Healthcare, Regulatory and Reimbursement Landscape Russia

Introduction

Abstract

Healthcare, Regulatory and Reimbursement Landscape - Russia

Summary

GlobalData, the industry analysis specialist, has released its new report, "Healthcare, Regulatory and Reimbursement Landscape - Russia". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Russia. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical devices markets. It is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData's team of industry experts.

Russia's population decreased at a CAGR of 0.1% between 2005 and 2010. As in most developed countries, the population contains a high proportion of elderly people, with approximately 13.2% of the population above the age of 65 years in 2010. The disease burden associated with this large elderly population is expected to boost growth in the pharmaceutical market, although hinder growth in the economy at the same time. Russia's pharmaceutical market is one of the fastest growing markets in the world, and was valued at approximately $18.7 billion in 2010, having grown at a CAGR of 23% from 2005. The medical device market is one of the most stable industries in the healthcare sector. The main segments in 2010 were diagnostic imaging, ophthalmic devices, cardiovascular devices, in vitro diagnostics and diabetes care devices.

The positive trends in the healthcare market can be attributed primarily to -

• Large elderly population
• Increased government spending
• Government initiatives focusing on the prevention and management of chronic diseases
• Government efforts to simplify regulatory guidelines
• Increased prevalence of non-communicable diseases

Scope

The report provides information on the healthcare, regulatory and reimbursement landscape, and its scope includes -

• Overview of the pharmaceutical and medical devices markets, including size, segmentation, and key drivers and barriers.
• Profiles and SWOT analysis of the major players in the pharmaceutical and medical device markets.
• Insightful review of the reimbursement and regulatory landscape, including details of the reimbursement process, regulatory agencies, and approval processes for new drugs and medical devices.
• A detailed analysis of the political and economic environment, including economic indicators, demographics, healthcare infrastructure and healthcare expenditure.
• An overview of the opportunities for and challenges to growth in the healthcare market.

Reasons to buy

The report comprehensively covers both the pharmaceutical and the medical device markets. It will enhance your decision-making capability and allow you to -

• Develop business strategies by understanding the trends shaping and driving the healthcare market in Russia.
• Drive revenues by understanding the key trends, reimbursement and regulatory policies, and pharmaceutical and medical devices market segments and companies likely to impact the healthcare market in future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of the main competitors.
• Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnerships.
• Identify, understand and capitalize on the opportunities and challenges in the healthcare market.

Table of Contents

TOC

1 Table of Contents

1 Table of Contents 5

• 1.1 List of Tables 7
• 1.2 List of Figures 9

2 Introduction 11

• 2.1 Report Guidance 11

3 Overview of the Pharmaceutical and Medical Device Market 12

• 3.1 Pharmaceutical Market 12
• 3.1.1 Market Overview 12
• 3.1.2 Supply Channels 16
• 3.1.3 Market Segments 18
• 3.1.4 Major Therapeutic Areas 19
• 3.1.5 Major Players 26
• 3.2 Medical Device Market 49
• 3.2.1 Market Overview 49
• 3.2.2 Overview of Top Five Segments 51
• 3.2.3 Major Players 61
• 3.3 Market Drivers and Barriers 81
• 3.3.1 Drivers 81
• 3.3.2 Barriers 82

4 Market Access 84

• 4.1 Reimbursement and Payer Landscape 84
• 4.1.1 Overview of Healthcare System 84
• 4.1.2 Reimbursement Process 86
• 4.1.3 Overview of Insurance Providers 88
• 4.1.4 Patient Share in Healthcare Spending 90
• 4.1.5 Drug Price Trends 91
• 4.1.6 Pricing Policies 91
• 4.2 Regulatory Landscape 91
• 4.2.1 Overview of Regulatory Agencies 91
• 4.2.2 New Drug Approval Process 92
• 4.2.3 New Device Approval Process 94
• 4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 95
• 4.2.5 Licensing Process for Pharmaceutical Exports and Imports 95
• 4.2.6 Intellectual Property Rights 96
• 4.2.7 Clinical Trial Regulations 96
• 4.2.8 Pharmaceutical Advertising Regulations 97
• 4.2.9 Labeling and Packaging Regulations 98

5 Country Analysis 99

• 5.1 Political Environment 99
• 5.1.1 Political Structure 99
• 5.1.2 Analysis of Current Political Environment 100
• 5.1.3 Healthcare Policy Initiatives 102
• 5.2 Economic Landscape 104
• 5.3 Economic Indicators 105
• 5.3.1 Gross Domestic Product 105
• 5.3.2 Gross National Income 108
• 5.3.3 Inflation 108
• 5.3.4 Currency Exchange Rate 112
• 5.3.5 Foreign Direct Investment 113
• 5.3.6 Foreign Exchange Reserves 114
• 5.3.7 Trade Balance 114
• 5.3.8 Government Structural Balance 117
• 5.3.9 Government Gross Debt 119
• 5.3.10 Major Industries 121
• 5.4 Demographics 122
• 5.4.1 Population 122
• 5.4.2 Education and Literacy 140
• 5.4.3 Employment 141
• 5.4.4 Disease Burden 144
• 5.5 Healthcare Infrastructure 146
• 5.5.1 Healthcare Facilities 146
• 5.5.2 Healthcare Parameters 153
• 5.5.3 Healthcare Personnel 161
• 5.6 Healthcare Expenditure 162
• 5.6.1 Overview 162
• 5.6.2 Major Components of Healthcare Spending 164
• 5.6.3 Share of Public and Private Sectors 165
• 5.6.4 Spending on Pharmaceutical R&D 166
• 5.7 Trade Associations 166
• 5.7.1 Association of Russian Pharmaceutical Manufacturers 166
• 5.7.2 Association of International Pharmaceutical Manufacturers 166
• 5.7.3 Russian Association of Pharmaceutical Marketing 166
• 5.8 Trade Fairs 167

6 Opportunities and Challenges 168

• 6.1 Opportunities 168
• 6.2 Challenges 168

7 Appendix 170

• 7.1 Abbreviations 170
• 7.2 Bibliography 172
• 7.3 Methodology 176
• 7.3.1 Coverage 176
• 7.3.2 Secondary Research 177
• 7.3.3 Forecasting 177
• 7.3.4 Primary Research 177
• 7.3.5 Expert Panel Validation 178
• 7.4 Contact Us 178
• 7.5 Disclaimer 178

List of Tables

1.1 List of Tables

• Table 1: Pharmaceutical Market ($bn), Russia, 2005-2010 12
• Table 2: Pharmaceutical Market ($bn), Russia, Forecast, 2011-2020 13
• Table 3: Sources of Pharmaceuticals, Russia, Share (%), 2008-2010 14
• Table 4: Innovative and Generic Products, Russia, Market Share (%), 2007 15
• Table 5: Wholesaler Mark-ups (%), Various Countries, 2008 17
• Table 6: Cardiovascular Disease, Russia, Economic Burden ($bn), 2005-2010 20
• Table 7: Structure of Economic Burden of Cardiovascular Disease, Russia, Share (%), 2009 21
• Table 8: Causes of Mortality among People with Type 1 Diabetes, Russia, 2007 22
• Table 9: Causes of Mortality among People with Type 2 Diabetes, Russia, 2007 23
• Table 10: Patients with Mental and Behavior Disorders (Per 100,000 Population), Russia, 2010 25
• Table 11: Major Products, Novartis, Global, Revenue ($m), 2011 26
• Table 12: Planned Filings, Novartis, 2012 to ≥ 2016 27
• Table 13: Major Products, Pharmstandard, Revenue ($m), 2011 32
• Table 14: Major Products, Bayer AG, Global, Revenue ($m), 2011 36
• Table 15: Late-stage Pipeline, Bayer AG, 2011 36
• Table 16: Major Products, Servier, 2011 42
• Table 17: Major Products, Berlin-Chemie/Menarini, 2011 45
• Table 18: Pipeline, Menarini, 2011 46
• Table 19: Medical Device Market ($bn), Russia, 2005-2010 50
• Table 20: Medical Device Market ($bn), Russia, Forecast, 2011-2020 50
• Table 21: Medical Device Market, Russia, Segment Share (%), 2010 51
• Table 22: Diagnostic Imaging Market ($m), Russia, 2005-2010 52
• Table 23: Sales Trends for Major Players*, Diagnostic Devices, Russia, 2005-2010 53
• Table 24: Ophthalmic Devices Market ($m), Russia, 2005-2010 54
• Table 25: Sales Trends for Major Players*, Ophthalmic Devices, Russia, 2010 55
• Table 26: Cardiovascular Devices Market ($m), Russia, 2005-2010 56
• Table 27: Sales Trends for Major Players*, Cardiovascular Devices, Russia, 2010 57
• Table 28: In Vitro Diagnostics Market ($m), Russia, 2005-2010 58
• Table 29: Sales Trends for Major Players*, In Vitro Diagnostics, Russia, 2010 59
• Table 30: Diabetes Care Devices Market ($m), Russia, 2005-2010 60
• Table 31: Sales Trends for Major Players*, Diabetes Care Devices, Russia, 2010 61
• Table 32: Major Medical Device Companies, Russia, Revenue ($m), 2010 61
• Table 33: Major Products, Medtronic, Global, Revenue ($m), 2011 62
• Table 34: Major Products, Siemens, Global, Revenue ($m), 2012 70
• Table 35: Major Products, Philips Healthcare, 2012 78
• Table 36: Reimbursement Drug Lists, Russia, 2011 87
• Table 37: Healthcare Spending, Russia, Patient Share (%), 2005-2010 90
• Table 38: Medical Equipment Classification, Russia, 2011 94
• Table 39: GDP Per Capita ($), Russia, 2005-2010 105
• Table 40: GDP Per Capita ($), Russia, Forecast, 2011-2020 106
• Table 41: GDP, Russia, Annual Growth (%), 2005-2010 107
• Table 42: GDP, Russia, Annual Growth (%), Forecast, 2011-2020 107
• Table 43: GNI Per Capita ($), Russia, 2005-2010 108
• Table 44: Average Consumer Price Index, Russia, 2005-2010 109
• Table 45: Consumer Price, Russia, Annual Change (%), 2005-2010 110
• Table 46: Average Consumer Price, Russia, Annual Change (%), Forecast, 2011-2020 111
• Table 47: Currency Exchange Rate (RUB/$), Russia, 2005-2010 112
• Table 48: Foreign Direct Investment ($bn), Russia, 2005-2010 113
• Table 49: Foreign Exchange Reserves ($bn), Russia, 2005-2010 114
• Table 50: Imports ($bn), Russia, 2005-2010 115
• Table 51: Exports ($bn), Russia, 2005-2010 116
• Table 52: General Government Structural Balance ($bn), Russia, 2005-2010 117
• Table 53: General Government Structural Balance ($bn), Russia, 2011-2020 118
• Table 54: General Government Gross Debt ($bn), Russia, 2005-2010 119
• Table 55: General Government Gross Debt ($bn), Russia, 2011-2020 120
• Table 56: Major Industries, Russia, Production ($bn), 2010 121
• Table 57: Population (m), Russia, 2005-2010 123
• Table 58: Population (m), Russia, Forecast, 2011-2020 124
• Table 59: Urban and Rural Population, Russia, Share (%), 2005-2010 125
• Table 60: Urban and Rural Population, Russia, Share (%), Forecast, 2011-2020 126
• Table 61: Age Groups, Russia, Population Distribution (%), 2005-2010 127
• Table 62: Age Groups, Russia, Population Distribution (%), Forecast, 2011-2020 128
• Table 63: Births (Per 1,000 Population), Russia, 2005-2010 129
• Table 64: Births (Per 1,000 Population), Russia, Forecast, 2011-2020 130
• Table 65: Mortality (Per 1,000 Population), Russia, 2005-2010 131
• Table 66: Mortality (Per 1,000 Population), Russia, Forecast, 2011-2020 132
• Table 67: Major Causes of Mortality ('000s), Russia, 2008 133
• Table 68: Children <5 Years, Russia, Mortality (Per 1,000 Live Births), 2005-2010 134
• Table 69: Immunization Rate (%), Russia, 2005-2010 135
• Table 70: Major Causes of Male Mortality ('000s), Russia, 2008 136
• Table 71: Major Causes of Female Mortality ('000s), Russia, 2008 137
• Table 72: Gender Ratio (M/F), Russia, 2005-2010 138
• Table 73: Life Expectancy at Birth (Years), Russia, 2005-2010 139
• Table 74: Life Expectancy at Birth (Years), Russia, Forecast, 2011-2020 140
• Table 75: Students ('000s), Russia, 2005-2010 141
• Table 76: Unemployment Rate (%), Russia, 2005-2010 142
• Table 77: Employees, Russia, Segment Share (%), 2008 143
• Table 78: Major Diseases, Russia, Incidence ('000s), 2008 144
• Table 79: Major Diseases, Russia, Disability-adjusted Life Years (Per 100,000 Population), 2004 145
• Table 80: Hospitals, Russia, 2005-2010 146
• Table 81: Out-patient Clinics, Russia, 2005-2010 147
• Table 82: Out-patient Clinics, Russia, Urban-Rural, 2005-2010 148
• Table 83: Dental Clinics, Russia, 2005-2010 149
• Table 84: Public Hospitals, Russia, 2005-2010 150
• Table 85: Private Hospitals, Russia, 2005-2010 151
• Table 86: Hospital Beds by Specialization ('000s), Russia, 2010 152
• Table 87: Beds (Per 1,000 Population), Russia, 2005-2010 153
• Table 88: Physicians (Per 1,000 Population), Russia, 2005-2010 154
• Table 89: Physicians by Specialization ('000s), Russia, 2010 155
• Table 90: Deaths Attributed to the Environment (Per 100,000 Population), Russia, 2004 156
• Table 91: Common Air Pollutants (Million Tons), Russia, 2005-2010 157
• Table 92: PM10 (micrograms per cubic meter), Russia, 2005-2010 158
• Table 93: CO2 Emissions (Million Tons), Russia, 2005-2010 159
• Table 94: Organic Water Pollutant Emissions (Metric Tons Per Day), Russia, 2005-2010 160
• Table 95: Healthcare Personnel, Russia, Share (%), 2010 161
• Table 96: Healthcare Expenditure (% of GDP), Russia, 2005-2010 162
• Table 97: Healthcare Expenditure (% of GDP), Russia, 2011-2020 163
• Table 98: Healthcare Expenditure, Russia, Share of Major Components (%), 2007 164
• Table 99: Healthcare Expenditure, Russia, Public-Private Share (%), 2005-2010 165
• Table 100: Major Healthcare Trade Fairs, Russia 167

List of Figures

1.2 List of Figures

• Figure 1: Pharmaceutical Market ($bn), Russia, 2005-2010 12
• Figure 2: Pharmaceutical Market ($bn), Russia, Forecast, 2011-2020 13
• Figure 3: Sources of Pharmaceuticals, Russia, Share (%), 2008-2010 14
• Figure 4: Innovative and Generic Products, Russia, Market Share (%), 2007 15
• Figure 5: Distribution Channels, Russia, 2011 16
• Figure 6: Wholesaler Mark-ups (%), Various Countries, 2008 17
• Figure 7: Cardiovascular Disease, Russia, Economic Burden ($bn), 2005-2010 20
• Figure 8: Structure of Economic Burden of Cardiovascular Disease, Russia, Share (%), 2009 21
• Figure 9: Causes of Mortality among People with Type 1 Diabetes, Russia, 2007 22
• Figure 10: Causes of Mortality among People with Type 2 Diabetes, Russia, 2007 23
• Figure 11: Patients with Mental and Behavior Disorders (Per 100,000 Population), Russia, 2010 25
• Figure 12: Medical Device Market ($bn), Russia, 2005-2010 49
• Figure 13: Medical Device Market ($bn), Russia, Forecast, 2011-2020 50
• Figure 14: Medical Device Market, Russia, Segment Share (%), 2010 51
• Figure 15: Diagnostic Imaging Market ($m), Russia, 2005-2010 52
• Figure 16: Sales Trends for Major Players*, Diagnostic Devices, Russia, 2005-2010 53
• Figure 17: Ophthalmic Devices Market ($m), Russia, 2005-2010 54
• Figure 18: Sales Trends for Major Players*, Ophthalmic Devices, Russia, 2005-2010 55
• Figure 19: Cardiovascular Devices Market ($m), Russia, 2005-2010 56
• Figure 20: Sales Trends for Major Players*, Cardiovascular Devices, Russia, 2005-2010 57
• Figure 21: In Vitro Diagnostics Market ($m), Russia, 2005-2010 58
• Figure 22: Sales Trends for Major Players*, In Vitro Diagnostics, Russia, 2005-2010 59
• Figure 23: Diabetes Care Devices Market ($m), Russia, 2005-2010 60
• Figure 24: Sales Trends for Major Players*, Diabetes Care Devices, Russia, 2005-2010 60
• Figure 25: Major Medical Device Companies, Russia, Revenue ($m), 2010 61
• Figure 26: Drivers and Barriers, Healthcare Market, Russia, 2012 83
• Figure 27: Organizational Structure of the Healthcare System, Russia, 2011 85
• Figure 28: Health Service Financing, Russia, 2011 86
• Figure 29: Inclusion Process for Reimbursement List, Russia, 2011 88
• Figure 30: Healthcare Spending, Russia, Patient Share (%), 2005-2010 90
• Figure 31: New Drug Approval Process, Russia, 2011 93
• Figure 32: Political System, Russia, 2012 100
• Figure 33: Pharma-2020 Strategy, Russia, 2009 103
• Figure 34: GDP Per Capita ($), Russia, 2005-2010 105
• Figure 35: GDP Per Capita ($), Russia, Forecast, 2011-2020 106
• Figure 36: GDP, Russia, Annual Growth (%), 2005-2010 106
• Figure 37: GDP, Russia, Annual Growth (%), Forecast, 2011-2020 107
• Figure 38: GNI Per Capita ($), Russia, 2005-2010 108
• Figure 39: Average Consumer Price Index, Russia, 2005-2010 109
• Figure 40: Consumer Price, Russia, Annual Change (%), 2005-2010 110
• Figure 41: Average Consumer Price, Russia, Annual Change (%), Forecast, 2011-2020 111
• Figure 42: Currency Exchange Rate (RUB/$), Russia, 2005-2010 112
• Figure 43: Foreign Direct Investment ($bn), Russia, 2005-2010 113
• Figure 44: Foreign Exchange Reserves ($bn), Russia, 2005-2010 114
• Figure 45: Imports ($bn), Russia, 2005-2010 115
• Figure 46: Exports ($bn), Russia, 2005-2010 116
• Figure 47: General Government Structural Balance ($bn), Russia, 2005-2010 117
• Figure 48: General Government Structural Balance ($bn), Russia, 2011-2020 118
• Figure 49: General Government Gross Debt ($bn), Russia, 2005-2010 119
• Figure 50: General Government Gross Debt ($bn), Russia, 2011-2020 120
• Figure 51: Major Industries, Russia, Production ($bn), 2010 121
• Figure 52: Population (m), Russia, 2005-2010 123
• Figure 53: Population (m), Russia, Forecast, 2011-2020 124
• Figure 54: Urban and Rural Population, Russia, Share (%), 2005-2010 125
• Figure 55: Urban and Rural Population, Russia, Share (%), Forecast, 2011-2020 126
• Figure 56: Age Groups, Russia, Population Distribution (%), 2005-2010 127
• Figure 57: Age Groups, Russia, Population Distribution (%), Forecast, 2011-2020 128
• Figure 58: Births (Per 1,000 Population), Russia, 2005-2010 129
• Figure 59: Births (Per 1,000 Population), Russia, Forecast, 2011-2020 130
• Figure 60: Mortality (Per 1,000 Population), Russia, 2005-2010 131
• Figure 61: Mortality (Per 1,000 Population), Russia, Forecast, 2011-2020 132
• Figure 62: Major Causes of Mortality ('000s), Russia, 2008 133
• Figure 63: Children <5 Years Age, Russia, Mortality (Per 1,000 Live Births), 2005-2010 134
• Figure 64: Immunization Rate (%), Russia, 2005-2010 135
• Figure 65: Major Causes of Male Mortality ('000s), Russia, 2008 136
• Figure 66: Major Causes of Female Mortality ('000s), Russia, 2008 137
• Figure 67: Gender Ratio (M/F), Russia, 2005-2010 138
• Figure 68: Life Expectancy at Birth (Years), Russia, 2005-2010 139
• Figure 69: Life Expectancy at Birth (Years), Russia, Forecast, 2011-2020 140
• Figure 70: Students ('000s), Russia, 2005-2010 141
• Figure 71: Unemployment Rate (%), Russia, 2005-2010 142
• Figure 72: Employees, Russia, Segment Share (%), 2008 143
• Figure 73: Major Diseases, Russia, Incidence ('000s), 2008 144
• Figure 74: Major Diseases, Russia, Disability-adjusted Life Years (Per 100,000 Population), 2004 145
• Figure 75: Hospitals, Russia, 2005-2010 146
• Figure 76: Out-patient Clinics, Russia, 2005-2010 147
• Figure 77: Out-patient Clinics, Russia, Urban-Rural, 2005-2010 148
• Figure 78: Dental Clinics, Russia, 2005-2010 149
• Figure 79: Public Hospitals, Russia, 2005-2010 150
• Figure 80: Private Hospitals, Russia, 2005-2010 151
• Figure 81: Hospital Beds by Specialization ('000s), Russia, 2010 152
• Figure 82: Beds (Per 1,000 Population), Russia, 2005-2010 153
• Figure 83: Physicians (Per 1,000 Population), Russia, 2005-2010 154
• Figure 84: Physicians by Specialization ('000s), Russia, 2010 155
• Figure 85: Deaths Attributed to the Environment (Per 100,000 Population), Russia, 2004 156
• Figure 86: Common Air Pollutants (Million Tons), Russia, 2005-2010 157
• Figure 87: PM10 (Microgram Per Cubic Meter), Russia, 2005-2010 158
• Figure 88: CO2 Emissions (Million Tons), Russia, 2005-2010 159
• Figure 89: Organic Water Pollutant Emissions (Metric Tons Per Day), Russia, 2005-2010 160
• Figure 90: Healthcare Personnel, Russia, Share (%), 2010 161
• Figure 91: Healthcare Expenditure (% of GDP), Russia, 2005-2010 162
• Figure 92: Healthcare Expenditure (% of GDP), Russia, 2011-2020 163
• Figure 93: Healthcare Expenditure, Russia, Share of Major Components (%), 2007 164
• Figure 94: Healthcare Expenditure, Russia, Public-Private Share (%), 2005-2010 165
• Figure 95: Opportunities and Challenges, Healthcare Market, Russia, 2012 169

Healthcare, Regulatory and Reimbursement Landscape Russia published by GlobalData in June 18, 2012. This report consists of Pages: 178 and the price starts from US $ 1995.