Espicom's highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators. Specialised intelligence on OTCs, generics, biologics and biosimilars. Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series. A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel. The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis.

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The Pharmaceutical Market: Bulgaria
Published on March 2011
Report Summary
Espicom's highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a
user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:
Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators.
Specialised intelligence on OTCs, generics, biologics and biosimilars.
Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series.
A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel.
The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to
date with market and industry news on a regular basis.
Table of Content
Table of Contents
EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis 2
Snapshot: Key Data Projections3
MACROENVIRONMENT 4
POLITICAL 4
ECONOMIC5
Projections 5
LEGAL 6
EU Patent Protection & Intellectual Property Rights 6
Proposal for Unitary Patent 6
Patent Settlements 6
National Patent Protection & Intellectual Property Rights 6
Supplementary Protection Certificates 7
Data Exclusivity 7
DEMOGRAPHIC 7
Projections 7
Demographic Indicators 8
Births 8
Deaths 8
Infant Deaths 8
Life Expectancy at Birth 8
EPIDEMIOLOGY 9
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DISEASE BURDEN 9
Leading Causes of Death 9
DISEASE PREVALENCE 10
Communicable Diseases 10
HIV/AIDS 11
Non-Communicable Diseases 11
HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 12
EU DIRECTIVE12
Cross-Border Healthcare Directive 12
ORGANISATION 12
EXPENDITURE 13
Projections 13
Social Security14
INFRASTRUCTURE 14
Hospital Infrastructure 14
Ambulatory Infrastructure 15
SERVICES 16
Hospital Inpatient Services 16
WORKFORCE 17
Projections 17
Medical Personnel 18
REGULATORY AFFAIRS 19
EU REGULATORY AUTHORITY 19
NATIONAL AUTHORITY 19
MARKETING REGISTRATION 19
EU Regulation19
Centralised Procedure 19
National Regulation 20
Clinical Trials 20
Post-Market Surveillance 21
GMP 21
PROMOTION 21
Advertising 21
PRICING & REIMBURSEMENT 22
EU NETWORKING MEETING 22
NM CAPR 22
PRICING 22
REIMBURSEMENT 23
Health Sector Debts to be Passed on to Patients 23
DISTRIBUTION CHANNELS 24
DRUG WHOLESALING 24
Leading Wholesalers 24
Commercial League 24
Higia AD 24
Kaliman RT 24
Phoenix-Libra 24
Sopharma Trading 24
Sting 25
DRUG RETAILING 25
MARKET ANALYSIS 26
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SIZE 26
Projections 26
Historical Figures 27
Current Structure 28
PRODUCT DEVELOPMENT 32
EU IMI 32
National Product Development 32
MANUFACTURING 32
TRADE33
Exports 33
Imports 35
Balance of Trade 39
COMPETITION 40
TRADE ASSOCIATION 40
ARPharM40
TRADE FAIRS 40
Medicus, Dento & Galenia40
COMPANY INTELLIGENCE 41
Foreign Producers 41
Actavis (formerly Balkanpharma) 41
Local Producers 42
Bul Bio - National Centre of Infectious & Parasitic Diseases (BB-NCIPD) 42
Sopharma 42
OTC PHARMACEUTICALS 44
REGULATION 44
MARKET SIZE 44
GENERIC PHARMACEUTICALS 45
REGULATION 45
EU Marketing Registration 45
MARKET SIZE 45
COMPETITION 45
Trade Association45
BGPharmA 45
BIOLOGICS & BIOSIMILARS 46
REGULATION 46
EU Approval Process 46
EU Regulation of Biosimilars 46
EMA Guideline Documents 47
Biosimilar mAb Guideline 47
COMPETITION 47
CONCLUSIONS: OPPORTUNITIES & CHALLENGES 48
Strategic Espicom Analysis 48
MACROENVIRONMENT 48
EPIDEMIOLOGY 48
HEALTHCARE 48
REGULATORY AFFAIRS 49
PRICING & REIMBURSEMENT49
DISTRIBUTION CHANNELS 50
MARKET 50
COMPETITION 50
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OTC PHARMACEUTICALS 51
GENERIC PHARMACEUTICALS 51
BIOLOGICS & BIOSIMILARS 51
Radar Analysis 53
SWOT Analysis 53
DIRECTORY 54
GOVERNMENT ORGANISATIONS 54
PHARMACEUTICAL PRODUCERS 54
Foreign Pharmaceutical Producers 54
Local Pharmaceutical Producers54
TRADE ORGANISATIONS 54
List of Tables
Espicom Analysis of the Pharmaceutical Market, 2011 2
Key Data Projections, 2011-2016 3
Political Landscape, 2011 4
Regional Comparison of Projected Economies, 2016 5
Projected Economy, 2011-2016 5
Regional Comparison of Projected Demographics, 2016 7
Projected Demographics, 2011-2016 8
Demographic Indicators, 2001-2008 8
Leading Causes of Death, 2005-2008 9
Infectious Diseases, 2001-2006 10
Reported Cases of HIV/AIDS, 2002-2009 11
Registered Cases of Malignant Neoplasms, 1998-2006 11
Regional Comparison of Projected Health Expenditure, 2016 13
Projected Health Expenditure, 2011-201613
Hospitals by Type, 2001-2008 14
Hospital Beds by Type, 2001-2008 15
Outpatient Facilities by Type, 2003-200815
Outpatient Bed Capacity by Type, 2003-2008 16
Hospital Activity Trends, 2000-2006 16
Regional Comparison of Projected Physicians, 2016 17
Projected Physicians, 2011-2016 17
Public Physicians & Nurses, 2000-2008 18
Pharmacies by Type, 2007-2009 25
Regional Comparison of Projected Pharmaceutical Markets, 2016 26
Projected Pharmaceutical Market, 2011-2016 27
Historical Pharmaceutical Market at Retail Prices, 1995-2010 27
Drug Consumption by Value and Volume, 2009 28
Top-Ten Drugs by Volume, 2009 29
Top-Ten Drugs by Value, 2009 29
Top-Ten Prescription Drugs by Volume, 2009 29
Top-Ten Prescription Drugs by Value, 2009 30
Top-Ten Non-Prescription Drugs by Volume, 2009 30
Top-Ten Non-Prescription Drugs by Value, 200930
Leading ATC Groups by Volume, 2009 31
Leading ATC Groups by Value, 2009 31
Pharmaceutical Exports by Category, 2005-2009 (US$000s) 34
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Pharmaceutical Exports by Country/Region, 2009 (US$000s) 34
Pharmaceutical Imports by Category, 2005-2009 (US$000s) 36
Imports of Raw Materials by Country/Region, 2009 (US$000s) 37
Imports of Antisera & Vaccines by Country/Region, 2009 (US$000s) 37
Imports of Medicaments by Country/Region, 2009 (US$000s) 38
Balance of Pharmaceutical Trade, 2005-2009 (US$000s) 39
Members of ARPharM, 2010 40
Sopharma Financial Data, 2001-2009 (Thousand Leva) 42
OTC Market, 2006-2009 (Million Euros) 44
Members of BGPharmA, 2010 45
Espicom Analysis of the Pharmaceutical Market, 2011 52
SWOT Analysis of the Pharmaceutical Market, 2011 53
List of Charts
Regional Comparison of Top 7-14 Projected Pharmaceutical Markets at Retail Prices, 2016 26
Historical Pharmaceutical Market at Retail Prices, 1995-2010 28
Pharmaceutical Exports, 1997-2009 (US$ Millions) 33
Change in Pharmaceutical Exports, 1998-2009 (%) 33
Pharmaceutical Imports, 1997-2009 (US$ Millions) 35
Change in Pharmaceutical Imports, 1998-2009 (%) 35
Pharmaceutical Imports by Country/Region, 2009 (%) 36
Pharmaceutical Balance of Trade, 1997-2009 (US$000s) 39
Radar Graph of the Pharmaceutical Market, 2011 53
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