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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
