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					HEALTH CARE MARKET



    EUROPE
                presented by
       Veronika Novakova
         HC Team Europe Liaison &
 Commercial Specialist, Prague, Czech Republic

         AACC Washington, July 2008
             WHAT IS EUROPE?

•   27 EU members
•   Candidate
    Countries:
    Croatia
    Turkey
    Macedonia
•   Other countries:
    Switzerland
    Norway, etc.
•   http://europa.eu
             MARKET SIZE


• Population: EU27 – 495 mln. inhabitants (+ Candidate
countries + Norway, Switzerland, Ukraine, etc.) versus USA -
304 mln. inhabitants, Europe market is about twice the size
• Economic output (GDP): EU27 – EUR10,957 bln. versus
USA – EUR10,012 bln.
•   HC market: Market no. 2 after US, Japan is third
• Europe: EU Single Market x Regional
Approach: Western Europe, Central Europe,
Eastern Europe, non-EU countries & former Soviet
Union countries
            EU LEGISLATION

• EU does not have FDA         the European Commission
works in cooperation with member state health authorities
• CE Mark
• Medical devices regulated under three directives:
1. The Medical Devices Directive (MDD) – all general medical
devices not covered by the other two directives.
2. Active Implantable Medical Devices (AIMD) - all active
devices and related accessories intended to be permanently
implanted in humans.
3. In Vitro Diagnostic Devices (IVDD) - all devices and kits
used away from the patient to make diagnosis.
           MEDICAL DEVICE


• Competitive market with a good potential
for innovative and state of art technologies
• Top three markets: 1. Germany - no. 3 in
the world, 6.9% of the world market ($12.9
bln.); 2. France ($7.14 bln.); 3. UK – high
price market ($4.9 bln.)
• Western Europe X Central & Eastern
Europe
                  MARKET STATISTICS I

EU Projected Medical Equipment Market in 2007-8 (in $, mln.)
Medical Equipment Category              2007       2008
Medical Supplies                        $437.8    $453.1
Medical X-ray Film                      $104.2    $107.9
Surgical Gloves                         $57.3      $59.3
Medical & Surgical Sterilizers          $26.1       $27
Wheelchairs                             $46.9      $48.5
Contact Lenses                          $125.1    $129.5
Medical Equipment                      $2,584.9   $2,675.4
Electro-medical Equipment               $594.1    $614.9
Syringes, Needles & Catheters           $656.7    $679.6
                   MARKET STATISTICS II


EU Projected Medical Equipment Market in 2007-8 (in $, mln.)

Medical Equipment Category                                        2007      2008
Dental Instruments & Appliances                                  $125.1    $129.5
Ophthalmic Instruments & Appliances                              $83.4      $86.3
Other Medical & Surgical Instruments                           $1,120.5    $1,159.7
Therapy Apparatus                                                $229.3    $237.3
Orthopaedic & Prosthetic Appliances                              $995.4    $1,030.2
Medical X-ray, Alpha, Beta, Gamma Ray Eq.                        $531.6    $550.2
Medical Furniture                                                $78.2      $80.9
Total                                                          $5,211.5    $5,393.9

Source: EpiscomBus Intelligence – 01 June 2005 (taken from Austrade PPP)
           DENTAL EQUIPMENT


• The Federation of the European Dental
Industry (FIDE) - www.fide-online.org
regulatory issues
• Number of dentists: problem in some CEE
• Estimated Market size: $129.5 mln.

• Best prospects: cosmetic dentistry, innovative products
and equipment
            PHARMACEUTICALS

• Europe 30% of world market x NA 47%
• The 12 states in CEE are an overall market of EUR11.8 bln.,
  less than 10% of the total pharmaceutical market of EU-15
  (EUR162.2 bln.); CEE growth 6% x EU15 2-3%
• Regulated market: balancing expenditures and patient health
  & treatment accessibility
• Reference pricing: used in many European countries
  transparency issues (EU Transparency Directive)
• Increasing level of private expenditures especially in Eastern
  Europe       OTC drugs, supermarket sales on rise
                  GENERICS




Source: EGA internal survey 2005
           SUPPLEMENTS

• Highly competitive market: rise in custom duties for
supplements from US after EU entry for new members
• European Union Food Directive: challenged at the EU court,
went into effect in August 2005; Annex of Directive 2002/46/EC
and its 2006 Amendment (2006/37/EC) list all vitamins &
minerals allowed on the EU market
http://ec.europa.eu/food/food/labellingnutrition/supplements/inde
x_en.htm
• Trends: CEE: self-medication (young generation), informed
customers, spending power on rise, growth in supplements
popularity, demand for consultation services
            IN VITRO DIAGNOSTICS

• IVD Expenditures out of
THE (2006):
EU 15 - 0.9% (i.e. €21.3 per
capita), New EU states - of
1.5% (i.e. €6.2 per capita) X
US -1.1% (i.e. €36.7 per
capita)
• EDMA: European
organization for national
associations of the in vitro
diagnostics industry
www.edma-ivd.be
           HEALTH CARE IT

• Growth of the market: expected at
around 7%; new EU countries offer
good potential as their private sector
expands
• Opportunities: national e-Health
initiatives - Germany's Health
Smartcard, the English NHS's
National Program for Information
Technology
• The European Commission's e-
Health initiative – voices for single
EU harmonized systems
          MARKET CHALLENGES




• Product Registration: all the products have to be
registered to sell in Europe –sometimes lengthy process
• Reimbursement: challenging problem especially in
pharmaceutical sector - calls for transparency
• Late payments: especially in case of hospitals, in some
cases delay in payment may be over 1 year (challenge for
distributor)
          OPPORTUNITIES


• World’s second largest market
• Demand for innovative US technologies – US products
considered high quality backed by extensive research
• EU Tender database
www.buyusa.gov/europeanunion/tender_search.html
• Financing
  US Trade and Development Agency (TDA) - www.ustda.gov
  US AID – www.usaid.gov
  EU Funds -
http://www.buyusa.gov/europeanunion/eu_funds.html
         CONTACTS


Ms. Veronika Novakova
Commercial Specialist
US Commercial Service, US Embassy
Trziste 15, 118 01 Praha 1, Czech Republic
Phone: +420 257 022 437, Fax: +420 257 022 810
E-mail: Veronika.Novakova@mail.doc.gov
www.buyusa.gov/czechrepublic
www.buyusa.gov/europe

				
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