.foreign-investment.de
German Customs Administration – www.zoll-d.de/english_version/index.html
The European Agency for the evaluation of Medicinal Products – www.emea.eu.int/
Bavaria’s investment agency – www.invest-in-bavaria.com

Media

The industry magazine for German is Itranscript (only available in German). In addition most of the biotechnology clusters have their own newsletter often with news in English.

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Contact details

The Australian Trade Commission (Austrade) is the Australian Government’s trade and investment development agency, operating as a statutory agency within the Foreign Affairs and Trade portfolio.

Austrade assists Australian businesses contribute to national prosperity by succeeding in trade and investment, internationally, and promoting and supporting productive foreign investment into Australia.

Austrade:

  • Delivers services that assist Australian businesses initiate, sustain and grow trade and outward investment.
  • Promotes Australia as an inward investment destination and, with the States and Territories, supports the inflow of productive foreign direct investment.
  • Administers the Export Market Development Grants scheme.
  • Undertakes initiatives designed to improve community awareness of, and commitment to, international trade and investment.
  • Provides advice to the Australian Government on its trade and investment development activities.
  • Delivers consular, passport and other government services in designated overseas locations.

A list of Austrade offices (in alphabetical order of country) is available.

More information

For further information please contact Austrade on 13 28 78 or email info@austrade.gov.au

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