• Japanese
  • Korean
  • Chinese
Cover Image

Generic and innovative drugs market in Central Europe 2014.Comparative analysis, reimbursement policies and development forecasts for 2014-2018.

  • Published:
  • 324 Pages
  • PMR

This document reports on current conditions and future prospects in the markets for generic and innovative drugs in the Eastern European countries of Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria.

It presents data describing the current values of generic and innovative drugs segments in each country and analysis of the effects of regulation on the conduct of business in this market - specifically those pertaining to pricing, reimbursement processes, data exclusivity and patent expirations.

This publication also offers in-depth profiles of companies that participate in generic and innovative drug development and manufacturing in Central European markets and contains forecasts for market development from 2014-2018.

Bolster your market knowledge on a wide variety of topics

From reimbursement processes to market share of generic and innovative drugs, this report addresses a variety of important issues:

  • Segment value of generic drugs and innovative medicines from 2009-2014 in each of the six highlighted Central European countries
  • Size of the generic drugs segments in Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria, growth expectations to 2018
  • Innovative medicines segment - size and development forecasts for markets in each country from 2009-2018
  • Market share of each country's generic and innovative drug industry in relation to overall pharmaceutical sectors
  • Planned changes to the content of reimbursement lists in each country
  • Existing reimbursement processes in each of the six CE countries
  • Pricing rules for all types of generic and innovative medications, regardless of eligibility for reimbursement
  • Average drug mark ups and rates as governed by regulations
  • Medical professional and patient views on the use of generic drugs and innovative treatments
  • Upcoming modifications in store for the markets in each country
  • New alterations to medication reimbursement programs in each country
  • Significant recent changes and future forecasts for each country's reimbursement lists
  • Data exclusivity, patent expiration dates and SPCs (supplemental protection certificates) - roles in the generic and innovative drug markets in each country
  • The largest generic and innovative drug manufacturers operating in the Central European markets
  • Top selling generic and innovative drugs in each country.

Our clients ask questions. PMR supplies answers

PMR market intelligence reports are compiled with our clients' needs for information in mind. Here is a selection of questions answered in Generic and innovative drugs market in Central Europe 2014:

  • What are the most recent value assessments of the generic and innovative drug market in Central Europe from 2009-2018?
  • In which of the six countries addressed in this document is the generic drug market expected to grow fastest during 2014-2018?
  • Which country will see the fastest growth in its innovative drug market from 2014-2018?
  • What are the opinions of medical professionals and patients with regard to the use of generic and innovative drugs in each of the six CE countries considered in this report?
  • Which regulations in each country govern drug prices and reimbursements?
  • How are medications reimbursed in each of these six CE countries?
  • How will reimbursement procedures be altered by changes in regulation over the period 2014-2018? How will these changes affect the market?
  • How have recent regulations influenced the Central European markets for generic drugs and innovative therapies?
  • What are the specific patent expiry periods for Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria?
  • According to sales data, which products are the top sellers in Central European countries?
  • Which companies are the largest generic and innovative drug manufacturers and producers in the Central European market?

Consult this report for detailed comparison, evaluation and forecasts for

  • Generic and innovative drug market conditions in Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria
  • Market results of upcoming economic and regulatory changes in each country to 2018 and analysis of their influence on generic and innovative drugs' value
  • Reimbursement procedures and pricing regulations in effect in each CE country
  • The generic and innovative drug industries in each country, gathered and presented in a convenient format for a single, affordable price.

This report is a key source of information, analysis and forecasts for

  • Businesses that produce and distribute generic and innovative drugs and therapies for sale in Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria
  • Companies considering participation in one or more CE pharmaceutical markets
  • Business consultants, market analysts and research specialists
  • Government, educational and research institutes
  • Banking, brokerage and investment professionals
  • Commerce and trade organisations related to the pharmaceutical industry.

The information supplied in this report can be used to

  • Plan and execute a seamless market entry strategy
  • Build and/or make revisions to a corporate portfolio of products
  • Analyse the regulatory environments in the generic and innovative drug markets in Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria
  • Evaluate potential for expansion in the overall Central European market and in each of the included countries
  • Respond to additions and deletions to drug reimbursement lists in each country
  • Compile accurate predictions for market development in the entire generic drugs market in CE and in each included country
  • Compile accurate predictions for market development in the entire innovative drugs market in CE and in each included country.

Market commentary by expert

“In the past, the most substantial increases in the generic and innovative subgroups were recorded in Romania and Bulgaria. This is because these countries are, in general, the least developed (the least saturated) among those analysed. At the other end of the scale are Poland and Hungary, as the governments in both countries implemented very severe cost-containment policies - the Reimbursement Act in Poland and the Szell Kalman Plan in Hungary. These were more harmful for the innovative drugs subgroup. The policies also had a severe effect on innovative drugs trade in Slovakia, where innovative drugs account for a substantial proportion of the market but where some pro-generic mechanisms have recently been introduced, e.g. a new reference pricing system and the API prescription.” Monika Stefanczyk, Head Pharma & Healthcare market Analyst.

Table of Contents

1. Methodology

2. Executive summary

3. Characteristics of generic and innovative drugs markets in CE countries - comparative analysis

  • 1. Share of generic and innovative medicines in the market
  • 2. Average CAGR for generic and innovative drugs markets in CE countries 2013-2018
  • 3. API prescription
  • 4. External price referencing systems
  • 5. VAT on medicines
  • 6. Prices of first generics
  • 7. Changes in reimbursement lists in 2011-2012
  • 8. Competition of manufacturers outside Europe

4. Analysis of individual countries

  • 1. Poland
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018
    • 5. Attitudes towards generic and innovative drugs
      • 1. Generic substitution
      • 2. Behaviour of asthma and COPD patients
  • 2. Romania
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018
    • 5. Attitudes towards generic and innovative drugs
  • 3. Hungary
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018
    • 5. Attitudes towards generic and innovative drugs
  • 4. Czech Republic
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018
    • 5. Attitudes towards generic and innovative drugs
  • 5. Bulgaria
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018
  • 6. Slovakia
    • 1. Main past trends and events on the generic and innovative drugs market
    • 2. Main anticipated trends and events on the generic and innovative drugs market
    • 3. Share of the pharmaceutical market
    • 4. Market size and forecasts for 2014-2018

5. Generic and innovative drugs

  • 1. Poland
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 2. Romania
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 3. Hungary
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 4. Czech Republic
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 5. Bulgaria
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 6. Slovakia
    • 1. Bestselling drugs
    • 2. Drug patent expiry and data exclusivity periods
  • 7. Counterfeit drugs
    • 1. Poland
    • 2. Romania
    • 3. Czech Republic
    • 4. Hungary
    • 5. Bulgaria
    • 6. Slovakia

6. Pricing and reimbursement

  • 1. Poland
    • 1. Pricing policies
      • 1. Non-reimbursed drugs on the pharmacy market
      • 2. Reimbursed drugs on the pharmacy market
      • 3. Patient co-payment
      • 4. Drugs on the hospital market
      • 5. Generic substitution
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. Reimbursement process
      • 3. Assessment of the off-label reimbursement process
      • 4. Latest changes in reimbursement laws
      • 5. Reimbursement spending
      • 6. Drug programmes
      • 7. Chemiotherapy
      • 8. Latest changes to reimbursement lists
      • 9. Expected changes to reimbursement
  • 2. Romania
    • 1. Pricing policies
      • 1. Non-reimbursed drugs on the pharmacy market
      • 2. Reimbursed drugs on the pharmacy market
      • 3. Drugs on the hospital market
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. Reimbursement process
      • 3. Reimbursement spending
      • 4. Latest changes in reimbursement laws
      • 5. Latest changes to reimbursement lists
  • 3. Hungary
    • 1. Pricing policies
      • 1. Price-volume agreements
      • 2. Non-reimbursed drugs on the pharmacy market
      • 3. Reimbursed drugs on the pharmacy market
      • 4. Generic drugs
      • 5. Drugs on the hospital market
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. General reimbursement
      • 3. Reimbursement process
      • 4. Latest changes in reimbursement laws
      • 5. Reimbursement spending
      • 6. Szell Kalman Plan
      • 7. Latest changes to reimbursement lists
      • 8. Reimbursement of insulin analogues
      • 9. Expected changes to reimbursement
  • 4. Czech Republic
    • 1. Pricing policies
      • 1. Non-reimbursed drugs on the pharmacy market
      • 2. Reimbursed drugs on the pharmacy market
      • 3. Drugs on the hospital market
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. Reimbursement process
      • 3. Latest changes in reimbursement laws
      • 4. Reimbursement spending
      • 5. Latest changes to reimbursement lists
      • 6. Expected changes to reimbursement
  • 5. Bulgaria
    • 1. Pricing policies
      • 1. Non-reimbursed drugs on the pharmacy market
      • 2. Reimbursed drugs on the pharmacy market
      • 3. Generic substitution
      • 4. Drugs on the hospital market
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. Reimbursement of medicines for rare and contagious diseases
      • 3. Reimbursement process
      • 4. Latest changes in reimbursement laws
      • 5. Reimbursement spending
      • 6. Latest changes to reimbursement lists
      • 7. Expected changes to reimbursement
  • 6. Slovakia
    • 1. Pricing policies
      • 1. Non-reimbursed drugs on the pharmacy market
      • 2. Reimbursed drugs on the pharmacy market
      • 3. Generic and innovative drug prices
      • 4. API prescription
      • 5. Generic substitution
      • 6. Drugs on the hospital market
    • 2. Reimbursement policies
      • 1. Reimbursement system
      • 2. Reimbursement process
      • 3. Latest changes in reimbursement laws
      • 4. Latest changes to reimbursement lists

7. Key manufacturers

  • 1. Profiles of selected leading generic drugs manufacturers in CE
  • 2. Profiles of selected leading innovative drugs manufacturers in CE
  • 3. Key players by individual CE countries

8. List of graphs

9. List of tables

10. About PMR

LIST OF GRAPHS

  • 1. Share of generic and innovative drugs in the total market in CE countries analysed (%), by value, 2013 18
  • 2. CAGR for generic drugs markets in CE countries analysed (%), 2014-2018 19
  • 3. CAGR for innovative drugs markets in CE countries analysed (%), 2014-2018 20
  • 4. Share of generic and innovative drugs in the total market in CE countries analysed (%), by value, 2013 22
  • 5. Share of brands no longer protected as a proportion of Rx drug market in selected CE countries (%), October 2011-September 2012 22
  • 6. Sales value of 46 innovative products in selected CE countries (€ per capita), Q2 2013 23
  • 7. Uptake of innovative anti-diabetics in selected CE countries (DDD per 100,000 inhabitants), Q2 2013 23
  • 8. Penetration of innovative anti-diabetics and insulins in selected CE countries (DDD per 100,000 inhabitants), Q2 2013 24
  • 9. CAGR for generic drugs markets in CE countries analysed (%), 2014-2018 25
  • 10. CAGR for innovative drugs markets in CE countries analysed (%), 2014-2018 26
  • 11. VAT rates on pharmaceutical products applied in CE countries analysed (%), 2014 28
  • 12. Prices of first generics as % of prices of original drugs in CE countries analysed, 2014 30
  • 13. Average price of innovative drugs on the pharmacy market in selected CE countries (€), July 2012-June 2013 30
  • 14. Average price of generic drugs on the pharmacy market in selected CE countries (€), July 2012-June 2013 31
  • 15. Generic costs for selected therapy areas (€), in selected CE countries, Q1 2013 31
  • 16. Share of generic and innovative drugs in the overall pharmaceutical market in Poland (%), by value, 2007-2011 and April 2012-March 2013 39
  • 17. Share of Rx generic drugs in the Polish pharmaceutical market (%), by value, 2006 and 2012 40
  • 18. Share of domestic and foreign drugs as a proportion of the Polish generic drugs market (%), by value, 2012 40
  • 19. Share of generic drugs as a proportion of the overall unprotected drugs market in Poland, (%), by volume, 2003, 2008 and 2013 41
  • 20. Share of Rx generic drugs in the Polish pharmaceutical market (%), by volume, 2006 and 2012 41
  • 21. Share of domestic and foreign drugs as a proportion of the Polish generic drugs market (%), by volume, 2012 42
  • 22. Value (PLN bn) and y-o-y change (%) of the Polish generic drugs market, 2010-2018 43
  • 23. Value (PLN bn) and y-o-y change (%) of the Polish innovative drugs market, 2010-2018 44
  • 24. Value (PLN bn) and y-o-y change (%) of the Polish pharmaceutical market, 2010-2018 44
  • 25. Patient opinions on lower quality of cheaper drugs in Poland (%), 2011 45
  • 26. Reasons why pharmacists advise patients against the use of generic drugs in Poland (%), 2011 47
  • 27. Value (RON bn) and y-o-y change (%) of the Romanian generic drugs market, 2013-2018 53
  • 28. Value (RON bn) and y-o-y change (%) of the Romanian innovative drugs market, 2013-2018 54
  • 29. Value (RON bn) and y-o-y change (%) of the Romanian pharmaceutical market, 2013-2018 54
  • 30. R&D and capex of Magyosz member companies (HUF bn), 2000, 2005 and 2010-2012 57
  • 31. Share of generic and innovative drugs as a proportion of the overall pharmaceutical market in Hungary (%), by value, July 2012-June 2013 58
  • 32. Share of generic drugs as a proportion of the overall unprotected drugs market in Hungary (%), by volume, 2003, 2008 and 2013 59
  • 33. Value (HUF bn) and y-o-y change (%) of the Hungarian generic drugs market, 2013-2018 60
  • 34. Value (HUF bn) and y-o-y change (%) of the Hungarian innovative drugs market, 2013-2018 61
  • 35. Value (HUF bn) and y-o-y change (%) of the Hungarian pharmaceutical market, 2013-2018 61
  • 36. Share of generic and innovative drugs as a proportion of the overall pharmaceutical market in the Czech Republic (%), by value, July 2012-June 2013 69
  • 37. Share of Rx generic medicines in the Czech pharmaceutical market (%), by value, 2005-2012 70
  • 38. Share of generic drugs as a proportion of the total unprotected drugs' market in the Czech Republic (%), by volume, 2003, 2008 and 2013 70
  • 39. Value (CZK m) and y-o-y change (%) of the Czech generic drugs market, 2013-2018 72
  • 40. Value (CZK m) and y-o-y change (%) of the Czech innovative drugs market, 2013-2018 72
  • 41. Value (CZK m) and y-o-y change (%) of the Czech pharmaceutical market, 2013-2018 73
  • 42. Share of generic and innovative drugs in the overall pharmaceutical market in Bulgaria (%), by value, July 2012-June 2013 82
  • 43. Share of generic and innovative drugs in the NHIF spending in Bulgaria (%), by value, 2011-2012 82
  • 44. Share of generic and innovative drugs in the Rx market in Bulgaria (%), by volume, 2009-2013 83
  • 45. Share of generic and innovative drugs in the NHIF spending in Bulgaria (%), by volume, 2011-2012 83
  • 46. Value (BGN m) and y-o-y change (%) of the Bulgarian generic drugs market, 2007-2018 86
  • 47. Value (BGN m) and y-o-y change (%) of the Bulgarian innovative drugs market, 2007-2018 87
  • 48. Value (BGN m) and y-o-y change (%) of the Bulgarian pharmaceutical market, 2007-2018 87
  • 49. Share of Rx generic medicines in the Slovak pharmaceutical market (%), by volume, 2006 and 2012 94
  • 50. Volume (million packages) and y-o-y change (%) of the Slovak generic drugs market, 2009-2013 95
  • 51. Volume (million packages) and y-o-y change (%) of the Slovak innovative drugs market, 2009-2013 95
  • 52. Value (€ m) and y-o-y change (%) of the Slovak generic drugs market, 2009-2018 96
  • 53. Value (€ m) and y-o-y change (%) of the Slovak innovative drugs market, 2009-2018 97
  • 54. Value (€ m) and y-o-y change (%) of the Slovak pharmaceutical market, 2009-2018 97
  • 55. SPCs granted in Bulgaria, 2008-2012 116
  • 56. Number of applications and SPCs granted in Slovakia, 2006-2013 120
  • 57. Patient co-payment for medicines in Poland (%), H1 2011-H1 2013 130
  • 58. Reimbursement process in Poland, 2014 135
  • 59. NFZ spending on drug reimbursement (PLN bn) and y-o-y change (%) in Poland, 2005-2014 139
  • 60. Public spending on reimbursement of medicines (PLN m) and growth rates (%) in Poland, 2014-2020 140
  • 61. NFZ spending on drug programmes (PLN bn) and y-o-y change (%) in Poland, 2007-2014 141
  • 62. NFZ spending on chemotherapy (PLN bn) and y-o-y change (%) in Poland, 2006-2014 141
  • 63. Reimbursement process scheme in Romania, 2014 148
  • 64. Spending on drug reimbursement in Romania (RON m), by diseases, 2012 149
  • 65. Claw-back tax formula in Romania, 2014 151
  • 66. Categories of reimbursement in Hungary, 2014 162
  • 67. Reimbursement process scheme in Hungary, 2014 165
  • 68. Pharmaceutical reimbursement spending (HUF bn) and y-o-y change (%) in Hungary, 2013-2014 168
  • 69. Top 10 ATC categories in terms of most substantial reimbursement spending in Hungary (HUF bn), 2013 168
  • 70. Summary of the implementation of the Szell Kalman Plan in Hungary, 2012-2013 170
  • 71. Procedure for establishing maximum drug prices for reimbursed medicines and reimbursement levels in the Czech Republic, 2014 184
  • 72. Development of prices of reimbursed medicines in Bulgaria (%), 1999-2012 200
  • 73. NHIF spending on rare diseases (BGN m) and y-o-y change (%) in Bulgaria, 2011-2013 203
  • 74. NHIF's spending on outpatient reimbursement of drugs (BGN m) and y-o-y change (%) in Bulgaria, 2012-2014 205
  • 75. Accessibility of orphan drugs in Bulgaria (number of drugs), September 2012 and July 2013 214
  • 76. Rate of growth for access to orphan drugs in Bulgaria (%), 2012-2013 215
  • 77. Number of orphan drugs in Bulgaria, by PDL Appendix number, July 2013 215
  • 78. Average price per packet of generic and innovative drugs in Slovakia (€), 2009-2013 218
  • 79. Egis sales revenues in Central Europe (€ m) and y-o-y change (%), 2009/2010-2012/2013 232
  • 80. Gedeon Richter sales revenues in Central Europe (€ m) and y-o-y change (%), 2008-2013 237
  • 81. Selected Teva clinical trials carried out in CE countries, March 2013 and March 2014 256
  • 82. Selected AstraZeneca clinical trials carried out in CE countries, March 2013 and March 2014 259
  • 83. Selected Bayer clinical trials carried out in CE countries, March 2013 and March 2014 262
  • 84. Selected GlaxoSmithKline clinical trials carried out in CE countries, March 2013 and March 2014 267
  • 85. Selected Novartis clinical trials carried out in CE countries, March 2013 and March 2014 271
  • 86. Selected Pfizer clinical trials carried out in CE countries, March 2013 and March 2014 274
  • 87. Selected Roche clinical trials carried out in CE countries, March 2013 and March 2014 278
  • 88. Selected Sanofi clinical trials carried out in CE countries, March 2013 and March 2014 284
  • 89. Estimated market shares of 10 leading pharmaceutical companies on the Polish generic drugs market (%), by value, H1 2013 287
  • 90. Estimated market share of 10 leading pharmaceutical companies on the Polish generic drugs market (%), by volume, H1 2013 287
  • 91. NFZ spending on reimbursement in case of top 10 innovative companies in Poland (%), 2012 288
  • 92. NFZ spending on reimbursement in case of top 10 generic companies in Poland (%), 2012 288
  • 93. Proportion of sales value of top 15 innovative companies on the Rx pharmacy market in Poland (%), 2012 289
  • 94. Proportion of sales value of top 10 generic companies on the Rx pharmacy market in Poland (%), 2012 289
  • 95. Change in sales value of top 15 innovative companies on the Rx pharmacy market in Poland (%), January-May 2013 290
  • 96. Change in sales value of top 10 generic companies on the Rx pharmacy market in Poland (%), January-May 2013 290
  • 97. Largest amounts spent on promotion to doctors by generic companies, in terms of change in spending (PLN m), March 2012-February vs March 2011-February 2012 291
  • 98. Largest amounts spent on promotion to doctors by innovative companies, in terms of change in spending (PLN m), March 2012-February vs March 2011-February 2012 291

LIST OF TABLES

  • 1. Policies of CE countries with regard to API prescriptions, 2014 26
  • 2. Policies of CE countries with regard to external price referencing systems for setting maximum price, 2014 27
  • 3. Manufacturer price changes for 10 innovative drugs in selected CE countries (%), 2011-2012 32
  • 4. Average manufacturer price changes for 10 innovative drugs in selected CE countries (%), 2011-2012 32
  • 5. Frequency of exchanging a drug for its cheaper equivalent in Poland (%), 2011 45
  • 6. Frequency of exchanging a drug for its cheaper equivalent in Poland, by gender (%), 2011 46
  • 7. Frequency of patients' requests for a drug to be exchanged for its cheaper equivalent in Poland, by age (%), 2011 46
  • 8. Reasons for doctors' choosing innovative drugs instead of generics in Poland (%), 2011 46
  • 9. Selected subsidies for professional events offered by pharmaceutical companies operating in Hungary, 2013 56
  • 10. Sales of original products losing patent protection in Hungary between 2012 and 2016 (€ m), by retail and hospital, 2011 62
  • 11. Volume, value (CZK m) and y-o-y change (%) of drugs delivered from the Czech Republic to medical facilities abroad, 2011-2013 64
  • 12. Drug most frequently delivered from the Czech Republic to medical facilities abroad, Q2-Q3 2013 64
  • 13. Volume and y-o-y change (%) of drugs most frequently delivered from the Czech Republic to foreign wholesalers for further distribution abroad, 2011-2013 65
  • 14. Drug most frequently delivered from the Czech Republic to foreign drugs wholesalers for further distribution abroad, Q2 2013-Q4 2013 65
  • 15. Share of Rx generic medicines in the Czech pharmaceutical market (%), by volume, 2005-2012 71
  • 16. Price reductions after investigation by the National Council on Prices and the Reimbursement of Medicinal Products in Bulgaria (%), 30 April-31 December 2013 77
  • 17. Breakdown of drugs whose prices were reduced after investigation by the National Council on Prices and the Reimbursement of Medicinal Products in Bulgaria, 30 April-31 December 2013 77
  • 18. Number of new products introduced on the pharmaceutical market in Bulgaria, by product status, Q1-Q3 2013 84
  • 19. Number of new products introduced on the pharmaceutical market in Bulgaria, by origin of the product, Q1-Q3 2013 84
  • 20. Appearance of Rx new products on the pharmaceutical market in Bulgaria as a proportion of the total number of generic and original products introduced (%), 1989 and 2012 84
  • 21. Most frequent diseases in Slovakia by particular age groups, 2013 89
  • 22. Share of generic and innovative drugs in the overall pharmaceutical market in Slovakia, by value (€ m), 2013 93
  • 23. Share of generic and innovative drugs in the pharmacy market in Slovakia, by volume, 2014 93
  • 24. Top 20 bestselling products on the pharmacy market in Poland (PLN m), 2013 98
  • 25. Drugs generating highest reimbursement expenses to the NFZ in Poland, 2013 100-101
  • 26. Pharmaceutical substances generating highest reimbursement costs for the NFZ within therapeutic programmes and chemotherapy, 2013 102
  • 27. Fees for supplementary protection certificate in Poland (PLN), 2014 102
  • 28. Top 20 bestselling innovative and generic drugs in Romania, by value (€ m), March 2012-February 2013 103
  • 29. Top 10 bestselling innovative and generic drugs in Romania, by value (€ m), June 2012-May 2013 104
  • 30. Top 20 bestselling innovative and generic drugs in Romania, by volume (million packages), March 2012-February 2013 104
  • 31. Top 10 bestselling innovative and generic drugs in Romania, by volume (million packages), June 2012-May 2013 105
  • 32. Fees for supplementary protection certificate in Romania (RON, €), 2014 105
  • 33. Top 10 bestselling drugs in Hungary, by value (HUF bn), 2013 106
  • 34. Fees for supplementary protection certificate in Hungary (HUF), 2014 107
  • 35. Number of SPC applications in Hungary, 2004-2014 107
  • 36. SPCs to expire within the next five years in Hungary, April 2014 108-110
  • 37. Top 29 bestselling innovative drugs in the Czech Republic, by value (CZK m), 2013 111
  • 38. Selected top 10 bestselling generic drugs in the Czech Republic, by value (CZK m), Q1-Q3 2013 112
  • 39. Top 10 bestselling generic drugs in the Czech Republic, by volume (‘000 packets), Q1-Q3 2013 112
  • 40. Fees for supplementary protection certificate in the Czech Republic (CZK), 2014 113
  • 41. Applications for SPCs filed and SPCs granted, pending and valid in the Czech Republic, 2004-2012 113
  • 42. SPC certificates to expire within the next five years in the Czech Republic, March 2014 114
  • 43. 10 bestselling drugs in Bulgaria, by value (BGN m), 2012 115
  • 44. 10 bestselling drugs in Bulgaria, by volume (million packets), 2012 116
  • 45. Fees for supplementary protection certificate in Bulgaria (BGN), 2014 117
  • 46. Number of patents in pharmaceutical industry granted in Bulgaria, by origin of owner, 2001-2012 117
  • 47. Number of Bulgarian pharmaceutical patent owners in Bulgaria, 2008-2012 117
  • 48. Top 27 best selling innovative drugs in Slovakia, by value (€ m), 2013 118
  • 49. Top 10 bestselling Rx innovative drugs in Slovakia, by volume, Q3 2013 119
  • 50. Top 10 bestselling Rx generic drugs in Slovakia, by volume, Q3 2013 119
  • 51. Fees for supplementary protection certificate in Slovakia, 2014 120
  • 52. SPCs to expire within the next five years in Slovakia, December 2013 121-122
  • 53. Share of drugs and medical devices as a proportion of total number of goods infringing intellectual property rights seized by customs authorities in Poland, by volume (%), 2012 123
  • 54. Share of drugs and medical devices as a proportion of all goods infringing intellectual property rights seized by customs authorities in Poland, by value (%), 2012 123
  • 55. Official retail margins for reimbursed drugs in Poland, 2014 129
  • 56. Difference in shares of the number of prescription packets of drugs and sales market, by volume, Q1 2011-Q1 2013 132
  • 57. Rules governing operation of drug programmes in Poland, 2014 133
  • 58. Summary of impact of the Pharmaceutical Law on the pharmaceutical market in Poland, H1 2013 138
  • 59. NFZ expenses on innovative drugs added to open reimbursement in 2012 in Poland (PLN m), January-November 2012 139
  • 60. Changes to reimbursement lists in Poland, 2012, 2013 and January-March 2014 142
  • 61. Summary of changes in lists of reimbursed drugs in Poland, March 2014 142-143
  • 62. Summary of changes in lists of reimbursed drugs in Poland, January 2014 144
  • 63. Official wholesale margins for drugs in Romania, 2014 146
  • 64. Official retail margins and gross margins for drugs in Romania, 2014 146
  • 65. CNAS spending on drug reimbursement (RON m) and y-o-y change (%) in Romania, 2006-2014 149
  • 66. Number of drugs on reimbursement lists in Romania, October 2012 and October 2013 151
  • 67. Price-volume agreements in the reimbursement system in Hungary, 2012 153
  • 68. Official wholesale markups for reimbursed drugs in Hungary, 2014 154
  • 69. Official retail markups for reimbursed drugs in Hungary, 2013 154
  • 70. Price reductions in biannual price competition between pharmaceutical manufacturers in Hungary (HUF), January-March 2014 157
  • 71. Categories of referencing in the reimbursement system in Hungary, 2014 160
  • 72. Leading 10 brands in terms of most substantial amounts of reimbursement spending in Hungary (HUF m), 2013 169
  • 73. Summary of changes to reimbursement lists in Hungary, 2013 171
  • 74. Summary of changes to reimbursement lists in Hungary, January-February 2014 171
  • 75. New and withdrawn generic and innovative brands on reimbursement list in Hungary, March 2014 172
  • 76. Changes in reimbursement list in Hungary, by ATC category, March 2014 173
  • 77. New and withdrawn generic and innovative brands on reimbursement list in Hungary, February 2014 174
  • 78. Changes in reimbursement list in Hungary, by ATC category, February 2014 175
  • 79. New and withdrawn generic and innovative brands on reimbursement list
  • 80. in Hungary, January 2014 176-177
  • 81. Changes in reimbursement list in Hungary, by ATC category, January 2014 177
  • 82. Official margins for reimbursed drugs in the Czech Republic, 2014 180
  • 83. Summary of changes introduced through the amendment to the Act on Public Health Insurance from 2011 185
  • 84. Drugs placed on and withdrawn from reimbursement list in the Czech Republic, 1 March 2014 188-189
  • 85. Drugs placed on and withdrawn from reimbursement list in the Czech Republic,
  • 86. 1 February 2014 190-194
  • 87. Drugs placed on and withdrawn from reimbursement list in the Czech Republic,
  • 88. 1 January 2014 195-196
  • 89. Price breakdown of pharmaceuticals in Bulgaria (%), 2000-2012 198
  • 90. Price breakdown of pharmaceuticals in Bulgaria (%), by price category, 2000-2012 198
  • 91. Official wholesale and retail margins for reimbursed drugs in Bulgaria, 2014 200
  • 92. Funds allocated to pharmaceutical market in Bulgaria (€ m), by public bodies, 2012-2013 204
  • 93. Most substantial amounts spent by the NHIF on outpatient drug reimbursement in Bulgaria (BGN), 2011-2013 207
  • 94. Innovative and generic drugs introduced to and withdrawn from Positive Drug List in Bulgaria, 16 February 2014 208
  • 95. Innovative and generic drugs introduced to and withdrawn from Positive Drug List in Bulgaria, 1 February 2014 209-211
  • 96. Innovative and generic drugs added to and withdrawn from Positive Drug List in Bulgaria, 16 January 2014 213
  • 97. Generic immunosuppressants withdrawn from Positive Drug List in Bulgaria, April 2014 213
  • 98. Reimbursement status of orphan drugs in Bulgaria with valid market authorisation in the European Union, July 2013 214
  • 99. Orphan drugs placed on and withdrawn from Positive Drug List in Bulgaria, 2012-2013 215
  • 100. Official wholesale and retail margins for Rx medicines in Slovakia, 2014 217
  • 101. Average price per packet of best selling innovative medicines in Slovakia (€), 2013 218
  • 102. Average price per drug packet of leading innovative drugs manufacturers in Slovakia (€ m), 2013 218
  • 103. Average price per drug packet of leading generic drugs manufacturers in Slovakia (€), 2013 219
  • 104. Number of drugs on reimbursement lists in Slovakia, by ATC category, January, February, March and April 2014 225
  • 105. Comparison between March 2014 and April 2014 reimbursement lists in Slovakia, in terms of patient co-payment (%) 225
  • 106. Comparison between March 2014 and April 2014 reimbursement lists in Slovakia, in terms of patient co-payment (€) 225
  • 107. Patient co-payment for drugs in Slovakia (€), April 2013 and April 2014 226
  • 108. Comparison between February 2014 and March 2014 reimbursement lists in Slovakia, in terms of patient co-payment (%) 226
  • 109. Comparison between February 2014 and March 2014 reimbursement lists in Slovakia, in terms of patient co-payment (€) 226
  • 110. Comparison between January 2014 and February 2014 reimbursement lists in Slovakia, in terms of patient co-payment (%) 227
  • 111. Comparison between January 2014 and February 2014 reimbursement lists in Slovakia, in terms of patient co-payment (€) 227
  • 112. Sales of individual Actavis companies registered in selected CE countries (€ m), 2012 229
  • 113. Actavis clinical trials carried out in CE countries, April 2014 231
  • 114. Egis sales revenues in CE countries analysed (€ m) and y-o-y change (%), 2012/2013 232
  • 115. Selected drugs launched by Egis in Hungary, FY 2012/2013 234
  • 116. Egis spending on research and development (HUF m), its y-o-y change and share as a proportion of company's net sales (%), FY 2002/2003-2012/2013 234
  • 117. Gedeon Richter sales revenues in selected CE countries (€ m) and y-o-y change (%), 2013 237
  • 118. Selected generic and innovative drugs launched by Gedeon Richter in CE countries analysed, 2013 239
  • 119. Gedeon Richter spending on research and development (HUF m), its y-o-y change and share as a proportion of company's sales (%), 2000-2013 240
  • 120. Selected Gedeon Richter clinical trials, March 2014 241
  • 121. Krka sales revenues in selected CE countries (€ m) and y-o-y change (%), 2013 243
  • 122. Krka sales revenues in Central Europe (€ m) and y-o-y change (%), Q1-Q3 2008 - Q1-Q3 2013 243
  • 123. Krka: bestselling pharmaceuticals, sales drivers and newly launched products in selected CE countries, Q1-Q3 2013 244
  • 124. Number of new marketing authorisations for Krka Group in the CE region, 2006-2013 245
  • 125. Krka spending on research and development (€ m), its y-o-y change and share as a proportion of company's sales revenues (%), 2006-2013 245
  • 126. Sales of individual Sandoz companies registered in selected CE countries (€ m), 2012 247
  • 127. Sandoz spending on research and development ($ m), its y-o-y change and share as a proportion of company's net sales (%), 2006-2012 249
  • 128. Sandoz clinical trials carried out in CE countries, March 2014 249
  • 129. Stada sales revenues in selected CE countries (€ m) and y-o-y change (%), 2012 250
  • 130. Sales of generic and branded drugs of Stada in selected CE countries (€ m), 2013 251
  • 131. Stada spending on research and development (€ m), its y-o-y change and share in company's sales (%), 2002-2013 251
  • 132. Sales of individual Teva companies registered in selected CE countries (€ m), 2012 253
  • 133. Teva annual spending on research and development ($ m), its y-o-y change and share in company's revenues (%), 2004-2013 255
  • 134. Examples of areas investigated by Teva in clinical trials in CE, March 2014 256
  • 135. Sales of individual AstraZeneca companies registered in selected CE countries (€ m), 2012 257
  • 136. AstraZeneca spending on research and development ($ m), its y-o-y change and share as 259
  • 137. Examples of areas investigated by AstraZeneca in clinical trials in CE, March 2014 260
  • 138. Sales of individual Bayer companies registered in selected CE countries (€ m), 2012 260
  • 139. Bayer HealthCare spending on research and development (€ m), its y-o-y change and share as a proportion of company's net sales (%), 2010-2013 261
  • 140. Examples of areas investigated by Bayer in clinical trials in CE, March 2014 262
  • 141. Sales of individual GSK companies registered in selected CE countries (€ m), 2012 263
  • 142. GlaxoSmithKline's spending on research and development (£ m), its y-o-y change and share as a proportion of company's turnover (%), 2001-2013 267
  • 143. Examples of areas investigated by GlaxoSmithKline in clinical trials in CE, March 2014 268
  • 144. Sales of individual Novartis companies registered in selected CE countries (€ m), 2012 269
  • 145. Novartis' spending on research and development ($ m), its y-o-y change and share as a proportion of company's net sales (%), 2004-2013 270
  • 146. Examples of areas investigated by Novartis in clinical trials in CE, March 2014 271
  • 147. Sales of individual Pfizer companies registered in selected CE countries (€ m), 2012 273
  • 148. Pfizer spending on research and development ($ m), its y-o-y change and share as a proportion of company's revenues (%), 2004-2013 274
  • 149. Examples of areas investigated by Pfizer in clinical trials in CE, March 2014 274
  • 150. Sales of individual Roche companies registered in selected CE countries (€ m), 2012 275
  • 151. Roche's bestselling drugs in Bulgaria (BGN ‘000), 2011-2012 277
  • 152. Roche Pharmaceuticals spending on research and development (CHF m), its y-o-y change and share as a proportion of company's sales (%), 2004-2013 278
  • 153. Examples of areas investigated by Roche in clinical trials in CE, March 2014 278
  • 154. Sales of individual Sanofi companies registered in selected CE countries (€ m), 2012 280
  • 155. Sanofi spending on research and development (€ m), its y-o-y change and share as a proportion of company's revenues (%), 2004-2013 283
  • 156. Examples of areas investigated by Sanofi in clinical trials in CE, March 2014 284
  • 157. Sales of individual Servier companies registered in selected CE countries (€ m), 2012 285
  • 158. Selected investments of foreign pharmaceutical companies in Poland, May 2011-September 2015 292
  • 159. Spending on R&D by local manufacturers in Poland (PLN m), 2008-2018 296
  • 160. Top 20 leading generic and innovative corporations on the Romanian pharmaceutical market, by sales value (RON m), October-December 2013 and 2013 299
  • 161. Top 10 leading generic and innovative companies on the Hungarian pharmaceutical market, by sales value, 2013 302
  • 162. Top 20 leading generic and innovative corporations on the Czech pharmaceutical market, by sales value, 2013 304
  • 163. Y-o-y change (%) of sales value and volume of selected leading generic and innovative drugs manufacturers on the Czech pharmaceutical market, 2013 305
  • 164. Top 10 leading generic and innovative companies on the Bulgarian pharmaceutical market, by sales value, 2011-2012 307
  • 165. Market share of top 10 leading generic and innovative companies on the Bulgarian pharmaceutical market (%), by sales value, 2012-2013 307
  • 166. Top 10 of selected leading generic and innovative companies on the Bulgarian pharmaceutical market (%), by sales volume, 2012 and 2013 308
  • 167. 10 leading generic corporations on the Slovak pharmaceutical market, by sales value, 2013 310
  • 168. 10 leading generic corporations on the Slovak pharmaceutical market, by sales volume, 2013 311
  • 169. 10 leading innovative corporations on the Slovak pharmaceutical market, by sales value, 2013 311
Show More
Pricing
Get Notified
Email me when related reports are published