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The Russian pharmaceutical market generated $10.1 billion in sales in 2009, growing by 14.5% between 2008 and 2009. Key growth drivers include a preference for foreign drugs rather than domestically manufactured products. The government has also designated healthcare a strategic priority for the countrys future development which is expected to stimulate Russias pharmaceutical market. Scope *Overview of socioeconomic and demographic trends, healthcare system, regulation, pricing and reimbursement and intellectual property in Russia *Assesses the size of the Russian pharmaceutical market by prescribing setting, therapy area, leading brands and by leading companies *Examines the Russian generics and biosimilars landscape in terms of regulatory issues, level of penetration, key players and degree of brand erosion *Quantifies the R&D and manufacturing infrastructure for the leading pharmaceutical companies, including key metrics and domestic M&A analysis Highlights Private health expenditure accounts for one third of all healthcare costs of which 82%% is met by out-of-pocket costs due to insufficient availability of healthcare services and medicines through the public healthcare system, as well as the widespread informal payments for healthcare services. Registration of drugs in the Russian Federation remains a cumbersome and lengthy procedure which lacks clarity and transparency and is subject to frequent change. Cultural and language barriers present further obstacles to foreign companies "going it alone". The generics industry is complex and fragmented, dominated by a small number of international generics manufacturers. Generics produced by these companies enjoy preferential uptake driven by their perceived superiority to domestically manufactured generics, with Russians choosing to pay higher prices for guaranteed quality. Reasons to Purchase *Evaluate the evolving regulatory landscape and the impact of pricing and
reimbursement controls on market access in Russia *Quantify the size and growth of the prescription pharmaceutical market in Russia, analyzing key therapy areas, brands and companies *Assess drivers and resistors of generic and biosimilars uptake in Russia Table of Contents : ABOUT DATAMONITOR HEALTHCARE 2 About the Healthcare Strategic Analysis Team 2 Geographic specific reports: 2 Global issue reports: 2 1. Executive Summary 3 Introduction 3 Strategic scoping and focus 4 Key Findings 5 Russia - Socio-demographic and economic analysis 5 Socio-demographic trends 5 Socio-economic trends 6 Russia - Healthcare system and drug regulatory analysis 8 Healthcare expenditure 8 Healthcare insurance 9 Regulatory issues 10 Pricing and reimbursement issues 11 Russia - Prescription pharmaceutical sales analysis 13 Pharmaceutical market size 13 Leading therapy areas 13 Leading pharmaceutical brands 13 Leading pharmaceutical companies 13 Russia - Drug expiry analysis 15 Generics market 15 Brand erosion post patent expiry 15 Biosimilars market 15 Russia - Drug Industry Infrastructure analysis 17 Pharmaceutical industry infrastructure overview 17 Related reports 19 Upcoming related reports 19 Table of Contents 20 2. Russia - Socio-demographic and economic analysis 21 Russia - Key findings 21 Socio-demographic trends 21 Socio-economic trends 21 Russia - Demographic trends 23 Population in Russia expected to decline rapidly 24 Population growth rate in Russia remains low due to low birth rates 24
Proportion of elderly people will remain lower than in all other markets 27 Life expectancy in Russia is poor and will remain so 27 Russia - Disease burden in Russia 29 Cardiovascular diseases and injuries are the leading cause of death and account for the highest disease burden in Russia 31 High level of preventable deaths in Russia 31 HIV/AIDS presents a worrying trend in Russia 32 Russia - Political climate 33 The political climate in Russia has undergone recent changes 33 Russia remains a centralized country with power centered on Moscow 33 Russia - Economic climate 34 Economy - recovery post-recession is slow but will gain momentum from 2010 34 Economic growth is impacted by income inequality in Russia 35 Russia - Business environment 37 Although impediments to investing in Russia remain, the government is prioritizing healthcare 37 The recession has impacted unemployment levels 37 Russia has a uniform tax rate 38 Pharmaceuticals are subject to a reduced VAT rate of 10% 38 Corruption significantly impedes foreign investment in Russia 39 Local knowledge is critical for business success 39 3. Russia - Healthcare system and drug regulatory analysis 40 Russia - Key findings 40 Healthcare expenditure 40 Healthcare insurance 40 Regulatory issues 41 Pricing and reimbursement issues 41 Russia - Healthcare expenditure 43 Russia - Healthcare System 45 Key bodies regulating the healthcare system 45 Ministry of Health and Social Development (MOH) 46 Parallel healthcare system 46 The Federal and Territorial Mandatory Health Insurance Fund 46 Additional experts and coordinating bodies 46 Primary versus hospital healthcare in Russia 47 In efficiencies in the primary care system lead to over-referral, over-hospitalization and over treatment 47 Significant disparities exist in the distribution of physicians and healthcare facilities 47 Access to healthcare is especially problematic for the poor population... 48 ...but healthcare modernization plans are in place 49 Project Zdorovie is focused on developing healthcare in Russia 49 Local governments draft modernization plans for regions 49 ...but the government 2020 healthcare plan is aimed at improving healthcare 50 Russia - Health insurance 51 Mandatory health insurance was introduced in 1991 but has done little to improve healthcare 51
The healthcare system is funded by formal and informal means 52 Guaranteed Package Program does not necessarily guarantee access to medicines 53 Reformed mandatory medical insurance system is intended to give patients more choice 55 Private health insurance 55 Voluntary Health Insurance is in high demand 55 Concerns raised over privatization of a number of public hospitals 56 Russia - Regulatory issues 57 Drug approval and regulatory processes - registration of drugs in Russia is considered a cumbersome process 57 The high number of registered drugs indicates inadequate control of the registration process 57 There are two regulatory bodies involved in the licensing of medicines in Russia 57 New Federal Law on Circulation of Medicines attracts criticism 58 Regulation process now less costly but time taken to register a drug is increasing 58 Russias manufacturing facilities will need to align with international GMP standards 59 Domestic clinical trials were to be required as a registration prerequisite under the new law 59 New law lacks orphan drug clause 59 Additional new provisions 60 Russia - Intellectual property environment 61 There are two ways of obtaining patent protection in Russia 61 Enforceability of patent laws is still weak and data exclusivity remains an unresolved issue 61 Drug counterfeiting is an ongoing problem but there are few recent developments 62 Drug importation - new law streamlines import procedures 63 Russia - Pricing and reimbursement 64 Russia is looking to its Essential Drug List to contain costs 64 Pricing issues - the government is increasing its controls 66 New Essential Drug List compiled in 2009 66 Mandatory state registration of maximum prices replaces voluntary system 66 Reimbursement issues - introduction of the federal reimbursement system DLO was a major change 68 Supply and deficit problems have historically hampered the DLOs success 69 DLO was modernized again and split into two procurement branches 70 Centralized program covers seven expensive-to-treat diseases 70 ONLS program covers remaining drugs 70 Oncology drugs had the highest sales volume in the DLO 71 Ongoing issues regarding the DLO program 71 4. Russia - Pharmaceutical sales analysis 72 Russia - Key findings 72 Pharmaceutical market size 72 Leading therapy areas 72 Leading pharmaceutical brands 72 Leading pharmaceutical companies 72 Russia - Pharmaceutical market size 74
Russia - Leading therapy areas 76 Central nervous system drugs hold the largest share of the Russian market value 78 Infectious disease drugs exhibited the strongest annual sales growth (2008-09) 78 Hematology drugs showed the fastest growth in terms of sales CAGR (2005-09) 79 Russia - Leading pharmaceutical brands 80 Velcade was the top selling brand in Russia 82 Octavi exhibited the strongest sales CAGR of the top 20 brands, but faces competition from its follow-on product 83 Glivecs gold-standard position drives uptake 83 Russia - Leading pharmaceutical companies 84 The leading international companies offer both innovative therapies and generic products 85 Domestic companies offer largely generic and consumer healthcare products 88 Pharmstandard 89 Valenta 89 Biosyntez 90 5. Russia - Drug expiry analysis 91 Russia - Key findings 91 Generics market 91 Brand erosion post patent expiry 91 Biosimilars market 91 Russia - Generics market dynamics 93 Russia generics volume uptake 94 Russia generics value uptake 95 Russia generics market size 96 Russia - Generics drivers and resistors 97 Despite universal health insurance, significant out-of-pocket costs limit access to generics 99 The new pharmaceutical bill will lead to enforced pricing and preferential listing of domestically manufactured generics 100 Domestic GMP standards are poor, but are set to improve 100 Lack of adequate pharmacovigilance puts patients at risk and reduces trust 101 Patients prefer branded generics 101 Russia - Key generics players 102 International funds invest in Pharmstandard 103 ratiopharm acquisition gives Teva a leading role in Russia 103 Stada sees high growth levels in the Russian market 103 Novartis holds a strong position in Russia through Sandoz, Lek and Hexal 103 Zentiva continues to shine in the Russian market for Sanofi-Aventis 104 Ranbaxy fails in its attempt to enter the Russian market 104 Opportunities for the generics industry 105 Russia - Small molecule brand erosion 106 Overview of drugs analyzed 106 Mean level of brand erosion in Russia 107 Brand erosion in the Russian retail and hospital setting 109 Brand erosion by therapy area in Russia 111
Brand erosion by drug formulation in Russia 113 Russia - Biosimilars market dynamics 115 Drivers and resistors to biosimilar uptake in Russia - development costs and lack of regulation is attractive to biosimilar manufacturers 115 Biosimilars available in Russia 117 Biosimilar filgrastim 118 Opportunities for the biosimilar industry 120 Biosimilars in development internationally 122 Russia presents challenges for monoclonal antibody manufacturers 123 6. Russia - Pharmaceutical industry infrastructure analysis 125 Russia - Key findings 125 Russia - Pharmaceutical infrastructure overview 126 The new pharmaceutical bill will lead to enforced pricing and preferential listing of domestically manufactured generics 126 Domestic GMP standards are poor, but are set to improve 126 Russia is becoming a hotspot for clinical trials 128 Russia - key company infrastructure 130 Novartis 131 Sanofi-Aventis 134 Johnson & Johnson 137 Roche 140 Pharmstandard 143 Bayer Schering 146 Servier 149 Teva 152 Merck & Co. 155 Gedeon Richter 158 Gedeon Richter boosts its Russian presence 160 7. Russia - Bibliography 161 Russia - Executive summary 161 Publications and online articles 161 Datamonitor reports and products 162 Russia - Socio-demographic and economic analysis 162 Publications and online articles 162 Publications and online articles 165 Russia - Healthcare systems and regulations 165 Publications and online articles 165 Datamonitor products 170 Russia - Prescription pharmaceutical sales analysis 170 Publications and online articles 170 Datamonitor reports and products 170 Russia - Drug expiry analysis 170 Publications and online articles 170 Datamonitor reports and products 173 Russia - Pharmaceutical industry infrastructure analysis 174 Publications and online articles 174
Appendix 177 Exchange rates used in this report 177 Russia brand erosion - additional data and analysis 178 Brand erosion - methodology 180 Datamonitor prescription pharmaceutical definition and therapy area classification 183 About Datamonitor 184 About Datamonitor Healthcare 184 Datamonitor consulting 184 Disclaimer 186 For some-more information, Great fully visit: http://www.aarkstore.com/reports/Russia-Pharmaceutical-Market-Overview-Pharmacompanies-target-Russia-despite-the-challenges-it-presents-80662.html