Description :

Growth in the Bulgarian pharmaceutical market will be negatively impacted by the recession that is forecast to hit the country in 2009 and 2010 although it is proving to be more resilient than other sectors. BMI forecasts that drug market expenditure in Bulgaria should grow from US$1.09bn to US$1.16bn between 2008 and 2013, a rise of 1.3% per year.

However, the health budget is being undermined by the economic difficulties facing the country, with the IMF predicting that the economy will shrink by 3.5% in 2009 and 1% in 2010. With government finances being stretched this year by the deterioration in tax collection and increased demand for fiscal stimulus, Bulgarian MPs warned the public that they may be forced to pay for medical services in hospitals. Though this will have little impact on the Bulgarian Socialist Party-led coalition government, which stands little chance of surviving the June parliamentary election, BMI cautions that the incoming government may face sharp criticism as a result of the reduction in medical provision. Indeed, this will further compound the burdensome legacy likely to be left by the Socialists, which also includes endemic organised crime and still-low living standards. These will be the key problems facing the new government, which will likely be formed by the centre-right Citizens for European Development of Bulgaria (GERB).

In March 2009, Ivan Kokalov, head of the health federation at the Confederation of Independent Trade Unions in Bulgaria (CITUB), stated that 40,000 more people are unable to pay social security contributions as a result of the global economic downturn. The National Health Insurance Fund (NHIF) has only collected BGN90mn (US$63.5mn) in January 2009 as the number of uninsured cases have increased to more than 1mn.

Bulgarian drugmaker Sopharma registered a 6% year-over-year (y-o-y) growth in sales for FY08. Sopharma’s exports were in line with its FY08 expectations. Revenues from the international markets grew by 14% y-o-y; however, the company witnessed a 6% decline in the domestic market. Sopharma exports products to Russia, the US, Latvia, Vietnam, Ukraine, Kazakhstan, the UK, Georgia, Serbia, Azerbaijan, Moldova, Germany, Mongolia, Albania, Singapore, India, Benin, Hungary, Poland and Armenia.

In BMI’s Pharmaceutical Business Environment Rankings for Q309, Bulgaria occupies a shared 12th place (out of 20) in Central and Eastern Europe (CEE) with its overall score falling due to the small size of the pharmaceutical market and growing problems with corruption.

Executive Summary ................7
Bulgaria Pharmaceuticals And Healthcare SWOT ... 8
Bulgaria Political SWOT.. 9
Bulgaria Economic SWOT 9
Bulgaria Business Environment SWOT................... 10
Pharmaceutical Business Environment Ratings ........11
Table: Pharmaceutical Business Environment Ratings............... 11
Limits Of Potential Returns................. 12
Risks To Realisation Of Returns ......... 12
Bulgaria – Market Summary.14
Regulatory Regime................15
Recent Regulatory Developments ....... 16
Intellectual Property Environment...... 17
Intellectual Property Deficiencies....... 18
Corruption And Counterfeit Drugs ..... 18
Pricing Regime ............... 19
Table: Wholesale Mark-Ups ............... 20
Table: Retail Mark-Ups .. 21
Reimbursement Regime... 21
Recent Pricing And Reimbursement Developments  22
Industry Developments.........24
Epidemiology.................. 24
Table: Main Causes Of Death In Bulgaria (per 100,000 population ............... 24
Table: Disease Burden In CEE........... 26
Healthcare Sector ........... 27
National Healthcare Plan................... 29
Healthcare Insurance ..... 31
Recent Healthcare Insurance Developments........... 32
Hospital Privatisation Programme ..... 34
Healthcare Information System........... 35
Introduction Of Patient E-Cards......... 36
Industry Forecast Scenario ...37
Overall Market Forecast. 37
Table: Pharmaceutical Market Indicators (US$mn unless otherwise stated)... 38
Key Growth Factors – Industry........... 39
Table: Health Expenditure Indicators. 41
Macroeconomic Forecast Scenario .... 42
Table: Bulgaria - Economic Activity... 44
Prescription Market Forecast ............. 45
Table: Prescription Market Indicators (BGNmn unless otherwise stated)....... 46
Patented Market Forecast................... 48
Table: Patented Market Indicators (US$mn unless otherwise stated).............. 48
Generics Market Forecast .................. 49
Table: Generics Market Indicators ..... 49
OTC Market Forecast..... 50
Table: OTC Market Indicators (US$mn unless otherwise stated) 51
Export/Import Market Forecasts......... 52
Table: Pharmaceutical Trade Indicators (US$mn). 53
Medical Device Forecast  54
Table: Classification Of Medical Devices In The EU ................. 54
Table: Bulgaria Medical Device Market Forecast.. 56
Other Healthcare Data Forecasts....... 57
Table: Other Healthcare Data Forecasts................ 57
Key Risks To BMI’s Forecast Scenario................... 58
Competitive Landscape........59
Local Pharmaceutical Industry........... 60
Foreign Pharmaceutical Industry ....... 61
Recent Industry Developments............ 61
Wholesale Sector ............ 63
Retail Sector ................... 64
Research And Development ................ 65
Clinical Trials................. 66
Company Monitor..................67
Foreign Companies.............. 67
GlaxoSmithKline............. 67
Novartis ...... 69
Sanofi-Aventis................. 70
Pfizer .......... 71
Merck & Co  72
Indigenous Companies......... 73
Actavis Bulgaria (formerly Balkanpharma)............ 73
Sopharma.... 76
Biovet.......... 80
Country Snapshot: Bulgaria Demographic Data ........82
Section 1: Population...... 82
Table: Demographic Indicators, 2005-2030........... 82
Table: Rural/Urban Breakdown, 2005-2030 .......... 83
Section 2: Education And Healthcare. 83
Table: Education, 2002-2005 ............. 83
Table: Vital Statistics, 2005-2030....... 83
Section 3: Labour Market And Spending Power ..... 84
Table: Employment Indicators, 2001-2006............. 84
Table: Consumer Expenditure, 2000-2012 (US$) ... 85
Table: Average Annual Wages, 2000-2012............. 85
BMI Forecast Modelling........86
How We Generate Our Pharmaceutical Industry Forecasts ....... 86
Pharmaceutical Business Environment Ratings Methodology ......... 87
Ratings Overview............ 87
Table: Pharmaceutical Business Environment Indicators .......... 88
Weighting.... 89
Table: Weighting Of Components....... 89
Sources ............ 89

List of Tables :

Table: Pharmaceutical Business Environment Ratings. 11

Table: Wholesale Mark-Ups . 20

Table: Retail Mark-Ups . 21

Table: Main Causes Of Death In Bulgaria (per 100,000 population . 24

Table: Disease Burden In CEE. 26

Table: Pharmaceutical Market Indicators (US$mn unless otherwise stated). 38

Table: Health Expenditure Indicators. 41

Table: Bulgaria - Economic Activity. 44

Table: Prescription Market Indicators (BGNmn unless otherwise stated). 46

Table: Patented Market Indicators (US$mn unless otherwise stated). 48

Table: Generics Market Indicators . 49

Table: OTC Market Indicators (US$mn unless otherwise stated). 51

Table: Pharmaceutical Trade Indicators (US$mn). 53

Table: Classification Of Medical Devices In The EU . 54

Table: Bulgaria Medical Device Market Forecast. 56

Table: Other Healthcare Data Forecasts. 57

Table: Demographic Indicators, 2005-2030. 82

Table: Rural/Urban Breakdown, 2005-2030 . 83

Table: Education, 2002-2005 . 83

Table: Vital Statistics, 2005-2030. 83

Table: Employment Indicators, 2001-2006. 84

Table: Consumer Expenditure, 2000-2012 (US$) . 85

Table: Average Annual Wages, 2000-2012. 85

Table: Pharmaceutical Business Environment Indicators . 88

Table: Weighting Of Components. 89